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INFECTION PREVENTION AND CONTROL ESSENTIALS FOR AMBULATORY CARE A RESOURCE WORKBOOK

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Page 1: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

INFECTION PREVENTION AND CONTROL ESSENTIALS FOR

AMBULATORY CAREA RESOURCE WORKBOOK

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Table of Contents

Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

MODULE 1: Infection Preventionist’s Role in Ambulatory Care . . . . . . . . 4

MODULE 2: Infection Prevention & Control Plan/Risk Assessments . . . 11

MODULE 3: Infection Prevention & Control Basics . . . . . . . . . . . . . . . . . . . 78

MODULE 4: Epidemiology & Infectious Diseases . . . . . . . . . . . . . . . . . . . . 117

MODULE 5: Occupational-Employee Health . . . . . . . . . . . . . . . . . . . . . . . . 118

MODULE 6: Construction & Water Management . . . . . . . . . . . . . . . . . . . .127

MODULE 7: Environmental Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

MODULE 8: Cleaning/Disinfection/Sterilization . . . . . . . . . . . . . . . . . . . . 156

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Acknowledgements

Development of this Workbook required input and expertise from a team of subject matter experts who selected and organized the materials from a range of facilities and other resources . The Association for Professionals in Infection Control and Epidemiology acknowledges the valuable contributions from the following individuals:

Contributors

Judie Bringhurst, RN, MSN, CICInfection Preventionist and Instrument Reprocessing SpecialistUniversity of North Carolina HospitalsChapel Hill, NC

Pamela S . Falk, MPH, CIC, FAPIC, FSHEAEpidemiologistNorthside HospitalSandy Springs, GA

Carolyn Kiefer, BSN, RN, CICInfection PreventionistCarilion Medical CenterRoanoke, VA

Carol McLay, DrPH, MPH, RN, CIC, FAPICCEOInfection Control InternationalLexington, KY

Sara Townsend, MS, HQS, CIC, FAPICInfection Prevention ManagerChildren’s Hospital of PhiladelphiaPhiladelphia, PA

Project Management

Elizabeth M .R . HartkeDirector, Practice ResourcesAssociation for Professionals in Infection Control and Epidemiology

Elizabeth GarmanVice President, Communications and Practice ResourcesAssociation for Professionals in Infection Control and Epidemiology

Groff CreativeCover Design, Text Design and LayoutSilver Spring, MD

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Module 1

Infection Preventionist’s Role in Ambulatory Care

Contents

1.1 Emerging Models of Ambulatory Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Constance Cutler, RN, MS, CIC, FSHEA, FAPIC; Jill Lindmair-Snell, MSN, RN, CIC, FAPIC, and Brian Dennen, MBA, AIA, NCARB Prevention Strategist, Winter 2018, p .56-60https://apic .org/publication_types/prevention-strategist/

1.2 Infection Control Compliance Rounding Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Forms & Checklists for Infection Prevention, Volume 1

Resources

Infection Preventionist Competency ModelAssociation for Professionals in Infection Control and Epidemiology (APIC)https://apic .org/professional-practice/infection-preventionist-ip-competency-model/

One and Only CampaignCenters for Disease Control and Prevention (CDC)https://www .cdc .gov/injectionsafety/1anonly .html

Bloodborne Pathogen and Needlestick PreventionOccupational Safety and Health Administration (OSHA)https://www .osha .gov/SLTC/bloodbornepathogens/gen_guidance .html

Healthcare-Associated Infections in Outpatient SettingsCDChttps://www .cdc .gov/hai/settings/outpatient/outpatient-settings .html

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FEATURE

Emerging models of ambulatory care

BY CONSTANCE CUTLER, RN, MS, CIC, FSHEA, FAPIC, JILL LINDMAIR-SNELL, MSN, RN, CIC, FAPIC, AND BRIAN DENNEN, MBA, AIA, NCARB

I t used to be that an infection preventionist (IP) was responsible for only one location, usually a hospital, but now they have more than one outpatient venue because of acquisitions and mergers.

Those days are coming to an end as healthcare evolves in new ways with many outpatient facilities now under the IP’s umbrella. If your facility is similar to the authors’, you may have an outpatient pain clinic, cancer care center, immediate/urgent care facility(ies), owned physician offices, offsite endoscopy procedure site, and an ambula-tory surgery center, as well as others. All provide new opportunities and challenges, which this article will address to give you an idea how to start and what resources are able to assist you.

Healthcare data show increasing shifts from inpatient to outpatient care.1 Figure 1 illustrates this trend, which is predicted to continue into at least the next 10 years. As healthcare facilities compete on value not volume, there are six market forces driving this change (Figure 2):11. Compression 2. Care management 3. Contraction 4. Consolidation 5. Consumerism 6. Connectivity

There is also a change in all specialties for which patients will be treated as outpatients, ranging from a slight increase (5.6 per-cent) in colorectal patients to a substantial

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increase (44.4 percent) in hematology oncol-ogy patients.1 Studies show that revenue derived from outpatients is rising dramati-cally, as compared to inpatient revenue.2

Outpatient ophthalmology and colorec-tal surgeons’ offices have also been impli-cated in disease transmission, as shown in these headlines (Figure 3) that show some occurrences, including a shocking one where anal catheters were reused in 2018.

Now that the stage is set for our shift-ing focus as IPs, we can prepare to take on these new arenas. To start, do your research on historic outbreaks when care was mostly provided to inpatients.

PATIENT-TO-PATIENT TRANSMISSION

As recently as the 1970s, outpatient hemodialysis centers saw clusters of cases of both hepatitis B and C occurring at their free-standing centers. These were addressed by recommendations from the Centers for Disease Control and Prevention (CDC) and other agencies to do blood testing and use separate cleaning protocols and machines on known positive patients. Thankfully, in recent years the numbers of these blood-borne pathogens in dialysis patients have decreased with improved oversight by both dialysis personnel and IPs. Dialysis cen-ter issues haven’t completely disappeared, though. An article reviewing hepatitis B virus (HBV) in dialysis centers summarized several outbreaks that occurred from 1992 through 2014. There were 16 outbreaks that involved 118 patients on maintenance dialysis; 10 fatal cases occurred; multiple deficiencies in standard or hemodialysis-specific procedures was the most common route of patient-to-patient transmission of HBV.3

A survey of clinicians found that 12 percent of physicians and 3 percent of nurses indicated syringe reuse occurs in their workplace.4 This, along with other surprising and depressing results, led the CDC to develop the “One Needle, One Syringe, One Time” Campaign.

AMBULATORY SURGICAL CENTERS

An assessment performed by the Centers for Medicare & Medicaid Services (CMS) of ambulatory surgical centers (ASCs)

WHAT CAN AN IP DO?• Review what kind of issues have occurred in the past and with what frequency.• Make the business case that it is “potentially” scary out there but that regular

visits from a qualified IP can mitigate the real risks. • Go out and see for yourself what’s actually happening, focusing first on the

riskiest areas: - Those performing sterilization of instruments. - Those doing high-level disinfection. - The others “just” providing routine patient care such as using syringes.

Figure 1. Increasing shift to outpatient care. Adapted from Truven Market Expert. 2017-2027 Total US Market.1

Figure 2. Six types of market forces. Adapted from Truven Market Expert. 2017-2027 Total US Market.1

Figure 3. Infection prevention headlines. Adapted from Truven Market Expert. 2017-2027 Total US Market.1

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showed that practices in those increas-ingly prevalent areas also pose infection prevention risks, leading to a specialization in ASCs for IPs.5 The actual pilot survey is summarized in Figure 4.

ASCs pose unique challenges and an IP may take on responsibility for them, specializing in them. The concept of hav-ing surgery and going home on the same day started in 1970, when two physicians opened the first freestanding ASC in Phoenix.6 Surgery in an ASC offers patients a cost-effective and convenient alternative to surgery in a hospital setting. As of 2017, there were approximately 5,500 Medicare-certified ASCs in the United States.7 The shift continues from inpatient to outpa-tient as CMS adds to the 3,500 procedures approved for payment in an ASC.6 Surgeries that were typically scheduled in hospital operating rooms are being performed in ASCs. In January 2018, CMS no longer required total knee replacement surgery to be performed only in an inpatient setting.8

Since CMS reimburses for surgical pro-cedures, there is an expectation that ASCs follow CMS’s Conditions for Coverage (CfC). In 2009, CMS enhanced the CfC by adding specific requirements for an IPC program in an ASC.9 The ASC infection control surveyor worksheet (ICSW) is an 18-page document that assists the CMS

surveyor in evaluating healthcare practices during an onsite visit.10 The surveyor will observe at least one surgical procedure and follow a patient from registration through discharge.10 The ICSW will be used to obtain details about the facility includ-ing the types of procedures performed, number of procedural rooms, types of contracted or employed services, hand hygiene, medication practices, cleaning and reprocessing of reusable medical devices, environmental cleaning, point of care testing, and the infection prevention program.10 The surveyor will interview or perform observations to acquire enough information to complete the worksheet; however, if a breach in IPC practices is noted, the breach will be documented.10

Infection prevention has become more important as the number of complex sur-gical procedures that are performed in ambulatory settings increases. If the IP has not previously worked in a periopera-tive setting, they may not feel comfortable with the environment. It is vital for the IP to inquire and learn about all processes within the ASC. Additionally, to be effec-tive, the IP must develop relationships with anesthesia providers, surgeons, surgical techs, nursing, sterile processing, environ-mental services, facilities, nursing, and leadership. The IP can use the ICWS to

make sure the ASC is prepared for a regula-tory visit any time. In addition to the work-sheet, the IP should establish and maintain an environmental rounding program. A multi-disciplinary team can examine the center for potential patient safety and infection prevention concerns. The team should observe medication administra-tion in all areas: aseptic technique, surgi-cal procedures, cleaning of patient care items, reprocessing of medical equipment including transporting, decontaminating, and sterilizing of surgical instruments. Observing these practices can assist the IP in creating a prioritized risk assessment to develop a successful IPC program plan.

MICROHOSPITALMicrohospitals, sometimes known as

neighborhood hospitals, are an emerging model of care delivery. Components of a microhospital typically include 8-12 emergency department rooms, a similar count of inpatient beds, and limited diag-nostics; they often incorporate procedural and medical office space as well (Figure 5). The characteristics of some health systems that have built microhospitals can be seen in Figure 6. These facilities are typically located in suburban and exurban areas and are predominantly in states without certif-icate-of-need regulations. Many facilities

FEATURE

Figure 4. Summary of ASC pilot survey findings. Adapted from Truven Market Expert. 2017-2027 Total US Market.1

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share resources, including IPs, with their parent organization.

HOSPITAL AT HOMEAnother concept which is taking hold

is called “hospital at home.” My 90-year-old mother may benefit from this in the near future because she travels to and from physician visits, and an inpatient stay could become unnecessary if this becomes more prevalent. I know she would prefer to receive care this way. These “hospital at home” programs provide hospital-level care and monitoring and lead to quick recovery at a lower cost. To take part in this concept, a patient would be “admitted” from the emergency department and transported home by ambulance, then met there by a nurse with equipment who would provide daily physical rounding.11

METHODOLOGYThe decisions of healthcare networks to

move care outside the four walls of the hos-pital are strategic to increase market share or locations in far-flung areas. The strate-gies shown in Figure 7 display the method-ical approach health systems follow.

An article published in the American Journal of Infection Control describes a

Figure 5. Components of aa microhospital. Adapted from Truven Market Expert. 2017-2027 Total US Market.1

Figure 7. Methodical approach to health systems. Adapted from Truven Market Expert. 2017-2027 Total US Market.1

Figure 6. Health systems with microhospitals. Adapted from Truven Market Expert. 2017-2027 Total US Market.1

www.apic.org | 59

ST. VINCENT (Indianapolis)

ST. LUKE’S HEALTH SYSTEM (Kansas City)

BAYLOR SCOTT & WHITE HEALTH (Dallas)

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systematic approach to determine how a healthcare system has changed, or would need to change, the staffing models for IPs and support staff required to build and sustain effective IPC programs.12

The challenges may seem insurmount-able, especially to a novice IP, but doing your homework and making the business case for increased resources are good first steps. Physically going to see these outpa-tient/ambulatory facilities is the key, and prioritization based on a risk assessment of infection transmission will assist in break-ing this down into manageable steps.

It’s possible to survive and thrive because of growing needs for IPC expertise in the current and future healthcare environ-ment. So, what resources does the IP have when facing shifting focus from inpatient to outpatient? Fortunately, there are many, with more coming out from a variety of sources all the time.

These areas are all surveyed by accred-iting agencies, and even accrediting bod-ies such as The Joint Commission have developed, and are developing, publica-tions to assist the IP.13 A potential concern

I do have, because patients do not always understand the definition of surgical site infections or other HAIs, is if the agency includes the following question in its sur-vey of outpatient and ambulatory surgery centers: “At any time after leaving the facil-ity, did you have any signs of infection?”

There’s no need to reinvent the wheel, just educate yourself by attending courses especially designed with a focus on ambu-latory surgery centers or other outpatient venues. The basic principles haven’t changed though. If it’s necessary to do for safe inpatient care, it’s necessary to do for safe outpatient care.

In conclusion, movement of care is hap-pening and will continue to occur in health systems and hospitals from inpatient to outpatient venues. My hope is that the IP will embrace this change and understand and be able to use the information and resources provided in this article to survive and thrive in this new world of outpatient and ambulatory healthcare.

Jill Lindmair-Snell, MSN, CIC, FAPIC, is a system infection prevention manager for Advocate Aurora Health where she is responsible for acute care and ambulatory surgery centers. Jill has more than 25 years of healthcare experience, with the last 11 years in infection prevention and control. She has a Master of Science in Nursing from the University of Phoenix.

Constance Cutler, RN, MS, CIC, FSHEA, FAPIC, spent 37 years as a hospital/healthcare system-based infection preventionist, and is now a consultant for Chicago Infection Control, Inc. She has worked in both large and small hospi-tals, many with extensive networks of outpatient/ambulatory sites. Connie is a former treasurer and board member on the Certification Board of Infection Control and Epidemiology, and past president of the Chicago Metropolitan Chapter of APIC. She has a Bachelor of Science in Nursing from Creighton University, a bachelor’s in biol-ogy from Villanova University, and a master’s in biology from Drexel University.

Brian Dennen, MBA, is a director with Ankura’s Healthcare Capital Asset Strategy team. He has served in senior positions in healthcare admin-istration and in project management of major capital initiatives. Brian works with national and regional health systems, academic medical

FEATURE

centers, physician practices, and other health-care clients on engagements ranging from broad strategic visioning to focused operational initia-tives. He has a Master of Business Administration from Northwestern University’s Kellogg School of Management and a Bachelor of Architecture from Iowa State University; he is a licensed architect in Illinois and a member of the National Council of Architectural Registration Boards.

References

1. Truven Market Expert. 2017-2027 Total US Market. Accessed September 2018.

2. American Hospital Association. Trendwatch Chartbook 2016: Trends Affecting Hospitals and Health Systems. https://www.aha.org/system/files/research/reports/tw/chartbook/2016/2016chartbook.pdf. Published 2016. Accessed September 2018.

3. Fabrizi F, Dixit V, Messa P, Martin P. Transmission of hepati-tis B virus in dialysis units: a systematic review of reports on outbreaks. Int J Artif Organs, 2015;38(1):1-7. doi:10.5301/ijao.5000376.

4. Kossover-Smith RA, Coutts K, Hatfield KM. One needle, one syringe, only one time? A survey of physician and nurse knowledge, attitudes, and practices around injection safety. Am J Infect Control, doi.org/10.1016/j.ajic.2017.04.292. Published June 2017. Accessed June 2018.

5. Schaefer MK, Jhung M, Dahl M, et al. Infection control assessment of ambulatory surgical centers. JAMA, 2010; 303(22):2273-9. doi: 10.1001/jama.2010.744.

6. Ambulatory Surgery Center Association. Ambulatory Surgery Centers: A Positive Trend in HealthCare. Published October 2011.

7. Rechtoris, M. 51 Things to Know About the ASC Industry. Becker’s ASC Review. https://www.beckersasc.com/asc-turnarounds-ideas-to-improve-performance/50-things-to-know-about-the-asc-industry-2017.html. Published February 2017. Accessed September 2018.

8. 2018 Final ASC Medicare Payment Rule Released. Ambulatory Surgery Center Association website. https://www.ascassociation.org/aboutus/latestnews/news-archive/newsarchive2017/latestnews112017/201711finalrule2018. Published November 2017. Accessed September 2018.

9. Temple, M. Chapter 64: Ambulatory Surgery Centers. In: Grota P, ed. APIC Text Online. APIC 2018.

10. Ambulatory Surgery Center Infection Control Surveyor Worksheet. Center for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-43.pdf. 2015.

11. Healthcare solutions: Hospital at home. Johns Hopkins University website. https://www.johnshopkinssolutions.com/solution/hospital-at-home/. Accessed October 2018.

12. Bartles R, Dickson A, Oluwatomiwa B. A systemic approach to quantifying infection prevention staffing and coverage needs. Am J Infect Control, 2018;46(5):487-91.

13. CDC Outpatient Settings Policy Options for Improving Infection Prevention. The Joint Commission website. https://www.jointcommission.org/cdc_outpa-tient_settings_policy_options_for_improving_infec-tion_prevention.aspx. Accessed September 2018.

Additional resources The Environment of Care and Healthcare-Associated Infections. (published by ASHE)

Guidelines for Design and Construction (published by Facility Guidelines Institute).

OSHA Bloodborne Pathogens and Needlestick Prevention Standard

CDC’s Guidelines Library: https://www.cdc.gov/infection-control/guidelines/index.html CDC’s Injection Safety: https://www.cdc.gov/injectionsafety/

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READ MORE ABOUT AMBULATORY CARE IN THE AMERICAN JOURNAL OF INFECTION CONTROLHealth care worker hand contamination at critical moments in outpatient care set-tings. Bingham J, Abell G, Kienast L, et al. Am J Infect Control, Vol. 44, Issue 11, p1198–1202.

Safe Injection Practices: Opportunities for Improvement in Ambulatory Care. Kuznets N, Lerner B, Davidson J. Am J Infect Control, Vol. 46, Issue 6, S4–S5.

A pragmatic approach to infection preven-tion and control guidelines in an ambula-tory care setting. Ng J, Le-Abuyen S, Mosley J, et al. Am J Infect Control, Vol. 42, Issue 6, p671–673.

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6-3. Infection Control Compliance Rounding Checklist

Compliance Rounding Check List: Infection Control

Date:

Location:

Individual(s)performingComplianceRounds:

Otherindividualspresent:

YES NO N/A Action Plan Owner

Patientroomsappearcleanandsanitary;freefromclutterandvisibledebris.

Alcoholbasedhandrubs(ABHR)nearpointofuse,inworkingorder,not

locatedoverelectricaloutlets/switchesandnotexpired.Soapdispenserand

towelsavailablenearsinks.

DisposableglovesandotherPPElocatedconventienttoareasofuse.

Datedsupplieswithinexpirationdates.

Sharpscontainerslessthan3/4fullandlocatednearpointofuse.

Cleanequipmentisstoredincleanarea,dirtyequipmentindesignatedsoiled

holdingareas(i.e.soiledutilityrooms).

Soiledlinenislocatedincontainedhampers/bagsandnotoverfilled.

Areafreefromvisibledustincludingfiresprinklerheadsandventgrills.

Patientcontactsurfacesaredisinfectedbetweenpatients.

Overheadlightsfreefromvisibleinsects,dustanddebris.

Floorscoveringsappeartobewellmaintainedinhallsandpublicareas.

Floorfinishappearstobewellmaintainedinpatientrooms,visiblyclean.

Patientequipmentcleanedanddisinfectedbetweeneachpatientuse.

Icemachineexteriorcomonentsvisiblycleanuponinspection.

Refrigeratorsclean,maintainedperpolicy.

Eyewashstationsvisiblyclean,maintainedperpolicy.

EVSclosetsclean,orderly.Floorsinkcleanedonregularbasis.

ReferenceDebbie Hurst, RN, BSN, CHESP, CIC

Forms & Checklists for Infection Prevention, Volume 1160

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Module 2

Infection Prevention & Control Plan/ Risk Assessments

Contents

2.1 Ambulatory Care Suite of Quick Observation Infection Prevention Tools . . . . . . . . . . . . . .13Centers for Disease Control and Prevention (CDC)https://www .cdc .gov/infectioncontrol/pdf/QUOTS/Ambulatory-Care-Suite-P .pdf

2.2 Tuberculosis (TB) Risk Assessment Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31CDC, Division of Tuberculosis Elimination

2.3 Risk Assessment for Infection Surveillance, Prevention and Control Programs in Ambulatory Healthcare Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

2.4 IPC Assessment Tool for Outpatient Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50CDC/HHS

2.5 A pragmatic approach to IPC guidelines in an ambulatory care setting . . . . . . . . . . . . . . 72Jessica Ng, MSc, CIC; Sheila Le-Abuyen, MPH, CPHI(C); Jane Mosley, MScN, RN; Michael Gardam, MD, MSc, CM, FRCPC, CICAmerican Journal of Infection Control, June 2014 Vol 42, Issue 6, p . 671-673https://www .ajicjournal .org/article/S0196-6553(14)00127-8/fulltext

2.6 Infection Prevention in a System of Ambulatory Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 75Sandy SmithPrevention Strategist, Fall 2019, p . 49-50https://rise .apic .org/web/apic/publications/issue .aspx?issueId=prevention_strategist_-_fall_2019&issueTitle=Prevention%20Strategist%E2%80%94Fall%202019

Resources

Outpatient Settings Policy Options for Improving Infection PreventionCDChttps://www .cdc .gov/hai/pdfs/prevent/Outpatient-Settings-Policy-Options .pdf

Infection Prevention Observation Tools Library Association for Professionals in Infection Control and Epidemiology (APIC) http://ipcobservationtools .site .apic .org/observation-tools-library

Tuberculosis Control in Healthcare Settings CDChttps://www .cdc .gov/tb/topic/infectioncontrol/TBhealthCareSettings .htm

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Tuberculosis Centers of ExcellenceCDChttps://www .cdc .gov/tb/education/tb_coe/default .htm

State Tuberculosis ResourcesCDChttps://www .cdc .gov/tb/links/tboffices .htm

National Tuberculosis Controllers Associationhttp://www .tbcontrollers .org

Find TB Resourceshttps://findtbresources .cdc .gov

Tuberculosis Screening, Testing, and Treatment of U.S. Health Care Personnel: Recommendations from the National Tuberculosis Controllers Association and CDC, 2019Lynn E . Sosa, MD; Gibril J . Njie, MPH; Mark N . Lobato, MD; et al . Morbidity and Mortality Weekly ReportMay 17, 2019; 68(19); 439-443https://www .cdc .gov/mmwr/volumes/68/wr/mm6819a3 .htm?s_cid=mm6819a3_w

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tion

Cate

gorie

sRo

om 1Ro

om 2Ro

om 3Ro

om 4Ro

om 5Su

mm

ary

of O

bser

vatio

ns

Yes

Tota

l Obs

erve

d

1Ar

e gl

oves

read

ily a

vaila

ble

outs

ide

each

pat

ient

room

or

any

poin

t of c

are?

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

2Ar

e co

ver g

owns

read

ily

avai

labl

e ne

ar e

ach

patie

nt

room

or p

oint

of c

are?

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

3Is

eye

pro

tect

ion

(face

shie

lds o

r go

ggle

s) re

adily

ava

ilabl

e ne

ar

each

pat

ient

room

or p

oint

of

care

?

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

4Ar

e fa

ce m

asks

read

ily a

vaila

ble

near

eac

h pa

tient

roo

m o

r poi

nt

of ca

re?

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

5Ar

e al

coho

l disp

ense

rs re

adily

ac

cess

ible

and

func

tioni

ng?

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

Tota

l YES

and

TO

TAL

OBS

ERVE

D

Stan

dard

Pre

caut

ions

: Obs

erva

tion

of

Pers

onal

Pro

tect

ive

Equi

pmen

t Pro

visio

nIn

stru

ctio

ns: O

bser

ve p

atie

nt c

are

area

s or a

reas

out

side

of p

atie

nt ro

oms.

For

eac

h ca

tego

ry, r

ecor

d th

e ob

serv

atio

n. In

the

colu

mn

on th

erig

ht,

sum

(acr

oss)

the

tota

l num

ber o

f “Ye

s” a

nd th

e to

tal n

umbe

r of o

bser

vatio

ns (“

Yes”

+ “

No”

). S

um a

ll ca

tego

ries (

dow

n) fo

r ove

rall

perf

orm

ance

.

AMB-

2

15

Page 16: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Date

:___

____

____

___

Obs

erve

r Rol

e:

Nur

se

Tech

O

ther

____

____

__

Initi

als:

____

__

Loca

tion/

Uni

t:___

____

____

_

Not

es a

nd co

mm

ents

:

Stan

dard

Pre

caut

ions

: Obs

erva

tion

of

Pers

onal

Pro

tect

ive

Equi

pmen

t Pro

visio

nAM

B-2

16

Page 17: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Isol

atio

n ro

om: O

bser

vatio

n Ca

tego

ries

Room 1

Room 2

Room 3

Sum

mar

y of

Obs

erva

tions

Yes

Tota

l “Y

es”&

“N

o”

1Is

an

isola

tion

sign

at th

e pa

tient

’s do

or?

Ye

s

No

Ye

s

No

Ye

s

No

2Ar

e gl

oves

ava

ilabl

e ou

tsid

e of

eac

h pa

tient

room

or

trea

tmen

t are

a?

Ye

s

No

N

/A

Ye

s

No

N

/A

Ye

s

No

N

/A

3Ar

e co

ver g

owns

ava

ilabl

e ne

ar e

ach

patie

nt ro

om

or tr

eatm

ent a

rea?

Ye

s

No

Ye

s

No

Ye

s

No

4Is

oth

er P

PE fo

r sta

ndar

dpr

ecau

tions

(e.g

., ey

e pr

otec

tion,

face

mas

ks) a

vaila

ble

near

eac

h pa

tient

ro

om o

r tre

atm

ent a

rea?

Ye

s

No

N

/A

Ye

s

No

N

/A

Ye

s

No

N

/A

5Ar

e su

rgic

al fa

ce m

asks

or f

ace

shie

lds

or N

95

resp

irato

rs a

vaila

ble

near

pat

ient

room

?

Ye

s

No

N

/A

Ye

s

No

N

/A

Ye

s

No

N

/A

6Is

dedi

cate

d pa

tient

equ

ipm

ent,

such

as s

teth

osco

pes

or b

lood

pre

ssur

e cu

ffs, a

vaila

ble?

Ye

s

No

Ye

s

No

Ye

s

No

TOTA

L (D

o no

t inc

lude

N/A

in to

tals)

Isol

atio

n: O

bser

vatio

n of

Are

a Ex

terio

r to

Cont

act I

sola

tion

Room

s

Inst

ruct

ions

: Obs

erve

are

asou

tsid

e of

isol

atio

n ro

oms.

Obs

erve

eac

h pr

actic

e an

d re

cord

the

obse

rvat

ion.

In th

e co

lum

n on

the

right

, sum

(acr

oss)

the

tota

l num

ber

of “

Yes”

and

the

tota

l num

ber o

f obs

erva

tions

(“Ye

s” +

“N

o”).

Sum

all

cate

gorie

s (d

own)

for o

vera

ll pe

rfor

man

ce. D

isreg

ard

not a

pplic

able

cate

gorie

s. F

or e

xam

ple,

co

ver g

owns

shou

ld b

e ou

tsid

e co

ntac

t pre

caut

ions

room

s, b

ut m

ay n

ot b

e re

quire

d ou

tsid

e a

room

with

airb

orne

isol

atio

n pr

ecau

tions

onl

y.

AMB-

3

17

Page 18: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Date

:___

____

____

___

Obs

erve

r Rol

e:

Nur

se

Tech

O

ther

____

____

__

Initi

als:

____

__

Loca

tion/

Uni

t:___

____

____

_

Not

es a

nd co

mm

ents

:

Isol

atio

n: O

bser

vatio

n of

Are

a Ex

terio

r to

Isol

atio

n Ro

oms

AMB-

3

18

Page 19: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Isol

atio

n ro

om: O

bser

vatio

n Ca

tego

ries

Room 1

Room 2

Room 3

Sum

mar

y of

Obs

erva

tions

Yes

Tota

l Obs

erve

d

1Is

an

Airb

orne

Infe

ctio

n Is

olat

ion

sign

at th

e pa

tient

’s do

or?

Ye

s

No

Ye

s

No

Ye

s

No

2Is

the

door

to th

e ro

om cl

osed

?

Yes

N

o

Yes

N

o

Yes

N

o

3Do

es a

man

omet

er o

r oth

er m

easu

rem

ent

mec

hani

sm in

dica

te n

egat

ive

pres

sure

in th

e ro

om?

Ye

s

No

Ye

s

No

Ye

s

No

4Ar

e ap

prop

riate

resp

irato

rs, (

N-9

5)in

mul

tiple

size

s an

d/or

cha

rged

, pow

ered

air

purif

ying

resp

irato

rs

(PAP

R), a

vaila

ble?

Ye

s

No

Ye

s

No

Ye

s

No

5Ar

e re

spira

tors

stor

ed o

utsid

e th

e ro

om o

r in

an

ante

room

?

Yes

N

o

Yes

N

o

Yes

N

o

Tota

l YES

and

TO

TAL

OBS

ERVE

D

Isol

atio

n: O

bser

vatio

n of

Are

a Ex

terio

r to

Airb

orne

In

fect

ion

Isol

atio

n Ro

oms

Inst

ruct

ions

: If t

here

are

any

pat

ient

s req

uirin

g Ai

rbor

ne In

fect

ion

Isol

atio

n on

uni

t, ob

serv

e ar

ea o

utsid

e of

eac

h is

olat

ion

room

. Obs

erve

eac

h pr

actic

e an

d re

cord

the

obse

rvat

ion.

In th

e co

lum

n on

the

right

, sum

(acr

oss)

the

tota

l num

ber o

f “Ye

s” a

nd th

e to

tal n

umbe

r of o

bser

vatio

ns (“

Yes”

+ “

No”

). S

um a

ll ca

tego

ries

(dow

n) fo

r ove

rall

perf

orm

ance

.

AMB-

4

19

Page 20: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Isol

atio

n: O

bser

vatio

n of

Are

a Ex

terio

r to

Airb

orne

Infe

ctio

n Is

olat

ion

Room

s

Date

:___

____

____

___

Obs

erve

r Rol

e:

Nur

se

Tech

O

ther

____

____

__

Initi

als:

____

__

Loca

tion/

Uni

t:___

____

____

_

Not

es a

nd co

mm

ents

:

AMB-

4

20

Page 21: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Stan

dard

Pre

caut

ions

: Obs

erva

tion

Cate

gorie

sRo

om/

Area 1

Room

/Ar

ea 2

Room

/Ar

ea 3

Room

/Ar

ea 4

Room

/Ar

ea 5

Sum

mar

y of

O

bser

vatio

ns

Yes

Tota

l Obs

erve

d

1Ar

e sh

arps

con

tain

ers a

vaila

ble?

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

2Ar

e sh

arps

con

tain

ers p

rope

rly

secu

red

and

not f

ull?

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

3Ar

e sh

arps

con

tain

ers p

ositi

oned

at

52”

to 5

6” a

bove

floo

r?

Yes

N

o

Yes

N

o

Yes

N

o

Yes

N

o

Yes

N

o

4Ar

e ha

mpe

rs fo

r soi

led

laun

dry

labe

led

or co

lor-

code

d?

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

5Ar

e cl

ean

linen

sup

plie

s spa

tially

se

para

ted

from

soile

d ar

eas o

rw

aste

and

cove

red

or co

ntai

ned

with

in a

cab

inet

?

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

Ye

s

No

Tota

l YES

and

TO

TAL

OBS

ERVE

D

Stan

dard

Pre

caut

ions

: Obs

erva

tion

of N

eedl

estic

kPr

even

tion

and

Care

of L

aund

ryIn

stru

ctio

ns: O

bser

ve p

atie

nt c

are

area

s or a

reas

out

side

of p

atie

nt ro

oms.

For

eac

h ca

tego

ry, r

ecor

d th

e ob

serv

atio

n. In

the

colu

mn

on th

erig

ht,

sum

(acr

oss)

the

tota

l num

ber o

f “Ye

s” a

nd th

e to

tal n

umbe

r of o

bser

vatio

ns (“

Yes”

+ “

No”

). S

um a

ll ca

tego

ries (

dow

n) fo

r ove

rall

perf

orm

ance

.

AMB-

5

21

Page 22: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Date

:___

____

____

___

Obs

erve

r Rol

e:

Nur

se

Tech

O

ther

____

____

__

Initi

als:

____

__

Loca

tion/

Uni

t:___

____

____

_

Not

es a

nd co

mm

ents

:

Stan

dard

Pre

caut

ions

: Obs

erva

tion

of N

eedl

estic

kPr

even

tion

and

Care

of L

aund

ryAM

B-5

22

Page 23: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Med

icat

ion

prep

arat

ion

room

: Obs

erva

tion

Cate

gorie

s

1If

mul

ti-do

se in

ject

able

med

icat

ions

are

pre

sent

, is t

he m

edic

atio

n co

ntai

ner

mai

ntai

ned

in a

ded

icat

ed m

edic

atio

n pr

epar

atio

n sp

ace?

Yes

N

o

N/A

2Is

the

med

icat

ion

prep

arat

ion

area

free

of o

pene

d sin

gle

dose

via

ls or

ope

ned

singl

e us

e co

ntai

ners

?

Yes

N

o

3If

open

mul

ti-do

se v

ials

are

pres

ent,

are

they

dat

ed a

nd w

ithin

the

Beyo

nd U

se

Date

(BU

D) a

nd th

e m

anuf

actu

rer’s

exp

iratio

n pe

riod?

Ye

s

No

N

/A

4M

edic

atio

nsar

e pr

epar

ed in

a c

lean

are

a fr

ee fr

om co

ntam

inat

ion

or co

ntac

t with

bl

ood,

bod

y flu

ids,

or c

onta

min

ated

equ

ipm

ent.

Ye

s

No

5Ar

esp

lash

gua

rds i

nsta

lled

at si

nks t

hat a

re lo

cate

d cl

ose

to m

edic

atio

n pr

ep

area

s?

Yes

N

o

6Ar

e sin

ks re

adily

acc

essib

le to

hea

lthca

re p

rovi

ders

?

Yes

N

o

7Ar

e ha

nd w

ashi

ng su

pplie

s, s

uch

as so

ap, a

nd p

aper

tow

els,

ava

ilabl

e?

Yes

N

o

8Ar

e al

coho

l disp

ense

rs re

adily

ava

ilabl

e, fi

lled,

and

func

tioni

ng p

rope

rly?

Ye

s

No

TOTA

L (T

otal

YES

and

No

Onl

y)

Inje

ctio

n Sa

fety

: Obs

erva

tion

of C

entr

alize

d M

edic

atio

n Ar

ea

Inst

ruct

ions

: Obs

erve

med

icat

ion

prep

arat

ion

area

. For

eac

h ca

tego

ry, r

ecor

d th

e ob

serv

atio

n. O

bser

ve e

ach

prac

tice

belo

w a

nd a

nsw

er Y

es, N

o, o

r N/A

. Su

m a

ll Ye

s and

No

resp

onse

s. D

ivid

e by

sum

of “

Yes”

+”N

o”. D

isreg

ard

not a

pplic

able

cat

egor

ies.

AMB-

6

23

Page 24: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Date

:___

____

____

___

Obs

erve

r Rol

e:

Nur

se

Tech

O

ther

____

____

__

Initi

als:

____

__

Loca

tion/

Uni

t:___

____

____

_

Not

es a

nd co

mm

ents

:

Inje

ctio

n Sa

fety

: Obs

erva

tion

of C

entr

alize

d M

edic

atio

n Ar

eaAM

B-6

24

Page 25: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Ambu

lato

ry W

aitin

g Ro

om: O

bser

vatio

n Ca

tego

ries

Sum

mar

y of

O

bser

vatio

ns

1As

pat

ient

s firs

t reg

ister

for c

are,

is th

ere

visib

le si

gnag

e in

stru

ctin

g th

em to

ale

rt th

e st

aff

of a

resp

irato

ry in

fect

ion?

Ye

s

No

2Ar

e fa

ce m

asks

and

tiss

ues r

eadi

ly a

vaila

ble

for p

atie

nts a

nd v

isito

rs w

ith re

spira

tory

or

flu-li

ke sy

mpt

oms?

Ye

s

No

3Ar

e ha

nd h

ygie

ne su

pplie

s rea

dily

ava

ilabl

e to

visi

tors

in th

e w

aitin

g ro

om?

Ye

s

No

4Ar

e tr

ash

rece

ptac

les r

eadi

ly a

vaila

ble

to v

isito

rs in

the

wai

ting

room

?

Yes

N

o

TOTA

L

Coug

h Co

urte

sy: W

aitin

g Ro

om

Inst

ruct

ions

: Obs

erve

the

ambu

lato

ry c

are

poin

t of c

are

test

ing

area

. For

eac

h ca

tego

ry, r

ecor

d th

e ob

serv

atio

n. S

um a

ll Ye

s and

No

resp

onse

s.Di

vide

by

sum

of “

Yes”

+ ”

No”

.

AMB-

7

25

Page 26: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Date

:___

____

____

___

Obs

erve

r Rol

e:

Nur

se

Tech

O

ther

____

____

__

Initi

als:

____

__

Loca

tion/

Uni

t:___

____

____

_

Not

es a

nd co

mm

ents

:

Coug

h Co

urte

sy: W

aitin

g Ro

omAM

B-7

26

Page 27: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Vacc

ine

Stor

age

Area

: O

bser

vatio

n Ca

tego

ries

Sum

mar

y of

O

bser

vatio

ns

1Ar

e va

ccin

e st

orag

e re

frig

erat

or a

nd fr

eeze

r tem

pera

ture

s with

in th

e ap

prop

riate

rang

es

(Ref

riger

ator

: 2°C

to 8

°C; 3

6°F

to 4

6°Fr

eeze

r:-5

0°C

to -1

5°C;

-58°

F to

+5°

F)?

Ye

s

No

2Ar

e va

ccin

e st

orag

e re

frig

erat

or a

nd fr

eeze

r tem

pera

ture

s rec

orde

d tw

ice

daily

?

Yes

N

o

3Ar

e sa

fegu

ards

, suc

h as

self-

clos

ing

hing

esan

d do

or a

larm

s,in

pla

ce to

ens

ure

that

the

refr

iger

ator

/fre

ezer

doo

rs re

mai

n cl

osed

.

Yes

N

o

4Ar

e re

frig

erat

or/f

reez

er d

oor g

aske

ts c

lean

?

Yes

N

o

5Ar

e va

ccin

es st

ored

in th

e ce

nter

of t

here

frig

erat

or a

nd fr

eeze

r spa

ces,

in th

e or

igin

al p

acka

ging

, an

d in

side

desig

nate

d st

orag

e tr

ays?

Ye

s

No

6Ar

e dr

inks

and

food

abs

ent f

rom

the

refr

iger

ator

/fre

ezer

?

Yes

N

o

TOTA

L

Envi

ronm

ent o

f Car

e: V

acci

ne S

tora

ge A

reas

Inst

ruct

ions

: Obs

erve

vac

cine

stor

age

area

. For

eac

h ca

tego

ry, r

ecor

d th

e ob

serv

atio

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Page 29: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

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29

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30

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______

______

__________

_____ _____

______

09/27/2006 Centers for Disease Control and Prevention Division of Tuberculosis Elimination

Appendix B. Tuberculosis (TB) risk assessment worksheet This model worksheet should be considered for use in performing TB risk assessments for health-care facilities and nontraditional facility-based settings. Facilities with more than one type of setting will need to apply this table to each setting.

Scoring √ or Y = Yes X or N = No NA = Not Applicable

1. Incidence of TB What is the incidence of TB in your community (county or region served by Community rate_______ the health-care setting), and how does it compare with the state and national State rate ____________ average? What is the incidence of TB in your facility and specific settings National rate _________ and how do those rates compare? (Incidence is the number of TB cases in Facility rate your community the previous year. A rate of TB cases per 100,000 persons Department 1 rate _______ should be obtained for comparison.)* This information can be obtained from Department 2 rate _______ the state or local health department. Department 3 rate _______

Are patients with suspected or confirmed TB disease encountered in your Yes No setting (inpatient and outpatient)? If yes, how many patients with suspected and confirmed TB disease are treated in your health-care setting in 1 year (inpatient and outpatient)? Review laboratory data, infection-control records, and databases containing discharge diagnoses.

Year No. patients Suspected Confirmed

1 year ago 2 years ago _____ _____ 5 years ago _____ _____

If no, does your health-care setting have a plan for the triage of patients with Yes No suspected or confirmed TB disease? Currently, does your health-care setting have a cluster of persons with Yes No confirmed TB disease that might be a result of ongoing transmission of Mycobacterium tuberculosis within your setting (inpatient and outpatient)?

2. Risk Classification Inpatient settings How many inpatient beds are in your inpatient setting? How many patients with TB disease are encountered in the inpatient setting in 1 Previous year year? Review laboratory data, infection-control records, and databases 5 years ago ______ containing discharge diagnoses. Depending on the number of beds and TB patients encountered in 1 year, what ο Low risk is the risk classification for your inpatient setting? (See Appendix C.) ο Medium risk

ο Potential ongoing transmission

Does your health-care setting have a plan for the triage of patients with Yes No suspected or confirmed TB disease? Outpatient settings How many TB patients are evaluated at your outpatient setting in 1 year? Previous year Review laboratory data, infection-control records, and databases containing 5 years ago discharge diagnoses. Is your health-care setting a TB clinic? Yes No (If yes, a classification of at least medium risk is recommended.) Does evidence exist that a high incidence of TB disease has been observed in Yes No the community that the health-care setting serves? Does evidence exist of person-to-person transmission of M. tuberculosis in the Yes No health-care setting? (Use information from case reports. Determine if any tuberculin skin test [TST] or blood assay for M. tuberculosis [BAMT] conversions have occurred among health-care workers [HCWs]). Does evidence exist that ongoing or unresolved health-care–associated Yes No

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2.2

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______

__________________

______

________

09/27/2006 Centers for Disease Control and Prevention Division of Tuberculosis Elimination

transmission has occurred in the health-care setting (based on case reports)? Is there a high incidence of immunocompromised patients or HCWs in the Yes No health-care setting? Have patients with drug-resistant TB disease been encountered in your health- Yes No care setting within the previous 5 years? Year ________

When was the first time a risk classification was done for your health-care setting? Considering the items above, would your health-care setting need a higher risk Yes No classification? Depending on the number of TB patients evaluated in 1 year, what is the risk ο Low risk classification for your outpatient setting? (See Appendix C) ο Medium risk

ο Potential ongoing transmission

Does your health-care setting have a plan for the triage of patients with Yes No suspected or confirmed TB disease? Nontraditional facility-based settings

How many TB patients are encountered at your setting in 1 year? Previous year 5 years ago

Does evidence exist that a high incidence of TB disease has been observed in Yes No the community that the setting serves? Does evidence exist of person-to-person transmission of M. tuberculosis in the Yes No setting? Have any recent TST or BAMT conversions occurred among staff or clients? Yes No

Is there a high incidence of immunocompromised patients or HCWs in the Yes No setting? Have patients with drug-resistant TB disease been encountered in your health- Yes No care setting within the previous 5 years? Year When was the first time a risk classification was done for your setting?

Considering the items above, would your setting require a higher risk Yes No classification? Does your setting have a plan for the triage of patients with suspected or Yes No confirmed TB disease? Depending on the number of patients with TB disease who are encountered in a nontraditional setting in 1 year, what is the risk classification for your setting? (See Appendix C)

ο Low risk ο Medium risk ο Potential ongoing transmission

3. Screening of HCWs for M. tuberculosis Infection Does the health-care setting have a TB screening program for HCWs?If yes, which HCWs are included in the TB screening program? (Check all that apply.)

ο Physicians ο Mid-level practitioners (nurse practitioners [NP] and physician’s assistants [PA])ο Nurses ο Administrators ο Laboratory workers ο Respiratory therapists

Yes No

ο Janitorial staffο Maintenance or engineering staffο Transportation staffο Dietary staffο Receptionistsο Trainees and studentsο Volunteersο Others_________________

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_________________________________ _________________________________

_________

09/27/2006 Centers for Disease Control and Prevention Division of Tuberculosis Elimination

ο Physical therapistsο Contract staff

ο Construction or renovation workersο Service workersIs baseline skin testing performed with two-step TST for HCWs? Yes No

Is baseline testing performed with QFT or other BAMT for HCWs? Yes No

How frequently are HCWs tested for M. tuberculosis infection?

Are the M. tuberculosis infection test records maintained for HCWs? Yes No

Where are the M. tuberculosis infection test records for HCWs maintained? Who maintains the records?

If the setting has a serial TB screening program for HCWs to test for M. tuberculosis infection, what are the conversion rates for the previous years? †

1 year ago _________________ 4 years ago _________________ 2 years ago _________________ 5 years ago _________________ 3 years ago _________________Has the test conversion rate for M. tuberculosis infection been increasing or decreasing, or has it remained the same over the previous 5 years? (check one)

ο Increasing ο Decreasing ο No change

Do any areas of the health-care setting (e.g., waiting rooms or clinics) or any group of HCWs (e.g., lab workers, emergency department staff, respiratory therapists, and HCWs who attend bronchoscopies) have a test conversion rate for M.tuberculosis infection that exceeds the health-care setting’s annual average?

Yes No If yes, list _________________________

For HCWs who have positive test results for M. tuberculosis infection and who leave employment at the health setting, are efforts made to communicate test results and recommend follow-up of latent TB infection (LTBI) treatment with the local health department or their primary physician?

Yes No Not applicable

4. TB Infection-Control Program Does the health-care setting have a written TB infection-control plan? Yes No Who is responsible for the infection-control program? When was the TB infection-control plan first written? When was the TB infection-control plan last reviewed or updated? Does the written infection-control plan need to be updated based on the timing of the previous update (i.e., >1 year, changing TB epidemiology of the community or setting, the occurrence of a TB outbreak, change in state or local TB policy, or other factors related to a change in risk for transmission of M. tuberculosis)?

Yes No

Does the health-care setting have an infection-control committee (or another committee with infection control responsibilities)?

Yes No

If yes, which groups are represented on the infection-control committee? (Check all that apply.)

ο Physiciansο Nursesο Epidemiologistsο Engineersο Pharmacists

ο Laboratory personnelο Health and safety staffο Administratorο Risk assessmentο Quality control (QC)ο Others (specify)

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_____

_____

_____

_____

___________

___________

_____

_____

_____

___________

___________

______________________ ______________________

09/27/2006 Centers for Disease Control and Prevention Division of Tuberculosis Elimination

If no, what committee is responsible for infection control in the setting?

5. Implementation of TB Infection-Control Plan Based on Review by Infection-Control Committee Has a person been designated to be responsible for implementing an infection-control plan in your health-care setting? If yes, list the name: _________________________

Yes No

Based on a review of the medical records, what is the average number of days for the following:• Presentation of patient until collection of specimen _____ • Specimen collection until receipt by laboratory• Receipt of specimen by laboratory until smear results are provided to health-care provider• Diagnosis until initiation of standard antituberculosis treatment• Receipt of specimen by laboratory until culture results are provided to health-care provider• Receipt of specimen by laboratory until drug-susceptibility results are provided to

health-care provider• Receipt of drug-susceptibility results until adjustment of antituberculosis treatment,

if indicated• Admission of patient to hospital until placement in airborne infection isolation (AII)Through what means (e.g., review of TST or BAMT conversion rates, patient medical records, and time analysis)are lapses in infection control recognized? What mechanisms are in place to correct lapses in infection control? Based on measurement in routine QC exercises, is the infection-control plan being properly implemented?

Yes No

Is ongoing training and education regarding TB infection-control practices provided for HCWs?

Yes No

6. Laboratory Processing of TB-Related Specimens, Tests, and Results Based on Laboratory Review Which of the following tests are either conducted in-house at your health-care setting’s laboratory or sent out to a reference laboratory?

In-house Sent out

Acid-fast bacilli (AFB) smears Culture using liquid media (e.g., Bactec and MB-BacT) Culture using solid media Drug-susceptibility testing Nucleic acid amplification (NAA) testing What is the usual transport time for specimens to reach the laboratory for the following tests?

AFB smears Culture using liquid media (e.g., Bactec, MB-BacT)Culture using solid media ___________Drug-susceptibility testingOther (specify)NAA testing ___________

Does the laboratory at your health-care setting or the reference laboratory used by your health-care setting report AFB smear results for all patients within 24 hours of receipt of specimen? What is the procedure for weekends?

Yes No

7. Environmental Controls Which environmental controls are in place in your health-care setting? (Check all that apply and describe)

Environmental control Description ο AII rooms _____________________

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__________________________________________

_____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________ _____________________________________________________________________________________

09/27/2006 Centers for Disease Control and Prevention Division of Tuberculosis Elimination

ο Local exhaust ventilation (enclosing devices and exterior devices) ο General ventilation (e.g., single-pass system, recirculation system.)ο Air-cleaning methods (e.g., high-efficiency particulate air [HEPA] filtration and ultraviolet germicidal

irradiation [UVGI]) ___________________________________________________________ What are the actual air changes per hour (ACH) and design for various rooms in the setting?

Room ACH Design

Which of the following local exterior or enclosing devices such as exhaust ventilation devices are used in your health-care setting? (Check all that apply) ο Laboratory hoodsο Booths for sputum inductionο Tents or hoods for enclosing patient or procedure What general ventilation systems are used in your health-care setting? (Check all that apply) ο Single-pass systemο Variable air volume (VAV) ο Constant air volume (CAV)ο Recirculation systemο Other____________________

What air-cleaning methods are used in your health-care setting? (Check all that apply) HEPA filtration

ο Fixed room-air recirculation systems ο Portable room-air recirculation systems

UVGIο Duct irradiationο Upper-air irradiationο Portable room-air cleaners

How many AII rooms are in the health-care setting?

What ventilation methods are used for AII rooms? (Check all that apply) Primary (general ventilation):ο Single-pass heating, ventilating, and air conditioning (HVAC) ο Recirculating HVAC systems

Secondary (methods to increase equivalent ACH): ο Fixed room recirculating units ο HEPA filtration ο UVGI ο Other (specify) _________________

Does your health-care setting employ, have access to, or collaborate with an environmental engineer (e.g., professional engineer) or other professional with appropriate expertise (e.g., certified industrial hygienist) for consultation on design specifications, installation, maintenance, and evaluation of environmental controls?

Yes No

Are environmental controls regularly checked and maintained with results recorded in maintenance logs?

Yes No

Are AII rooms checked daily for negative pressure when in use? Yes No Is the directional airflow in AII rooms checked daily when in use with smoke tubes or visual checks?

Yes No

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______________________________________

_________________ _______________________________ _______________________________ _______________________________ _______________________________

______________________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________

____________________________

____________________________

______________________________________________________________________________________ ______________________________________________________________________________________

______________________________________________________________________________ ____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________

09/27/2006 Centers for Disease Control and Prevention Division of Tuberculosis Elimination

Are these results readily available? Yes No What procedures are in place if the AII room pressure is not negative? Do AII rooms meet the recommended pressure differential of 0.01-inch water column negative to surrounding structures?

Yes No

8. Respiratory-Protection Program Does your health-care setting have a written respiratory-protection program? Yes No Which HCWs are included in the respiratory protection program? (Check all that apply)

ο Physicians ο Mid-level practitioners (NPs and PAs) ο Nurses ο Administrators ο Laboratory personnel ο Contract staff ο Construction or renovation staff ο Service personnel

ο Janitorial staff ο Maintenance or engineering staff ο Transportation staff ο Dietary staff ο Students ο Others (specify)

Are respirators used in this setting for HCWs working with TB patients? If yes, include manufacturer, model, and specific application (e.g., ABC model 1234 for bronchoscopy and DEF model 5678 for routine contact with infectious TB patients).

Manufacturer Model Specific application

Is annual respiratory-protection training for HCWs performed by a person with advanced training in respiratory protection?

Yes No

Does your health-care setting provide initial fit testing for HCWs? If yes, when is it conducted?

Yes No

Does your health-care setting provide periodic fit testing for HCWs? If yes, when and how frequently is it conducted?

Yes No

What method of fit testing is used? Describe.

Is qualitative fit testing used? Yes No Is quantitative fit testing used? Yes No

9. Reassessment of TB risk How frequently is the TB risk assessment conducted or updated in the health-care setting? When was the last TB risk assessment conducted? What problems were identified during the previous TB risk assessment?

1)

2)

3)

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_____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________

______________________________________________________________________________ ____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________

09/27/2006 Centers for Disease Control and Prevention Division of Tuberculosis Elimination

4)

5)

What actions were taken to address the problems identified during the previous TB risk assessment? 1)

2)

3)

4)

5)

Did the risk classification need to be revised as a result of the last TB risk assessment? Yes No * If the population served by the health-care facility is not representative of the community in which the

facility is located, an alternate comparison population might be appropriate. † Test conversion rate is calculated by dividing the number of conversions among HCWs by the number of

HCWs who were tested and had prior negative results during a certain period (see Supplement, Surveillance and Detection of M. tuberculosis infections in Health-Care Settings).

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Risk Assessment for Infection Surveillance, Prevention and Control Programs in Ambulatory Healthcare Settings

Explanation of Risk Assessment Tool and the Template for a Risk Assessment Report

This Risk Assessment tool, beginning on page 43, can be used to conduct a facility risk assess-ment for acquiring and transmitting infections in a variety of ambulatory healthcare settings . The results of the risk assessment can then be reported using the accompanying template for a Risk Assessment Report (beginning on page 40) . The findings of the risk assessment should be used to provide information about where an organization should focus its infection surveillance, prevention and control activities.

A facility risk assessment is conducted by identifying and reviewing potential risk factors for infection related to the care, treatment, and services provided and to the environment of care in a specific healthcare setting . The identified risks of greatest importance and urgency are then selected and prioritized . Based on these identified risks, facility personnel should develop the organization’s Infection Surveillance, Prevention and Control (ISPC) Plan (i.e., an action plan).

The ISPC Plan should include a goal for reducing the risk of infection associated with each of these identified risks, a measurable objective for each goal, and evidence based strategies for meeting each of these objectives . The Plan should also identify the personnel responsible for implementing the strategies and include mechanisms for evaluating the effectiveness of meet-ing the ISPC Plan’s objectives .

Assessment Process

1 . Convene a team to conduct the risk assessment .

2 . Identify potential risk factors in each of the following categories:

• Community and populations served

• Potential for specific infection

• Treatment and care practices

• Instrument and medical device cleaning, disinfection and handling

• Environment of care

• Emergency management

• Others identified by the organization

3 . Assess and score each potential risk factor based on the following:

a . Potential impact of the event/condition on patients and personnel, determined by evaluating the potential for patient illness, injury, infection, death, need for admission to an inpatient facility; the potential for personnel illness, injury, infection, shortage; potential to impact the organization’s ability to function/remain open; and degree of clinical and financial impact .

2.3

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b . Probability of the event/condition occurring determined by evaluating the risk of the potential threat actually occurring . Information regarding historical data, infection surveillance data, the scope of services provided by the facility, and the environment of the surrounding area (topography, interstate roads, chemical plants, railroad, ports, etc .) are considered when determining this score .

c . Organization’s preparedness to deal with the event/condition determined by consider-ing policies and procedures already in place, staff experience and response to actual situations, and available services and equipment .

4 . After risk scores are assigned in the three assessment groups, total the numbers in each group to provide a numerical risk level for each event/ condition .

5 . Rank the events/conditions from the highest to lowest score in the table provided . Select the risks with the highest scores for priority focus for developing the annual ISPC Plan . NOTE: Some events/conditions with a lower score may be selected because they are an accreditation or regulatory requirement .

The risk assessment and ISPC Plan should be reviewed and approved by the organization’s quality assurance and performance improvement committee (or other designated committee) . The risk assessment and ISPC Plan should be reviewed annually (and sooner if circumstances change) .

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Cover Page for Risk Assessment Report

Risk Assessment Report for Infection Surveillance, Prevention and Control (ISPC) Program

Year: 20__

Organization Name: ________________________________

Date of Report: __________________

Overview

A facility risk assessment for acquiring and transmitting infections should be conducted annu-ally in each healthcare facility . [Note: An annual risk assessment is required for organizations accredited by The Joint Commission and other accreditation organizations .] The risk assess-ment provides a foundation for the Infection Surveillance, Prevention and Control Program because it is used is used to provide information about where an organization should focus its infection surveillance, prevention and control activities .

This facility risk assessment was conducted by identifying and reviewing potential risk factors for infection related to the care, treatment, and services provided and to the environment of care in a specific healthcare setting . The identified risks of greatest importance and urgency were selected and prioritized and are noted below . Based on these identified risks, facility personnel will develop the organization’s Infection Surveillance, Prevention and Control (ISPC) Plan (i .e ., an action plan, with goals and measurable objectives .)

The ISPC Plan includes a goal for reducing the risk of infection associated with each of the prioritized risks, a measurable objective for each goal, and evidence based strategies for meeting each of these objectives . The Plan also (1) identifies the personnel responsible for developing the Plan and implementing the ISPC Program strategies and (2) includes mecha-nisms for evaluating the effectiveness of the meeting the ISPC Program’s objectives .

Assessment Tool

An organizational Infection Risk Assessment tool (below) was reviewed and adapted for use by (Organization name) by the following personnel:

______________________________________________________________________________

The Risk Assessment tool was used to identify potential infection risk factors in each of the following categories:

• Community and populations served

• Potential for specific infection

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• Treatment and care practices

• Instrument and medical device cleaning, disinfection and handling

• Environment of care

• Emergency management

• Others identified by the organization

Process

The following personnel conducted the risk assessment:

______________________________________________________________________________

The group identified, assessed and scored each potential risk factor based on the following:

1 . Potential impact of the event/condition on patients and personnel, determined by evaluat-ing the potential for patient illness, injury, infection, death, need for admission to an inpatient facility; the potential for personnel illness, injury, infection, shortage; potential to impact the organization’s ability to function/remain open; and degree of clinical and financial impact .

2 . Probability of the event/condition occurring, determined by evaluating the risk of the potential threat actually occurring . Information regarding historical data, infection surveil-lance data, the scope of services provided by the facility, the environment of the surround-ing area (topography, interstate roads, chemical plants, railroad, ports, etc .), and health department data, are considered when determining this score .

3 . Organization’s preparedness to deal with the event/condition, determined by considering policies and procedures already in place, staff experience and response to actual situations, and available services and equipment .

Ranking of Scores

After risk scores are assigned in the three assessment groups, the numbers in each group were totaled to provide a numerical risk level for each event/condition . The numerical risk level can range from 0 (lowest vulnerability) to 9 (highest vulnerability) . The risk factors (i .e ., events/conditions) were then ranked from highest to lowest risk level in the table below . The risks with the highest scores will be used for priority focus for developing the annual ISPC Plan . NOTE: Some events/conditions with a lower score may be selected because they are an accreditation or regulatory requirement, or can be quickly and easily implemented .

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Distribution of Risk Assessment

The Risk assessment was shared with others, such as the ____________________, to solicit comments . The original group evaluated and incorporated the comments, as needed, and finalized this risk assessment . The risk assessment will be taken to the (governing body) ______________ and the ______________Committee for final approvals before the Infection Surveillance, Prevention and Control Plan is developed . After final approval of the risk assess-ment findings, the ISPC Plan will be developed by __________with periodic reports back to the ____________Committee until the Plan has been fully implemented .

Results

A numerical risk level of 9 is identified as the highest perceived potential risk .

Event or Condition Score

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49

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Infection Prevention and Control Assessment Tool for Outpatient Settings

This tool is intended to assist in the assessment of infection control programs and practices in outpatient settings. In order to complete the assessment, direct observation of infection control practices will be necessary. To facilitate the assessment, health departments are encouraged to share this tool with facilities in advance of their visit.

Please note, Not Applicable should only be checked if the element or domain is not applicable to the types of services provided by the facility (e.g., the facility never performs point-of-care testing, controlled substances are never kept at the facility). If a particular service is provided by the facility but is unable to be observed during the visit (e.g., no injections were prepared or administered during the visit) that section should still be completed by interviewing relevant personnel about their practices.

Overview

Section 1: Facility Demographics

Section 2: Infection Control Program and Infrastructure

Section 3: Direct Observation of Facility Practices

Section 4: Infection Control Guidelines and Other Resources

Infection Control Domains for Gap Assessment

I. Infection Control Program and Infrastructure

II. Infection Control Training and Competency

III. Healthcare Personnel Safety

IV. Surveillance and Disease Reporting

V.a/b. Hand Hygiene

VI.a/b. Personal Protective Equipment (PPE)

VII.a/b. Injection Safety (if applicable)

VIII.a/b. Respiratory Hygiene/Cough Etiquette

IX.a/b. Point-of-Care Testing (if applicable)

X.a/b. Environmental Cleaning

XI.a/b. Device Reprocessing

XII. Sterilization of Reusable Devices (if applicable)

XIII. High-level Disinfection of Reusable Devices (if applicable)

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Section 1: Facility Demographics

Facility Name (for health department use only) NHSN Facility Organization ID (for health department use only) State-assigned Unique ID Date of Assessment

Type of Assessment ☐ On-site ☐ Other (specify): Rationale for Assessment (Select all that apply)

☐ Outbreak ☐ Input from accrediting organization or state survey agency ☐ Other (specify):

Is the facility licensed by the state?

☐ Yes ☐ No

Is the facility certified by the Centers for Medicare & Medicaid Services (CMS)?

☐ Yes ☐ No

Is the facility accredited? ☐ Yes ☐ No

If yes, list the accreditation organization: ☐ Accreditation Association for Ambulatory Health Care (AAAHC) ☐ American Association for Accreditation of Ambulatory Surgery

Facilities (AAAASF) ☐ American Osteopathic Association (AOA) ☐ The Joint Commission (TJC) ☐ Other (specify):

Is the facility affiliated with a hospital?

☐ Yes (specify – for health department use only): ☐ No

Which procedures are performed by the facility?

Select all that apply.

☐ Chemotherapy ☐ Endoscopy ☐ Ear/Nose/Throat ☐ Imaging (MRI/CT) ☐ Immunizations ☐ OB/Gyn ☐ Ophthalmologic ☐ Orthopedic ☐ Pain remediation ☐ Plastic/reconstructive ☐ Podiatry ☐ Other (specify):

What is the primary procedure-type performed by the facility?

Select only one.

☐ Chemotherapy ☐ Endoscopy ☐ Ear/Nose/Throat ☐ Imaging (MRI/CT) ☐ Immunizations ☐ OB/Gyn ☐ Ophthalmologic ☐ Orthopedic ☐ Pain remediation ☐ Plastic/reconstructive ☐ Podiatry ☐ Other (specify):

How many physicians work at the facility? What is the average number of patients seen per week?

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Section 2: Infection Control Program and Infrastructure

I. Infection Control Program and Infrastructure

Elements to be assessed Assessment Notes/Areas for Improvement

A. Written infection prevention policies and procedures are available, current, and based on evidence-based guidelines (e.g., CDC/HICPAC), regulations, or standards.

Note: Policies and procedures should be appropriate for the services provided by the facility and should extend beyond OSHA bloodborne pathogens training

Yes No

B. Infection prevention policies and procedures are re-assessed at least annually or according to state or federal requirements, and updated if appropriate.

Yes No

C. At least one individual trained in infection prevention is employed by or regularly available (e.g., by contract) to manage the facility’s infection control program.

Note: Examples of training may include: Successful completion of initial and/or recertification exams developed by the Certification Board for Infection Control & Epidemiology; participation in infection control courses organized by the state or recognized professional societies (e.g., APIC, SHEA).

Yes No

D. Facility has system for early detection and management of potentially infectious persons at initial points of patient encounter.

Note: System may include taking a travel and occupational history, as appropriate, and elements described under respiratory hygiene/cough etiquette.

Yes No

II. Infection Control Training and Competency

Elements to be assessed Assessment Notes/Areas for Improvement

A. Facility has a competency-based training program that provides job-specific training on infection prevention policies and procedures to healthcare personnel.

Note: This includes those employed by outside agencies and available by contract or on a volunteer basis to the facility.

See sections below for more specific assessment of training related to: hand hygiene, personal protective equipment (PPE), injection safety, environmental cleaning, point-of-care testing, and device reprocessing

Yes No

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III. Healthcare Personnel Safety

Elements to be assessed Assessment Notes/Areas for Improvement

A. Facility has an exposure control plan that is tailored to the specific requirements of the facility (e.g., addresses potential hazards posed by specific services provided by the facility).

Note: A model template, which includes a guide for creating an exposure control plan that meets the requirements of the OSHA Bloodborne Pathogens Standard is available at: https://www.osha.gov/Publications/osha3186.pdf

Yes No

B. HCP for whom contact with blood or other potentially infectious material is anticipated are trained on the OSHA bloodborne pathogens standard upon hire and at least annually.

Yes No

C. Following an exposure event, post-exposure evaluation and follow-up, including prophylaxis as appropriate, are available at no cost to employee and are supervised by a licensed healthcare professional.

Note: An exposure incident refers to a specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an individual’s duties.

Yes No

D. Facility tracks HCP exposure events and evaluates event data and develops/implements corrective action plans to reduce incidence of such events.

Yes No

E. Facility follows recommendations of the Advisory Committee on Immunization Practices (ACIP) for immunization of HCP, including offering Hepatitis B and influenza vaccination.

Note: Immunization of Health-Care Personnel: Recommendations of the ACIP available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6007a1.htm

Yes No

F. All HCP receive baseline tuberculosis (TB) screening prior to placement; HCP receive repeat testing, if appropriate, based on the facility-level risk assessment.

Note: For more information, facilities should refer to the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/ rr5417a1.htm ?s_cid=rr5417a1_e

Yes No

G. If respirators are used, the facility has a respiratory protection program that details required worksite-specific procedures and elements for required respirator use, including provision of medical clearance, training, and fit testing as appropriate.

Yes No Not Applicable

H. Facility has well-defined policies concerning contact of personnel with patients when personnel have potentially transmissible conditions.

These policies include: i. Work-exclusion policies that encourage reporting of

illnesses and do not penalize with loss of wages, benefits, or job status.

ii. Education of personnel on prompt reporting of illness to supervisor.

Yes No

Yes No

Yes No

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IV. Surveillance and Disease Reporting

Elements to be assessed Assessment Notes/Areas for Improvement

A. An updated list of diseases reportable to the public health authority is readily available to all personnel.

Yes No

B. Facility can demonstrate knowledge of and compliance with mandatory reporting requirements for notifiable diseases, healthcare associated infections (as appropriate), and for potential outbreaks.

Yes No

C. Patients who have undergone procedures at the facility are educated regarding signs and symptoms of infection that may be associated with the procedure and instructed to notify the facility if such signs or symptoms occur.

Yes No

V.a. Hand Hygiene

Elements to be assessed Assessment Notes/Areas for Improvement

A. All HCP are educated regarding appropriate indications for hand hygiene:

i. Upon hire, prior to provision of care

ii. Annually

Yes No

Yes No B. HCP are required to demonstrate competency with hand

hygiene following each training Yes No

C. Facility routinely audits (monitors and documents) adherence to hand hygiene.

Yes No

D. Facility provides feedback from audits to personnel regarding their hand hygiene performance.

Yes No

E. Hand hygiene policies promote preferential use of alcohol-based hand rub (ABHR) over soap and water in most clinical situations.

Note: Soap and water should be used when hands are visibly soiled (e.g., blood, body fluids) and is also preferred after caring for a patient with known or suspected C. difficile or norovirus during an outbreak.

Yes No

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VI.a. Personal Protective Equipment (PPE)

Elements to be assessed Assessment Notes/Areas for Improvement

A. HCP who use PPE receive training on proper selection and use of PPE:

i. Upon hire, prior to provision of care

ii. Annually

iii. When new equipment or protocols are introduced

Yes No

Yes No Yes No

B. HCP are required to demonstrate competency with selection and use of PPE following each training.

Yes No

C. Facility routinely audits (monitors and documents) adherence to proper PPE selection and use.

Yes No

D. Facility provides feedback from audits to personnel regarding their performance with selection and use of PPE.

Yes No

VII.a. Injection Safety (This element does not include assessment of pharmacy/compounding practices)

If injectable medications are never prepared or administered at the facility check Not Applicable here and skip to Section VIII.a. Respiratory Hygiene/Cough Etiquette.

Elements to be assessed Assessment Notes/Areas for Improvement

A. HCP who prepare and/or administer parenteral medications receive training on safe injection practices:

i. Upon hire, prior to being allowed to prepare and/or administer parenteral medications

ii. Annually iii. When new equipment or protocols are introduced

Yes No

Yes No Yes No

B. HCP are required to demonstrate competency with safe injection practices following each training.

Yes No

C. Facility routinely audits (monitors and documents) adherence to safe injection practices.

Yes No

D. Facility provides feedback from audits to personnel regarding their adherence to safe injection practices.

Yes No

E. Facility has policies and procedures to track HCP access to controlled substances to prevent narcotics theft/diversion.

Note: Policies and procedures should address: how data are reviewed, how facility would respond to unusual access patterns, how facility would assess risk to patients if tampering (alteration or substitution) is suspected or identified, and who the facility would contact if diversion is suspected or identified.

Yes No Not Applicable (Facility does not prepare or administer controlled substances)

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VIII.a. Respiratory Hygiene/Cough Etiquette

Elements to be assessed Assessment Notes/Areas for Improvement

A. Facility has policies and procedures to contain respiratory secretions in persons who have signs and symptoms of a respiratory infection, beginning at point of entry to the facility and continuing through the duration of the visit.

Policies include: i. Offering facemasks to coughing patients and other

symptomatic persons upon entry to the facility, at a minimum, during periods of increased respiratory infection activity in the community.

ii. Providing space in waiting rooms and encouraging persons with symptoms of respiratory infections to sit as far away from others as possible.

Note: If available, facilities may wish to place patients with symptoms of a respiratory infection in a separate area while waiting for care.

Yes No

Yes No

Yes No

B. Facility educates HCP on the importance of infection prevention measures to contain respiratory secretions to prevent the spread of respiratory pathogens.

Yes No

IX.a. Point-of-Care Testing (e.g., blood glucose meters, INR monitor)

If point-of-care testing is never performed at the facility check Not Applicable here and skip to Section X.a. Environmental Cleaning

Elements to be assessed Assessment Notes/Areas for Improvement

A. HCP who perform point-of-care testing receive training on recommended practices:

i. Upon hire, prior to being allowed to perform point-of-care testing

ii. Annually

iii. When new equipment or protocols are introduced

Yes No

Yes No

Yes No B. HCP are required to demonstrate competency with

recommended practices for point-of-care testing following each training.

Yes No

C. Facility routinely audits (monitors and documents) adherence to recommended practices during point-of-care testing.

Yes No

D. Facility provides feedback from audits to personnel regarding their adherence to recommended practices.

Yes No

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X.a. Environmental Cleaning

Elements to be assessed Assessment Notes/Areas for Improvement

A. Facility has written policies and procedures for routine cleaning and disinfection of environmental surfaces, including identification of responsible personnel.

Yes No

B. Personnel who clean and disinfect patient care areas (e.g., environmental services, technicians, nurses) receive training on cleaning procedures

i. Upon hire, prior to being allowed to perform environmental cleaning

ii. Annually

iii. When new equipment or protocols are introduced

Note: If environmental cleaning is performed by contract personnel, facility should verify this is provided by contracting company.

Yes No

Yes No Yes No

C. HCP are required to demonstrate competency with environmental cleaning procedures following each training.

Yes No

D. Facility routinely audits (monitors and documents) adherence to cleaning and disinfection procedures, including using products in accordance with manufacturer’s instructions (e.g., dilution, storage, shelf-life, contact time).

Yes No

E. Facility provides feedback from audits to personnel regarding their adherence to cleaning and disinfection procedures.

Yes No

F. Facility has a policy/procedure for decontamination of spills of blood or other body fluids.

Yes No

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X.a. Environmental Cleaning, continued

Operating Room

For the purposes of this checklist, an operating room is defined as a patient care area that met the Facilities Guidelines Institute’s (FGI) or American Institute of Architects’ (AIA) criteria for an operating room when it was constructed or renovated. This is the same definition that is used in the National Healthcare Safety Network’s Procedure-associated Module for the SSI Event (http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf)

If the facility does not have an operating room check Not Applicable here and skip to section XI.a. Device Reprocessing Elements to be assessed Assessment Notes/Areas for Improvement

G. Operating rooms are terminally cleaned after last procedure of the day.

Yes No

H. Facility routinely audits (monitors and documents) adherence to recommended infection control practices for surgical infection prevention including:

i. Adherence to preoperative surgical scrub and hand hygiene

ii. Appropriate use of surgical attire and drapes

iii. Adherence to aseptic technique and sterile field

iv. Proper ventilation requirements in surgical suites

v. Minimization of traffic in the operating room

vi. Adherence to cleaning and disinfection of environmental surfaces

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

I. Facility provides feedback from audits to personnel regarding their adherence to surgical infection prevention practices.

Yes No

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XI.a. Device Reprocessing

The following basic information allows for a general assessment of policies and procedures related to reprocessing of reusable medical devices. Outpatient facilities that are performing on-site sterilization or high-level disinfection of reusable medical devices should refer to the more detailed checklists in separate sections of this document devoted to those issues.

Categories of Medical Devices:

• Critical items (e.g., surgical instruments) are objects that enter sterile tissue or the vascular system and must be sterile prior to use (see Sterilization Section).

• Semi-critical items (e.g., endoscopes for upper endoscopy and colonoscopy, vaginal probes) are objects that contact mucous membranes or non-intact skin and require, at a minimum, high-level disinfection prior to reuse (see High-level Disinfection Section).

• Non-critical items (e.g., blood pressure cuffs) are objects that may come in contact with intact skin but not mucous membranes and should undergo cleaning and low- or intermediate-level disinfection depending on the nature and degree of contamination.

Single-use devices (SUDs) are labeled by the manufacturer for a single use and do not have reprocessing instructions. They may not be reprocessed for reuse except by entities which have complied with FDA regulatory requirements and have received FDA clearance to reprocess specific SUDs.

Note: Cleaning must always be performed prior to sterilization and disinfection

Elements to be assessed Assessment Notes/Areas for Improvement

A. Facility has policies and procedures to ensure that reusable medical devices are cleaned and reprocessed appropriately prior to use on another patient.

Note: This includes clear delineation of responsibility among HCP for cleaning and disinfection of equipment including, non-critical equipment, mobile devices, and other electronics (e.g., point-of-care devices) that might not be reprocessed in a centralized reprocessing area.

Yes No

B. The individual(s) in charge of infection prevention at the facility is consulted whenever new devices or products will be purchased or introduced to ensure implementation of appropriate reprocessing policies and procedures.

Yes No

C. HCP responsible for reprocessing reusable medical devices receive hands-on training on proper selection and use of PPE and recommended steps for reprocessing assigned devices:

i. Upon hire, prior to being allowed to reprocess devices ii. Annually

iii. When new devices are introduced or policies/procedures change.

Note: If device reprocessing is performed by contract personnel, facility should verify this is provided by contracting company.

Yes No Yes No Yes No

D. HCP are required to demonstrate competency with reprocessing procedures (i.e., correct technique is observed by trainer) following each training.

Yes No

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XI.a. Device Reprocessing, continued

Elements to be assessed Assessment Notes/Areas for Improvement

E. Facility routinely audits (monitors and documents) adherence to reprocessing procedures.

Yes No

F. Facility provides feedback from audits to personnel regarding their adherence to reprocessing procedures.

Yes No

G. Facility has protocols to ensure that HCP can readily identify devices that have been properly reprocessed and are ready for patient use (e.g., tagging system, storage in designated area).

Yes No

H. Facility has policies and procedures outlining facility response (i.e., risk assessment and recall of device) in the event of a reprocessing error or failure.

Yes No

I. Routine maintenance for reprocessing equipment (e.g., automated endoscope reprocessors, steam autoclave) is performed by qualified personnel in accordance with manufacturer instructions; confirm maintenance records are available.

Yes No Not Applicable (Reprocessing equipment is not used at the facility)

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Section 3: Direct Observation of Facility Practices

Certain infection control lapses (e.g., reuse of syringes on more than one patient or to access a medication container that is used for subsequent patients; reuse of lancets) have resulted in bloodborne pathogen transmission and should be halted immediately. Identification of such lapses warrants appropriate notification and testing of potentially affected patients.

If an element is unable to be observed during an assessment (e.g., no patients received point-of-care testing during the visit), assess the element by interviewing appropriate personnel about facility practices. Notation should also be made in the notes section that the element was not able to be directly observed.

V.b. Hand hygiene

Elements to be assessed Assessment Notes/Areas for Improvement

A. Supplies necessary for adherence to hand hygiene (e.g., soap, water, paper towels, alcohol-based hand rub) are readily accessible to HCP in patient care areas.

Yes No

Hand hygiene is performed correctly:

B. Before contact with the patient Yes No C. Before performing an aseptic task (e.g., insertion of IV or

preparing an injection, administering eye drops) Yes No Not Applicable

D. After contact with the patient Yes No E. After contact with objects in the immediate vicinity of the

patient Yes No

F. After contact with blood, body fluids or contaminated surfaces Yes No G. After removing gloves Yes No H. When moving from a contaminated-body site to a clean-body

site during patient care Yes No Not Applicable

VI.b. Personal Protective Equipment (PPE)

Elements to be assessed Assessment Notes/Areas for Improvement

A. Sufficient and appropriate PPE is available and readily accessible to HCP.

Yes No

PPE is used correctly:

B. PPE, other than respirator, is removed and discarded prior to leaving the patient’s room or care area. If a respirator is used, it is removed and discarded (or reprocessed if reusable) after leaving the patient room or care area and closing the door.

Yes No

C. Hand hygiene is performed immediately after removal of PPE. Yes No

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VI.b. Personal Protective Equipment (PPE), continued

Elements to be assessed Assessment Notes/Areas for Improvement D. Gloves

i. HCP wear gloves for potential contact with blood, body fluids, mucous membranes, non-intact skin, or contaminated equipment.

ii. HCP do not wear the same pair of gloves for the care of more than one patient.

iii. HCP do not wash gloves for the purpose of reuse.

Yes No

Yes No

Yes No E. Gowns

i. HCP wear gowns to protect skin and clothing during procedures or activities where contact with blood or body fluids is anticipated.

ii. HCP do not wear the same gown for the care of more than one patient.

Yes No Not Applicable

Yes No Not Applicable

F. Facial protection i. HCP wear mouth, nose, and eye protection during

procedures that are likely to generate splashes or sprays of blood or other body fluids.

Yes No Not Applicable

VII.b. Injection safety (This element does not include assessment of pharmacy/compounding practices)

If injectable medications are never prepared or administered at the facility check Not Applicable here and skip to Section VIII.b. Respiratory Hygiene/Cough Etiquette

Elements to be assessed Assessment Notes/Areas for Improvement A. Injections are prepared using aseptic technique in a clean area

free from contamination or contact with blood, body fluids or contaminated equipment.

Yes No

B. Needles and syringes are used for only one patient (this includes manufactured prefilled syringes and cartridge devices such as insulin pens).

Yes No

C. The rubber septum on a medication vial is disinfected with alcohol prior to piercing. Yes No

D. Medication containers are entered with a new needle and a new syringe, even when obtaining additional doses for the same patient.

Yes No

E. Single dose (single-use) medication vials, ampules, and bags or bottles of intravenous solution are used for only one patient. Yes No

F. Medication administration tubing and connectors are used for Yes No only one patient.

Not Applicable (Facility does not use tubing or connectors)

G. Multi-dose vials are dated by HCP when they are first opened Yes No and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Not Applicable

(Facility does not use

Note: This is different from the expiration date printed on the vial. multi-dose vials or discards them after single patient use)

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VII.b. Injection safety (This element does not include assessment of pharmacy/compounding practices), continued

Elements to be assessed Assessment Notes/Areas for Improvement

H. Multi-dose vials to be used for more than one patient are kept in Yes No a centralized medication area and do not enter the immediate patient treatment area (e.g., operating room, patient Not Applicable room/cubicle). (Facility does not use

multi-dose vials or Note: If multi-dose vials enter the immediate patient treatment area discards them after

they should be dedicated for single-patient use and discarded single patient use)

immediately after use.

I. All sharps are disposed of in a puncture-resistant sharps container.

Yes No

J. Filled sharps containers are disposed of in accordance with state regulated medical waste rules.

Yes No

K. All controlled substances (e.g., Schedule II, III, IV, V drugs) are kept locked within a secure area.

Yes No Not Applicable (Controlled substances are not kept at the facility)

L. HCP wear a facemask (e.g., surgical mask) when placing a Yes No catheter or injecting material into the epidural or subdural space (e.g., during myelogram, epidural or spinal anesthesia). Not Applicable

(Facility does not perform spinal injection procedures)

VIII.b. Respiratory Hygiene/Cough Etiquette

Elements to be assessed Assessment Notes/Areas for Improvement

A. Facility:

i. Posts signs at entrances with instructions to patients with symptoms of respiratory infection to: a. Inform HCP of symptoms of a respiratory

infection when they first register for care, and b. Practice Respiratory Hygiene/Cough Etiquette

(cover their mouths/noses when coughing or sneezing, use and dispose of tissues, and perform hand hygiene after hands have been covered with respiratory secretions).

ii. Provides tissues and no-touch receptacles for disposal of tissues.

iii. Provides resources for performing hand hygiene in or near waiting areas.

Yes No

Yes No

Yes No

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IX.b. Point-of-Care Testing (e.g., blood glucose meters, INR monitor)

If point-of-care testing is never performed at the facility check Not Applicable here and skip to Section X.b. Environmental Cleaning

Elements to be assessed Assessment Notes/Areas for Improvement

A. New single-use, auto-disabling lancing device is used for each patient.

Note: Lancet holder devices are not suitable for multi-patient use.

Yes No Not Applicable

B. If used for more than one patient, the point-of-care blood testing meter is cleaned and disinfected after every use according to manufacturer’s instructions.

Note: If the manufacturer does not provide instructions for cleaning and disinfection, then the testing meter should not be used for >1 patient.

Yes No Not Applicable

X.b. Environmental Cleaning

Elements to be assessed Assessment Notes/Areas for Improvement

A. Supplies necessary for appropriate cleaning and disinfection procedures (e.g., EPA-registered disinfectants) are available.

Note: If environmental services are performed by contract personnel, facility should verify that appropriate EPA-registered products are provided by contracting company

Yes No

B. High-touch surfaces in rooms where surgical or other invasive procedures (e.g., endoscopy, spinal injections) are performed are cleaned and then disinfected with an EPA-registered disinfectant after each procedure.

Yes No Not Applicable

C. Cleaners and disinfectants are used in accordance with manufacturer’s instructions (e.g., dilution, storage, shelf-life, contact time).

Yes No

D. HCP engaged in environmental cleaning wear appropriate PPE to prevent exposure to infectious agents or chemicals (PPE can include gloves, gowns, masks, and eye protection).

Note: The exact type of correct PPE depends on infectious or chemical agent and anticipated type of exposure.

Yes No

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XI.b. Device Reprocessing

Elements to be assessed Assessment Notes/Areas for Improvement

A. Policies, procedures, and manufacturer reprocessing instructions for reusable medical devices used in the facility are available in the reprocessing area(s).

Yes No

B. Reusable medical devices are cleaned, reprocessed (disinfection or sterilization) and maintained according to the manufacturer instructions.

Note: If the manufacturer does not provide such instructions, the device may not be suitable for multi-patient use.

Yes No

C. Single-use devices are discarded after use and not used for more than one patient unless they have been appropriately reprocessed as described in the note below.

Note: If the facility elects to reuse single-use devices, these devices must be reprocessed prior to reuse by a third-party reprocessor that it is registered with the FDA as a third-party reprocessor and cleared by the FDA to reprocess the specific device in question. The facility should have documentation from the third party reprocessor confirming this is the case.

Yes No

D. Reprocessing area: i. Adequate space is allotted for reprocessing activities.

ii. A workflow pattern is followed such that devices clearly flow from high contamination areas to clean/sterile areas (i.e., there is clear separation between soiled and clean workspaces).

Yes No Yes No

E. Adequate time for reprocessing is allowed to ensure adherence to all steps recommended by the device manufacturer, including drying and proper storage.

Note: Facilities should have an adequate supply of instruments for the volume of procedures performed and should schedule procedures to allow sufficient time for all reprocessing steps.

Yes No

F. HCP engaged in device reprocessing wear appropriate PPE to prevent exposure to infectious agents or chemicals (PPE can include gloves, gowns, masks, and eye protection).

Note: The exact type of correct PPE depends on infectious or chemical agent and anticipated type of exposure.

Yes No

G. Medical devices are stored in a manner to protect from damage and contamination.

Yes No

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XII. Sterilization of Reusable Devices

If all device sterilization is performed off-site, complete elements M-O and check Not Applicable for the remaining elements in this section.

If sterilization of reusable devices is never performed (either at the facility or off-site) check Not Applicable here and skip to Section XIII.

Elements to be assessed Assessment Notes/Areas for Improvement A. Devices are thoroughly cleaned according to manufacturer

instructions and visually inspected for residual soil prior to sterilization.

Note: Cleaning may be manual (i.e., using friction) and/or mechanical (e.g., with ultrasonic cleaners, washer-disinfector, washer-sterilizers).

Ensure appropriately sized cleaning brushes are selected for cleaning device channels and lumens.

Yes No Not Applicable

B. Cleaning is performed as soon as practical after use (e.g., at the point of use) to prevent soiled materials from becoming dried onto devices.

Yes No Not Applicable

C. Enzymatic cleaner or detergent is used for cleaning and discarded according to manufacturer’s instructions (typically after each use)

Yes No Not Applicable

D. Cleaning brushes are disposable or, if reusable, cleaned and high-level disinfected or sterilized (per manufacturer’s instructions) after use.

Yes No Not Applicable

E. After cleaning, instruments are appropriately wrapped/packaged for sterilization (e.g., package system selected is compatible with the sterilization process being performed, items are placed correctly into the basket, shelf or cart of the sterilizer so as not to impede the penetration of the sterilant, hinged instruments are open, instruments are disassembled if indicated by the manufacturer).

Yes No Not Applicable

F. A chemical indicator (process indicator) is placed correctly in the instrument packs in every load.

Yes No Not Applicable

G. A biological indicator, intended specifically for the type and cycle parameters of the sterilizer, is used at least weekly for each sterilizer and with every load containing implantable items.

Yes No Not Applicable

H. For dynamic air removal-type sterilizers (e.g., prevacuum steam sterilizer), an air removal test (Bowie-Dick test) is performed in an empty dynamic-air removal sterilizer each day the sterilizer is used to verify efficacy of air removal.

Yes No Not Applicable

I. Sterile packs are labeled with a load number that indicates the sterilizer used, the cycle or load number, the date of sterilization, and, if applicable, the expiration date.

Yes No Not Applicable

J. Sterilization logs are current and include results from each load. Yes No Not Applicable

K. Immediate-use steam sterilization, if performed, is only done in circumstances in which routine sterilization procedures cannot be performed.

Yes No Not Applicable

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XII. Sterilization of Reusable Devices, continued

Elements to be assessed Assessment Notes/Areas for Improvement

L. Instruments that undergo immediate-use steam sterilization are used immediately and not stored.

Yes No Not Applicable

M. After sterilization, medical devices are stored so that sterility is not compromised.

Yes No Not Applicable

N. Sterile packages are inspected for integrity and compromised packages are reprocessed prior to use.

Yes No Not Applicable

O. The facility has a process to perform initial cleaning of devices (to prevent soiled materials from becoming dried onto devices) prior to transport to the off-site reprocessing facility.

Yes No Not Applicable

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XIII. High-Level Disinfection of Reusable Devices

If all high-level disinfection is performed off-site, complete elements L-N below and check Not Applicable for the remaining elements in this section.

If high-level disinfection of reusable devices is never performed (either at the facility or off-site) check here: Not Applicable Elements to be assessed Assessment Notes/Areas for Improvement

A. Flexible endoscopes are inspected for damage and leak tested as part of each reprocessing cycle. Any device that fails the leak test is removed from clinical use and repaired.

Yes No Not Applicable

B. Devices are thoroughly cleaned according to manufacturer instructions and visually inspected for residual soil prior to high-level disinfection.

Note: Cleaning may be manual (i.e., using friction) and/or mechanical (e.g., with ultrasonic cleaners, washer-disinfector, washer-sterilizers).

Ensure appropriately sized cleaning brushes are selected for cleaning device channels and lumens.

Yes No Not Applicable

C. Cleaning is performed as soon as practical after use (e.g., at the point of use) to prevent soiled materials from becoming dried onto instruments.

Yes No Not Applicable

D. Enzymatic cleaner or detergent is used and discarded according to manufacturer instructions (typically after each use).

Yes No Not Applicable

E. Cleaning brushes are disposable or, if reusable, cleaned and high-level disinfected or sterilized (per manufacturer instructions) after use.

Yes No Not Applicable

F. For chemicals used in high-level disinfection, manufacturer instructions are followed for:

i. Preparation Yes No Not Applicable

ii. Testing for appropriate concentration Yes No Not Applicable

iii. Replacement (i.e., upon expiration or loss of efficacy) Yes No Not Applicable

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XIII. High-Level Disinfection of Reusable Devices, continued

Elements to be assessed Assessment Notes/Areas for Improvement

G. If automated reprocessing equipment (e.g., automated endoscope reprocessor) is used, proper connectors are used to assure that channels and lumens are appropriately disinfected.

Yes No Not Applicable

H. Devices are disinfected for the appropriate length of time as specified by manufacturer instructions.

Yes No Not Applicable

I. Devices are disinfected at the appropriate temperature as specified by manufacturer instructions.

Yes No Not Applicable

J. After high-level disinfection, devices are appropriately rinsed as specified by the manufacturer.

Yes No Not Applicable

K. Devices are dried thoroughly prior to reuse.

Note: For lumened instruments (e.g., endoscopes) this includes flushing all channels with alcohol and forcing air through channels.

Yes No Not Applicable

L. After high-level disinfection, devices are stored in a manner to protect from damage or contamination.

Note: Endoscopes should be hung in a vertical position.

Yes No Not Applicable

M. Facility maintains a log for each endoscopy procedure which includes: patient’s name and medical record number (if available), procedure, date, endoscopist, system used to reprocess the endoscope (if more than one system could be used in the reprocessing area), and serial number or other identifier of the endoscope used.

Yes No Not Applicable

N. The facility has a process to perform initial cleaning of devices (to prevent soiled materials from becoming dried onto devices) prior to transport to the off-site reprocessing facility.

Yes No Not Applicable

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Section 4: Infection Control Guidelines and Other Resources

• General Infection Prevention

☐ CDC/HICPAC Guidelines and recommendations: http://www.cdc.gov/HAI/prevent/prevent_pubs.html

• Healthcare Personnel Safety

☐ Guideline for Infection Control in Healthcare Personnel: http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

☐ Immunization of HealthCare Personnel: http://www.cdc.gov/vaccines/spec-grps/hcw.htm

☐ Occupational Safety & Health Administration (OSHA) Bloodborne Pathogens and Needlestick Prevention Standard: http://www.osha.gov/SLTC/bloodbornepathogens/index.html

☐ OSHA Respiratory Protection Standard: https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=12716&p_table=STANDARDS

☐ OSHA Respirator Fit Testing: https://www.osha.gov/video/respiratory_protection/fittesting_transcript.html

• Hand Hygiene

☐ Guideline for Hand Hygiene in Healthcare Settings: http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf

☐ Hand Hygiene in Healthcare Settings: http://www.cdc.gov/handhygiene/

Examples of tools that can be used to conduct a formal audit of hand hygiene practices:

☐ http://www.jointcommission.org/assets/1/18/hh_monograph.pdf

☐ http://compepi.cs.uiowa.edu/index.php/Research/IScrub

• Personal Protective Equipment

☐ 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf

☐ Guidance for the Selection and Use of Personal Protective Equipment in Healthcare Settings: http://www.cdc.gov/HAI/prevent/ppe.html

• Injection Safety

☐ 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf

☐ CDC Injection Safety Web Materials: http://www.cdc.gov/injectionsafety/

☐ CDC training video and related Safe Injection Practices Campaign materials: http://www.oneandonlycampaign.org/

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• Respiratory Hygiene/Cough Etiquette

☐ 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf

☐ Recommendations for preventing the spread of influenza: http://www.cdc.gov/flu/professionals/infectioncontrol/

• Environmental Cleaning

☐ Guidelines for Environmental Infection Control in Healthcare Facilities: http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_HCF_03.pdf

☐ Options for Evaluating Environmental Infection Control: http://www.cdc.gov/HAI/toolkits/Evaluating-Environmental-Cleaning.html

• Equipment Reprocessing

☐ Guideline for Disinfection and Sterilization in Healthcare Facilities: http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf

☐ FDA regulations on reprocessing of single-use devices: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071434

• Point-of-Care Testing

☐ Infection Prevention during Blood Glucose Monitoring and Insulin Administration: http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html

☐ Frequently Asked Questions (FAQs) regarding Assisted Blood Glucose Monitoring and Insulin Administration: http://www.cdc.gov/injectionsafety/providers/blood-glucose-monitoring_faqs.html

• Resources to assist with evaluation and response to breaches in infection control

☐ Patel PR, Srinivasan A, Perz JF. Developing a broader approach to management of infection control breaches in health care settings. Am J Infect Control. 2008 Dec; 36(10); 685-90 http://www.ajicjournal.org/article/S0196-6553(08)00683-4/abstract

☐ Steps for Evaluating an Infection Control Breach: http://www.cdc.gov/hai/outbreaks/steps_for_eval_IC_breach.html

☐ Patient Notification Toolkit: http://www.cdc.gov/injectionsafety/pntoolkit/index.html

• Antibiotic Stewardship

☐ Get Smart Programs & Observances: http://www.cdc.gov/getsmart/

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Practice forum

A pragmatic approach to infection prevention and control guidelinesin an ambulatory care setting

Jessica Ng MSc, CIC a,*, Sheila Le-Abuyen MPH, CPHI(C) a, Jane Mosley MScN, RN a,Michael Gardam MD, MSc, CM, FRCPC, CIC a,b

aDepartment of Infection Prevention and Control, Women’s College Hospital, Toronto, Ontario, CanadabDepartment of Infection Prevention and Control, University Health Network, Toronto, Ontario, Canada

Key Words:OutpatientInfection Prevention and Control ProgramTransitionPractice change

The vast majority of infection prevention and control (IPAC) experience and practice guidance relates tothe inpatient setting. We have taken a pragmatic approach to applying IPAC guidance in our ambulatorysetting, and here we identify and describe the 4 key areas where we modified our IPAC program andadapted current guidelines to fit with our setting.

Copyright � 2014 by the Association for Professionals in Infection Control and Epidemiology, Inc.Published by Elsevier Inc. All rights reserved.

Women’s College Hospital (WCH) is an academic health carefacility in Ontario, Canada, with a primary focus on the health ofwomen. WCH transitioned from an acute care hospital to anambulatory care hospital during 2006. The transition of infectionprevention and control (IPAC) practices from an acute careapproach to an approach appropriate to ambulatory care has beengradual but determined.

The vast majority of IPAC experience and practice guidance re-lates to inpatient settings. The Centers for Disease Control andPrevention,1 Public Health Agency of Canada,2 World Health Or-ganization,3 College of Physicians and Surgeons of Ontario,4 andProvincial Infectious Diseases Advisory Committee5 all publish IPACguidance documents but provide little concrete direction forambulatory care settings. As a result, until recently, we looselyadapted inpatient practices to fit our ambulatory setting.

In light of this, we conducted an extensive review of our IPACprogram in 2011, evaluating where gaps existed and identifyingwhere practice changes were needed to fit our new reality. We alsoconsciously moved to a less rigid, more pragmatic approach toapplying IPAC guidelines in our setting. In this report, we identifyand describe the 4 key areas where we modified our program andadapted current guidelines, specifically screening and surveillance,isolation practices and personal protective equipment (PPE) use,environmental cleaning, and hand hygiene (Table 1).

SCREENING AND SURVEILLANCE

In contrast to inpatient settings, the antibiotic resistant organ-ism (ARO) status of patients is largely unknown in standaloneambulatory care settings. Laboratory turnaround times are criticalfor preventing ARO transmission amongst inpatients.6 When WCHwas an inpatient facility, this was achieved by patient AROscreening upon admission and immediate telephone calls to IPACwhen a positive laboratory result was received. As we transitionedinto an ambulatory care setting, ARO screening became mootbecause patients would visit and leave the hospital within a day,long before results were available. Therefore, we worked with thelaboratory to stop immediate ARO reporting by telephone. In a fewof our clinical areas, we also eliminated ARO screening for thepurpose of implementing IPACmeasures and encouraged screeningonly for clinical decision-making purposes such as choosing theappropriate perioperative antimicrobial prophylaxis.

Because it is difficult to attribute a patient infection to a healthcare encounter in an ambulatory care setting, we do not formallytrack and publicly report infection rates. Instead, we have focusedour efforts on public health reporting of communicable diseasesand process surveillance of IPAC practices within our hospital, suchas promoting good respiratory etiquette, improving compliancewith antibiotic prophylaxis guidelines, and ensuring the use of asurgical safety checklist.

ISOLATION PRACTICES AND PPE USE

Despite understanding that Routine Practices (RP)7 (ie, Centersfor Disease Control and Prevention standard precautions) should

* Address correspondence to Jessica Ng, MSc, CIC, Department of InfectionPrevention and Control, Women’s College Hospital, 76 Grenville St, Toronto,Ontario, Canada M5S 1B2.

E-mail address: [email protected] (J. Ng).Conflicts of interest: None to report.

Contents lists available at ScienceDirect

American Journal of Infection Control

journal homepage: www.aj ic journal .org

American Journal of Infection Control

0196-6553/$36.00 - Copyright � 2014 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.http://dx.doi.org/10.1016/j.ajic.2014.02.011

American Journal of Infection Control 42 (2014) 671-32.5

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be applied to all patients at all times, staff members often relied onthe patient flagging system to guide practice. Before becoming anambulatory care hospital, WCH screened inpatients for AROs andpatients who were positive for an ARO were identified with anelectronic flag. When a patient was flagged for an ARO, there wouldbe heightened attention to perform hand hygiene, use PPE (often inexcess), and ensure appropriate environmental cleaning. Because ofthis, adherence to RP for patients not flaggedwith an AROwas oftenlax.

To provide clarity and address the inconsistent use of RP andAdditional Precautions (AP),7 we revised our policy to emphasizethe systematic application of RP for all patients, including patientsknown to be carrying an ARO. For staff, this meant that ARO statusdoes not automatically necessitate AP; instead, it would depend onthe risk of exposure to uncontained secretions. Finally, to furtherprevent the selective use of RP, we are in the process of deactivatingthe ARO flagging option in our patient record system.

ENVIRONMENTAL CLEANING

The cleaning practices for patients and hospital environmentsare not as well defined in an ambulatory care setting. Generally,because outpatient visits create less environmental contamination,less intensive cleaning is needed compared with an inpatientsetting. At WCH, there have often been misconceptions regardingwhat needs to be cleaned and how frequently; RP for environ-mental cleaning were often only focused on ARO-positive patients.To facilitate cleaning, ARO-positive patients would be scheduled asthe final visit of the day and then a so-called terminal clean wouldbe performed. These practices posed a risk because RP for envi-ronmental cleaning were not being applied to all patients.

In 2012, we discontinued these practices and engaged thefrontline staff, clinical managers, and clinical directors to allocateadequate resources to ensure that routine practice environmentalcleaning could be applied to all patients. We also emphasized thatspecial cleaning by environmental services was no longer requiredfor ARO-positive patients if there was no visible soiling of theenvironment. We explained that with diligent use of RP, ARO-positive patients could be scheduled at any time. An audit con-ducted April 2013-December 2013 confirmed that 97% of frontlinestaff (N ¼ 67) were following this policy and cleaned patientequipment between uses. Lastly, best practices for environmentalcleaning in an inpatient setting include specific guidelines on dailyand terminal cleaning of patient rooms.8With no patients requiringdischarge or transfer from our hospital, we shifted from the con-cepts of daily and terminal cleaning to applying RP of environ-mental cleaning between patient visits and thorough cleaning atthe end of each day.

HAND HYGIENE

Until recently, there have been few resources addressing specifichand hygiene practice guidelines for an outpatient setting. Since2008, the WCH approach to hand hygiene practices has been basedon the program developed by the Ontario Ministry of Health andLong-Term Care.9 This program was created primarily to helpinpatient facilities improve health care worker hand hygienecompliance. Therefore, we found that applying the moments forhand hygiene in an ambulatory care setting required adaptations.We had to redefine the patient environment and focus on theconcept of performing hand hygiene at the point-of-care in a clinicroom. Although the Hand Hygiene Human Factors Toolkit issued bythe Canadian Patient Safety Institute10 recommends installingalcohol-based hand rub dispensers by the door inside and outside apatient room, we chose to focus resources on ensuring that, at aminimum, alcohol-based hand rubs are provided at the point-of-care; that is, on a health care provider’s desk or within reach ofexam bed areas. As a result of this work, hand hygiene compliancebefore contact with patients or patient environments increasedfrom 80%-93% during the period 2010-2013.

In accordance with best practices for monitoring hand hy-giene,3,11,12 WCH began monitoring hand hygiene practices bydirect observation. However, adapting this approach to our clinicalareas proved difficult because most patient visits involve 1 patientand 1 health care provider in a private examination room. Toobserve practices meant that an auditor would have to be presentin the same room as the patient and health care provider. Not onlywas this highly uncomfortable for all involved, but it also raisedconcerns related to patient privacy and workflow disruption.Moreover, the Hawthorne effect would have significantly biasedthe results for health care providers’ hand hygiene compliance.Compounding the challenges was the fact that the direct observermethod was labor-intensive because few hand hygiene indicationswere observed during a typical patient visit lasting 15-30 minutes.

To address these challenges, we instituted an alternativemethod for hand hygiene monitoring that was inspired by anapproach described by Bittle and LaMarche.13 This method engagespatients to observe their health care providers’ compliance to handhygiene. We invited patients to complete a survey card after theirvisit with their health care provider. During the pilot program,patients returned 75.1% of the survey cards distributed, and overallhand hygiene compliance was 96.8%. The accuracy/interrater reli-ability of patient observations were determined to be in concor-dance with an independent observer 87% of the time, suggestingthat patients were generally able to correctly evaluate health careprovider hand hygiene practices. Based on these results, weconcluded that engaging patients as observers is an effective

Table 1Key areas differing in approach to infection prevention and control (IPAC) in an ambulatory care setting

Area Inpatient care Ambulatory care

Screening Patients are screened upon admission to implement AP Patients are not screened for IPAC purposesSurveillance Larger focus on outcome surveillance; infection rates for AROs

such as MRSA and Clostridium difficile are trackedDifficult to attribute causation and track infection rates. Main focus is

on process surveillance such as antibiotic prophylaxis and use of asurgical safety checklist

Isolation precautionsand PPE use

AP are implemented, which include specific strategies forpatient placement, use of PPE, and environmental cleaning

Emphasis on use of RP for all patients, including patients with aknown ARO

Environmentalcleaning

Daily and terminal cleaning for patient rooms. Terminal cleaningrequired for patients identified with an ARO

Focus on cleaning patient equipment between use and a thoroughend-of-day room cleaning for all patients, including patients witha known ARO

Hand hygiene Patient environment is well defined in the moments for handhygiene. A direct observer can monitor hand hygiene at ease

Patient environment is less defined in the moments for hand hygieneDirect observer for monitoring hand hygiene raises numerous issues

Alternative methods such as engaging patients as observers havebeen effective

AP, Additional Precautions; ARO, antibiotic resistant organism; MRSA, methicillin-resistant Staphylococcus aureus; PPE, personal protective equipment; RP, Routine Practices.

J. Ng et al. / American Journal of Infection Control 42 (2014) 671-3672

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method for monitoring health care provider hand hygiene practicesin an ambulatory care setting.14

CONCLUSIONS

The dearth of practical IPAC guidelines appropriate for anambulatory care setting motivated us to assume a more prag-matic approach to applying IPAC best practice guidelines to ourhospital. The decision to take this approach has allowed us totranslate and define current best practice guidelines for use inambulatory care settings. We have identified IPAC practices thatmay be applicable for an inpatient setting but do not easilytransfer to an outpatient setting. Our hope is that this work willlead to further development of IPAC best practice guidelines forambulatory care settings.

References

1. Centers for Disease Control and Prevention. Guide for IPAC for outpatientsettings: minimum expectations for safe care 2011. Available from: http://www.cdc.gov/HAI/pdfs/guidelines/standatds-of-ambulatory-care-7-2011.pdf.Accessed September 1, 2013.

2. Canadian Committee on Antibiotic Resistance (CCAR). Infection preventionand control best practices for long term care, home and community careincluding health care offices and ambulatory clinics 2007. Available from: http://www.phac-aspc.gc.ca/amr-ram/ipcbp-pepci/pdf/amr-ram-eng.pdf. AccessedSeptember 1, 2013.

3. World Health Organization. Hand hygiene in outpatient care, home-based careand long-term care facilities 2012. Available from: http://www.who.int/gpsc/5may/EN_GPSC1_PSP_HH_Outpatient_care/en/. Accessed September 1, 2013.

4. The College of Physicians and Surgeons of Ontario. Infection control in thephysician’s office 2004. Available from: http://www.cpso.on.ca/uploadedFiles/policies/guidelines/office/Infection_Controlv2.pdf. Accessed September 1, 2013.

5. Ontario Agency for Health Protection and Promotion, Provincial InfectiousDiseases Advisory Committee. Infection prevention and control programs

in Ontario 2012. Available from: http://www.publichealthontario.ca/en/eRepository/BP_IPAC_Ontario_HCSettings_2012.pdf. Accessed September 1, 2013.

6. Ontario Agency for Health Protection and Promotion, Provincial InfectiousDiseases Advisory Committee. Annex A e screening, testing and surveillancefor antibiotic-resistant organisms (AROs). Annexed to: Routine Practices andAdditional Precautions in all health care settings 2013. Available from: http://www.publichealthontario.ca/en/eRepository/PIDAC-IPC_Annex_A_Screening_Testing_Surveillance_AROs_2013.pdf. Accessed September 1, 2013.

7. Ontario Agency for Health Protection and Promotion, Provincial Infectious Dis-eases Advisory Committee. Routine Practices and Additional Precautions in AllHealth Care Settings. 3rd edition. Toronto, ON: Queen’s Printer for Ontario;November 2012. Available from: http://www.publichealthontario.ca/en/eRepository/RPAP_All_HealthCare_Settings_Eng2012.pdf. Accessed April 15, 2014.

8. Ontario Agency for Health Protection and Promotion, Provincial InfectiousDiseases Advisory Committee. Environmental Cleaning for Prevention andControl of Infections 2012. Available from: http://www.publichealthontario.ca/en/eRepository/Best_Practices_Environmental_Cleaning_2012.pdf. AccessedSeptember 1, 2013

9. Ontario Agency for Health Protection and Promotion. Just Clean YourHands program. 2013. Available from: http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/JustCleanYourHands/Pages/Just-Clean-Your-Hands.aspx#.Uionu-FsGHV. Accessed September 1, 2013.

10. Canadian Patient Safety Institute. Human Factors Toolkit. 2012. Available from:http://www.handhygiene.ca/English/Tools/Pages/Human-Factors-Toolkit.aspx.Accessed September 1, 2013.

11. Ontario Agency for Health Protection and Promotion, Provincial InfectiousDiseases Advisory Committee. Hand Hygiene 2010. Available: http://www.publichealthontario.ca/en/eRepository/2010-12%20BP%20Hand%20Hygiene.pdf.Accessed September 1, 2013.

12. Boyce JM, Pittet D, Healthcare Infection Control Practices Advisory Committee,HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Guideline for hand hygienein health-care settings: recommendations of the Healthcare Infection ControlPractices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand HygieneTask Force. MMWR Recomm Rep 2002;51:1-45.

13. Bittle MJ, LaMarche S. Engaging the patient as observer to promote handhygiene compliance in ambulatory care. Jt Comm J Qual Patient Saf 2009;35:519-25.

14. Le-Abuyen S, Ng J, Kim S, De La Franier A, Khan B, Gardam M, et al. Patient-as-observer approach: an alternative method for hand hygiene auditing in anambulatory care setting. Am J Infect Control 2014;42:439-42.

J. Ng et al. / American Journal of Infection Control 42 (2014) 671-3 673

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ith an extensive network that stretches close to a 200-mile radius and includes a 540-plus-bed main hospital, a research center, four surgery centers, 31 physician practices, 11 specialty care centers, and emergency care, the Children’s Hospital of Philadelphia (CHOP) wants to

ensure that it offers quality care in the places where patients are seen most frequently: facilities in the ambulatory setting. In a session titled “Making a Case for an Ambulatory IPC Program,” at the APIC 2019 Annual Conference, Lori Handy, MD, MSCE, associate medical director, infection prevention, and Sara Townsend, MS-HQS, CIC, FAPIC, infection prevention supervisor for the Philadelphia-based hospital, discussed how CHOP has successfully restructured its infection prevention and control (IPC) program to cover its vast system.

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FEATURE

Infection prevention in a system of ambulatory settingsChildren’s Hospital of Philadelphia shows how it’s doneBY SANDY SMITH

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Members of the Children’s Hospital of Philadelphia ambulatory infection prevention control team, from left to right: Regina Wagoner, infection preventionist; Sara Townsend, infection prevention supervisor; Lori Handy, associate medical director, infection prevention and control; Grayson Privette, infection preventionist II; and Kimberly Wilson, hand hygiene manager. Sara Townsend (left) and Lauren Satchell, infection prevention associate II.

The ambulatory care setting is “where most of our patients are seen, so it was a cornerstone when we were thinking about what our restructured program would look like,” Handy said. “We were already providing infection prevention services in ambulatory settings, but we wanted to do it in a more formalized way,” she noted. To support this vision of infection prevention in ambulatory care, Sarah Smathers, the department’s senior

manager, had developed a business case for this restructure, recognizing the growth of the institution.

GETTING THE IPC HOUSE IN ORDERBefore implementing any system-wide changes, the IPC

department itself had to change. Prior to the launch of CHOP’s dedicated ambulatory program, the department

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had one part-time infection preventionist (IP) devoted to the ambulatory setting, with ambulatory sites assigned to IPs within the department. With limited ability to regularly visit sites, CHOP “relied on those offices to call to ask for help,” Handy said. “Sometimes, we’d get a lot of informa-tion from these calls and sometimes we didn’t know what we didn’t know.”

Knowing this was not an ideal way to deliver reliable infec-tion prevention practice, the IPC leadership began to think through a holistic approach for the system. “We wanted to look at our program in a different way, to see if we could find a way to improve role clarity within the department,” said Townsend.

With this in mind, CHOP reorganized the IPC department. Handy and Townsend formed a strong physician-administra-tive leader dyad, which had shown to be successful in other areas of the network and was known to be supported by the literature, to oversee CHOP’s IPC ambulatory and procedure services program.

Additional staffing changes were also made during the department reorganization. Today, the department has an entire team focused on ambulatory care and procedure ser-vices that includes two full-time IPs; the ambulatory team is also supported by the department’s data and logistics team. The latter includes two IP associates who manage data and surveillance, a clinical practice analyst, and the hand hygiene program manager. This ambulatory team works throughout the CHOP enterprise.

SETTING FIRST PRIORITIESA first step for the newly constituted ambulatory IPC team

was assessing IP practices and knowledge across CHOP’s vast network. A survey was sent out to partners, asking both quan-titative and qualitative questions. “We really wanted to better understand where we were at, so we could understand where we should be going,” Townsend said. While the responses were

generally positive, answers revealed a need for better monitor-ing of respiratory etiquette and more education about infection prevention, Townsend said.

In another early initiative, the IPC team worked with ambula-tory partners on a risk assessment, determining the likelihood of events, identifying the risks to the organization if those events occurred, and evaluating current systems for readiness. These data were then used to help the team set priorities. “The problem with collecting that much data at the beginning is you feel you have to do everything,” Handy said.

Using the CHOP system’s own framework for improve-ment, the team began by developing a charter to clearly identify the work that lay ahead. “We wanted to iron out how we could move this project forward,” Handy said. She noted that this process “feels a little tedious sometimes, but is really important. For example, we had to write down the goal that we wanted a program-based approach to the ambulatory network.”

Additionally, measures had to be clarified. Handy noted key questions: “How are we going to know that what we’re doing is better than what we did before? Would we look at the number of people educated? Or the number of exposure events?”

The team set specific goals for what would be accomplished in the first year, identifying primary drivers for these goals—responsive learning and proactive prevention—as well as sec-ondary drivers. It also included a “parking lot” for ideas that were worth exploring in the future.

Putting an idea on hold is “hard to do, but it’s really impor-tant,” Handy explained. “It allows you to focus on the first couple of priorities.” At the same time, Handy advised choos-ing one’s words carefully in these situations. “Try to say to your stakeholders, ‘That’s important work, and I can get back to you in October.’ We found decent response when we were able to phrase things like that, compared to ‘I can’t get to that right now.’”

Members of the Children’s Hospital of Philadelphia ambulatory infection prevention control team.Grayson Privette and Regina Wagoner review hand hygiene data for Children’s Hospital of Philadelphia primary care sites.

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READ MORE ABOUT INFECTION PREVENTION IN AMBULATORY CARE SETTINGS IN THE AMERICAN JOURNAL OF INFECTION CONTROLAmbulatory infection prevention risk assessment: Not all ambulatory sites are created equal. Havill NL, Nucci D, Sullivan L, Dembry L-M. Am J Infect Control, Vol. 42, Issue 6, S87-S88.

Infection surveillance systems in primary health care: A literature review. Manning ML, Pogorzelska-Maziarz M. Am J Infect Control, Vol. 44, Issue 4, 482-484.

Once potential goals were identified, the team ranked them in terms of effort needed to execute the task and levels of impact. Emphasis was placed on those goals with the highest impact and lowest barriers to implementation. Additionally, the ambulatory IPC team agreed that if a facility asked a question about an idea that didn’t make the list of goals, the team would be available to consult.

MAKING CONNECTIONSThe team has faced multiple hurdles, to be sure, including the

sheer number of sites and the distances between them. To help make in-person connections, the team identified a number of ambulatory forums where leaders of certain areas—like nurse managers or medical directors—would meet. The ambulatory IPC team began attending those meetings, which allowed them to “start identifying groups of people we could meet face to face,” Handy said.

Even with these outreach efforts, the team cannot possibly meet everyone. In the beginning, the team struggled to get the attention of staff outside the main facility, who were suddenly receiving emails from people they didn’t know. Recognizing that important messages are better received when the recipient connected with the person sending it, “we needed to leverage our regional medical directors for impact,” Handy said. “At times, for key messaging, I would send an email out to the regional medical director, who would then send it out to their staff.”

The team quickly learned there were institutional differences that needed to be overcome. For example, most of their initial resources provided a five-digit phone number, but some locations outside the main campus did not have access to that quick-dial sys-tem—and didn’t know how to complete the rest of the sequence.

In another instance, the IPC team considered various high-tech ideas, such as alerts in the electronic health record system, to help remind nurses to call an IP if they noticed any cases of reportable diseases. But after talking with the ambula-tory teams, “we learned that we didn’t need to be fancy; what they actually wanted was a sign for the back of their door, reminding them to call us,” Handy said.

IMPROVING DATA SUBMISSIONThe network already had a hand hygiene program developed in

both the inpatient and ambulatory settings, but data submission was inconsistent in the ambulatory setting. “The variation of data led to variable compliance results,” Townsend said. “Also, there was a lack of understanding about the different hand hygiene moments in the ambulatory setting.” A future focus for the team

will be observing hand hygiene collection practices and revamping the training process to improve compliance and data integrity.

Working in the individual offices and settings was not as easy as it might seem. There were siloes, even within a single small office. Townsend recalled how she thought she had a great relationship with the nurses at a particular site. The nurses were good at letting her know when test results for reportable communicable diseases had come back positive. However, “at the same site, someone told Lori they didn’t know what our website, @CHOP, was.” This comment led the IPC team to start asking questions such as, “Do administrators, physicians, and nurses who work at the same office have meetings together?” According to Townsend, the incident “made us aware of the fact that, just because you talk often to one type of professional, they may not share that information with their colleagues.”

MOVING FORWARDEven with those challenges, CHOP’s IPC team soon learned

that personnel who worked in ambulatory settings “want our team’s input in their daily work and also want our team to understand their work,” Townsend said. “We recognize this is a complicated process, and it’s going to take time and evolve.”

And there is work that remains to be done. “There still is confu-sion over which communicable diseases must be reported to the IPC team. Our infection prevention website needs some work to make it simpler so that staff in clinics and other ambulatory settings can find what they need when they need it,” Handy said.

More generally, “We need to work on how to connect people in the network to our team,” Townsend stressed. “That’s hard with so many sites and so few people. To do this well, you need to be able to adapt and adopt.” Handy further explained the team’s long-term objective: “We hope to provide the opportunity for reliable practices and the ability to develop transparent data because with data we can drive improvement. What we hope to do is reach all the practice partners, to put the picture together regarding what IPC is, and how we can ultimately help them.”

Sandy Smith is a medical writer for Prevention Strategist.

“We wanted to look at our program in a different way, to see if we could find a way to improve role clarity within the department.”

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Module 3

Infection Control & Prevention Basics

Contents

3.1 Hand Sanitizer Factsheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80Centers for Disease Control and Prevention (CDC)https://www .cdc .gov/handwashing/pdf/hand-sanitizer-factsheet .pdf

3.2 Core Practices for Infection Prevention in all Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82CDC/Healthcare Infection Control Practices Advisory Committee (HICPAC)https://www .cdc .gov/hicpac/pdf/core-practices .pdf

3.3 Clean Hands Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97Association for Professionals in Infection Control and Epidemiology (APIC)Forms & Checklists for Infection Prevention, Volume 1

3.4 Personal Protective Equipment Efficiency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98APICForms & Checklists for Infection Prevention, Volume 1

3.5 Personal Protective Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100APICForms & Checklists for Infection Prevention, Volume 1

3.6 Cover Your Cough . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103CDC Posters in English and Spanish

3.7 Handwashing, at Home, at Play, and Out and About . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105CDC Posters in English and Spanish

3.8 Five Moments for Hand Hygiene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107World Health Organization (WHO)

3.9 Healthcare worker hand contamination at critical moments in outpatient care settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108James Bingham, MS; Ginnie Abell, BA, RN, CIC; LeAnne Kienast, BS, et al . American Journal of Infection ControlNov . 2016, Vol 44, Issue 11, p . 1198-1202

3.10 Safe Injection Guidelines Pocket Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113CDC

3.11 Safe Injection Practices Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114CDC

3.12 Patient Injection Safety Handout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115CDC

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Resources

Standard Precautions for All Patient CareCDChttps://www .cdc .gov/infectioncontrol/basics/standard-precautions .html

Chart for Recommendations for Application of Standard Precautions for the Care of All Patients in All Healthcare SettingsCDChttps://www .cdc .gov/infectioncontrol/guidelines/isolation/appendix/standard-precautions .html

One and Only CampaignCDChttps://www .cdc .gov/injectionsafety/1anonly .html

Five Moments for Hand HygieneWHO https://www .who .int/gpsc/5may/background/5moments/en/

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U.S. Department of Health and Human ServicesCenters for Disease Control and Prevention

Handwashing and Hand Sanitizer Use at Home, at Play, and Out and About

CS270631

Germs are everywhere! They can get onto hands and items we touch during daily activities and make you sick. Cleaning hands at key times with soap and water or hand sanitizer is one of the most important steps you can take to avoid getting sick and spreading germs to those around you.

There are important differences between washing hands with soap and water and cleaning them with hand sanitizer. For example, alcohol-based hand sanitizers don’t kill ALL types of germs, such as a stomach bug called norovirus, some parasites, and Clostridium difficile, which causes severe diarrhea. Hand sanitizers also may not remove harmful chemicals, such as pesticides and heavy metals like lead. Handwashing reduces the amounts of all types of germs, pesticides, and metals on hands. Knowing when to clean your hands and which method to use will give you the best chance of preventing sickness.

When should I use?

Soap and Water • Before, during, and after preparing food

• Before eating food

• Before and after caring for someone who is sick

• Before and after treating a cut or wound

• After using the bathroom, changing diapers, or cleaning up a child who has used the bathroom

• After blowing your nose, coughing, or sneezing

• After touching an animal, animal food or treats, animal cages, or animal waste

• After touching garbage

• If your hands are visibly dirty or greasy

Alcohol-Based Hand Sanitizer • Before and after visiting a friend or a loved

one in a hospital or nursing home, unless the person is sick with Clostridium difficile (if so, use soap and water to wash hands).

• If soap and water are not available, use an alcohol-based hand sanitizer that contains at least 60% alcohol, and wash with soap and water as soon as you can.

* Do NOT use hand sanitizer if your hands are visibly dirty or greasy: for example, after gardening, playing outdoors, or after fishing or camping (unless a handwashing station is not available). Wash your hands with soap and water instead.

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How should I use?

Soap and Water• Wet your hands with clean running water

(warm or cold) and apply soap.

• Lather your hands by rubbing them together with the soap.

• Scrub all surfaces of your hands, including the palms, backs, fingers, between your fingers, and under your nails. Keep scrubbing for 20 seconds. Need a timer? Hum the “Happy Birthday” song twice.

• Rinse your hands under clean, running water.

• Dry your hands using a clean towel or air dry them.

Alcohol-Based Hand Sanitizer Use an alcohol-based hand sanitizer that contains at least 60% alcohol. Supervise young children when they use hand sanitizer to prevent swallowing alcohol, especially in schools and childcare facilities.

• Apply. Put enough product on hands to cover all surfaces.

• Rub hands together, until hands feel dry. This should take around 20 seconds.

Note: Do not rinse or wipe off the hand sanitizer before it’s dry; it may not work as well against germs.

For more information, visit the CDC handwashing website, www.cdc.gov/handwashing.

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Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings – Recommendations of the Healthcare Infection Control Practices Advisory Committee

Preface The Healthcare Infection Control Practices Advisory Committee (HICPAC) is a federal advisory committee chartered in 1991 to provide advice and guidance to the Centers for Disease Control and Prevention (CDC) and the Secretary of the Department of Health and Human Services (HHS) regarding the practice of infection control and strategies for surveillance, prevention, and control of healthcare-associated infections, antimicrobial resistance and related events in United States healthcare settings. CDC has been developing recommendations for healthcare infection control to prevent infections in patients and healthcare personnel since the 1970’s. These recommendations continue to evolve over time as evidence bases are built and serve as a foundation for healthcare safety across settings, a basis for quality improvement efforts, and part of the process that identifies important research gaps. Guideline development methods have since moved beyond expert opinion alone and incorporated systematic approaches to evidence analysis. A number of core practices are recommended by CDC and considered standards of care and/or accepted practices (e.g., aseptic technique, hand hygiene before patient contact) to prevent infection in healthcare settings. These widely agreed upon practices are elements of care that are not expected to change based on additional research, either because of an overwhelming preponderance of evidence (e.g., hand hygiene requirements), or in some cases due to ethical concerns (e.g., randomizing patients to procedures performed by trained versus untrained personnel). Therefore, these accepted practices are categorized as strong recommendations, even when high-quality randomized controlled trials are not available to support them. In an effort to streamline and systematize the process for updating existing guidelines without recreating the analytic process for each of these accepted/core practices, in March 2013, CDC charged HICPAC to review existing CDC guidelines and identify all recommendations that warrant inclusion as core practices. A HICPAC workgroup was formed that was led by HICPAC members and contained representatives from the following stakeholder organizations: America’s Essential Hospitals, the Association for Professionals in Infection Control and Epidemiology (APIC), the Council of State and Territorial Epidemiologists (CSTE), the Public Health Agency of Canada (PHAC), the Society for Healthcare Epidemiology of America (SHEA), and the Society of Hospital Medicine (SHM). The Workgroup provided updates and obtained HICPAC input at the June 2013, November 2013, April 2014, and July 2014 public meetings. HICPAC voted to finalize the recommendations at the July 2014

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meeting. Additional information about HICPAC is available at the HICPAC website (www.cdc.gov/hicpac).

Introduction Adherence to infection prevention and control practices is essential to providing safe and high-

quality patient care across all settings where healthcare is delivered. Substantial attention has been focused in recent years on improving infection prevention practices within acute care hospitals to optimize patient safety; many of these practices also need to be applied across multiple aspects of patient care. In addition, changes in healthcare during the past decade, driven at least in part by efforts to contain costs, have resulted in an increasing proportion and range of healthcare services being delivered outside of the acute care setting.1,2 These ambulatory and community-based healthcare encounters also can lead to infectious complications that can be prevented using those same infection prevention and control practices.

This document concisely describes a core set of infection prevention and control practices that are required in all healthcare settings, regardless of the type of healthcare provided. The practices were selected from among existing CDC recommendations and are the subset that HICPAC and its Core Practices Working Group determined were fundamental standards of care that are not expected to change based on emerging evidence or to be regularly altered by changes in technology or practices, and are applicable across the continuum of healthcare settings. This document also is intended to improve consistency of language, reduce redundancy across guidelines, and provide a convenient reference wherein these recommendations are maintained. A review of existing CDC guidelines demonstrated many examples of similar recommendations in multiple guidelines with variability in language. The recommendations outlined in this document are intended to serve as a standard reference and reduce the need to repeatedly evaluate practices that are considered basic and accepted as standards of medical care. Readers are urged to consult the full text of CDC guidelines (see references) for additional background and rationale related to the core practice recommendations captured here.

Scope The core practices in this document should be implemented in all settings where healthcare is

delivered. These venues include both inpatient settings (e.g., acute, long-term care, rehabilitation, behavioral health) and outpatient settings (e.g., physician and nurse practitioner offices, clinics, urgent care, ambulatory surgical centers, imaging centers, dialysis centers, physical therapy and rehabilitation centers, alternative medicine clinics). In addition, these practices apply to healthcare delivered in settings other than traditional healthcare facilities, such as homes, pharmacies, and health fairs.

Healthcare personnel (HCP) referred to in this document include all persons, paid and unpaid, in the healthcare setting having direct patient contact and/or potential for exposure to patients and/or to infectious materials (e.g., body substances, used medical supplies and equipment, soiled environmental surfaces). This also includes persons not directly involved in patient care (e.g., clerical

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staff, environmental services, volunteers) who could be exposed to infectious material in a healthcare setting.

Methods CDC healthcare infection control guidelines3-19 were reviewed, and recommendations included in

more than one guideline were grouped into core infection prevention practice domains (e.g., education and training of HCP on infection prevention, injection and medication safety). Additional CDC materials aimed at providing general infection prevention guidance outside of the acute care setting20-22 were also reviewed. HICPAC formed a workgroup led by HICPAC members and including representatives of professional organizations (see Contributors for full list). The workgroup reviewed and discussed all of the practices, further refined the selection and description of the core practices, and presented drafts to HICPAC at public meetings in June 2013, November 2013, April 2014, and July 2014 to inform HICPAC’s final recommendations. The recommendations (see Table) were approved by the full Committee in July 2014.

Conclusions Adherence to basic infection prevention and control practices are essential, not only in acute care

hospitals but also in settings with limited infection prevention infrastructure. The frequency of infectious outbreaks stemming from errors in infection control across settings (e.g., reuse of syringes between patients leading to transmission of viral hepatitis23-25) underscores the critical importance of adherence to these core infection prevention practices wherever healthcare is provided. Recommendations highlighted in this document represent minimum expectations, and healthcare personnel and facilities will need to supplement them according to their settings, procedures performed, and patient populations.

Readers should consult the full texts of CDC healthcare infection control guidelines for background, rationale, and related infection prevention recommendations for more comprehensive information. We encourage professional associations and societies and the research community to develop tools to facilitate implementation and maintenance of these core infection prevention practices across the continuum of healthcare.

Text References 1. Hsiao CJ, Cherry DK, Beatty PC, Rechsteiner EA. National Ambulatory Medical Care Survey: 2007

Summary. National health statistics reports; no 27. Hyattsville, MD: National Center for Health Statistics. 2010.

2. Medicare Payment Advisory Committee. A data book: Health care spending and the Medicare program, June 2016 [PDF - 4.1 MB] (http://www.medpac.gov/docs/default-source/data-book/june-2016-data-book-health-care-spending-and-the-medicare-program.pdf?sfvrsn=0).

3. Bolyard EA. Tablan OC, Williams WW, Pearson ML, Shapiro CN, Deitchmann SD. Guideline for Infection Control in Healthcare Personnel, 1998 (https://stacks.cdc.gov/view/cdc/7250). Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1998 Jun; 19(6):407-63.

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4. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999 (https://stacks.cdc.gov/view/cdc/7160). Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 1999 Apr 20(4):250-78.

5. Boyce JM, Pittet D, Healthcare Infection Control Practices Advisory Committee, Society for Healthcare Epidemiology of America, Association for Professionals in Infection Control, Infectious Diseases Society of America, and the Hand Hygiene Task Force. Guideline for Hand Hygiene in Health-Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force (https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm). Infect Control Hosp Epidemiol. 2002 Dec 23(12 Suppl):S3-40.

6. Sehulster L, Chin RY, Healthcare Infection Control Practices Advisory Committee. Guidelines for Environmental Infection Control in Health-Care Facilities. Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee [PDF - 2.31 MB] (https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines.pdf). MMWR Recomm Rep 2003 Jun 6:52(RR-10):1-42.

7. Jensen PA, Lambert LA, Iademarco MF, Ridzon R. Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 [PDF - 4.2 MB] (https://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf). MMWR Recomm Rep. 2005 Dec 30:54(RR-17):1-141.

8. Siegel JD, Rhinehart E, Jackson M, Chiarello L, Healthcare Infection Control Practices Advisory Committee. Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006 [PDF - 553 KB] (https://www.cdc.gov/infectioncontrol/pdf/guidelines/mdro-guidelines.pdf). Am J Infect Control, 2007 Dec 35 (10 Suppl 2):S165-93.

9. Siegel JD, Rhinehart E, Jackson M, Chiarello L, Healthcare Infection Control Practices Advisory Committee. 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings [PDF - 1.42 MB] (https://wwwdev.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines.pdf). Am J Infect Control. 2007 Dec 35(10 Suppl 2)S65-164.

10. Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA, Healthcare Infection Control Practices Advisory Committee, Guideline for Prevention of Catheter-Associated Urinary Tract Infection 2009 [PDF - 650 KB] (https://www.cdc.gov/infectioncontrol/pdf/guidelines/cauti-guidelines.pdf). Infect Control Hosp Epidemiol, 2010 Apr 31(4):319-26.

11. Centers for Disease Control and Prevention. Guidance for Control of Infections with Carbapenem-Resistant or Carbapenemase-Producing Enterobacteriaceae in Acute Care Facilities [PDF - 381 KB] (https://www.cdc.gov/hai/pdfs/cre/cre-guidance-508.pdf). MMWR 2009 Mar 20:58 (10):256-60.

12. Division of Viral Disease, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention. Updated Norovirus Outbreak Management and Disease Prevention Guidelines (https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6003a1.htm). MMWR 2011 Mar 4:60(RR-3):1-18.

13. O’Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad I, Randolph AG, Rupp ME, Saint S, Healthcare Infection Control

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Last updated: March 15, 2017 Page 5 of 15

Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-Related Infections [PDF - 678 KB] (https://www.cdc.gov/infectioncontrol/pdf/guidelines/bsi-guidelines.pdf). Am J Infect Control. 2011 May 39(4 Suppl 1):S1-34.

14. Rutala WA, Weber DJ, Healthcare Infection Control Practices Advisory Committee. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 [PDF - 1.26 MB] (https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf). Am J Infect Control. 2013;41(5 Suppl):S67-71.

15. Tablan OC, Anderson LJ, Besser R, Bridges C, Haijeh R, Healthcare Infection Control Practices Advisory Committee. Guidelines for Preventing Healthcare-associated Pneumonia, 2003 Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5303a1.htm. MMWR Recomm Rep 204 Mar 26:53(RR-3):1-26.

16. World Health Organization. WHO Guidelines on Hand Hygiene in Health Care: First Global Patient Safety Challenge Clean Care Is Safer Care [PDF - 4.26 MB] (http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf). Geneva. World Health Organization, 2009.

17. Centers for Disease Control and Prevention. Immunization of Healthcare Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP) [PDF - 705 KB] (https://www.cdc.gov/mmwr/pdf/rr/rr6007.pdf). MMWR Recomm Rep. 2011 Nov 25:60(RR-7):1-45.

18. U.S. Public Health Service Working Group on Occupational Postexposure Prophylaxis, Kuhar DT, Henderson DK, et. al., https://stacks.cdc.gov/view/cdc/20711. September, 2013.

19. US Department of Labor. Occupational Safety & Health Standards. 29 CFR 1910.1030, Bloodborne Pathogens (https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10051&p_table=STANDARDS). March 6, 1992.

20. Centers for Disease Control and Prevention. Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients (https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm). MMWR. April 27, 2001/50(RR05); 1-43.

21. Centers for Disease Control and Prevention. Guide to Infection Prevention in Outpatient Settings: Minimum Expectations for Safe Care [PDF - 632 KB] (https://www.cdc.gov/hai/pdfs/guidelines/ambulatory-care-04-2011.pdf). April, 2011.

22. Centers for Disease Control and Prevention. Basic Infection Control and Prevention Plan for Outpatient Oncology Settings [PDF - 1.67 MB] (https://www.cdc.gov/hai/pdfs/guidelines/basic-infection-control-prevention-plan-2011.pdf). December, 2011.

23. Thompson ND, Perz JF, Moorman AC, Holmberg SD. Nonhospital health care-associated Hepatitis B and C virus transmission: United States, 1998-2008. Ann Intern Med. 2009;150:33-39.

24. Greeley RD, Semple S, Thompson ND, et al. Hepatitis B outbreak associated with a hematology-oncology office practice in New Jersey, 2009. Am J Infect Control. 2011;39:663-670.

25. Thompson ND, Perz JF, Moorman AC, et al. Nonhospital health care–associated hepatitis B and C virus transmission: United States, 1998–2008. Ann Intern Med 2009;150:33-39.

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Core

Infe

ctio

n Pr

even

tion

and

Cont

rol P

ract

ices

for S

afe

Heal

thca

re D

eliv

ery

in A

ll Se

ttin

gs

Reco

mm

enda

tions

of t

he H

ICPA

C La

st u

pdat

ed: M

arch

15,

201

7 Pa

ge 6

of 1

5

Core

Pra

ctic

es T

able

Co

re P

ract

ice

Cate

gory

Co

re P

ract

ices

Co

mm

ents

1.

Lea

ders

hip

Supp

ort

Refe

renc

es a

nd re

sour

ces:

1-

12

1.En

sure

that

the

gove

rnin

g bo

dy o

f the

hea

lthca

re fa

cilit

y or

org

aniza

tion

is ac

coun

tabl

e fo

r the

succ

ess o

f inf

ectio

n pr

even

tion

activ

ities

. 2.

Allo

cate

suffi

cien

t hum

an a

nd m

ater

ial r

esou

rces

to in

fect

ion

prev

entio

n to

ens

ure

cons

isten

t and

pro

mpt

act

ion

to re

mov

e or

m

itiga

te in

fect

ion

risks

and

stop

tran

smiss

ion

of in

fect

ions

. Ens

ure

that

st

affin

g an

d re

sour

ces d

o no

t pre

vent

nur

ses,

env

ironm

enta

l sta

ff, e

t. al

., fr

om c

onsis

tent

ly a

dher

ing

to in

fect

ion

prev

entio

n an

d co

ntro

l pr

actic

es.

3.As

sign

one

or m

ore

qual

ified

indi

vidu

als w

ith tr

aini

ng in

infe

ctio

n pr

even

tion

and

cont

rol t

o m

anag

e th

e fa

cilit

y’s i

nfec

tion

prev

entio

n pr

ogra

m.

4.Em

pow

er a

nd su

ppor

t the

aut

horit

y of

thos

e m

anag

ing

the

infe

ctio

n pr

even

tion

prog

ram

to e

nsur

e ef

fect

iven

ess o

f the

pro

gram

.

To b

e su

cces

sful

, inf

ectio

n pr

even

tion

prog

ram

s req

uire

vi

sible

and

tang

ible

supp

ort f

rom

all

leve

ls of

the

heal

thca

re

faci

lity’

s lea

ders

hip.

2. E

duca

tion

and

Trai

ning

of

Hea

lthca

re P

erso

nnel

on

Infe

ctio

n Pr

even

tion

Refe

renc

es a

nd re

sour

ces:

1-

4, 6

-8, 1

0-13

1.Pr

ovid

e jo

b-sp

ecifi

c, in

fect

ion

prev

entio

n ed

ucat

ion

and

trai

ning

to a

ll he

alth

care

per

sonn

el fo

r all

task

s.

2.De

velo

p pr

oces

ses t

o en

sure

that

all

heal

thca

re p

erso

nnel

und

erst

and

and

are

com

pete

nt to

adh

ere

to in

fect

ion

prev

entio

n re

quire

men

ts a

s th

ey p

erfo

rm th

eir r

oles

and

resp

onsib

ilitie

s.

3.Pr

ovid

e w

ritte

n in

fect

ion

prev

entio

n po

licie

s and

pro

cedu

res t

hat a

re

avai

labl

e, c

urre

nt, a

nd b

ased

on

evid

ence

-bas

ed g

uide

lines

(e.g

., CD

C/

HICP

AC, e

tc.)

4.

Requ

ire tr

aini

ng b

efor

e in

divi

dual

s are

allo

wed

to p

erfo

rm th

eir d

utie

s an

d at

leas

t ann

ually

as a

refr

eshe

r. 5.

Prov

ide

addi

tiona

l tra

inin

g in

resp

onse

to re

cogn

ized

laps

es in

ad

here

nce

and

to a

ddre

ss n

ewly

reco

gniz

ed in

fect

ion

tran

smiss

ion

thre

ats (

e.g.

, int

rodu

ctio

n of

new

equ

ipm

ent o

r pro

cedu

res)

.

Trai

ning

shou

ld b

e ad

apte

d to

refle

ct th

e di

vers

ity o

f the

w

orkf

orce

and

the

type

of f

acili

ty, a

nd ta

ilore

d to

mee

t the

ne

eds o

f eac

h ca

tego

ry o

f hea

lthca

re p

erso

nnel

bei

ng

trai

ned.

3. P

atie

nt, F

amily

and

Ca

regi

ver E

duca

tion

Refe

renc

es a

nd re

sour

ces:

2-

5, 7

-8, 1

0-11

1.Pr

ovid

e ap

prop

riate

infe

ctio

n pr

even

tion

educ

atio

n to

pat

ient

s, fa

mily

m

embe

rs, v

isito

rs, a

nd o

ther

s inc

lude

d in

the

care

givi

ng n

etw

ork.

In

clud

e in

form

atio

n ab

out h

ow in

fect

ions

are

spre

ad, h

ow

they

can

be

prev

ente

d, a

nd w

hat s

igns

or s

ympt

oms s

houl

d pr

ompt

reev

alua

tion

and

notif

icat

ion

of th

e pa

tient

’s

heal

thca

re p

rovi

der.

Inst

ruct

iona

l mat

eria

ls an

d de

liver

y sh

ould

add

ress

var

ied

leve

ls of

edu

catio

n, la

ngua

ge

com

preh

ensio

n, a

nd c

ultu

ral d

iver

sity.

87

Page 88: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Core

Infe

ctio

n Pr

even

tion

and

Cont

rol P

ract

ices

for S

afe

Heal

thca

re D

eliv

ery

in A

ll Se

ttin

gs

Reco

mm

enda

tions

of t

he H

ICPA

C La

st u

pdat

ed: M

arch

15,

201

7 Pa

ge 7

of 1

5

Core

Pra

ctic

e Ca

tego

ry

Core

Pra

ctic

es

Com

men

ts

4. P

erfo

rman

ce M

onito

ring

and

Feed

back

Re

fere

nces

and

reso

urce

s:

1-14

1.M

onito

r adh

eren

ce to

infe

ctio

n pr

even

tion

prac

tices

and

infe

ctio

n co

ntro

l req

uire

men

ts.

2.Pr

ovid

e pr

ompt

, reg

ular

feed

back

on

adhe

renc

e an

d re

late

d ou

tcom

es

to h

ealth

care

per

sonn

el a

nd fa

cilit

y le

ader

ship

. 3.

Trai

n pe

rfor

man

ce m

onito

ring

pers

onne

l and

use

stan

dard

ized

tool

s an

d de

finiti

ons.

4.

Mon

itor t

he in

cide

nce

of in

fect

ions

that

may

be

rela

ted

to c

are

prov

ided

at t

he fa

cilit

y an

d ac

t on

the

data

and

use

info

rmat

ion

colle

cted

thro

ugh

surv

eilla

nce

to d

etec

t tra

nsm

issio

n of

infe

ctio

us

agen

ts in

the

faci

lity.

Perf

orm

ance

mea

sure

s sho

uld

be ta

ilore

d to

the

care

ac

tiviti

es a

nd th

e po

pula

tion

serv

ed.

5. S

tand

ard

Prec

autio

ns

Use

Sta

ndar

d Pr

ecau

tions

to c

are

for a

ll pa

tient

s in

all s

ettin

gs.

Stan

dard

Pre

caut

ions

incl

ude:

5a

. Han

d hy

gien

e

5b. E

nviro

nmen

tal c

lean

ing

and

disin

fect

ion

5c

. Inj

ectio

n an

d m

edic

atio

n sa

fety

5d

. Risk

ass

essm

ent w

ith u

se o

f app

ropr

iate

per

sona

l pro

tect

ive

equi

pmen

t (e.

g., g

love

s, g

owns

, fac

e m

asks

) bas

ed o

n ac

tiviti

es b

eing

pe

rfor

med

5e

. Min

imizi

ng P

oten

tial E

xpos

ures

(e.g

. res

pira

tory

hyg

iene

and

cou

gh

etiq

uett

e)

5f. R

epro

cess

ing

of re

usab

le m

edic

al e

quip

men

t bet

wee

n ea

ch p

atie

nt

and

whe

n so

iled

Stan

dard

Pre

caut

ions

are

the

basic

pra

ctic

es th

at a

pply

to a

ll pa

tient

car

e, re

gard

less

of t

he p

atie

nt’s

susp

ecte

d or

co

nfirm

ed in

fect

ious

stat

e, a

nd a

pply

to a

ll se

ttin

gs w

here

ca

re is

del

iver

ed. T

hese

pra

ctic

es p

rote

ct h

ealth

care

pe

rson

nel a

nd p

reve

nt h

ealth

care

per

sonn

el o

r the

en

viro

nmen

t fro

m tr

ansm

ittin

g in

fect

ions

to o

ther

pat

ient

s.

5a. H

and

Hyg

iene

Re

fere

nces

and

re

sour

ces:

3, 7

, 11

1.Re

quire

hea

lthca

re p

erso

nnel

to p

erfo

rm h

and

hygi

ene

in a

ccor

danc

e w

ith C

ente

rs fo

r Dis

ease

Con

trol

and

Pre

vent

ion

(CDC

) re

com

men

datio

ns.

2.U

se a

n al

coho

l-bas

ed h

and

rub

or w

ash

with

soap

and

wat

er fo

r the

fo

llow

ing

clin

ical

indi

catio

ns:

a.Im

med

iate

ly b

efor

e to

uchi

ng a

pat

ient

b.

Befo

re p

erfo

rmin

g an

ase

ptic

task

(e.g

., pl

acin

g an

indw

ellin

g de

vice

) or

ha

ndlin

g in

vasiv

e m

edic

al d

evic

es

c.Be

fore

mov

ing

from

wor

k on

a so

iled

body

site

to a

cle

an b

ody

site

on th

e sa

me

patie

nt

d.Af

ter t

ouch

ing

a pa

tient

or t

he p

atie

nt’s

imm

edia

te e

nviro

nmen

t e.

Afte

r con

tact

with

blo

od, b

ody

fluid

s or c

onta

min

ated

surf

aces

f.

Imm

edia

tely

aft

er g

love

rem

oval

3.

Ensu

re th

at h

ealth

care

per

sonn

el p

erfo

rm h

and

hygi

ene

with

soap

and

w

ater

whe

n ha

nds a

re v

isibl

y so

iled.

4.

Ensu

re th

at su

pplie

s nec

essa

ry fo

r adh

eren

ce to

han

d hy

gien

e ar

e re

adily

acc

essib

le in

all

area

s whe

re p

atie

nt c

are

is be

ing

deliv

ered

.

Unl

ess h

ands

are

visi

bly

soile

d, a

n al

coho

l-bas

ed h

and

rub

is pr

efer

red

over

soap

and

wat

er in

mos

t clin

ical

situ

atio

ns d

ue

to e

vide

nce

of b

ette

r com

plia

nce

com

pare

d to

soap

and

w

ater

. Han

d ru

bs a

re g

ener

ally

less

irrit

atin

g to

han

ds a

nd

are

effe

ctiv

e in

the

abse

nce

of a

sink

.

Refe

r to

“CDC

Gui

delin

e fo

r Han

d Hy

gien

e in

Hea

lth-C

are

Sett

ings

” or

“Gu

idel

ine

for I

sola

tion

Prec

autio

ns: P

reve

ntin

g Tr

ansm

issio

n of

Infe

ctio

us A

gent

s in

Heal

thca

re S

ettin

gs,

2007

” fo

r add

ition

al d

etai

ls.

88

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Core

Infe

ctio

n Pr

even

tion

and

Cont

rol P

ract

ices

for S

afe

Heal

thca

re D

eliv

ery

in A

ll Se

ttin

gs

Reco

mm

enda

tions

of t

he H

ICPA

C La

st u

pdat

ed: M

arch

15,

201

7 Pa

ge 8

of 1

5

Core

Pra

ctic

e Ca

tego

ry

Core

Pra

ctic

es

Com

men

ts

5b. E

nviro

nmen

tal

Clea

ning

and

Di

sinf

ectio

n Re

fere

nces

and

re

sour

ces:

4, 7

, 10,

11,

13

, 21

1.Re

quire

rout

ine

and

targ

eted

cle

anin

g of

env

ironm

enta

l sur

face

s as

indi

cate

d by

the

leve

l of p

atie

nt c

onta

ct a

nd d

egre

e of

soili

ng.

a.Cl

ean

and

disin

fect

surf

aces

in c

lose

pro

xim

ity to

the

patie

nt a

nd

freq

uent

ly to

uche

d su

rfac

es in

the

patie

nt c

are

envi

ronm

ent o

n a

mor

e fr

eque

nt sc

hedu

le c

ompa

red

to o

ther

surf

aces

. b.

Prom

ptly

cle

an a

nd d

econ

tam

inat

e sp

ills o

f blo

od o

r oth

er

pote

ntia

lly in

fect

ious

mat

eria

ls.

2.Se

lect

EPA

-reg

ister

ed d

isinf

ecta

nts t

hat h

ave

mic

robi

ocid

al a

ctiv

ity

agai

nst t

he p

atho

gens

mos

t lik

ely

to c

onta

min

ate

the

patie

nt-c

are

envi

ronm

ent.

3.Fo

llow

man

ufac

ture

rs’ i

nstr

uctio

ns fo

r pro

per u

se o

f cle

anin

g an

d di

sinfe

ctin

g pr

oduc

ts (e

.g.,

dilu

tion,

con

tact

tim

e, m

ater

ial

com

patib

ility

, sto

rage

, she

lf-lif

e, sa

fe u

se a

nd d

ispos

al).

Whe

n in

form

atio

n fr

om m

anuf

actu

rers

is li

mite

d re

gard

ing

sele

ctio

n an

d us

e of

age

nts f

or sp

ecifi

c m

icro

orga

nism

s,

envi

ronm

enta

l sur

face

s or e

quip

men

t, fa

cilit

y po

licie

s re

gard

ing

clea

ning

and

disi

nfec

ting

shou

ld b

e gu

ided

by

the

best

ava

ilabl

e ev

iden

ce a

nd c

aref

ul c

onsid

erat

ion

of th

e ris

ks

and

bene

fits o

f the

ava

ilabl

e op

tions

.

Refe

r to

“CDC

Gui

delin

es fo

r Env

ironm

enta

l Inf

ectio

n Co

ntro

l in

Hea

lth-C

are

Faci

litie

s” a

nd “

CDC

Guid

elin

e fo

r Disi

nfec

tion

and

Ster

iliza

tion

in H

ealth

care

Fac

ilitie

s” fo

r det

ails.

5c. I

njec

tion

and

Med

icat

ion

Safe

ty

Refe

renc

es a

nd

reso

urce

s: 1

1, 1

7-20

1.U

se a

sept

ic te

chni

que

whe

n pr

epar

ing

and

adm

inist

erin

g m

edic

atio

ns

2.Di

sinfe

ct th

e ac

cess

dia

phra

gms o

f med

icat

ion

vial

s bef

ore

inse

rtin

g a

devi

ce in

to th

e vi

al

3.U

se n

eedl

es a

nd sy

ringe

s for

one

pat

ient

onl

y (t

his i

nclu

des

man

ufac

ture

d pr

efill

ed sy

ringe

s and

car

trid

ge d

evic

es su

ch a

s ins

ulin

pe

ns).

4.En

ter m

edic

atio

n co

ntai

ners

with

a n

ew n

eedl

e an

d a

new

syrin

ge, e

ven

whe

n ob

tain

ing

addi

tiona

l dos

es fo

r the

sam

e pa

tient

. 5.

Ensu

re si

ngle

-dos

e or

sing

le-u

se v

ials,

am

pule

s, a

nd b

ags o

r bot

tles o

f pa

rent

eral

solu

tion

are

used

for o

ne p

atie

nt o

nly.

6.

Use

flui

d in

fusio

n or

adm

inist

ratio

n se

ts (e

.g.,

intr

aven

ous t

ubin

g) fo

r on

e pa

tient

onl

y 7.

Dedi

cate

mul

tidos

e vi

als t

o a

singl

e pa

tient

whe

neve

r pos

sible

. If

mul

tidos

e vi

als a

re u

sed

for m

ore

than

one

pat

ient

, res

tric

t the

m

edic

atio

n vi

als t

o a

cent

raliz

ed m

edic

atio

n ar

ea a

nd d

o no

t brin

g th

em

into

the

imm

edia

te p

atie

nt tr

eatm

ent a

rea

(e.g

., op

erat

ing

room

, pa

tient

room

/cub

icle

) 8.

Wea

r a fa

cem

ask

whe

n pl

acin

g a

cath

eter

or i

njec

ting

mat

eria

l int

o th

e ep

idur

al o

r sub

dura

l spa

ce (e

.g.,

durin

g m

yelo

gram

, epi

dura

l or s

pina

l an

esth

esia

)

Refe

r to

“Gui

delin

e fo

r Iso

latio

n Pr

ecau

tions

: Pre

vent

ing

Tran

smiss

ion

of In

fect

ious

Age

nts i

n He

alth

care

Set

tings

, 20

07”

for d

etai

ls.

89

Page 90: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Core

Infe

ctio

n Pr

even

tion

and

Cont

rol P

ract

ices

for S

afe

Heal

thca

re D

eliv

ery

in A

ll Se

ttin

gs

Reco

mm

enda

tions

of t

he H

ICPA

C La

st u

pdat

ed: M

arch

15,

201

7 Pa

ge 9

of 1

5

Core

Pra

ctic

e Ca

tego

ry

Core

Pra

ctic

es

Com

men

ts

5d. R

isk

Asse

ssm

ent

with

App

ropr

iate

U

se o

f Per

sona

l Pr

otec

tive

Equi

pmen

t Re

fere

nces

and

re

sour

ces:

7, 1

1, 2

0

1.En

sure

pro

per s

elec

tion

and

use

of p

erso

nal p

rote

ctiv

e eq

uipm

ent (

PPE)

ba

sed

on th

e na

ture

of t

he p

atie

nt in

tera

ctio

n an

d po

tent

ial f

or

expo

sure

to b

lood

, bod

y flu

ids a

nd/o

r inf

ectio

us m

ater

ial:

a.W

ear g

love

s whe

n it

can

be re

ason

ably

ant

icip

ated

that

con

tact

with

bl

ood

or o

ther

pot

entia

lly in

fect

ious

mat

eria

ls, m

ucou

s mem

bran

es,

non-

inta

ct sk

in, p

oten

tially

con

tam

inat

ed sk

in o

r con

tam

inat

ed

equi

pmen

t cou

ld o

ccur

. b.

Wea

r a g

own

that

is a

ppro

pria

te to

the

task

to p

rote

ct sk

in a

nd

prev

ent s

oilin

g of

clo

thin

g du

ring

proc

edur

es a

nd a

ctiv

ities

that

co

uld

caus

e co

ntac

t with

blo

od, b

ody

fluid

s, se

cret

ions

, or

excr

etio

ns.

c.U

se p

rote

ctiv

e ey

ewea

r and

a m

ask,

or a

face

shie

ld, t

o pr

otec

t the

m

ucou

s mem

bran

es o

f the

eye

s, n

ose

and

mou

th d

urin

g pr

oced

ures

an

d ac

tiviti

es th

at c

ould

gen

erat

e sp

lash

es o

r spr

ays o

f blo

od, b

ody

fluid

s, se

cret

ions

and

exc

retio

ns. S

elec

t mas

ks, g

oggl

es, f

ace

shie

lds,

an

d co

mbi

natio

ns o

f eac

h ac

cord

ing

to th

e ne

ed a

ntic

ipat

ed b

y th

e ta

sk p

erfo

rmed

. d.

Rem

ove

and

disc

ard

PPE,

oth

er th

an re

spira

tors

, upo

n co

mpl

etin

g a

task

bef

ore

leav

ing

the

patie

nt’s

room

or c

are

area

. If a

resp

irato

r is

used

, it s

houl

d be

rem

oved

and

disc

arde

d (o

r rep

roce

ssed

if

reus

able

) aft

er le

avin

g th

e pa

tient

room

or c

are

area

and

clo

sing

the

door

. e.

Do n

ot u

se th

e sa

me

gow

n or

pai

r of g

love

s for

car

e of

mor

e th

an

one

patie

nt. R

emov

e an

d di

scar

d di

spos

able

glo

ves u

pon

com

plet

ion

of a

task

or w

hen

soile

d du

ring

the

proc

ess o

f car

e.

f.Do

not

was

h gl

oves

for t

he p

urpo

se o

f reu

se.

2.En

sure

that

hea

lthca

re p

erso

nnel

hav

e im

med

iate

acc

ess t

o an

d ar

e tr

aine

d an

d ab

le to

sele

ct, p

ut o

n, re

mov

e, a

nd d

ispos

e of

PPE

in a

m

anne

r tha

t pro

tect

s the

mse

lves

, the

pat

ient

, and

oth

ers

PPE,

e.g

., gl

oves

, gow

ns, f

ace

mas

ks, r

espi

rato

rs,

gogg

les a

nd fa

ce sh

ield

s, c

an b

e ef

fect

ive

barr

iers

to

tran

smiss

ion

of in

fect

ions

but

are

seco

ndar

y to

the

mor

e ef

fect

ive

mea

sure

s suc

h as

adm

inist

rativ

e an

d en

gine

erin

g co

ntro

ls.

Refe

r to

“Gui

delin

e fo

r Iso

latio

n Pr

ecau

tions

: Pre

vent

ing

Tran

smiss

ion

of In

fect

ious

Age

nts i

n He

alth

care

Set

tings

, 20

07”

as w

ell a

s Occ

upat

iona

l Saf

ety

and

Heal

th

Adm

inist

ratio

n (O

SHA)

requ

irem

ents

for d

etai

ls.

5e. M

inim

izin

g Po

tent

ial E

xpos

ures

Re

fere

nces

and

re

sour

ces:

1, 7

, 11,

16

1.U

se re

spira

tory

hyg

iene

and

cou

gh e

tique

tte

to re

duce

the

tran

smiss

ion

of re

spira

tory

infe

ctio

ns w

ithin

the

faci

lity.

2.

Prom

pt p

atie

nts a

nd v

isito

rs w

ith sy

mpt

oms o

f res

pira

tory

infe

ctio

n to

co

ntai

n th

eir r

espi

rato

ry se

cret

ions

and

per

form

han

d hy

gien

e af

ter

cont

act w

ith re

spira

tory

secr

etio

ns b

y pr

ovid

ing

tissu

es, m

asks

, han

d hy

gien

e su

pplie

s and

inst

ruct

iona

l sig

nage

or h

ando

uts a

t poi

nts o

f en

try

and

thro

ugho

ut th

e fa

cilit

y 3.

Whe

n sp

ace

perm

its, s

epar

ate

patie

nts w

ith re

spira

tory

sym

ptom

s fro

m

othe

rs a

s soo

n as

pos

sible

(e.g

., du

ring

tria

ge o

r upo

n en

try

into

the

faci

lity)

.

Refe

r to

“Gui

delin

e fo

r Iso

latio

n Pr

ecau

tions

: Pr

even

ting

Tran

smiss

ion

of In

fect

ious

Age

nts i

n He

alth

care

Set

tings

, 200

7” fo

r det

ails.

90

Page 91: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Core

Infe

ctio

n Pr

even

tion

and

Cont

rol P

ract

ices

for S

afe

Heal

thca

re D

eliv

ery

in A

ll Se

ttin

gs

Reco

mm

enda

tions

of t

he H

ICPA

C La

st u

pdat

ed: M

arch

15,

201

7 Pa

ge 1

0 of

15

Core

Pra

ctic

e Ca

tego

ry

Core

Pra

ctic

es

Com

men

ts

5f. R

epro

cess

ing

of

Reus

able

Med

ical

Eq

uipm

ent

Refe

renc

es a

nd

reso

urce

s: 2

-4, 7

-8,

11-1

3

1.Cl

ean

and

repr

oces

s (di

sinfe

ct o

r ste

rilize

) reu

sabl

e m

edic

al e

quip

men

t (e

.g.,

bloo

d gl

ucos

e m

eter

s and

oth

er p

oint

-of-c

are

devi

ces,

blo

od

pres

sure

cuf

fs, o

xim

eter

pro

bes,

surg

ical

inst

rum

ents

, end

osco

pes)

pr

ior t

o us

e on

ano

ther

pat

ient

and

whe

n so

iled.

a.

Cons

ult a

nd a

dher

e to

man

ufac

ture

rs’ i

nstr

uctio

ns fo

r rep

roce

ssin

g.

2.M

aint

ain

sepa

ratio

n be

twee

n cl

ean

and

soile

d eq

uipm

ent t

o pr

even

t cr

oss c

onta

min

atio

n.

Man

ufac

ture

r’s in

stru

ctio

ns fo

r rep

roce

ssin

g re

usab

le

med

ical

equ

ipm

ent s

houl

d be

read

ily a

vaila

ble

and

used

to

esta

blish

cle

ar o

pera

ting

proc

edur

es a

nd tr

aini

ng c

onte

nt fo

r th

e fa

cilit

y. In

stru

ctio

ns sh

ould

be

post

ed a

t the

site

whe

re

equi

pmen

t rep

roce

ssin

g is

perf

orm

ed. R

epro

cess

ing

pers

onne

l sho

uld

have

trai

ning

in th

e re

proc

essin

g st

eps a

nd

the

corr

ect u

se o

f PPE

nec

essa

ry fo

r the

task

. Com

pete

ncie

s of

thos

e pe

rson

nel s

houl

d be

doc

umen

ted

initi

ally

upo

n as

signm

ent o

f the

ir du

ties,

whe

neve

r new

equ

ipm

ent i

s in

trod

uced

, and

per

iodi

cally

(e.g

., an

nual

ly).

Addi

tiona

l de

tails

abo

ut re

proc

essin

g es

sent

ials

for f

acili

ties c

an b

e fo

und

in H

ICPA

C’s r

ecom

men

datio

ns E

ssen

tial E

lem

ents

of a

Re

proc

essin

g Pr

ogra

m fo

r Fle

xibl

e En

dosc

opes

(h

ttps

://w

ww

.cdc

.gov

/hic

pac/

reco

mm

enda

tions

/fle

xibl

e-en

dosc

ope-

repr

oces

sing.

htm

l).

Refe

r to

“CDC

Gui

delin

e fo

r Disi

nfec

tion

and

Ster

iliza

tion

in H

ealth

care

Fac

ilitie

s” fo

r det

ails.

6.

Tra

nsm

issi

on-B

ased

Pr

ecau

tions

Re

fere

nces

and

reso

urce

s:

7, 1

1

1.Im

plem

ent a

dditi

onal

pre

caut

ions

(i.e

., Co

ntac

t, Dr

ople

t, an

d/or

Ai

rbor

ne P

reca

utio

ns) f

or p

atie

nts w

ith d

ocum

ente

d or

susp

ecte

d di

agno

ses w

here

con

tact

with

the

patie

nt, t

heir

body

flui

ds, o

r the

ir en

viro

nmen

t pre

sent

s a su

bsta

ntia

l tra

nsm

issio

n ris

k de

spite

adh

eren

ce

to S

tand

ard

Prec

autio

ns

2.Ad

apt t

rans

miss

ion-

base

d pr

ecau

tions

to th

e sp

ecifi

c he

alth

care

sett

ing,

th

e fa

cilit

y de

sign

char

acte

ristic

s, a

nd th

e ty

pe o

f pat

ient

inte

ract

ion.

3.

Impl

emen

t tra

nsm

issio

n-ba

sed

prec

autio

ns b

ased

on

the

patie

nt’s

cl

inic

al p

rese

ntat

ion

and

likel

y in

fect

ion

diag

nose

s (e.

g., s

yndr

omes

su

gges

tive

of tr

ansm

issib

le in

fect

ions

such

as d

iarr

hea,

men

ingi

tis, f

ever

an

d ra

sh, r

espi

rato

ry in

fect

ion)

as s

oon

as p

ossib

le a

fter

the

patie

nt

ente

rs th

e he

alth

care

faci

lity

(incl

udin

g re

cept

ion

or tr

iage

are

as in

em

erge

ncy

depa

rtm

ents

, am

bula

tory

clin

ics o

r phy

sicia

ns’ o

ffice

s) th

en

adju

st o

r disc

ontin

ue p

reca

utio

ns w

hen

mor

e cl

inic

al in

form

atio

n be

com

es a

vaila

ble

(e.g

., co

nfirm

ator

y la

bora

tory

resu

lts).

4.To

the

exte

nt p

ossib

le, p

lace

pat

ient

s who

may

nee

d tr

ansm

issio

n-ba

sed

prec

autio

ns in

to a

sing

le-p

atie

nt ro

om w

hile

aw

aitin

g cl

inic

al

asse

ssm

ent.

5.N

otify

acc

eptin

g fa

cilit

ies a

nd th

e tr

ansp

ortin

g ag

ency

abo

ut su

spec

ted

infe

ctio

ns a

nd th

e ne

ed fo

r tra

nsm

issio

n-ba

sed

prec

autio

ns w

hen

patie

nts a

re tr

ansf

erre

d.

Impl

emen

tatio

n of

Tra

nsm

issio

n-Ba

sed

Prec

autio

ns m

ay

diffe

r dep

endi

ng o

n th

e pa

tient

car

e se

ttin

gs (e

.g.,

inpa

tient

, out

patie

nt, l

ong-

term

car

e), t

he fa

cilit

y de

sign

char

acte

ristic

s, a

nd th

e ty

pe o

f pat

ient

inte

ract

ion,

and

sh

ould

be

adap

ted

to th

e sp

ecifi

c he

alth

care

sett

ing.

Refe

r to

“Gui

delin

e fo

r Iso

latio

n Pr

ecau

tions

: Pre

vent

ing

Tran

smiss

ion

of In

fect

ious

Age

nts i

n He

alth

care

Set

tings

, 20

07”

for d

etai

ls.

91

Page 92: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Core

Infe

ctio

n Pr

even

tion

and

Cont

rol P

ract

ices

for S

afe

Heal

thca

re D

eliv

ery

in A

ll Se

ttin

gs

Reco

mm

enda

tions

of t

he H

ICPA

C La

st u

pdat

ed: M

arch

15,

201

7 Pa

ge 1

1 of

15

Core

Pra

ctic

e Ca

tego

ry

Core

Pra

ctic

es

Com

men

ts

7. T

empo

rary

inva

sive

M

edic

al D

evic

es fo

r Clin

ical

M

anag

emen

t Re

fere

nces

and

reso

urce

s:

8, 1

1.Du

ring

each

hea

lthca

re e

ncou

nter

, ass

ess t

he m

edic

al n

eces

sity

of a

ny

inva

sive

med

ical

dev

ice

(e.g

., va

scul

ar c

athe

ter,

indw

ellin

g ur

inar

y ca

thet

er, f

eedi

ng tu

bes,

ven

tilat

or, s

urgi

cal d

rain

) in

orde

r to

iden

tify

the

earli

est o

ppor

tuni

ty fo

r saf

e re

mov

al.

2.En

sure

that

hea

lthca

re p

erso

nnel

adh

ere

to re

com

men

ded

inse

rtio

n an

d m

aint

enan

ce p

ract

ices

Early

and

pro

mpt

rem

oval

of i

nvas

ive

devi

ces s

houl

d be

par

t of

the

plan

of c

are

and

incl

uded

in re

gula

r ass

essm

ent.

Heal

thca

re p

erso

nnel

shou

ld b

e kn

owle

dgea

ble

rega

rdin

g ris

ks o

f the

dev

ice

and

infe

ctio

n pr

even

tion

inte

rven

tions

as

soci

ated

with

the

indi

vidu

al d

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Table References 1. Bolyard EA. Tablan OC, Williams WW, Pearson ML, Shapiro CN, Deitchmann SD. Guideline for

Infection Control in Healthcare Personnel, 1998. Hospital Infection control Practices Advisory committee. Infect Control Hosp Epidemiol. 1998 Jun; 19(6):407-63. (Available at https://stacks.cdc.gov/view/cdc/7250.)

2. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Hospital Infection Control Practices Advisory committee. Infect control Hosp Epidemiol 1999 Apr 20(4):250-78. (Available at https://stacks.cdc.gov/view/cdc/7160.)

3. Boyce JM, Pittet D, Healthcare Infection control Practices Advisory Committee, Society for Healthcare Epidemiology of America, Association for Professionals in Infection control, Infectious Diseases Society of America, Hand Hygiene Task Force. Guideline for Hand Hygiene in Health-Care Settings: recommendation of the Healthcare Infection Control Practices Advisory committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Infect control Hosp Epidemiol. 2002 Dec 23(12 Suppl):S3-40. (Available at https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm.)

4. Sehulster L, Chin RY, Healthcare Infection Control Practices Advisory Committee. Guidelines for Environmental Infection Control in Health-Care Facilities. Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. MMWR Recomm Rep 2003 Jun 6:52(RR-10):1-42. (Available at https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines.pdf [PDF - 2.31 MB].)

5. Jensen PA, Lambert LA, Iademarco MF, Ridzon R. Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005. MMWR Recomm Rep. 2005 Dec 30:54(RR-17):1-141. (Available at https://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf [PDF - 4.15 MB].)

6. Siegel JD, Rhinehart E, Jackson M, Chiarello L, Healthcare Infection Control Practices Advisory Committee. Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006. Am J Infect control, 2007 Dec 35 (10 Suppl 2):S165-93. (Available at https://www.cdc.gov/infectioncontrol/pdf/guidelines/mdro-guidelines.pdf [PDF - 553 KB].)

7. Siegel JD, Rhinehart E, Jackson M, Chiarello L, Healthcare Infection Control Practices Advisory Committee. 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. Am J Infect Control. 2007 Dec 35(10 Suppl 2)S65-164. (Available at https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines.pdf [PDF - 1.42 MB].)

8. Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA, Healthcare Infection Control Practices Advisory committee, Guideline for Prevention of Catheter-Associated Urinary Tract Infection 2009. Infect control Hosp Epidemiol, 2010 Apr 31(4):319-26. (Available at https://www.cdc.gov/infectioncontrol/pdf/guidelines/cauti-guidelines.pdf [PDF - 650 KB].)

9. Centers for Disease Control and Prevention. Guidance for Control of Infections with Carbapenem-Resistant or Carbapenemase-Producing Enterobacteriaceae in Acute Care Facilities. MMWR 2009 Mar 20:58 (10):256-60. (Available at https://www.cdc.gov/hai/pdfs/cre/cre-guidance-508.pdf [PDF - 381 KB].)

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10. Division of Viral Disease, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention. Updated Norovirus Outbreak Management and Disease Prevention Guidelines. MMWR 2011 Mar 4:60(RR-3):1-18. (Available at https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6003a1.htm.)

11. O’Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad I, Randolph AG, Rupp ME, Saint S, Healthcare Infection Control Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-Related Infections. Am J Infect Control. 2011 May 39(4 Suppl 1):S1-34. (Available at https://www.cdc.gov/infectioncontrol/pdf/guidelines/bsi-guidelines.pdf [PDF - 678 KB].)

12. Centers for Disease Control and Prevention. Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care. November, 2015. (Available at https://www.cdc.gov/infectioncontrol/pdf/outpatient/guide.pdf [PDF - 1.43 MB].)

13. Rutala WA, Weber DJ, Healthcare Infection Control Practices Advisory Committee. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Am J Infect Control.2013;41(5 Suppl):S67-71. (Available at https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf [PDF - 1.26 MB].)

14. Tablan OC, Anderson LJ, Besser R, Bridges C, Haijeh R, Healthcare Infection Control Practices Advisory Committee. Guidelines for Preventing Healthcare-associated Pneumonia, 2003 Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. MMWR Recomm Rep 204 Mar 26:53(RR-3):1-26. (Available at https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5303a1.htm.)

15. Centers for Disease Control and Prevention. Immunization of Healthcare Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011 Nov 25:60(RR-7):1-45. (Available at https://www.cdc.gov/mmwr/pdf/rr/rr6007.pdf [PDF - 705 KB].)

16. Centers for Disease Control and Prevention. Injection safety materials. (Available at https://www.cdc.gov/injectionsafety/.)

17. Centers for Disease Control and Prevention. The One & Only Campaign injection safety training materials. (Available at https://www.cdc.gov/injectionsafety/1anonly.html.)

18. U.S. Public Health Service Working Group on Occupational Postexposure Prophylaxis, Kuhar DT, Henderson DK, et. al., Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis. September, 2013. (Available at https://stacks.cdc.gov/view/cdc/20711.)

19. US Department of Labor. Occupational Safety & Health Administration. 29 CFR 1910.1030 Bloodborne Pathogens. March 6, 1992. (Available at https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10051&p_table=STANDARDS.)

20. Centers for Disease Control and Prevention. Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients. MMWR. April 27, 2001 / 50(RR05);1-43. (Available at https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm.)

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Suggested Citation Healthcare Infection Control Practices Advisory Committee. Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings–Recommendations of the Healthcare Infection Control Practices Advisory Committee (HICPAC) 2017.

Contributors

HICPAC Workgroup Members Ruth M. Carrico, PhD, RN, CIC, HICPAC Member (Workgroup Chair); Gina Pugliese, RN, MS, HICPAC Member (Workgroup Co-Chair); Deborah S. Yokoe, MD, MPH, HICPAC Member (Workgroup Co-Chair); Loretta L. Fauerbach, MS, CIC; Susan Courage, Public Health Agency of Canada; Kathleen Dunn, BScN, MN, RN, Public Health Agency of Canada; Neil O. Fishman, MD, HICPAC; Silvia Munoz-Price, MD, PhD, America’s Essential Hospitals; Michael Anne Preas, RN CIC, Association of Professionals of Infection Control and Epidemiology, Inc. (APIC); Mark E. Rupp, MD, Society for Healthcare Epidemiology of America (SHEA); Sanjay Saint, MD, MPH, Society of Hospital Medicine (SHM); and Rachel Stricof, MPH, Council of State and Territorial Epidemiologists (CSTE).

HICPAC Members Neil O. Fishman, MD, University of Pennsylvania Health System; Hilary M. Babcock, MD, MPH, Washington University School of Medicine; Ruth M. Carrico, PhD, RN, CIC, University of Louisville School of Medicine; Sheri Chernetsky Tejedor, MD, Emory University School of Medicine; Daniel J. Diekema, MD, University of Iowa Carver College of Medicine; Mary K. Hayden, MD, Rush University Medical Center; Susan Huang, MD, MPH; University of California Irvine School of Medicine; W. Charles Huskins, MD, MSc, Mayo Clinic College of Medicine; Lynn Janssen, MS, CIC, CPHQ, California Department of Public Health; Gina Pugliese, RN, MS, Premier Healthcare Alliance; Selwyn O. Rogers Jr., MD, MPH, FACS, The University of Texas Medical Branch; Tom Talbot, MD, MPH, Vanderbilt University Medical Center; Michael L. Tapper, MD, Lenox Hill Hospital; and Deborah S. Yokoe, MD, MPH, Brigham & Women’s Hospital.

HICPAC Ex Officio Members William B. Baine, MD, Agency for Healthcare Research and Quality (AHRQ); David Henderson, MD, National Institutes of Health (NIH); Elizabeth Claverie-Williams, MS, U.S. Food and Drug Administration (FDA); Daniel Schwartz, MD, MBA, Center for Medicare and Medicaid Services (CMS); and Gary A. Roselle, MD, Department of Veterans Affairs (VA); Rebecca Wilson, MPH, CHES, Health Resources and Services Administration (HRSA).

HICPAC Liaison Representatives Kathleen Dunn, BScN, MN, RN, Public Health Agency of Canada; Janet Franck, RN, MBA, CIC, DNV Healthcare, Inc.; Diana Gaviria, MD, MPH, National Association of County and City Health Officials (NACCHO); Michael D. Howell, MD, MPH, Society of Critical Care Medicine (SCCM); Marion Kainer, MD, MPH, Council of State and Territorial Epidemiologists (CSTE); Emily Lutterloh, MD, MPH, Association of State and Territorial Health Officials (ASTHO); Michael Anne Preas, RN CIC, Association of Professionals of Infection Control and Epidemiology, Inc. (APIC); Mark E. Rupp, MD, Society for Healthcare Epidemiology of America (SHEA); Sanjay Saint, MD, MPH, Society of Hospital Medicine

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(SHM); Robert G. Sawyer, MD, FACS, FIDSA, FCCM, Surgical Infection Society (SIS); Margaret VanAmringe, MHS, The Joint Commission; and Amber Wood, MSN, RN, CNOR, CIC, CPN, Association of periOperative Registered Nurses (AORN).

Acknowledgments Melissa Schaefer, MD; Joseph Perz, DrPH; Michael Bell, MD; Erin Stone, MA; and Jeffrey Hageman, MHS, the Division of Healthcare Quality Promotion (DHQP), the Centers for Disease Control and Prevention.

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PATIENTS AND VISITORS

K N OW T H E T R U T H TO P R OT E C TYO U R S E L F F R O M S E R I O U S I N F E C T I O N S

TRUTH On average, healthcare providers clean their hands less than half of the times they should.

THE NITTY GRITTY:This can put you at risk for a serious infection. It’s OK to ask your care team questions like, “Before you start the exam, would you mind cleaning your hands again?” Another way to bring it up is to thank them for cleaning their hands if you are uncomfortable asking.

TRUTH Alcohol-based hand sanitizer kills most of the bad germs that make you sick.

THE NITTY GRITTY:Your hands have good germs on them that your body needs to stay healthy. Your hands can also have bad germs on them that make you sick. Alcohol-based hand sanitizers kill the good and bad germs, but the good germs quickly come back on your hands.

TRUTH Alcohol-based hand sanitizer does not kill C. difficile.

THE NITTY GRITTY:If you have a C. difficile infection, make sure your healthcare providers wear gloves to examine you. You and your loved ones should wash your hands with soap and water to prevent the spread of C. difficile.

WHAT IS C. DIFFICILE?C. difficile or “C. diff” is a common healthcare-associated infection that causes severe diarrhea.

TRUTH Alcohol-based hand sanitizer does not create antibiotic-resistant superbugs.

THE NITTY GRITTY:Alcohol-based hand sanitizers kill germs quickly and in a different way than antibiotics. Using alcohol-based hand sanitizers to clean your hands does not cause antibiotic resistance.

ALCOHOL-BASED HAND SANITIZERis a product that contains at least 60% alcohol to kill germs on the hands.

TRUTH Your hands can spread germs.

THE NITTY GRITTY :Make sure you and your visitors are cleaning your hands at these important times:

www.cdc.gov/Hand Hygiene

This material was developed by CDC. The Clean Hands Count Campaign is made possible by a partnership between the CDC Foundation and GOJO.

ReferenceCDC

3.3

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2-5. Personal Protective Equipment Competency

Personal Protective Equipment (PPE) Competency Validation

DonningandDoffing

StandardPrecautionsandTransmissionBasedPrecautions

Typeofvalidation:Returndemonstration

Orientation

Annual

Other

EmployeeName: JobTitle:

Donning PPECompetent

YES NO

1. PerformHandHygiene

2. Don Gown:

Fullycoveringtorsofromnecktoknees,armstoendofwrists

3. Tie/fasteninbackofneckandwaist

4. Don Mask/Respirator:

Secureties/elasticbandsatmiddleofhead&neck

5. Fitflexiblebandtonosebridge

6. Fitsnugtofaceandbelowchin(Fit-checkrespiratorifapplicable)

7. Don Goggles or Face Shield:

Placeoverfaceandeyes;adjusttofit

8. Don Gloves:

Extendtocoverwristofgown

Doffing PPE

9. Remove Gloves:

Graspoutsideofglovewithoppositeglovedhand;peeloff

10.Holdremovedgloveinglovedhand

11. Slidefingersofunglovedhandunderremaininggloveatwrist

12.Peelgloveoffoverfirstglove

13.Discardglovesinwastecontainer

14.Remove Goggles or Face Shield:

Handlebyheadbandorearpieces

15.Discardindesignatedreceptacleifre-processedorinwastecontainer

16.Remove Gown:

Unfastenties/fastener

Forms & Checklists for Infection Prevention, Volume 1 673.4

2-5. Personal Protective Equipment Competency

Personal Protective Equipment (PPE) Competency Validation

DonningandDoffing

StandardPrecautionsandTransmissionBasedPrecautions

Typeofvalidation:Returndemonstration

Orientation

Annual

Other

EmployeeName: JobTitle:

Donning PPECompetent

YES NO

1. PerformHandHygiene

2. Don Gown:

Fullycoveringtorsofromnecktoknees,armstoendofwrists

3. Tie/fasteninbackofneckandwaist

4. Don Mask/Respirator:

Secureties/elasticbandsatmiddleofhead&neck

5. Fitflexiblebandtonosebridge

6. Fitsnugtofaceandbelowchin(Fit-checkrespiratorifapplicable)

7. Don Goggles or Face Shield:

Placeoverfaceandeyes;adjusttofit

8. Don Gloves:

Extendtocoverwristofgown

Doffing PPE

9. Remove Gloves:

Graspoutsideofglovewithoppositeglovedhand;peeloff

10.Holdremovedgloveinglovedhand

11. Slidefingersofunglovedhandunderremaininggloveatwrist

12.Peelgloveoffoverfirstglove

13.Discardglovesinwastecontainer

14.Remove Goggles or Face Shield:

Handlebyheadbandorearpieces

15.Discardindesignatedreceptacleifre-processedorinwastecontainer

16.Remove Gown:

Unfastenties/fastener

Forms & Checklists for Infection Prevention, Volume 1 67

2-5. Personal Protective Equipment Competency

Personal Protective Equipment (PPE) Competency Validation

DonningandDoffing

StandardPrecautionsandTransmissionBasedPrecautions

Typeofvalidation:Returndemonstration

Orientation

Annual

Other

EmployeeName: JobTitle:

Donning PPECompetent

YES NO

1. PerformHandHygiene

2. Don Gown:

Fullycoveringtorsofromnecktoknees,armstoendofwrists

3. Tie/fasteninbackofneckandwaist

4. Don Mask/Respirator:

Secureties/elasticbandsatmiddleofhead&neck

5. Fitflexiblebandtonosebridge

6. Fitsnugtofaceandbelowchin(Fit-checkrespiratorifapplicable)

7. Don Goggles or Face Shield:

Placeoverfaceandeyes;adjusttofit

8. Don Gloves:

Extendtocoverwristofgown

Doffing PPE

9. Remove Gloves:

Graspoutsideofglovewithoppositeglovedhand;peeloff

10.Holdremovedgloveinglovedhand

11. Slidefingersofunglovedhandunderremaininggloveatwrist

12.Peelgloveoffoverfirstglove

13.Discardglovesinwastecontainer

14.Remove Goggles or Face Shield:

Handlebyheadbandorearpieces

15.Discardindesignatedreceptacleifre-processedorinwastecontainer

16.Remove Gown:

Unfastenties/fastener

Forms & Checklists for Infection Prevention, Volume 1 67

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17.Pullawayfromneckandshoulders,touchinginsideofgownonly

18.Turngowninsideout

19.Foldorrollintobundleanddiscard

20.Remove Mask/Respirator(respiratorremovedafterexitroom/closed

door):Graspbottom,thentoptiesorelasticsandremove

21.Discardinwastecontainer

22.PerformHandHygiene

Standard Precautions & Transmission Based PrecautionsCompetent

YES NO

21.StaffcorrectlyidentifiestheappropriatePPEforthefollowingscenarios:

a. StandardPrecautions(PPEtobewornbasedonanticipatedlevelof

exposure)*

b.Contact/ContactEntericPrecautions(gown&gloves)

c. DropletPrecautions(surgicalmask)

d.AirbornePrecautions(fit-testedrespiratorifapplicable)

*NOTE: Examples include: mask for coughing/vomiting patient, goggles/face shield for irrigating draining wound, gown for dressing change if scrubs may touch patient, etc.

Comments or follow up actions:

EmployeeSignature

ValidatorSignature /Date

References CDCathttp://www.cdc.gov/HAI/pdfs/ppe/ppeposter148.pdf NCSPICE;9-2016

Forms & Checklists for Infection Prevention, Volume 168

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SEQUENCE FOR PUTTING ON PERSONAL PROTECTIVE EQUIPMENT (PPE)

ThetypeofPPEusedwillvarybasedonthelevelofprecautionsrequired,suchasstandardandcontact,dropletorairborneinfectionisolationprecautions.TheprocedureforputtingonandremovingPPEshouldbetailoredtothespecifictypeofPPE.

1. GOWN• Fullycovertorsofromnecktoknees,armstoendofwrists,andwraparoundtheback

• Fasteninbackofneckandwaist

2. MASK OR RESPIRATOR• Securetiesorelasticbandsatmiddleofheadandneck

• Fitflexiblebandtonosebridge• Fitsnugtofaceandbelowchin• Fit-checkrespirator

3. GOGGLES OR FACE SHIELD• Placeoverfaceandeyesandadjusttofit

4. GLOVES• Extendtocoverwristofisolationgown

USE SAFE WORK PRACTICES TO PROTECT YOURSELF AND LIMIT THE SPREAD OF CONTAMINATION

• Keephandsawayfromface• Limitsurfacestouched• Changegloveswhentornorheavilycontaminated• Performhandhygiene

3.5

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HOW TO SAFELY REMOVE PERSONAL PROTECTIVE EQUIPMENT (PPE) EXAMPLE 1ThereareavarietyofwaystosafelyremovePPEwithoutcontaminatingyourclothing,skin,ormucousmembraneswithpotentiallyinfectiousmaterials.Hereisoneexample.Remove all PPE before exiting the patient roomexceptarespirator,ifworn.Removetherespiratorafterleavingthepatientroomandclosingthedoor.RemovePPEinthefollowingsequence:

1. GLOVES• Outsideofglovesarecontaminated!• Ifyourhandsgetcontaminatedduringgloveremoval,immediately

washyourhandsoruseanalcohol-basedhandsanitizer• Usingaglovedhand,graspthepalmareaoftheotherglovedhand

andpeelofffirstglove• Holdremovedgloveinglovedhand• Slidefingersofunglovedhandunderremaininggloveatwristand

peeloffsecondgloveoverfirstglove• Discardglovesinawastecontainer

2. GOGGLES OR FACE SHIELD• Outsideofgogglesorfaceshieldarecontaminated!• Ifyourhandsgetcontaminatedduringgoggleorfaceshieldremoval,

immediatelywashyourhandsoruseanalcohol-basedhandsanitizer• Removegogglesorfaceshieldfromthebackbyliftingheadbandor

earpieces• Iftheitemisreusable,placeindesignatedreceptaclefor

reprocessing.Otherwise,discardinawastecontainer

3. GOWN• Gownfrontandsleevesarecontaminated!• Ifyourhandsgetcontaminatedduringgownremoval,immediately

washyourhandsoruseanalcohol-basedhandsanitizer• Unfastengownties,takingcarethatsleevesdon’tcontactyourbody

whenreachingforties• Pullgownawayfromneckandshoulders,touchinginsideofgownonly• Turngowninsideout• Foldorrollintoabundleanddiscardinawastecontainer

4. MASK OR RESPIRATOR• Frontofmask/respiratoriscontaminated—DONOTTOUCH!• Ifyourhandsgetcontaminatedduringmask/respiratorremoval,

immediatelywashyourhandsoruseanalcohol-basedhandsanitizer• Graspbottomtiesorelasticsofthemask/respirator,thentheonesat

thetop,andremovewithouttouchingthefront• Discardinawastecontainer

OR5. WASH HANDS OR USE AN

ALCOHOL-BASED HAND SANITIZERIMMEDIATELY AFTER REMOVINGALL PPE

PERFORM HAND HYGIENE BETWEEN STEPS IF HANDS BECOME CONTAMINATED AND IMMEDIATELY AFTER REMOVING ALL PPE

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HOW TO SAFELY REMOVE PERSONAL PROTECTIVE EQUIPMENT (PPE) EXAMPLE 2

HereisanotherwaytosafelyremovePPEwithoutcontaminatingyourclothing,skin,ormucousmembraneswithpotentiallyinfectiousmaterials.Remove all PPE before exiting the patient room exceptarespirator,ifworn.Removetherespirator after leavingthepatientroomandclosingthedoor.RemovePPEinthefollowingsequence:

1. GOWN AND GLOVES• Gownfrontandsleevesandtheoutsideofglovesare

contaminated!• Ifyourhandsgetcontaminatedduringgownorgloveremoval,

immediatelywashyourhandsoruseanalcohol-basedhandsanitizer

• Graspthegowninthefrontandpullawayfromyourbodysothatthetiesbreak,touchingoutsideofgownonlywithglovedhands

• Whileremovingthegown,foldorrollthegowninside-outintoabundle

• Asyouareremovingthegown,peeloffyourglovesatthesametime,onlytouchingtheinsideoftheglovesandgownwithyourbarehands.Placethegownandglovesintoawastecontainer

A B

D E

C

2. GOGGLES OR FACE SHIELD• Outsideofgogglesorfaceshieldarecontaminated!• Ifyourhandsgetcontaminatedduringgoggleorfaceshieldremoval,

immediatelywashyourhandsoruseanalcohol-basedhandsanitizer• Removegogglesorfaceshieldfromthebackbyliftingheadbandand

withouttouchingthefrontofthegogglesorfaceshield• Iftheitemisreusable,placeindesignatedreceptaclefor

reprocessing.Otherwise,discardinawastecontainer

3. MASK OR RESPIRATOR• Frontofmask/respiratoriscontaminated—DONOTTOUCH!• Ifyourhandsgetcontaminatedduringmask/respiratorremoval,

immediatelywashyourhandsoruseanalcohol-basedhandsanitizer• Graspbottomtiesorelasticsofthemask/respirator,thentheonesat

thetop,andremovewithouttouchingthefront• Discardinawastecontainer

OR

4. WASH HANDS OR USE ANALCOHOL-BASED HAND SANITIZERIMMEDIATELY AFTER REMOVINGALL PPE

PERFORM HAND HYGIENE BETWEEN STEPS IF HANDS BECOME CONTAMINATED AND IMMEDIATELY AFTER REMOVING ALL PPE

Reference CDC

102

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o

despues de toser o estornudar.

o

Minnesota Department of Health717 SE Delaware StreetMinneapolis, MN 55414612-676-5414 or 1-877-676-5414www.health.state.mn.us

MinnesotaAntibioticResistance Collaborative

Cubretetoseral

Deten el contagio de germenes que te enferman a ti y a otros!

cúbrete con la partesuperior del brazo cuandotosas o estornudes, nocon las manos.

Cúbrete la boca y la narizcon un panuelo cuandotosas o estornudes

Tira el panuelo usadoa la basura.

Lávate las manos conagua tibia y jabón

utiliza un limpiadorde manos a base de alcohol.

`

~

``

` `

~

!

Lavatemanoslas

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CS 280522A

Handwashing at Home, at Play, and Out and About

Germs are everywhere! They can get onto your hands and items you touch throughout the day. Washing hands at key times with soap and water is one of the most important steps you can take to get rid of germs and avoid spreading germs to those around you.

How can washing your hands keep you healthy? Germs can get into the body through our eyes, nose, and mouth and make us sick. Handwashing with soap removes germs from hands and helps prevent sickness. Studies have shown that handwashing can prevent 1 in 3 diarrhea-related sicknesses and 1 in 5 respiratory infections, such as a cold or the flu.

Handwashing helps prevent infections for these reasons:

People often touch their eyes, nose, and mouth without realizing it, introducing germs into their bodies.

Germs from unwashed hands may get into foods and drinks when people prepare or consume them. Germs can grow in some types of foods or drinks and make people sick.

Germs from unwashed hands can be transferred to other objects, such as door knobs, tables, or toys, and then transferred to another person’s hands.

What is the right way to wash your hands? 1. Wet your hands with clean running water (warm or cold) and

apply soap.

2. Lather your hands by rubbing them together with the soap.

3. Scrub all surfaces of your hands, including the palms, backs, fingers, between your fingers, and under your nails. Keep scrubbing for at least 20 seconds. Need a timer? Hum the “Happy Birthday” song twice.

4. Rinse your hands under clean, running water.

5. Dry your hands using a clean towel or air dry them.

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Lavado de manos en casa, en donde jugamos y cuando salimos

¡Los microbios están en todas partes! Pueden llegar a sus manos y a los objetos que toca a lo largo de todo el día. Lavarse las manos con agua y jabón en momentos clave es una de las medidas más importantes que puede tomar para librarse de los microbios y evitar transmitirlos a quienes lo rodean.

¿Cómo es que lavarse las manos lo mantiene sano? Los microbios pueden entrar al cuerpo a través de los ojos, la nariz y la boca, y enfermarnos. Lavarse las manos con jabón elimina los microbios que estén en ellas y ayuda a prevenir las enfermedades. Los estudios han mostrado que lavarse las manos puede prevenir 1 de cada 3 enfermedades diarreicas y 1 de cada 5 infecciones respiratorias, como el resfriado o la influenza (gripe).

Lavarse las manos ayuda a prevenir infecciones por estas razones:

Con frecuencia, las personas se tocan los ojos, la nariz y la boca sin darse cuenta, y de ese modo introducen microbios en el cuerpo.

Los microbios de las manos que no se lavaron pueden llegar a los alimentos y a las bebidas cuando las personas los preparan o los consumen. Los microbios pueden multiplicarse en algunos tipos de alimentos o bebidas y causarles enfermedades a las personas.

Los microbios de las manos sin lavar pueden transferirse a otros objetos, como las manijas de las puertas, las mesas o los juguetes y, luego, transferirse a las manos de otra persona.

¿Cuál es la forma correcta de lavarse las manos? 1. Mójese las manos con agua corriente limpia (tibia o fría) y enjabónelas.

2. Frótese las manos con jabón, formando espuma.

3. Frote todas las superficies, incluidos los dedos, entre los dedos, debajo de las uñas, las palmas y el dorso de las manos. Siga frotándose las manos por al menos 20 segundos. ¿Necesita un reloj? Tararee dos veces la canción “Cumpleaños feliz”.

4. Enjuáguese las manos con agua corriente limpia.

5. Séquese las manos con una toalla limpia o al aire.

CS 280522A MLS-283078

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3.8

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Major Article

Health care worker hand contamination at critical moments inoutpatient care settings

James Bingham MS a,*, Ginnie Abell BA, RN, CIC b, LeAnne Kienast BS a,Lorie Lerner MSN, MDiv, RN, CNS c, Brittney Matuschek BS a,Wanda Mullins MPH, BSN, RN, CIC d, Albert Parker PhD e, Nancy Reynolds BSN, RN, CIC b,Diane Salisbury MSN, RN, CIC f, Joan Seidel MA, BSN, RN, CIC g,Elizabeth Young BSN, RN, CIC h, Jane Kirk MSN, RN, CIC a

a GOJO Industries, Inc, Akron, OHb Summa Health System, Akron, OHc LJL Consulting, Akron, OHd Cleveland Clinic Akron General, Akron, OHe Center for Biofilm Engineering, Department of Mathematical Sciences, Montana State University, Bozeman, MTf Salisbury IP Consulting, LLC, Akron, OHg University Hospitals Portage Medical Center, Ravenna, OHh Infection Prevention Consultant, Vermilion, OH

Key Words:Hand hygieneAmbulatory careWHO 5 MomentsGloveWound careStandard precautions

Background: The delivery of health care in outpatient settings has steadily increased over the past 40years. The risk of infection in these settings is considered to be low. However, the increasing severity ofillness and complexity of care in outpatient settings creates a need to reexamine the transmission of patho-gens in this setting.Materials and Methods: Seventeen health care workers from 4wound care facilities were sampled during46 patient care encounters to determine the presence of health care-associated pathogens (ie, methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus, multidrug-resistant Acinetobacter species,and Clostridium difficile) on their hands at key moments of care.Results: Health care workers acquired at least 1 pathogen on their hands during 28.3% of all patient careencounters. Hands sampled before a clean or aseptic procedure and hands sampled after body fluid ex-posure risk were each contaminated in 17.4% of instances. Hand contamination occurred in 19.6% of instanceswhere health care workers wore gloves during care compared with 14.6% when health care workers wereungloved.Conclusions: Contamination of health care workers’ hands presents a significant risk of pathogen trans-mission in outpatient settings. Gloving education, hand hygiene solutions at the point of care, and handhygiene surveillance are important solutions for reducing transmission of pathogenic organisms.© 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier

Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

BACKGROUND

Thedeliveryof health carehas transitioned fromcentralized, acutecare hospitals to community-based outpatient (ambulatory) caresettings over thepast several decades.Outpatient care settings consist

of physician offices, hospital emergency departments, hospital andnonhospital-basedclinics, surgical centers, andmanyother specializedservice centers.1,2 During the 10-year period from 1997-2007, out-patient care visits increased by 25% to an estimated 1.2 billion visitswith a rate of 4 visits per year per person.3 The rise in utilization ofoutpatient care centershasbeenattributed toadvancement inmedicaltechnology, insurance reimbursement, convenienceof care, andeffortsto control health care costs.

Infection prevention infrastructure and resources in outpatientsettings are often not equivalent to those of acute care hospitals.4,5

The lack of infection prevention resources combined with the

* Address correspondence to James Bingham, MS, GOJO Industries, Inc, PO Box 991,Akron, OH 44309.

E-mail address: [email protected] (J. Bingham).Conflicts of Interest: None to report.

0196-6553/© 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).http://dx.doi.org/10.1016/j.ajic.2016.04.208

American Journal of Infection Control 44 (2016) 1198-202

Contents lists available at ScienceDirect

American Journal of Infection Control

journal homepage: www.aj ic journal .org

American Journal of Infection Control

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increasing severity of illness, increasingly complicated proce-dures, and time pressure make infection prevention programs andpractices critical to protect patients and health care workers (HCWs)from health care-associated infections (HAIs) in outpatient set-tings. In 2014, the Centers for Disease Control and Prevention (CDC)updated the guide to infection prevention in outpatient settings tohighlight the need for dedicated infection prevention staff, train-ing, HAI surveillance, and the use of standard precautions.1 Inaddition, the World Health Organization (WHO) adapted their rec-ommendations on hand hygiene best practices for outpatientsettings.2

Hand hygiene is among the most important measures to preventthe transmission and acquisition of HAIs.6 The WHO has defined 5key moments for hand hygiene in outpatient care settings and CDChas suggested 6 key situations when hand hygiene should beperformed.6,7 Despite the hand hygiene recommendations, the sci-entific evidence of microbial transmission during critical momentsof care in outpatient care settings is limited.2 In this study, theprimary research objective was to quantify the presence of healthcare-associated pathogens on the hands of HCWs at 2 of the keymoments for hand hygiene in an outpatient care setting and to de-termine the influence of glove use. In addition, the study sought toclarify the distribution of hand contamination among HCWs in out-patient care facilities.

MATERIALS AND METHODS

Study design

The institutional review board at each facility approved the study.HCWs at 4 wound care facilities in northeastern Ohio were invitedto participate on each day of sampling and those who chose to par-ticipate signed an informed consent. Sampling took place on 2separate days at each facility. Participants were asked to performroutine patient care activities, including hand hygiene, with no de-viation from their routine practices, except requiring hand hygienebefore entering the examination room. Research staff monitored andrecorded the application of hand hygiene before entering the ex-amination room. For this study, a patient care encounter was definedas the entire care process for 1 patient, including patient rooming,initial patient contact, wound care, and patient discharge. Duringthe patient care encounter hand samples were taken before per-forming a clean or aseptic procedure (WHO moment 2) and aftergloves were removed following body fluid exposure risk (WHOmoment 3). In this study moment 2 corresponded to the momentimmediately before wound treatment and moment 3 corresponded

to the moment immediately after wound treatment (Fig 1). WHOmoments 2 and 3 relate to the moments in the Canadian guide-lines 4 moments and are similar to the indications for hand hygienerecommended in the CDC guidelines. Only paired samples takenbefore moment 2 and after moment 3 from the same patient wereincluded in the results. Participants were allowed to be sampledwhile giving care to a maximum of 3 patients (ie, 6 total samples)per day to limit workflow disruption. Samples were only taken fromHCWs who were providing care during the entire patient encoun-ter of a single patient (ie, rooming to exam conclusion). Whenmultiple patient encounters were sampled from the same HCWduring the same clinic day, the encounters sampled were alwaystaken sequentially and never occurred simultaneously. Observa-tion of hand hygiene upon room entry and self-reported glove usewere recorded during patient care. Three of the facilities followedCDC hand hygiene guidelines, whereas 1 facility followed the WHOguidelines.

Hand sampling

A hand sampling method described in the American Society forTesting and Materials Standard Test Method E1115-10 was used torecover bacteria from HCWs’ hands. Briefly, a sterile, powder-freesurgical glove was placed on the dominant hand of the partici-pant, and 50 mL sterile sampling solution (0.075 mol/L phosphatebuffer, pH 7.9, containing 0.1% polysorbate 80, 0.1% sodium thio-sulfate, and 0.3% lecithin) was added to the glove. The glove wassecured at the wrist with a tourniquet, and the gloved hand wasuniformly massaged for 1 minute by the research staff. While theglove remained on the hand, 20 mL sampling solution was asepti-cally removed from the glove and placed in a sterile sample cup.After sampling, the participants washed hands to remove any re-sidual sampling solution.

Bacteria recovery and identification

The sampled solution was centrifuged at 10,000 g for 10minutes,and 15 mL supernatant was discarded. The pellet was resus-pended in the remaining 5 mL supernatant, and the concentratedsample was plated on various growth media. The limit of detec-tion for the identification of each pathogen was 250 CFU per hand.The identification of methicillin-resistant Staphylococcus aureus(MRSA), vancomycin-resistant Enterococcus (VRE), multidrug resis-tant Acinetobacter sp, and Clostridium difficile are describedpreviously.8 Gram stains were performed on all isolates and coagu-lase tests were used to further confirm MRSA-positive samples.

Fig 1. Patient encounter and hand sampling schematic.

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Growth of any single organism was recorded as a positive for handcontamination.

Statistical analysis

The odds of hand contamination was assessed by a mixed effectslogistic regression model with random effects for date crossed withfacility, and HCW nested in facility. The random effects accountedfor the repeated measures taken from each HCW, date, and facili-ty. At moment 2, gloved and ungloved users were analyzedseparately. At moment 3, there were no ungloved users. Thus, theeffect of glove use is based solely onmoment 2 data. Individual valueplots, residual plots, and Hosmer and Lemeshow goodness-of-fit testswere used to assess the fit of the logistic regression model to thedata. All analyses were performed using lme4 in R (R Foundationfor Statistical Computing, Vienna, Austria).9 All statements of sta-tistical significance are based on Wald tests at a significance levelof 5%.

RESULTS

Prevalence of hand contamination

SeventeenHCWs from4 facilitieswere sampled during 46patientcare encounters to determine the presence of health care-associatedpathogens on their hands during critical moments of care. Handhygienewith an alcohol-based handrubwas performed by theHCWwhen entering the patient room to eliminate transient organismspresent from contact with previous patients, environmental sur-faces, or other sources. No confirmation of the effectiveness of handhygiene during this step was performed considering the broad-spectrum antimicrobial activity of alcohol-based handrubs and therelatively high detection limit (250 CFU per hand). Hands weresampled before beginning wound treatment (ie, before clean/aseptic procedure [WHO moment 2]) and after wound treatment(ie, after body fluid exposure risk [WHOmoment 3]). After the handsampling procedure atmoment 2, handwashing to remove the sam-pling solution also removed any remaining transient organisms. Thisprevented any cross-contamination into the sampling at moment3.

HCWs acquired a health care-associated pathogen on their handsduring 28.3% (13 out of 46) of patient care encounters (Table 1).When broken down by moments during care, 17.4% (8 out of 46)of hands sampled at moment 2 and 17.4% (8 out of 46) of handssampled at moment 3 were positive for at least 1 pathogen. Therewere 3 patient care encounters (6.5%) where the HCW’s hands werepositive at both moment 2 and moment 3. However, only 1 of thosecases involved the same organism. No HCWswere sequentially pos-itive between patients for the same organism. This suggests HCWsin the study were contaminated by sources within the outpatient

setting (eg, patients, environment, or staff) and not colonized withany of the targeted organisms. MRSA and C difficile were detectedduring 13.0% and 15.2% of patient care encounters, respectively,whereas VRE and Acinetobacter were each only detected in 2.2% ofencounters. There was no access to patient medical records; there-fore, correlation between the organisms identified from HCW handsand any known patient colonization or infection could not be made.Intrafacility hand contamination rates at moment 2 and moment3 were similar and rates among facilities were also comparable.

Influence of glove use on hand contamination

Glove use during the patient encounter was self-reported by par-ticipants; however, the duration of glove use during care was nottracked. Hence, regardless of duration, wearing gloves at themomentof care was recorded as either positive or negative for glove use.Overall, hand contamination occurred in 19.6% of instances whereHCWs wore gloves during care compared with 14.6% when HCWsdid not wear gloves (Table 2).

During patient care that occurred at moment 2, HCWs woregloves in 10.9% of occurrences (5 out of 46) (Table 2). Appropriate-ness of glove use at this stage of patient care was not assessed andhand hygiene immediately before donning gloves was not re-corded. Hand contamination rates were 14.6% (6 out of 41) forungloved hands and 40.0% (2 out of 5) for gloved hands. The con-tamination rate for ungloved hands was statistically significantly>0% (P < .0005) but the rate of contamination for gloved hands wasnot (P = .657). Lack of significance in the latter case may be due tothe low sample size (n = 5) of glove users at moment 2. The oddsof contamination was 3.9 times larger for gloved HCWs comparedwith ungloved HCWs, but this increase was not statistically signif-icant (P = .181).

Gloves were worn during all wound care treatments (ie, the caregiven atmoment 3) (Table 2). Hands sampled immediately after gloveremoval after wound treatment were found to be contaminated in17.4% (8 out of 46) of occurrences, which was statistically signifi-cantly >0% (P < .0005). A comparison of the odds of contaminationbetween glove users could not be ascertained because there wereno ungloved HCWs during wound care treatment.

Influence of HCWs

Seventeen HCWs from 4 facilities were sampled during the study,which represented 85.0% of the eligible staff. On average, each patientencounter took 60 minutes for established patients or 90-120minutes for new patients, and each HCW provided care to 6-10 pa-tients per clinic day. Paired samples were taken during 9, 15, 10,and 12 patient encounters at facility A, B, C, and D, respectively. Onaverage, each HCWwas sampled during 1.8, 2.1, 2.5, and 1.1 patientencounters at facility A, B, C, and D, respectively, on each sam-pling day. When combined for all facilities, samples were takenduring 1.7 patients encounters per HCW per clinic day, on average.This rate of sampling represented 17.0% of the high to 28.3% of thelow daily patient load for each HCW.

Table 1Breakdown of health care worker hand contamination during patient care encounters

Pathogen

Moment 2 events:Before clean or

aseptic procedure(n = 46)

Moment 3 events:Following body

fluid exposure risk(n = 46)

Patient careencounters(n = 46)

Methicillin-resistantStaphylococcus aureus

4.4 (2) 10.9 (5) 13.0 (6)

Vancomycin-resistantEnterococcus

2.2 (1) 0.0 (0) 2.2 (1)

Acinetobacter 0.0 (0) 2.2 (1) 2.2 (1)Clostridium difficile 10.9 (5) 4.4 (2) 15.2 (7)Any pathogen 17.4 (8) 17.4 (8) 28.3 (13)

NOTE. Values are presented as % (n).

Table 2Incidence of hand contamination based on glove use

Time of care

Positive samples (n = 16)

Gloved Ungloved

Moment 2: Before clean or aseptic procedure 40.0 (2/5) 14.6 (6/41)Moment 3: Following body fluid exposure risk 17.4 (8/46) NA (0/0)Combined 19.6 (10/51) 14.6 (6/41)

NOTE. Values are presented as % (positive samples/total samples).NA, not available.

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Eleven (64.2%) of 17 HCWs in the study were contaminated witha pathogen at least once during the combined 46 patient encoun-ters, whereas 2 (16.7%) of 12 HCWs who gave care to at least 2patients were contaminated during 2 of those patient encounters(Table 3). Eight HCWs (47.1%) were contaminated at least once atmoment 2, whereas 6 HCWs (35.3%) were contaminated at least onceat moment 3. The data indicate that the majority of HCWs’ handsbecome contaminated during patient care and contamination is notassociated with a subset of HCWs.

DISCUSSION

As health care transitions from hospital settings to outpatientsettings the need for scientific evidence to support outpatient in-fection prevention practices increases. Although much has beenpublished about hand hygiene and hand contamination in hospi-tals very little research has been conducted in outpatient caresettings.2,6 This study may be the first to investigate the presenceof pathogens on HCWs’ hands at WHO moments 2 and 3 for handhygiene in an outpatient setting. These moments for hand hygienetypically occur behind privacy curtains or closed doors and evenin hospital settings are less likely to be observed and recorded. Inwound care settings, moments 2 and 3 occur during almost everypatient encounter, providing an opportunity for transmission and/or acquisition of health care-associated pathogens by patients andHCWs.

In this study, HCWs’ hands were contaminated during 28.3% ofpatient care encounters andwhen broken down bymoments of care,17.4% of the time before a clean or aseptic procedure (ie, beforewound treatment) and 17.4% of the time after body fluid exposurerisk (ie, after wound treatment). These contamination rates aresimilar to those reported during different moments of care in otheroutpatient settings, further supporting the importance of handhygiene in these settings.10-14 Hand contamination occurred as fre-quently after casual patient contact as it did after wound care,emphasizing that even brief contact can result in hand contami-nation. Studies, including 2 outpatient studies,12,13,15-18 found handcontamination with organisms such as VRE, S aureus, and C difficilefollowing casual or low-risk contact. Contamination rates in thisstudy support the currentWHO and CDC recommendations for handhygiene before a clean or aseptic procedure and after body fluid ex-posure risk as ways to prevent the transmission of pathogens.

Glove use is explicitly linked with infection prevention and handhygiene practices.6,7,19 Wearing gloves when there is a potential forcontact with blood, body fluids, mucous membranes, nonintact skin,or contaminated equipment is a basic tenet of standard precautions.20

Furthermore, glove use is the strongest recommended infectioncontrol procedure to prevent the contamination of HCWs’ hands.21-24

In this study, gloves were not worn during 89.1% of contact beforewound care. During wound care, when there was potential for ex-posure to blood, body fluids, and nonintact skin, gloves wereuniversally worn. Studies have shown the rate of hand hygiene islower when gloves are worn.25,26 This study suggests that substi-tuting glove use for hand hygiene can place both HCWs and patients

at risk of colonization or infection with pathogenic organisms. De-contaminating hands after glove removal is a CDC recommendation(IB), andWHO guidelines clearly state that wearing gloves does notreplace the need for hand hygiene.6,7 Whether the contaminationis related to the quality of the gloves or HCW practices in donningand doffing of gloves, knowledge and practices of infection pre-vention procedures (including donning and doffing of gloves) shouldbe part of staff onboarding and also regularly reviewed. The recentEbola virus disease outbreak in West Africa demonstrated the po-tential for self-contamination when doffing gloves and otherprotective equipment, and led to the practice of trained observersof HCWs when donning and doffing of protective equipment.27

Because of the contamination of HCW hands at moment 2 andmoment 3 and the time pressure placed on HCWs, hand hygienesolutions need to be placed in convenient locations. Inconvenientplacement of dispensers or sinks is cited as a reason for poor handhygiene compliance by CDC andWHO.2,6 Wound care clinics presenta special challenge to place hand hygiene in convenient locations;therefore, manufacturers of hand hygiene products should consid-er options for nontraditional health care settings so that HCWs donot have to leave the patient zone to perform hand hygiene. As thedelivery of health care shifts toward outpatient care settings, in-fection preventionists and HCWs in these settings should beconsulted to advise a convenient location for hand hygiene dis-pensing products to accommodate their unique workflow patterns.One method to address the workflow and special hand hygiene re-quirements for outpatient settings is workflowmapping. Son et al28

created workflowmaps detailing the steps required to complete the5 most common tasks, including indicating when hand hygiene wasnecessary. This process could be applied to the routine tasks of ad-mitting patients to their room, helping patients onto the exam table,removal of wound dressing, application of new dressing, and helpingthe patient exit the room.

This study sought to understand the distribution of hand con-tamination among HCWs in outpatient care facilities. The majorityof HCWs’ hands (64.2%) became contaminated during patient care,demonstrating that contamination is not concentrated within asubset of HCWs. The distribution of sampling was not controlledin the study. Themajority of HCWswere sampled during 1-2 patientencounters; however, several HCWswere sampled during 5-6 patientencounters. Increasing the sampling of those HCWs who were onlysampled during 1 or 2 patient encounters may result in an in-creased percentage of HCWswith contaminated hands during patientcare. Hand hygiene surveillance programs should be implementedto monitor compliance with hand hygiene guidelines due to thewidespread hand contamination. In the outpatient setting, moni-toring of hand hygiene compliance should include more than justroom entry and room exit, but also within the patient zone. Ob-serving hand hygiene behavior at WHO hand hygiene moments 2and 3 is necessary for patient safety in a wound care setting.

LIMITATIONS

The results reported in this study may not be representative ofall outpatient settings. Wound care facilities were chosen for thisstudy because the care administered in this setting was likely toinclude both a clean or aseptic procedure and body fluid exposurerisk. This setting may bias the results toward higher levels of handcontamination due to the type of care administered and the pres-ence of pathogens in wounds. Wound care center patients may alsobe at higher risk for multidrug resistant organisms due to previ-ous or current antimicrobial therapy, invasive procedures, andhospitalization. The sources of hand contamination could not be de-termined because environment contamination was not quantified

Table 3Analysis of hand contamination by health care workers

Handcontaminationevents

Percent of contaminated health care workers

Moment 2:Before clean or

aseptic procedure

Moment 3:Following body

fluid exposure riskPatient careencounters

1 47.1 (8) 35.3 (6) 64.2 (11)2 0.0 (0) 16.7 (2) 16.7 (2)

NOTE. Values are presented as % (n).

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or characterized, baseline colonization of HCWs was not identified,and patient records were not accessed to determine infection status.

CONCLUSIONS

Outpatient care settings, especially wound care centers, presentunique infection prevention challenges. The hand contamination re-ported at moment 2 and moment 3 provides a strong case forattention to hand hygiene and infection prevention practices in thesesettings to protect both patients and HCWs. The results of this studyemphasize the need for attention to glove donning and doffing prac-tices because glove use did not prevent contamination of the hands.The study also highlights the need for hand hygiene surveillanceand hand hygiene solutions at the point of care so HCWs can cleantheir hands without leaving the patient zone.

References

1. Guide to infection prevention in outpatient settings: minimum expectations forsafe care. Atlanta, GA: Centers for Disease Control and Prevention; 2014.

2. World Health Organization. Hand hygiene in outpatient care, home-based careand long-term care facilities. Geneva, Switzerland: 2014.

3. Schappert SM, Rechtsteiner EA. Ambulatory medical care utilization estimatesfor 2007. Vital Health Stat 13 2011;131-8.

4. Jarvis WR. Infection control and changing health-care delivery systems. EmergInfect Dis 2001;7:170-3.

5. Maki DG, Crnich CJ. History forgotten is history relived: nosocomial infectioncontrol is also essential in the outpatient setting. Arch Intern Med2005;165:2565-7.

6. Boyce JM, Pittet D. Guideline for Hand Hygiene in Health-Care Settings.Recommendations of the Healthcare Infection Control Practices AdvisoryCommittee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Societyfor Healthcare Epidemiology of America/Association for Professionals in InfectionControl/Infectious Diseases Society of America. MMWR Recomm Rep 2002;51:1-45.

7. Pittet D, Allegranzi B, Boyce J. TheWorld Health Organization guidelines on handhygiene in health care and their consensus recommendations. Infect Control HospEpidemiol 2009;30:611-22.

8. Istenes N, Bingham J, Hazelett S, Fleming E, Kirk J. Patients’ potential role in thetransmission of health care-associated infections: prevalence of contaminationwith bacterial pathogens and patient attitudes toward hand hygiene. Am J InfectControl 2013;41:793-8.

9. Bates D, Maechler M, Bolker B, Walker S. Lme4: linear mixed-effects models usingEigen and S4. R package version 1.1-5. 2014.

10. Cohen HA, Matalon A, Amir J, Paret G, Barzilai A. Handwashing patterns inprimary pediatric community clinics. Infection 1998;26:45-7.

11. Girier P, Le Goaziou MF. Are multiresistant micro-organisms present in GPs’offices? Med Mal Infect 2005;35(Suppl 2):S69-71.

12. Grabsch EA, Burrell LJ, Padiglione A, O’Keeffe JM, Ballard S, Grayson ML. Risk ofenvironmental and healthcare worker contamination with vancomycin-resistantenterococci during outpatient procedures and hemodialysis. Infect Control HospEpidemiol 2006;27:287-93.

13. Lam RF, Hui M, Leung DY, Chow VC, Lam BN, Leung GM, et al. Extent andpredictors of microbial hand contamination in a tertiary care ophthalmicoutpatient practice. Invest Ophthalmol Vis Sci 2005;46:3578-83.

14. Zuckerman JB, Zuaro DE, Prato BS, Ruoff KL, Sawicki RW, Quinton HB, et al.Bacterial contamination of cystic fibrosis clinics. J Cyst Fibros 2009;8:186-92.

15. Bhalla A, Pultz NJ, Gries DM, Ray AJ, Eckstein EC, Aron DC, et al. Acquisition ofnosocomial pathogens on hands after contact with environmental surfaces nearhospitalized patients. Infect Control Hosp Epidemiol 2004;25:164-7.

16. Pittet D, Dharan S, Touveneau S, Sauvan V, Perneger TV. Bacterial contaminationof the hands of hospital staff during routine patient care. Arch Intern Med1999;159:821-6.

17. Casewell M, Phillips I. Hands as route of transmission for Klebsiella species. BrMed J 1977;2:1315-7.

18. Pessoa-Silva CL, Dharan S, Hugonnet S, Touveneau S, Posfay-Barbe K, Pfister R,et al. Dynamics of bacterial hand contamination during routine neonatal care.Infect Control Hosp Epidemiol 2004;25:192-7.

19. Ellingson K, Haas JP, Aiello AE, Kusek L, Maragakis LL, Olmsted RN, et al. Strategiesto prevent healthcare-associated infections through hand hygiene. Infect ControlHosp Epidemiol 2014;35:937-60.

20. Siegel JD, Rhinehart E, Jackson M, Chiarello L. 2007 Guideline for isolationprecautions: preventing transmission of infectious agents in health care settings.Am J Infect Control 2007;35:S65-164.

21. Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, et al. Clinicalpractice guidelines for Clostridium difficile infection in adults: 2010 update bythe society for healthcare epidemiology of America (SHEA) and the InfectiousDiseases Society of America (IDSA). Infect Control Hosp Epidemiol 2010;31:431-55.

22. Dubberke ER, Gerding DN, Classen D, Arias KM, Podgorny K, Anderson DJ, et al.Strategies to prevent Clostridium difficile infections in acute care hospitals. InfectControl Hosp Epidemiol 2008;29(Suppl 1):S81-92.

23. Edmonds SL, Zapka C, Kasper D, Gerber R, McCormack R, Macinga D, et al.Effectiveness of hand hygiene for removal of Clostridium difficile spores fromhands. Infect Control Hosp Epidemiol 2013;34:302-5.

24. Johnson S, Gerding DN, Olson MM, Weiler MD, Hughes RA, Clabots CR, et al.Prospective, controlled study of vinyl glove use to interrupt Clostridium difficilenosocomial transmission. Am J Med 1990;88:137-40.

25. Fuller C, Savage J, Besser S, Hayward A, Cookson B, Cooper B, et al. The dirty handin the latex glove”: a study of hand hygiene compliance when gloves are worn.Infect Control Hosp Epidemiol 2011;32:1194-9.

26. Girou E, Chai SH, Oppein F, Legrand P, Ducellier D, Cizeau F, et al. Misuse ofgloves: the foundation for poor compliance with hand hygiene and potentialfor microbial transmission? J Hosp Infect 2004;57:162-9.

27. Guidance on Personal Protective Equipment (PPE) To Be Used By HealthcareWorkers during Management of Patients with Confirmed Ebola or Persons underInvestigation (PUIs) for Ebola who are Clinically Unstable or Have Bleeding,Vomiting, or Diarrhea in U.S. Hospitals, Including Procedures for Donning andDoffing PPE. Centers for Disease Control and Prevention. 2015. Available from:http://www.cdc.gov/vhf/ebola/healthcare-us/ppe/guidance.html. Accessed May23, 2016.

28. Son C, Chuck T, Childers T, Usiak S, Dowling M, Andiel C, et al. Practicallyspeaking: rethinking hand hygiene improvement programs in health caresettings. Am J Infect Control 2011;39:716-24.

1202 J. Bingham et al. / American Journal of Infection Control 44 (2016) 1198-202

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Injection SafetyPractice

Performed?If answer is No, document plan for remediation

Proper hand hygiene, using alcohol-based hand rub or soap and water, is performed prior to preparing and administering medications.

Yes No

Injections are prepared using aseptic technique in a clean area free from contamination or contact with blood, body fluids, or contaminated equipment.

Yes No

Needles and syringes are used for only one patient (this includes manufactured prefilled syringes and cartridge devices such as insulin pens).

Yes No

The rubber septum on a medication vial is disinfected with alcohol prior to piercing. Yes No

Medication vials are entered with a new needle and a new syringe, even when obtaining additional doses for the same patient.

Yes No

Single-dose or single-use medication vials, ampules, and bags or bottles of intravenous solution are used for only one patient.

Yes No

Medication administration tubing and connectors are used for only one patient. Yes No

Multi-dose vials are dated by healthcare when they are first opened and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.

Note: This is different from the expiration date printed on the vial.

Yes No

Multi-dose vials are dedicated to individual patients whenever possible. Yes No

Multi-dose vials to be used for more than one patient are kept in a centralized medication area and do not enter the immediate patient treatment area (e.g., operating room, patient room/cubicle).

Note: If multi-dose vials enter the immediate patient treatment area, they should be dedicated for single-patient use and discarded immediately after use.

Yes No

INJECTION SAFETY CHECKLISTThe following Injection Safety checklist items are a subset of items that can be found in the CDC Infection Prevention Checklist for Outpatient Settings: Minimum Expectations for Safe Care.

The checklist, which is appropriate for both inpatient and outpatient settings, should be used to systematically assess adherence of healthcare providers to safe injection practices. Assessment of adherence should be conducted by direct observation of healthcare personnel during the performance of their duties.

The One & Only Campaign is a public health effort to eliminate unsafe medical injections. To learn more about safe injection practices, please visit www.cdc.gov/injectionsafety/1anonly.html.

306089-G

3.11

Injection SafetyPractice

Performed?If answer is No, document plan for remediation

Proper hand hygiene, using alcohol-based hand rub or soap and water, is performed prior to preparing and administering medications.

Yes No

Injections are prepared using aseptic technique in a clean area free from contamination or contact with blood, body fluids, or contaminated equipment.

Yes No

Needles and syringes are used for only one patient (this includes manufactured prefilled syringes and cartridge devices such as insulin pens).

Yes No

The rubber septum on a medication vial is disinfected with alcohol prior to piercing. Yes No

Medication vials are entered with a new needle and a new syringe, even when obtaining additional doses for the same patient.

Yes No

Single-dose or single-use medication vials, ampules, and bags or bottles of intravenous solution are used for only one patient.

Yes No

Medication administration tubing and connectors are used for only one patient. Yes No

Multi-dose vials are dated by healthcare when they are first opened and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.

Note: This is different from the expiration date printed on the vial.

Yes No

Multi-dose vials are dedicated to individual patients whenever possible. Yes No

Multi-dose vials to be used for more than one patient are kept in a centralized medication area and do not enter the immediate patient treatment area (e.g., operating room, patient room/cubicle).

Note: If multi-dose vials enter the immediate patient treatment area, they should be dedicated for single-patient use and discarded immediately after use.

Yes No

INJECTION SAFETY CHECKLISTThe following Injection Safety checklist items are a subset of items that can be found in the CDC Infection Prevention Checklist for Outpatient Settings: Minimum Expectations for Safe Care.

The checklist, which is appropriate for both inpatient and outpatient settings, should be used to systematically assess adherence of healthcare providers to safe injection practices. Assessment of adherence should be conducted by direct observation of healthcare personnel during the performance of their duties.

The One & Only Campaign is a public health effort to eliminate unsafe medical injections. To learn more about safe injection practices, please visit www.cdc.gov/injectionsafety/1anonly.html.

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Safe Injection Practices CoalitionThe Safe Injection Practices Coalition (SIPC) is a partnership of healthcare-related organizations led by the Centers for Disease Control and Prevention that was formed to promote safe injection practices in all U.S. healthcare settings. The SIPC has developed the One & Only Campaign – a public health education and awareness campaign – aimed at both healthcare providers and patients to advance and promote safe injection practices.

Become an active partner in your health care.

Glossary healthcare providers – doctors, nurses and other trained healthcare professionals

hepatitis B – a liver disease caused by the hepatitis B virus (HBV)

hepatitis C – a liver disease caused by the hepatitis C virus (HCV)

HIV – the virus that can lead to acquired immune deficiency syndrome, or AIDS

injection – forcing a fluid into the body by means of a syringe

IV – intravenous, or “within a vein”

needle – a sharp pointed object used for injection or removal of fluid from the body

syringe – an instrument used to inject fluids into the body or draw them from it

transmission – spread, as of an infection from one patient to another

vial – a small container or bottle that holds medicine

3.12

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Here is what you should know about safe injection practices:

What are safe injection practices?Safe injection practices are a set of practices that healthcare providers should follow when they give injections. For example, healthcare providers should not use the same syringe on more than one patient, even if the needle is changed. A good rule to remember is One Needle, One Syringe, only One Time.

Why are safe injection practices so important?These practices will prevent the spread of diseases like hepatitis B, hepatitis C, or HIV.

Who should be aware of safe injection practices?Anyone who receives an injection or IV therapy should be aware of these practices. Anyone who gives an injection or IV therapy (like a healthcare provider) should understand and follow safe injection practices.

What can patients do to find information about safe injection practices?Patients can take the following steps to learn more about safe injection practices:

• Talkwithyourhealthcareprovideraboutsafe injection practices.

• Gotowww.cdc.gov/injectionsafety/1anonly.html for more information.

Did you know?Most healthcare providers follow safe injection practices. Though not common, unsafe practices sometimes occur. Healthcare providers can spread diseases like hepatitis B, hepatitis C, or HIV if they reuse injection equipment like needles or syringes on more than one patient or to access vials that are shared between patients.

For more information, please visit: www.cdc.gov/injectionsafety/1anonly.html.

SyringeNeedle

Vial

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Module 4

Epidemiology & Infectious Diseases

Resources

Principles of EpidemiologyCenters for Disease Control and Prevention (CDC)https://www .cdc .gov/csels/dsepd/ss1978/lesson1/section10 .html

Chart of Clinical Syndromes or Conditions Warranting Empiric Transmission-Based Precautions in Addition to Standard PrecautionsCDChttps://www .cdc .gov/infectioncontrol/guidelines/isolation/appendix/ transmission-precautions .html

Measles outbreak toolkit CDChttps://www .cdc .gov/measles/toolkit/state-health-departments .html

MeaslesCDChttps://www .cdc .gov/measles/hcp/index .html

Chicken PoxCDChttps://www .cdc .gov/chickenpox/hcp/index .html

ShinglesCDChttps://www .cdc .gov/shingles/hcp/index .html

Respiratory Synctial Virus InfectionCDChttps://www .cdc .gov/rsv/clinical/index .html

MeningitisCDChttps://www .cdc .gov/meningitis/clinical-resources .html

Multidrug Resistant Organisms ManagementCDChttps://www .cdc .gov/infectioncontrol/guidelines/mdro/index .html

Red Book 2018American Academy of Pediatricshttps://redbook .solutions .aap .org/Book .aspx?bookid=2205

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Module 5

Occupational/Employee Health

Contents

5.1 Recommended vaccines for healthcare workers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120Immunization Action Coalition https://www .immunize .org/catg .d/p2017 .pdf

5.2 Checklist for Bloodborne Pathogens Content Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122Forms & Checklists for Infection Control, Volume 2

5.3 Sharps Injury Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123Forms & Checklists for Infection Control, Volume 2

5.4 Employee Training Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124Forms & Checklists for Infection Control, Volume 2

5.5 Injection Safety Competency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125Forms & Checklists for Infection Control, Volume 1

Resources

Healthcare Worker GuidelinesCenters for Disease Control and Prevention (CDC)/Healthcare Infection Control Practices Advisory Committee (HICPAC)https://www .cdc .gov/hicpac/pdf/infectcontrol98 .pdf

Vaccine guidelines for healthcare providers/professionalsCDChttps://www .cdc .gov/vaccines/hcp/index .html

Standards for Adult immunization PracticeCDChttps://www .cdc .gov/vaccines/hcp/adults/for-practice/standards/index .html

Bloodborne Pathogens Quick Reference GuideOccupational Safety and Health Administration (OSHA)https://www .osha .gov/SLTC/bloodbornepathogens/bloodborne_quickref .html

Immunization Action Coalitionhttps://www .immunize .org/

InfluenzaSociety for Healthcare Epidemiology of America (SHEA)https://www .shea-online .org/index .php/practice-resources/priority-topics/influenza

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MeaslesCDChttps://www .cdc .gov/infectioncontrol/guidelines/measles/index .html

Red Book 2018American Academy of Pediatricshttps://redbook .solutions .aap .org/Book .aspx?bookid=2205

Control of Communicable Diseases ManualAmerican Public Health Associationhttps://www .apha .org/ccdm

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Hepatitis BUnvaccinated healthcare personnel (HCP) and/or those who cannot document previous vac-cination should receive either a 2-dose series of Heplisav-B at 0 and 1 month or a 3-dose series of either Engerix-B or Recombivax HB at 0, 1, and 6 months. HCP who perform tasks that may involve exposure to blood or body fluids should be tested for hepatitis B surface anti-body (anti-HBs) 1–2 months after dose #2 of Heplisav-B or dose #3 of Engerix-B or Recom-bivax HB to document immunity.

• If anti-HBs is at least 10 mIU/mL (positive), the vaccinee is immune. No further serologic testing or vaccination is recommended.

• If anti-HBs is less than 10 mIU/mL (negative), the vaccinee is not protected from hepatitis B virus (HBV) infection, and should receive another 2-dose or 3-dose series of HepB vaccine on the routine schedule, followed by anti-HBs testing 1–2 months later. A vaccinee whose anti-HBs remains less than 10 mIU/mL after 2 complete series is considered a “non-responder.”

For non-responders: HCP who are non-responders should be considered susceptible to HBV and should be counseled regarding precautions to prevent HBV infection and the need to obtain HBIG prophylaxis for any known or probable parenteral exposure to hepatitis B surface antigen (HBsAg)-positive blood or blood with unknown HBsAg status. It is also possible that non-responders are people who are HBsAg positive. HBsAg testing is recommended. HCP found

to be HBsAg positive should be counseled and medically evaluated.

For HCP with documentation of a complete 2-dose (Heplisav-B) or 3-dose (Engerix-B or Re-combivax HB) vaccine series but no documen-tation of anti-HBs of at least 10 mIU/mL (e.g., those vaccinated in childhood): HCP who are at risk for occupational blood or body fluid expo- sure might undergo anti-HBs testing upon hire or matriculation. See references 2 and 3 for details.

Influenza All HCP, including physicians, nurses, paramedics, emergency medical technicians, employees of nursing homes and chronic care facilities, students in these professions, and volunteers, should receive annual vaccination against influ-enza. Live attenuated influenza vaccine (LAIV) may be given only to non-pregnant healthy HCP age 49 years and younger. Inactivated injectable influenza vaccine (IIV) is preferred over LAIV for HCP who are in close contact with severely immunosuppressed patients (e.g., stem cell transplant recipients) when they require protec-tive isolation.

Measles, Mumps, Rubella (MMR)HCP who work in medical facilities should be immune to measles, mumps, and rubella.

• HCP born in 1957 or later can be considered immune to measles, mumps, or rubella only if they have documentation of (a) laboratory confirmation of disease or immunity or (b) appropriate vaccination against measles, mumps, and rubella (i.e., 2 doses of live

measles and mumps vaccines given on or after the first birthday and separated by 28 days or more, and at least 1 dose of live rubella vaccine). HCP with 2 documented doses of MMR are not recommended to be serologically tested for immunity; but if they are tested and results are negative or equivocal for measles, mumps, and/or rubella, these HCP should be considered to have presumptive evidence of immunity to measles, mumps, and/or rubella and are not in need of additional MMR doses.

• Although birth before 1957 generally is con- sidered acceptable evidence of measles, mumps, and rubella immunity, 2 doses of MMR vaccine should be considered for unvacci-nated HCP born before 1957 who do not have laboratory evidence of disease or immunity to measles and/or mumps. One dose of MMR vaccine should be considered for HCP with no laboratory evidence of disease or immunity to rubella. For these same HCP who do not have evidence of immunity, 2 doses of MMR vaccine are recommended during an outbreak of measles or mumps and 1 dose during an outbreak of rubella.

Varicella It is recommended that all HCP be immune to varicella. Evidence of immunity in HCP includes documentation of 2 doses of varicella vaccine given at least 28 days apart, laboratory evidence of immunity, laboratory confirmation of disease, or diagnosis or verification of a history of vari-cella or herpes zoster (shingles) by a healthcare provider.

Tetanus/Diphtheria/Pertussis (Td/Tdap)All HCPs who have not or are unsure if they have previously received a dose of Tdap should receive a dose of Tdap as soon as feasible, with- out regard to the interval since the previous dose of Td. Pregnant HCP should be revaccinated during each pregnancy. All HCPs should then receive Td boosters every 10 years thereafter.

MeningococcalVaccination with MenACWY and MenB is recommended for microbiologists who are routinely exposed to isolates of N. meningitidis. The two vaccines may be given concomitantly but at different anatomic sites, if feasible.

references1 CDC. Immunization of Health-Care Personnel: Recom-

mendations of the Advisory Committee on Immunization Practices (ACIP). MMWR, 2011; 60(RR-7).

2 CDC. Prevention of Hepatitis B Virus Infection in the Unit-ed States. Recommendations of the Advisory Committee on Immunization Practices. MMWR, 2018; 67(RR1):1–30.

3 IAC. Pre-exposure Management for Healthcare Personnel with a Documented Hepatitis B Vaccine Series Who Have Not Had Post-vaccination Serologic Testing. Accessed at www.immunize.org/catg.d/p2108.pdf.

For additional specific ACIP recommendations, visit CDC’s website at www.cdc.gov/vaccines/hcp/acip-recs/index.html or visit IAC’s website at www.immunize.org/acip.

Healthcare Personnel Vaccination Recommendationsvaccines and recommendations in brief

Hepatitis B – If previously unvaccinated, give a 2-dose (Heplisav-B) or 3-dose (Engerix-B or Recombivax HB) series. Give intramuscularly (IM). For HCP who perform tasks that may involve exposure to blood or body fluids, obtain anti-HBs serologic testing 1–2 months after dose #2 (for Heplisav-B) or dose #3 (for Engerix-B or Recombivax HB).

Influenza – Give 1 dose of influenza vaccine annually. Inactivated injectable vaccine is given IM, except when using the intradermal influenza vaccine. Live attenuated influenza vaccine (LAIV) is given intranasally.

MMR – For healthcare personnel (HCP) born in 1957 or later without serologic evidence of immunity or prior vaccination, give 2 doses of MMR, 4 weeks apart. For HCP born prior to 1957, see below. Give subcutaneously (Subcut).

Varicella (chickenpox) – For HCP who have no serologic proof of immunity, prior vaccination, or diagnosis or verification of a history of varicella or herpes zoster (shingles) by a healthcare provider, give 2 doses of varicella vaccine, 4 weeks apart. Give Subcut.

Tetanus, diphtheria, pertussis – Give 1 dose of Tdap as soon as feasible to all HCP who have not received Tdap previously and to pregnant HCP with each pregnancy (see below). Give Td boosters every 10 years thereafter. Give IM.

Meningococcal – Give both MenACWY and MenB to microbiologists who are routine-ly exposed to isolates of Neisseria meningitidis. Every 5 years boost with MenACWY if risk continues. Give MenACWY and MenB IM.

Hepatitis A, typhoid, and polio vaccines are not routinely recommended for HCP who may have on-the-job exposure to fecal material.

Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.orgTechnical content reviewed by the Centers for Disease Control and Prevention

www.immunize.org/catg.d/p2017.pdf • Item #P2017 (3/18)

5.1

Hepatitis BUnvaccinated healthcare personnel (HCP) and/or those who cannot document previous vac-cination should receive either a 2-dose series of Heplisav-B at 0 and 1 month or a 3-dose series of either Engerix-B or Recombivax HB at 0, 1, and 6 months. HCP who perform tasks that may involve exposure to blood or body fluids should be tested for hepatitis B surface anti-body (anti-HBs) 1–2 months after dose #2 of Heplisav-B or dose #3 of Engerix-B or Recom-bivax HB to document immunity.

• If anti-HBs is at least 10 mIU/mL (positive), the vaccinee is immune. No further serologic testing or vaccination is recommended.

• If anti-HBs is less than 10 mIU/mL (negative), the vaccinee is not protected from hepatitis B virus (HBV) infection, and should receive another 2-dose or 3-dose series of HepB vaccine on the routine schedule, followed by anti-HBs testing 1–2 months later. A vaccinee whose anti-HBs remains less than 10 mIU/mL after 2 complete series is considered a “non-responder.”

For non-responders: HCP who are non-responders should be considered susceptible to HBV and should be counseled regarding precautions to prevent HBV infection and the need to obtain HBIG prophylaxis for any known or probable parenteral exposure to hepatitis B surface antigen (HBsAg)-positive blood or blood with unknown HBsAg status. It is also possible that non-responders are people who are HBsAg positive. HBsAg testing is recommended. HCP found

to be HBsAg positive should be counseled and medically evaluated.

For HCP with documentation of a complete 2-dose (Heplisav-B) or 3-dose (Engerix-B or Re-combivax HB) vaccine series but no documen-tation of anti-HBs of at least 10 mIU/mL (e.g., those vaccinated in childhood): HCP who are at risk for occupational blood or body fluid expo- sure might undergo anti-HBs testing upon hire or matriculation. See references 2 and 3 for details.

Influenza All HCP, including physicians, nurses, paramedics, emergency medical technicians, employees of nursing homes and chronic care facilities, students in these professions, and volunteers, should receive annual vaccination against influ-enza. Live attenuated influenza vaccine (LAIV) may be given only to non-pregnant healthy HCP age 49 years and younger. Inactivated injectable influenza vaccine (IIV) is preferred over LAIV for HCP who are in close contact with severely immunosuppressed patients (e.g., stem cell transplant recipients) when they require protec-tive isolation.

Measles, Mumps, Rubella (MMR)HCP who work in medical facilities should be immune to measles, mumps, and rubella.

• HCP born in 1957 or later can be considered immune to measles, mumps, or rubella only if they have documentation of (a) laboratory confirmation of disease or immunity or (b) appropriate vaccination against measles, mumps, and rubella (i.e., 2 doses of live

measles and mumps vaccines given on or after the first birthday and separated by 28 days or more, and at least 1 dose of live rubella vaccine). HCP with 2 documented doses of MMR are not recommended to be serologically tested for immunity; but if they are tested and results are negative or equivocal for measles, mumps, and/or rubella, these HCP should be considered to have presumptive evidence of immunity to measles, mumps, and/or rubella and are not in need of additional MMR doses.

• Although birth before 1957 generally is con- sidered acceptable evidence of measles, mumps, and rubella immunity, 2 doses of MMR vaccine should be considered for unvacci-nated HCP born before 1957 who do not have laboratory evidence of disease or immunity to measles and/or mumps. One dose of MMR vaccine should be considered for HCP with no laboratory evidence of disease or immunity to rubella. For these same HCP who do not have evidence of immunity, 2 doses of MMR vaccine are recommended during an outbreak of measles or mumps and 1 dose during an outbreak of rubella.

Varicella It is recommended that all HCP be immune to varicella. Evidence of immunity in HCP includes documentation of 2 doses of varicella vaccine given at least 28 days apart, laboratory evidence of immunity, laboratory confirmation of disease, or diagnosis or verification of a history of vari-cella or herpes zoster (shingles) by a healthcare provider.

Tetanus/Diphtheria/Pertussis (Td/Tdap)All HCPs who have not or are unsure if they have previously received a dose of Tdap should receive a dose of Tdap as soon as feasible, with- out regard to the interval since the previous dose of Td. Pregnant HCP should be revaccinated during each pregnancy. All HCPs should then receive Td boosters every 10 years thereafter.

MeningococcalVaccination with MenACWY and MenB is recommended for microbiologists who are routinely exposed to isolates of N. meningitidis. The two vaccines may be given concomitantly but at different anatomic sites, if feasible.

references1 CDC. Immunization of Health-Care Personnel: Recom-

mendations of the Advisory Committee on Immunization Practices (ACIP). MMWR, 2011; 60(RR-7).

2 CDC. Prevention of Hepatitis B Virus Infection in the Unit-ed States. Recommendations of the Advisory Committee on Immunization Practices. MMWR, 2018; 67(RR1):1–30.

3 IAC. Pre-exposure Management for Healthcare Personnel with a Documented Hepatitis B Vaccine Series Who Have Not Had Post-vaccination Serologic Testing. Accessed at www.immunize.org/catg.d/p2108.pdf.

For additional specific ACIP recommendations, visit CDC’s website at www.cdc.gov/vaccines/hcp/acip-recs/index.html or visit IAC’s website at www.immunize.org/acip.

Healthcare Personnel Vaccination Recommendationsvaccines and recommendations in brief

Hepatitis B – If previously unvaccinated, give a 2-dose (Heplisav-B) or 3-dose (Engerix-B or Recombivax HB) series. Give intramuscularly (IM). For HCP who perform tasks that may involve exposure to blood or body fluids, obtain anti-HBs serologic testing 1–2 months after dose #2 (for Heplisav-B) or dose #3 (for Engerix-B or Recombivax HB).

Influenza – Give 1 dose of influenza vaccine annually. Inactivated injectable vaccine is given IM, except when using the intradermal influenza vaccine. Live attenuated influenza vaccine (LAIV) is given intranasally.

MMR – For healthcare personnel (HCP) born in 1957 or later without serologic evidence of immunity or prior vaccination, give 2 doses of MMR, 4 weeks apart. For HCP born prior to 1957, see below. Give subcutaneously (Subcut).

Varicella (chickenpox) – For HCP who have no serologic proof of immunity, prior vaccination, or diagnosis or verification of a history of varicella or herpes zoster (shingles) by a healthcare provider, give 2 doses of varicella vaccine, 4 weeks apart. Give Subcut.

Tetanus, diphtheria, pertussis – Give 1 dose of Tdap as soon as feasible to all HCP who have not received Tdap previously and to pregnant HCP with each pregnancy (see below). Give Td boosters every 10 years thereafter. Give IM.

Meningococcal – Give both MenACWY and MenB to microbiologists who are routine-ly exposed to isolates of Neisseria meningitidis. Every 5 years boost with MenACWY if risk continues. Give MenACWY and MenB IM.

Hepatitis A, typhoid, and polio vaccines are not routinely recommended for HCP who may have on-the-job exposure to fecal material.

Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.orgTechnical content reviewed by the Centers for Disease Control and Prevention

www.immunize.org/catg.d/p2017.pdf • Item #P2017 (3/18)

120

Page 121: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

Hepatitis BUnvaccinated healthcare personnel (HCP) and/or those who cannot document previous vac-cination should receive either a 2-dose series of Heplisav-B at 0 and 1 month or a 3-dose series of either Engerix-B or Recombivax HB at 0, 1, and 6 months. HCP who perform tasks that may involve exposure to blood or body fluids should be tested for hepatitis B surface anti-body (anti-HBs) 1–2 months after dose #2 of Heplisav-B or dose #3 of Engerix-B or Recom-bivax HB to document immunity.

• If anti-HBs is at least 10 mIU/mL (positive), the vaccinee is immune. No further serologic testing or vaccination is recommended.

• If anti-HBs is less than 10 mIU/mL (negative), the vaccinee is not protected from hepatitis B virus (HBV) infection, and should receive another 2-dose or 3-dose series of HepB vaccine on the routine schedule, followed by anti-HBs testing 1–2 months later. A vaccinee whose anti-HBs remains less than 10 mIU/mL after 2 complete series is considered a “non-responder.”

For non-responders: HCP who are non-responders should be considered susceptible to HBV and should be counseled regarding precautions to prevent HBV infection and the need to obtain HBIG prophylaxis for any known or probable parenteral exposure to hepatitis B surface antigen (HBsAg)-positive blood or blood with unknown HBsAg status. It is also possible that non-responders are people who are HBsAg positive. HBsAg testing is recommended. HCP found

to be HBsAg positive should be counseled and medically evaluated.

For HCP with documentation of a complete 2-dose (Heplisav-B) or 3-dose (Engerix-B or Re-combivax HB) vaccine series but no documen-tation of anti-HBs of at least 10 mIU/mL (e.g., those vaccinated in childhood): HCP who are at risk for occupational blood or body fluid expo- sure might undergo anti-HBs testing upon hire or matriculation. See references 2 and 3 for details.

Influenza All HCP, including physicians, nurses, paramedics, emergency medical technicians, employees of nursing homes and chronic care facilities, students in these professions, and volunteers, should receive annual vaccination against influ-enza. Live attenuated influenza vaccine (LAIV) may be given only to non-pregnant healthy HCP age 49 years and younger. Inactivated injectable influenza vaccine (IIV) is preferred over LAIV for HCP who are in close contact with severely immunosuppressed patients (e.g., stem cell transplant recipients) when they require protec-tive isolation.

Measles, Mumps, Rubella (MMR)HCP who work in medical facilities should be immune to measles, mumps, and rubella.

• HCP born in 1957 or later can be considered immune to measles, mumps, or rubella only if they have documentation of (a) laboratory confirmation of disease or immunity or (b) appropriate vaccination against measles, mumps, and rubella (i.e., 2 doses of live

measles and mumps vaccines given on or after the first birthday and separated by 28 days or more, and at least 1 dose of live rubella vaccine). HCP with 2 documented doses of MMR are not recommended to be serologically tested for immunity; but if they are tested and results are negative or equivocal for measles, mumps, and/or rubella, these HCP should be considered to have presumptive evidence of immunity to measles, mumps, and/or rubella and are not in need of additional MMR doses.

• Although birth before 1957 generally is con- sidered acceptable evidence of measles, mumps, and rubella immunity, 2 doses of MMR vaccine should be considered for unvacci-nated HCP born before 1957 who do not have laboratory evidence of disease or immunity to measles and/or mumps. One dose of MMR vaccine should be considered for HCP with no laboratory evidence of disease or immunity to rubella. For these same HCP who do not have evidence of immunity, 2 doses of MMR vaccine are recommended during an outbreak of measles or mumps and 1 dose during an outbreak of rubella.

Varicella It is recommended that all HCP be immune to varicella. Evidence of immunity in HCP includes documentation of 2 doses of varicella vaccine given at least 28 days apart, laboratory evidence of immunity, laboratory confirmation of disease, or diagnosis or verification of a history of vari-cella or herpes zoster (shingles) by a healthcare provider.

Tetanus/Diphtheria/Pertussis (Td/Tdap)All HCPs who have not or are unsure if they have previously received a dose of Tdap should receive a dose of Tdap as soon as feasible, with- out regard to the interval since the previous dose of Td. Pregnant HCP should be revaccinated during each pregnancy. All HCPs should then receive Td boosters every 10 years thereafter.

MeningococcalVaccination with MenACWY and MenB is recommended for microbiologists who are routinely exposed to isolates of N. meningitidis. The two vaccines may be given concomitantly but at different anatomic sites, if feasible.

references1 CDC. Immunization of Health-Care Personnel: Recom-

mendations of the Advisory Committee on Immunization Practices (ACIP). MMWR, 2011; 60(RR-7).

2 CDC. Prevention of Hepatitis B Virus Infection in the Unit-ed States. Recommendations of the Advisory Committee on Immunization Practices. MMWR, 2018; 67(RR1):1–30.

3 IAC. Pre-exposure Management for Healthcare Personnel with a Documented Hepatitis B Vaccine Series Who Have Not Had Post-vaccination Serologic Testing. Accessed at www.immunize.org/catg.d/p2108.pdf.

For additional specific ACIP recommendations, visit CDC’s website at www.cdc.gov/vaccines/hcp/acip-recs/index.html or visit IAC’s website at www.immunize.org/acip.

Healthcare Personnel Vaccination Recommendationsvaccines and recommendations in brief

Hepatitis B – If previously unvaccinated, give a 2-dose (Heplisav-B) or 3-dose (Engerix-B or Recombivax HB) series. Give intramuscularly (IM). For HCP who perform tasks that may involve exposure to blood or body fluids, obtain anti-HBs serologic testing 1–2 months after dose #2 (for Heplisav-B) or dose #3 (for Engerix-B or Recombivax HB).

Influenza – Give 1 dose of influenza vaccine annually. Inactivated injectable vaccine is given IM, except when using the intradermal influenza vaccine. Live attenuated influenza vaccine (LAIV) is given intranasally.

MMR – For healthcare personnel (HCP) born in 1957 or later without serologic evidence of immunity or prior vaccination, give 2 doses of MMR, 4 weeks apart. For HCP born prior to 1957, see below. Give subcutaneously (Subcut).

Varicella (chickenpox) – For HCP who have no serologic proof of immunity, prior vaccination, or diagnosis or verification of a history of varicella or herpes zoster (shingles) by a healthcare provider, give 2 doses of varicella vaccine, 4 weeks apart. Give Subcut.

Tetanus, diphtheria, pertussis – Give 1 dose of Tdap as soon as feasible to all HCP who have not received Tdap previously and to pregnant HCP with each pregnancy (see below). Give Td boosters every 10 years thereafter. Give IM.

Meningococcal – Give both MenACWY and MenB to microbiologists who are routine-ly exposed to isolates of Neisseria meningitidis. Every 5 years boost with MenACWY if risk continues. Give MenACWY and MenB IM.

Hepatitis A, typhoid, and polio vaccines are not routinely recommended for HCP who may have on-the-job exposure to fecal material.

Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.orgTechnical content reviewed by the Centers for Disease Control and Prevention

www.immunize.org/catg.d/p2017.pdf • Item #P2017 (3/18)

Hepatitis BUnvaccinated healthcare personnel (HCP) and/or those who cannot document previous vac-cination should receive either a 2-dose series of Heplisav-B at 0 and 1 month or a 3-dose series of either Engerix-B or Recombivax HB at 0, 1, and 6 months. HCP who perform tasks that may involve exposure to blood or body fluids should be tested for hepatitis B surface anti-body (anti-HBs) 1–2 months after dose #2 of Heplisav-B or dose #3 of Engerix-B or Recom-bivax HB to document immunity.

• If anti-HBs is at least 10 mIU/mL (positive), the vaccinee is immune. No further serologic testing or vaccination is recommended.

• If anti-HBs is less than 10 mIU/mL (negative), the vaccinee is not protected from hepatitis B virus (HBV) infection, and should receive another 2-dose or 3-dose series of HepB vaccine on the routine schedule, followed by anti-HBs testing 1–2 months later. A vaccinee whose anti-HBs remains less than 10 mIU/mL after 2 complete series is considered a “non-responder.”

For non-responders: HCP who are non-responders should be considered susceptible to HBV and should be counseled regarding precautions to prevent HBV infection and the need to obtain HBIG prophylaxis for any known or probable parenteral exposure to hepatitis B surface antigen (HBsAg)-positive blood or blood with unknown HBsAg status. It is also possible that non-responders are people who are HBsAg positive. HBsAg testing is recommended. HCP found

to be HBsAg positive should be counseled and medically evaluated.

For HCP with documentation of a complete 2-dose (Heplisav-B) or 3-dose (Engerix-B or Re-combivax HB) vaccine series but no documen-tation of anti-HBs of at least 10 mIU/mL (e.g., those vaccinated in childhood): HCP who are at risk for occupational blood or body fluid expo- sure might undergo anti-HBs testing upon hire or matriculation. See references 2 and 3 for details.

Influenza All HCP, including physicians, nurses, paramedics, emergency medical technicians, employees of nursing homes and chronic care facilities, students in these professions, and volunteers, should receive annual vaccination against influ-enza. Live attenuated influenza vaccine (LAIV) may be given only to non-pregnant healthy HCP age 49 years and younger. Inactivated injectable influenza vaccine (IIV) is preferred over LAIV for HCP who are in close contact with severely immunosuppressed patients (e.g., stem cell transplant recipients) when they require protec-tive isolation.

Measles, Mumps, Rubella (MMR)HCP who work in medical facilities should be immune to measles, mumps, and rubella.

• HCP born in 1957 or later can be considered immune to measles, mumps, or rubella only if they have documentation of (a) laboratory confirmation of disease or immunity or (b) appropriate vaccination against measles, mumps, and rubella (i.e., 2 doses of live

measles and mumps vaccines given on or after the first birthday and separated by 28 days or more, and at least 1 dose of live rubella vaccine). HCP with 2 documented doses of MMR are not recommended to be serologically tested for immunity; but if they are tested and results are negative or equivocal for measles, mumps, and/or rubella, these HCP should be considered to have presumptive evidence of immunity to measles, mumps, and/or rubella and are not in need of additional MMR doses.

• Although birth before 1957 generally is con- sidered acceptable evidence of measles, mumps, and rubella immunity, 2 doses of MMR vaccine should be considered for unvacci-nated HCP born before 1957 who do not have laboratory evidence of disease or immunity to measles and/or mumps. One dose of MMR vaccine should be considered for HCP with no laboratory evidence of disease or immunity to rubella. For these same HCP who do not have evidence of immunity, 2 doses of MMR vaccine are recommended during an outbreak of measles or mumps and 1 dose during an outbreak of rubella.

Varicella It is recommended that all HCP be immune to varicella. Evidence of immunity in HCP includes documentation of 2 doses of varicella vaccine given at least 28 days apart, laboratory evidence of immunity, laboratory confirmation of disease, or diagnosis or verification of a history of vari-cella or herpes zoster (shingles) by a healthcare provider.

Tetanus/Diphtheria/Pertussis (Td/Tdap)All HCPs who have not or are unsure if they have previously received a dose of Tdap should receive a dose of Tdap as soon as feasible, with- out regard to the interval since the previous dose of Td. Pregnant HCP should be revaccinated during each pregnancy. All HCPs should then receive Td boosters every 10 years thereafter.

MeningococcalVaccination with MenACWY and MenB is recommended for microbiologists who are routinely exposed to isolates of N. meningitidis. The two vaccines may be given concomitantly but at different anatomic sites, if feasible.

references1 CDC. Immunization of Health-Care Personnel: Recom-

mendations of the Advisory Committee on Immunization Practices (ACIP). MMWR, 2011; 60(RR-7).

2 CDC. Prevention of Hepatitis B Virus Infection in the Unit-ed States. Recommendations of the Advisory Committee on Immunization Practices. MMWR, 2018; 67(RR1):1–30.

3 IAC. Pre-exposure Management for Healthcare Personnel with a Documented Hepatitis B Vaccine Series Who Have Not Had Post-vaccination Serologic Testing. Accessed at www.immunize.org/catg.d/p2108.pdf.

For additional specific ACIP recommendations, visit CDC’s website at www.cdc.gov/vaccines/hcp/acip-recs/index.html or visit IAC’s website at www.immunize.org/acip.

Healthcare Personnel Vaccination Recommendationsvaccines and recommendations in brief

Hepatitis B – If previously unvaccinated, give a 2-dose (Heplisav-B) or 3-dose (Engerix-B or Recombivax HB) series. Give intramuscularly (IM). For HCP who perform tasks that may involve exposure to blood or body fluids, obtain anti-HBs serologic testing 1–2 months after dose #2 (for Heplisav-B) or dose #3 (for Engerix-B or Recombivax HB).

Influenza – Give 1 dose of influenza vaccine annually. Inactivated injectable vaccine is given IM, except when using the intradermal influenza vaccine. Live attenuated influenza vaccine (LAIV) is given intranasally.

MMR – For healthcare personnel (HCP) born in 1957 or later without serologic evidence of immunity or prior vaccination, give 2 doses of MMR, 4 weeks apart. For HCP born prior to 1957, see below. Give subcutaneously (Subcut).

Varicella (chickenpox) – For HCP who have no serologic proof of immunity, prior vaccination, or diagnosis or verification of a history of varicella or herpes zoster (shingles) by a healthcare provider, give 2 doses of varicella vaccine, 4 weeks apart. Give Subcut.

Tetanus, diphtheria, pertussis – Give 1 dose of Tdap as soon as feasible to all HCP who have not received Tdap previously and to pregnant HCP with each pregnancy (see below). Give Td boosters every 10 years thereafter. Give IM.

Meningococcal – Give both MenACWY and MenB to microbiologists who are routine-ly exposed to isolates of Neisseria meningitidis. Every 5 years boost with MenACWY if risk continues. Give MenACWY and MenB IM.

Hepatitis A, typhoid, and polio vaccines are not routinely recommended for HCP who may have on-the-job exposure to fecal material.

Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.orgTechnical content reviewed by the Centers for Disease Control and Prevention

www.immunize.org/catg.d/p2017.pdf • Item #P2017 (3/18)

Hepatitis BUnvaccinated healthcare personnel (HCP) and/or those who cannot document previous vac-cination should receive either a 2-dose series of Heplisav-B at 0 and 1 month or a 3-dose series of either Engerix-B or Recombivax HB at 0, 1, and 6 months. HCP who perform tasks that may involve exposure to blood or body fluids should be tested for hepatitis B surface anti-body (anti-HBs) 1–2 months after dose #2 of Heplisav-B or dose #3 of Engerix-B or Recom-bivax HB to document immunity.

• If anti-HBs is at least 10 mIU/mL (positive), the vaccinee is immune. No further serologic testing or vaccination is recommended.

• If anti-HBs is less than 10 mIU/mL (negative), the vaccinee is not protected from hepatitis B virus (HBV) infection, and should receive another 2-dose or 3-dose series of HepB vaccine on the routine schedule, followed by anti-HBs testing 1–2 months later. A vaccinee whose anti-HBs remains less than 10 mIU/mL after 2 complete series is considered a “non-responder.”

For non-responders: HCP who are non-responders should be considered susceptible to HBV and should be counseled regarding precautions to prevent HBV infection and the need to obtain HBIG prophylaxis for any known or probable parenteral exposure to hepatitis B surface antigen (HBsAg)-positive blood or blood with unknown HBsAg status. It is also possible that non-responders are people who are HBsAg positive. HBsAg testing is recommended. HCP found

to be HBsAg positive should be counseled and medically evaluated.

For HCP with documentation of a complete 2-dose (Heplisav-B) or 3-dose (Engerix-B or Re-combivax HB) vaccine series but no documen-tation of anti-HBs of at least 10 mIU/mL (e.g., those vaccinated in childhood): HCP who are at risk for occupational blood or body fluid expo- sure might undergo anti-HBs testing upon hire or matriculation. See references 2 and 3 for details.

Influenza All HCP, including physicians, nurses, paramedics, emergency medical technicians, employees of nursing homes and chronic care facilities, students in these professions, and volunteers, should receive annual vaccination against influ-enza. Live attenuated influenza vaccine (LAIV) may be given only to non-pregnant healthy HCP age 49 years and younger. Inactivated injectable influenza vaccine (IIV) is preferred over LAIV for HCP who are in close contact with severely immunosuppressed patients (e.g., stem cell transplant recipients) when they require protec-tive isolation.

Measles, Mumps, Rubella (MMR)HCP who work in medical facilities should be immune to measles, mumps, and rubella.

• HCP born in 1957 or later can be considered immune to measles, mumps, or rubella only if they have documentation of (a) laboratory confirmation of disease or immunity or (b) appropriate vaccination against measles, mumps, and rubella (i.e., 2 doses of live

measles and mumps vaccines given on or after the first birthday and separated by 28 days or more, and at least 1 dose of live rubella vaccine). HCP with 2 documented doses of MMR are not recommended to be serologically tested for immunity; but if they are tested and results are negative or equivocal for measles, mumps, and/or rubella, these HCP should be considered to have presumptive evidence of immunity to measles, mumps, and/or rubella and are not in need of additional MMR doses.

• Although birth before 1957 generally is con- sidered acceptable evidence of measles, mumps, and rubella immunity, 2 doses of MMR vaccine should be considered for unvacci-nated HCP born before 1957 who do not have laboratory evidence of disease or immunity to measles and/or mumps. One dose of MMR vaccine should be considered for HCP with no laboratory evidence of disease or immunity to rubella. For these same HCP who do not have evidence of immunity, 2 doses of MMR vaccine are recommended during an outbreak of measles or mumps and 1 dose during an outbreak of rubella.

Varicella It is recommended that all HCP be immune to varicella. Evidence of immunity in HCP includes documentation of 2 doses of varicella vaccine given at least 28 days apart, laboratory evidence of immunity, laboratory confirmation of disease, or diagnosis or verification of a history of vari-cella or herpes zoster (shingles) by a healthcare provider.

Tetanus/Diphtheria/Pertussis (Td/Tdap)All HCPs who have not or are unsure if they have previously received a dose of Tdap should receive a dose of Tdap as soon as feasible, with- out regard to the interval since the previous dose of Td. Pregnant HCP should be revaccinated during each pregnancy. All HCPs should then receive Td boosters every 10 years thereafter.

MeningococcalVaccination with MenACWY and MenB is recommended for microbiologists who are routinely exposed to isolates of N. meningitidis. The two vaccines may be given concomitantly but at different anatomic sites, if feasible.

references1 CDC. Immunization of Health-Care Personnel: Recom-

mendations of the Advisory Committee on Immunization Practices (ACIP). MMWR, 2011; 60(RR-7).

2 CDC. Prevention of Hepatitis B Virus Infection in the Unit-ed States. Recommendations of the Advisory Committee on Immunization Practices. MMWR, 2018; 67(RR1):1–30.

3 IAC. Pre-exposure Management for Healthcare Personnel with a Documented Hepatitis B Vaccine Series Who Have Not Had Post-vaccination Serologic Testing. Accessed at www.immunize.org/catg.d/p2108.pdf.

For additional specific ACIP recommendations, visit CDC’s website at www.cdc.gov/vaccines/hcp/acip-recs/index.html or visit IAC’s website at www.immunize.org/acip.

Healthcare Personnel Vaccination Recommendationsvaccines and recommendations in brief

Hepatitis B – If previously unvaccinated, give a 2-dose (Heplisav-B) or 3-dose (Engerix-B or Recombivax HB) series. Give intramuscularly (IM). For HCP who perform tasks that may involve exposure to blood or body fluids, obtain anti-HBs serologic testing 1–2 months after dose #2 (for Heplisav-B) or dose #3 (for Engerix-B or Recombivax HB).

Influenza – Give 1 dose of influenza vaccine annually. Inactivated injectable vaccine is given IM, except when using the intradermal influenza vaccine. Live attenuated influenza vaccine (LAIV) is given intranasally.

MMR – For healthcare personnel (HCP) born in 1957 or later without serologic evidence of immunity or prior vaccination, give 2 doses of MMR, 4 weeks apart. For HCP born prior to 1957, see below. Give subcutaneously (Subcut).

Varicella (chickenpox) – For HCP who have no serologic proof of immunity, prior vaccination, or diagnosis or verification of a history of varicella or herpes zoster (shingles) by a healthcare provider, give 2 doses of varicella vaccine, 4 weeks apart. Give Subcut.

Tetanus, diphtheria, pertussis – Give 1 dose of Tdap as soon as feasible to all HCP who have not received Tdap previously and to pregnant HCP with each pregnancy (see below). Give Td boosters every 10 years thereafter. Give IM.

Meningococcal – Give both MenACWY and MenB to microbiologists who are routine-ly exposed to isolates of Neisseria meningitidis. Every 5 years boost with MenACWY if risk continues. Give MenACWY and MenB IM.

Hepatitis A, typhoid, and polio vaccines are not routinely recommended for HCP who may have on-the-job exposure to fecal material.

Immunization Action Coalition Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.orgTechnical content reviewed by the Centers for Disease Control and Prevention

www.immunize.org/catg.d/p2017.pdf • Item #P2017 (3/18)

121

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5.2 113Forms & Checklists for Infection Prevention, Volume 2

3-5. Checklist for Bloodborne Pathogens Training Content

Date: Reviewer:

Note “Yes” or “No” as to if required content is included in training

Subject matter to include:

Epidemiology, symptoms, and transmission of bloodborne pathogen diseases

A copy and explanation of the OSHA bloodborne pathogen standard

An explanation of our ECP and how to obtain a copy

An explanation of methods to recognize tasks and other activities that may involve exposure to blood and OPIM, including what constitutes an exposure incident

An explanation of the use and limitations of engineering controls, work practices, and PPE

An explanation of the types, uses, location, removal, handling, decontamination, and disposal of PPE

An explanation of the basis for PPE selection

Information on the hepatitis B vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine will be offered free of charge

Information on the appropriate actions to take and persons to contact in an emergency involving blood or OPIM

An explanation of the procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical follow-up that will be made available

Information on the post-exposure evaluation and follow-up that the employer is required to provide for the employee following an exposure incident

An explanation of the signs and labels and/or color coding required by the standard and used at this facility

An opportunity for interactive questions and answers with the person conducting the training session.

Comments:

Reference

Debbie Hurst, RN, BSN, CIC

113Forms & Checklists for Infection Prevention, Volume 2

3-5. Checklist for Bloodborne Pathogens Training Content

Date: Reviewer:

Note “Yes” or “No” as to if required content is included in training

Subject matter to include:

Epidemiology, symptoms, and transmission of bloodborne pathogen diseases

A copy and explanation of the OSHA bloodborne pathogen standard

An explanation of our ECP and how to obtain a copy

An explanation of methods to recognize tasks and other activities that may involve exposure to blood and OPIM, including what constitutes an exposure incident

An explanation of the use and limitations of engineering controls, work practices, and PPE

An explanation of the types, uses, location, removal, handling, decontamination, and disposal of PPE

An explanation of the basis for PPE selection

Information on the hepatitis B vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine will be offered free of charge

Information on the appropriate actions to take and persons to contact in an emergency involving blood or OPIM

An explanation of the procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical follow-up that will be made available

Information on the post-exposure evaluation and follow-up that the employer is required to provide for the employee following an exposure incident

An explanation of the signs and labels and/or color coding required by the standard and used at this facility

An opportunity for interactive questions and answers with the person conducting the training session.

Comments:

Reference

Debbie Hurst, RN, BSN, CIC

113Forms & Checklists for Infection Prevention, Volume 2

3-5. Checklist for Bloodborne Pathogens Training Content

Date: Reviewer:

Note “Yes” or “No” as to if required content is included in training

Subject matter to include:

Epidemiology, symptoms, and transmission of bloodborne pathogen diseases

A copy and explanation of the OSHA bloodborne pathogen standard

An explanation of our ECP and how to obtain a copy

An explanation of methods to recognize tasks and other activities that may involve exposure to blood and OPIM, including what constitutes an exposure incident

An explanation of the use and limitations of engineering controls, work practices, and PPE

An explanation of the types, uses, location, removal, handling, decontamination, and disposal of PPE

An explanation of the basis for PPE selection

Information on the hepatitis B vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine will be offered free of charge

Information on the appropriate actions to take and persons to contact in an emergency involving blood or OPIM

An explanation of the procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical follow-up that will be made available

Information on the post-exposure evaluation and follow-up that the employer is required to provide for the employee following an exposure incident

An explanation of the signs and labels and/or color coding required by the standard and used at this facility

An opportunity for interactive questions and answers with the person conducting the training session.

Comments:

Reference

Debbie Hurst, RN, BSN, CIC

113Forms & Checklists for Infection Prevention, Volume 2

3-5. Checklist for Bloodborne Pathogens Training Content

Date: Reviewer:

Note “Yes” or “No” as to if required content is included in training

Subject matter to include:

Epidemiology, symptoms, and transmission of bloodborne pathogen diseases

A copy and explanation of the OSHA bloodborne pathogen standard

An explanation of our ECP and how to obtain a copy

An explanation of methods to recognize tasks and other activities that may involve exposure to blood and OPIM, including what constitutes an exposure incident

An explanation of the use and limitations of engineering controls, work practices, and PPE

An explanation of the types, uses, location, removal, handling, decontamination, and disposal of PPE

An explanation of the basis for PPE selection

Information on the hepatitis B vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine will be offered free of charge

Information on the appropriate actions to take and persons to contact in an emergency involving blood or OPIM

An explanation of the procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical follow-up that will be made available

Information on the post-exposure evaluation and follow-up that the employer is required to provide for the employee following an exposure incident

An explanation of the signs and labels and/or color coding required by the standard and used at this facility

An opportunity for interactive questions and answers with the person conducting the training session.

Comments:

Reference

Debbie Hurst, RN, BSN, CIC 122

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5.3 115Forms & Checklists for Infection Prevention, Volume 2

3-7. Sharps Injury Log

Incident Date Incident ID # Device Type Device Brand Incident Location

Brief Description of Incident

29 CFR 1910.1030, OSHA’s Bloodborne Pathogens Standard, in paragraph (h)(5), requires an employer to establish and maintain a Sharps Injury Log for recording all percutaneous injuries in a facility occurring from contaminated sharps. The purpose of the Log is to aid in the evaluation of devices being used in healthcare and other facilities and to identify problem devices or procedures requiring additional attention or review. This log must be kept in addition to the injury and illness log required by 29 CFR 1904.The Sharps Injury Log should include all sharps injuries occurring in a calendar year. The log must be retained for five years following the end of the year to which it relates. The Log must be kept in a manner that preserves the confidentiality of the affected employee.

Reference

George Allen, RN, PhD, FAPIC, CIC, CNOR

Year:

115Forms & Checklists for Infection Prevention, Volume 2

3-7. Sharps Injury Log

Incident Date Incident ID # Device Type Device Brand Incident Location

Brief Description of Incident

29 CFR 1910.1030, OSHA’s Bloodborne Pathogens Standard, in paragraph (h)(5), requires an employer to establish and maintain a Sharps Injury Log for recording all percutaneous injuries in a facility occurring from contaminated sharps. The purpose of the Log is to aid in the evaluation of devices being used in healthcare and other facilities and to identify problem devices or procedures requiring additional attention or review. This log must be kept in addition to the injury and illness log required by 29 CFR 1904.The Sharps Injury Log should include all sharps injuries occurring in a calendar year. The log must be retained for five years following the end of the year to which it relates. The Log must be kept in a manner that preserves the confidentiality of the affected employee.

Reference

George Allen, RN, PhD, FAPIC, CIC, CNOR

Year:

115Forms & Checklists for Infection Prevention, Volume 2

3-7. Sharps Injury Log

Incident Date Incident ID # Device Type Device Brand Incident Location

Brief Description of Incident

29 CFR 1910.1030, OSHA’s Bloodborne Pathogens Standard, in paragraph (h)(5), requires an employer to establish and maintain a Sharps Injury Log for recording all percutaneous injuries in a facility occurring from contaminated sharps. The purpose of the Log is to aid in the evaluation of devices being used in healthcare and other facilities and to identify problem devices or procedures requiring additional attention or review. This log must be kept in addition to the injury and illness log required by 29 CFR 1904.The Sharps Injury Log should include all sharps injuries occurring in a calendar year. The log must be retained for five years following the end of the year to which it relates. The Log must be kept in a manner that preserves the confidentiality of the affected employee.

Reference

George Allen, RN, PhD, FAPIC, CIC, CNOR

Year:

115Forms & Checklists for Infection Prevention, Volume 2

3-7. Sharps Injury Log

Incident Date Incident ID # Device Type Device Brand Incident Location

Brief Description of Incident

29 CFR 1910.1030, OSHA’s Bloodborne Pathogens Standard, in paragraph (h)(5), requires an employer to establish and maintain a Sharps Injury Log for recording all percutaneous injuries in a facility occurring from contaminated sharps. The purpose of the Log is to aid in the evaluation of devices being used in healthcare and other facilities and to identify problem devices or procedures requiring additional attention or review. This log must be kept in addition to the injury and illness log required by 29 CFR 1904.The Sharps Injury Log should include all sharps injuries occurring in a calendar year. The log must be retained for five years following the end of the year to which it relates. The Log must be kept in a manner that preserves the confidentiality of the affected employee.

Reference

George Allen, RN, PhD, FAPIC, CIC, CNOR

Year:

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5.4Forms & Checklists for Infection Prevention, Volume 2116

3-8. Employee Training Record

Training SubjectDate

CommentsTrained Retrained

Employee’s Signature Date Supervisor’s Signature Date

Reference

OSHA, https://www.osha.gov/SLTC/etools/safetyhealth/employeetrainingrec.pdf

Name of employee:

Employee number:

Department:

Job title:

I have received and understood the safety and health training listed above and acknowledge that it has

been given to me.

Forms & Checklists for Infection Prevention, Volume 2116

3-8. Employee Training Record

Training SubjectDate

CommentsTrained Retrained

Employee’s Signature Date Supervisor’s Signature Date

Reference

OSHA, https://www.osha.gov/SLTC/etools/safetyhealth/employeetrainingrec.pdf

Name of employee:

Employee number:

Department:

Job title:

I have received and understood the safety and health training listed above and acknowledge that it has

been given to me.

Forms & Checklists for Infection Prevention, Volume 2116

3-8. Employee Training Record

Training SubjectDate

CommentsTrained Retrained

Employee’s Signature Date Supervisor’s Signature Date

Reference

OSHA, https://www.osha.gov/SLTC/etools/safetyhealth/employeetrainingrec.pdf

Name of employee:

Employee number:

Department:

Job title:

I have received and understood the safety and health training listed above and acknowledge that it has

been given to me.

Forms & Checklists for Infection Prevention, Volume 2116

3-8. Employee Training Record

Training SubjectDate

CommentsTrained Retrained

Employee’s Signature Date Supervisor’s Signature Date

Reference

OSHA, https://www.osha.gov/SLTC/etools/safetyhealth/employeetrainingrec.pdf

Name of employee:

Employee number:

Department:

Job title:

I have received and understood the safety and health training listed above and acknowledge that it has

been given to me.

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5.52-6. Injection Safety Competency

Injection Safety Competency Validation

PointofCareTesting

Typeofvalidation:Returndemonstration

Orientation

Annual

Other

EmployeeName: JobTitle:

Medication PreparationCompetent

N/AYES NO

1. Performhandhygienepriortopreparingoradministering

medications

2. Injectionsarepreparedusingaseptictechniqueinacleararea

freefromcontaminationorcontactwithblood,bodyfluids,or

contaminatedequipment

3. Needlesandsyringesareusedforonlyonepatient(this

includesmanufacturedprefilledsyringesandcartridge

devices)

4. Rubberseptumonmedicationvialisdisinfectedwithalcohol

priortopiercing

5. Medicationvialsareenteredwithanewneedleandnew

syringe,evenwhenobtainingadditionaldosesforsame

patient

6. Single-doseorsingle-usemedicationvials,ampules,and

bags/bottlesofintravenoussolutionareusedforonlyone

patient

7. Medicationadministrationtubingandconnectorsareusedfor

onlyonepatient

8. Multi-dosevialsaredatedwhenfirstopenedanddiscarded

within28daysunlessmanufacturerspecifiesadifferent

(shorterorlonger)dateforthatopenedvial

9. Multi-dosevialsarededicatedtoindividualpatientswhenever

possible(e.g.,insulinvials,lidocaine,etc.)

10.Multi-dosevialstobeusedformorethanonepatientare

keptinacentralizedmedicationareaanddonotenterthe

immediatepatienttreatmentarea(e.g.,operatingroom,

patientroom/cubicle)

11. Insulinpensdedicatedtoonlyonepatient

12.Medicationisadministeredwithin1hourofpreparation

Forms & Checklists for Infection Prevention, Volume 1 69

2-6. Injection Safety Competency

Injection Safety Competency Validation

PointofCareTesting

Typeofvalidation:Returndemonstration

Orientation

Annual

Other

EmployeeName: JobTitle:

Medication PreparationCompetent

N/AYES NO

1. Performhandhygienepriortopreparingoradministering

medications

2. Injectionsarepreparedusingaseptictechniqueinacleararea

freefromcontaminationorcontactwithblood,bodyfluids,or

contaminatedequipment

3. Needlesandsyringesareusedforonlyonepatient(this

includesmanufacturedprefilledsyringesandcartridge

devices)

4. Rubberseptumonmedicationvialisdisinfectedwithalcohol

priortopiercing

5. Medicationvialsareenteredwithanewneedleandnew

syringe,evenwhenobtainingadditionaldosesforsame

patient

6. Single-doseorsingle-usemedicationvials,ampules,and

bags/bottlesofintravenoussolutionareusedforonlyone

patient

7. Medicationadministrationtubingandconnectorsareusedfor

onlyonepatient

8. Multi-dosevialsaredatedwhenfirstopenedanddiscarded

within28daysunlessmanufacturerspecifiesadifferent

(shorterorlonger)dateforthatopenedvial

9. Multi-dosevialsarededicatedtoindividualpatientswhenever

possible(e.g.,insulinvials,lidocaine,etc.)

10.Multi-dosevialstobeusedformorethanonepatientare

keptinacentralizedmedicationareaanddonotenterthe

immediatepatienttreatmentarea(e.g.,operatingroom,

patientroom/cubicle)

11. Insulinpensdedicatedtoonlyonepatient

12.Medicationisadministeredwithin1hourofpreparation

Forms & Checklists for Infection Prevention, Volume 1 69

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Point of Care Testing (e.g., glucometer, PT/INR)Competent

N/AYES NO

13.Performhandhygiene

14.Dongloves

15.Single-use,auto-disablingfingerstickdeviceusedforone

patientonly&discardedintosharpscontainer

16.Individualpatientdedicatedglucometer(preferred)is

storedtoavoidcross-contaminationandinadvertentuseon

additionalpatients(ideally,inthepatientroom)—bestpractice

istoclean/disinfectpriortostoragepermanufacturer’s

instructions

17.Sharedglucometers/equipmentmustbecleanedand

disinfectedaftereveryusepermanufacturer’sinstructions

(ifthemanufacturerdoesnotspecifyhowthedeviceshould

becleanedanddisinfected,thenitshouldnotbeshared)

18.Glovesremoved

19.Handhygieneperformed

Comments or follow up actions:

EmployeeSignature

ValidatorSignature /Date

References CDCathttp://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html

OneandOnlyCampaignathttp://www.oneandonlycampaign.org/ NCSPICE;9-2016

Forms & Checklists for Infection Prevention, Volume 170

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Module 6

Construction and Water Management

Contents

6.1 Infection Control Risk Assessment (ICRA) Matrix of Precautions for Construction & Renovation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128https://apic .org/Resource_/TinyMceFileManager/Education/ASC_Intensive/Resources_Page/ICRA_Risk_Assessment_for_Construction_and_Renovation .pdf

6.2 What Clinicians need to know about Legionnaires disease . . . . . . . . . . . . . . . . . . . . . . . . . 134Centers for Disease Control (CDC)https://www .cdc .gov/legionella/downloads/fs-legionella-clinicians .pdf

6.3 Healthcare Facility Water Management Program Checklist . . . . . . . . . . . . . . . . . . . . . . . . . 135CDChttps://www .cdc .gov/HAI/pdfs/Water-Management-Checklist-P .pdf

Resources

Environmental Infection Control guidelinesCDChttps://www .cdc .gov/infectioncontrol/guidelines/environmental/index .html#anchor_ 1556902049

Infection Prevention Manual for Construction & Renovation Association for Professionals in Infection Control and Epidemiology (APIC)https://rise .apic .org/WEB/ItemDetail?iProductCode=SLS9808&Category=BOOKS

Guidelines for Design and Construction of Outpatient FacilitiesFacility Guidelines Institutehttps://www .fgiguidelines .org/guidelines/2018-fgi-guidelines/

ANSI/ASHRAE Standard 188:2018, Legionellosis: Risk Management for Building Water SystemsAmerican Society of Heating, Refrigerating, and Air Conditioning Engineershttps://www .ashrae .org/technical-resources/bookstore/ansi-ashrae-standard-188-2018-legio-nellosis-risk-management-for-building-water-systems

ANSI/ASHRAE Standard 188-2018 for Legionnaires’ Disease Risk ManagementAmerican National Standards Institute (ANSI) bloghttps://blog .ansi .org/2018/09/ansi-ashrae-standard-188-2018-legionnaires/#gref

Legionella CDChttps://www .cdc .gov/legionella/clinicians .html

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Steps 1-3 Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX; C Fine CA Steps 4-14 Adapted with permission Fairview University Medical Center Minneapolis MN Forms modified /updated; provided courtesy of Judene Bartley, ECSI Inc. Beverly Hills MI 2002. [email protected] Updated, 2009.

Infection Control Risk AssessmentMatrix of Precautions for Construction & Renovation

Step One:Using the following table, identify the Type of Construction Project Activity (Type A-D)

TYPE A

Inspection and Non-Invasive Activities.Includes, but is not limited to:

removal of ceiling tiles for visual inspection only, e.g., limited to 1 tile per 50 square feetpainting (but not sanding) wallcovering, electrical trim work, minor plumbing, and activities which do not generate dust or require cutting of walls or access to ceilings other than for visual inspection.

TYPE B

Small scale, short duration activities which create minimal dustIncludes, but is not limited to:

installation of telephone and computer cabling access to chase spaces cutting of walls or ceiling where dust migration can be controlled.

TYPE C

Work that generates a moderate to high level of dust or requires demolition or removal of any fixed building components or assemblies Includes, but is not limited to:

sanding of walls for painting or wall covering removal of floorcoverings, ceiling tiles and casework new wall construction minor duct work or electrical work above ceilings major cabling activities any activity which cannot be completed within a single workshift.

TYPE D

Major demolition and construction projectsIncludes, but is not limited to:

activities which require consecutive work shifts requires heavy demolition or removal of a complete cabling system new construction.

Step 1: _________________________________________________________

6.1

Steps 1-3 Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX; C Fine CA Steps 4-14 Adapted with permission Fairview University Medical Center Minneapolis MN Forms modified /updated; provided courtesy of Judene Bartley, ECSI Inc. Beverly Hills MI 2002. [email protected] Updated, 2009.

Infection Control Risk AssessmentMatrix of Precautions for Construction & Renovation

Step One:Using the following table, identify the Type of Construction Project Activity (Type A-D)

TYPE A

Inspection and Non-Invasive Activities.Includes, but is not limited to:

removal of ceiling tiles for visual inspection only, e.g., limited to 1 tile per 50 square feetpainting (but not sanding) wallcovering, electrical trim work, minor plumbing, and activities which do not generate dust or require cutting of walls or access to ceilings other than for visual inspection.

TYPE B

Small scale, short duration activities which create minimal dustIncludes, but is not limited to:

installation of telephone and computer cabling access to chase spaces cutting of walls or ceiling where dust migration can be controlled.

TYPE C

Work that generates a moderate to high level of dust or requires demolition or removal of any fixed building components or assemblies Includes, but is not limited to:

sanding of walls for painting or wall covering removal of floorcoverings, ceiling tiles and casework new wall construction minor duct work or electrical work above ceilings major cabling activities any activity which cannot be completed within a single workshift.

TYPE D

Major demolition and construction projectsIncludes, but is not limited to:

activities which require consecutive work shifts requires heavy demolition or removal of a complete cabling system new construction.

Step 1: _________________________________________________________

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Steps 1-3 Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX; C Fine CA Steps 4-14 Adapted with permission Fairview University Medical Center Minneapolis MN Forms modified /updated; provided courtesy of Judene Bartley, ECSI Inc. Beverly Hills MI 2002. [email protected] Updated, 2009.

Step Two: Using the following table, identify the Patient Risk Groups that will be affected.If more than one risk group will be affected, select the higher risk group:

Low Risk Medium Risk High Risk Highest Risk Officeareas

CardiologyEchocardiographyEndoscopyNuclear Medicine Physical Therapy Radiology/MRIRespiratoryTherapy

CCUEmergency Room Labor & Delivery Laboratories(specimen) Medical Units Newborn Nursery Outpatient Surgery PediatricsPharmacy Post Anesthesia Care UnitSurgical Units

Any area caring for immunocompromised patients Burn Unit Cardiac Cath Lab Central Sterile Supply Intensive Care Units Negative pressure isolation rooms OncologyOperating rooms including C-section rooms

Step 2__________________________________________________________Step Three: Match the

Patient Risk Group (Low, Medium, High, Highest) with the planned … Construction Project Type (A, B, C, D) on the following matrix, to find the …Class of Precautions (I, II, III or IV) or level of infection control activities required.Class I-IV or Color-Coded Precautions are delineated on the following page.

IC Matrix - Class of Precautions: Construction Project by Patient Risk

Construction Project Type Patient Risk Group TTYYPPEE AA TTYYPPEE BB TTYYPPEE CC TTYYPPEE DD

LLOOWW Risk Group II IIII IIII IIIIII//IIVVMMEEDDIIUUMM Risk Group II IIII IIIIII IIVVHHIIGGHH Risk Group II IIII IIIIII//IIVV IIVVHHIIGGHHEESSTT Risk Group IIII IIIIII//IIVV IIIIII//IIVV IIVVNote: Infection Control approval will be required when the Construction Activity and Risk Level indicate that CCllaassss IIIIII or CCllaassss IIVV control procedures are necessary.

Step 3 ______________________________________________________

Steps 1-3 Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX; C Fine CA Steps 4-14 Adapted with permission Fairview University Medical Center Minneapolis MN Forms modified /updated; provided courtesy of Judene Bartley, ECSI Inc. Beverly Hills MI 2002. [email protected] Updated, 2009.

Infection Control Risk AssessmentMatrix of Precautions for Construction & Renovation

Step One:Using the following table, identify the Type of Construction Project Activity (Type A-D)

TYPE A

Inspection and Non-Invasive Activities.Includes, but is not limited to:

removal of ceiling tiles for visual inspection only, e.g., limited to 1 tile per 50 square feetpainting (but not sanding) wallcovering, electrical trim work, minor plumbing, and activities which do not generate dust or require cutting of walls or access to ceilings other than for visual inspection.

TYPE B

Small scale, short duration activities which create minimal dustIncludes, but is not limited to:

installation of telephone and computer cabling access to chase spaces cutting of walls or ceiling where dust migration can be controlled.

TYPE C

Work that generates a moderate to high level of dust or requires demolition or removal of any fixed building components or assemblies Includes, but is not limited to:

sanding of walls for painting or wall covering removal of floorcoverings, ceiling tiles and casework new wall construction minor duct work or electrical work above ceilings major cabling activities any activity which cannot be completed within a single workshift.

TYPE D

Major demolition and construction projectsIncludes, but is not limited to:

activities which require consecutive work shifts requires heavy demolition or removal of a complete cabling system new construction.

Step 1: _________________________________________________________

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Steps 1-3 Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX; C Fine CA Steps 4-14 Adapted with permission Fairview University Medical Center Minneapolis MN Forms modified /updated; provided courtesy of Judene Bartley, ECSI Inc. Beverly Hills MI 2002. [email protected] Updated, 2009.

Description of Required Infection Control Precautions by ClassDuring Construction Project Upon Completion of Project

CLA

SS I 1. Execute work by methods to minimize raising dust

from construction operations. 2. Immediately replace a ceiling tile displaced for

visual inspection

1. Clean work area upon completion of task.

CLA

SS II

1. Provide active means to prevent airborne dust from dispersing into atmosphere.

2. Water mist work surfaces to control dust while cutting.

3. Seal unused doors with duct tape. 4. Block off and seal air vents. 5. Place dust mat at entrance and exit of work area 6. Remove or isolate HVAC system in areas where

work is being performed.

1. Wipe work surfaces with cleaner/disinfectant. 2. Contain construction waste before transport in

tightly covered containers. 3. Wet mop and/or vacuum with HEPA filtered

vacuum before leaving work area. 4. Upon completion, restore HVAC system

where work was performed.

CLA

SS II

I

1. Remove or Isolate HVAC system in area where work is being done to prevent contamination of duct system.

2. Complete all critical barriers i.e. sheetrock, plywood, plastic, to seal area from non work area or implement control cube method (cart with plastic covering and sealed connection to work site with HEPA vacuum for vacuuming prior to exit) before construction begins.

3. Maintain negative air pressure within work site utilizing HEPA equipped air filtration units.

4. Contain construction waste before transport in tightly covered containers.

5. Cover transport receptacles or carts. Tape covering unless solid lid.

1. Do not remove barriers from work area until completed project is inspected by the owner’s Safety Department and Infection Prevention & Control Department and thoroughly cleaned by the owner’s Environmental Services Department.

2. Remove barrier materials carefully to minimize spreading of dirt and debris associated with construction.

3. Vacuum work area with HEPA filtered vacuums.

4. Wet mop area with cleaner/disinfectant. 5. Upon completion, restore HVAC system

where work was performed.

CLA

SS IV

1. Isolate HVAC system in area where work is being done to prevent contamination of duct system.

2. Complete all critical barriers i.e. sheetrock, plywood, plastic, to seal area from non work area or implement control cube method (cart with plastic covering and sealed connection to work site with HEPA vacuum for vacuuming prior to exit) before construction begins.

3. Maintain negative air pressure within work site utilizing HEPA equipped air filtration units.

4. Seal holes, pipes, conduits, and punctures. 5. Construct anteroom and require all personnel to

pass through this room so they can be vacuumed using a HEPA vacuum cleaner before leaving work site or they can wear cloth or paper coveralls that are removed each time they leave work site.

6. All personnel entering work site are required to wear shoe covers. Shoe covers must be changed each time the worker exits the work area.

1. Do not remove barriers from work area until completed project is inspected by the owner’s Safety Department and Infection Prevention & Control Department and thoroughly cleaned by the owner’s Environmental Services Dept.

2. Remove barrier material carefully to minimize spreading of dirt and debris associated with construction.

3. Contain construction waste before transport in tightly covered containers.

4. Cover transport receptacles or carts. Tape covering unless solid lid.

5. Vacuum work area with HEPA filtered vacuums.

6. Wet mop area with cleaner/disinfectant. 7. Upon completion, restore HVAC system

where work was performed.

Steps 1-3 Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX; C Fine CA Steps 4-14 Adapted with permission Fairview University Medical Center Minneapolis MN Forms modified /updated; provided courtesy of Judene Bartley, ECSI Inc. Beverly Hills MI 2002. [email protected] Updated, 2009.

Infection Control Risk AssessmentMatrix of Precautions for Construction & Renovation

Step One:Using the following table, identify the Type of Construction Project Activity (Type A-D)

TYPE A

Inspection and Non-Invasive Activities.Includes, but is not limited to:

removal of ceiling tiles for visual inspection only, e.g., limited to 1 tile per 50 square feetpainting (but not sanding) wallcovering, electrical trim work, minor plumbing, and activities which do not generate dust or require cutting of walls or access to ceilings other than for visual inspection.

TYPE B

Small scale, short duration activities which create minimal dustIncludes, but is not limited to:

installation of telephone and computer cabling access to chase spaces cutting of walls or ceiling where dust migration can be controlled.

TYPE C

Work that generates a moderate to high level of dust or requires demolition or removal of any fixed building components or assemblies Includes, but is not limited to:

sanding of walls for painting or wall covering removal of floorcoverings, ceiling tiles and casework new wall construction minor duct work or electrical work above ceilings major cabling activities any activity which cannot be completed within a single workshift.

TYPE D

Major demolition and construction projectsIncludes, but is not limited to:

activities which require consecutive work shifts requires heavy demolition or removal of a complete cabling system new construction.

Step 1: _________________________________________________________

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Steps 1-3 Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX; C Fine CA Steps 4-14 Adapted with permission Fairview University Medical Center Minneapolis MN Forms modified /updated; provided courtesy of Judene Bartley, ECSI Inc. Beverly Hills MI 2002. [email protected] Updated, 2009.

Step 4. Identify the areas surrounding the project area, assessing potential impact

Unit Below Unit Above Lateral Lateral Behind Front

Risk Group Risk Group Risk Group Risk Group Risk Group Risk Group

Step 5. Identify specific site of activity e.g., patient rooms, medication room, etc. __________________________________________________________________

Step 6. Identify issues related to: ventilation, plumbing, electrical in terms of the occurrence of probable outages.__________________________________________________________________

Step 7. Identify containment measures, using prior assessment. What types of barriers? (E.g., solids wall barriers); Will HEPA filtration be required?

_________________________________________________________________(Note: Renovation/construction area shall be isolated from the occupied areas during construction and shall be

negative with respect to surrounding areas)

Step 8. Consider potential risk of water damage. Is there a risk due to compromising structural integrity? (e.g., wall, ceiling, roof)

Step 9. Work hours: Can or will the work be done during non-patient care hours?

Step 10. Do plans allow for adequate number of isolation/negative airflow rooms?

Step 11. Do the plans allow for the required number & type of handwashing sinks?

Step 12. Does the infection prevention & control staff agree with the minimum number of sinks for this project? (Verify against FGI Design and Construction Guidelines for types and area)

Step 13. Does the infection prevention & control staff agree with the plans relative to clean and soiled utility rooms?

Step 14. Plan to discuss the following containment issues with the project team. E.g., traffic flow, housekeeping, debris removal (how and when),

___________________________________________________________________________________________________________________________________________________________________________________________________

Appendix: Identify and communicate the responsibility for project monitoring that includes infection prevention & control concerns and risks. The ICRA may be modified throughout the project.

Revisions must be communicated to the Project Manager.

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Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX. Form modified /updated & provided courtesy of Judene Bartley, ECSI Inc Beverly Hills MI 2002. [email protected], 2009

5

Infection Control Construction Permit Permit No:

Location of Construction: Project Start Date: Project Coordinator: Estimated Duration: Contractor Performing Work Permit Expiration Date: Supervisor: Telephone:YES NO CONSTRUCTION ACTIVITY YES NO INFECTION CONTROL RISK GROUP

TYPE A: Inspection, non-invasive activity GROUP 1: Low Risk TYPE B: Small scale, short duration, moderate to high levels

GROUP 2: Medium Risk

TYPE C: Activity generates moderate to high levels of dust, requires greater 1 work shift for completion

GROUP 3: Medium/High Risk

TYPE D: Major duration and construction activities Requiring consecutive work shifts

GROUP 4: Highest Risk

CLASS I 1. Execute work by methods to minimize raising dust from construction operations.

2. Immediately replace any ceiling tile displaced for visual inspection.

3. Minor Demolition for Remodeling

CLASS II 1. Provides active means to prevent air-borne dust from dispersing into atmosphere

2. Water mist work surfaces to control dust while cutting. 3. Seal unused doors with duct tape. 4. Block off and seal air vents. 5. Wipe surfaces with cleaner/disinfectant.

6. Contain construction waste before transport in tightly covered containers.

7. Wet mop and/or vacuum with HEPA filtered vacuum before leaving work area.

8. Place dust mat at entrance and exit of work area. 9. Isolate HVAC system in areas where work is being

performed; restore when work completed.

CLASS III 1. Obtain infection control permit before construction begins. 2. Isolate HVAC system in area where work is being done to

prevent contamination of the duct system. 3. Complete all critical barriers or implement control cube

method before construction begins.

6. Vacuum work with HEPA filtered vacuums. 7. Wet mop with cleaner/disinfectant 8. Remove barrier materials carefully to minimize

spreading of dirt and debris associated with construction.

9. Contain construction waste before transport in Date

Initial

4. Maintain negative air pressure within work site utilizing HEPA equipped air filtration units.

5. Do not remove barriers from work area until complete project is checked by Infection Prevention & Control and thoroughly cleaned by Environmental Services.

tightly covered containers. 10. Cover transport receptacles or carts. Tape covering. 11. Upon completion, restore HVAC system where work

was performed.

CLASS IV

Date

Initial

1. Obtain infection control permit before construction begins. 2. Isolate HVAC system in area where work is being done to

prevent contamination of duct system. 3. Complete all critical barriers or implement control cube

method before construction begins. 4. Maintain negative air pressure within work site utilizing

HEPA equipped air filtration units. 5. Seal holes, pipes, conduits, and punctures appropriately. 6. Construct anteroom and require all personnel to pass

through this room so they can be vacuumed using a HEPA vacuum cleaner before leaving work site or they can wear cloth or paper coveralls that are removed each time they leave the work site.

7. All personnel entering work site are required to wear shoe covers.

8. Do not remove barriers from work area until completed project is checked by Infection Prevention & Control and thoroughly cleaned by Environmental. Services.

9. Vacuum work area with HEPA filtered vacuums. 10. Wet mop with disinfectant. 11. Remove barrier materials carefully to minimize

spreading of dirt and debris associated with construction.

12. Contain construction waste before transport in tightly covered containers.

13. Cover transport receptacles or carts. Tape covering. 14. Upon completion, restore HVAC system where work

was performed.

Additional Requirements:

___________Date Initials

___________ Exceptions/Additions to this permit Date Initials are noted by attached memoranda

Permit Request By: Permit Authorized By:

Date: Date:

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What Clinicians Need to Know about

LEGIONNAIRES’ DISEASE

Legionnaires’ disease is a sometimes fatal form of pneumonia that is on the rise in the United States. Unfortunately, this disease is also underrecognized and underdiagnosed. Clinicians are in a unique position to make sure cases are detected, allowing rapid investigation by public health officials and prevention of additional cases.

Diagnosis and TestingClinical features of Legionnaires’ disease include cough, fever, and radiographic pneumonia. Signs and symptoms for Legionnaires’ disease are similar to pneumonia caused by other pathogens; the only way to tell if a pneumonia patient has Legionnaires’ disease is by getting a specific diagnostic test. Indications that warrant testing include:

• Patients who have failed outpatient antibiotic therapy for community-acquired pneumonia

• Patients with severe pneumonia, in particular those requiring intensive care

• Immunocompromised patients with pneumonia*

• Patients with a travel history (patients who have traveled away from their home within 10 days before the onset of illness)

• All patients with pneumonia in the setting of a Legionnaires’ disease outbreak

• Patients at risk for Legionnaires’ disease with healthcare-associated pneumonia (pneumonia with onset ≥48 hours after admission)

* Clinicians may also consider testing for Legionnaires’ disease in patients with other risk factors for this infection (see page 2).

Testing for healthcare-associated Legionnaires’ disease is especially important if any of the following are identified in your facility:

• Other patients with healthcare-associated Legionnaires’ disease diagnosed in the past 12 months

• Positive environmental tests for Legionella in the past 2 months

• Current changes in water quality that may lead to Legionella growth (such as low chlorine levels)

Infection control staff may have more information about these situations in your facility.

The preferred diagnostic tests for Legionnaires’ disease are culture of lower respiratory secretions (e.g., sputum, bronchoalveolar lavage) on selective media and the Legionella urinary antigen test. Serological assays can be nonspecific and are not recommended in most situations. Best practice is to obtain both sputum culture and a urinary antigen test concurrently. Sputum should ideally be obtained prior to antibiotic administration, but antibiotic treatment should not be delayed to facilitate this process. The urinary antigen test can detect Legionella infections in some cases for days to weeks after treatment. The urinary antigen test detects Legionella pneumophila serogroup 1, the most common cause of Legionnaires’ disease; isolation of Legionella by culture is important for detection of other species and serogroups and for public health investigation. Molecular techniques can be used to compare clinical isolates to environmental isolates and confirm the outbreak source.

Order both a culture of a lower respiratory specimen and a urinary antigen test when testing patients for Legionella.

In the United States, reported cases of Legionnaires’ disease have grown by nearly four and a half times since 2000. More than 6,000 cases of Legionnaires’ disease were reported in 2015, but this number is likely an underestimate as the illness is thought to be underdiagnosed.

More illness occurs in the summer and early fall, but Legionnaires’ disease can happen any time of year.

20

00

20

01

20

02

20

03

20

04

20

05

20

06

20

07

20

08

20

09

20

10

20

11

20

12

20

13

20

14

20

15

Inci

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ce (c

ases

/100

,000

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0.2

0.4

0.6

0.8

1.0

1.2

1.4

1.6

1.8

2.0

*National Notifiable Diseases Surveillance System

Legionnaires’ Disease Is On the Rise2000–2015*

6.2

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TreatmentIf your patient has Legionnaires’ disease, see the most recent guidelines for treatment of community-acquired pneumonia (http://bit.ly/CommunityPneumonia) and hospital-acquired pneumonia (http://bit.ly/HospitalPneumonia). Macrolides and respiratory fluoroquinolones are currently the preferred agents for treating Legionnaires’ disease.

ReportingMake sure your infection control department or lab are promptly reporting cases of Legionnaires’ disease to your local health department. Timely identification and reporting of cases is important, as this allows public health officials to quickly identify and stop potential clusters and outbreaks by linking new cases to previously reported ones.

EtiologyLegionnaires’ disease is a severe form of pneumonia that often requires hospitalization and is fatal in about 10% of cases overall, and in 25% of healthcare-associated cases. Legionnaires’ disease is caused by Legionella bacteria. There are at least 60 different species of Legionella, and most are considered capable of causing disease. However, most disease is caused by L. pneumophila, particularly serogroup 1.

TransmissionWhile Legionella is found in natural, freshwater environments, it can become a health concern in human-made water systems (e.g., plumbing system of large buildings, cooling towers, certain medical devices, decorative fountains, hot tubs) where conditions allow it to multiply and come in contact with vulnerable persons. People contract Legionella by inhaling aerosolized water droplets containing the bacteria, or, less commonly, by aspiration of contaminated drinking water. Legionella is usually not transmitted from person to person; however, a single episode of person-to-person transmission has been reported. Fortunately, most people exposed to the bacteria do not become ill.

Risk FactorsRisk factors for developing Legionnaires’ disease include:

• Age ≥50 years

• Smoking (current or historical)

• Chronic lung disease, such as emphysema or COPD

• Immune system disorders due to disease or medication

• Systemic malignancy

• Underlying illness, such as diabetes, renal failure, or hepatic failure

PreventionThe key to preventing Legionnaires’ disease is maintenance of the water systems in which Legionella may grow. If Legionella is found in a healthcare facility’s water system, the facility should work to eliminate the bacteria. CDC encourages all building owners, and especially those in healthcare facilities, to develop comprehensive water management programs to reduce the risk of Legionella growth and spread. Learn more about how to develop a water management program at www.cdc.gov/legionella/WMPtoolkit.

Timely reporting of Legionnaires’ disease cases is important for controlling clusters and outbreaks.

Commons Sources of InfectionOutbreaks of Legionnaires’ disease are most often associated with large or complex water systems, like those found in hospitals, long-term care facilities, hotels, and cruise ships.

The most likely sources of infection include:

Water used for showering (potable water)

Cooling towers (parts of large air conditioning systems)

Decorative fountains

Hot tubs

cdc.gov/legionella | CS278126-A 05/15/2017134

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Updated: 12/11/2018 Page 1 of 4

Healthcare Facility Water Management Program Checklist Available from: www.cdc.gov/hai/prevent/water-management.html

This checklist is intended to assist in the development of an all-hazards approach to water management in a healthcare facility, and may be used to:

• Evaluate a comprehensive water management program. • Identify individuals to participate in the water management program. • Assist in conducting assessments, including hazard analyses, environmental risk assessments,

and infection control risk assessments. • Inform water monitoring practices guided by the management program.

Depending on complexity of the building plumbing systems, a comprehensive program may include several water management plans. These plans should include areas within the system where control points are identified as well as monitoring methods and procedures.

Establish a Water Management Program Team For all facility types, establish clear lines of communication to facilitate dialogue with representatives from the water utility/drinking water provider, as well as the local health department, on an as needed basis.

☐ Define membership (at a minimum, the following ‘roles’ should be represented; may include others depending on facility size, type • facility administration/ownership or C-Suite • facilities management • facilities engineer • infection prevention

☐ Develop a charter that defines roles and responsibilities of members, chair, meeting schedule, etc.

☐ Have you identified team members who should:

☐ Y ☐ N Be familiar with the facility water system(s) ☐ Y ☐ N Identify control locations and control limits ☐ Y ☐ N Identify and take corrective actions ☐ Y ☐ N Monitor and document program performance ☐ Y ☐ N Communicate to the C-suite, staff, health department, and representatives of the

drinking water supplier (if needed) ☐ Y ☐ N Oversee the program ☐ Y ☐ N Access necessary resources to implement changes

☐ Develop the Water Management Policies and Procedures, Plans, and Protocols

Describe your building water systems

☐ Text description of the building water systems, campus water systems, etc.

☐ Develop flow diagrams that describes these systems

For nursing homes, the group may consist of three or more individuals representing management, nursing (someone filling the role of infection control), and the facilities engineer; ad hoc members with subject matter expertise (to provide advice) may be water consultants.

Larger facilities representation may include a designee from the C-suite, risk management, infection prevention, facilities engineers, central services, laboratory, and ad hoc members from clinical departments or water consultants.

Updated: 12/11/2018 Page 1 of 4

Healthcare Facility Water Management Program Checklist Available from: www.cdc.gov/hai/prevent/water-management.html

This checklist is intended to assist in the development of an all-hazards approach to water management in a healthcare facility, and may be used to:

• Evaluate a comprehensive water management program. • Identify individuals to participate in the water management program. • Assist in conducting assessments, including hazard analyses, environmental risk assessments,

and infection control risk assessments. • Inform water monitoring practices guided by the management program.

Depending on complexity of the building plumbing systems, a comprehensive program may include several water management plans. These plans should include areas within the system where control points are identified as well as monitoring methods and procedures.

Establish a Water Management Program Team For all facility types, establish clear lines of communication to facilitate dialogue with representatives from the water utility/drinking water provider, as well as the local health department, on an as needed basis.

☐ Define membership (at a minimum, the following ‘roles’ should be represented; may include others depending on facility size, type • facility administration/ownership or C-Suite • facilities management • facilities engineer • infection prevention

☐ Develop a charter that defines roles and responsibilities of members, chair, meeting schedule, etc.

☐ Have you identified team members who should:

☐ Y ☐ N Be familiar with the facility water system(s) ☐ Y ☐ N Identify control locations and control limits ☐ Y ☐ N Identify and take corrective actions ☐ Y ☐ N Monitor and document program performance ☐ Y ☐ N Communicate to the C-suite, staff, health department, and representatives of the

drinking water supplier (if needed) ☐ Y ☐ N Oversee the program ☐ Y ☐ N Access necessary resources to implement changes

☐ Develop the Water Management Policies and Procedures, Plans, and Protocols

Describe your building water systems

☐ Text description of the building water systems, campus water systems, etc.

☐ Develop flow diagrams that describes these systems

For nursing homes, the group may consist of three or more individuals representing management, nursing (someone filling the role of infection control), and the facilities engineer; ad hoc members with subject matter expertise (to provide advice) may be water consultants.

Larger facilities representation may include a designee from the C-suite, risk management, infection prevention, facilities engineers, central services, laboratory, and ad hoc members from clinical departments or water consultants.

6.3

Updated: 12/11/2018 Page 1 of 4

Healthcare Facility Water Management Program Checklist Available from: www.cdc.gov/hai/prevent/water-management.html

This checklist is intended to assist in the development of an all-hazards approach to water management in a healthcare facility, and may be used to:

• Evaluate a comprehensive water management program. • Identify individuals to participate in the water management program. • Assist in conducting assessments, including hazard analyses, environmental risk assessments,

and infection control risk assessments. • Inform water monitoring practices guided by the management program.

Depending on complexity of the building plumbing systems, a comprehensive program may include several water management plans. These plans should include areas within the system where control points are identified as well as monitoring methods and procedures.

Establish a Water Management Program Team For all facility types, establish clear lines of communication to facilitate dialogue with representatives from the water utility/drinking water provider, as well as the local health department, on an as needed basis.

☐ Define membership (at a minimum, the following ‘roles’ should be represented; may include others depending on facility size, type • facility administration/ownership or C-Suite • facilities management • facilities engineer • infection prevention

☐ Develop a charter that defines roles and responsibilities of members, chair, meeting schedule, etc.

☐ Have you identified team members who should:

☐ Y ☐ N Be familiar with the facility water system(s) ☐ Y ☐ N Identify control locations and control limits ☐ Y ☐ N Identify and take corrective actions ☐ Y ☐ N Monitor and document program performance ☐ Y ☐ N Communicate to the C-suite, staff, health department, and representatives of the

drinking water supplier (if needed) ☐ Y ☐ N Oversee the program ☐ Y ☐ N Access necessary resources to implement changes

☐ Develop the Water Management Policies and Procedures, Plans, and Protocols

Describe your building water systems

☐ Text description of the building water systems, campus water systems, etc.

☐ Develop flow diagrams that describes these systems

For nursing homes, the group may consist of three or more individuals representing management, nursing (someone filling the role of infection control), and the facilities engineer; ad hoc members with subject matter expertise (to provide advice) may be water consultants.

Larger facilities representation may include a designee from the C-suite, risk management, infection prevention, facilities engineers, central services, laboratory, and ad hoc members from clinical departments or water consultants.

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Healthcare Facility Water Management Program Checklist

Updated: 12/11/2018 Page 2 of 4

Identify external hazards (i.e., compromised supply) and describe plans for mitigating or managing these events:

☐ Trace or no disinfectant residual upon entry into the building

☐ Water main breaks

☐ Low pressure events

☐ Flushing hydrants

☐ Boil Water Advisory

☐ Nearby construction ☐ Other (specify):

Identify areas where biofilms may be present and areas where opportunistic pathogens of premise plumbing may grow and spread

☐ Identify storage tanks and describe (water turnover rates, residence times, etc.)

☐ Identify areas of stagnation (dead legs, vacant units/rooms, etc.)

☐ Identify areas with hand-held showers, faucets with aerators/flow restrictors,

☐ Identify areas with no residual disinfectant

☐ Identify areas where temperatures can support microbial growth

☐ Identify locations of commodes and hoppers

☐ Y ☐ N Do all commodes and hoppers have covers that can be closed when flushing?

☐ Y ☐ N If no cover present, are they located in a separate room with a door that can closed?

☐ Identify sinks and sink locations

☐ Y ☐ N Do sinks in patient care areas have aerators and flow restrictors?

☐ Y ☐ N Identify electronic sinks/faucets and temperature setting for mixing valve

☐ Y ☐ N Do all sinks in patient care areas have drains that are offset from faucet flow stream?

☐ Y ☐ N Are there barriers (splash guards) between sinks and adjacent medication preparation areas and patient supplies?

☐ Y ☐ N If splash guards are present, is medication prep and clean supply storage > 3 feet from sinks?

Conduct an Infection Control Risk Assessment (ICRA Adapt for potential water exposures both direct and indirect)

☐ Identify patients at increased risk (e.g., burn patients, patients with immune suppression, patients with lung disease/injury, patients with indwelling devices (e.g., central venous catheters, peritoneal dialysis catheters, etc.), patients with open wounds, patients undergoing endoscopy, etc.)

☐ Risk stratify procedures and processes

☐ Identify potential exposures to water

See From Plumbing to Patients: Water Management Programs for Healthcare Facilities (https://www.cdc.gov/hai/prevent/water-management.html)

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Healthcare Facility Water Management Program Checklist

Updated: 12/11/2018 Page 3 of 4

Identify control point locations and determine how control measures will be applied using both the environmental assessment and ICRA Decide how to monitor control measures (some examples) ☐ Water temperature

See: Guidelines for Environmental Infection Control in Healthcare Facilities (https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html)

☐ Residual disinfectant

☐ Heterotrophic plate count (HPC)

☐ Total Organic Carbon

☐ Review trend data and report out of control results

☐ Determine frequency for monitoring

☐ Other (specify):

Set control limits for control measures that will be monitored (water temperature, residual disinfectant, HPC, and/or total organic carbon). Corrective Actions (some examples)

☐ Eliminate dead legs, unused branches

☐ Remove or repurpose high risk features (e.g., water features, decorative fountains)

☐ Flush taps/fixtures in vacant rooms

☐ Decontamination (shock treatment or remediation using supplemental treatment for short period of time)

☐ Change fixtures/hand held showers

☐ Point of use filtration; supplemental building disinfection systems Routine and intermittent supplemental disinfection (requires registration with State drinking water program); once one starts to treat water facility is now a small drinking water utility subject to drinking water regulations

☐ Raise hot water temperature if in tepid zone (16°C - 38°C)

☐ Other (specify):

Outbreak and Contingency Response Plans

☐ Ability to detect, investigate, and respond to a sentinel infection or cluster that is potentially linked to a water source

☐ Collect epidemiologically linked samples

☐ Notify Health Department

☐ Arrange for molecular typing or relatedness testing

☐ Reassess water control measures and apply corrective actions

See also HAI Outbreak Investigation Toolkit (https://www.cdc.gov/hai/outbreaks/ outbreaktoolkit.html) Tap Water Quality and Infrastructure Discussion Guide for Investigation of Potential Water-Associated Infections in Healthcare Facilities [PDF - 5 pages] (https://www.cdc.gov/hai/pdfs/Water-Quality-Discussion-Guide-P.pdf)

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Healthcare Facility Water Management Program Checklist

Updated: 12/11/2018 Page 4 of 4

Verification: has the plan been implemented as designed and are you following it?

Validation: Determine what conditions, outcomes inform you that your program is effective

☐ Perform clinical surveillance for infections due to opportunistic pathogens of premise plumbing See: From Plumbing to Patients: Water Management Programs for Healthcare Facilities (https://www.cdc.gov/hai/prevent/water-management.html)

☐ Identify clusters and conduct an epidemiologic investigation

☐ Routine environmental sampling for Legionella (optional consideration) Base decisions on building environmental assessment, water quality data, and context of whether disease is present or absent: Legionella Routine Environmental Sampling (https://www.cdc.gov/legionella/wmp/monitor-water.html#env-sampling).

Documentation

☐ Team Roster: Names, titles, contact info, team responsibility, member roles

☐ Building Description: Location, building age, use, occupants, visitors, bed occupancy rate, additions or renovations, etc.

☐ Water system description: both text and process diagrams, location of attached equipment

☐ Control Measures: identify control measures, locations in the system where critical limits can be monitored and where controls can be monitored and applied

☐ Confirmatory procedures: verification steps, and validation to show effectiveness of the water management plan as designed

☐ Sampling and testing: document collection and transport methods, chain of custody, and laboratory identified performing assays if environmental testing is conducted, results

Communication Plan

☐ Notification to building staff/occupants that a plan is in place and provide team’s contact info; issue regular updates as plan is implemented or modified

☐ Reports to team, infection control, hospital administration, other affected parties if control limits are exceeded, and corrective actions to be applied

☐ Consider quarterly and annual reports: reports to management and occupants, consider part of facility quality review; since activity is part of Continuous Quality Improvement (CQI).

☐ Notification protocols with public health points of contact for when a sentinel infection or cluster is detected.

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Module 7

Environmental Cleaning

Contents

7.1 Environmental Checklist for Monitoring Terminal Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . 140CDC

7.2 Options for Evaluating Environmental Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141CDC

Resources

Guidelines for Environmental Infection Control in Health-Care FacilitiesCDChttps://www .cdc .gov/infectioncontrol/guidelines/environmental/index .html

Pesticide Product and Label SystemEnvironmental Protection Agencyhttps://iaspub .epa .gov/apex/pesticides/f?p=PPLS:1

Disinfection and Sterilization CDChttps://www .cdc .gov/infectioncontrol/guidelines/disinfection/index .html

Chemical DisinfectantsCDChttps://www .cdc .gov/infectioncontrol/guidelines/disinfection/disinfection-methods/ chemical .html

Bed BugsCDChttps://www .cdc .gov/parasites/bedbugs/faqs .html

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7.1

140

CDC Environmental Checklist for Monitoring Terminal Cleaning1

Date: Unit: Room Number: Initials of ES staff (optional):2 Evaluate the following priority sites for each patient room: High-touch Room Surfaces3 Cleaned Not Cleaned Not Present in Room Bed rails / controls Tray table IV pole (grab area) Call box / button Telephone Bedside table handle Chair Room sink Room light switch Room inner door knob Bathroom inner door knob / plate Bathroom light switch Bathroom handrails by toilet Bathroom sink Toilet seat Toilet flush handle Toilet bedpan cleaner Evaluate the following additional sites if these equipment are present in the room: High-touch Room Surfaces3 Cleaned Not Cleaned Not Present in Room IV pump control Multi-module monitor controls Multi-module monitor touch screen Multi-module monitor cables Ventilator control panel Mark the monitoring method used: Direct observation Fluorescent gel Swab cultures ATP system Agar slide cultures ____________________________ 1Selection of detergents and disinfectants should be according to institutional policies and procedures 2Hospitals may choose to include identifiers of individual environmental services staff for feedback purposes. 3Sites most frequently contaminated and touched by patients and/or healthcare workers

CDC Environmental Checklist for Monitoring Terminal Cleaning1

Date: Unit: Room Number: Initials of ES staff (optional):2 Evaluate the following priority sites for each patient room: High-touch Room Surfaces3 Cleaned Not Cleaned Not Present in Room Bed rails / controls Tray table IV pole (grab area) Call box / button Telephone Bedside table handle Chair Room sink Room light switch Room inner door knob Bathroom inner door knob / plate Bathroom light switch Bathroom handrails by toilet Bathroom sink Toilet seat Toilet flush handle Toilet bedpan cleaner Evaluate the following additional sites if these equipment are present in the room: High-touch Room Surfaces3 Cleaned Not Cleaned Not Present in Room IV pump control Multi-module monitor controls Multi-module monitor touch screen Multi-module monitor cables Ventilator control panel Mark the monitoring method used: Direct observation Fluorescent gel Swab cultures ATP system Agar slide cultures ____________________________ 1Selection of detergents and disinfectants should be according to institutional policies and procedures 2Hospitals may choose to include identifiers of individual environmental services staff for feedback purposes. 3Sites most frequently contaminated and touched by patients and/or healthcare workers

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Options for Evaluating Environmental Cleaning

Prepared by: Alice Guh, MD, MPH1

Philip Carling, MD2

Environmental Evaluation Workgroup3

December 2010

1Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, Georgia 2Carney Hospital and Boston University School of Medicine, Boston, MA; Dr. Philip Carling has been compensated as a consultant of Ecolab and Steris. He owns a patent for the fluorescent targeting evaluation system described in this document (DAZO Fluorescent Marking Gel). 3Brian Koll, Beth Israel Medical Center, New York, NY; Marion Kainer and Ellen Borchers, Tennessee Department of Health, Nashville, TN; and Brandi Jordan, Illinois Department of Public Health, Chicago, IL

7.2

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Introduction: In view of the evidence that transmission of many healthcare acquired pathogens (HAPs) is related to contamination of near-patient surfaces and equipment, all hospitals are encouraged to develop programs to optimize the thoroughness of high touch surface cleaning as part of terminal room cleaning at the time of discharge or transfer of patients. Since dedicated resources to implement objective monitoring programs may need to be developed, hospitals can initially implement a basic or Level I program, the elements of which are outlined below. Some hospitals should consider implementing the advanced or Level II program from the start, particularly those with increased rates of infection caused by healthcare acquired pathogens (e.g., high Clostridium difficile infection rate). All hospitals that have successfully achieved a Level I program should advance to Level II. At present, the objective monitoring of the cleaning process of certain high touch surfaces (e.g., the curtain that separates patient beds) beyond those outlined in the attached checklist is not well defined. Additionally, there is no standard method for measuring actual cleanliness of surfaces or the achievement of certain cleaning parameters (e.g., adequate contact time of disinfectant) or for defining the level of microbial contamination that correlates with good or poor environmental hygienic practices. As our understanding of these issues evolve and a standardization of assessment in these respective areas can be developed and practically implemented, hospitals that have obtained a high compliance rate with surface cleaning as outlined in the Level II program are encouraged to advance their efforts in optimizing environmental hygienic practices. Level I Program Elements of the program:

1. The program will be an infection preventionist/hospital epidemiologist infection prevention & control (IPC) based program internally coordinated and maintained through environmental services (ES) management level participation. The goal should be seen as a joint (IPC/ES), team effort during planning implementation and ongoing follow-up phases.

2. Each program will be hospital-specific and based on a joint (IC/ES) definition

of institutional expectations consistent with the CDC standards1,2 and the attached check list. The responsibilities of ES staff and other hospital personnel for cleaning high touch surfaces (e.g., equipment in ICU rooms) will be clearly defined.

3. Structured education of the ES staff to define programmatic and institutional

expectations will be carried out and the proportion of ES staff who participate

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will be monitored (see Elements of the Educational Intervention – Appendix A).

4. Development of measures for monitoring along with methods and identified

staff for carrying out monitoring will be undertaken by the IPC/ES team. Monitoring measures may include competency evaluation of ES staff by ES management, IPC staff or, preferably, both. Teams are also encouraged to utilize patient satisfaction survey results in developing measures. Regular ongoing structured monitoring of the program will be performed and documented.

5 Interventions to optimize the thoroughness of terminal room cleaning and

disinfection will be a standing agenda item for the Infection Control Committee (ICC) or Quality Committee as appropriate for the facility.

6. Consideration of the feasibility of moving to the Level II program will be

discussed by the ICC and documented in the committee minutes.

Reporting:

Results should be reported to the ICC and facility leadership.

Level II Program Elements of the Program 1. The program will be an infection preventionist/hospital epidemiologist infection

prevention & control (IPC) based program internally coordinated and maintained through environmental services (ES) management level participation. The goal should be seen as a joint (IPC/ES), team effort during planning implementation and ongoing follow-up phases.

2. Each program will be hospital-specific and based on a joint (IC/ES) definition of

institutional expectations consistent with the CDC standards1,2 and the attached check list. The responsibilities of ES staff and other hospital personnel for cleaning high touch surfaces (e.g., equipment in ICU rooms) will be clearly defined.

3. Either covertly or in conjunction with ES staff, an objective assessment of the

terminal room thoroughness of surface disinfection cleaning will be done using one or more of the methods discussed below (see Objective Methods for

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Evaluating Environmental Hygiene - Appendix B) to document the pre-intervention thoroughness of disinfection cleaning (generally referred to as the “TDC Score” calculated as # of objects cleaned / total # of objects evaluated X 100). Such results will be maintained by the institution and used internally to optimize programmatic and educational interventions.

4. Structured education of the ES staff to define programmatic and institutional

expectations will be carried out and the proportion of ES staff who participate will be monitored. It would be expected that the results of the pre-intervention objective evaluation of disinfection cleaning be incorporated into the ES educational activity in a non-punitive manner (see Elements of the Educational Intervention – Appendix A).

5. Scheduled ongoing monitoring of the TDC cleaning using one or more of the

objective monitoring approaches discussed in Appendix B will be performed at least three times a year. The monitoring will use a projected sample size based on the previous level of TDC in order to detect a 10-20% change in performance (see Sample Size Determination – Appendix C). The results will be recorded in an excel spreadsheet to calculate aggregate TDC scores (see Appendix D).

6. The results of the objective monitoring program and the objectively developed

TDC scores will be used in ongoing educational activity and feedback to the ES staff following each cycle of evaluation. It is recommended that such results be shared more widely within and beyond the institution as useful and appropriate.

7. Results of the objective monitoring program and interventions to optimize the

thoroughness of terminal room cleaning and disinfection will be a standing agenda item for the Infection Control Committee (ICC).

Reporting: Results should be reported to the ICC and facility leadership and could be reported to the state health department through the state prevention collaborative coordinator by various mechanisms (e.g., NHSN template), depending on infrastructure. ________________ 1 Guidelines for Environmental Infection Control in Healthcare Facilities, 2003 (http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_HCF_03.pdf) 2 Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 (http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf)

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Appendices to the Conceptual Program Model for Environmental Evaluation

APPENDIX A Elements of the Educational Intervention Environmental Services Line Personnel – A presentation should be developed for all line staff involved in terminal room cleaning and should: A. Provide an overview of the importance of HAIs in a manner commensurate with their

educational level using as many pictorial illustrations as is feasible. B. Explain their role in improving patient safety through optimized hygienic practice. C. Review specific terminal room cleaning practice expectations. D. Discuss the manner in which their practice will be evaluated. For Level II programs,

a participatory demonstration of the monitoring method is very useful. E. Provide them with information from the baseline evaluation emphasizing or possibly

exclusively showing them results for those objects which have been most thoroughly cleaned (Level II).

F. Stress the non-punitive nature of the program. G. Inform them that their good performance will be broadly recognized (i.e., beyond

their department) and highlighted within their department for others to emulate. (Level II)

H. Repeatedly reinforce the importance of their work, and how it directly relates to the hospital’s goals and mission and how it is appreciated by patients and plays a major role in a patient’s satisfaction with the hospital.

Many hospitals have provided a small (possibly ES staff-language specific) pictorial booklet to the environmental services personnel at the conclusion of the presentation which is often developed to be language skill appropriate. ES managers – As senior managers will be actively involved in the design and implementation of either Level I or Level II programs, educational interventions for them will need to be customized. While many of these individuals have an excellent understanding of the basic policies and procedures involved in terminal room cleaning, most will benefit from focused educational interventions related to our evolving understanding of the role of the environment in healthcare-associated pathogen (HAP) transmission. Evaluation of mid-level managers also needs to be customized. Most importantly, the impact of the program on mid-level ES managers needs to be monitored since additional formal and informal education is frequently needed for those individuals who are somewhat unsure of the importance of developing programmatic approaches to optimize terminal room cleaning.

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Other groups – Given the overall importance of optimizing the thoroughness of hygienic practice in healthcare settings, hospital specific educational interventions graphically illustrating the impact of the program should be considered for both Level I and Level II programs. Such communications should be developed for a range of audiences within the hospital including the senior hospital administration, the medical staff, nursing personnel on the units, executive nursing and medical staff committees and the hospital’s board of managers or directors. APPENDIX B Objective Methods for Evaluating Environmental Hygiene In considering implementation of a Level II program, the advantages and limitations of various monitoring approaches must be considered carefully. The factors which distinguish each approach to Level II monitoring are discussed below and summarized in Fig.1. With any method or methods used it is important that neither the system itself (fluorescent marker) nor its use (precleaning cultures or ATP measurements) induce a Hawthorne type effect. Direct Practice Observation – Covert monitoring of disinfection cleaning can provide an objective assessment of individual ES staff performance and compliance with cleaning protocols. This approach has been used to objectively evaluate and improve ICU environmental hygiene in one hospital.1 While conceptually feasible, logistical issues related to maintaining such a program outside a research setting may limit adaptation of this form of Level II monitoring. Furthermore, the complexity of monitoring cleaning practice in individual patient rooms without the evaluator being recognized as such might represent a difficult confounding issue. Swab Cultures – While several outbreak intervention studies have associated decreased environmental contamination by target organisms as a result of modified cleaning practice leading to decreased acquisition of targeted pathogens, none of the reports specifically note if serial environmental culture results were actually used to provide practice feedback to the ES staff. Although swab cultures are easy to use, the cost of processing, including isolate identification, the delay in analyzing results, the need to determine pre-cleaning levels of contamination for each object evaluated in order to accurately assess cleaning practice, and the limited feasibility of monitoring multiple surfaces in multiple patient rooms as part of an ongoing Level II monitoring program represent issues which could limit the broad application of this system. Agar Slide Cultures – Agar coated glass slides with finger holds were developed to simplify quantitative cultures of liquids. The slides have been adopted for use in environmental surface monitoring in healthcare settings.2 These studies have used agar

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coated slide systems to evaluate cleaning practice by quantifying aerobic colony counts (ACCs) per cm.2,3 While studies have measured aggregate ACCs before and after cleaning, no studies to date have evaluated the actual thoroughness of cleaning of the same objects to determine if objects with relatively high ACCs were either poorly cleaned or actually overlooked by the ES staff. Although some difficulties have been encountered in utilizing the agar slide cultures on other than large, flat surfaces, they potentially provide an easy method for quantifying viable microbial surface contamination. There is a need, similar to that noted above for swab cultures, to determine pre-cleaning levels of contamination for each object evaluated in order to accurately assess cleaning practice. Fluorescent Markers – Fluorescent gel, powder, and lotion have all been developed for the purpose of marking high touch objects prior to room cleaning. While the powder and lotion have been used as part of educational interventions, their overt visibility (lotions and powder), ease with which they can be disturbed (powder), and difficulty with easy removal (lotion if allowed to air dry) may limit their use in a monitoring system and there is little or no published experience in their use for this purpose. In contrast, the fluorescent gel dries transparent on surfaces, resists abrasion, and there are several studies demonstrating the accuracy of the system in objectively evaluating cleaning practice and quantifying the impact of educational interventions on such cleaning.4,5 Because these fluorescent markers are all designed to indicate physical removal of an applied substance, surfaces that are effectively disinfected but less effectively cleaned may be more likely flagged as failing to meet a quality standard using one of these markers than one of the culture techniques.

ATP Bioluminesence – The measurement of organic ATP on surfaces using a luciferase assay and luminometer has been used to evaluate cleanliness of food preparation surfaces for more than thirty years. A specialized swab is used to sample a standardized surface area which is then analyzed using a portable handheld luminometer. The total amount of ATP, both microbial and non-microbial, is quantified and expressed as relative light units. Although readout scales vary more than 10 fold and sensitivity varies between commercially available systems, very low readings are typically associated with low aerobic colony counts (ACCs).6 Very high readings may represent either a viable bioburden, organic debris including dead bacteria or a combination of both. An independent study in 2007 by the U.K. National Health Service evaluating the potential role of the ATP tool in assessing cleaning practice concluded that the tool could potentially be used effectively for ES education.7 Although it is likely that part of the lack of correlation between ATP readings and ACCs noted in the preceding studies relates to the fact that ATP systems measure organic debris as well as viable bacterial counts, several studies have noted additional environmental factors which may increase or decrease ATP readings. Because a large proportion of surface contamination with ATP is non-microbial in origin, surfaces that are effectively disinfected but less effectively cleaned may be more likely flagged as failing to meet a quality standard

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using the ATP tool than one of the culture techniques. Additionally, high concentrations of bleach may potentially quench the ATP bioluminescence reaction and result in a signal reduction, but further research is needed to better understand the impact of bleach-based disinfectants on the use of the ATP system. If a bleach-based disinfectant is used, it is important that the surface is dry before using the ATP tool. Similar to the culture methods described above, it is unclear whether “threshold values” for a clean hospital surface can be established using existing methods, suggesting use of the ATP tool is likely to require pre-cleaning levels of contamination for each object evaluated in order to accurately assess cleaning practice. Despite these limitations, the ATP system has been used to broadly document significant improvement in daily cleaning as well as provide quantitative measurement to indicate the level of cleanliness of high touch surfaces.8,9 Final Points No matter which of the Level II monitoring approaches is chosen by the hospital, it is important that the monitoring be performed by hospital epidemiologists, infection preventionists or their designees who are not part of the actual ES cleaning program. Such an approach assures the validity of the information collected and provides an opportunity for the Infection Control and Prevention Department to independently champion the value of well performed disinfection cleaning.

A more detailed and fully referenced discussion of the above noted approaches to Level II monitoring of terminal room cleaning, may be found in the article Evaluating Hygienic Cleaning in Healthcare Settings: What You Don’t Know Can Harm Your Patients by P.C. Carling and J.M. Bartley in the June, 2010 supplement to the American Journal of Infection Control http://www.ajicjournal.org/issues/contents?issue_key=S0196-6553(10)X0005-0 . APPENDIX C Sample Size Determination Logistical issues must also be considered as part of planning for the implementation of an enhanced program. Before a decision has been made to use one of the Level II methods to objectively monitor cleaning practice, it is important to determine the number of surfaces to be evaluated for establishing baseline level of thoroughness of cleaning and the number of data points which must be monitored on a regular basis to accurately assess improvement or deterioration in practice. While it would be ideal to be able to identify small fluctuations in practice accurately (e.g., 10% relative change), such an approach would be highly labor intensive. Instead, a meaningful change in cleaning practice (e.g., 20% relative change) can be detected without having to evaluate a substantial number of surfaces. Previous experience suggests that conducting a baseline

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evaluation of all available surfaces (listed in the checklist) in a 10-15% sample of representative patient rooms is reasonable in a hospital with ≥150 beds. When hospitals have achieved a thoroughness of cleaning rate of >80%, the number of surfaces to be monitored can be decreased to those available in a 5% sample of rooms per evaluation cycle unless there is a deterioration in practice. In hospitals with less than 150 beds, all available surfaces (listed in the checklist) in a minimum of 15 rooms may be monitored for baseline and ongoing evaluation.

APPENDIX D Calculation of Aggregate Thoroughness of Disinfection Cleaning (TDC) Score The results of the evaluation of each object listed on the check list can be recorded in the attached excel spreadsheet template. The percentage of individual surfaces cleaned across multiple patient rooms will be automatically calculated by the excel spreadsheet. Because it has been found that cleaning practice within an institution is more likely to vary between types of objects than by patient units, the high touch surfaces listed in the check list have been grouped into 5 categories for calculating aggregate TDC scores: High Touch I, High Touch II, High Touch III, Bathroom Surfaces, and Equipment Surfaces. The aggregate TDC scores for each category of objects can be reported to the HAI prevention collaborative coordinator by various mechanisms (e.g., NHSN), depending on infrastructure.

References: 1. Hayden MK, Bonten MJ, Blom DW, Lyle EA. Reduction in acquisition of vancomycin-

resistant enterococcus after enforcement of routine environmental cleaning measures. Clin Infect Disease 2006;42:11,1552-60.

2. Dancer SJ, White LF, Lamb J, Girvan EK, Robertson C. Measuring the effect of enhanced cleaning in a UK hospital: a prospective cross-over study. BMC Med 2009;June8:7-28.

3. Griffith CJ, Cooper RA, Gilmore J, Davies C, Lewis M. An evaluation of hospital cleaning regimes and standards. J Hosp Infect 2000;45:19-28.

4. Carling PC, Parry MM, Rupp ME, Po JL, Dick BL, Von Beheren S. for the Healthcare Environmental Hygiene Study Group. Improving cleaning of the environment surrounding patients in 36 acute care hospitals. Inf Control Hosp Epidem 2008; 29:11,1035-1041.

5. Goodman ER, Platt R, Bass R, Onderdonk AB, Yokoe DS, Huang SS. Impact of an environmental cleaning intervention on the presence of methicillin-resistant

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Staphylococcus aureus and vancomycin-resistant enterococci on surfaces in intensive care unit rooms. Infect Control Hosp Epi Demiol 2008; 29:593-599.

6. Aycicek H, Oguz U, Karci K. Comparison of results of ATP bioluminescence and traditional hygiene swabbing methods for the determination of surface cleanliness at a hospital kitchen. Int J Hyg Environ Health 2006;209:203-6.

7. Willis C, Morley J,Westbury J, Greenwood M, Pallett A. Evaluation of ATP bioluminescence swabbing as a monitoring and training tool for effective hospital cleaning. Br J of Infect Control 2007 8:17-21.

8. Boyce JM, Havill NL, Dumigan DG, Golebiewski M, Balogun O, Rizvani R. Monitoring the effectiveness of hospital cleaning practices by use of an adenosine triphosphate bioluminescence assay. Infect Control Hosp Epidemiol 2009;30,7:678-84.

9. Boyce JM, Havill NL, Lipka A, Havill H, Rizvani R. Variations in hospital daily cleaning practices. Infect Control Hosp Epidemiol 2010;31,1:99-101.

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Figure 1

Evaluating Patient Zone Environmental Hygiene

Method Ease of Use

Identifies Pathogens

Useful for Individual Teaching

Directly Evaluates Cleaning

Published Use in Programmatic Improvement

Direct Practice Low No Yes Yes 1 Hospital

Observation

Swab cultures High Yes Not Studied Potentially 1 Hospital

Agar slide cultures Good Limited Not Studied Potentially 1 Hospital Fluorescent gel High No Yes Yes 49 Hospitals ATP system High No Yes Potentially 2 Hospitals

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INSTRUCTIONS FOR EVALUATING THE CLEANING OF OBJECTS IN THE PATIENT ZONE

The group of objects on the checklist was chosen on the basis of information regarding the contamination of these surfaces with healthcare-associated pathogens (HAPs) as well as a consideration of the likelihood they would be touched during routine care by healthcare personnel without changing gloves or performing hand hygiene prior to using these items. The following descriptions and suggestions should be used to standardize, to the degree feasible, the manner in which the thoroughness of cleaning can be most consistently evaluated. If the evaluation system utilizes a fluorescent gel targeting system, the targets should generally be placed very near but not in/on the area of the object touched in routine use (as noted in the outline below) in order to avoid disturbing the target during actual use of the object. If one of the direct evaluation systems (one of the two culture methods or the ATP method as described in the Appendix) is being used, the primary hand touch area of each object should be evaluated as noted in the outline below, taking particular care to evaluate exactly the same area of the object before and after cleaning. All available objects noted below should be marked in each room. Patient Area Bed rails – If the bed rail incorporates bed controls, evaluate the control area (on the patient side) slightly away from the control buttons. If the rails do not contain the new style control areas, the rails are best evaluated on the smooth inner surface in an area easily accessible to cleaning. Tray table - The top of the tray table should be evaluated in one corner. Call boxes – Evaluation is done on the back mid portion of the call box in an area easily accessible to cleaning. If tiny call buttons are used, mark the separate TV control box instead if feasible. Telephones – Evaluation is best done on the back side of the hand-held portion of the telephone near the top of the phone, away from the end that is attached to the phone wire. Bedside tables – The drawer pull is evaluated. Patient chair – Evaluation is done in the center of the seat of the chair close to the rear of the cushion. If the cushion is covered in textured fabric, evaluate the arm of the chair.

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IV pole – For hanging IV poles, the shaft of the pole just above the textured grab area should be evaluated. For standing IV poles, the chest-high portion where hand contact is most common should be evaluated. Toilet Area Sinks – If using a targeting system, the best place to mark the sink rim is towards the rear in order to avoid water splash interference with evaluation of the target. If direct evaluation is used, the faucet handle should be evaluated. Bathroom and patient room light switches – When using a targeting method, a target is placed on the plate portion of the light switch. When using a direct evaluation system, the switch or plate should be evaluated because of its relatively large surface area. Door knobs and door levers – The inside door knob or lever is marked for each bathroom door and each patient room door. If using a targeting system on a round door knob, the mark is best placed as close to the middle of the face of the door knob as possible. If the knob has a locking mechanism, place the target on the circular door plate that surrounds the handle. Lever-type handles are marked on any easily cleanable surface somewhat away from the end of the lever where direct hand contact would be most frequent. Similarly, when using a fluorescent system, door push plates are marked in the middle of the smooth part of the plate. When using direct evaluation systems, the most frequently contacted portion of the door knob, lever or push plate should be evaluated. Toilet area hand holds (bathroom handrails) – Evaluate the most accessible surface of the hand hold just off the edge of the textured surface at the curve where the hand hold goes towards the wall. If there are two hand holds, mark the one most likely to be touched by a patient using the toilet. Toilet seats – When using a targeting method, the target is placed on the back of the toilet seat just below the outside edge of the seat in an area readily accessible to cleaning activities. When using a direct evaluation method, the surface of the toilet seat should be evaluated, being sure to evaluate the same area before and after cleaning. Toilet handles – When using a targeting method, the target is placed on top of the handle approximately two thirds away from the end of the handle. Bed pan cleaning equipment – Two types of bed pan cleaning equipment designed as part of toilet units are in general use in hospitals.

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Hinged pipe type cleaner - The most commonly used bed pan cleaner consists of a pipe with a small shower head type device that is lowered over the toilet bowl by the user. When the arm is lowered, the toilet flush water is sprayed in a stream through the cleaner head. This device is best targeted by marking the spray head (the most common area which would be touched by users).

Spray hoses – Some toilets have a spray hose with a lever-type trigger on the handle which is depressed to activate the spray head. Evaluate the handle itself.

Where Applicable IV Pump control panel – Evaluate an area that is just adjacent to the portion of the panel that is most frequently touched by healthcare providers. Monitor control panel – When using a targeting method, the control panel should be evaluated in an area immediately adjacent to a part of the panel which is directly contacted by caregivers’ hands. When using a direct method, the control area itself is evaluated. Monitor touch screen – The touch screen should be evaluated in the lower right hand corner in an area easily accessible to cleaning. Monitor cables – Evaluate the junction box area. Ventilator control panel – Evaluate an area immediately adjacent to a part of the panel which is most frequently touched by healthcare provider.

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Module 8

Cleaning, Disinfection, Sterilization

Contents

8.1 Essential Elements of a Reprocessing Program for Flexible Endoscopes—Recommendations of the Healthcare Infection Control Practices Advisory Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159Centers for Disease Control and Prevention (CDC)/Healthcare Infection Control Practices Advisory Committee (HICPAC)https://www .cdc .gov/hicpac/recommendations/flexible-endoscope-reprocessing .html

8.2 HICPAC Sample Policy Template: Reprocessing Flexible Endoscopes . . . . . . . . . . . . . . . 171CDC/HICPAChttps://www .cdc .gov/hicpac/pdf/FlexEndoReprocessing-Policy .docx

8.3 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176CDC/HICPAChttps://www .cdc .gov/hicpac/pdf/FlexEndoReprocessing-Competency .docx

8.4 HICPAC Sample Audit Tool: Reprocessing Flexible Endoscopes . . . . . . . . . . . . . . . . . . . . 194CDC/HICPAChttps://www .cdc .gov/hicpac/pdf/FlexEndoReprocessing-AuditTool .docx

8.5 Autoclave Biological Indicator (BI) Test Results Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

8.6 Reported Gastrointestinal Endoscope Reprocessing Lapses: The Tip of the Iceberg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198Alexandra M . Dirlam Langlay, PhD; Cori L . Ofstead, MSPH; Natalie J . Mueller, MPH; et al . American Journal of Infection ControlDecember 2013, Vol 41, Issue 12, p . 1188-1194https://www .ajicjournal .org/article/S0196-6553(13)00974-7/fulltext

8.7 Special problems associated with reprocessing instruments in outpatient care facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205Judie Bringhurst MSN, RN, CICAmerican Journal of Infection ControlJune 2019, Vol 47, Supplement, p . A58-A61https://www .ajicjournal .org/article/S0196-6553(19)30155-5/fulltext

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Resources

Association for the Advancement of Medical Instrumentationwww .aami .org

The Joint Commissionwww .jointcommission .org

Accreditation Association for Ambulatory Health Carewww .aaahc .org

Centers for Medicare & Medicaid Serviceswww .cms .gov

Disinfection and Sterilization GuidelinesCDChttps://www .cdc .gov/infectioncontrol/guidelines/disinfection/index .html

SterilizationAssociation of periOperative Registered Nurses (AORN) guidelineshttps://aornguidelines .org/tool/filter?categoryid=42865

High Level DisinfectionAORN guidelineshttps://aornguidelines .org/tool/filter?categoryid=42845

High Level DisinfectionFood & Drug Administration (FDA)https://www .fda .gov/medical-devices/reprocessing-reusable-medical-devices-informa-tion-manufacturers/fda-cleared-sterilants-and-high-level-disinfectants-general-claims-process-ing-reusable-medical-and

Instrument CleaningAORN guidelineshttps://aornguidelines .org/tool/filter?categoryid=42841

Flexible EndoscopeAssociation of periOperative Registered Nurses (AORN) guidelineshttps://aornguidelines .org/tool/filter?categoryid=42855

The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing InstructionsFDA Safety Communicationhttps://www .fda .gov/medical-devices/safety-communications/fda-continues-remind-facili-ties-importance-following-duodenoscope-reprocessing-instructions-fda

Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopeshttps://www .sgna .org/Portals/0/SGNA%20Standards%20of%20infection%20prevention%20in%20reprocessing_FINAL .pdf?ver=2018-11-16-084835-387

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Spaulding Classification Systemhttps://cdn .hpnonline .com/inside/2014-06/1406-PnP .html

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016 updatePrepared by: Reprocessing Guideline Task Force, Bret T . Petersen, MD, FASGE (Chair); Jonathan Cohen, MD, FASGE; Ralph David Hambrick III, RN; Navtej Buttar, MD; David A . Green-wald, MD, FASGE; Jonathan M . Buscaglia, MD, FASGE; James Collins, RN; Glenn Eisen, MD, MPH, FASGEGastrointestinal Endoscopy February 2017, Vol 85, Issue 2, p . 282-294 .e1https://www .giejournal .org/article/S0016-5107(16)30647-2/fulltext

ANSI/AAMI ST58:2013 (R2018)Chemical and High-Level Disinfection in Health Care Facilitieshttps://webstore .ansi .org/Standards/AAMI/ANSIAAMIST582013R2018

ANSI/AAMI ST79:2017Comprehensive guide to steam sterilization and sterility assurance in health care facilitieshttps://my .aami .org/store/detail .aspx?id=ST79

ANSI/AAMI ST91:2015Comprehensive guide to flexible and semi-rigid endoscope processing in health care facilitieshttps://www .aami .org/productspublications/ProductDetail .aspx?ItemNumber=2477

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Last update: January 25, 2017 Page 1 of 12 From: https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html

Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of the Healthcare Infection Control Practices Advisory Committee

Preface The Healthcare Infection Control Practices Advisory Committee (HICPAC) is a federal advisory committee chartered to provide advice and guidance to the Centers for Disease Control and Prevention (CDC) and the Secretary of the Department of Health and Human Services (HHS) regarding the practice of infection control and strategies for surveillance, prevention, and control of healthcare-associated infections, antimicrobial resistance and related events in United States healthcare settings. At the July 2015 HICPAC Meeting, CDC asked HICPAC for guidance on ways to improve facility-level training and ensuring competency for reprocessing endoscopes. To develop recommendations for HICPAC to consider, a HICPAC workgroup was formed that contained the following key stakeholder organizations: Accreditation Association for Ambulatory Health Care (AAAHC), Association for the Advancement of Medical Instrumentation (AAMI), American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE), Association of periOperative Registered Nurses (AORN), Association for Professionals in Infection Control and Epidemiology (APIC), Centers for Medicare & Medicaid (CMS), Council of State and Territorial Epidemiologists (CSTE), DNVGL Healthcare, Food and Drug Administration (FDA), International Association of Healthcare Central Service Material Management (IAHCSMM), Public Health Agency of Canada (PHAC), Society of Gastroenterology Nurses and Associates (SGNA), Society for Healthcare Epidemiology of America (SHEA), and The Joint Commission (TJC). The Workgroup provided updates and obtained HICPAC input at the November 2015, March 2016, and July 2016 HICPAC Meetings. HICPAC voted to finalize the recommendations at the July 2016 meeting. Additional information about HICPAC is available on the HICPAC Website (https://www.cdc.gov/hicpac/).

Introduction Healthcare facilities should have a reliable, high-quality system for endoscope reprocessing which minimizes infection risks. To achieve this goal, all reprocessing programs must have an infrastructure that supports training and competencies, quality measurement, and management. The following guidance is provided to assist healthcare facilities, including clinical and administrative staff, to achieve a reliable, high-quality reprocessing program. A toolkit of sample documents accompanies this guidance to help facilities create and maintain the infrastructure to support their flexible endoscope reprocessing program (available from: https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html).

8.1

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Recommendations

Essential Steps for Flexible Endoscope Reprocessing To ensure flexible endoscopes are safe for patient use, all staff involved in reprocessing this equipment must understand and consistently follow a number of steps which have been distilled down to seven essential steps. Ensuring adherence to these steps requires a complete and effective reprocessing program. These recommendations apply to all settings where endoscopic procedures are performed and where endoscopes are reprocessed.

1. Pre-cleaning a. Pre-clean flexible endoscopes and reusable accessories by following the device manufacturer’s

instructions for use (IFU). Perform pre-cleaning immediately following completion of the endoscope procedure to help prevent the formation of biofilm.

2. Leak Testing a. For endoscopes that require leak testing, perform the leak test using manufacturer’s IFU after

each use and prior to manual cleaning. Leak testing detects damage to the external surfaces and internal channels of the endoscope that can lead to inadequate disinfection and further damage of the endoscope.

3. Manual Cleaning a. Perform meticulous manual cleaning including brushing and flushing channels and ports

consistent with the manufacturer’s IFU before performing high-level disinfection (HLD) or sterilization. Perform manual cleaning within the timeframe specified in the manufacturer’s IFU. Manual cleaning is the most critical step in the disinfection process since residual organic material can reduce the effectiveness of HLD and sterilization.

4. Visual Inspection a. After manual cleaning, visually inspect the endoscope and its accessories. Visual inspection

provides additional assurance that the endoscope and its accessories are clean and free of defects. Complex devices such as flexible endoscopes may require the use of lighted magnification or additional methods to assist with the inspection process.

5. Disinfection or Sterilization a. Following cleaning and visual inspection perform HLD or sterilization in accordance with the

manufacturer’s IFU. Carefully review and adhere to the endoscope manufacturer’s reprocessing instructions and to the IFU for chemicals or sterilants and any equipment (e.g., automated endoscope reprocessors) used for reprocessing to help ensure that effective disinfection occurs.

6. Storage a. After reprocessing is complete, store endoscopes and accessories in a manner that prevents

recontamination, protects the equipment from damage, and promotes drying. Store processed flexible endoscopes in a cabinet that is either: 1. of sufficient height, width, and depth to allow flexible endoscopes to hang vertically

without coiling and without touching the bottom of the cabinet OR

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2. designed and intended by the manufacturer for horizontal storage of flexible endoscopes 7. Documentation

a. Maintain documentation of adherence to these essential steps each time an endoscope is reprocessed. Documentation is essential for quality assurance purposes and for patient tracing in the event a look back is necessary.

Essential Elements of a Reprocessing Program for Flexible Endoscopes Administrative

1. Leadership of the healthcare organization or practice setting where flexible endoscopes are used and/or reprocessed is accountable for: a. Allocating sufficient human and material resources to ensure that the selection, use, and

reprocessing of endoscopes and related accessories are managed in a manner that minimizes infection risk and supports patient and healthcare worker safety.

b. Supporting and empowering the authority of those responsible for managing infection prevention practices to ensure effectiveness of the program.

c. Ensuring that the essential elements of an endoscope reprocessing program are followed and that endoscopes are reprocessed according to manufacturers’ IFU.

2. Policies a. In all practice settings where endoscopy is performed, policies related to the reprocessing of

endoscopes should be developed by a multidisciplinary team that includes physicians, nurses, endoscope reprocessing personnel, infection preventionists, and other personnel who are involved in the use and reprocessing of endoscopes. For facilities with limited personnel where formation of a multidisciplinary team is not possible, consider seeking external expertise to obtain multidisciplinary input.

b. Policies should address the selection, use, transport, reprocessing, and storage of endoscopes and accessory devices to ensure compliance with endoscope and reprocessing equipment manufacturers’ IFUs. In addition, policies should clearly include requirements for documentation of adherence to essential reprocessing steps, parameters regarding the physical setting where endoscope reprocessing occurs, staff education, training, and assessment of competency, ongoing quality assurance procedures, and protocols for responding to equipment and HLD/sterilization failures or breaches (see sections below).

c. Policies should include the management of “loaner” endoscopes (i.e., endoscopes that are not owned by the healthcare facility but are provided for temporary use by manufacturers, equipment suppliers or other healthcare facilities) to ensure adherence to the same reprocessing standards described above required for facility-owned equipment. This includes: 1. Assessing the condition (i.e., visual inspection, leak testing) of loaner endoscopes prior to use. 2. Cleaning and high level disinfection or sterilization of loaner endoscopes supplied by the

manufacturer or another healthcare facility prior to use. d. Policies must be in compliance with all federal and local regulatory (e.g., FDA, CMS, OSHA, state

health departments) and relevant accrediting organization (e.g. AAAASF, AAAHC, DNVGL Healthcare, TJC) standards and requirements. Policies should also take into consideration the

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standards and recommendations from professional organizations (e.g., AAMI, AGA, AORN, ASGE, SGNA).

3. Management should ensure that: a. Policies related to the reprocessing of endoscopes are in place and are reviewed on a regular basis

as required by the facility governing body and any applicable regulatory organization. In addition, policies should be updated regularly when new equipment/products are purchased and when new information is published.

b. Single-use devices should not be reprocessed. If a facility chooses to reprocess a single use device, FDA regulations for reprocessing of single use devices must be followed.

c. Occupational health needs are addressed that include but are not be limited to the provision of hepatitis B vaccine, prevention of exposure to infectious agents (e.g., bloodborne pathogens, enteric pathogens) and availability of post-exposure prophylaxis when indicated, convenient access to and appropriate use of personal protective equipment (PPE), and monitoring for exposure to chemicals used for reprocessing when applicable. The CDC provides multiple resources related to occupational health.1,2

d. Patient scheduling and staffing levels are adequate to allow for enough time to consistently perform adequate reprocessing of endoscopes and to avoid delays between completion of an endoscopic procedure and initiation of reprocessing of the endoscope used for that procedure. Management should be knowledgeable about the manufacturer’s IFUs related to delayed reprocessing to ensure that appropriate steps are taken if a reprocessing delay occurs.

e. Staff has access to personnel with infection prevention knowledge and training to support the development and implementation of infection prevention policies and procedures.

f. All personnel involved in the reprocessing of endoscopes, including the supervisors and managers of reprocessing personnel, receive ongoing education, training and assessment of competency as outlined in the Education, Training and Competencies section. 1. If personnel are responsible for reprocessing more than one type of endoscope, verify

reprocessing competency for each type of endoscope, including the appropriate use of all equipment required for reprocessing.

2. Endoscope reprocessing certification is encouraged but does not negate the need for ongoing assessments of competency.

g. At minimum, water used for reprocessing of endoscopes meets the specifications that are recommended by the device and reprocessing equipment manufacturers.3,4 Professional society guidelines that recommend more stringent water specifications should be considered.5

h. All the essential elements of an effective endoscope reprocessing program are met and maintained.

Documentation 1. Documentation requirements vary depending upon the methods and the products that are used for

HLD or sterilization. 2. For all methods of reprocessing using HLD or sterilization, document endoscope and patient

identifiers. Tracking is essential in the event of a disinfection failure and for responding to device or product recalls.

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3. Ensure that there is a process in place to record the procedure end time and the start time for manual cleaning. Recording these times enables reprocessing personnel to ascertain how long the endoscope has been awaiting reprocessing, to prioritize reprocessing of specific endoscopes, and to determine whether routine reprocessing within the manufacturer’s recommended time to cleaning is achievable, and if not, to implement the manufacturer’s procedures for delayed processing.

4. Maintain documentation of the effectiveness of the products used for cleaning and disinfection (e.g., document the results of testing for effective concentrations of the chemical disinfectant, expiration dates for test strips and chemical disinfectants).

5. Maintain records of preventive maintenance and repair of endoscopes and reprocessing equipment (e.g., leak testers, automated endoscope reprocessors [AERs], sterilizers).

6. Documentation should include the investigation of critical or potential critical events such as HLD or sterilization process failures or equipment failures.

7. Retain documentation as designated by the facility record retention policy. This includes documentation for AERs and retired endoscopes.

Inventory 1. Conduct an endoscope inventory to identify all endoscopes and method of reprocessing in use by the

facility. Information reviewed for each endoscope should include but is not limited to the: a. Endoscope manufacturer and model b. Location of use c. Number of procedures performed d. Location of the endoscope manufacturer’s IFUs e. Location for reprocessing f. Equipment used for HLD and/or sterilization g. Status of the endoscope (i.e., retired, out for repair, in use)

2. Ensure that each endoscope has a unique identifier to facilitate tracking. Tracking should include the ability to determine when specific endoscopes were used for specific patients, loaned to other units or facilities, reprocessed, or repaired. Tracking is also essential for responding to device or product recalls.

Physical Setting 1. The reprocessing area should be in a space that is separate from the patient procedural area. 2. Review the physical setting to ensure a “one way” work flow that separates contaminated work spaces

from clean work spaces. 3. If a separate room is used for manual cleaning of endoscopes, ensure a directional airflow that

maintains negative pressure within that room relative to adjoining spaces. 4. Ensure that heating, ventilation, and air conditioning parameters are appropriate for the chemicals and

equipment in use. 5. Staff should have access to a handwashing sink that is separate from the reprocessing sink(s). 6. Install eyewash stations, either plumbed or self-contained, within the endoscopy reprocessing room

where chemicals that are hazardous to the eyes are used. Eyewash stations should not be installed in a location that requires flushing of the eyes in the decontamination sink.

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7. Ensure that manufacturer’s IFUs for reprocessing of the endoscopes and for use of the AERs and associated chemicals are readily available.

8. Provide designated space to enable access to files electronically (e.g., computer) or hard copy (e.g., in binders for IFUs and Safety Data Sheets for chemicals used to reprocess flexible endoscopes.

Education, Training, and Competencies 1. Education and training should include the rationale for each of the seven essential steps of

reprocessing outlined in this document. Training and competency assessments should be based upon the endoscope manufacturer’s IFUs as well as the reprocessing equipment and chemicals used. If more than one type/model of endoscope is used, staff should be able to demonstrate they are competent to reprocess each specific type of endoscope.

a. Model-specific competency assessment check lists may be required. b. Post visual educational aids and standard operating procedures to reinforce best reprocessing

practices. 2. Education and training should also address decontamination, cleaning and sterilization of reusable

accessories that breach the mucosal barrier (e.g., biopsy forceps). 3. Ensure that trainers and managers are competent to reprocess endoscopes and are able to adequately

train and verify the competency of their staff. 4. Perform staff competencies:

a. Initially upon hire and periodically as required by facility policy. An educational update followed by direct observation of staff performing endoscope reprocessing is recommended.

b. Whenever a new model of endoscope, reprocessing equipment (e.g., AER, leak tester), or chemical is purchased.

c. Whenever there are updates to the manufacturer’s IFUs. d. That include essential steps of reprocessing from pre-clean to storage and documentation. e. That include a review of procedures to be followed in the case of equipment failure (e.g., use

of manual reprocessing methods as per manufacturer’s IFU or use of an alternative automated reprocessor that is validated for the endoscope).

f. That include how and when to perform supplemental testing or other assessments of endoscope cleaning (e.g., tests that measure residual organic material or adenosine triphosphate) when those tests are used by the facility.

5. Certification in reprocessing of endoscopes does not mitigate the need for orientation, ongoing education training/education and competency assessments.

Risk Assessment and Quality Assurance 1. A risk assessment or comprehensive gap analysis should be conducted to ensure that:

a. All essential steps of reprocessing and essential elements of an endoscope reprocessing program are met and maintained.

b. Flexible endoscopes are precleaned at the point of use and transported safely to the reprocessing area.

c. Staff competencies are verified d. Sufficient numbers of reprocessing personnel are available when routine and/or emergency

endoscopic procedures are performed

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e. Manufacturer’s IFUs are readily available and followed f. Necessary reprocessing equipment and supplies are available g. Physical space is adequate for reprocessing h. Heating, ventilation and air conditioning parameters are monitored and controlled i. Storage of endoscopes is appropriate j. Documentation providing complete traceability is maintained.

2. When conducting the risk assessment or gap analysis, if an AER is used, assess for documentation that AER has been validated for reprocessing the endoscope and endoscope components. Obtain the model-specific reprocessing protocols for both the endoscope and AER and verify compatibility.

3. Perform periodic audits of facility reprocessing protocols and the completeness of documentation to monitor compliance. Gap analyses and risk assessments should be conducted periodically and whenever new endoscopes are purchased, manufacturer’s IFUs change, and when changes occur in guidance from professional and regulatory organizations.

Disinfection/Sterilization Breach or Failure 1. Breaches in adherence to essential disinfection and sterilization steps can be a result of malfunctioning

of equipment and/or human error. Each breach is a result of unique circumstances and should be evaluated to determine the risk of disease transmission. A multi-disciplinary team that includes infection prevention, risk management, and endoscopy personnel should review each event carefully to determine the necessary corrective steps and the need for patient notification.

2. There are several resources available to assist in a breach evaluation. The multi-disciplinary team should use one or more of these documents to guide their investigation.5-7

3. When a breach involves a suspicion of patient exposure to an improperly reprocessed endoscope, the decision to notify patients of their potential exposure should be made in consultation with an infection preventionist and state and local health departments.

4. If a healthcare provider suspects persistent bacterial contamination of an endoscope following reprocessing, either because of an increase in infections after endoscopic procedures or because of the results of microbiological culturing of endoscopes, the healthcare provider should file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.8

Unresolved Issues 1. Supplemental measures for duodenoscope reprocessing following HLD

• Some healthcare facilities have chosen to use a supplemental method(s) following high level disinfection for reprocessing of duodenoscopes. Because there is currently insufficient evidence to adequately assess the balance between potential benefits and unintended consequences associated with these supplemental methods, these methods have not been included as essential elements of a reprocessing program9. Examples of supplemental measures as of July 2016 include but are not limited to: o Repeat high level disinfection o Microbiological culturing and quarantine until negative culture o Liquid chemical sterilant processing system o Ethylene oxide sterilization

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o FDA-cleared low-temperature sterilization 2. Endoscope Storage Interval

• The available data on the maximum interval of endoscope storage before reprocessing is required prior to use is inconclusive. The length of time may depend on multiple factors as identified on organizational risk assessment that may include endoscope usage/turnover of endoscopes used and manufacturer’s instructions-for-use.

3. Endoscope Storage Space • The storage cabinet features that are optimal for prevention of contamination have not been

determined (e.g., cabinet ventilation parameters, capacity to store accessories). 4. Replacement of Endoscopes

• While endoscopes should be serviced no less frequently than indicated in the FDA-cleared manufacturer’s IFUs, the optimal time interval for replacement of the endoscope and its associated parts is unknown.

References 1. Centers for Disease Control and Prevention. Healthcare Infection Control Practices Advisory Committee.

Bolyard EA, Tablan OC, Williams W, et. al., Guideline for infection control in health care personnel, 1998. Available at: https://stacks.cdc.gov/view/cdc/7250. Accessed August 3, 2015.

2. Healthcare Infection Control Practices Advisory Committee. Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings – The Recommendations of the Healthcare Infection Control Practices Advisory Committee (HICPAC). 2017. Accessed August 3, 2016 prior to publication. Available at: https://www.cdc.gov/hicpac/pdf/core-practices.pdf.

3. Association for the Advancement of Medical Instrumentation. Technical Information Report 34: Water for the Reprocessing of Medical Devices. 2014.

4. Association for the Advancement of Medical Instrumentation. ST91 Flexible and semi-rigid endoscope processing in health care facilities 2015.

5. Van Wicklin SA, Spry C, Conner R. Guideline For Processing Flexible Endoscopes. In: Connor, R,. ed. AORN Guidelines for Perioperative Practice: AORN; 2016.

6. American Society for Gastrointestinal Endoscopy Standards of Practice Committee, Banerjee S, Nelson DB, et al. ASGE Standards of Practice Committee Statement: Reprocessing failure. Gastrointest Endosc. 2007;66(5):869-871.

7. Weber DJ, Rutala WA. Assessing the risk of disease transmission to patients when there is a failure to follow recommended disinfection and sterilization guidelines. Am J Infect Control. 2013;41(5 Suppl):S67-71.

8. US Food and Drug Administration. Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication; Issued September 17, 2015. 2015. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm462949.htm. Accessed June 14, 2016, 2016.

9. Rutala WA, Weber DJ. ERCP scopes: what can we do to prevent infections? Infect Control Hosp Epidemiol. 2015;36(6):643-648.

Additional Resources

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• American National Standards Institute Inc., and the Association for the Advancement of Medical Instrumentation. ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities. Arlington, VA: AAMI, 2015. [Available from: http://my.aami.org/store/detail.aspx?id=ST91-PDF. Accessed 28 September 2016.]

• American Society for Gastrointestinal Endoscopy (ASGE), Quality Assurance in Endoscopy Committee, Petersen BT, Chennat J, et. al. Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011. Gastrointest Endosc. 2011 Jun;73(6):1075-84 (under revision).

• American Society for Gastrointestinal Endoscopy Standards of Practice Committee, Banerjee S, Nelson DB, et al. ASGE Standards of Practice Committee Statement: Reprocessing failure. Gastrointest Endosc. 2007;66(5):869-871.

• Canadian Standards Association. CSA Z314.8-14 Decontamination of reusable medical devices. Chapter 11. Flexible endoscopes. [Available from: http://shop.csa.ca/search?q=Decontamination&categories=shop. Accessed 28 September 2016.]

• Sehulster LM, Chinn RYW, Arduino MJ, Carpenter J, Donlan R, Ashford D, Besser R, Fields B, McNeil MM, Whitney C, Wong S, Juranek D, Cleveland J. Guidelines for environmental infection control in health-care facilities. Recommendations from CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Chicago IL; American Society for Healthcare Engineering/American Hospital Association; 2004. [Available from: https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines.pdf [PDF - 2.32 MB]. Accessed 28 September 2016.]

• Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee, 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings [Available from: https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines.pdf [PDF - 1.4 MB]. Accessed 28 September 2016.]

• Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities, Recommendations from CDC and the Healthcare Infection Control Practices Advisory Committee; 2008 [Available from: https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf [PDF - 1.3 MB]. Accessed 28 September 2016.]

• Rutala WA, and Weber DJ. SHEA Guideline for Disinfection and Sterilization of Prion-Contaminated Medical Instruments (2010). Infection Control and Hospital Epidemiology. Vol. 31, No. 2 (February 2010), pp. 107-117. [Available from: http://www.jstor.org/stable/10.1086/650197. Accessed 28 September 2016.]

• Public Health Agency of Canada. Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy. 2011. [Available from: http://www.phac-aspc.gc.ca/nois-sinp/guide/endo/intro-eng.php. Accessed 28 September 2016.]

• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Guideline for Use of High Level Disinfectants & Sterilants for Reprocessing Flexible Gastrointestinal Endoscopes (2013). Published 1998. Revised 2003, 2006, 2007, 2010, and 2013. [Available from: http://www.sgna.org/Portals/0/Issues/PDF/Infection-Prevention/6_HLDGuideline_2013.pdf [PDF - 243 KB]. Accessed 28 September 2016.]

• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Infection Prevention Champion Program. [Available from: https://www.sgna.org/Issues/Infection-Prevention/Become-A-Champion. Accessed 28 September 2016.]

• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Infection Prevention Toolkit. [Available

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from: https://www.sgna.org/Issues/Infection-Prevention/Infection-Prevention-Toolkit. Accessed 28 September 2016.]

• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Position Statement: Reuse of Single-Use Critical Medical Devices (2015). Published February 1998. Revised May 2002, October 2005, August 2008, March 2012, and May 2013 [Available from: http://www.sgna.org/Portals/0/Issues/PDF/Infection-Prevention/8_SUDPositionStatement_2013.pdf [PDF - 118 KB]. Accessed 28 September 2016.]

• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Position Statement: Statement on Reprocessing of Endoscopic Accessories and Valves (2014). Published May 2002. Revised 2005, May 2009, September 2011, and September 2014 [Available from: https://www.sgna.org/Portals/0/Education/PDF/Position-Statements/Reprocessingvalvesdocument_FINAL.pdf [PDF - 123 KB]. Accessed 28 September 2016.]

• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Position Statement: Statement on Water and Irrigation Bottles Used During Endoscopy (2014). Published May 2002. Revised October 2005, August 2008, May 2009, September 2011, and September 2014. [Available from: https://www.sgna.org/Portals/0/Education/PDF/Position-Statements/WaterandIrrigationBottles_final.pdf [PDF - 126 KB]. Accessed 28 September 2016.]

• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes (2016). Published 1996. Revised 2000, 2005, 2007, 2008, 2011, 2012, 2015, and 2016. [Available from: https://www.sgna.org/Portals/0/Standards%20for%20reprocessing%20endoscopes_FINAL.pdf [PDF – 309 KB]. Accessed 28 September 2016.]

• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Standard of Infection Prevention in the Gastroenterology Setting (2015). Published 2015. [Available from: https://www.sgna.org/Portals/0/Standard%20of%20Infection%20Prevention_FINAL.pdf [PDF – 235 KB]. Accessed 28 September 2016.]

• The Joint Commission. High-Level Disinfection and Sterilization BoosterPak™. [Available from: https://www.jointcommission.org/standards_booster_paks/. Accessed 28 September 2016.]

• Van Wicklin SA, Spry C, Conner R. Guideline for Processing Flexible Endoscopes. In: Connor, R. ed. AORN Guidelines for Perioperative Practice: AORN; 2016. [Available from: http://www.aornstandards.org/. Accessed 28 September 2016.]

Suggested Citation Healthcare Infection Control Practices Advisory Committee. Essential Elements of a Reprocessing Program for Flexible Endoscopes – The Recommendations of the Healthcare Infection Control Practices Advisory Committee (HICPAC). 2016. Available at: https://www.cdc.gov/hicpac/pdf/flexible-endoscope-reprocessing.pdf [PDF - 237 KB].

Contributors

HICPAC Workgroup Members Vickie Brown, RN, MPH; HICPAC Member (Workgroup Co-Chair); Lisa L. Maragakis, MD, MPH; HIPCAC Member (Workgroup Co-Chair); Elizabeth Claverie-Williams, MS; US Food and Drug Administration (FDA); Barbara

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Connell, CAE, CMP, American Society for Gastrointestinal Endoscopy (ASGE); Mary Ann Drosnock, MS, CIC, CFER, RM (NRCM), Association for the Advancement of Medical Instrumentation (AAMI); Glenn Eisen, MD, MPH, FASGE, American Society for Gastrointestinal Endoscopy (ASGE); Eden Essex, American Society for Gastrointestinal Endoscopy (ASGE); Karen Hoffmann, RN, BSN, MS, CIC, FSHEA, FAPIC, Centers for Medicare & Medicaid Services (CMS); Michael L. Kochman, MD, AGAF, FASGE, American Gastroenterological Association (AGA); Naomi Kuznets, PhD; Accreditation Association for Ambulatory Health Care (AAAHC); Natalie Lind, International Association of Healthcare Central Service Materiel Management (IAHCSMM); Betty McGinty, MSHSA, CGRN, BSHA, RN, Society of Gastroenterology Nurses and Associates (SGNA); Laurie O'Neil, RN BN; Public Health Agency of Canada; Michael Anne Preas RN, BSN, CIC; Association for Professionals in Infection Control and Epidemiology (APIC); Sharon Roberson, RN, Centers for Medicare & Medicaid Services (CMS); Zachary Rubin, MD, Society for Healthcare Epidemiology of America (SHEA); Linda L. Spaulding RN, BC, CIC; DNVGL Healthcare; Rachel Stricof, MPH, Council of State and Territorial Epidemiologists (CSTE); Michael Tapper, MD, HICPAC Member; Sharon A. Van Wicklin, MSN, RN, CNOR, CRNFA(E), CPSN-R, PLNC, Association of periOperative Registered Nurses (AORN); Lisa Waldowski MS, APRN, CIC, The Joint Commission; Deborah Yokoe, MD, MPH, HICPAC Co-Chair

HICPAC Members Daniel J. Diekema, MD, University of Iowa Carver College of Medicine (Co-Chair); Deborah S. Yokoe, MD, MPH, Brigham & Women's Hospital (Co-Chair); Hilary M. Babcock, MD, MPH, Washington University School of Medicine; Vickie M. Brown, RN, MPH, WakeMed Health & Hospitals; Sheri Chernetsky Tejedor, MD, Emory University School of Medicine; Susan Huang, MD, MPH; University of California Irvine School of Medicine; Loretta L. Fauerbach, MS, CIC, Fauerbach & Associates, LLC; Michael D. Howell, MD MPH, University of Chicago Medicine; W. Charles Huskins, MD, MSc, Mayo Clinic College of Medicine; Lynn Janssen MS, CIC, CPHQ, California Department of Public Health; Lisa L. Maragakis, MD, MPH, Johns Hopkins University School of Medicine; Jan Patterson, MD, MS, University of Texas Health Science Center San Antonio; Gina Pugliese, RN. MS, Premier healthcare alliance; Selwyn O. Rogers Jr., MD, MPH, FACS, The University of Texas Medical Branch; Tom Talbot, MD, MPH, Vanderbilt University Medical Center; Michael L. Tapper, MD, Lenox Hill Hospital

HICPAC Ex-officios William B. Baine, MD, Agency for Healthcare Research and Quality (AHRQ); David Henderson, MD, National Institutes of Health (NIH); Melissa Miller, MD, Agency for Healthcare Research and Quality (AHRQ); Paul D. Moore, PhD, Health Resources and Services Administration (HRSA); Elizabeth Claverie-Williams, MS, U.S. Food and Drug Administration (FDA); Gary Roselle, MD, Veterans Administration (VA); Daniel Schwartz, MD, MBA Center for Medicare & Medicaid Services; Jacqueline Taylor, Health Resources and Service Administration (HRSA); Judy Trawick, Health Resources and Service Administration (HRSA)

HICPAC Liaison Representatives David Banach, MD, MPH, Society for Healthcare Epidemiology of America (SHEA); Vineet Chopra, MBBS, Society of Hospital Medicine; Craig M. Coopersmith, MD, Society of Critical Care Medicine; Elaine Dekker, RN, BSN, CIC, America’s Essential Hospitals; Akin Demehin, American Hospital

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Association (AHA); Kathleen Dunn, BScN, MN, RN, Public Health Agency of Canada; Sandra Fitzler, RN, American Health Care Association (AHCA); Nancy Foster, American Hospital Association (AHA); Diana Gaviria, MD, MPH, National Association of County and City Health Officials (NACCHO); Jennifer Gutowski, MPH, BSN, RN, CIC, National Association of County and City Health Officials (NACCHO); Valerie Haley, PhD, Association of State and Territorial Health Officials (ASTHO)Holly Harmon, RN, MBA, American Health Care Association (AHCA); Patrick Horine, MHA, DNVGL Healthcare Inc.; Michael D. Howell, MD, MPH, Society of Critical Care Medicine (SCCM); Marion Kainer, MD, MPH, Council of State and Territorial Epidemiologists (CSTE); Emily Lutterloh, MD, MPH, Association of State and Territorial Health Officials (ASTHO); Sarah Matthews, MD, National Association of County and City Health Officials (NACCHO); Michael McElroy, MPH, CIC, America’s Essential Hospitals; Lisa McGiffert, Consumers Union; Jennifer Meddings, MD, Society of Hospital Medicine (SHM); Toju Ogunremi, Public Health Agency of Canada; Laurie O’Neil, RN, BN, Public Health Agency of Canada; Michael Anne Preas, RN CIC, Association of Professionals of Infection Control and Epidemiology, Inc. (APIC); Mark E. Rupp, MD, Society for Healthcare Epidemiology of America (SHEA); Mark Russi, MD, MPH, American College of Occupational and Environmental Medicine; Sanjay Saint, MD, MPH, Society of Hospital Medicine (SHM); Robert G. Sawyer, MD, FACS, FIDSA, FCCM, Surgical Infection Society (SIS); Kathryn Spates, the Joint Commission; Linda Spaulding RN, CIC, DNVGL Healthcare; Donna Tiberi, RN, MHA Healthcare Facilities Accreditation Program (HFAP); Margaret VanAmringe, MHS, the Joint Commission; Stephen Weber, MD, Infectious Disease Society of America (IDSA); Elizabeth Wick, MD, American College of Surgeons (ACS); Amber Wood, MSN, RN, CNOR, CIC, FAPIC, Association of periOperative Registered Nurses (AORN)

Acknowledgements Erin Stone, MA, Lynne Sehulster, PhD, Joseph Perz, DrPH, MA , and Jeffrey Hageman, MHS; the Division of Healthcare Quality Promotion (DHQP), the Centers for Disease Control and Prevention

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HICPACSamplePolicyTemplate:ReprocessingFlexibleEndoscopes [Insertfacilitynameoraheader]

Adaptedwithpermissionfrom“GuidelinesandToolsfortheSterileProcessingTeam.AORN,Inc.,2170SouthParkerRoad,Suite400,Denver,CO80231.Allrightsreserved.” Page1of5

HICPACSamplePolicyTemplate:ReprocessingFlexibleEndoscopes

AdministrativeApprovalDateCreated: LastDateRevised: LastDateReviewed: DateofNextReview:

Approvalsignature(s)withtitleanddateofsignature:

Signature Title Date Signature Title Date Signature Title Date

Purpose:Facilitiescanuse this samplepolicy template todevelopa facility-specificpolicies that reflects theendoscopesandevidence-basedpracticesemployedbythefacility.Thepolicydocumentwillprovideguidancetopersonnelforprocessingalltypesofreusableflexibleendoscopesandaccessories.

PolicyItisthepolicyof[insertnameoffacility]that:• Allpersonnelinvolvedinthereprocessingofendoscopesreceiveongoingeducation,trainingand

assessmentofcompetency.• Ongoingperiodicauditsoffacilityreprocessingprotocolswillbeconductedtoensurequalityassurance,

monitorcompliance,andthecompletenessofdocumentation.• Flexibleendoscopesandaccessorieswillbeprecleanedatthepointofuse.• Flexibleendoscopesdesignedtobeleaktestedwillbeleaktestedaftereachuse,afteranyeventthatmay

havedamagedtheendoscope,andbeforeuseofanewlypurchased,repaired,orloanedendoscope.• Afterleaktestingandbeforehigh-leveldisinfection(HLD)orsterilization,flexibleendoscopeswillbe

manuallycleaned.• Flexibleendoscopes,accessories,andassociatedequipmentwillbevisuallyinspectedforcleanliness,

integrity,andfunctionbeforedisinfectionorsterilization.• Chemicalsandsolutionsusedforcleaningandreprocessingflexibleendoscopesandendoscope

accessorieswillbehandledinaccordancewithlocal,state,andfederalregulationsandthemanufacturer’sIFU.

• Flexibleendoscopesandaccessorieswillbestoredinamannerthatminimizescontaminationandprotectsthedeviceoritemfromdamage.

• Recordsofflexibleendoscopeprocessingandproceduresthatenabletraceabilityintheeventofaprocessingfailurewillbecompletedandmaintained.o Recordswillbemaintainedfor[insertfacility-specifictimeperiod].

HICPACSamplePolicyTemplate:ReprocessingFlexibleEndoscopes [Insertfacilitynameoraheader]

Adaptedwithpermissionfrom“GuidelinesandToolsfortheSterileProcessingTeam.AORN,Inc.,2170SouthParkerRoad,Suite400,Denver,CO80231.Allrightsreserved.” Page1of5

HICPACSamplePolicyTemplate:ReprocessingFlexibleEndoscopes

AdministrativeApprovalDateCreated: LastDateRevised: LastDateReviewed: DateofNextReview:

Approvalsignature(s)withtitleanddateofsignature:

Signature Title Date Signature Title Date Signature Title Date

Purpose:Facilitiescanuse this samplepolicy template todevelopa facility-specificpolicies that reflects theendoscopesandevidence-basedpracticesemployedbythefacility.Thepolicydocumentwillprovideguidancetopersonnelforprocessingalltypesofreusableflexibleendoscopesandaccessories.

PolicyItisthepolicyof[insertnameoffacility]that:• Allpersonnelinvolvedinthereprocessingofendoscopesreceiveongoingeducation,trainingand

assessmentofcompetency.• Ongoingperiodicauditsoffacilityreprocessingprotocolswillbeconductedtoensurequalityassurance,

monitorcompliance,andthecompletenessofdocumentation.• Flexibleendoscopesandaccessorieswillbeprecleanedatthepointofuse.• Flexibleendoscopesdesignedtobeleaktestedwillbeleaktestedaftereachuse,afteranyeventthatmay

havedamagedtheendoscope,andbeforeuseofanewlypurchased,repaired,orloanedendoscope.• Afterleaktestingandbeforehigh-leveldisinfection(HLD)orsterilization,flexibleendoscopeswillbe

manuallycleaned.• Flexibleendoscopes,accessories,andassociatedequipmentwillbevisuallyinspectedforcleanliness,

integrity,andfunctionbeforedisinfectionorsterilization.• Chemicalsandsolutionsusedforcleaningandreprocessingflexibleendoscopesandendoscope

accessorieswillbehandledinaccordancewithlocal,state,andfederalregulationsandthemanufacturer’sIFU.

• Flexibleendoscopesandaccessorieswillbestoredinamannerthatminimizescontaminationandprotectsthedeviceoritemfromdamage.

• Recordsofflexibleendoscopeprocessingandproceduresthatenabletraceabilityintheeventofaprocessingfailurewillbecompletedandmaintained.o Recordswillbemaintainedfor[insertfacility-specifictimeperiod].

HICPACSamplePolicyTemplate:ReprocessingFlexibleEndoscopes [Insertfacilitynameoraheader]

Adaptedwithpermissionfrom“GuidelinesandToolsfortheSterileProcessingTeam.AORN,Inc.,2170SouthParkerRoad,Suite400,Denver,CO80231.Allrightsreserved.” Page1of5

HICPACSamplePolicyTemplate:ReprocessingFlexibleEndoscopes

AdministrativeApprovalDateCreated: LastDateRevised: LastDateReviewed: DateofNextReview:

Approvalsignature(s)withtitleanddateofsignature:

Signature Title Date Signature Title Date Signature Title Date

Purpose:Facilitiescanuse this samplepolicy template todevelopa facility-specificpolicies that reflects theendoscopesandevidence-basedpracticesemployedbythefacility.Thepolicydocumentwillprovideguidancetopersonnelforprocessingalltypesofreusableflexibleendoscopesandaccessories.

PolicyItisthepolicyof[insertnameoffacility]that:• Allpersonnelinvolvedinthereprocessingofendoscopesreceiveongoingeducation,trainingand

assessmentofcompetency.• Ongoingperiodicauditsoffacilityreprocessingprotocolswillbeconductedtoensurequalityassurance,

monitorcompliance,andthecompletenessofdocumentation.• Flexibleendoscopesandaccessorieswillbeprecleanedatthepointofuse.• Flexibleendoscopesdesignedtobeleaktestedwillbeleaktestedaftereachuse,afteranyeventthatmay

havedamagedtheendoscope,andbeforeuseofanewlypurchased,repaired,orloanedendoscope.• Afterleaktestingandbeforehigh-leveldisinfection(HLD)orsterilization,flexibleendoscopeswillbe

manuallycleaned.• Flexibleendoscopes,accessories,andassociatedequipmentwillbevisuallyinspectedforcleanliness,

integrity,andfunctionbeforedisinfectionorsterilization.• Chemicalsandsolutionsusedforcleaningandreprocessingflexibleendoscopesandendoscope

accessorieswillbehandledinaccordancewithlocal,state,andfederalregulationsandthemanufacturer’sIFU.

• Flexibleendoscopesandaccessorieswillbestoredinamannerthatminimizescontaminationandprotectsthedeviceoritemfromdamage.

• Recordsofflexibleendoscopeprocessingandproceduresthatenabletraceabilityintheeventofaprocessingfailurewillbecompletedandmaintained.o Recordswillbemaintainedfor[insertfacility-specifictimeperiod].

8.2

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ProcedureInterventionsPrecleaning

• Precleanflexibleendoscopesandaccessoriesatthepointofuseassoonaspossibleaftertheendoscopeisremovedfromthepatient(ortheprocedureiscompleted)andbeforeorganicmaterialhasdriedonthesurfaceorinthechannelsoftheendoscope.

• Performprecleaninginaccordancewiththeendoscopemanufacturer’sIFUandbyo preparingafreshsolutionofthecleaningproductwithpropertiesrecommendedbythemanufacturer;o washingtheexteriorsurfacesoftheendoscopewithasoft,lint-freeclothorspongesaturatedwiththe

cleaningsolution;o suctioningthecleaningsolutionthroughthesuctionandbiopsychannels;o placingthedistalendoftheendoscopeinthecleaningsolutionandsuctioningthesolutionthrough

theendoscope;o flushingtheair,water,andotherchannelsoftheendoscopealternatelywiththecleaningsolutionand

air,finishingwithair;o visuallyinspectingtheendoscopefordamage;ando discardingthecleaningsolutionandcleaningclothorspongeafteruse.

Transporting

• Transportcontaminatedflexibleendoscopesandaccessoriestotheendoscopyprocessingroomassoonaspossibleafteruse.

• Keeptheendoscopewetordamp,butnotsubmergedinliquid,duringtransport.• Transportcontaminatedendoscopesandaccessoriestothedecontaminationareainaclosedcontaineror

closedtransportcart.o Useacontainerthatisleakproof,punctureresistant,andlargeenoughtocontainallcontents.o Useacontainerthatisofsufficientsizetoaccommodatetheendoscopewhentheendoscopeiscoiled

inlargeloops.• Labelthetransportcartorcontainerwithabiohazardlegend.

o Securelyaffixthebiohazardlabeltothecartorcontainer.• Transporttheaccessorieswiththeendoscopebutcontainthemseparatelyfromtheendoscope.• Beginprocessingflexibleendoscopesandaccessoriesassoonaspossibleaftertransporttotheendoscopy

processingroomorwithinthemanufacturer’srecommendedtimetoprocessing.o Whenitisnotpossibletoinitiatethecleaningprocesswithintheendoscopemanufacturer’s

recommendedtimetocleaning,followthemanufacturer’sIFUfordelayedprocessing.o Donotleaveflexibleendoscopessoakinginenzymaticcleaningsolutionsbeyondtheendoscope

manufacturer’sdesignatedcontacttimeunlessthisisrecommendedinthemanufacturer’sIFUfordelayedprocessing.

LeakTesting

• Performleaktestingbeforemanualcleaningandbeforetheendoscopeisplacedintocleaningsolutions.• Performleaktestinginaccordancewiththeendoscopeandleak-testingequipmentmanufacturers’IFU

andbyo removingallportcoversandfunctionvalves;o placingtheendoscopeinalooseconfiguration;o pressurizingtheendoscopetotherecommendedpressure;o manipulatingallmovingparts,includingtheelevator,andangulatingthebendingsectionofthedistal

end;o actuatingvideoswitches;ando maintainingpressureandinspectionforaminimumof30seconds.

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Adaptedwithpermissionfrom“GuidelinesandToolsfortheSterileProcessingTeam.AORN,Inc.,2170SouthParkerRoad,Suite400,Denver,CO80231.Allrightsreserved.” Page3of5

• Whenanendoscopefailsaleaktest,removeitfromserviceandsendforrepairorreplacementperfacilitypolicyandprocedure.

ManualCleaning

• Performmanualcleaninginaccordancewiththeendoscopemanufacturer’sIFU.• Performmanualcleaningusingthetypeofwaterandcleaningsolutionrecommendedbytheendoscope

manufacturer.• Performmanualcleaningusingafreshlypreparedcleaningsolution.• Followthecleaningsolutionmanufacturer’sIFUfor

o waterquality,hardness,andpH;o concentrationanddilution;o watertemperature;o contacttime;o conditionsofstorage;ando uselifeandshelflife.

• Completelysubmergetheendoscopeinthecleaningsolutionduringthecleaningprocess.o Detachremovableparts(e.g.,valves,buttons,caps)fromtheendoscopeandsubmergethemif

recommendedbytheendoscopemanufacturer’sIFU.• Cleanallexteriorsurfacesoftheendoscopewithasoft,lint-freeclothorspongesaturatedwiththe

cleaningsolution.• Cleanallaccessiblechannelsandthedistalendoftheendoscopewithacleaningbrushofthelength,

width,andmaterialrecommendedbytheendoscopemanufacturer.• Manuallyactuatetheendoscopevalveswhilecleaning.• Cleanandbrushtheelevatormechanism(ifpresent)andtherecessessurroundingitwithacleaningbrush

ofthelength,width,andmaterialrecommendedbytheendoscopemanufacturer.o Raiseandlowertheelevatorchannelthroughoutthemanualcleaningprocess.

• Useacleanbrushforeachendoscopecleaning.o Visuallyinspectbrushesandotheritemsusedtocleanendoscopechannelsbeforeuseanddonotuse

iftheintegrityofthebrushorothercleaningitemisinquestion.• Brushtheaccessiblechannelsoftheendoscopemultipletimesuntilnodebrisappearsonthebrush.

o Removedebrisfromthebrushbeforethebrushisretractedbackthroughthechannelandaftereachpassbyswirlingthebrushinthecleaningsolutionandrinsingit.

• Flushthechannelsoftheendoscopewithcleaningsolution.• Flushandrinsetheexteriorsurfacesandinternalchannelsoftheendoscopewithtapwateruntilall

cleaningsolutionandresidualdebrisisremoved.• Drytheexteriorsurfacesoftheendoscopewithasoft,lint-freeclothorspongeandpurgeallchannelswith

air.• Clean,brush,rinse,dry,andhigh-leveldisinfectorsterilizeallreusableparts(e.g.,valves,buttons,port

covers,tubing,waterbottles),accessories(e.g.,forceps)andcleaningimplements(e.g.,brushes,channelcleaningadapters).o High-leveldisinfectorsterilizewaterandirrigationbottlesatleastdaily.o Donotallowanyresidualwaterormoisturetoremaininthewaterbottleassembly.o Usesterilewatertofillwaterandirrigationbottles.

• Discardsingle-useparts,accessories,andcleaningimplementsaftereachuseanddonotreprocess.

Inspecting

• Visuallyinspectandevaluateendoscopes,accessories,andequipmentforo cleanliness,o missingparts,

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o clarityoflenses,o integrityofsealsandgaskets,o moisture,o physicalandchemicaldamage,ando function.

• Uselightedmagnificationtoinspectendoscopesandaccessoriesforcleanlinessanddamage,asneeded.• Removedefectiveendoscopes,accessories,andequipmentfromserviceandsendforrepairor

replacementperfacilitypolicyandprocedure.

High-LevelDisinfectionorSterilization

• ManuallycleantheendoscopeandaccessoriesbeforemechanicalormanualHLDorsterilization.

Mechanicalmethods

• Checktheexpirationdateofthehigh-leveldisinfectantorliquidchemicalsterilantbeforeeachuse.• UseateststriporotherUSFoodandDrugAdministration(FDA)-clearedtestingdevicespecifictothe

disinfectantorliquidchemicalsterilantandminimumeffectiveconcentrationoftheactiveingredientformonitoringsolutionpotencybeforeeachuse.

• Performmechanicalprocessinginaccordancewiththeendoscopemanufacturer’sIFUandthemechanicalprocessor’sIFU.o Verifycompatibilitybetweentheendoscopeandthemechanicalprocessorbeforeprocessing.o Positiontheendoscopeandaccessorieswithinthemechanicalprocessorinamannerthatensures

contactoftheprocessingsolutionswithallsurfacesoftheendoscope.o Ensureallconnectorsbetweentheendoscopeandthemechanicalprocessorareconnectedcorrectly.o Monitorthemechanicalprocessingcycletoverifyitiscompletedasprogrammed.

§ Ifamechanicalprocessingcycleisinterrupted,repeattheentirecycle.• Performmechanicalprocessingusingthecleaning,disinfectant,andsterilantsolutionsandchemicals

recommendedbytheendoscopemanufacturerandthemechanicalprocessormanufacturer.o Knowthelocationofthesafetydatasheetforeachchemicalused.o Knowthelocationofthechemicalspillkit.

Manualmethods

• Checktheexpirationdateofthehigh-leveldisinfectantbeforeeachuse.• UseateststriporotherUSFoodandDrugAdministration(FDA)-clearedtestingdevicespecifictothe

disinfectantandminimumeffectiveconcentrationoftheactiveingredientformonitoringsolutionpotencybeforeeachuse.

• Completelyimmersetheendoscopeinthehigh-leveldisinfectantsolutionforthedesignatedtimeaccordingtothedeviceandhigh-leveldisinfectantmanufacturer’sIFU.

• Flushandfilllumensandportswiththehigh-leveldisinfectantsolutionthencompletelyimmersetheitemsinthedisinfectantsolutionforthedesignatedtime.

• Followingdisinfection,thoroughlyrinsetheendoscopeandallofitschannelsandportswithwaterthatmeetsthemanufacturer’sspecificationorasrecommendedbyprofessionalorganizations.o Rinseallremovablepartsandendoscopeaccessories.

Mayberequiredforbothmechanicalandmanualmethods

• Flushendoscopelumenswith70%to90%ethylorisopropylalcoholaccordingtotheendoscopemanufacturer’sIFU.

• Drytheexteriorsurfacesoftheendoscopewithasoft,lint-freeclothorsponge.o Purgetheendoscopechannelswithair.o Dryallremovablepartsandendoscopeaccessories.

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Sterilization

• Packageandsterilizeendoscopesandendoscopeaccessoriesinaccordancewiththemanufacturers’IFU.

Storing• Storeflexibleendoscopesinaccordancewiththeendoscopeandstoragecabinetmanufacturers’IFU.

o Donotstoreflexibleendoscopesintheiroriginalshipmentcases.o Storeflexibleendoscopeswithallvalvesopenandremovablepartsdetached,butstoredwiththe

endoscope.• Wearclean,low-protein,powder-free,naturalrubberlatexglovesorlatex-freegloveswhenhandling

processedflexibleendoscopesandwhentransportingthemtoandfromthestoragecabinet.• Identifyprocessedendoscopeswiththefacility-specificvisualcue.• Visuallyinspectendoscopesandstoragecabinetsforcleanlinessbeforeplacingendoscopesintoor

removingthemfromthecabinet.• Storesterileitemsinasterilestorageareaperfacilitypolicyandprocedure.

Records• Recordsrelatedtoflexibleendoscopeprocessingwillincludethe

o dateandtime,o identityofendoscopeandendoscopeaccessories,o methodandverificationofcleaningandresultsofcleaningverificationtesting,o numberoridentifierofthemechanicalprocessororsterilizerandresultsofprocessefficacytesting,o identityofthepersonsperformingtheprocessing,o lotnumbersofprocessingsolutions,o dispositionofdefectiveitemsorequipment,ando maintenanceofwatersystems,endoscopesandendoscopeaccessories,andprocessingequipment.

• Recordsrelatedtoflexibleendoscopyprocedureswillincludetheo dateandtime,o identityofthepatient,o procedure,o identityofthelicensedindependentpractitionerperformingtheprocedure,ando identityoftheendoscopeandendoscopeaccessoriesusedduringtheprocedure.

• Recordsrelatedtoannualtrainingandcompetencyauditwillincludetheo dateandtimeoftrainingandcompetencyverificationo nameofpersonneltakingtraining/competencyverificationo resultsofcompetencyverificationo resultsofaudittool

• Recordsrelatedtofacilityauditsshouldincludetheo dateandtimeo facilitynameo completenessofinventoryandrepairlogo gapanalysis

§ actionstakeno riskassessment

§ actionstaken Availablefrom:https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html

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176

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f18

Com

pete

ncy

Stat

emen

ts/P

erfo

rman

ceC

riter

ia

Verif

icat

ion

Met

hod

[See

lege

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Met

[E

xpla

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hy]

c.

suct

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ecl

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hth

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opsy

cha

nnel

s;

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d.

plac

ing

the

dist

ale

ndo

fthe

end

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☐DE

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DO

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T☐

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☐DA

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e.

flush

ing

the

air,

wat

er,a

ndo

ther

cha

nnel

soft

he

endo

scop

eal

tern

atel

yw

ithth

ecl

eani

ngso

lutio

nan

dai

r,fin

ishin

gw

itha

ir;

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

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er

☐DA

CS

☐KA

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f. vi

sual

lyin

spec

ting

the

endo

scop

efo

rdam

age;

DEM

S☐

RWM

V☐

DO

☐SB

T☐

P&P

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er

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g.

disc

ardi

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eani

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nan

dcl

eani

ngc

loth

or

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gea

fter

use

.☐

DEM

S☐

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V☐

DO

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T☐

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een

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opy

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essin

gro

oma

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nas

pos

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eru

se.

☐DE

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S☐

RWM

V☐

DO

☐SB

T☐

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er

☐DA

CS

☐KA

T

177

Page 178: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

HICP

ACS

ampl

eCo

mpe

tenc

yVe

rificat

ion

Tool

:Rep

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Page

3o

f18

Com

pete

ncy

Stat

emen

ts/P

erfo

rman

ceC

riter

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Verif

icat

ion

Met

hod

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lege

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]Not

Met

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4. K

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5. T

rans

port

scon

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inat

ede

ndos

cope

sand

acc

esso

riest

oth

ede

cont

amin

atio

nar

eain

ac

lose

dco

ntai

nero

rclo

sed

tran

spor

tcar

t.a.

U

sesa

con

tain

erth

atis

leak

pro

of,p

unct

ure

resis

tant

,an

dla

rge

enou

ghto

con

tain

all

cont

ents

.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

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er

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T

b.

Use

sac

onta

iner

that

iso

fsuf

ficie

ntsi

zeto

acc

omm

odat

eth

een

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ope

whe

nth

een

dosc

ope

isco

iled

inla

rge

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s.

☐DE

M☐

S☐

RWM

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DO

☐SB

T☐

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6. L

abel

sthe

tran

spor

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iner

with

ab

ioha

zard

le

gend

.a.

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cure

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ffixe

sthe

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haza

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belt

oth

eca

rto

rco

ntai

ner.

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M☐

S☐

RWM

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T☐

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7. T

rans

port

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esso

riesw

ithth

een

dosc

ope

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onta

ins

them

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rate

lyfr

omth

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ope.

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S☐

RWM

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DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

8. B

egin

sto

proc

essf

lexi

ble

endo

scop

esa

nda

cces

sorie

sas

soon

asp

ossib

lea

fter

tran

spor

tto

the

endo

scop

ypr

oces

sing

room

orw

ithin

the

man

ufac

ture

r’sre

com

men

ded

time

to

proc

essin

g.

a.

Whe

nit

isno

tpos

sible

toin

itiat

eth

ecl

eani

ngp

roce

ss

with

inth

een

dosc

ope

man

ufac

ture

r’sre

com

men

ded

time

toc

lean

ing,

follo

wst

hem

anuf

actu

rer’s

IFU

for

dela

yed

proc

essin

g.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

178

Page 179: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

HICP

ACS

ampl

eCo

mpe

tenc

yVe

rificat

ion

Tool

:Rep

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exib

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icat

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,Inc

.,21

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Allr

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Page

4o

f18

Com

pete

ncy

Stat

emen

ts/P

erfo

rman

ceC

riter

ia

Verif

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Met

hod

[See

lege

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]Not

Met

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anuf

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☐DE

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man

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ope

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cle

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DO

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10. P

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ing

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ew

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ting

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pmen

tman

ufac

ture

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y

a.

rem

ovin

gal

lpor

tcov

ersa

ndfu

nctio

nva

lves

;

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M☐

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DO

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T☐

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er

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CS

☐KA

T

b.

plac

ing

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endo

scop

ein

alo

ose

conf

igur

atio

n;

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M☐

S☐

RWM

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DO

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er

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T

c.

pres

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endo

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eto

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mm

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re;

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d.

man

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s,in

clud

ing

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ator

,an

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ting

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HICP

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ampl

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rificat

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Tool

:Rep

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Page

4o

f18

Com

pete

ncy

Stat

emen

ts/P

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Verif

icat

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Met

hod

[See

lege

nda

bove

]Not

Met

[E

xpla

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b.

Does

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opes

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ing

ine

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atic

cl

eani

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ope

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esig

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men

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em

anuf

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☐DE

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cle

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S☐

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DO

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T☐

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10. P

erfo

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test

ing

ina

ccor

danc

ew

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een

dosc

ope

and

leak

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ting

equi

pmen

tman

ufac

ture

rs’I

FUa

ndb

y

a.

rem

ovin

gal

lpor

tcov

ersa

ndfu

nctio

nva

lves

;

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M☐

S☐

RWM

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DO

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T☐

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CS

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b.

plac

ing

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scop

ein

alo

ose

conf

igur

atio

n;

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M☐

S☐

RWM

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DO

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T☐

P&P

Oth

er

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CS

☐KA

T

c.

pres

suriz

ing

the

endo

scop

eto

the

reco

mm

ende

dpr

essu

re;

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

d.

man

ipul

atin

gal

lmov

ing

part

s,in

clud

ing

the

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ator

,an

dan

gula

ting

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bend

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sect

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stal

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S☐

RWM

V☐

DO

☐SB

T☐

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er

☐DA

CS

☐KA

T

179

Page 180: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

HICP

ACS

ampl

eCo

mpe

tenc

yVe

rificat

ion

Tool

:Rep

roce

ssin

gFl

exib

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cope

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Page

5o

f18

Com

pete

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Stat

emen

ts/P

erfo

rman

ceC

riter

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Verif

icat

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Met

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Met

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ale

akte

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ice

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repa

iror

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acem

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edur

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ing

12. P

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gin

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orda

nce

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endo

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em

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.

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M☐

S☐

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T☐

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13. P

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anua

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gus

ing

the

type

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ater

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cl

eani

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nre

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men

ded

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een

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man

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14. P

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anua

lcle

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gus

ing

afr

eshl

ypr

epar

edc

lean

ing

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tion.

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S☐

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V☐

DO

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T☐

P&P

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er

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CS

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T

HICP

ACS

ampl

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mpe

tenc

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rificat

ion

Tool

:Rep

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exib

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Page

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f18

Com

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Stat

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lean

ing

12. P

erfo

rmsm

anua

lcle

anin

gin

acc

orda

nce

with

the

endo

scop

em

anuf

actu

rer’s

IFU

.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

13. P

erfo

rmsm

anua

lcle

anin

gus

ing

the

type

ofw

ater

and

cl

eani

ngso

lutio

nre

com

men

ded

byth

een

dosc

ope

man

ufac

ture

r.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

14. P

erfo

rmsm

anua

lcle

anin

gus

ing

afr

eshl

ypr

epar

edc

lean

ing

solu

tion.

DEM

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

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☐KA

T

180

Page 181: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

HICP

ACS

ampl

eCo

mpe

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ion

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:Rep

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Com

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Met

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15. F

ollo

wst

hec

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ing

solu

tion

man

ufac

ture

r’sIF

Ufo

ra.

w

ater

qua

lity,

har

dnes

s,a

ndp

H;

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

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☐KA

T

b.

conc

entr

atio

nan

ddi

lutio

n;

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

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☐KA

T

c.

wat

erte

mpe

ratu

re;

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

d.

cont

actt

ime;

DEM

S☐

RWM

V☐

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☐SB

T☐

P&P

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er

☐DA

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☐KA

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e.

cond

ition

sofs

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ge;

☐DE

M☐

S☐

RWM

V☐

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☐SB

T☐

P&P

Oth

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☐DA

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☐KA

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f. us

elif

ean

dsh

elfl

ife.

☐DE

M☐

S☐

RWM

V☐

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☐SB

T☐

P&P

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☐KA

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HICP

ACS

ampl

eCo

mpe

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rificat

ion

Tool

:Rep

roce

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gFl

exib

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ndos

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s Ad

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erm

issio

nfr

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icat

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Desc

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,Inc

.,21

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Page

6o

f18

Com

pete

ncy

Stat

emen

ts/P

erfo

rman

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riter

ia

Verif

icat

ion

Met

hod

[See

lege

nda

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]Not

Met

[E

xpla

inw

hy]

15. F

ollo

wst

hec

lean

ing

solu

tion

man

ufac

ture

r’sIF

Ufo

ra.

w

ater

qua

lity,

har

dnes

s,a

ndp

H;

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

b.

conc

entr

atio

nan

ddi

lutio

n;

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

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☐DA

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☐KA

T

c.

wat

erte

mpe

ratu

re;

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

d.

cont

actt

ime;

DEM

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

e.

cond

ition

sofs

tora

ge;

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

f. us

elif

ean

dsh

elfl

ife.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

181

Page 182: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

HICP

ACS

ampl

eCo

mpe

tenc

yVe

rificat

ion

Tool

:Rep

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exib

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ndos

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s Ad

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dw

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d.”

Page

7o

f18

Com

pete

ncy

Stat

emen

ts/P

erfo

rman

ceC

riter

ia

Verif

icat

ion

Met

hod

[See

lege

nda

bove

]Not

Met

[E

xpla

inw

hy]

16. C

ompl

etel

ysu

bmer

gest

hee

ndos

cope

inth

ecl

eani

ng

solu

tion

durin

gth

ecl

eani

ngp

roce

ss.

a.

Deta

ches

rem

ovab

lep

arts

(e.g

.,va

lves

,but

tons

,cap

s)

from

the

endo

scop

ean

dsu

bmer

gest

hem

if

reco

mm

ende

dby

the

endo

scop

em

anuf

actu

rer’s

IFU

.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

17. C

lean

sall

exte

riors

urfa

ceso

fthe

end

osco

pew

itha

soft

,lin

t-fr

eec

loth

ors

pong

esa

tura

ted

with

the

clea

ning

solu

tion.

DEM

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

18. C

lean

sall

acce

ssib

lec

hann

elsa

ndth

edi

stal

end

oft

he

endo

scop

ew

itha

cle

anin

gbr

ush

ofth

ele

ngth

,wid

th,a

nd

mat

eria

lrec

omm

ende

dby

the

endo

scop

em

anuf

actu

rer.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

19. M

anua

llya

ctua

test

hee

ndos

cope

val

vesw

hile

cle

anin

g.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

20. C

lean

sand

bru

shes

the

elev

ator

mec

hani

sm(i

fpre

sent

)and

th

ere

cess

essu

rrou

ndin

git

with

ac

lean

ing

brus

hof

the

leng

th,w

idth

,and

mat

eria

lrec

omm

ende

dby

the

endo

scop

em

anuf

actu

rer.

a.

Raise

sand

low

erst

hee

leva

torm

echa

nism

thro

ugho

ut

the

man

ualc

lean

ing

proc

ess.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

21. U

sesa

cle

anb

rush

fore

ach

endo

scop

ecl

eani

ng.

a.

Visu

ally

insp

ects

bru

shes

and

oth

erit

emsu

sed

toc

lean

en

dosc

ope

chan

nels

befo

reu

sea

ndd

oesn

otu

seth

em

ifth

ein

tegr

ityo

fthe

bru

sho

roth

erc

lean

ing

item

isin

qu

estio

n.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

HICP

ACS

ampl

eCo

mpe

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rificat

ion

Tool

:Rep

roce

ssin

gFl

exib

leE

ndos

cope

s Ad

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dw

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erm

issio

nfr

om“

Perio

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icat

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Tool

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Desc

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©2

016

AORN

,Inc

.,21

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Page

7o

f18

Com

pete

ncy

Stat

emen

ts/P

erfo

rman

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riter

ia

Verif

icat

ion

Met

hod

[See

lege

nda

bove

]Not

Met

[E

xpla

inw

hy]

16. C

ompl

etel

ysu

bmer

gest

hee

ndos

cope

inth

ecl

eani

ng

solu

tion

durin

gth

ecl

eani

ngp

roce

ss.

a.

Deta

ches

rem

ovab

lep

arts

(e.g

.,va

lves

,but

tons

,cap

s)

from

the

endo

scop

ean

dsu

bmer

gest

hem

if

reco

mm

ende

dby

the

endo

scop

em

anuf

actu

rer’s

IFU

.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

17. C

lean

sall

exte

riors

urfa

ceso

fthe

end

osco

pew

itha

soft

,lin

t-fr

eec

loth

ors

pong

esa

tura

ted

with

the

clea

ning

solu

tion.

DEM

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

18. C

lean

sall

acce

ssib

lec

hann

elsa

ndth

edi

stal

end

oft

he

endo

scop

ew

itha

cle

anin

gbr

ush

ofth

ele

ngth

,wid

th,a

nd

mat

eria

lrec

omm

ende

dby

the

endo

scop

em

anuf

actu

rer.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

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19. M

anua

llya

ctua

test

hee

ndos

cope

val

vesw

hile

cle

anin

g.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

20. C

lean

sand

bru

shes

the

elev

ator

mec

hani

sm(i

fpre

sent

)and

th

ere

cess

essu

rrou

ndin

git

with

ac

lean

ing

brus

hof

the

leng

th,w

idth

,and

mat

eria

lrec

omm

ende

dby

the

endo

scop

em

anuf

actu

rer.

a.

Raise

sand

low

erst

hee

leva

torm

echa

nism

thro

ugho

ut

the

man

ualc

lean

ing

proc

ess.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

21. U

sesa

cle

anb

rush

fore

ach

endo

scop

ecl

eani

ng.

a.

Visu

ally

insp

ects

bru

shes

and

oth

erit

emsu

sed

toc

lean

en

dosc

ope

chan

nels

befo

reu

sea

ndd

oesn

otu

seth

em

ifth

ein

tegr

ityo

fthe

bru

sho

roth

erc

lean

ing

item

isin

qu

estio

n.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

182

Page 183: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

HICP

ACS

ampl

eCo

mpe

tenc

yVe

rificat

ion

Tool

:Rep

roce

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exib

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ndos

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Page

8o

f18

Com

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Stat

emen

ts/P

erfo

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ia

Verif

icat

ion

Met

hod

[See

lege

nda

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]Not

Met

[E

xpla

inw

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22. B

rush

esth

eac

cess

ible

cha

nnel

soft

hee

ndos

cope

mul

tiple

tim

esu

ntil

nod

ebris

app

ears

on

the

brus

h.

a.

Rem

oves

deb

risfr

omth

ebr

ush

befo

reth

ebr

ush

isre

trac

ted

back

thro

ugh

the

chan

nela

nda

fter

eac

hpa

ss

bysw

irlin

gth

ebr

ush

inth

ecl

eani

ngso

lutio

nan

drin

sing

it.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

23. F

lush

esth

ech

anne

lsof

the

endo

scop

ew

ithc

lean

ing

solu

tion.

DEM

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

24. F

lush

esa

ndri

nses

the

exte

riors

urfa

ceso

fthe

end

osco

pe

with

tap

wat

eru

ntil

allc

lean

ing

solu

tion

and

resid

uald

ebris

is

rem

oved

.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

25. D

riest

hee

xter

iors

urfa

ceso

fthe

end

osco

pew

itha

soft

,lin

t-fr

eec

loth

ors

pong

ean

dpu

rges

all

chan

nels

with

air.

DEM

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

26. C

lean

s,b

rush

es,r

inse

s,d

ries,

and

hig

h-le

veld

isinf

ects

or

ster

ilize

sall

reus

able

par

ts(e

.g.,

valv

es,b

utto

ns,p

ortc

over

s,

tubi

ng,w

ater

bot

tles)

,acc

esso

ries(

e.g.

,for

ceps

)and

cl

eani

ngim

plem

ents

(e.g

.,br

ushe

s,c

hann

elc

lean

ing

adap

ters

).a.

Hi

gh-le

veld

isinf

ects

ors

teril

izesw

ater

and

irrig

atio

nbo

ttle

satl

east

dai

ly.

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

b.

Does

not

allo

wa

nyre

sidua

lwat

ero

rmoi

stur

eto

rem

ain

inth

ew

ater

bot

tlea

ssem

bly.

DEM

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

183

Page 184: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

HICP

ACS

ampl

eCo

mpe

tenc

yVe

rificat

ion

Tool

:Rep

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exib

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ndos

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Com

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Stat

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27. D

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dssi

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-use

par

ts,a

cces

sorie

s,a

ndc

lean

ing

impl

emen

tsa

fter

eac

hus

ean

ddo

esn

otre

proc

esst

hem

.☐

DEM

S☐

RWM

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☐SB

T☐

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Oth

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☐DA

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☐KA

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Inspectin

g28

. Visu

ally

insp

ects

and

eva

luat

ese

ndos

cope

s,a

cces

sorie

s,a

nd

equi

pmen

tfor

a.

cl

eanl

ines

s,

☐DE

M☐

S☐

RWM

V☐

DO

☐SB

T☐

P&P

Oth

er

☐DA

CS

☐KA

T

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184

Page 185: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

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ACS

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185

Page 186: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

HICP

ACS

ampl

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mpe

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Com

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186

Page 187: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

HICP

ACS

ampl

eCo

mpe

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rificat

ion

Tool

:Rep

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Com

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187

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188

Page 189: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

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ACS

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189

Page 190: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

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190

Page 191: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

HICP

ACS

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191

Page 192: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

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192

Page 193: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

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193

Page 194: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

HICPACSampleAuditTool:ReprocessingFlexibleEndoscopes

AdaptedwithpermissionfromGuidelineEssentials.Copyright©2016,AORN,Inc,2170S.ParkerRoad,Suite400,Denver,CO80231.Allrightsreserved. Page1of3

HICPACSampleAuditTool:ReprocessingFlexibleEndoscopes

Purpose:FacilitiescanusethissampleAuditTooldocumentasatemplatetodeveloptheirownaudittoolspecifictotheirendoscopesandevidence-basedreprocessingpractices.ThissampletoolisdesignedtobeusedinconjunctionwiththeCompetencyVerificationTool.Facilitiesareencouragedtousethesetoolstogethertoverifycompetencyandauditcurrentpracticeaswellastoensurethattheirpracticesareconsistentwith“EssentialElementsofaReprocessingProgramforFlexibleEndoscopes–RecommendationsoftheHealthcareInfectionControlPracticesAdvisoryCommittee.”

Auditor: Date:

AuditItem Yes No Comments/ActionPrecleaning Precleanstheflexibleendoscopeatthepointofuse. Discardsthecleaningsolutionandclothafteruse. Transporting Transportsthecontaminatedendoscopeandaccessoriestotheendoscopyprocessingroomassoonaspossibleafteruse.

Ensuresthecontainerorcartislabeledwithabiohazardlegend. LeakTesting Performsleaktestingbeforemanualcleaningifindicated. ManualCleaning Usesafreshlypreparedcleaningsolutionanddoesnotaddadditionalproductstothewaterunlessrecommendedbythemanufacturer.

Completelysubmergestheendoscopeandaccessories. Cleansexteriorsurfacesoftheendoscopewithasoft,lint-freeclothorsponge.

Cleansallaccessiblechannelsandtheendoftheendoscopewithacleaningbrushofthelength,width,andmaterialrecommendedbytheendoscopemanufacturer.

Usesacleanbrushforeachendoscopecleaning. Iftheendoscopehasanelevator,raisesandlowerstheelevatorthroughoutthemanualcleaningprocess.

Brushestheaccessiblechannelsuntilnodebrisappearsonthebrush.

Removesdebrisbeforeretractingthebrushbackthroughtheendoscope.

Flushesthechannelsoftheendoscopewiththecleaningsolution. Manuallyactuatesthevalvesduringthecleaningprocess. Flushesandrinsesexteriorsurfacesandinternalchannelswithwateruntilallcleaningsolutionandresidualdebrisisremoved.

Driesexteriorsurfacesandremovablepartsoftheendoscopeandpurgesallchannelswithair.

Reprocessesreusableparts,accessories,andcleaningimplementsaccordingtothemanufacturer’sinstructionsforuse(IFU).

Disposesofsingle-useparts,accessories,andcleaningimplements.

HICPACSampleAuditTool:ReprocessingFlexibleEndoscopes

AdaptedwithpermissionfromGuidelineEssentials.Copyright©2016,AORN,Inc,2170S.ParkerRoad,Suite400,Denver,CO80231.Allrightsreserved. Page1of3

HICPACSampleAuditTool:ReprocessingFlexibleEndoscopes

Purpose:FacilitiescanusethissampleAuditTooldocumentasatemplatetodeveloptheirownaudittoolspecifictotheirendoscopesandevidence-basedreprocessingpractices.ThissampletoolisdesignedtobeusedinconjunctionwiththeCompetencyVerificationTool.Facilitiesareencouragedtousethesetoolstogethertoverifycompetencyandauditcurrentpracticeaswellastoensurethattheirpracticesareconsistentwith“EssentialElementsofaReprocessingProgramforFlexibleEndoscopes–RecommendationsoftheHealthcareInfectionControlPracticesAdvisoryCommittee.”

Auditor: Date:

AuditItem Yes No Comments/ActionPrecleaning Precleanstheflexibleendoscopeatthepointofuse. Discardsthecleaningsolutionandclothafteruse. Transporting Transportsthecontaminatedendoscopeandaccessoriestotheendoscopyprocessingroomassoonaspossibleafteruse.

Ensuresthecontainerorcartislabeledwithabiohazardlegend. LeakTesting Performsleaktestingbeforemanualcleaningifindicated. ManualCleaning Usesafreshlypreparedcleaningsolutionanddoesnotaddadditionalproductstothewaterunlessrecommendedbythemanufacturer.

Completelysubmergestheendoscopeandaccessories. Cleansexteriorsurfacesoftheendoscopewithasoft,lint-freeclothorsponge.

Cleansallaccessiblechannelsandtheendoftheendoscopewithacleaningbrushofthelength,width,andmaterialrecommendedbytheendoscopemanufacturer.

Usesacleanbrushforeachendoscopecleaning. Iftheendoscopehasanelevator,raisesandlowerstheelevatorthroughoutthemanualcleaningprocess.

Brushestheaccessiblechannelsuntilnodebrisappearsonthebrush.

Removesdebrisbeforeretractingthebrushbackthroughtheendoscope.

Flushesthechannelsoftheendoscopewiththecleaningsolution. Manuallyactuatesthevalvesduringthecleaningprocess. Flushesandrinsesexteriorsurfacesandinternalchannelswithwateruntilallcleaningsolutionandresidualdebrisisremoved.

Driesexteriorsurfacesandremovablepartsoftheendoscopeandpurgesallchannelswithair.

Reprocessesreusableparts,accessories,andcleaningimplementsaccordingtothemanufacturer’sinstructionsforuse(IFU).

Disposesofsingle-useparts,accessories,andcleaningimplements.

HICPACSampleAuditTool:ReprocessingFlexibleEndoscopes

AdaptedwithpermissionfromGuidelineEssentials.Copyright©2016,AORN,Inc,2170S.ParkerRoad,Suite400,Denver,CO80231.Allrightsreserved. Page1of3

HICPACSampleAuditTool:ReprocessingFlexibleEndoscopes

Purpose:FacilitiescanusethissampleAuditTooldocumentasatemplatetodeveloptheirownaudittoolspecifictotheirendoscopesandevidence-basedreprocessingpractices.ThissampletoolisdesignedtobeusedinconjunctionwiththeCompetencyVerificationTool.Facilitiesareencouragedtousethesetoolstogethertoverifycompetencyandauditcurrentpracticeaswellastoensurethattheirpracticesareconsistentwith“EssentialElementsofaReprocessingProgramforFlexibleEndoscopes–RecommendationsoftheHealthcareInfectionControlPracticesAdvisoryCommittee.”

Auditor: Date:

AuditItem Yes No Comments/ActionPrecleaning Precleanstheflexibleendoscopeatthepointofuse. Discardsthecleaningsolutionandclothafteruse. Transporting Transportsthecontaminatedendoscopeandaccessoriestotheendoscopyprocessingroomassoonaspossibleafteruse.

Ensuresthecontainerorcartislabeledwithabiohazardlegend. LeakTesting Performsleaktestingbeforemanualcleaningifindicated. ManualCleaning Usesafreshlypreparedcleaningsolutionanddoesnotaddadditionalproductstothewaterunlessrecommendedbythemanufacturer.

Completelysubmergestheendoscopeandaccessories. Cleansexteriorsurfacesoftheendoscopewithasoft,lint-freeclothorsponge.

Cleansallaccessiblechannelsandtheendoftheendoscopewithacleaningbrushofthelength,width,andmaterialrecommendedbytheendoscopemanufacturer.

Usesacleanbrushforeachendoscopecleaning. Iftheendoscopehasanelevator,raisesandlowerstheelevatorthroughoutthemanualcleaningprocess.

Brushestheaccessiblechannelsuntilnodebrisappearsonthebrush.

Removesdebrisbeforeretractingthebrushbackthroughtheendoscope.

Flushesthechannelsoftheendoscopewiththecleaningsolution. Manuallyactuatesthevalvesduringthecleaningprocess. Flushesandrinsesexteriorsurfacesandinternalchannelswithwateruntilallcleaningsolutionandresidualdebrisisremoved.

Driesexteriorsurfacesandremovablepartsoftheendoscopeandpurgesallchannelswithair.

Reprocessesreusableparts,accessories,andcleaningimplementsaccordingtothemanufacturer’sinstructionsforuse(IFU).

Disposesofsingle-useparts,accessories,andcleaningimplements.

8.4

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HICPACSampleAuditTool:ReprocessingFlexibleEndoscopes

AdaptedwithpermissionfromGuidelineEssentials.Copyright©2016,AORN,Inc,2170S.ParkerRoad,Suite400,Denver,CO80231.Allrightsreserved. Page2of3

AuditItem Yes No Comments/ActionInspection Inspectsandevaluatesendoscopesandaccessoriesfor• cleanliness

• missingparts • clarityoflenses • integrityofsealsandgaskets • physicalorchemicaldamage • moisture • function Usesadditionalilluminationandmagnificationforinspection,asneeded.

High-levelDisinfectionorSterilization Manuallycleanstheendoscopeandaccessoriesbeforemechanicalormanualhigh-leveldisinfectionorsterilization.

MechanicalmethodsCheckstheexpirationdateofthehigh-leveldisinfectantorliquidchemicalsterilantbeforeeachuse.

UsesateststriporotherFDA-clearedtestingdevicespecifictothedisinfectantorliquidchemicalsterilantandminimumeffectiveconcentrationoftheactiveingredientformonitoringsolutionpotencybeforeeachuse.

Positionsendoscopesandaccessorieswithinthemechanicalprocessortoensurecontactoftheprocessingsolutionswithallsurfacesoftheendoscope.

Connectstheendoscopetothemechanicalprocessorcorrectly. Verifiesmechanicalprocessingcyclesarecompletedasprogrammed.

ManualmethodsCheckstheexpirationdateofthehigh-leveldisinfectantbeforeeachuse.

UsesateststriporotherFDA-clearedtestingdevicespecifictothedisinfectantandminimumeffectiveconcentrationoftheactiveingredientformonitoringsolutionpotencybeforeeachuse.

Flushesandfillslumensandportswiththehigh-leveldisinfectant. Completelyimmersestheendoscopeinthehigh-leveldisinfectantsolutionforthedesignatedtimeaccordingtothedeviceandhigh-leveldisinfectantsolutionmanufacturer’sIFU.

Rinsestheendoscopewithwaterthatmeetsthemanufacturer’sspecificationorasrecommendedbyprofessionalorganizationsafterdisinfection.

MayberequiredforbothmechanicalandmanualmethodsFlusheslumensusing70%to90%ethylorisopropylalcoholaccordingtotheendoscopemanufacturer’sIFU.

Driesexteriorsurfacesandremovablepartsoftheendoscopeandpurgesallchannelswithair.

195

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HICPACSampleAuditTool:ReprocessingFlexibleEndoscopes

AdaptedwithpermissionfromGuidelineEssentials.Copyright©2016,AORN,Inc,2170S.ParkerRoad,Suite400,Denver,CO80231.Allrightsreserved. Page3of3

AuditItem Yes No Comments/ActionSterilizationPackagesandsterilizesendoscopicaccessoriesthatentersteriletissueorthevascularsystemperthehealthcarefacility’spolicyandprocedure.

Storage Wearscleangloveswhentransportingtheendoscopetoandfromthestoragecabinet.

Basedonthecabinetdesign,storesflexibleendoscopeshorizontallyorhangsthemverticallysotheydonotcoilortouchthefloorofthecabinet.

Storestheflexibleendoscopewithallvalvesopenandremovablepartsdetached.

Storessterileitemsinasterilestoragearea. Records Processingrecordsinclude• dateandtime

• identityofendoscopeandendoscopeaccessories • methodandverificationofcleaningandresultsofcleaning

verificationtesting

• numberoridentifierofthemechanicalprocessororsterilizerandresultsofprocessefficacytesting

• identityofthepersonsperformingtheprocessing • lotnumbersoftheprocessingsolutions • dispositionofdefectiveitemsorequipment • maintenanceofwatersystems,endoscopesandendoscope

accessories,andprocessingequipment

Proceduralrecordsinclude• dateandtime

• identityofthepatient • procedure • identityofthelicensedindependentpractitionerperforming

theprocedure

• identityoftheendoscopeandendoscopeaccessoriesused

Availablefrom:https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html

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A

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Major article

Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg

Alexandra M. Dirlam Langlay PhD a, Cori L. Ofstead MSPH a,*, Natalie J. Mueller MPH a,Pritish K. Tosh MDb, Todd H. Baron MDc, Harry P. Wetzler MD, MSPH a

aOfstead & Associates, Inc, Saint Paul, MNbDivision of Infectious Diseases, Mayo Clinic, Rochester, MNcDivision of Gastroenterology & Hepatology, Mayo Clinic, Rochester, MN

Key Words:Instrument cleaningGuideline adherenceHigh-level disinfectionEpidemiologyColonoscopyMultidrug-resistant organismsInfection

Background: Most cases of microbial transmission to patients via contaminated endoscopes haveresulted from nonadherence to reprocessing guidelines. We evaluated the occurrence, features, andimplications of reprocessing lapses to gauge the nature and breadth of the problem in the context ofwidely available and accepted practice guidelines.Methods: We examined peer-reviewed and non-peer-reviewed literature to identify lapses reported inNorth America during 2005 to 2012 resulting in patient exposure to potentially contaminated gastro-intestinal endoscopes.Results: Lapses occurred in various types of facilities and involved errors in all major steps of reproc-essing. Each lapse continued for several months or years until the problemwas discovered except for onethat was described as a single incident. There were significant implications for patients, includingnotification and testing, microbial transmission, and increased morbidity and mortality. Only 1 reproc-essing lapse was found in a peer-reviewed journal article, and other incidents were reported ingovernmental reports, legal documents, conference abstracts, and media reports.Conclusion: Reprocessing lapses are an ongoing and widespread problem despite the existence ofguidelines. Lack of publication in peer-reviewed literature contributes to the perception that lapses arerare and inconsequential. Reporting requirements and epidemiologic investigations are needed todevelop better evidence-based policies and practices.

Copyright � 2013 by the Association for Professionals in Infection Control and Epidemiology, Inc.Published by Elsevier Inc. All rights reserved.

Gastrointestinal (GI) endoscopes are used in bodily cavities thatare heavily colonized with microorganisms.1 Proper endoscopereprocessing, including thorough cleaning and high-level disin-fection (HLD), is necessary between patients to minimize the riskof cross contamination.1 Reprocessing guidelines for fiberopticendoscopes were first published in 1978.2 Since then, governmentaland professional organizations have updated them and developednew guidelines for reprocessing specific types of endoscopes.1,3,4

Guideline nonadherence led to the use of improperly reproc-essed endoscopes at Veterans Affairs (VA) medical facilities inTennessee, Florida, and Georgia between 2003 and 2009, requiringnotification of over 10,000 patients.5,6 Other reprocessing lapses(“lapses”) have come to light following investigations into facilities’practices.5-8 In 2008, the United States Centers for Medicare andMedicaid Services (CMS) conducted unannounced inspections ofinfection control practices at 68 ambulatory surgical centers, overhalf of which performed endoscopies.7 Among these facilities, 39had deficiencies in infection control serious enough to warrantcitation, and 19 failed to properly reprocess instruments. In 2010,an observational, multisite study revealed that only 48% of 183 GIendoscopes were properly reprocessed, even though managers atall sites asserted institutional adherence to guidelines and reproc-essing personnel were aware of being observed.8 Nonadherencewas particularly high (99%) when manual methods were used toclean endoscopes.8

A study conducted at Beth Israel Deaconess Medical Center andHarvard Medical School found that GI endoscopy-associated

* Address correspondence to Cori L. Ofstead, MSPH, Ofstead & Associates, Inc, 400Selby Avenue, Suite V, Blair Arcade West, Saint Paul, MN 55102.

E-mail address: [email protected] (C.L. Ofstead).Ofstead & Associates, Inc. has received funding from Johnson & Johnson and 3M

Company for infection prevention studies. Research reported here was supportedwith internal resources from Ofstead and Mayo Clinic. Outside corporations did nothave access to data and were not involved in manuscript preparation.

Conflicts of interest: C.L.O. has received honoraria from Johnson & Johnsonand 3M Company for speaking engagements related to instrument reprocessing.A.M.D.L., C.L.O., N.J.M., and H.P.W. are employed by Ofstead & Associates, Inc. Theremaining authors disclose no conflicts.

Contents lists available at ScienceDirect

American Journal of Infection Control

journal homepage: www.aj ic journal .org

American Journal of Infection Control

0196-6553/$36.00 - Copyright � 2013 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.http://dx.doi.org/10.1016/j.ajic.2013.04.022

American Journal of Infection Control 41 (2013) 1188-948.6

198

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complications resulting in an emergency department visit or hos-pitalization occurred after approximately 1% of 18,015 outpatientprocedures, including screening colonoscopies.9 Complicationsincluded fever and other potential signs of infection. Other res-earchers have reported numerous cases of postendoscopy infectionassociated with endoscope contamination, including transmissionof multidrug-resistant organisms (MDROs).2,10-12 Although the riskof infection following endoscopy is stated to be extremely remoteby nearly all major guidelines including the 2008 Centers forDisease Control and Prevention/Healthcare Infection Control Prac-tices Advisory Committee (CDC/HICPAC) Guideline for Disinfectionand Sterilization in Healthcare Facilities and the 2011 MultisocietyGuideline on Reprocessing Flexible GI Endoscopes,1,4 existing riskestimates were recently found to be outdated, inaccurate, based onflawed methods, and too low.13

Since the introduction of reprocessing guidelines, there havebeen increases in the volume of endoscopic procedures, thecomplexity of endoscope design, and the economic pressures oninstitutions. Given the current challenges, we evaluated theoccurrence, features, and implications of recently reported lapses.

METHODS

Searches for scientific, peer-reviewed journal articles describinglapses were conducted via PubMed. Internet searches were per-formed to identify lapses published in media reports, includingnewspapers, magazines, press releases, or other articles. Govern-ment Web sites and reports were also reviewed, including sourcesfrom state departments of health, the Department of VeteransAffairs Office of Inspector General (VAOIG), CDC’s Epidemic Intel-ligence Service, and the Food and Drug Administration (FDA).Whenever possible, multiple sources were obtained to compileinformation about a lapse because individual documents oftencontained incomplete information.

We sought to identify lapses reported between January 2005and June 2012 in North America. Reports that met these searchparameters and described a lapse resulting in patient exposureto a potentially contaminated GI endoscope were included. Lap-ses were defined as any incident involving 1 or more reprocessingerrors resulting in the exposure of 1 or more patients. Errorsincluded nonadherence to cleaning and disinfection guidelines,improper use of reprocessing equipment, or inadequate standardoperating procedures or staff competence records for reproces-sing. Endoscopes under consideration included colonoscopes,gastroscopes, duodenoscopes (eg, endoscopic retrograde chol-angiopancreatography endoscopes), and endoscopes not other-wise specified.

RESULTS

Geographic and facility spread

Reported lapses occurred with various GI endoscopes andprocedures at health care facilities throughout the United Statesand Canada (Tables 1 and 2). Public and private facilities, includinghospitals, medical centers from large health systems, outpatientendoscopy centers, and outpatient surgical centers were involved(Tables 1 and 2). In some cases, multiple facilities within the samehealth system were implicated.5,14,15

Sources of reports

Among the lapses identified, only 1 was published in a peer-reviewed journal,16 whereas all others were described in mediareports and related sources (Table 1) or government reports

(Table 2). Individual government documents and certain mediareports described lapses at multiple health care facilities, including4 reports published by state agencies (Table 2).17-20

Following the well-publicized lapses at 3 VA medical facilities,unannounced inspections of 36 VA medical facilities with 38reprocessing units for colonoscopes were conducted by the VAOIGin 2009.5 Among these units, 52.6% were found to have inadequatestandard operating procedures or documentation of demonstratedstaff competence for reprocessing (Table 2). Since then, the VAOIGhas continued tomonitor facilities and publish reviews that indicatewhether processes are in place to ensure effective reprocessing.These recent reviews described additional lapses in the reprocessingof reusable medical equipment, including GI endoscopes.

Lapses were also readily identifiable in the FDA’s Manufacturerand User Facility Device Experience (MAUDE) database, whichconsists of adverse event reports involving medical devices. Theseare voluntary reports or other reports submitted by device manu-facturers, distributors, and health care facilities, typically followingdevice malfunction or incidents resulting in serious patient injuryor death. Recent MAUDE reports described postendoscopy com-plications, including infections or chemical colitis, attributed toreprocessing errors or defective equipment that was undetectedprior to patient use. When the FDA reviewed MAUDE reports onendoscopes filed between January 1, 2007, and May 11, 2010, theagency found 80 reports of lapses and 28 reports of infectionpossibly because of inadequate reprocessing (Table 2).21 Supple-mental data and references documenting lapses described inMAUDE and VAOIG reports are available from the authors onrequest.

Duration and nature of errors

Reports described errors in each of themajor reprocessing steps,whereas general noncompliance with guidelines and manufacturerprotocols was also cited. Steps were skipped or done improperly forentire endoscopes as well as for certain channels (Tables 1 and 2).Only 1 lapse was described as a single incident,22 whereas multiplelapses continued for several years, exposing numerous patients topotentially contaminated endoscopes.23-27 In some cases, the lapseduration was unknown, either because it was not disclosed orbecause investigators were unable to determine when the prob-lems started.28,29

Many lapses were identified as a result of surveillance orinspections. The single lapse reported in a peer-reviewed journalwas discovered during surveillance for deviations from reprocess-ing protocols.16 Government reports also described improperreprocessing practices identified through inspections or mandatoryadverse event reports.17,18 Generally, states having multiple lapses,such as Pennsylvania, New Jersey, and California, had mandatorypatient safety reporting requirements, whereas other states maynot gather data or publicly report lapses.

Improper cleaning occurred on multiple occasions, andemployees detected visually apparent residual matter on endo-scopes during several of these lapses.18,30-34 At 3 hospitals, residueon duodenoscopes was associated with bacterial infections.31,34 Atone of the hospitals, guidelines were violated over a period of 20months when contaminated duodenoscopes were allowed to drybefore cleaning.30,35 MAUDE reports described multiple lapsesinvolving detection of debris or residue in various endoscopechannels or components. Other lapses described in MAUDE reportsinvolved broken cleaning brushes that were left in endoscopes andfound during subsequent procedures, occasionally after beingexpelled into patients.

Errors in disinfection often involved lack of HLD for entire endo-scopes or certain channels.16,18,19,23,36-39 For example, endoscopes at

A.M. Dirlam Langlay et al. / American Journal of Infection Control 41 (2013) 1188-94 1189

199

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Table

1Lapsespublished

inmed

iareports

andrelatedsources:North

America,

January20

05-June20

12

Typeof

hea

lthcare

facility

Location

Pub.

Yea

rTy

peof

endosco

pe

Errors

Estimated

duration

oflapse

Estimated

patients

Microorga

nismsfound

Exposed

Notified

Tested

Tested

positive

Privatehospital

32,33

North

Carolina

2012

GIen

dosco

peNOS

Noclea

ningor

sterilization

for1ch

annel

5mon

ths

10Yes

Yes

(viral)

ND

ND

Outpatienten

doscop

yclinic

26,71-73

Ontario

2011

;20

12GIen

dosco

peNOS

Multiple

reprocessing

andch

emical

issu

es9ye

ars

6,80

0Yes

Yes

(viral)

408

Hep

atitis

B;

hep

atitis

CAcadem

icmed

ical

center3

6,74

Louisiana

2011

GIen

dosco

peNOS

NoHLD

8mon

ths

222

Yes

Yes

(viral)

ND

ND

Privatemed

ical

center3

8,75,76

Orego

n20

11Colon

osco

pe

NoHLD

ND

18Yes

Yes

(viral)

ND

ND

Academ

icmed

ical

center7

7-79

Louisiana

2011

GIen

dosco

peNOS

Inad

equateHLD

temperature

8wee

ks36

0Yes

Yes

(viral)

ND

ND

Public

hospital

30,31,35,80

British

Columbia

2010

;20

11Duod

enosco

pe

Improper

reprocessing;

Endosco

pes

allowed

todry

before

clea

ning

20mon

ths

536

Yes

Yes

(viral)

11Pseu

domon

as;

hep

atitis

C*;HIV*

Public

hospital

andacad

emic

med

ical

center2

3,81

Minnesota

2010

GIen

dosco

peNOS

Improper

HLD

of1ch

annel

3ye

ars

2,60

0Yes

No

ND

ND

Privatemed

ical

center,

hospital,a

ndou

tpatient

surgerycenter1

4,82,83

California

2010

Colon

osco

pe

Improper

HLD

;Ex

pired

disinfectan

t16

mon

ths

3,40

0Yes

Yes

(viral)

ND

ND

Privatehospital

24

Pennsylvan

ia20

10GIen

dosco

peNOS

Improper

HLD

of1ch

annel

5ye

ars

75Yes

Yes

ND

ND

Public

hospital

27,39,84

British

Columbia

2010

Colon

osco

pe;

Gastrosco

pe

NoHLD

for1ch

annel

28mon

ths

9,00

0Yes

No

ND

ND

Twoco

unty

hospitals

and

aregion

alcancertrea

tmen

tcenter3

4,54,56

Florida

2009

;20

10Duod

enosco

pe

Improper

clea

ningof

elev

ator

chan

nel

�8mon

ths

191

Yes

Yes

13Klebsiella

pneu

mon

iae

(carba

pen

emase-producing);

Esch

erichiacoli

(carba

pen

emase-producing);

Pseu

domon

asae

rugino

sa;

Proteu

smirab

ilis;

Serratia

Outpatientsu

rgery

center4

1,85,86

Geo

rgia

2009

;20

10Colon

osco

pe

Inad

equateHLD

time

17mon

ths

1,30

0Yes

Yes

ND

ND

Public

hospital

44,46

New

foundland

andLabrad

or20

09GIen

dosco

peNOS

Inad

equatedisinfectan

tam

ount;

AER

malfunction

17mon

ths

2,90

0ND

ND

ND

ND

Outpatientsu

rgerycenter4

2,87

Nev

ada

2008

;20

09GIen

dosco

peNOS

Inad

equateHLD

time

2ye

ars

ND

Yes

Yes

ND

ND

GIfacilityNOS2

2U.S.N

OS

2008

Colon

osco

pe

Improper

storag

eof

contaminated

,dam

aged

endosco

pe

Singleinciden

t1

ND

ND

ND

ND

Public

hospital

25,50,52,88,89

Alberta

2007

;20

08En

dosco

peNOS

Improper

clea

ningan

dHLD

;Nodisassembly

4ye

ars

2,87

2(300

dueto

endo-scop

es)

Yes

Yes

(viral)

ND

Stap

hylococcus

aureus

(methicillin-resistant)

Twopriva

tehospitals15,90,91

California

2006

Gastrosco

pe

Improper

reprocessing

>1ye

ar30

5Yes

Yes

ND

ND

Privatehospital

92

WestVirginia

2006

Endosco

peNOS

Improper

HLD

19mon

ths

“100

s”Yes

ND

ND

ND

Privatehospital

37,93

Pennsylvan

ia20

05Colon

osco

pe

NoHLD

ofau

xilia

rych

annels

4mon

ths

200

Yes

Yes

(viral)

ND

ND

Privatehospital

94

Virginia

2005

GIen

dosco

peNOS

Inad

equateHLD

time

10day

s14

4Yes

Yes

(viral)

ND

ND

Privatehospital

28,95

California

2005

GIen

dosco

peNOS

Multiple

equipmen

tan

dop

erator

issu

esND

2,11

6Yes

Yes

(viral)

ND

ND

AER

,automated

endosco

pereprocessor;GI,ga

strointestinal;HLD

,high-lev

eldisinfection;ND,n

otdisclosed

;NOS,

not

otherwisesp

ecified

.*Indicates

previou

slyiden

tified

casesthat

tested

positive.

A.M. Dirlam Langlay et al. / American Journal of Infection Control 41 (2013) 1188-941190

200

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a large medical center received no HLD during an 8-monthperiod.36,40 At another large center, HLD was not performedon an endoscope channel for nearly 3 years because ofmisinformation from the manufacturer.23 MAUDE reports dis-cussed incorrect connectors used to attach endoscopes toautomated endoscope reprocessors (AERs) or flushing aids,resulting in no HLD of certain channels. Other failures involvedinadequate HLD time or temperature41-43 and errors in disin-fectant concentration or water quality during reprocess-ing.14,44,45 At 1 hospital, only 25% of the required amount ofdisinfectant was used over a period of 17 months.46 Expireddisinfectant was used for over 1 year at each of 4 otherfacilities.14,47 In addition, 1 MAUDE report described a lapsewhere water was used in place of disinfectant, and problemswith endoscope flushing or rinsing were found when residualchemicals caused chemical colitis.

Improper endoscope storage was also reported.22 One lapseinvolved patient exposure to a damaged, contaminated colono-scope that was hung unlabeled in a cabinet with clean endo-scopes.22 Other errors involved equipment problems, includingAER malfunction or incorrect programming.46,48 In some cases,inadequate staff training was recognized as an underlying prob-lem.5,49 VAOIG investigations revealed insufficient documentationof staff competency at several VA medical centers.5 One stateagency reported receiving 3 notifications when staff knowinglyused incompletely reprocessed endoscopes on patients.18

Certain individual lapses involved multiple reprocessingerrors.26,30,31,50 At 1 private endoscopy clinic, reprocessing errorsinvolved expired chemicals, inadequate cleaning and HLD, andcross contamination of clean and dirty endoscopes.26,51 At a largegeneral hospital, failure to preclean duodenoscopes contributed toproblems cleaning them.31,35 Multiple cleaning and HLD errors alsooccurred at another general hospital.25,50,52

Effects on patient safety

The impact of lapses on patient safety was a focus of mediareports, but not the peer-reviewed journal article or governmentreports, with the exception of MAUDE reports. Lapses discussed inthe media typically involved exposure and notification of hundredsof patients, and several lapses involved more than 1,000 patients(Table 1). Patient notification often recommended testing forinfection transmission; however, testing was typically done onlyfor viruses such as HIV, hepatitis B, and hepatitis C rather than forenteric pathogens. In 1 lapse at a single provider’s clinic, 6,800patients were exposed to potentially contaminated GI endoscopesand offered only viral testing.26 In 2 other lapses, thousands ofpatients treated at large medical facilities were notified about thelapse but not tested.23,53 In each instance, national health author-ities had asserted the risk of disease transmission was too low towarrant testing.23,53

Microorganisms were reported to have been transmitted bycontaminated endoscopes.31,34 Various types of microorganismsand occasionally multiple species were detected, including virusesand bacteria (Table 1). Pseudomonas spp was most common, andother bacterial pathogens included Serratia spp, Proteus mirabilis,and Clostridium difficile (Table 1). One MAUDE report described 9patients who acquired C difficile after undergoing procedures withan endoscope that was found to have retained debris. Multidrug-resistant bacteria, including methicillin-resistant Staphylococcusaureus (MRSA) and Klebsiella pneumoniae carbapanemase (KPC)-producing Klebsiella pneumoniae and Escherichia coli, were detectedfollowing 2 lapses.25,34 One of these lapses involving a contami-nated duodenoscope resulted in 13 cases of multidrug-resistant Kpneumoniae among 191 endoscopy patients, indicating a 7% attackTa

ble

2Lapsespublished

ingo

vern

men

treports:North

America,

January20

05-June20

12

Typeofhea

lthca

refacility

Hea

lthca

refacilities

Loca

tions

Rep

ortingag

ency

Pub.Y

ear

Typeofen

doscope

Erro

rsTo

talNo.

insp

ected

No.w

ithlapses

1ou

tpatientsu

rgerycenter;

1ou

tpatientclinic;

5hospitals2

0,96

NA

7lapses;

5facilities

Minnesota

MN

Dep

artm

entof

Hea

lth

2012

Colon

osco

pe;

Duod

enosco

pe;

Gastrosco

pe;

Upper

GIen

dosco

pe;

Non

-GIen

dosco

pes

Improper

clea

ningan

dHLD

;Rep

rocessingasingle-use

dev

ice;

Usedim

proper

AER

connector;

Inad

equatestafftraining

ND21

NA

80*

USNOS

FDA

2011

Endosco

peNOS

Inad

equatereprocessing

Outpatientsu

rgerycenters

andsu

rgical

practices

17

91�3

New

Jersey

NJHea

lthCareQualityInstitute

2011

Colon

osco

pe;

Endosco

peNOS

Improper

reprocessing;

Unch

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rate.34,54 Two other lapses were associated with patients whotested positive for viruses. In 1 instance, 408 of 4,353 exposedpatients who underwent laboratory testing for bloodborne patho-gens tested positive for hepatitis B or C, including previouslyundiagnosed cases and 20 cases of active infection.26,55 Viraltransmissionwas attributed to patient lifestyles, yet reports did notprovide substantiating data to rule out transmission from con-taminated endoscopes.26 In the other instance, 10 patients testedpositive for hepatitis C and HIV after exposure to a contaminatedduodenoscope; however, these cases had been previously diag-nosed.55 Nonetheless, these reports revealed that numerouspatients were exposed to improperly reprocessed endoscopes thathad been previously used on patients with viral infections.

Several lapses were associated with serious patient injury.On multiple occasions, reprocessing chemicals remaining in endo-scopes caused colitis in exposed patients. MAUDE reports describeda variety of patient complications after exposure to contaminatedendoscopes, including abdominal pain, inflammation, and bacter-emia. In other instances, patients who tested positive for microor-ganisms after a lapse required treatment and hospitalization.31,56 At1 hospital, an ill patient who had undergone endoscopy witha contaminated duodenoscope was hospitalized with a Pseudo-monas infection.31 The patient died soon after acquiring the infec-tion as a result of the preexisting illness.31 Following another lapse,patients who underwent endoscopies and acquired multidrug-resistant K pneumoniae were found to have longer hospital staysand 5 times higher mortality than other patients.34,54,56

DISCUSSION

By looking beyond peer-reviewed literature for evidence, weidentified numerous recent reprocessing lapses in North America,including several that were associated with patient infection, injury,or death.21,31,34,56 Recent lapses have also been reported in othercountries,10,11,57-61 indicating that improper reprocessing is wide-spread and continues to occur despite the existence of reprocessingguidelines. Other researchers have acknowledged that most lapsesnever get publicly reported.2,6 Reluctance by institutions to reportlapses may contribute to the lack of peer-reviewed articlesdescribing them. In addition, some journals do not publish casereports.62,63 Lack of reporting in peer-reviewed journals contributesto the perception that lapses are rare and inconsequential.

Current endoscopy-associated infection (EAI) risk estimates areerroneously based on the number of infections reported in peer-reviewed articles.13 As a result, numerous experts and organiza-tions have asserted the risk of EAI is virtually nonexistent.1,3,4,12 Basedon existing estimates, fewer than a dozen EAIs would be expected tooccur each year in the United States. However, multiple cases of EAIresulting from individual lapses have exceeded these estimates,indicating current estimates are inaccurate and far too low.13

Researchers have identified retained debris in lumened instru-ments, including endoscopes, as a result of inadequate reprocessingand complex device design.64,65 A recent study found that proteinresidue and water remained on endoscope channels even afterthorough cleaning.66 Studies by Alfa et al found that 14% of patient-ready GI endoscopes had bacterial or fungal growth67 and that upto 19% of manually cleaned channels tested positive for protein,hemoglobin, or carbohydrates.68 Detailed outbreak investigationshave implicated endoscopes as likely sources of microbial trans-mission.10,11,31,34,64 Matching strains of MDROs were collected frompatients and endoscopes following several of these lapses, indi-cating that MDROs may be transmitted by contaminated endo-scopes.10,11,34,56 With the exception of methicillin-resistantStaphylococcus aureus, the vast majority of MDROs are harboredin the GI tract and can be clinically silent for months to years before

causing extraintestinal infection. Endoscopies with contaminateddevices may place patients at high risk for acquiring MDROsbecause bowel preparation alters colonic microflora,69,70 therebyreducing patient resistance to colonization with MDROs.

At present, there is no central repository for reports on lapsesand no requirement that local or federal officials maintain recordsor make them available to clinicians, researchers, or policy makers.Exposed patients are not routinely recalled for testing because thehealth risks are assumed to be very low.23,27 This leads to a viciouscycle whereby institutions do not notify or test patients whena lapse is discovered because decision makers rely on erroneousrisk estimates that have been propagated in the guidelines.Mandatory reporting of lapses to a national registry would supportepidemiologic review and investigation and the consideration ofnew policies based on sound data.

Adherence to reprocessing guidelines needs to be improved.8 Ina multisite study that revealed poor adherence, staff reported thatthey did not like to do various reprocessing tasks, felt pressure towork quickly, and attributed health problems to working withendoscopes.8 The link between reprocessing errors and factors thatmay influence health care worker behavior suggests that trainingand competency testing need to be supplemented with account-ability measures and active surveillance of reprocessing effective-ness so that contaminated endoscopes can be identified before theyare used on patients.

Limitations

Because of the lack of a central repository or peer-reviewedjournal articles describing lapses, ad hoc searches of media,government reports, and other online sources were used to identifythem. Even when multiple reports on individual lapses wereavailable, the information was frequently incomplete and difficultto interpret. Thus, the results of this review may not be generaliz-able. Furthermore, the information provided in media andgovernment reports was neither scrutinized by peer reviewers noredited for technical accuracy or clarity of communication. Datawere sometimes reported using potentially inaccurate terms (eg,sterilization rather than HLD).

Conclusion

Improper endoscope reprocessing is an ongoing and pervasiveproblem that has the potential to cause significant patient harm.Reprocessing guidelines should be revised to reflect the true risk oftransmitting infections, including enteric pathogens and MDROs,when lapses occur. These revisions will require additional researchbecause the magnitude of risk associated with particular types oflapses is unknown. As such, there is a need for a central repositoryof data pertaining to lapses and associated outcomes. Infectionpreventionists should recognize risks associated with improperreprocessing and continuously evaluate reprocessing effectivenessto ensure that endoscopes are clean and disinfected prior to use onevery patient.

Acknowledgment

The authors thank Jeremy Ward and Lisa Mattson for theresearch, editorial, and logistical assistance provided.

References

1. Rutala WA, Weber DJ. Healthcare Infection Control Practices AdvisoryCommittee (HICPAC). Guideline for disinfection and sterilization in healthcarefacilities, 2008. Washington [DC]: Department of Health and Human Services;2008.

A.M. Dirlam Langlay et al. / American Journal of Infection Control 41 (2013) 1188-941192

202

Page 203: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

2. Spach DH, Silverstein FE, Stamm WE. Transmission of infection by gastroin-testinal endoscopy and bronchoscopy. Ann Intern Med 1993;118:117-28.

3. Society of Gastroenterology Nurses and Associates, Inc. Standards of infectioncontrol in reprocessing of flexible gastrointestinal endoscopes. Chicago [IL]:Society of Gastroenterology Nurses and Associates, Inc; 2012.

4. Petersen BT, Chennat J, Cohen J, Cotton PB, Greenwald DA, Kowalski TE, et al.Multisociety guideline on reprocessing flexible GI endoscopes: 2011. InfectControl Hosp Epidemiol 2011;32:527-37.

5. Veterans Affairs Office of Inspector General. Use and reprocessing of flexiblefiberoptic endoscopes at VA medical facilities. Report No.: 09-01784-146.Washington [DC]: Department of Veterans Affairs; 2009.

6. Holodniy M, Oda G, Schirmer PL, Lucero CA, Khudyakov YE, Xia G, et al. Resultsfrom a large-scale epidemiologic look-back investigation of improperly reproc-essed endoscopy equipment. Infect Control Hosp Epidemiol 2012;33:649-56.

7. Schaefer MK, Jhung M, Dahl M, Schillie S, Simpson C, Llata E, et al. Infectioncontrol assessment of ambulatory surgical centers. JAMA 2010;303:2273-9.

8. Ofstead CL, Wetzler HP, Snyder AK, Horton RA. Endoscope reprocessingmethods: a prospective study on the impact of human factors and automation.Gastroenterol Nurs 2010;33:304-11.

9. Leffler DA, Kheraj R, Garud S, Neeman N, Nathanson LA, Kelly CP, et al. Theincidence and cost of unexpected hospital use after scheduled outpatientendoscopy. Arch Intern Med 2010;170:1752-7.

10. Aumeran C, Poincloux L, Souweine B, Robin F, Laurichesse H, Baud O, et al.Multidrug-resistant Klebsiella pneumoniae outbreak after endoscopic retro-grade cholangiopancreatography. Endoscopy 2010;42:895-9.

11. Carbonne A, Thiolet JM, Fournier S, Fortineau N, Kassis-Chikhani N, Boytchev I,et al. Control of a multi-hospital outbreak of KPC-producing Klebsiella pneu-moniae type 2 in France, September to October 2009. Euro Surveill 2010;15:1-6.

12. Nelson DB, Muscarella LF. Current issues in endoscope reprocessing andinfection control during gastrointestinal endoscopy. World J Gastroenterol2006;12:3953-64.

13. Ofstead CL, Dirlam Langlay AM, Mueller NJ, Tosh PK, Wetzler HP. Re-evaluatingendoscopy-associated infection risk estimates and their implications. Am JInfect Control 2013;41:734-6.

14. Garrick D. Escondido: PPH testing 3,400 patients when only 45 at risk ofexposure. The San Diego Union-Tribune; June 15, 2010. Available from: http://www.utsandiego.com/news/2010/Jun/15/escondido-pph-testing-3400-patients-when-only-45/. Accessed January 21, 2011.

15. Clark C. Hospital’s surgical tool was improperly sterilized. The San DiegoUnion-Tribune; June 13, 2006. Available from: http://www.utsandiego.com/uniontrib/20060613/news_1m13scripps.html. Accessed May 16, 2012.

16. Kelly LL. When your best is not good enough. Gastroenterol Nurs 2010;33:62-4.

17. New Jersey ambulatory surgery center and surgical practice transparencyreport. Pennington [NJ]: New Jersey Health Care Quality Institute; 2011.

18. Pennsylvania Patient Safety Authority. The dirt on flexible endoscope reproc-essing. Harrisburg [PA]: Pennsylvania Patient Safety Advisory; 2010;7:135-40.

19. Billingsley K. Inadequate reprocessing of semicritical instruments. Sacramento[CA]: California Department of Health Services; 2007.

20. Lesher L, DeVries A, Danila R, Harper J. Reported endoscope reprocessingbreaches, Minnesota, 2010-2011. San Antonio [TX]: APIC 2012 AnnualConference; June 4-6, 2012.

21. Food and Drug Administration. FDA looks to improve design and cleaninginstructions for reusable medical devices. April 29, 2011. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253108.htm.Accessed November 9, 2012.

22. Giving scopes a clean bill of health. Infection Control Today; April 16, 2008.Available from: http://www.infectioncontroltoday.com/articles/2008/04/giving-scopes-a-clean-bill-of-health.aspx. Accessed January 27, 2011.

23. Minn. GI center warns of improperly sterilized scopes. EndoNurse; July 6, 2010.Available from: http://www.endonurse.com/news/2010/07/minn-gi-center-warns-of-improperly-sterilized-scopes.aspx. Accessed August 15, 2013.

24. Fabregas L. 75 St. Clair Hospital patients treated with unsterile device. Pitts-burgh Tribune-Review; November 24, 2010. Available from: http://triblive.com/x/pittsburghtrib/news/pittsburgh/s_710662.html#axzz2bz3QsI8G. AccessedAugust 11, 2011.

25. Sullivan M. Task force on adverse health events background documents.December 2, 2008. Available from: http://www.gov.nl.ca/ahe/additions/back-groundweb.pdf. Accessed August 11, 2011.

26. Levy I. Interim report on Ottawa public health’s response to the communityinfection control lapse. Report No.: ACS2012-OPH-IQS-001. Ottawa [ON]:Ottawa Board of Health; 2012.

27. Etherington J. Kamloops patient notification letter. Kelowna [BC]: InteriorHealth Authority; 2010.

28. Thompson AC. Ass out: local hospital snafus hint at a larger problem. SanFrancisco Bay Guardian News; 2005. Available from: http://www.sfbg.com/39/17/news_ass.html. Accessed January 21, 2011.

29. WFMD. A hospital in Oregon hasn't been sterilizing their colonoscopy scopebetween patients. January 12, 2011. Available from: http://www.wfmd.com/pages/TMNE.html?article=8034236. Accessed January 21, 2011.

30. Tsikitas I. 500 patients potentially exposed to contaminated scope at VictoriaHospital. Outpatient Surgery Magazine; April 18, 2010. Available from: http://www.outpatientsurgery.net/news/2010/04/18-500-patients-potentially-exposed-to-contaminated-scope-at-victoria-hospital. Accessed February 17, 2011.

31. Vancouver Island Health Authority. Backgrounder: ERCP scope reprocessingand infection control. Victoria [BC]: Vancouver Island Health Authority; 2010.

32. Dixson R. In Asheville, 10 Mission patients urged to seek viral testing. AshevilleCitizen-Times; May 18, 2012. Available from: http://www.citizen-times.com/article/20120519/NEWS/305190033/In-Asheville-10-Mission-patients-urged-seek-viral-testing?nclick_check=1. Accessed May 25, 2012.

33. Mission Hospital identifies a cleaning issue with endoscopic scope. WSPAChannel 7 News; May 19, 2012. Available from: http://www.wspa.com/story/21515769/mission-hospital-identifies-a-cleaning-issue-with-endoscopic-scope.Accessed May 25, 2012.

34. Sanderson R, Braithwaite L, Ball L, Ragan P, Eisenstein L. An outbreak ofcarbapenem-resistant Klebsiella pneumoniae infections associated with endo-scopic retrograde cholangiopancreatography (ERCP) procedures at a hospital.Am J Infect Control 2010;38:e141.

35. The Canadian Press. Patients not infected after tests with dirty equipment:health authority. Pharmacy News; October 20, 2010. Available from: http://www.guelphmercury.com/news-story/2697981-patients-not-infected-after-tests-with-dirty-equipment-health-authority/. Accessed January 21, 2011.

36. Ochsner Health System. Ochsner Medical Center, Jefferson Highway Endos-copy Lab audit shows small number of endoscopes did not complete highlevel disinfection process. New Orleans [LA]: Ochsner Health System Update;2011.

37. Bails J. Candor praised in scope problems. Pittsburgh Tribune-Review; April 1,2005. Available from: http://triblive.com/x/pittsburghtrib/news/pittsburgh/s_319469.html#axzz2bzGXfFIA. Accessed January 5, 2011.

38. Taylor T. St Charles: colonoscope not fully sanitized. KTVZ News; January 11,2011. Available from: http://www.ktvz.com/news/St-Charles-Colonoscope-Not-Fully-Sanitized/-/413192/622490/-/c3xp3fz/-/index.html. Accessed November15, 2011.

39. Endoscope reprocessing and infection control. Kelowna [BC]: Interior HealthAuthority; 2010.

40. Ochsner: hundreds of endoscopies may not have gone through full cleaningprocess. WWLTV News; April 19, 2011. Available from: http://www.wwltv.com/home/Ochsner-Hundreds-of-endoscopies-may-not-have-gone-through-full-cleaning-process-120239574.html?commentPage=1#comments. Accessed May5, 2011.

41. Beasley K. Evans Surgery Center warns patients may be infected. WRDW-TVAugusta News; March 5, 2009. Available from: http://www.wrdw.com/home/headlines/40805497.html. Accessed August 9, 2011.

42. Allen M. Clinic reports lapses in disinfection: patients are at minimal risk,health officials say. Las Vegas Sun; December 31, 2008. Available from: http://www.lasvegassun.com/news/2008/dec/31/clinic-reports-lapses-disinfection/.Accessed November 15, 2011.

43. Lynch R. Letter to patient. New Orleans [LA]: Tulane Medical Center; 2011.44. CBC News. Infection risk “remote” after Carbonear hospital equipment problem:

Eastern Health. CBC News; April 16, 2009. Available from: http://www.cbc.ca/health/story/2009/04/16/eastern-health-416.html?ref=rss. Accessed January 27,2011.

45. Hospital malpractice press release: Weitz & Luxenberg responds to report onhospital bacteria outbreak. February 1, 2007; Available from: http://www.weitzlux.com/malpractice/bacteriaoutbreak_435576.html. Accessed August12, 2011.

46. Scope washer malfunction causes concern at Eastern Health. The Telegram; April16, 2009. Available from: http://www.thetelegram.com/Health/2009-04-16/article-1452317/Scope-washer-malfunction-causes-concern-at-Eastern-Health/1. Accessed September 1, 2011.

47. 1310News Staff. Ottawa Public Health reveals site of possible HIV/Hepatitis expo-sure. 1310News; October 17, 2011. Available from: http://www.1310news.com/2011/10/17/ottawa-public-health-reveals-site-of-possible-hivhepatitis-exposure-3/. Accessed November 1, 2011.

48. Food and Drug Administration. Advanced Sterilization Products EvotechSystem Evotech Endoscope Cleaner and Reprocessor. MDR Report Key No.:1545037. Silver Spring [MD]: Food and Drug Administration; 2009.

49. Woznicki K. Colonoscopy patients put at infection risk. MedPage Today; April1, 2005. Available from: http://www.medpagetoday.com/Gastroenterology/ColonCancer/815. Accessed January 5, 2011.

50. Cowell J, Poloway L, Weidner A, Matheson DS. Review of the infectionprevention and control and CSR sterilization issues in the East Central HealthRegion. Calgary [AB]: Health Quality Council of Alberta; 2007.

51. Willing J. Ottawa’s public health names clinic at heart of infection scare.Toronto Sun; October 17, 2011. Available from: http://www.torontosun.com/2011/10/17/ottawas-public-health-names-clinic-at-heart-of-infection-scare.Accessed November 1, 2011.

52. Kleiss K. Negligent sterilization alleged. Edmonton Journal; July 27, 2007. Avail-able from: http://www.canada.com/nationalpost/news/story.html?id=0e0fb0aa-87d9-45ca-9285-cbbadc947b5c&k=65295. Accessed January 21, 2011.

53. The Canadian Press. 9,000 B.C. patients warned of surgical tools. CBC News;December 8, 2010. Available from: http://www.cbc.ca/canada/british-columbia/story/2010/12/08/bc-surgical-tools-kamloops.html. Accessed January 27, 2011.

54. Sanderson R. An outbreak of carbapenem-resistant Klebsiella pneumoniaeinfections associated with endoscopic retrograde cholangiopancreatography(ERCP) procedures at a hospital. New Orleans [LA]: APIC 2010 AnnualConference; July 11-15, 2010.

55. Watts R. Dirty instrument did not infect 463 other patients in Victoria. Van-couver Sun; October 24, 2010. Available from: http://www.canada.com/

A.M. Dirlam Langlay et al. / American Journal of Infection Control 41 (2013) 1188-94 1193

203

Page 204: INFECTION PREVENTION AND CONTROL ESSENTIALS FOR …

vancouversun/news/westcoastnews/story.html?id=80df42eb-5cba-44ed-bbc9-1d1d1c79b66d. Accessed January 20, 2011.

56. DePasquale JM, Endimimani A, Forero S, Roberts D, Fiorella P, Pickens N, et al.Outbreak of carbapenem-resistant Klebsiella pneumoniae infections in a long-term acute care hospital: Florida, 2008. Atlanta [GA]: CDC 58th Annual EISConference; April 20-24, 2009.

57. Gonzalez-Candelas F, Guiral S, Carbo R, Valero A, Vanaclocha H, Gonzalez F,et al. Patient-to-patient transmission of hepatitis C virus (HCV) during colo-noscopy diagnosis. Virol J 2010;7:217.

58. Kappelle L. SA patients at risk from colonoscope. Nine MSN News; October 18,2011. Available from: http://www.news.com.au/breaking-news/sa-patients-at-risk-from-colonoscope/story-e6frfku0-1226169848523. Accessed April 11, 2012.

59. Tschudin-Sutter S, Frei R, Kampf G, Tamm M, Pflimlin E, Battegay M, et al.Emergence of glutaraldehyde-resistant Pseudomonas aeruginosa. Infect ControlHosp Epidemiol 2011;32:1173-8.

60. Ribeiro MM, de Oliveira AC. Analysis of the air/water channels of gastrointes-tinal endoscopies as a risk factor for the transmission of microorganismsamong patients. Am J Infect Control 2012;40:913-6.

61. Ribeiro MM, de Oliveira AC, Ribeiro SM, Watanabe E, de Resende Stoianoff MA,Ferreira JA. Effectiveness of flexible gastrointestinal endoscope reprocessing.Infect Control Hosp Epidemiol 2013;34:309-12.

62. American Medical Association. JAMA instructions for authors. Available from:http://jama.jamanetwork.com/public/instructionsForAuthors.aspx. Accessed July31, 2012.

63. Healthcare Infection Society. Journal of hospital infection guide for authors.Available from: http://www.elsevier.com/wps/find/journaldescription.cws_home/623052/authorinstructions. Accessed July 31, 2012.

64. Tosh PK, Disbot M, Duffy JM, Boom ML, Heseltine G, Srinivasan A, et al.Outbreak of Pseudomonas aeruginosa surgical site infections after arthroscopicprocedures: Texas, 2009. Infect Control Hosp Epidemiol 2011;32:1179-86.

65. Azizi J, Basile RJ. Doubt and proof: the need to verify the cleaning process.Biomed Instrum Technol 2012;(46):49-54.

66. Herve R, Keevil CW. Current limitations about the cleaning of luminal endo-scopes. J Hosp Infect 2013;83:22-9.

67. Alfa MJ, Sepehri S, Olson N, Wald A. Establishing a clinically relevant bioburdenbenchmark: a quality indicator for adequate reprocessing and storage offlexible gastrointestinal endoscopes. Am J Infect Control 2011;40:233-6.

68. Alfa MJ, Olson N, Degagne P, Simner PJ. Development and validation of rapiduse scope test strips to determine the efficacy of manual cleaning for flexibleendoscope channels. Am J Infect Control 2012;40:860-5.

69. Mai V, Greenwald B, Morris JG Jr, Raufman JP, Stine OC. Effect of bowel prep-aration and colonoscopy on post-procedure intestinal microbiota composition.Gut 2006;55:1822-3.

70. Harrell L, Wang Y, Antonopoulos D, Young V, Lichtenstein L, Huang Y, et al.Standard colonic lavage alters the natural state of mucosal-associated micro-biota in the human colon. PloS One 2012;7:e32545.

71. Cautillo C. Three claimants in Farazli suit learn they have Hep. C. CTVNews; November 17, 2011. Available from: http://ottawa.ctv.ca/servlet/an/local/CTVNews/20111116/OTT-hep-c-results-farazli-111116/20111117/?hub=OttawaHome. Accessed December 3, 2011.

72. CBC News. Ottawa says 6,800 exposed to infection risk. CBC News; October 15,2011. Available from: http://www.cbc.ca/news/canada/ottawa/story/2011/10/15/ottawa-public-health.html. Accessed October 15, 2011.

73. Nease K. Four Farazli patients test positive for hepatitis C. Ottawa Citizen;November 16, 2011. Available from: http://globalnews.ca/news/178705/four-farazli-patients-test-positive-for-hepatitis-c/. Accessed November 17, 2011.

74. Barrow B. Ochsner Health System notifies 222 patients of potential errorssanitizing endoscopes. The Times-Picayune; April 19, 2011. Available from:http://www.nola.com/health/index.ssf/2011/04/ochsner_health_system_notifies.html. Accessed April 29, 2011.

75. Nogueras D. Bend Hospital notifies patients of equipment malfunction. OPBNews; January 13, 2011. Available from: http://news.opb.org/article/bend-hospital-notifies-patients-equipment-malfunction/. Accessed February 3, 2011.

76. Oh J. St. Charles Health still scheduled for trial over alleged failure to disinfectcolonoscope. Becker’s Hospital Review; April 21, 2011. Available from: http://www.beckershospitalreview.com/quality/st-charles-health-still-scheduled-for-trial-over-alleged-failure-to-disinfect-colonoscope.html. Accessed April29, 2011.

77. Bolano V. Tulane Medical Center puts patients at risk for hepatitis B, C & HIV.WGNO ABC26 News; March 10, 2011. Available from: http://www.latimes.com/topic/wgno-news-lawsuit-tulane-medical-center,0,2378174.story?track¼rss-topicgallery. Accessed March 15, 2011.

78. Lawsuit: Tulane failed to sterilize endoscope: patients sue for exposure todiseases.WDSU-NBC New Orleans; March 11, 2011. Available from: http://www.nbc33tv.com/news/lawsuit-tulane-failed-to-sterilize-endoscope.AccessedMarch15, 2011.

79. Barrow B. Tulane Medical Center alerts patients after medical gear improp-erly sterilized. The Times-Picayune; March 10, 2011. Available from: http://www.nola.com/health/index.ssf/2011/03/tulane_medical_center_alerts_p.html.Accessed March 15, 2011.

80. Ctvbc.ca. 500 at risk from contaminated endoscopes in B.C. CTV News Winni-peg; April 22, 2010. Available from: http://bc.ctvnews.ca/500-at-risk-from-contaminated-endoscopes-in-b-c-1.504883. Accessed January 20, 2011.

81. Lerner M. HCMC tells 2,600 patients device wasn’t properly disinfected. TheStar Tribune; June 22, 2010. Available from: http://www.startribune.com/lifestyle/health/96944634.html. Accessed July 16, 2010.

82. Clark C. Hospital sends letters to 3,400 patients about possible endoscopicequipment contamination. HealthLeaders Media; June 16, 2010. Available from:http://www.healthleadersmedia.com/content/QUA-252543/Hospital-Sends-Letters-to-3400-Patients-About-Possible-Endoscopic-Equipment-Contamination.html. Accessed January 27, 2011.

83. Patients at 2 North County hospitals potentially exposed to viruses: hundredsurged to get tested for hepatitis, HIV because of improperly cleaned equip-ment. KGTV 10 News; June 14, 2010. Available from: http://www.10news.com/news/patients-at-2-north-county-hospitals-potentially-exposed-to-viruses.Accessed August 9, 2011.

84. Young M. Thousands of RIH patients notified about scope disinfection problems.Merritt News; December 10, 2010. Available from: http://www.merrittnews.net/article/20101210/MERRITT0101/312109964/thousands-of-rih-patients-notified-about-scope-disinfection-problems. Accessed August 9, 2011.

85. Evans surgery center sends warning letter to 1,300 patients. The AugustaChronicle; March 4, 2009. Available from: http://chronicle.augusta.com/stories/latest/lat_500650.shtml. Accessed January 10, 2011.

86. Doctors Hospital Surgery Center LP v. Webb Report No. A10A1317. Atlanta[GA]: Court of Appeals of Georgia; 2010.

87. Wells A. LV surgery center notifying patients. Las Vegas Review-Journal; January1, 2009. Available from: http://www.reviewjournal.com/news/lv-surgery-center-notifying-patients. Accessed November 15, 2011.

88. CBC News. Alberta hospital closed after superbug, sterilization problems. CBCNews; March 20, 2007. Available from: http://www.cbc.ca/news/canada/edmon-ton/story/2007/03/20/vegreville-hospital.html. Accessed August 11, 2011.

89. Henton D. Vegreville hospital lawsuit expected. Sun Media; March 24, 2007.Available from: http://chealth.canoe.ca/channel_health_news_details.asp?news_id¼20454&channel_id¼1020. Accessed August 11, 2011.

90. 10News.com. Nurse fired for not properly sterilizing surgical instrument. KGTV10 News; May 2, 2006. Available from: http://www.10news.com/lifestyle/health/nurse-fired-for-not-properly-sterilizing-surgical-instrument. AccessedMay 16, 2012.

91. Associated Press. Hospital mishap may have exposed 300 patients to diseases.KABC-TV; May 4, 2006. Available from: http://abclocal.go.com/kabc/story?section¼news/local&id¼4142061. Accessed May 16, 2012.

92. DickersonC.Putnamhospital named inclassaction suit. TheWestVirginiaRecord;November21,2006.Available from:http://wvrecord.com/news/186993-putnam-hospital-named-in-class-action-suit. Accessed February 8, 2011.

93. Fahy J, SpiceB.Monroevillehospital urges200colonoscopypatients toget checkedfor hepatitis, HIV. PittsburghPost-Gazette;March31, 2005. Available from: http://www.post-gazette.com/stories/local/neighborhoods-east/monroeville-hospital-urges-200-colonoscopy-patients-to-get-checked-for-hepatitis-hiv-576233/.Accessed January 27, 2011.

94. Smith L. VA hospital urges endoscopy patients to get tested. Washington Post;August 24, 2005. Available from: http://www.washingtonpost.com/wp-dyn/content/article/2005/08/23/AR2005082301187.html. Accessed January 27, 2011.

95. Buchanan W. Redwood City: Hepatitis fears at Kaiser. SFGate; September 9,2004. Available from: http://www.sfgate.com/health/article/REDWOOD-CITY-Hepatitis-fears-at-Kaiser-2726821.php. Accessed November 11, 2011.

96. Lynfield R, Harper J. Inadequate endoscope reprocessing. St Paul [MN]: Min-nesota Department of Health; 2012.

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8.7

State of the Science Review

Special problems associated with reprocessing instruments in outpatientcare facilities: Physical spaces, education, infection preventionists,industry, reflections

Judie Bringhurst MSN, RN, CIC *Department of Hospital Epidemiology, UNC Hospitals, Chapel Hill, NC

The infection preventionists’ (IPs’) presence and intervention in outpatient facilities continues to lag behindthe inpatient hospital IPs’ presence. Additionally, in an outpatient world that is heavy on instrument reproc-essing, IPs must be prepared to assess instrument reprocessing practices, including high-level disinfectionand sterilization to keep our patients and staffs safe. This paper presents 3 problems associated with instru-ment reprocessing practices in health care facilities, with a special emphasis on outpatient facilities: physicalspace problems, training and education problems, and lack of IPs’ presence. We offer solutions and mitigationstrategies for these 3 problems. We also give some reflections on the current state of IP presence and respon-sibilities, and industry responsibilities, and we call for robust partnerships between IPs and the instrumentreprocessing industry.© 2019 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All

rights reserved.

Key Words:High-level disinfectionHLDSterilizationAmbulatory careClinicsCounter-top sterilizers

In the United States, more patients obtain health care in specialtyclinics, ambulatory surgery centers, and physicians’ offices than inhospitals. In 2008, there were 1.2 billion ambulatory care visits in theUnited States, including physicians’ offices, outpatient hospitals, andemergency departments. Nearly 61% of those visits were to primarycare physician offices.1

Although many outbreaks of infection associated with instrumentreprocessing in outpatient care facilities go unreported, multiple out-breaks have been reported. In 2003, Srinivasan et al2 reported an out-break of Pseudomonas aeruginosa associated with bronchoscopes in anoutpatient setting, apparently caused by loose biopsy ports on the bron-choscopes. Thirty-nine patients were infected, 67% of whom wereinfectedwith P aeruginosa. In 2012, a commentary byWeber and Rutala3

onbronchoscopies, for the 12-year period between2000 and2012, found25 outbreaks and pseudo-outbreaks in the literature. The outbreaksdescribed in their commentary resulted in 82 infections and 4 deaths.Notably, single use, disposable bronchoscopes are nowavailable.

In 2013, Kovaleva et al4 reported on transmission of infections viaendoscopy and found that, of the 98 outbreaks assessed, 1,113patients were contaminated and 249 patients were infected. Kovalevaet al noted that if deficiencies related to cleaning, disinfection, auto-mated endoscope reprocessors (AERs), contaminated water, and dry-ing were eliminated, approximately 85% of outbreaks would beeliminated. Importantly, neither the works by Weber and Rutala norby Kovaleva distinguished between outbreaks associated with inpa-tient and outpatient facilities. Additionally, underreporting of trans-mission of infection associated with endoscopy is ongoing.11

This article looks at the following 3 problems associated withinstrument reprocessing practices in outpatient care facilities: (1)physical space problems, (2) training and education problems relatedspecifically to high-level disinfection (HLD) practices, and (3) lack ofinfection prevention presence. This article offers solutions or mitiga-tion strategies to these 3 problems. In addition, it will present somereflections on the current state of infection preventionists’ (IPs’)presence in outpatient facilities and collaborations between theinstrument reprocessing industry and IPs.

PROBLEM 1: PHYSICAL SPACE PROBLEMS

Ideally, instrument reprocessing should not be performed inpatient care areas. Instrument reprocessing contaminates the area inwhich is it performed. This environmental contamination may lead to

* Address correspondence to Judie Bringhurst, MSN, RN, CIC, Department of HospitalEpidemiology, UNC Hospitals, 101 Manning Dr., Campus Box 7600, Chapel Hill, NC27514.

E-mail address: [email protected] (J. Bringhurst).This work was presented as a 2019 Supplement at the Association for Professionals

in Infection Control and Epidemiology 45th Annual Conference, Minneapolis, MN, June13-15, 2018.

Conflicts of interest: Ms. Bringhurst has received consultant fees from Cogentixand honorarium fromMedivator.

https://doi.org/10.1016/j.ajic.2019.03.0060196-6553/© 2019 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

American Journal of Infection Control 47 (2019) A58−A61

Contents lists available at ScienceDirect

American Journal of Infection Control

journal homepage: www.aj ic journal .org

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patient and/or staff infections. A space designated specifically forinstrument reprocessing should be utilized to control quality andensure safety. The reprocessing area should be divided into distinctwork areas whenever feasible as follows: receiving, cleaning, anddecontamination; preparation; HLD/sterilization; and storage. Stor-age of reprocessed instruments should be in a manner that preventsrecontamination. Many endoscopy centers employ ventilated scopestorage cabinets, whereas other types of health care facilities such asphysician practices and specialty clinics store their reprocessedinstruments in a clean storage room. An overriding goal of instrumentreprocessing areas is to establish a dirty-to-clean flow in the area forthe instrument stream, which, ideally, terminates in storage of thesereprocessed items in clean utility rooms and ventilated cabinets spe-cifically designed for endoscope storage, not the instrument reproc-essing area or room.

Double sinks with 1 goose neck faucet serving both sinks aresometimes found in instrument reprocessing areas. This is not anissue within itself; however, staff may believe that 1 of these sinks is“clean” and 1 is “dirty” when both of the bowls in a double bowl sinkshould be either 1 or the other. Ideally, if the installation of separateclean and dirty sinks is not feasible, the sinks should be used as eitherboth dirty or both clean. If it is unavoidable that both clean and dirtyactivities occur in this double sink, the sink should be thoroughlycleaned with a bleach-based, Environmental Protection Agency-regis-tered hospital-grade surface disinfectant after dirty activities andbefore being used for clean activities. However, it is noted that this isa less-than-ideal situation and that there may be associated cross-transmission risks in using the same sink for clean and dirty activitiessince faucets and drains (areas that are typically unreachable) arecontaminated.13 Additionally, the use of the same sink for clean anddirty activities likely may lead to biofilm formation in the dischargeplumbing that may not allow decontamination even with periodicbleach flushes. Also, a microbial aerosol associated with use of 1 sinkfor clean and dirty activities may contaminate the faucet and/or fau-cet aerators. All avenues for the installation of additional sinks shouldbe explored. Certainly, if more than 1 dirty or clean sink is required,as is often the case in endoscopy instrument reprocessing rooms,then double or even triple sinks may be installed with the under-standing that these multiple sink units are designated as either allclean or all dirty.

Infrequently, instrument reprocessing may occur in very smallspaces (eg, closets) with no sink at all. In these rare cases, and whenspace cannot be carved out or dollars found for installation of a sink,one should consider either single use, disposable instruments orallowing minimal instrument reprocessing that can include a vapormanagement/soaking station device in facilities that reprocesssmooth, nonlumened, nonchanneled items such as some endocavi-tary probes. Additionally, using a high-level disinfectant chemicalthat requires only 1 final rinse (and can thus be rinsed in the rinsingtube of the soaking station device) is helpful in these sinkless instru-ment reprocessing areas. This rinse water must be changed with eachdisinfection run and cannot be reused. One may also consider use ofan endocavitary ultrasound probe high-level disinfecting system thatuses a vaporized hydrogen peroxide as the high-level disinfectant.This type of system requires no rinsing of ultrasound devices such asvaginal ultrasound probes. It is stressed that this “sinkless” room isanother less-than-ideal situation and there may be associated cross-transmission risks, staff safety risks, and inconsistencies with andeven violations of Occupational Safety and Health Administration(OSHA) regulations in these rare rooms with no sinks. The importanceof ready access to a handwash sink in case of exposure to blood andbody fluids is underscored.

Inadequate space is 1 of the most frequent problems encounteredin outpatient care instrument reprocessing areas. Clutter should beeliminated. When cluttered instrument reprocessing areas are found,

it is recommended to clear the room/area of all items, discard unnec-essary items, terminally clean the room, and then resupply the room.This activity has been found to provide space that was previouslyexhausted by storage of unused supplies. When renovations are notplanned, a dirty-to-clean flow and clear separation between cleanand dirty activities and clean and dirty items is imperative. Thus, sig-nificant improvements to instrument reprocessing areas may beaccomplished without renovation. Decluttering, installing uppershelves to use vertical space, and removing equipment and items thatcan be moved to other spaces or rooms greatly increases the usablespace and safety of these areas.

When renovations are planned, infection prevention activelyengages key personnel in requiring these spaces be expanded and ele-vated to national standards and guidelines. When renovations to out-patient facilities are planned, and in the absence of state designguidelines for physician practices and specialty clinics, the instrumentreprocessing room should be designed to comply with (at least) FacilityGuidelines Institute (FGI) Guidelines for the Design and Construction ofHealth Care Facilities5 and OSHA Bloodborne Pathogen regulations,8

including but not limited to air changes per hour, pressure differentials,and the presence of an eyewash where appropriate. The Joint Commis-sion (Environment of Care chapter, 02.06.05, element of performance1) indicates that health care systems planning new or renovated facili-ties should use state rules and regulations for design guidance and/orreputable standards and guidelines such as the Guidelines for Designand Construction of Health Care Facilities, 2018 edition, administeredby the FGI. When these rules, regulations, and guidelines do not meetspecific design needs, health care facilities should use other reputablestandards and guidelines that provide equivalent design criteria. Acomplicating factor is that outpatient clinic design codes may varyfrom state to state or be absent altogether. IPs are encouraged to checktheir respective state regulations regarding outpatient clinic construc-tion design codes. For example, North Carolina exempts from statehealth care design oversight and regulation, outpatient facilities thatare classified as business occupancy and are more than 30 feet fromany hospital facility. Therefore, in North Carolina these outpatient facil-ities should be designed to meet the standards set forth in the FGI6 andthe regulations in OSHA Bloodborne pathogens standards as well asother standards and guidelines.

In addition to the design recommendations for outpatient facilitiesin the FGI, utility sinks (ie, clean and dirty instrument washing andrinsing sinks) in instrument reprocessing areas should be specified tobe stainless steel, at least 24 inches from side-to-side (inside bowlwidth) and sometimes larger according to the clinic’s specific needs,and at least 8 inches deep or deeper. Importantly, at least 2 utilitysinks should be installed to accommodate instrument washing andrinsing, 1 designated as dirty (washing) and 1 as clean (for rinsingafter HLD). Some gastrointestinal scope reprocessing rooms have 3 or4 dirty sinks to accommodate high volumes of lumened flexible endo-scopes and decrease delays between use on a patient and soaking.These sinks designated as dirty and clean should be installed at a sig-nificant distance from each other to avoid cross-contamination. Fur-thermore, a separate handwash sink is required in these rooms tomeet OSHA regulations and to keep staff safe. Manual control ofwater sources (vs motion detection) to these sinks is necessary and isachieved by installing goose neck faucets or spring-loaded pull-downfaucets with wrist blade controls or single lever controls. It is usuallynot helpful to install splashguards in instrument reprocessing roomssince there should be no clean or sterile patient supplies stored onthe counters in these areas, and splashguards interfere with the ergo-nomics of moving items from sinks to counters and vice versa. Whenhazardous chemicals are being used, an American National StandardsInstitute-approved eyewash should also be installed either on a cleansink or as a separate wall-mounted version to meet staff safety regu-lations consistent with OSHA. Correspondingly, new construction and

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renovations of outpatient facilities such as physicians’ practices,ambulatory surgery centers, and specialty clinics should be consistentwith state design codes, FGI guidelines, and OSHA regulations.

PROBLEM 2: EDUCATION, TRAINING, VALIDATION, ANDSTANDARDIZATION: FOUR REASONS OUTPATIENT AREASNEED IPS’ PRESENCE

Because of the large margin of safety inherent in steam steriliza-tion processes−there is a 1:100 quadrillion chance of the steam-ster-ilized item not being sterile−whereas there is no margin of safetyassociated with HLD of gastrointestinal endoscopes, this article willfocus mainly on HLD challenges and complications in this section.12

Per the Spaulding classification scheme, HLD, minimally, is requiredfor semicritical devices (ie, those that contact mucous membranes ornon-intact skin).7 HLD is a time-consuming, complex process thatrequires training, education, and competency. Outpatient facilitiesthat reprocess semicritical devices generally will reprocess them viaHLD unless sterilization is an option.

Education and training

Recently, Olympus published a 111-page reprocessing manual(manufacturer’s instructions for use [IFU]) for their Q180V duodeno-scope (Olympus America Inc, Center Valley, PA). It is unlikely thatscope room staff have the resources to adhere to 111 pages of clean-ing instructions for endoscopes. This gap exposes 1 of the major prob-lems with HLD, which is that the complexity of many lumenedflexible endoscopes, in particular, has outstripped our ability to meetcomplex and time-consuming HLD instructions. In an effort to medi-ate the effects of this gap, a 3-hour HLD workshop curriculum at theUniversity of North Carolina Hospitals was designed and is deliveredby infection prevention. Results from onsite infection preventioninstrument reprocessing surveys were used to guide the curriculum.Infection prevention partnered with colleagues in the environmentalhealth and safety department to produce an occupational health com-ponent in the workshop applicable to personal protective equipment(PPE) usage when performing HLD, a process that exposes staff toblood and body fluids as well as hazardous chemicals. All personnelwith HLD responsibilities are required to attend as clinic schedulespermit. The workshop is not a “train-the-trainer” class nor is it anonline module. The workshop is conducted by an IP, personally, face-to-face. The lecture portion of the workshop includes, among otherrelevant issues, a review of outbreaks associated with inadequateHLD, the rationale for HLD, negative outcomes resulting from re-useof single use items, medical-legal implications, an overview of theSpaulding classification scheme, as well as explanations of the neces-sity for leak-testing flexible scopes. Students are urged to assumeaccountability as health care personnel (HCP) in the instrumentreprocessing environment−what to report to their supervisors and/or hospital infection prevention−and they are educated on the medi-cal-legal ramifications of errors in the reprocessing environment. Theworkshop portion includes instruction and return demonstration ofdonning and doffing appropriate PPE for HLD and the proper tech-nique for testing minimum effective concentrations of HLD chemicalswith test strips. Students are given a laminated, enlarged algorithmof the steps in HLD, a laminated poster describing the appropriatePPE for HLD processes, their own safety glasses, and a large packet ofinformation, including relevant peer-reviewed literature to place intheir workspaces. More than 600 HCP have attended the workshopover the past 6 years. HCP effectiveness (ie, less likelihood of makingmistakes during HLD activities) has been variable based on subse-quent visits to HLD areas. Student comments and evaluations havebeen positive. Students comment positively on the information theyreceive on outbreaks and the workshop portion of the session.

Perhaps the most significant benefit of the workshop is the familiaritystudents establish with infection prevention. This may ease anxietyassociated with reporting of challenges in their facilities to their IP. In2018, a 1-hour refresher HLD class was established for those whohave attended the 3-hour workshop and made mandatory every365 days. There are infection prevention benefits in requiring theworkshop for clinic HCP who may need remediation in HLD practices.Class materials, revised at least yearly to reflect current issues, areused for up-to-date education of staff.

Validation

Validation studies and their associated documents are a necessaryelement of any instrument reprocessing activity. Are the HLD chemi-cals in use validated effective by the instrument manufacturer? Arethe automated endoscope reprocessors (AERs) in use validated by theinstrument manufacturer and vice versa? Do our instruments havelumens that are validated to be effectively high-level disinfected withspecific connectors or hook-ups? The length and diameter of lumensmust be assessed before any HLD or sterilization process is assumedto be effective and validated. Most HLD chemical manufacturers andAER manufacturers have online, easy-to-use validation matrices.IFUs, Centers for Disease Control and Prevention, facility policies, andprofessional organizations’ guidelines should always be consulted forcleaning instructions with any instrument, automated instrumentreprocessors such as AERs, and HLD chemicals. Adherence to nation-ally accepted standards, guidelines, and manufacturer’s IFUs must bemeticulous. These standards, guidelines and IFUs are generally spe-cific to the product with which they are associated. Most medicaldevices, instruments, and instrument reprocessors must be evaluatedby the Food and Drug Administration (FDA) and should have com-plete IFUs9; however, not all instruments found in outpatient care aresubject to FDA evaluation nor are all IFUs written in a manner that isdecipherable to clinic staffs. The IP’s input pertaining to appropriatecleaning, disinfection, and sterilization should include interpretationof manufacturer’s IFUs where necessary. Improper use and disinfec-tion of equipment and instruments may harm the equipment andexpose staff and patients to cross-contamination. Furthermore, theIP’s assistance to weave together various IFUs for HLD chemicals andthe instruments and equipment (eg, AERs) for which those chemicalsare validated is invaluable to clinical staff. For example, some HLDchemicals are contraindicated for use in certain patients (eg, ortho-phthalaldehyde in bladder cancer patients), certain reprocessingenvironments, temperatures and equipment, whereas some HLDchemicals can be heated during the HLD process and some cannot,per FDA approvals. Manufacturer’s IFUs for the chemicals should bereviewed and the FDA list of cleared sterilants and high-level disin-fectants checked for validation of choices of HLD chemicals.10

Standardization

There is no standardization across manufacturers of instrumentreprocessing devices and consumables. The infection prevention pro-fession urges our industry partners to learn more about the chal-lenges faced on the front lines of our HLD areas and begin to addressthese challenges in a useful and, as far as possible, simple way. Thereis a plethora of products, each with their own specific, individualinstructions, including enzymatic detergents and other detergentcleaners with differing water-to-detergent ratios, HLD chemicalswith different soak times and usage days, and HLD chemical teststrips with different wait times and color changes. HCP should beclearly instructed by the IP that, although these variances exist, it isonly critical for personnel to read and follow all instructions thatapply to their HLD, detergents, test strips, instruments, and devices.Another method to mitigate some of this potential confusion is to

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decrease as much as possible the variety of HLDs and their attendantconsumables available to clinics.

PROBLEM 3: LACK OF IPS’ PRESENCE

If not already educated, IPs should become educated on the HLDprocess and proficient in assessing these practices. Multiple resourcesspecific to HLD practices, processes, and environments exist for theinquiring IP’s mind.14-17 In tandemwith these resources is all productinformation and IFUs that are relevant to HLD processes. Also neces-sary for the IP’s education are the regulatory notices that emanatefrom the Centers for Disease Control and Prevention and the FDA.18

IPs can develop the skills to assess whether an endoscope is reproc-essed correctly, whether all reprocessed instruments and devices arebeing stored appropriately, whether it is clear that an item is clean ordirty, and how to assist clinics in mediating some less-than-idealphysical plant situations to make these situations safer.

DON’T LET WHAT YOU CAN’T DO INTERFEREWITHWHATYOU CAN DO

The present time is “our watch.” IPs must take action to amelioratethe well-publicized problems with HLD. There has never been a timein which infection prevention must partner with industry like theprofession must partner today. Infection prevention must be engagedat a level not seen before. Thousands of known human infections(and thousands more unknown) are associated with failures in HLD−either human or engineering. IPs are responsible for immediately giv-ing solvable issues our attention. Industry is responsible for immedi-ately creating engineering controls on devices that make it difficult toinfect a patient, such as single use, sterile devices and sheaths andstandardizing products that perform the same function, such as HLDchemical test strips for minimum effective concentrations. The infec-tion prevention profession as a whole and individual IPs are responsi-ble for continuing the pressure on industry to do so. Our first step asIPs, committed to keeping our patients safe, should be to tuck ANYHLD guideline under our arm, walk into our instrument/scope reproc-essing room, and start a conversation.

SUMMARY AND REFLECTIONS

Historically, outpatient facilities have been overlooked by infec-tion prevention departments perhaps due to an assumption thatmost high-risk procedures occurred in hospitals rather than outpa-tient facilities and therefore the infection risk to patients was not assignificant in outpatient facilities. Today, we know the risks for cross-transmission and patient infections in outpatient facilities is ever-present as more patients receive their health care in outpatient facili-ties than in hospitals and many procedures that once required inpa-tient hospital stays are performed on an outpatient basis. The result isincreasingly complex care in outpatient facilities that often involvesreusable semicritical and critical devices. Failures in instrumentreprocessing have the potential to infect many patients in a shortperiod of time, and frequent reports of instrument reprocessing fail-ures and near-misses with or without resultant patient infectionsdemonstrate the need to continue to focus infection prevention’s andindustry’s attention to safer, simpler instrument reprocessingpractices in outpatient facilities. Fundamental to patient and staffsafety is infection prevention’s oversight of any facility−inpatient oroutpatient−that reprocesses reusable instruments.

An IP’s reflections:

1. It was a mistake for me to assume that people who HLD everydayknow the right way to do it.

2. Your instrument reprocessing sites, outpatient and inpatient, needyour attention and help−they may not know that yet.

3. We CANNOT always make it perfect or even consistent with regu-lations and guidelines but we CAN ALWAYS make it better andsafer for our patients and our staffs.

4. Start with your first visit−challenges will be uncovered, opportu-nities for improvement will become clear. Address the challengesand opportunities that present a risk to patients and staff first.

5. Once we, IPs, are fully engaged, the myriad elements and complex-ities of HLD within our facilities will lead us where they need usto go.

References

1. Ambulatory care use and physician office visits. Available from: http://www.cdc.gov/nchs/fastats/physician-visits.htm. Accessed March 28, 2019.

2. Srinivasan A, Wolfenden LL, Song X, Mackie K, Hartsell TL, Jones HD, et al. An out-break of Pseudomonas aeruginosa infections associated with flexible broncho-scopes. N Engl J Med 2003;348:221-7.

3. Weber DJ, Rutala WA. Lessons learned from outbreaks and pseudo-outbreaks asso-ciated with bronchoscopy. Infect Control Hosp Epidemiol 2012;33:230-4.

4. Kovaleva J, Peters FT, van der Mei HC, Degener JE. Transmission of infection byflexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol Rev2013;26:231-54.

5. Facilities Guidelines Institute: Guidelines for design and construction of healthcare facilities, 2010; American Society for Healthcare Engineering of the AmericanHospital Association.

6. North Carolina General Assembly. North Carolina General Statutes G.S. 131E-76(3). http://www.ncga.state.nc.us/gascripts/statutes/StatutesTOC.pl?Chapter=0131E.Accessed March 28, 2019.

7. Rutala WA, Weber DJ. The Healthcare Infection Control Practices Advisory Com-mittee (HICPAC): Guideline for Disinfection and Sterilization in Healthcare Facili-ties, 2008. Available from: https://www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html. Accessed March 28, 2019.

8. Berry C. The Bloodborne Pathogens Standard (29 CFR 1910.1030), NC Departmentof Labor, 2010. Available from: http://www.nclabor.com/osha/etta/indguide/ig7.pdf. Accessed March 28, 2019.

9. Food and Drug Administration. Available from: http://www.fda.gov/MedicalDevi-ces/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmis-sions/PremarketNotification510k/default.htm. Accessed March 28, 2019.

10. Food and Drug Administration. Available from: https://www.fda.gov/medicaldevi-ces/productsandmedicalprocedures/reprocessingofreusablemedicaldevices/default.htm. Accessed March 28, 2019.

11. Beekmann SE, Palmore TN, Polgreen PM, Bennett JE. Adequacy of duodenoscopereprocessing methods as reported by infectious disease physicians. Infect ControlHosp Epidemiol 2016;37:226-8.

12. Rutala WA, Weber DJ. Disinfection and sterilization: an overview. Am J Infect Con-trol 2013;41(Suppl):2-5.

13. Amoureux L, Riedweg K, Chapuis A, Bador J, Siebor E, P�echinot A, et al. Nosocomialinfections with IMP-19¡producing Pseudomonas aeruginosa linked to contami-nated sinks. Emerg Infect Dis 2017;23:304-7.

14. Centers for Medicare and Medicaid Services. Available from: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107_exhibit_351.pdf. Accessed March 28, 2019.

15. The Joint Commission. Available from: https://www.jointcommission.org/assets/1/6/TJC_HLD_BoosterPak.pdf. Accessed March 28, 2019.

16. Petersen BT, Cohen J, Hambrick RD III, Buttar N, Greenwald DA, Buscaglia JM, et al.Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update.Gastrointest Endosc 2017;85:282-94.

17. Association for the Advancement of Medical Instrumentation. ANSI/AAMIST91:2015. Flexible and semi-rigid endoscope processing in health care facilities.Available from: https://my.aami.org/aamiresources/previewfiles/ST91_1504_pre-view.pdf. Accessed March 28, 2019.

18. The Centers for Disease Control and Prevention (CDC). CDC Health Update: Regula-tory Recommendations: Health care facilities need to immediately review medicaldevice reprocessing procedures. Available from: https://oeps.wv.gov/healthalerts/documents/cdc/CDCHAN_383.pdf. Accessed March 28, 2019.

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