Regulatory Boot Camp: Infection Prevention

May 14, 2013

Jean Day, BSN, RN, CNOR

Director of Clinical Education

Infection Prevention Resources CMS - Revised Infection Control Surveyor Checklist

2012 www.cms.gov/sitevisit

CDC - Infection Prevention Checklist for Outpatient Settings www.cdc.gov/hai/settings/outpatient/checklist

ASGE - 2011 Multi-Society guidelines for reprocessing flexible gastrointestinal endoscopes http://cdc.gov.hicpac/disinfection_sterilization

CDC - 2013 NHSN Procedure Associated Events, SSIhttp://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

Objectives:

Identify common infection prevention deficiencies identified during survey conditions.

List best practices for the prevention of healthcare acquired infections.

Recognize 2013 changes to infection prevention accreditation standards.

Provide associated regulatory standards to achieve compliance of infection prevention practices.

Formal IP Plan IC.01.05.01 (RWD)

CH.7.SubCH.1.B (RWD)

CMS.416.51Approved by Governing Board – meeting minutes

Designated IPRN approved by Governing Board

IPRN accounts for time to conduct IP activities

IPRN demonstrates evidence of ongoing training & competence in IP practices

IPRN given authority to enforce IP policies

Infection Risk Analysis

IC.01.03.01 (RWD)

CH.7.SubCH.1.B.5 (RWD)

CMS.416.51.(b)(3)24% deficiency rating by TJC (YTD)24% deficiency rating by TJC (YTD)

Annual or when significant changes occur - New service: adding spine, total joint, pain management

Change in EVS contractor

Outbreak

Based on scope of services, geographic location & population served.

Clearly Stated Goals IC.01.04.01 (RWD)

CH.7.SubCH.1.C

CMS 416.51.(a)P&P represent nationally recognized practice

standardsstandards.

P&P make reference to practice standards the organization chooses to follow: AAMI CDC

AORN HICPAC

APIC SGNA

ASGE WHO

Clearly Stated Goals

HR.01.04.01 (RWD)Organization orients staff to key infection control

content before staff provides care, treatment or services.

CH.5.SubCH.2.D (new)

CH.7.1.F.1 (RWD)Infection control policies & processes are provided

to all staff within 30 days of commencement of employment; annually thereafter, or when need identified.

RISK ANALYSIS FOR INFECTIONS 2013

InfectionPrevention

PROBABILITY RISK CAUSE of transmission

Center Preparedness GOAL

HIGH – 3 MED – 2 LOW – 1 NONE – 0

See Below See Below Poor – 3 Fair – 2 Good - 1

See Below

SURGICAL SITE INFECTIONS

2 1 2,3 1 1,2,3,4,5,6,7,8,910, 11,13,14

MRSA (Community)MDRO

1 3 2,3,4 2 1,9,10,11,13

PANDEMIC FLU

1 5,4,3 4 1 1,6,9,10,11,12

Health Care Acquired (HAI) INFECTIONS CAUTI, C. Difficile

1 1 2 1 1,4,8,9,10,11,12

TB 1 1 4 2 1,10,11,13 Upper Respiratory (bacterial or viral)

2 1 1 1 1,6,9,11

Hepatitis B (HCW) 2 1 2 1 1,9,11,12,13,14 Other

RISK: 5 – Life Threatening 4 – Community Health Safety 3 – High Disruption to Business 2 – Moderate Disruption to Business 1 – Low Disruption to Business

Risk: 5 – Life Threatening 4 – Community Health Safety 3 – High disruption to business 2 – Moderate disruption to business 1 – low disruption to business

Cause of Transmission: 4 – Communicable, pre-existing 3 – Resistant organism, acquired 2 – Break in Sterile techniques, Quality Controls, direct contact 1 – Acute onset, diagnosed at time of admission

GOALS: Protect Patient from infection by:1. Consistent practice of hand hygiene. 2. Administering prophylactic antibiotics within 60 minutes of anticipated “cut” time. 3. Preparing surgical site by skin preparation & use of sterile barriers. 4. Maintaining sterile technique for invasive procedures. 5. Maintaining thermoregulation. 6. Cancelling patients showing signs & symptoms of acute illness. 7. Providing instruction and necessary supplies for wound management at home. 8. Applying best practices in reprocessing & sterilization of instruments. 9. Maintaining cleanliness in the environment using appropriate disinfectants. 10. Cancellation of patients with known communicable diseases until resolved. 11. Protect HCW, patients & visitors from infection by requiring compliance to infection

prevention practices. 12. Protect HCW from communicable diseases by providing vaccinations. 13. Protect HCW from exposure to BBP by providing PPE and evaluating protective sharp

medical devices. 14. Accomplish the above in a cost effective manner to the business.

GOALS: Protect patient from infection by –

1. Consistent practice of hand hygiene.2. Administering prophylactic antibiotics within 60 minutes of anticipated

“cut” time.3. Preparing surgical site by skin preparation & use of sterile barriers.4. Maintaining sterile technique for invasive procedures.5. Maintaining thermo regulation.6. Providing instruction and necessary supplies for wound management

at home.7. Applying best practices in reprocessing & sterilization of instruments.8. Maintaining cleanliness in the environment using appropriate

disinfectants.9. Cancellation of patients with known communicable diseases until

resolved.10. Protect HCW, patients & visitors from infection by requiring

compliance to infection prevention practices.11. Protect HCW from communicable diseases by providing

vaccinations.12. Protect HCW from exposure to BBP by providing PPE and evaluating

protective sharp medical devices.13. Accomplish the above in a cost effective manner to the business.

Surveillance - continuous

Hand Hygiene ComplianceNPSG.07.01.01

CH.7.SubCH.1.C.1

CMS 416.44(b)(5)22% deficiency rating by TJC (2011)

6% d fi i i b TJC (fi h lf ) 16% deficiency rating by TJC (first half 2012)

Top 10 list of AAAHC

Business must adopt CDC or WHO guidelines

Evidence of corrective action leading to improvement

Observing HCW for artificial nails and natural nail length

Soap & H2O NOT ABHR for C. Difficele exposure

Hand Hygiene will be performed:Before coming on duty.

Before and after each patient contact and between different types of care on the same patient.

Before and after donning or removing gloves or other personal protective equipment.

Any time there is a probability of contact with blood or other potentially infectious materialsother potentially infectious materials.

Before and after invasive procedures.

Before and after using the restrooms.

Before and after eating.

After using the computer or PDA.

At the end of shift.

• Based on CDC Guidelines

Why so much resistance?

Male physicians WORST for hand hygiene compliance.

Hand hygiene surveillance demonstrates 50% compliance to CDC guidelines.

Clearly the best defense known for the prevention of transmission of micro-organisms.

ABHR = >60% alcohol concentration to be effective. (exception – soap & H20 for C. Diff)

Universal Precautions

IC.02.01.01 (2) Use of PPE to reduce risk.

CH.3.C.1-3

CMS 416.51(b)(3) & 416.41HCW failure to use PPE appropriate to task or HCW failure to use PPE appropriate to task or

anticipated exposure.

HCW failure to report exposure incident.

Business failure to provide follow up care after exposure incident.

OSHA Violations “OSHA Surveys are coming”– triggered by

complaints.

Most common deficiencies cited during survey: Non-existent or outdated Exposure Plan.

Business failure to provide annual training:Business failure to provide annual training: Prevent exposure to BBP or OPIM.

Business failure to include risk of exposure within job description.

Employee failure to use PPE appropriate to task.

Employee failure to keep QC checks as verification of processes & conditions.

Protecting the HCW from illness

Organization policy to provide flu vaccination?

State mandatory flu vaccination program?Mask required with symptoms?

Presentee-ism – IPRN given authority to send ill g yHCW home?

Monitor HCW illness rate?

Hepatitis B vaccination – provided by employerMonitor HCW exposure incident rate?

OSHA 300 – annual reporting?

Manage Point of Care DevicesManufacturer’s IFU cleaning instructions

Manufacturer’s current product insert, especially if reagent is used

Manufactured as single or multi-use

Manage Point of Care devices IC.02.02.01

CH.7.SubCH.1.M26% deficiency rating by TJC (first half 2012)

31% deficiency rating by TJC (YTD)

b ( )CH.7.SubCH.1.N (new)Manufacturer’s IFU cleaning instructions.

HCW demonstrates competency in decontamination of device using IFU or best practice.

HCW knowledgeable of dwell time requirement of surface wipes in use.

Which product do I

use ?

How much contact time is

needed ?Evidence of Reality

Safe Medication Administration

• CMS 416.48(a)CDC

recommendations: Single dose vials? Multi dose vials?

MDVSDV

Multi-dose vials?

One needle, one syringe,

one use!Drug, dose, time, initials

Safe Medication Administration

MM.06.01.01

CH.7.SubCH.1.C.2CH.11.I

CMS 416.48(a)CMS 416.48(a)CDC

recommendations:

IV spike < 60” before use

IV ports covered, ETOH wiped before use

Sharps Injury Prevention

E t h 2/3 f ll

IC.02.01.01 CH.7.SubCH.I.F (RWD)18% deficiency rating by TJC (YTD)Annual evaluation of safer devicesPuncture proof Empty when 2/3 fullPuncture proof

containersNeutral Zone

Improper surgical attireOther breaches contributing to infection

Contamination of sterile field

What is acceptable OR attire?

Freshly laundered scrub attire.

No home laundered scrubs!

Compliance to Healthcare Laundry Accreditation Council guidelines for healthcare textiles.g

Long sleeves for circulator.

Warm up jackets – high performance textiles.

Designer caps (covered or freshly laundered).

White doctor coats (remains open for debate).

Personal digital assistants

Ubiquitous

Source of distraction

Patient privacy

M f t IFU dManufacturer IFU does not include how to sanitize

Hand hygiene best practice documented

Cleanliness of EOC

LD.04.03.09 - Evaluation of contracted service –annual.

CH.7.SubCH.1.A, D, G

CMS 416.44(a)(3)( )( )Satisfaction with level of performance?

Verified competency of EVS personnel?

Agreement delineates who cleans what?

Laundry service applies Healthcare Laundry Accreditation Council standards

How clean is clean?Housekeeping is contracted serviceHigh turnover rate of human resources?

Verified HR competency & knowledge?

Correct cleaning agent for the level of sanitation or di i f ti ?disinfection?

FDA approved cleaning products?

Demonstrate best practice & cleaning materials?

Frequency of cleaning?

Clarity of who is cleaning what?

Random surveillance for microorganism kill?

Instrument Reprocessing IC.02.02.01

CH.7.SubCH.1.E, J, K (RWD)

CMS 416.44(a)(3)28% deficiency rating by TJC

Top 10 list of AAAHC

AAMI ST79:A1:2010 & A2:2011

AORN 2013 Sterilization RP

Spaulding Classification

Equipment Operating Manuals

Manufacturer’s Instruction for Use

Personnel CompetencyHR.01.06.01 Competency assessed q 3 yrs.

CH.4.A & CH.3.B.5

Demonstrate understanding of quality control measures performed, when & why.Ability to respond to surveyor questions with

confidence!

Ability to describe quality control measures and results contained within QC log books.

Ability to locate equipment manuals.

Ability to discuss routine PM& Repair schedules.

Instrument Storage

CH.7.SubCH.1.L (new)30 - 60% humidity

62 - 75° F

Impervious lower shelf 8 -10” above floor, 18” from pnearest sprinkler, 2” away from wall

Event related shelf life

AORN 2013 Sterilization RP

Class 5 Integrator

Immediate Use Steam Sterilization

Impervious8 – 10”

Immediate Use Steam Sterilization

AAMI, AORN, CDC do not recommend except when no other option is available.

Not an option for insufficient inventory.

IUSS instruments – shortest duration between sterilization & use.

Transport to OR in closed container

Keep IUSS log – requesting capital needs.

Track instruments to individual patient.

Sterilization Assurance

Quality Controls:Repeatable SOPs

Manufacturer’s IFU

B i Di k f d d dBowie Dick – performed, recorded

Daily Biological Indicator

QC documentation maintained & current

Confidence of sterility

CONTROL

CONTROL

Sterile or Not Sterile?

LOT CONTROL NUMBER

Failure to adhere to established reprocessing guidelines (repeatable steps) accounts for most if not all accounts for most, if not all, of reportable bacterial & viral transmissions.

- American Society for Gastrointestinal Endoscopy

CLEANING = removing visible soil & foreign matter at bedside.

DECONTAMINATION =

Removing or reducing infectious organisms.

TWO most critical steps in preventing transmission of bacterial & viral contaminants.

Rapicide Test Strip

Quality Control Log is complete & current

Surveillance Activities

IC.01.05.01 (RWD)

CH.7.SubCH.1.I

CMS416.51(b)(3)Surveillance conducted on regular basis

Evidence investigation conducted – RCA or PI studies

Use of surveillance checklists SSI surveillance

Hand Hygiene

Environment of Care

Chart Audit

Surveillance Surgical Site Infection

NPSG.07.05.01 & IC.01.04.01 (RWD)

CH.7.SubCH.1.I

CMS 416.51SSI = Unexpected Outcome (CMS considers SSI

as preventable)

Deep Incision SSI surveillance – Time sensitive (30 day + 90 day when implant involved) Ongoing

Investigation

Data collection

Reporting

Patient Chart # 03478 03321 03452 03433 03382 03405

Prophylactic antibiotic IV administered < 60" of incision timeMethod of hair removal, time & person

Blood glucose within normal range pre-operatively (if applicable)Skin prep solution used, location & person

Normothermia (>96.8) maintained intraoperatively and up to 15" afterintraoperatively and up to 15 after anesthesia endPsO2 > 90% intraoperative

PsO2 > 90% initial reading in PACU

Blood glucose, 200 mg/dl in PACU (if applicable)Evidence of wound care instructions & supplies provided at time of discharge

Frequency Action Jan Feb Mar

Weekly Provide new hire orientation to Infection Prevention Policies (upon request)Weekly/   Monthly

Run Infection Surveillance report  by surgeon from PAS allowing > 30 day lapse from DOS

MonthlyRun Infection Surveillance report by surgeon using implant report naming patients identified for DOS with 90 day interval.

Monthly Send surgeon surveillance form(s) > 30 day or > 90 day

Monthly Conduct investigation of reported SSI: contact surgeon, patient, hospital

Monthly Enter SSI in Action Cue reporting system

Monthly Obtain Employee Illness report from HR Coordinator

IPRN Concurrent Checklist - Example

Monthly Conduct follow up from reported employee illness , or exposure incident

MonthlyConduct Hand Hygiene surveillance in one specialty area  (HH & glove use surveillance)

MonthlyConduct Universal Precautions surveillance in one specialty area  (IP & Safety Surveillance)

Monthly Conduct chart review for infection prevention initiatives  (Chart Audit)

Monthly Read current periodical, select one article for staff education

Quarterly Review infection rate reported from Action Cue reporting system

Quarterly Review employee illness/exposure incident rate from Action Cue report system

Quarterly Conduct staff education of selected topic, IP PI, other

Questions?Jean Day, RN / Director of Clinical Education

719-256-5831

jday@pinnacleiii comjday@pinnacleiii.com

www.pinnacleiii.com

References:

• AAAHC; Ambulatory Handbook, 2013

• AAMI ST-79;A1:2010 Comprehensive Guide to Steam Sterilization & Sterility Assurance in Healthcare Settings

• AORN; 2013 Perioperative Standards & Recommended Practices

• AJIC; November 2011, Rethinking hand hygiene improvement

b h bl• AJIC; September 2011, Nursing & physician attire as possible source of nosocomial infections

• CDC; Jan.2013, NHSN – Procedure Associated Events SSI

• CMS; Conditions for Coverage, 2009

• FDA; 2011, Processing/Reprocessing Medical Devices in Healthcare

• Outpatient Surgery Magazine; May 2012, Manager’s Guide to Infection Control

• TJC; CAMAC, 2012