its time for a survey final 2 18 16human resources (hr) infection prevention and control (ic)...

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© 3M 2016. All Rights Reserved

3M Health Care AcademySM


It's Survey Time! Preparing for TJC or CMS Accreditation SurveyFebruary 18, 2016


Welcome!Topic: It's Survey Time! Preparing for TJC or CMS Accreditation Survey

• Facilitators: Christophe de Campeau, 3M Sandra Velte, 3M

• Speakers: Rose Seavey

• For more information: www.3m.Com/3MSterileU

© 3M 2016. All Rights Reserved 3

House Keeping

From the GoToWebinar page:• Click on the orange box with a

white arrow to expand your control panel (upper right-hand corner of your screen).

• Type a question in the question box and click send.

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House Keeping

Continuing EducationEach 1 hour web meeting qualifies for 1 contact hour for nursing. 3M Health Care Provider is approved by the California Board of Registered Nurses CEP 5770.

Post webinar email• Link to Course Evaluation• CE Certificate Included• Forward eMail to Others in Attendance


Disclosure

• Rose Seavey• President/CEO of Seavey Healthcare Consulting, LLC

• Educational Consultant for 3M


Objectives

• Discuss rationale and focus of a healthcare accreditation survey process

• Discuss the latest requirements from TJC and CMS relating to reprocessing of medical devices

• Describe key published standards and recommended practices for safe and effective reprocessing of reusable devices

• Explain how healthcare facilities can prepare for an accreditation survey

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Polling Question In the last six months, have you had an accreditation survey in the following departments:

A. Only Central Sterile Supply DepartmentB. Only Endoscopy Reprocessing DepartmentC. Both DepartmentsD. Neither Department

© 3M 2016. All Rights Reserved© 3M 2016. All Rights ReservedSM

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Discuss rationale and focus of a healthcare accreditation

survey process


Risk Reduction and Process Improvement are the Heart and Soul of Accreditation SurveysRisk reduction and process improvement are

the heart and soul of accreditation surveys

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Accreditation Survey• Improving the quality of health care

– Peer review

– Focus on safety, quality, and process improvement

• Condition of payment– Private insurance companies

– Federal funding

• Measures compliance– Accreditation standards and supporting documents

– Published recommended practices

Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014.


Centers for Medicare & Medicaid Services (CMS)

Accrediting organization with deeming authority by CMS• Accreditation Association for Ambulatory Healthcare (AAAHC)

• Accreditation Commission for Healthcare (ACHC)

• American Association for Accreditation of Ambulatory Surgery Facilities (AAASF)

• American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFPA)

• Center for Improvement of Healthcare Quality (CIHQ) - new 8/9/2013

• Community Health Accreditation Program (CHAP)

• DNV Healthcare (DNV)

• The Joint Commission (TJC)


• Independent, nonprofit

• Accredits and certifies over 18,000 health care organizations and programs including:

– Hospitals,

– Doctor’s offices,

– Nursing Homes,

– Office-based surgeries,

– Behavioral health treatment facilities, and

– Providers of home care services.

• Nationally recognized as symbol of quality

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TJC Survey Process

• Submit an application • Pay a fee• Resurveyed within three years• 2006 unannounced survey process

• Between 18 and 39 months after previous survey

• Morning of survey• Biographies and pictures of surveyors assigned

Eiland, John E, Surveyor, The Joint Commission. Joint Commission presentation at IAHCSMM annual meeting in May 2013. Presentation available on flash drive provided to attendees.


Joint Commission Resources

Nonprofit affiliate of TJC, publishes the official handbooks used in the TJC survey process

• Comprehensive Accreditation Manual for Hospitals (CAMH)

• Comprehensive Accreditation Manual for Critical Access Hospitals (CAHs)

• Comprehensive Accreditation Manual for Ambulatory Care (CAMAC)

• 2013 Comprehensive Accreditation Manual for Office-Based Surgery Practices (CAMOBS)


• Which area represents the biggest challenge for you when preparing for a survey?

A. Staff TrainingB. Record KeepingC. IFUs (Maintaining and Following)D. Equipment Failure SOPsE. Standardized Processes

POLLING QUESTION

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TJC High-Level Disinfection (HLD) and Sterilization BoosterPakTM - Dec. 2015

Highlights the requirements and the potential flaws, andProvides reference and training links.

Resource for:HospitalsAmbulatory services,

Office-based surgery practiceshttp://www.jointcommission.org/standards_booster_paks/


TJC BoosterPakTM Dec. 7, 2015

High-Level Disinfection and Sterilization• Searchable document

• Detailed information about HLD or sterilization standards with high volume non-compliance scores

• Goal• Ensure evidence-based guidelines and regulatory standards are followed in

order to minimize risk of infection

• Available• TJC accredited and certified organizations - Joint Commission Connect

Extranethttp://www.jointcommission.org/standards_booster_paks/


HLD and Sterilization BoosterPak - TJC

• Table of Contents Leadership

Risk assessment

Sterilization

Environment of care

High-level Disinfection

HR – Competency and Training

Appendix – related standards

• Important Takeaways

• Target audience Front-line staff

Managers of front-line staff

Infection Preventionist

• Applicable Settings Hospitals

Critical Access hospitals

Ambulatory

Office-based Surgery

http://www.jointcommission.org/standards_booster_paks/

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Polling Question

In your last accreditation survey approximately how much time did the surveyor spend in Sterile Processing?

A. Less than an hour B. 1-2 hoursC. 3-4 hoursD. More than 4 hoursE. They did not come to SP


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Discuss the latest requirements from TJC and CMS relating to

reprocessing of medical devices survey


Accreditation Standards

• StandardsPerformance objectives

• Standards relating to reprocessing Environment of Care (EC)

Human Resources (HR)

Infection Prevention and Control (IC)

Leadership (LD)

Performance Improvement (PI)

• RationalesDescribe importance

• Elements of Performance (EPs) How you meet goals

scores determine the compliance

Min. score of 90% on every EP

Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014.

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TJC Second Generation Tracers -Cleaning, Disinfection & Sterilization (CDS)


TJC Second Generation Tracers• “The organization reduces the risk of infections associated with medical

equipment, devices, and supplies”Deficiencies:

• 47% Hospitals

• 43% Critical access hospitals

• 37% Ambulatory care organizations

• 26% Office based-surgery practices

• Leadership, IPC, OR, Sterile Processing, ES, and Engineering – all play a CRITICAL ROLE in reprocessing.

• Standardizing the use of HLD and sterilization practices

The Joint Commission. High-level Disinfection and Sterilization: Know Your Practice. Feb. 2014; 34(2):9-13


TJC Facilities Out of Compliance

1. Not using current evidence-based guidelines (EBG) (IC.01.05.01 EP 1)

2. Orientation, training, and competency not conducted by personnel trained on recent EBG (IC.02.02.01)

3. Lack of quality control and manufacturers’ instructions for use (IFU) - using nonvalidated conditions (concentration, exposure times, and temperatures)

4. Lack of participation and collaboration with IPC (IC.0202.01)

5. Recordkeeping - “incomprehensible” or non-standardized logs (IC.0202.01 EP 2)

Traceable path to the patient and product identification in the event of a recall

The Joint Commission. High-level Disinfection and Sterilization: Know Your Practice. Feb. 2014; 34(2):9-13

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TJC Personnel Considerations

HR.01.06.01: Staff are competent to perform their responsibilities EP 1. The facility defines the competencies it requires of its staff…

EP 2. The facility uses assessment methods to determine the individual’s competence…

Test taking, return demonstration, or the use of simulation.

EP 3. An individual with the educational background,experience, or knowledge …assesses competence.

The Joint Commission. 2015 Hospital Accreditation Standards (HAS)


Leadership Standards and EPsLD.04.01.11: The facility makes space and equipment available as

needed for the provision of care, treatment, and services.

– EP 2. The arrangement and allocation of space supports safe, efficient, and effective care, treatment, and services.

– EP 5. The leaders provide for equipment, supplies, and other resources.

The Joint Commission. 2015 Hospital Accreditation Standards (HAS)


Most Frequently Scored Standards

Patton Healthcare Consulting Newsletter, April 2015

56% EC.02.06.01Safe and Functional Environment EP 13 Temp. and Humidity

OR, Sterile Storage and SP (clean and dirty)•Staff know required temperature and humidity parameters• Log each day (paper or automation)

•Must have mandatory feedback

53% EC.02.05.01Risks with Utility Systems

Positive vs. Negative airflow•Staff know what it is and what they can do to maintain appropriate pressure

52% IC.02.02.01Reduce Risk of Infection

Cite any deviation from perfect compliance•More places performing sterilization or HLD the more risks you have•AAMI ST58 2013

36% EC.02.02.01Manage Risks Related to Hazardous Materials

Eyewash in Immediate Area•Plumbed•Inspection and documentation weekly•Evaluate new products

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2015 Frequent Reprocessing Issues Reported by TJC

• Failure to measure chemical solution dilution

• Hand carrying dirty scopes

• Missing biohazard labeling

• Failure to ID your clinical practice guideline for HLD

• No oversight of HLD by IPC

• Mixing clean and dirty instruments

• No temperature monitoring of chemical used in HLD

• Failure to document competency

News from TJC and CMS. Patton Healthcare Consulting Newsletter Nov. 2015


2015 Frequent Reprocessing Issues Reported by TJC (con’t)

• Failure to pre-clean instruments at the point-of-use

• Leaving hinged items in the closed/latched position during sterilization

• No documentation of washer and sterilizer maintenance and cleaning

• Failure to document biological indicator results

• Use of double peel packs where inner pack is folded over

• Premature release of IUSS

• Failure to document staff competency

News from TJC and CMS. Patton Healthcare Consulting Newsletter Nov. 2015


TJC: High-Level Disinfection (HLD) and Sterilization BoosterPakTM

• Hospitals,• Ambulatory services,

and• Office-based surgery

• IC.02.02.01- 45% increase in citations since 2009

• TJC recommendations:1. Risk assessment/gap analysis

2. Current Guidelines

3. Infection Control plan

4. Frequent, unannounced observations

5. Educate continuously


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TJC BoosterPakTM

Leadership - Important Takeaways

Citings for Std. IC.02.02.01 are on the rise EP2 - Intermediate, HLD and sterilization performance strictly adhered to standards

Know Spaulding Classification and follow manufacturer IFU

Leadership is ultimately responsible

Monitor front-line staff performance initially and regularly



TJC BoosterPakTM

Risk Assessment - Important Takeaways IC Risk Assessment is an ongoing, continual process

Must include: Identification of risks of transmitting infection

Goals based on Risk Assessment results

Development and implementation of IPC plan

Evaluation of IP plan effectiveness annually, and when risks change

Risk Assessment includes all stakeholders Directors

Managers/supervisors, and

Front line staff of multiple departments



TJC BoosterPakTM

Sterilization - Important Things to Know

All locations where:• Sterilization and HLD is conducted,

• Reprocessed instruments and equipment are kept, and

• IFUs are located (accessible to front-line staff)

Initial and on-going competency and training is documentedWhich published guidelines/standards have been selected and

where are they located


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TJC BoosterPakTM

Sterilization - Important Things to Know, con’t

Policies and Procedures are: current,

reflect evidence-based guidelines, and

staff have knowledge and access to these documents

Policy and Procedure development includes key stakeholders: SP manager and front-line staff,

OR manager and front-line staff,

IPC,

Environmental Services,

Facilities/ENG,

Leadership, etc.



TJC BoosterPakTM

Sterilization - Important Takeaways

Know and understand Spaulding Classification

Regardless of your position, learn all steps in sterilization process from point-of-use to sterile storage,

Understand IUSS and the criteria for it’s usage



TJC BoosterPakTM

Environment of Care - Important Takeaways

EC.02.04.03, EP4: must identify, monitor, and document all sterilizers for cleaning, maintenance and repairs Includes de-centralized (off-site or table-top sterilizers)

Adhere to IFUs

EC.02.05.01, EP15: Understand how to reduce airborne contaminates Essential roll in minimizing spread of contaminates and infection

Comply with specified filtration, room pressurization, air exchange rates, temp. ranges, and relative humidity ranges Which controlling authority are adopted - usually state or licensing entity


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TJC BoosterPakTM

Environment of Care - Important Things to Know

• How you monitor temperature and humidity in all sterile storage locations, or

• Develop a convincing risk assessment why you are not monitoring. Gaps in documentation, and

Efforts to control out of range

• Air pressure relationships Staff have a tool to assess negative or positive pressure


Air Flow Detection Tools


TJC BoosterPakTM

High-Level Disinfection - Important Things to Know

Where all scopes, probes, and devices requiring HLD are located

Initial and on-going competencies

Location and accessibility of: IFU (equipment, devices, and supplies)

Current HLD evidence-based guidelines – available to front-line staff use

HLD policies and procedures are current

Include key stakeholders in HLD process IP, EVS, Eng, leadership, front-line staff, management


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TJC BoosterPakTM

High-Level Disinfection - Important Takeaways

Know and follow Spaulding’s Classification

Dirty scope transportation to decontamination area Leak proof,

Puncture resistant container/device, and

Labeled as biohazardous

Always change cleaning solution after each scope. Always measure chemicals accurately, don’t approximate (solution

dilution)http://www.jointcommission.org/standards_booster_paks/


TJC BoosterPakTM

HR-Competency and Training - Important TakeawaysHLD and sterilization require competency:

front-line staff, and

those responsible for its oversight

Documented records of training and competency trained initially and on ongoing basis

Ensure sterilization and HLD follow: device manufacturer IFU, and

evidence-based guidelines



CMS Surveyor Worksheets

• Focus on patient safety and reducing Healthcare Acquired Infections (HAI) Infection Control Worksheet Module 1: Infection Control/Prevention Program Module 2: General Infection Control Elements Module 3: Equipment Reprocessing Module 4: Patient Tracers Module 5: Special Care Environments

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf

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CMS Pre-Decisional Surveyor Worksheet

Module 1: Infection Control/Prevention Program

“1. A.5 The Infection Control Officer(s) (ICO)can provide evidence that the hospital has developed general infection control policies and procedures that are based on internal organizational assessment, nationally recognized guidelines and applicable state and federal law.”

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf


CMS – Infections and ERCP Scopes April 3, 2015

• Looking for compliance with CDC and FDA advice

• Opening conference ask if duodenoscopes are used Ask for copy of MFG IFU

Surveyor must observe endoscope being processed• Strictly and meticulously follow MFG IFU

• Adhere to nationally recognized guidelines

• ADVICE: Rewrite polices and redo competency validation

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-32.pdf


Centers for Medicare and Medicaid Services

September 4, 2009 - CMS released a memo to state survey agency directors regarding sterilization practices.

“If manufacturers’ instructions are not followed, then the outcome of the sterilizer cycle is guesswork, and the ASC’s practices should be cited as a violation of 42 CFR 416.44(b)(5).” (CMS, 2009)

http://www.ascquality.org/Library/sterilizationhighleveldisinfectiontoolkit/CMS%20Flash%20Sterilization%20Memorandum.pdf

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Change in IUSS TerminologyMemo Aug. 2014

• IUSS not a substitute for maintaining a sufficient inventory of instruments.

• Survey procedure• IUSS used in a manner that places patients at risk? • No to any survey question = Automatic Infection Control Citation

• IUSS Position statement

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-44.pdf -accessed 12/21/2014


http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf


Polling Question

Was IUSS addressed by the surveyor during your last accreditation survey?

A. Yes

B. No

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© 3M 2016. All Rights Reserved© 3M 2016. All Rights Reserved 49

Describe key published standards and recommended practices for

safe and effective reprocessing of reusable devices


AAMI Standards• AAMI ST79 Comprehensive guide to steam sterilization and

sterility assurance in health care facilities ANSI/AAMI ST79:2010& A1:2010 &A2:2011 & A3:2012 &A4:2013

• AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities

• AAMI ST41:2008 (R2012) Ethylene oxide sterilization in health care facilities: safety and effectiveness

• AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities


AORN Guidelines – Evidence Based

• Guidelines for Perioperative Practices, 2016

• Guidelines and Tools for Sterile Processing• 8 guidelines related to reprocessing

• Competency verification tools,

• Customizable templates for: • Policy and procedures

• Job descriptions

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CDC Guideline for Decontamination and Sterilization - 2008

http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf


CDC - Guide to Infection Prevention for OUTPATIENT SETTINGS - July 2011

http://www.cdc.gov/HAI/settings/outpatient/outpatient-care-guidelines.html

• Every outpatient setting must have individual with training as an Infection Preventionist (IP)Regularly available to the facility

Involved in the development of policies based on:• regulations,

• evidence-based guidelines, and

• national published standards.


Unacceptable Excuses for Not Following Standards/Guidelines

Didn’t know about the standards/guidelines Standards/guidelines not available to staffAvailable but not current/up-to-dateNo one designed as subject matter expert Personnel are not trained on standards/guidelines etc. Not enough personnel and/or timeNecessary equipment and tools not available

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55

Explain how healthcare facilities can prepare for an accreditation survey


Preparing for a Processing Audit• Accreditation Documents

• Relevant Professional Standards and Recommended Practices

• Accreditation Preparation Committee

Representatives should include: Sterile processing,

Operating room,

Infection prevention and control,

Clinical/biomedical engineering,

Endoscopy,

Risk management,

Quality,

Safety,

Education,

Environmental services

Administration, and

Materials management, etc.


Surveys Preparation

Self assessment Subject Matter Experts

• Verify that each element of performance (EP) in each standard is addressed

Front line staff involvement• Cite the EP (not just the standard)

• Describe how that expectation is met

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Accreditation Preparation Resource Sterile Processing In Healthcare Facilities:

Preparing for Accreditation Surveys 2nd Ed. Hospitals

Ambulatory Care

Office-Based Surgery Practice

Professional guidelines AORN, AAMI, SGNA, CDC

Current Accreditation standards CMS, TJC, AAAASF

http://www.aami.org/publications/books/sphc.htmlSeavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014


CrosswalkTJC Standards linked to current AAMI ST79

Crosswalk

http://www.aami.org/publications/books/sphc.htmlSeavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014


TJC – Design Considerations

• EC.01.01.01: The hospital plans activities to minimize risks in the environment of care.

• EC.02.02.01: The hospital manages risks related to hazardous materials and waste.

• EC.02.04.01: The hospital manages medical equipment risks.

• IC.02.02.01: The organization reduces the risk of infections associated with medical equipment, devices, and supplies.

• LD.03.01.01: Leaders create and maintain a culture of safety and quality throughout the organization.

• LD.03.03.01: Leaders use hospital-wide planning to establish structures and processes that focus on safety and quality.

• LD.04.01.07: The organization has policies and procedures that guide and support patient care, treatment, or services.

• LD.04.01.11: The hospital makes space and equipment available as needed for the provision of care, treatment, and services.

• LD.04.04.07: The hospital considers clinical practice guidelines when designing or improving processes

Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. AAMI 2014. ANNEX G

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ST79 Relative to TJC Design Considerations • Functional workflow patterns (3.2.3)

• Traffic control (3.2.4)

• Electrical systems (3.3.3)

• Steam for sterile processing (3.3.4)

• Steam quality (3.3.4.2)

• Steam purity (3.3.4.3)

• Utility monitoring and alarm systems (3.3.5)

• General area requirements (3.3.6)

• Ventilation (3.3.6.4)

• Temperature (3.3.6.5)

• Humidity (3.3.6.6)

• Special area requirements and restrictions (3.3.7)

• Decontamination area (3.3.7.1)

• Preparation area (3.3.7.2)

• Sterile storage (3.3.7.4)

• Break-out area (3.3.7.8)

• Emergency eyewash/shower equipment (3.3.8)

• Housekeeping (3.4)

Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014. ANNEX G


Quality Process ImprovementAddress and reduce risks Objective is to:

• proactively identify risks, and

• reduce the likelihood of a process failure

Risk Reduction Tools Root Cause Analysis

Failure Modes and Effects Analysis (FMEA)

Tracers

Risk Assessment is your best friend in survey Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. AAMI 2014.


Common High-Risk Areas• IUSS

• P&Ps not standardized

• Loaner instrumentation

• Torn wrappers

• No IFUs

• Sets weighing more than 25 pounds

• Sterilization process failures

• Inefficient staff orientation

• No standardization

• Lack of competency documentation, etc.

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Risky business: Risk analysis in CSSD, written by Sue Klacik

Published in Healthcare Purchasing News in August2010

http://www.hpnonline.com/ce/pdfs/1008cetest.pdf

Are You Taking Risks When Cleaning Reusable Medical Devices?written by Martha Young, BS, MS, CSPDTJanuary, 2013 In-service article archived at http://www.3m.com/sterileu

Risk Analysis of the Sterilization Process Articles


It’s Survey Time! Summary• Know accreditation standards• Ensure staff are competent and it

is documented• Write policies referenced to

published standards/guidelines • Involve the multidisciplinary team

in risk assessment and policy development

• Follow all IFUs • Conduct ongoing assessments in

all areas


The Final Word… Risk reduction and process improvement

are the heart and soul of surveys.

Thank you

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Questions?


References • Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2016

• ST79 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013

• http://www.jointcommission.org/standards_booster_paks/• Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in

Healthcare Facilities: Preparing for Accreditation Surveys. 2014.

• Eiland, John E, Surveyor, The Joint Commission. Joint Commission presentation at IAHCSMM annual meeting in May 2013. Presentation available on flash drive provided to attendees.

• TJC High-Level Disinfection (HLD) and Sterilization BoosterPakTM Dec. 2015

• CMS Director of Survey and Certification Group memo to State Survey Directors on Flash Sterilization Clarification-FY 2010 Ambulatory Surgical Center (ASC) surveys, September 4, 2009. Accessed 7/8/2012 at: http://www.cms.gov/SurveyCertificationGenInfo/downloads/SCLetter09_55.pdf