REPROCESSING
ACCREDITATION SURVEY AUDITS
Rose Seavey MBA, BS, RN CNOR, CRCST, CSPDT SHC ©
SEAVEYHEALTHCARECONSULTING®
STERILE PROCESSING SURGICAL SERVICES . Established in 2003
Objectives
1. Review the importance of healthcare organization accreditation.
2. Discuss the essential requirements in reprocessing according to accreditation standards.
3. Provide examples of non-conformances and observations identified during facility audits.
Sterile Processing in Healthcare Facilities:
Preparing for Accreditation Surveys
•2ndEd. 2014 : Up-to-date information:•Current accreditation standards (e.g. CMS, TJC, AAAASF) •CMS Pre-Decisional Survey Worksheet
•2014 National Patient Safety Goals •Hospitals
•Ambulatory Care
•Office-Based Surgery Practice
•Current professional guidelines
(e.g. AAMI, AORN, SGNA, CDC)
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http://www.aami.org/publications/books/sphc.html
Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014
Risk Reduction and Process
Improvement are the Heart
and Soul of Accreditation
Surveys
© 4
Accreditation Survey
•Improving the quality of healthcare
–Peer review
–Focus on safety, quality and process improvement •Condition of payment
–Private insurance companies
–Federal funding •Measures compliance
–Published recommended practices
–Accreditation standards and supporting documents
Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014.
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CMS
-Compliance with Medicare Conditions
•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)
Policy and Requirements for an Application for Deeming Authority. Accessed 7/12/2012 at:
http://www.cms.gov/Medicare/Provider-
Enrollment-andCertification/SurveyCertificationGenInfo/downloads//applicationrequirements.pdf
•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
•Between18-39 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 2012. Presentation available on flash drive provided to attendees.
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Joint Commission Resources
Nonprofit affiliate of TJC, publishes the official handbooks used in the TJC survey process
•Comprehensive Accreditation Manual for Hospitals: The Official Handbook (CAMH)
•Comprehensive Accreditation Manual for Ambulatory Care (CAMAC)
•2013 Comprehensive Accreditation Manual for Office-Based Surgery Practices (CAMOBS)
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Accreditation Standards
•Standards= performance objectives
•Rationales= describe importance
•Elements of performance (EPs) = meet goals
–Scores determine the compliance –Minimum score of 90% on every EP
•Standards relating to reprocessing
–Environment of Care –Human Resources –Infection Prevention and Control –Leadership
–Performance Improvement 10
Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014.
TJC Focus on Reprocessing
“…beginning in 2010, surveyors have spent additional time during survey evaluating the cleaning, disinfection and sterilization(CDS) processes”
•Surveyors received in-depth training on sterilization processes through AAMI
•Survey to ANSI/AAMI ST79 •ST79 Available to staff
http://www.jointcommission.org/assets/1/18/jconline_July_20_11.pdf
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.
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TJC
Second Generation
Tracer - 2012
TJC
High-level Disinfection and Sterilization:
Know Your Practice. 2013
•“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 13
The Joint Commission. High-level Disinfection and Sterilization: Know Your Practice. Feb. 2014; 34(2):9-13
Facilities Out of Compliance
1. Lack of having or using CURRENT evidence based guidelines (EBG) (IC.01.05.01 EP 1)
2. Orientation, Training and Competency (IC.02.02.01) Initial and ongoing
Complete and current documentation
Conducted by personnel COMPLETELY trained on RECENT EBG and instructions for use (IFU).
3. Lack of quality control Using nonvalidated conditions
(concentration, exposure times and temps)
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The Joint Commission. High-level Disinfection and Sterilization: Know Your Practice. Feb. 2014; 34(2):9-13
Facilities Out of Compliance
(con’t) 4. Lack of participation and collaboration (IC.0202.01)Supervisory or managerial oversight should have CURRENT education, training and experience
Work closely with IPC staff
5. Lapses in record keeping and “incomprehensible” or non-standardized logs (IC.0202.01 EP 2)
TRACEABLE path to the PATIENT and product identification in the event of a recall (AAMI ST79 section 10.3)
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The Joint Commission. High-level Disinfection and Sterilization: Know Your Practice. Feb. 2014; 34(2):9-13
CMS Draft Surveyor Worksheets
(2012-2013)•Focus on Pt. safety and reducing healthcare-acquired conditions
1. Quality Assessment and Performance Improvement Worksheet 2. 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
3. Discharge Planning Worksheet
https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf
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TJC Personnel Considerations
•HR.01.06.01:Staff are competent to perform their responsibilities
–EP 1. The hospital defines the competencies it requires of its staff who provide patient care, treatment, or services.
–EP 2. The hospital uses assessment methods to determine the individual’s competence in the skills being assessed.
•Note: Methods may include test taking, return demonstration, or the use of simulation.
–EP 3. An individual with the educational background, experience, or knowledge related to the skills being reviewed assesses competence.
The Joint Commission. 2014 Hospital Accreditation Standards (HAS)
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Leadership Standards and EPs
•LD.04.01.11:
The hospital 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.
•Need for sufficient space to adequately reprocess
–EP 5. The leaders provide for equipment, supplies, and other resources.
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Preparing for a Processing Audit
•Accreditation Documents
•Relevant Professional Standards and Recommended Practices
•Accreditation Preparation Committee
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Committee representatives should include:
•Sterile Processing, •Operating room, •Infection prevention and control, •Clinical/biomedical engineering, •Endoscopy, •Risk management, •Quality, •Safety, •Education, •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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TJC National Patient Safety Goals
Goal 7: Reduce Risk of HAIs
NPSG.07.05.01
•Implement evidence-based practices for preventing surgical site infections.
•“Implements policies and practices aimed at reducing the risk of HAIs. These policies and practices meet regulatory requirements and are aligned with evidence-based guidelines (for example, the Centers for Disease Control and Prevention [CDC] and/or professional organization guidelines).”
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The Joint Commission. 2014 Hospital Accreditation Standards (HAS)
CMS Pre-decisional Surveyor
Worksheet
•Module 1: Infection Control/Prevention Program
“1. A.3 The Infection Control Officer(s) can provide evidence that the hospital has developed general infection control policies and procedures that are based on nationally recognized guidelines
and applicable state and federal law.”
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https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf
Standards & Guidelines
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Disinfection and Sterilization Standards,
Recommendations and Evidence-Based
Guidelines
• AORN Perioperative Standards and RecommendedPractices, 2014
• 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
• CDC Guideline for Decontamination and Sterilization in Healthcare Facilities, 2008
No acceptable Excuses for Not Following
Standards or RPs
•Didn’t know about them •They were not available to staff •Available but not up-to-date
•No one designed as subject matter expert in RPs •Not enough personnel and time
•Personnel are not trained on RPs, etc. •Necessary equipment and tools not available
Processing P&P
•Polices and Procedures –Facility design and housekeeping,
–Personnel – qualifications, training and continuing education,
–Dress code - PPE,
–Sterilization monitoring,
–Receiving purchased or borrowed items,
–Loaner instrumentation (min. 24 hr lead time)
–Handling, collection, and transport of contaminated items,
–Assembly, package configurations and sterilization monitoring,
–Following manufacturer’s written IFU,
–Maintenance and repair of medical devices, etc.
•Reference to current published standards and RPs •Notbecause it is a TJC or CMS standard!
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The Joint Commission (TJC)
Standard IC.01.03.01
•“The hospital identifies risks for acquiring and transmitting infections.”
Element of Performance # 4
•“The hospital reviews and identifies its risks at least
annuallyand whenever significant changes occur with input from, at a minimum, infection control personnel, medical staff, nursing, and leadership.”
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Quality Process Improvement
•Addressing and reducing risks
•Objective is to proactively identify the risks to reduce the likelihood of a process failure.
•Risk Reduction Tools • Root Cause Analysis
• Failure Modes and Effects Analysis (FMEA) • Tracers
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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
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Risk Analysis of the
Sterilization Process
•Klacik, Sue. Risky business: Risk analysis in CSSD. HPN Aug 2010, available at: http://www.hpnonline.com/ce/pdfs/1008cetest.pdf
•Klacik, Sue. Worth the Risk, HealthVI.com, May 2011, available at: http://solutions.3m.com/wps/portal/3M/en_US/Sterilization/3MSterileU/ Home/InServiceArticles/?WT.svl=5
Crosswalk
2014 TJC Standards Linked to Current AAMI ST79 31
Crosswalk
TJC –
Design Considerations
•EC.01.01.01: The hospital plans activities to minimize risksin 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 riskof infections associated with medical equipment, devices, and supplies. •LD.03.01.01: Leaders create and maintain
a culture of safetyand 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 availableas need 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
ST 79 Relative to TJC Survey’s
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
Contains Multiple Preparation Tools
•Self audit tools,• Sterile Processing,
• IUSS, and
• High-level-disinfection
•Risk reduction tools •Root cause analysis,
•Failure modes and effects analysis,
•Tracer methodology
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Instruments Held Completely Open?
•3 facilities issued “IJ” (Immediate Jeopardy) by CMS“All instruments must be held completely open with no tips touching”. “Stringers are not adequate to hold completely open”.
Surveyor “Opinions” Cost Hospital
•
One faculty
(part of a large system) issued “IJ”•10 days to fix the problem
•Purchased approximately 230 clamps at $30 apiece ($6,900)
•Vendor questioned if the order was a mistake (8- 10 is normal)
•Pulled every peel pack, instruments sets etc. and reprocessed them.
•Cost – packaging, sterilization costs, labor etc. ???
Devices Used to Hold Open
What does AAMI ST79 say?
8.4 Preparation and assembly of surgical instrumentation 8.4.1 General considerations
... Instruments sets shouldbe sterilized in perforated or wire-mesh-bottom trays or in containment devices such as specially designed rigid organizing trays or rigid sterilization container systems, with all
instruments held open and unlocked.
What does AAMI ST79 say, con’t.?
8.4.4 Instrument placement•Instruments to be sterilized should be arranged according to the following guidelines:
c) All jointed instruments shouldbe in the open or unlocked position with ratchets not engaged...
Racks, pins, stringers, or other specifically designed devices canbe used to hold the instruments in the open position.
Recommended Practice Wording
•Should -certain course of action is preferredbut not required •May -indicates that a course of action is permissible •Can -statement of possibilityand capability
•Must -used only to describe “unavoidable” situations including those
mandatedby government regulations (e.g.OSHA).
What does AORN Say?
Recommended Practices for Cleaning and Care of Surgical Instruments and Powered EquipmentXII.c. Instruments with hinges should be openedand those with removable parts should be disassembled when placed in trays designed for sterilization, unless the manufacturer has provided validated instructions to the contrary.
State Department of Public Health
•CMS Health Facilities Evaluator Nurse from that State Department of Public Health (not the surveyor)
•“Until there is something in writing from either AAMI or AORN the surveyor’s interpretation stands and the facility
will be held to it.”
•Surgical Service Director asked AAMI to write a statement of clarification
Changes to AAMI and AORN
•AAMI Director of Standards (Susan Gillespie) •Only guidance standards
•No regulatory authority
•Described the Immediate Jeopardy citing to AAMI’ CMS contact
•No new directive from CMS HQ
•It’s only one surveyor's interpretation
•Want all faculties held to the same standard regardless of the surveyor
• AORN Manager of RPs (Ramona Conner) – “Cleaning and Care of Surgical Instruments and Powered Equipment” revision in process
Decontam Stringers
Various types of stingers available used to hold instruments open for efficient cleaning.
Another interpretation?
•CMS surveyor – CA •Peel packs for single item only!
Figure 8—Example of single- and double-packaging with paper–plastic pouches
Documentation a Hot Button
•Air flow documentation
•Daily temp and humidity logs
•Logs for LMA reprocessing
•Logs for phaco coaxial I/A tips limited usage
•Instrument set weight logs
•IUSS – how facility is decreasing (PI standards)
•Premature release forms for implants etc.
•Loaners
•Documentation standardized
•Documentation of failed loads
•Documenting the disinfection of brushes between uses (CMS)
Equipment Maintenance Logs
•TJC surveyor cited for not documenting when vaporizer plate on their hydrogen peroxide sterilizer was changed.
•User’s guide (IFU ) routine maintenance
•Every 30 days or 145 cycles, whichever come first.
•ST 79 section 9.7 Record-keeping
•A maintenance record, in either paper or electronic format, should be kept for each sterilizer.
Surveyor Questions
•Goggles worn while usingautomated scope washers?
• Datinglaryngoscope blades after HLD
•Packaged and stored to prevent recontamination (not touched with bare hands)
10.3.3 Expiration dating
•Each item in a load should be labeled with a control date for stock rotation and the following statement (or its equivalent): “Contents sterile unless package is opened or damaged. Please check before using.”
•OK for stock rotation, but necessary after HLD which are bagged to keep clean?
Looking for Shelf Life Dates
•Shelf life vs. event related
•Wrap – 1 year, 6 months, 30 days???
•FDA representative at AAMI ST79 meeting – “Testing data is not the same as IFU”
•IFU stated to continue to use facility policy of event related
•Peel packs – expiration date from MFR
•Expiration date - when the box of peel pack is opened?
Shelf Life
AAMI ST79: 2010•Section 8.9.3: “The shelf life of a packaged sterile item is event-relatedand depends on the quality of the packaging material, the storage conditions during transport, and the amount of handling…”
AORN Recommended Practices for Selection and Use of Packaging Systems for Sterilization:
•Recommendation VIII.1: “Sterilized packages should be considered sterile until an event occurs to compromise the package barrier integrity…”
•Defend a violation of your policy or an unsafe practice •To build credibility do not defend the indefensible ADMIT to the
issue and commit to FIXING it and NOT HAVING IT RECUR.
•Lie (hiding is alright)
•Volunteer an answer you don’t know •Tell them you will find out soon
With a Surveyor NEVER EVER
•Tell a surveyor they are wrong •Instead:
•Tell them you haven’t remembered seeing that in the standard and you’ll need to take that REGULATION TO YOUR COMMITTEE to make that policy change so may you PLEASE HAVE IT.
•You didn’t know that and had just been following the COMMUNITY STANDARD and will NEED THE REGULATION to share with your peers at the other facilities.
•You hadn’t interpreted the standard to mean that but thought it meant this. (especially effective if you think the surveyor is testing your knowledge)
Never EVER
•Be rude or disrespectful
•Ask them why they are asking something •Contradict something in your minutes
•Suggest you have known of an issue for a prolonged time and done nothing or stopped trying
•Interrupt
•Disparage a standard or regulation
•Sometimes they know its stupid and are only following orders
NEVER EVER
•Don’t volunteer to change practice (if they HAVE NO STANDARD or evidence, obviously if they do, you will) •Tell them you see their point but politely and gently suggest
you won’t don’t think you will be able to get it through the committee without more evidence
•Tell them that is an amazing insight and you’ll take it to committee to discuss
When the idea is particularly idiotic and they have
NO EVIDENCE or standard………..
•Document, document, document. Emails not conversations. Minutes not discussions.
•Offer several solutions, not just one solution to administration
•Your authority statement for especially dangerous situations (unsafe sterilization or disinfection practices)
•Make sure administration is there at the meeting with the surveyors
Houston, we are the problem
(Administration just wouldn’t listen)
•Tell administration it is a PATIENT SAFETY and SURVEY ISSUE in writing and ask for a response back.
•If the response back to you is verbal EMAIL A SYNOPSIS of your understanding of the conversation back to them
•Keep good documentation of everyone you shared the issue with and all your interventions
Administration and Budgets and Patient Safety
•Give them a yes answer (if you can), but maybe not to the question they asked.
•e.g. “Have you eliminated vendor trays from getting dropped off within two hours of surgery forcing you to flash sterilize”
•FACTS: You made a lot of strides on this a few years back but for the last two years have been stuck at 87% of trays getting to the facility 24 hours or greater in advance.
•Statement: ”We have made it so the VENDORS KNOW BETTER
than to do that. We have WRITTEN IN OUR CONTRACTS that they don’t get paid for the tray if we don’t have it 24 hours in advance (true). So you know the VENDORS ARE AS MOTIVATED as us to have those trays to us 24 hours ahead of time.”
Survey Survival
•Document the event discuss with administration BEFORE THE SURVEYOR LEAVES (Once a surveyor leaves regulatory bodies will not usually reverse an issue)
•Accrediting bodies frequently reverse decisions of surveyors when more evidence is supplied
•Apologize for escalating if you did
•Keep difficult people away from surveyors if possible and appropriate or ask them if they’ll be Ok with the surveyor
If a surveyor is insane
•TJC will cite you if you claim 100% sterilization documentation compliance and they see violations
•More willing to ignore if you say you are working on it
Never claim perfection!!!!!
•Know every document you give them
•Know everyone they spoke with and what they said •Share this with other staff
•Know what questions are being asked •Share this with staff
•Know where your deficiencies are and fix if possible before they leave (more effective with accrediting bodies)
References
•Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014.
•The Joint Commission. Updated: The Joint Commission’s position on steam sterilization. Joint Commission Perspectives. July 2009:29(7):8. Accessed 7/8/2012 at:
http://www.jointcommission. org/joint_commission_online_july_20_2011/
•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 •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.
•Kuhny, Louise. The Joint Commission Standards and Survey Process. AORN webinar 9/22/2011. To order access at:
http://www.aorn.com/Secondary.aspx?id=21189&terms=Webinars#axzz20596Ipvv
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References
•Office of Clinical Standards & Quality/Survey & Certification to State Survey Agency Directors on CMS Survey & Certification Focus on Patient Safety and Quality-Draft surveyor Worksheets, Oct 14, 2011. Accessed 7/8/2012 at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf
•Office of Clinical Standards & Quality/Survey & Certification to State Survey Agency Directors on Patient Safety Initiative Pilot Phase-Revised Draft Surveyor Worksheets on May 18, 2011. Accessed 7/8/2012 at: http://www.apic.org/Resource_/TinyMce
•Policy and Requirements for an Application for Deeming Authority. Accessed 7/12/2012 at:
http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads//applicationrequirements.pdf •Immediate-Use Steam Sterilization. Accessed 7/8/2012 at:
http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf
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The Final Word…
Risk reduction and process improvement
are the heart and soul of surveys.