REPROCESSING ACCREDITATION SURVEY AUDITS

SHC REPROCESSING ACCREDITATION SURVEY AUDITS 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. Rose Seavey MBA, BS, RN CNOR, CRCST, CSPDT SEAVEY HEALTHCARE CONSULTING STERILE PROCESSING SURGICAL SERVICES. Established in 2003 3 4 Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys 2 nd Ed. 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 Risk Reduction and Process Improvement are the Heart and Soul of Accreditation Surveys Current professional guidelines (e.g. AAMI, AORN, SGNA, CDC) 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 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 5 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) 6 Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014. Policy and Requirements for an Application for Deeming Authority. Accessed 7/12/2012 at: http://www.cms.gov/medicare/provider- EnrollmentandCertification/SurveyCertificationGenInfo/downloads//applicationrequirements.pdf 1

7 8 TJC Survey Process 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 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. 9 10 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) 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 Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. 2014. TJC Focus on Reprocessing 11 TJC Second Generation Tracer - 2012 Cleaning, Disinfection & Sterilization (CDS) 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. 2

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 The Joint Commission. High-level Disinfection and Sterilization: Know Your Practice. Feb. 2014; 34(2):9-13 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) The Joint Commission. High-level Disinfection and Sterilization: Know Your Practice. Feb. 2014; 34(2):9-13 14 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 nonstandardized 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) 15 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 16 3. Discharge Planning Worksheet The Joint Commission. High-level Disinfection and Sterilization: Know Your Practice. Feb. 2014; 34(2):9-13 https://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf 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) 17 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. The Joint Commission. 2014 Hospital Accreditation Standards (HAS) 18 3

Preparing for a Processing Audit 19 Surveys Preparation 20 Accreditation Documents Relevant Professional Standards and Recommended Practices Accreditation Preparation Committee 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. 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 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). 21 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. 22 The Joint Commission. 2014 Hospital Accreditation Standards (HAS) https://www.cms.gov/medicare/provider-enrollment-and- Certification/SurveyCertificationGenInfo/downloads/SCLetter12_01.pdf Standards & Guidelines 23 Disinfection and Sterilization Standards, Recommendations and Evidence-Based Guidelines AORN Perioperative Standards and Recommended Practices, 2014 24 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 4

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 Not because it is a TJC or CMS standard! 26 27 28 The Joint Commission (TJC) Quality Process Improvement 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 annually and whenever significant changes occur with input from, at a minimum, infection control personnel, medical staff, nursing, and leadership. 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 Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys. AAMI 2014. IUSS Common High-Risk Areas 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 29 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 30 5

Crosswalk 2014 TJC Standards Linked to Current AAMI ST79 Crosswalk 31 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 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 34 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 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.??? Impact on surgery schedule 6

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 should be sterilized in perforated or wire-meshbottom 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 should be in the open or unlocked position with ratchets not engaged... Racks, pins, stringers, or other specifically designed devices can be used to hold the instruments in the open position. Recommended Practice Wording Should - certain course of action is preferred but not required May - indicates that a course of action is permissible Can - statement of possibility and capability Must - used only to describe unavoidable situations including those mandated by government regulations (e.g.osha). What does AORN Say? Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment XII.c. Instruments with hinges should be opened and 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 ST79 a consensus document 7

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 Decontam Stringers Various types of stingers available used to hold instruments open for efficient cleaning. AORN Manager of RPs (Ramona Conner) Cleaning and Care of Surgical Instruments and Powered Equipment revision in process Another interpretation? CMS surveyor CA Peel packs for single item only! Figure 8 Example of single- and double-packaging with paper plastic pouches Air flow documentation Documentation a Hot Button 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. Goggles worn while using automated scope washers? Surveyor Questions Dating laryngoscope 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? 8

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? AAMI ST79: 2010 Shelf Life Section 8.9.3: The shelf life of a packaged sterile item is eventrelated and 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 With a Surveyor NEVER EVER 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 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) Be rude or disrespectful NEVER EVER 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 When the idea is particularly idiotic and they have NO EVIDENCE or standard.. 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 9

Houston, we are the problem (Administration just wouldn t listen) 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 Administration and Budgets and Patient Safety 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 Survey Survival 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. If a surveyor is insane 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 Never claim perfection!!!!! 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 Other survey hints 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) 10

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 61 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 62 The Final Word Risk reduction and process improvement are the heart and soul of surveys. Thank you 11