12/02/2016. It's Survey Time! Preparing for TJC or CMS Accreditation Survey. Welcome! House Keeping. From the GoToWebinar page:

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1 SM 3M Health Care Academy It's Survey Time! Preparing for TJC or CMS Accreditation Survey February 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: 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. 3 1

2 House Keeping Continuing Education Each 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 Post webinar Link to Course Evaluation CE Certificate Included Forward to Others in Attendance 4 Disclosure Rose Seavey President/CEO of Seavey Healthcare Consulting, LLC Educational Consultant for 3M 5 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 6 2

3 SM 12/02/2016 Polling Question In the last six months, have you had an accreditation survey in the following departments: A. Only Central Sterile Supply Department B. Only Endoscopy Reprocessing Department C. Both Departments D. Neither Department Discuss rationale and focus of a healthcare accreditation survey process 8 Risk Reduction and Process Improvement are Risk reduction the Heart and and Soul process of Accreditation improvement Surveys are the heart and soul of accreditation surveys 3

4 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 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 4

5 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 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) POLLING QUESTION Which area represents the biggest challenge for you when preparing for a survey? A. Staff Training B. Record Keeping C. IFUs (Maintaining and Following) D. Equipment Failure SOPs E. Standardized Processes 5

6 TJC High-Level Disinfection (HLD) and Sterilization BoosterPak TM - Dec Highlights the requirements and the potential flaws, and Provides reference and training links. Resource for: Hospitals Ambulatory services, Office-based surgery practices TJC BoosterPak TM 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 Extranet 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 6

7 SM 12/02/2016 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 hours C. 3-4 hours D. More than 4 hours E. They did not come to SP Discuss the latest requirements from TJC and CMS relating to reprocessing of medical devices survey 20 Accreditation Standards Standards Performance objectives Standards relating to reprocessing Environment of Care (EC) Human Resources (HR) Infection Prevention and Control (IC) Leadership (LD) Performance Improvement (PI) Rationales Describe 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

8 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 EP 1) 2. Orientation, training, and competency not conducted by personnel trained on recent EBG (IC ) 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 ) 5. Recordkeeping - incomprehensible or non-standardized logs (IC 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 8

9 TJC Personnel Considerations HR : 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 Hospital Accreditation Standards (HAS) Leadership Standards and EPs LD : 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 Hospital Accreditation Standards (HAS) Most Frequently Scored Standards 56% EC Safe 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 Risks with Utility Systems 52% IC Reduce Risk of Infection 36% EC Manage Risks Related to Hazardous Materials Positive vs. Negative airflow Staff know what it is and what they can do to maintain appropriate pressure Cite any deviation from perfect compliance More places performing sterilization or HLD the more risks you have AAMI ST Eyewash in Immediate Area Plumbed Inspection and documentation weekly Evaluate new products Patton Healthcare Consulting Newsletter, April

10 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 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 TJC: High-Level Disinfection (HLD) and Sterilization BoosterPak TM Hospitals, Ambulatory services, and Office-based surgery IC % 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 10

11 TJC BoosterPak TM Leadership - Important Takeaways Citings for Std. IC 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 BoosterPak TM 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 BoosterPak TM 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 documented Which published guidelines/standards have been selected and where are they located 11

12 TJC BoosterPak TM 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. 34 TJC BoosterPak TM Sterilization - Important Takeaways Know and understand Spaulding Classification Regardless of your position, learn all steps in sterilization process from pointof-use to sterile storage, Understand IUSS and the criteria for it s usage TJC BoosterPak TM Environment of Care - Important Takeaways EC , 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 , 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 12

13 TJC BoosterPak TM 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 BoosterPak TM 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 13

14 TJC BoosterPak TM 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) TJC BoosterPak TM HR-Competency and Training - Important Takeaways HLD 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 14

15 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. 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 Centers for Medicare and Medicaid Services September 4, 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 (b)(5). (CMS, 2009) 15

16 Change in IUSS Terminology Memo Aug 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 - accessed 12/21/ Polling Question Was IUSS addressed by the surveyor during your last accreditation survey? A. Yes B. No 16

17 Describe key published standards and recommended practices for safe and effective reprocessing of reusable devices 49 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 50 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 17

18 CDC Guideline for Decontamination and Sterilization CDC - Guide to Infection Prevention for OUTPATIENT SETTINGS - July 2011 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. /outpatient-care-guidelines.html Unacceptable Excuses for Not Following Standards/Guidelines Didn t know about the standards/guidelines Standards/guidelines not available to staff Available but not current/up-to-date No one designed as subject matter expert Personnel are not trained on standards/guidelines etc. Not enough personnel and/or time Necessary equipment and tools not available 18

19 SM 12/02/2016 Explain how healthcare facilities can prepare for an accreditation survey 55 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 19

20 Accreditation Preparation Resource Sterile Processing In Healthcare Facilities: Preparing for Accreditation Surveys 2 nd Ed. Hospitals Ambulatory Care Office-Based Surgery Practice Professional guidelines AORN, AAMI, SGNA, CDC Current Accreditation standards CMS, TJC, AAAASF Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys Crosswalk TJC Standards linked to current AAMI ST79 Crosswalk Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys TJC Design Considerations EC : The hospital plans activities to minimize risks in the environment of care. EC : The hospital manages risks related to hazardous materials and waste. EC : The hospital manages medical equipment risks. IC : The organization reduces the risk of infections associated with medical equipment, devices, and supplies. LD : Leaders create and maintain a culture of safety and quality throughout the organization. LD : Leaders use hospital-wide planning to establish structures and processes that focus on safety and quality. LD : The organization has policies and procedures that guide and support patient care, treatment, or services. LD : The hospital makes space and equipment available as needed for the provision of care, treatment, and services. LD : 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 ANNEX G 20

21 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 ( ) Steam purity ( ) Utility monitoring and alarm systems (3.3.5) General area requirements (3.3.6) Ventilation ( ) Temperature ( ) Humidity ( ) Special area requirements and restrictions (3.3.7) Decontamination area ( ) Preparation area ( ) Sterile storage ( ) Break-out area ( ) 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 ANNEX G Quality Process Improvement Address 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 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. 21

22 Risk Analysis of the Sterilization Process Articles Risky business: Risk analysis in CSSD, written by Sue Klacik Published in Healthcare Purchasing News in August Are You Taking Risks When Cleaning Reusable Medical Devices? written by Martha Young, BS, MS, CSPDT January, 2013 In-service article archived at 64 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 22

23 Questions? 67 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 Seavey, R. Association for the Advancement of Medical Instrumentation. Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys Eiland, John E, Surveyor, The Joint Commission. Joint Commission presentation at IAHCSMM annual meeting in May Presentation available on flash drive provided to attendees. TJC High-Level Disinfection (HLD) and Sterilization BoosterPak TM Dec 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, Accessed 7/8/2012 at: 23