26/04/2016. Welcome! House Keeping. From the GoToWebinar page:

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1 SM 3M Health Care Academy What you need to know Preparing for a Survey of Sterile Processing in the Ambulatory Surgery Environment April 27, M All Rights Reserved Welcome! Topic: What you need to know Preparing for a Survey of Sterile Processing in the Ambulatory Surgery Environment Facilitator: Bethany Swick, 3M Sandra Velte, 3M Speaker: Jacqueline Daley, HBSc, MLT, CIC, CSPDS For more information: 3M All Rights Reserved 2 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. 3M All Rights Reserved 3 1

2 House Keeping Continuing Education Each 1 hour web meeting is approved by IAHCSMM, CBSPD and is 3M Health Care Provider approved by the California Board of Registered Nurses CEP 5770 for one contact hour. Post webinar Link to Course Evaluation CS Tech CE Certificate Included Forward to others in attendance 3M All Rights Reserved 4 Disclosure Jacqueline Daley, HBSc, MLT, CIC, CSPDS Manager Infection Prevention, Clinical Epidemiology and Vascular Access Service Sharp Metropolitan Medical Center Educational Consultant 3M Sage Products Halyard Health Advisory Panel 3M All Rights Reserved 5 Learning Objectives 1. Identify sterile processing standards and guidelines relevant to the ambulatory surgery setting. 2. Describe best practices for instrument processing in the ambulatory surgery setting. 3. List 3 key areas of focus in preparation for a survey 3M All Rights Reserved 6 2

3 Why Accreditation? Requirement for reimbursement Opportunity to evaluate practice Impetus for change/improvement in practice 3M All Rights Reserved 7 Polling Question At your last accreditation survey, how many infection control recommendations for improvement (RFI) did you receive? 3M All Rights Reserved 8 CMS Approved Medicare Accrediting Organizations (AO) Accreditation Association for Ambulatory Health Care (AAAHC) Accreditation Commission for Health Care, Inc. (ACHC) American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) American Osteopathic Association healthcare Facilities Accreditation Program (AOA/HFAP) Community Health Accreditation Program (CHAP) Center for Improvement in Healthcare (CIHQ) DNV GL Healthcare (DNV GL) The Compliance Team (TCT) The Joint Commission (JC) Comprehensive Accreditation Manual for Ambulatory Care (CAMAC) National Patient Safety Goals (NPSG) Ambulatory Care Accreditation Survey Activity Guide For Health Care Organizations M All Rights Reserved 9 3

4 CMS Conditions Of Participation (COP) Condition for Coverage: Governing Body and Management The ASC must have a governing body that assumes full legal responsibility for determining, implementing, and monitoring policies governing the ASC s total operation. The governing body has oversight and accountability for the quality assessment and performance improvement program, ensures that the facility policies and programs are administered so as to provide quality healthcare in a safe environment, and develops and maintains a disaster preparedness plan. 3M All Rights Reserved 10 CMS Conditions Of Participation (COP) cont d (c) Standard: Disaster Preparedness Plan The ASC must maintain a written disaster preparedness plan that provides for the emergency care of patients, staff and others in the facility in the event of fire, natural disaster, functional failure of equipment, or other unexpected events or circumstances that are likely to threaten the health and safety of those in the ASC. The ASC coordinates the plan with State and local authorities, as appropriate. The ASC conducts drills, at least annually, to test the plan s effectiveness. The ASC must complete a written evaluation of each drill and promptly implement any corrections to the plan. 3M All Rights Reserved 11 CMS Conditions Of Participation (COP) cont d (a)(3) and , concerning infection control, for example: The conformance to aseptic and, when applicable, sterile technique by all individuals in the surgical area; That there is appropriate cleaning between surgical cases and appropriate terminal cleaning applied; That operating room attire is suitable for the kind of surgical case performed; That equipment is available for rapid emergency high-level disinfection or, as applicable, sterilization of operating room materials 3M All Rights Reserved 12 4

5 CMS Conditions Of Participation (COP) cont d That sterilized materials are packaged, handled, labeled, and stored in a manner that ensures sterility e.g., in a moisture- and dust-controlled environment, and policies and procedures for expiration dates have been developed and are followed in accordance with accepted standards of practice. That, as applicable, temperature and humidity are monitored and maintained within accepted standards of practice; and (c) & (d), concerning emergency equipment and personnel for example: That surgical staff are trained in the use of emergency equipment. 3M All Rights Reserved 13 First Steps Consider purchase of: Seavey R. Sterile processing in health care facilities: Preparing for accreditation surveys 2 nd edition. AAMI. Arlington VA Summarizes the standards and associated documents related to the processing of reusable medical devices Contains valuable tools for preparing for accreditation surveys and maintaining compliance with accreditation requirements as they relate to sterile processing 3M All Rights Reserved 14 First Steps Identify the accrediting agency Obtain the accreditation manual from the agency Prepare to develop mock survey process Interdisciplinary team OR, SPD, Infection Preventionist, Educator Obtain relevant standards, guidelines - CURRENT AORN, AAMI, ASGE, SGNA Download CMS Ambulatory Surgery Surveyor Worksheet State Operations Manual may be of help 3M All Rights Reserved 15 5

6 Relevant Standards and Guidelines Association of perioperative Registered Nurses (AORN) Guidelines for Perioperative Practice CDC/HICPAC Guidelines for: Disinfection and Sterilization in Healthcare Facilities Hand Hygiene in Healthcare Settings Prevention of Surgical Site Infections Isolation Precautions Environmental Infection Control in Healthcare Facilities Other specialty surgical society/organization American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Registered Nurses. Recommended practices for cleaning and sterilizing intraocular surgical instruments. J Cataract Refract Surg, 23: , June M All Rights Reserved 16 Relevant Standards and Guidelines cont d Association for the Advancement of Medical Instrumentation (AAMI) ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, 2nd edition (Incorporates Amendment 1:2010, A2,2011, A3:2012, and A4:2013) ST58 Chemical sterilization and high-level disinfection in health care facilities, 3rd edition ST40 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities, 2nd edition TIR34 Water for the reprocessing of medical devices ST81 Information to be provided by the manufacturer for the processing of resterilizable medical devices, 1st edition 3M All Rights Reserved 17 Relevant Standards and Guidelines cont d Endoscopy Guidelines American Society of Gastrointestinal Endoscopy (ASGE) Multisociety Guideline on Reprocessing Flexible Gastrointestinal endoscopes Society of Gastroenterology Nurses and Associates, Inc (SGNA) Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes Association for the Advancement of Medical Instrumentation (AAMI). Flexible and semi-rigid endoscope processing in health care facilities M All Rights Reserved 18 ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities. Arlington, VA. 6

7 How will compliance be determined? Explicit infection control program Designated qualified professional to oversee the program Use of nationally recognized infection control guidelines Written policies and procedures Infection prevention and control Safe injection practices Single use devices, sterilization and high-level disinfection Environmental hygiene Staff training and proper documentation 3M All Rights Reserved 19 How will compliance be determined? Will visit areas where processing is performed - mandate Conversation/discussion with staff who process Staff more often than management Use the tracer process Track care for surgical patient from admission to discharge including surgery Follow an instrument set from the time it is used in surgery/procedure until the time it is ready to be used once more May ask to see instructions for use (IFU) for a device being processed Can judge compliance by comparing practice to instructions 3M All Rights Reserved 20 The Joint Commission Perspective April 2016 Volume 36 Number 4 3M All Rights Reserved 21 7

8 SM 26/04/2016 The Joint Commission Perspective April 2016 Volume 36 Number 4 3M All Rights Reserved 22 Conducting Tracers 3M All Rights Reserved 23 Tracer Methodology Individual or system or program Used to improve safety, care, services, etc. Engage frontline staff, not management Identify infection prevention and control issues Follow experience of the patient Follow instrumentation from use, processing to storage and back to point of use 3M All Rights Reserved 24 8

9 Conducting a Tracer Review incidents, adverse events, identified issues/problems Have they been addressed? Consider posting related quality improvement issues Network to find out what experiences others have had Professional organization Web based list serve, discussion, postings AORN specialty assembly, Linkedin 3M All Rights Reserved 25 Conducting a Tracer Use standards, guidelines, recommended practices to assist with tracers Use a management and education tool to identify issues to be addressed Engage staff and management Conduct at times where vulnerabilities may be at its highest Can be unannounced Record findings, opportunities for improvement and provide feedback 3M All Rights Reserved 26 Audit checklist should include: Staff training and competency PPE even to clean one instrument What to do when discrepancy between disinfectant and AER Disinfectant temp and contact time Room temperature / humidity Appropriate workflow / airflow Endoscope tracked to patient and procedure AER maintenance Brushes for all sized lumens CI, BI use in packages and for efficacy testing Sterilizer and other maintenance logs 3M All Rights Reserved 27 9

10 Audit checklist should include IUSS policy and procedure Sterilization failure policy and procedure No single use devices reprocessed policy as well as practice 3M All Rights Reserved 28 Audits Staff participation Rotate people who audit Audit routinely announced and unannounced Provide feedback Conducting Audits Staff participation Rotate people who audit Audit routinely announced and unannounced Provide feedback 3M All Rights Reserved 29 Polling Question Do you have an established tracer / audit process in place? 3M All Rights Reserved 30 10

11 SM 26/04/2016 Describe best practices for instrument processing in the ambulatory surgery setting 3M All Rights Reserved 31 According to the CDC In the United States, approximately 46.5 million surgical procedures and even more invasive medical procedures including approximately 5 million gastrointestinal endoscopies-are performed each year. 1 Surgical Site Infections are the most common adverse event for surgical patients. 1. Rutala, Weber and HICPAC. CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities, M All Rights Reserved CDC Health Alert Network (HAN) The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines. September 11, 2015, 12:15 EDT (12:15 PM EDT) CDCHAN M All Rights Reserved 33 11

12 Reprocessing - Ishikawa (Fishbone) Diagram Transportation to CSD Cleaning/ Decontamination Assembly/ Inspection/ Packaging Sterilization Product Recall Hand Hygiene Covered Cart Sorting Sharps Removed Items kept moist Dedicated lifts PPE Use Check locks, hinges, etc. Equipment maintenance Detergent Sterilization parameters Assembly Maintenance of Equipment Biological Indicator Lumens etc. Verification of Cleaning Proper Packaging Mechanical Monitors Presoak Chemical Bowie Dick Test Indicator Placement Disassembly Unloading sterilizer Loading Sterilizer Qualification Testing Record Keeping Recall procedures Recall order Recall report Prevent Infections Traffic control Work flow patterns Design criteria Physical facilities Product Testing Attire Regulation Case Cart CJD Hands on Training Sterilization Monitoring Restricted Tracking Access Competency Flash Sterilization Use of dust Flash Sterilization Continuing Education Receipt of new devices barriers Annual Retraining Occupational Health Extended Cycle Hire/orientation Review at Event related least annually Instrument Design outdating Department Design Qualification Loaner Standards & Guidelines Aseptic presentation Inspection of packaging And indicators before use Covered/Closed Containers Carts Quality control/process improvement Power Equipment Storage facilities Distribution Staff Education P&P Special Issues (FMEA) Sterile Storage Transportation to Point of use 3M All Rights Reserved Sterilization Risk Analysis Risk analysis = risk assessment + risk management + risk communication The sterilization risk analysis should be part of the overall infection prevention and control risk analysis in accordance with accreditation agency requirements. Risk assessment (Failure Modes and Effects Analysis (FMEA)) Risk management (ANSI/AAMI ST79, Root cause analysis) Risk communication (Recall procedure) It should be performed annually and should be reevaluated whenever significant changes occur. ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013, Section M All Rights Reserved 3M All Rights Reserved 12

13 SM 26/04/2016 Getting your material/documents in order is part of best practice! Documents Electronic or paper READILY ACCESSIBLE Guidelines - CURRENT Policies and Procedures CURRENT, DATED, SIGNED, and REFERENCED If policy or procedure differs from an IFU or guideline reference why Are they consistent all across the facility Accreditation Manual - CURRENT 3M All Rights Reserved 37 Getting your material/documents in order is part of best practice! Instructions for Use (IFU) Intense focus Organized How are they filed? Are they cross-referenced? Do they cover all equipment, instruments and supplies? Accessible If computerized staff must be able to work the program Complete Managed management assigned Process for currency Process for obtaining 3M All Rights Reserved 38 Environment of Care 3M All Rights Reserved 39 13

14 Environmental Cleaning 3M All Rights Reserved 40 Environmental Cleaning Intense focus Make sure your policy addresses instrument processing area Identify what, who, and when Identify quality monitoring procedures Rounds Commercial product to test (e.g., ATP) Procedure for documenting Storage space for cleaning supplies 3M All Rights Reserved 41 Facility Design Space constraints potential issues Work flow clean to dirty to clean Traffic control Storage clean, sterile HVAC Temperature, humidity, air flow 3M All Rights Reserved 42 14

15 HVAC Temperature, Humidity, Pressure Policies referenced Soiled work room temperature AAMI 60 o to 65 0 Humidity - AAMI 30% to 60%, AORN 20% - 60% Airflow patterns should not allow air contamination to enter clean areas Pressure direction of airflow (negative) Air exchange - AAMI 10 per hour; FGI 6 per hour When out of range Small variance, short time No significance Larger, longer variance - Critical thinking, multidisciplinary team decision ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013, Section , , AORN Guidelines for Perioperative Practices:2016, Guideline for Sterilization, Table 2 3M All Rights Reserved 43 HVAC Review IFU for all commercially prepared items for temp and humidity requirements Biological and chemical monitors Temp and humidity controlled cabinet 3M All Rights Reserved 44 Work Flow AORN When sterilization is performed within the surgical suite a sterile processing room shall have Separate clean and decontamination areas, which may be rooms or areas Decontamination and clean spaces that are separated by one of three methods a wall with a door or pass through a partial wall or partition at least 4 feet high and width of the counter, or What s wrong with this picture? a distance of 4 feet between instrument washing sink and area where instruments are prepared for sterilization AORN Guidelines for Perioperative Practice, AORN, Denver, CO M All Rights Reserved 45 15

16 SM 26/04/2016 Work Flow (separation of clean from contaminated) When same pathway must be used for clean/sterile and contaminated instruments and supplies Ensure that all contaminated supplies are contained (leak proof) and labeled Try to separate transport clean and contaminated by time Separate sink for instruments and for handwashing Use drop in sinks when additional sinks needed OSHA CFR Bloodborne Pathogens 3M All Rights Reserved 46 Manufacturer s Instructions 3M All Rights Reserved 47 Manufacturer s Instructions Follow instructions for use for detergents Concentration as per IFU Have thermometer monitor temp Have timer- monitor contact time Brushes for all lumen sizes NO YES YES 3M All Rights Reserved 48 16

17 SM 26/04/2016 Sterilization and Disinfection 3M All Rights Reserved 49 Sterilization Process Method of sterilization Steam Chemical Items pre-cleaned according to manufacturer s instructions or evidence-based guidelines Items inspected for residual soil and re-cleaned as needed Process monitoring Mechanical indicators Time, temperature, pressure Printout Chemical indicator (CI) placed in packs, trays or containers in every load Biological indicator used at least weekly, preferably daily, in each sterilizer Every load containing an implant 3M All Rights Reserved 50 Joint Statement on Immediate Use 3M All Rights Reserved 51 17

18 Immediate Use Steam Sterilization (IUSS) Policies and procedures available Efforts to reduce IUSS Not routine or frequent practice Documentation Not performed on implants Not performed on patients suspected to have Creutzfeld-Jakob Disease (CJD) Device IFU provide IUSS instructions Instruments cleaned with same resources as instruments that will be terminally sterilized PPE worn Process monitoring is done Mechanical BI CI Items aseptically transferred immediately from sterilizer to the point of use Not stored for future use on another patient or day 3M All Rights Reserved 52 High-Level Disinfection (HLD) Staff knows difference between HLD and sterilization and can verbalize Semi-critical items are, at a minimum, undergo HLD Automated (use of automated endoscope reprocessor (AER)) IFU available Pre-cleaning of equipment Documentation Manual Glutaraldehyde/OPA: IFU readily available Bin covered Solution in bin or receptacle dated when activated, when expired Solution remaining in bottle expiration label Quality control test performed and documented MEC tested before each use and documented Temperature monitored 3M All Rights Reserved 53 Endoscopy The one device with significant correlations to patient injury Outbreak of carbapenamase resistant Enterobacteriaceae (CRE) - 50% mortality Attributed to dirty ERCP endoscopes in multiple facilities across country Guidelines evolving AAMI ST91 up for revision AORN guideline published 3M All Rights Reserved 54 18

19 SM 26/04/2016 Endoscopy Be prepared for intense focus on processing procedures Dedicated personnel to process Competency on each type of scope and each manufacturer Instructions for processing - posted, be able to recite critical elements, accessories present Single use brushes (or decontaminated between each use) Debris not allowed to dry Bedside clean, leak test, pre-clean Quality monitoring policy current and implemented Alcohol flush Hung vertical, not touching, vented cabinet, no cloth or chuck beneath scopes Tagged to identify processing date (or expiration date) 3M All Rights Reserved 55 Sterile Storage 3M All Rights Reserved 56 Storage Clean and sterile separate Separate area Separate shelf Separate drawer Partition Nothing that can be damaged by water under the sink 3M All Rights Reserved 57 19

20 Sterile Storage Sterile items should be stored in a manner that reduces the potential for contamination. Separate area with restricted access Proper ventilation (at least 4 air changes/hour, positive pressure to corridor) to protect against dust, moisture and extremes of temperature (~24ºC /75ºF) and humidity (<70%) Free of insects and vermin Sterile items should be stored away from outside walls (at least 2 inches), off the floor (at least 8-10 inches) and away from the ceiling (18 inches) Stored to prevent physical damage (dragging, sliding, crushing, bending, compressing or puncturing) ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013, Section , M All Rights Reserved 58 Sterile Storage Cont d Sterile packages should be minimally handled to reduce the risk of contamination of the contents Should not be stored next to sinks or under exposed water or sewer pipes or in locations where they may become wet Should not be stored on floor or windowsills Shelf life is event related Sterile packages transported to the point of use should be protected to prevent contamination 3M All Rights Reserved 59 Sterile and Clean Storage Area Protect Clean and Sterile Supplies from Contamination NO OUTSIDE SHIPPING CONTAINERS OR CORRUGATED CARDBOARD / CARTONS Mature Indian Meal Moth Larvae Pupating in Corrugated Cardboard* * Photo courtesy of Department of Entomology, University of Nebraska-Lincoln. Photographer: Jim Kalisch. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012, A4:2013 Section M All Rights Reserved 20

21 SM 26/04/2016 Record Keeping 3M All Rights Reserved 61 Documentation What? Materials that have been processed Results of the sterilization process monitoring How? Load labels/package Paper log systems Electronic log systems Filed as individual document Expiration date or statement: Contents sterile unless package is open or damaged. Please check before using. ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4: M All Rights Reserved 62 Polling Question What is most challenging area in preparing for a survey challenge? 3M All Rights Reserved 63 21

22 SM 26/04/2016 Summary Be aware of content in the appropriate accreditation standard Staff are trained and competency documented to perform sterilization / high-level disinfection Policies and procedures are up to date, based on the most recent standards / guidelines and appropriately referenced Conduct ongoing tracers / audits / assessments Readiness is ongoing not a one time requirement 3M All Rights Reserved 64 Try to avoid this! CMS OSHA Accreditation Agency 3M All Rights Reserved Thank you Questions? 3M All Rights Reserved 66 22

23 Next Webinar 3M All Rights Reserved 67 References CMS Annual Report. Center for Clinical Standards and Quality/Survey & Certification Group. Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter pdf State Operations Manual Appendix L - Guidance for Surveyors: Ambulatory Surgical Centers Guidance/Guidance/Manuals/downloads/som107ap_l_ambulatory.pdf Exhibit 351 Ambulatory Surgical Center (ASC) INFECTION CONTROL SURVEYOR WORKSHEET (Rev: 142, Issued: , Effective: , Implementation: ). gastrointestinal.pdf AAM/ANSI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities. Arlington, VA. The Joint Commission Perspective April 2016 Volume 36 Number 4 Rutala, William A, Weber, David J and HICPAC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. CDC Healthcare Alert Network. September 11, 2015, 12:15 EDT (12:15 PM EDT) CDCHAN and Recommended Practices for Sterilization in the Perioperative Practice Settings. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc, 2015 The Joint Commission: 2016 Accreditation Standards Association for the Advancement of Medical Instrumentation (AAMI). Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities. ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3;2012 & A4:2013 Association for the Advancement of Medical Instrumentation (AAMI). Containment devices for reusable medical device sterilization. ANSI/AAMI ST77:2013 Occupational Safety and Health Administration. 29 CFR Occupational Exposure to Bloodborne Pathogens ; Final Rule. Federal Register December 6, Steam Sterilization Update on The Joint Commission s Position. June 16, M All Rights Reserved 23