Risk Assessment in the Sterile Processing Department: It s not what you know but what you don t

SM 3M Health Care Academy Risk Assessment in the Sterile Processing Department: It s not what you know but what you don t February 2, 2017 SM 3M Sterile Health Care U Webinar Academy 3M 2016. All Rights Reserved

Welcome! Topic: Risk Assessment in the Sterile Processing Department: It s not what you know but what you don t Facilitators: Andres Scherson, 3M Nikki Einerson, 3M Speaker: Jacqueline Daley, HBSc (Microbiology and Immunology) MLT, CIC, CSPDS For more information: www.3m.com/iped SM 3M Health Care Academy 3M 2016. All Rights Reserved

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

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 email Link to Course Evaluation CS Tech CE Certificate Included Forward email to others in attendance 4

Disclosure Jacqueline Daley HBSc (Microbiology and Immunology) MLT, CIC, CSPDS Manager, Infection Prevention, Clinical Epidemiology and the Vascular Access Service at the Sharp Metropolitan Medical Campus in San Diego, California Educational Consultant for 3M 5

Learning Objectives Discuss the purpose of performing risk assessments List three areas in the SPD where risk assessment is needed Discuss the steps in the risk assessment process 6

The Joint Commission IC.01.03.01 The hospital identifies risks for acquiring and transmitting infections. Expectation is that a multi-disciplinary team performs a risk assessment and put in place infection control activities. Customized to the organization Risk assessment should be prioritized In order of level of probability and potential for harm Prioritized risk are documented (Likelihood of occurrence / severity of impact) IC.02.02.01 The hospital reduces risk of infections associated with medical equipment, devices, and supplies. Cleaning and performing low-level disinfection of medical equipment, devices and supplies. Performing intermediate and high-level and sterilization of medical equipment, devices and supplies. Disposing of medical equipment, devices, and supplies. When reprocessing single-use devices, the hospital implements infection prevention and control activities that are consistent with regulatory and professional standards. The Joint Commission. Hospital Accreditation Standards. January 2017

Challenging Standards - January 1, 2016 June 30, 2016 IC.02.02.01 The hospital reduces risk of infections associated with medical equipment, devices, and supplies. Hospitals - 59% Ambulatory Care 49% Critical Access Hospital 73% Office-Based Surgery Practices 53% Joint Commission Online. August 31, 2016

Joint Commission Analysis of Hazards Safe Practice 4: Identification and Mitigation of Risks and Hazards Health care organizations must systematically identify and mitigate patient safety risks and hazards with an integrated approach in order to continuously drive down preventable patient harm. The Joint Commission. Improving Patient and Worker Safety: Opportunities for Synergy, Collaboration and Innovation. Oakbrook Terrace, IL: The Joint Commission, Nov 2012. https://www.jointcommission.org/improving_patient_worker_safety/ (accessed January 18, 2017)

Continuous Quality Improvement (CQI) AAMI ST 79 Section 11 CQI programs are used to assess and improve all components of the sterilization process Desired outcome of improving patient care by consistently delivering sterile product to the user No single right way to implement CQI Team approach Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Section 11

Medical Device Processing Risk Analysis The sterilization risk [medical device processing] analysis should be part of the health care facility s overall infection prevention and control risk analysis in accordance with accreditation agency requirements. Risk assessment (FMEA) - PROACTIVE Risk management (ANSI/AAMI ST79, Root cause analysis) - REACTIVE Risk communication (Recall procedure) HARDWIRE LEARNING It should be performed at least annually and should be reevaluated whenever significant changes occur. Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause 11.2.2

Sterilization Risk Analysis Risk assessment Identify sources of potential sterilization failures Estimate likelihood that each failure will occur Assess the consequences if that failure does occur Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013Clause 11.2.2 Risk management Determine which of the potential sterilization failures identified require management Select and implement the plans or actions needed to ensure those failures are controlled AAMI ST79 describes the accepted means of managing these risks

Failure Modes and Effects Analysis (FMEA) (WHAT IF?) Proactive risk assessment Sterilization Risk Analysis Assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change. LD.04.04.05, EP 10 At least every 18 months, the hospital selects one high-risk process and conducts a proactive risk assessment. Root Cause Analysis (WHY?) Reactive/Retrospective Process identify deficiencies or root cause for the error or adverse event Cause and effect fishbone diagram Answers the Why questions Based on analysis, identify improvements and implement to avoid recurrence The Joint Commission. Improving Patient and Worker Safety: Opportunities for Synergy, Collaboration and Innovation. Oakbrook Terrace, IL: The Joint Commission, Nov 2012. https://www.jointcommission.org/improving_patient_worker_safety/ (accessed January 18, 2017) http://www.ihi.org/

Risk Assessment Success depends upon previous preparation and without such preparation there is sure to be failure. Confucius

Risk Assessment PATIENT SAFETY EMPLOYEE SAFETY VISITOR SAFETY

Sterile Processing - 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 -- Detergent -- Maintenance of Equipment -- Verification of Cleaning-- Presoak - Check locks, hinges, etc. -- Assembly - Lumens etc. -- Proper Packaging -- Chemical Indicator Placement -- Equipment maintenance -- Sterilization parameters - Biological Indicator -- Mechanical Monitors -- Bowie- Dick Test -- - Recall procedures - Recall order - Recall report Disassembly - Loading Sterilizer -- Unloading sterilizer - Qualification Testing -- Record Keeping - Prevent Infections Department Design - Work flow patterns - Design criteria - Physical facilities -- Product Testing -- Attire -- Regulation -- Case Cart - Traffic control - CJD -- Hands on Training -- Sterilization Monitoring -- Restricted -- Tracking Access -- Competency -- Continuing Education Annual Retraining -- Hire/orientation - Qualification -- Flash Sterilization -- Receipt of new devices -- Occupational Health -- Review at least annually -- Standards & Guidelines - Quality control/process improvement -- IUSS -- Extended Cycle -- Instrument Design -- Loaner -- Power Equipment -- Use of dust barriers -- Event related outdating -- Storage facilities -- Inspection of packaging And indicators before use -- Covered/Closed Containers -- Carts - Distribution - Aseptic presentation Staff Education P&P Special Issues (FMEA) Sterile Storage Transportation to Point of use

Risk Assessment Where to Start? Identify Actual and Potential Risks Adverse Event Reporting Risk management department Review of root cause analysis Occupational exposures to bloodborne pathogens Internal Documentation Failed biological or chemical indicators Items returned from the OR because of residual contamination Repeated equipment failures Recalls more than expected OR Complaints Joint Commission Sentinel Event Reports Previous Accreditation Surveys Joint Commission Safety Alerts Media Reports Paper Electronic CDC Alerts HAN FDA Medwatch Standards, Guidelines, Regulations SDSs, manufacturers written instructions for use

CDC Health Alert Network (HAN) Alert - 0382 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: are complying with all steps as directed by the device manufacturers, and have in place appropriate policies and procedures that are consistent with current standards and guidelines. CDC HAN 0382 Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. September 11, 2015. https://emergency.cdc.gov/han/han00382.asp (accessed January 18, 2017)

CDC Health Alert Network (HAN) Alert - 0383 Audit and Feedback Healthcare facilities should regularly audit (monitor and document) adherence to cleaning, disinfection, sterilization, and device storage procedures. Audits should assess all reprocessing steps, including: Performing prompt cleaning after use, prior to disinfection or sterilization procedures Using disinfectants in accordance with manufacturers instructions (e.g., dilution, contact time, storage, shelf-life) Monitoring sterilizer performance (e.g., use of chemical and biological indicators, read-outs of sterilizer cycle parameters, appropriate record keeping) Monitoring automated endoscope reprocessor performance (e.g., print out of flow rate, time, and temperature, use of chemical indicators for monitoring high-level disinfectant concentration) Audits should be conducted in all areas of the facility where reprocessing occurs. Healthcare facilities should provide feedback from audits to personnel regarding their adherence to cleaning, disinfection, and sterilization procedures. 0383-9/29/2015 - CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. https://emergency.cdc.gov/han/han00383.asp (accessed January 18, 2017)

CDC HAN Alert - 0383 As a follow-up to HAN 00382 (distributed September 11, 2015), the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are providing this update to rescind the following recommendation: If healthcare facilities contract maintenance and repair of these devices to third-party vendors, healthcare facilities should verify that these vendors are approved or certified by the manufacturer to provide those services. We are making this change because there are currently no formal standardized programs or processes through which all manufacturers certify third-party vendors. We are also further clarifying that healthcare facilities which hire contractors to perform device reprocessing should verify that the contractor has an appropriate training program (i.e., consistent with what would be required in the healthcare facility) and that the training program includes the specific devices used by the healthcare facility. 0383-9/29/2015 - CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. https://emergency.cdc.gov/han/han00383.asp (accessed January 18, 2017)

Flexible Endoscopy- Ishikawa (Fishbone) Diagram Cleaning Disinfection Rinsing Record Keeping Product Recall Pre-cleaning --- Maintenance of Equipment -- Transport to processing room ---------- Verification of Cleaning-- Manual cleaning ----- AER---------- Water quality --------- Alcohol flush---------- Track to patient ------------- Print out------------ - Recall procedures - Recall order Leak testing ------ Manual ---------- Forced air drying----- - Recall report Dating of endoscope ------- Visual Inspection ---------------- Cleaning verification ------- Test disinfectant ----- Drying cabinet ---- Prevent Infections - Traffic control - Work flow -- Attire -- Regulation -- Hands on Training -- Sterilization Monitoring -- Tracking -- Restricted Access patterns -- Competency -- Receipt of new devices -- Instrument Design - Design criteria -- Continuing Education Annual Retraining ----MIFU - Physical facilities -- Occupational Health Department Design -- Hire/orientation - Qualification -- Review at least annually -- Standards & Guidelines - Quality control/process improvement -- Storage facilities -- Covered/Closed Containers Staff Education P&P Special Issues (FMEA) Storage Transportation to Point of use

The Outbreaks: In the news but not new.. There is a well documented history of outbreaks

RISK. Flexible endoscope reprocessing has been shown to have a narrow margin of safety. Any slight deviation from the recommended reprocessing protocol can lead to the survival of microorganisms and an increased risk of infection. Alfa, M.J., et al. (2006). American Journal of Infection Control, 34(9), 561-570.

Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg. Alexandra M. Dirlam-Langlay, Cori L. Ofstead, Natalie J. Mueller, Pritish K. Tosh, Todd H. Baron, Harry P. Wetzler. American Journal of Infection Control 2013 Dec;41(12):1188-94. Looked for reprocessing lapses in peer-reviewed literature, government reports, state health departments, CDC, FDA, Department of Veteran Affairs and media reports The study was limited to Jan. 2005 June 2012. They found that improper endoscope reprocessing is an ongoing and pervasive problem. Over 30,500 people exposed and this is just the tip of the iceberg. > 99% of these cases were not found in peer-reviewed medical journals Reprocessing lapses are rarely reported in medical journals leading to the false conclusion that reprocessing lapses are rare.

Risk assessment means GOING BEYOND THE OBVIOUS!

What does risk assessment mean in SPD? Determine where harm could occur in all areas where instruments, device and equipment processing occurs through a systematic process Inpatient / outpatient Sterile processing department / Endoscopy department Department-wide or individual process / new device or instrument Customize to meet needs Performed by a multi-disciplinary team At a minimum, infection preventionist, risk manager, OR staff, SPD staff, surgeon Review at a minimum, annually or when a change in process or an adverse event occurs

What you don t know can hurt your patient! Therefore Identify and remove or reduce identified risks and implement practices and protocols Walk the current process Gap analysis / Hazard vulnerability analysis Qualitative or quantitative Analyze and evaluate High, moderate or low risk Minimize, reduce or eliminate and / or control the risk Are existing measures in place to control hazards / risk adequate if not identify measures to mitigate the risks

What you don t know can hurt your patient! And Prioritize risks that have been found on analysis and the control measures Determine the likelihood of occurrence or severity of impact if it occurs Establish future process Walk the future process prior to hardwiring Monitor to ensure measures put in place to eliminate or minimize the risk is communicated and hard wired

Risks in Sterile Processing Department Hazard Identification Instruments requiring extended cycles Original packaging changed for sterilization Flexible endoscopes not properly processed for patient use Late arrival of loaner instruments to allow for reprocessing according to IFU and quarantine implants for BI results Wrong BI process challenge device is run during routine testing Improperly reprocessed eye sets with improper reprocessing to prevent TASS Daily verification of mechanical cleaning equipment not done at least daily Manufacturer s IFU for cleaning not followed Young, Martha Top 10 Risk in Sterile Processing. AAMI Horizons Spring 2012

Risks in Sterile Processing Department Hazard Identification Environment of Care Utility Systems EC.02.05.01: The hospital manages risks associated with its utility systems. EP 9: The hospital has written procedures for responding to utility system disruption. EP 15: In critical care areas designed to control airborne contaminants (such as biological agents, gases, fumes, dust), the ventilation system provides appropriate pressure relationships, air-exchange rates, filtration efficiencies, temperature, and humidity. The Joint Commission. Hospital Accreditation Standards. January 2017

Risks in Sterile Processing Department Hazard Identification Environment of Care Construction and renovation EC.02.06.05: The hospital manages its environment during demolition, renovation, or new construction to reduce risk of those in the organization. EP 3: The hospital takes action based on its assessment to minimize risks during demolition, construction, or renovation. Equipment EC.02.04.03: The hospital inspects, tests, and maintains medical equipment. EP 4: The hospital conducts performance testing of and maintains all sterilizers. The activities are documented. The Joint Commission. Hospital Accreditation Standards. January 2017

Risks in Sterile Processing Department Hazard Identification Instrument Management Critical (sterile space), semi-critical (mucous membranes) and non-critical (intact skin) devices Reprocessing Sterilization, high-level disinfection, intermediate-level disinfection and low-level disinfection People HR.01.02.01 The hospital defines staff qualifications Specific to job responsibilities HR.01.02.05 The hospital verifies staff qualifications HR.01.04.01 The hospital provides orientation to staff. HR.01.05.03 Staff participate in ongoing education and training HR.01.06.01 Staff are competent to perform their responsibilities The Joint Commission. Hospital Accreditation Standards. January 2017

Risks in Sterile Processing Department Hazard Identification Processes Center for Medicare & Medicaid Services (CMS) Draft and subject to changes Policies and procedures Early release of implants Prion contaminated devices Immediate Use Steam Sterilization (IUSS) Loaner instruments Robotics High-level disinfection processes Semi-critical devices Endoscopes Storage of clean and disinfected devices

Manage the Risk : Did the assessment identify new risks? Is it complete? Review of RCAs Limited pattern or widespread FMEA new risks determined Action plans Closing the gaps / address the risk RACI matrix Responsibility assignment matrix Responsible, Accountable, Consultation, Informed Policies and procedures (new or revised) Competency assessment Education and training Resources Staffing, equipment Control Methods - Eliminate the risk Administrative Control Process Control Personal protective equipment Engineering Controls Ventilation

Risk Prioritization Determine level of risk in the assessment Product information / manufacturer written instructions for use (device, cleaning/disinfecting agent, equipment, etc) Past experience Federal / State / Local regulations OSHA SDS Applicable standards and guidelines Peer reviewed literature / evidencebase best practices Results of BI/CI Environment Temperature / Humidity Adverse events, near miss Other items that contribute to risk Environment layout/design Staff experience/competency/supervision System designs and control

The Joint Commission Safer Matrix https://www.jointcommission.org/webinar_replay_refresh_safer_matrix/ (accessed January 18, 2017)

Manuele, F.A. (2005, May). Risk assessment and hierarchies of control. Professional Safety, 50(5), 33-39. www.asse.org

Decision Making Manuele, F.A. (2005, May). Risk assessment and hierarchies of control. Professional Safety, 50(5), 33-39. www.asse.org

Risk Prioritization - Example Establish top priorities SMH - 2016 Annual Infection Prevention and Control Program Risk Assessment and Analysis 2016 (Standard IC.01.03.01, IC.01.04.01 and IC.02.02.01 and NPSG 7) PROBABILITY (Likelihood of Occurrence) Outcome Severity (Harm) Preparedness Risk Priority Infection Issues, Condition, Problem and Events Frequent/ High Occasional/ Med Uncommon/ Low Rare/ None Life Threatening Permanent Disability, Prolonged Hospitalization Temporary, Recoverable, Treatable None None Poor Fair Good </= 6: no risk to low 7-11: medium Evaluation/Action SCORE 3 2 1 0 3 2 1 0 4 3 2 1 >/=12: high Probability x Outcome x Preparedness = Risk Priority Rank the identified risk - Is the risk High, Moderate or Low? Ref. Sharp Memorial Infection Prevention Risk Assessment 2016

Risk Prioritization - Determine what level of risk you are willing to accept? High/Very High Risk (e.g., >/=12) Risk reduction a priority / unacceptable Urgent implementation of risk reduction strategies in a defined time period May need to stop or restrict the activity / apply interim solutions until completed May be resource intensive to implement additional measures Monitor to ensure that control measures are hard wired to prevent harm Very Low (No Risk) / Low Risk (e.g., </=6) Acceptable No further action is necessary Monitor for increase in risk and current practices maintained Medium / Moderate Risk (e.g., 7-11) Can the risk be lowered to an acceptable level? Risk reduction strategies should be implemented promptly Monitor for increasing risk especially if harm could result

Risk Prioritization Develop goals and objectives based on findings in the risk assessment Written to address highest priorities Written to address how strategies will be put in place to reduce the risk adverse events such as infection transmission from instruments, devices and medical equipment Each goal should have measurable objectives Evaluation process According to the Joint Commission, By adding objectives to goals, organizations move beyond communicating intent to incorporating specific numeric targets and timeframes for outcomes. Approved by the Infection Prevention Committee Becomes a part of the infection prevention and control plan The Joint Commission Resources. Using the Risk Assessment to Set Goals and Develop the Infection Prevention and Control Plan. Chapter 3

Risk Mitigation Efforts Minimizing risks begins with Correct handling procedures in preparation for processing, to include precleaning steps at the point of use (e.g., bedside procedures), disassembly of parts, and safe transport. Cleaning according to the specific manufacturer's written IFU is then required to ensure that patient soil and other materials are removed prior to the antimicrobial processes of high-level disinfection or sterilization. Cleaning is followed by disinfection or sterilization to reduce or completely remove microbial contamination. At a minimum, it is recommended that devices are subjected to high-level disinfection after each use. When possible and practical, flexible and semi-rigid endoscopes should be sterilized due to the greater margin of safety built into sterilization. High-level disinfection is a multi-step process and is expected to be able to inactivate most pathogenic bacteria, viruses, and fungi but may not reliably inactivate certain types of microorganisms including bacterial spores. When these devices are used in sterile tissue procedures, sterilization is recommended Reprinted from ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities

Lean Six Sigma Tool - A3 A3 Title Name(s) Date Why you are talking about it. Background: What is the business reason for choosing this issue? Proposed Countermeasure(s): Your proposal to reach the future state, the target condition. - What alternatives could be considered? - How will you choose among the options? What decision criteria? How your recommended countermeasures will impact the root cause to change the current situation and achieve the target. Current Conditions: Where things stand today. - What s the problem with that, with where we stand? - What is the actual symptom that the business feels that requires action? Show visually pareto charts, graphs, drawings, maps, etc. Target(s)/Goal(s) The specific outcome required for the business. - What is the specific change you want to accomplish now.? - How will you measure success? Implementation Plan: A chart or table that shows actions/outcomes, timeline and responsibilities. May include details on the specific means of implementation. - Who will do what, when and how? Indicators of performance, of progress. - How will we know if the actions have the impact needed? - What are the critical few, visual, most natural measures? Analysis The root cause(s) of the problem. - Why are we experiencing the symptom? - What constraints prevent us from the goal? Choose the simplest problem-solving tool for this issue: - Five whys - Fishbone - QC Tools - LSS Tools Follow Up: Remaining issues that can be anticipated. - Any failure modes to watch out for? Any unintended consequences? Ensure ongoing P-D-C-A. Copyright 2014 GoLeanSixSigma.com. All Rights Reserved.

Other Triggers for Ongoing Risk Assessment Could changes in the SPD introduce new hazards or raise the risk from low to high Review the assessment on a regular basis to ensure there are no changes Establish triggers for a review SPD construction plans Work flow / process change Purchase of new instruments, equipment, etc. Hiring of new employees in training Relocation of services / decentralization of services Introduction of new chemicals (disinfectants, detergents, sterilants) Revision in manufacturer s written instructions for a device, equipment in use

Record Keeping Maintain record of risk assessment based on facility policies and procedures Process for determining risk Action plans / control measures appropriate to the identified risks Measures of success Federal / state / local regulations may dictate time for these records Demonstrate prioritization of identified risks / hazards and was thorough Assessed all work areas

Summary Regular risk assessment should be completed for sterile processing as part of the infection prevention risk assessment. Risk assessment is not a one time activity but an important part of the continuous quality improvement program. Risk assessment means going beyond the obvious. A comprehensive risk assessment is a key part of an overall sterilization risk analysis. Risk assessment is not done in a vacuum but with a multi-disciplinary team. Multiple sources are available to assist with determining what should be included in the risk assessment. Once risk assessment is completed, manage the risk by prioritizing based on high, medium or low risk and focus mitigation efforts. Continuously audit the changed process to monitor for unintended consequences and to ensure any further changes will be included in future assessments.

It always seems impossible until it s done. Nelson Mandela

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References The Joint Commission. Hospital Accreditation Standards. January 2017. Challenging Standards January to June 2016. Joint Commission Online. August 31, 2016 The Joint Commission. Improving Patient and Worker Safety: Opportunities for Synergy, Collaboration and Innovation. Oakbrook Terrace, IL: The Joint Commission, Nov 2012. https://www.jointcommission.org/improving_patient_worker_safety/ (accessed January 18, 2017) ANSI/AAMI ST79ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities http://www.ihi.org (accessed January 18, 2017) CDC HAN 0382 Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. September 11, 2015. https://emergency.cdc.gov/han/han00382.asp (accessed January 18, 2017) CDC HAN 0383-9/29/2015 - CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. https://emergency.cdc.gov/han/han00383.asp (accessed January 18, 2017) Alfa, M.J., et al. (2006). American Journal of Infection Control, 34(9), 561-570. Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg. Alexandra M. Dirlam-Langlay, Cori L. Ofstead, Natalie J. Mueller, Pritish K. Tosh, Todd H. Baron, Harry P. Wetzler. American Journal of Infection Control 2013 Dec;41(12):1188-94. SM 3M Health Care Academy 3M 2016. All Rights Reserved 55

References The Joint Commission: The Source, February 2010 Volume 8, Issue 2 Young, Martha Top 10 Risk in Sterile Processing. AAMI Horizons Spring 2012 Center for Medicare & Medicaid Services. Center for Clinical Standards and Quality/Survey & Certification Group. Draft Pilot Hospital Infection Control Worksheet. Released November 18, 2016. The Joint Commission Safer Matrix https://www.jointcommission.org/webinar_replay_refresh_safer_matrix/ (accessed January 18, 2017) The Joint Commission Resources. Using the Risk Assessment to Set Goals and Develop the Infection Prevention and Control Plan. Chapter 3 Manuele, F.A. (2005, May). Risk assessment and hierarchies of control. Professional Safety, 50(5), 33-39. www.asse.org Lean Six Sigma A3 Tool. GoLeanSixSigma.com (accessed January 18, 2017) Rutala W, Weber, D et. al. CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. http://www.cdc.gov/hicpac/disinfection_sterilization/5_0cleaning.html (accessed January 18, 2017) SM 3M Health Care Academy 3M 2016. All Rights Reserved 56

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Next Live Webinar Date: Thursday March 2, 2017 Title: A Breakthrough on Enhancing Collaboration with the OR and Contributing to Hospitals Goals Register: www.mmm.com/iped SM 3M Health Care Academy 3M 2016. All Rights Reserved 58