SESSION NAME SPEAKERS SESSION NUMBER 0027 DATE/TIME CONTACT HOURS (CH) 1.0 SESSION OVERVIEW: Quality Assurance: Crisis to Control Linda L. Condon, MBA, BSN, RN Cynthia Spry, MSN, MA, RN, CNOR, CRCST Monday, March 31, 2014, 4-5pm In the Sterile Processing Department (SPD), there is high risk for error because of complex products and processes, interruptions, scheduling conflicts, and other factors. Quality assurance is imperative and high reliability can only be achieved if processes are continually evaluated and monitored. This interactive presentation will define and identify process deviations that can occur in any SPD. Identifying process deviations allows departments to seek opportunities to continually improve operations and outcomes. Continual assessment allows the SPD to quickly identify process deviations so corrections can be made promptly. How do you determine if the sterilization process in your department is in control? Does your set quality data accurately measure set quality? This presentation will review how a SPD can implement proactive continual quality performance monitoring specific to set assembly and sterilization. This presentation will review two quality indicators and provide the attendee several tools that can be used to measure outcomes and help ensure that a safe quality product is delivered to the OR. OBJECTIVES: 1. Describe and develop tools that can be used to measure assembly and sterilizations processes. 2. Discuss how to implement a proactive quality assurance program to measure the quality of set assembly and sterilization. 3. Identify process deviations in the Central Sterile Processing Department that can impact set quality and sterilization outcomes. SPEAKER BIOGRAPHIES: Linda Condon, MBA, BSN, RN, is a registered nurse with over 29 years' experience working in or around the perioperative environment. Currently she works as the Assistant Director of the Sterile Processing Department at Johns Hopkins Hospital in Baltimore, Maryland. She has held various positions throughout her career including Manager and Educator of Central Sterile Processing. For the past 18 years, her attention has been focused on improving the practices in the Operating Room and Central Sterile Processing Department related to the cleaning, disinfection, sterilization, and distribution of surgical instrumentation.
AORN Surgical Conference & Expo 2014 P a g e 2 o f 2 Cynthia Spry, MSN, MA, RN, CNOR, CSIT, is an independent consultant with over 30 years of perioperative experience; with over seven years as an OR educator, five years as a director of surgical services, and 12.5 years as an international clinical consultant for a Johnson & Johnson Company. She provides consultation and education in sterilization, disinfection, and infection control. She is a past president of AORN. In 2002, Spry received the Association's Award for Excellence in Perioperative Nursing for her achievements in practice, education, and research, and The Jerry G. Peers Award. Spry has written more than 75 articles and has authored two books on topics relating to perioperative nursing. She lectures on a variety of topics and has presented in more than 17 countries. Her major area of expertise and consultation is sterilization and disinfection. She is currently the co-chair of the AAMI committee responsible for ST79 Guideline to Steam Sterilization and Sterility Assurance in Health Care Facilities. SPEAKER CONTACT INFORMATION: Linda L. Condon, MBA, BSN, RN Director Central Sterile Processing Johns Hopkins Hospital Baltimore, Maryland llcondon@jhmi.edu Cynthia Spry, MSN, MA, RN, CNOR, CRCST Consultant/Speaker New York, New York Cynthia350@gmail.com FACULTY DISCLOSURE: Linda Condon: 7. No conflict. Cynthia Spry: 1. Consultant/Speakers Bureau - Stryker, Aesculap, 3M, Best Practice Professionals
Scenario One 1 Scenario Two 2 1
Scenario Three 3 Crisis 4 2
Set Assembly Defects Missing instrument/s Damaged instrument/s Extra instrument/s Soiled instrument/s Stained instrument/s Missing/failed chemical indicator Compromised packaging Torn wrap Missing locks Wet set 5 Sterilization Defects Biological Indicator Failed test Missing test Read too early Missing documentation Load contents Signatures/sign off s Inaccurate sterilization Wrong cycle selected Wrong method (H 2 0 2 vs. EtO) 6 3
Defect Impact Patient infection Cancelled case Case delay Wasted supplies Feelings of mistrust Frustration Risk of patient or staff injury Poor relations between CS and OR Unhappy customers 7 Quality Assurance in Sterile Processing OR sees only the final product Many steps to prepare an instrument from the time it leaves the OR until it is returned for use Each step in the preparation is/should be accompanied with a quality assurance activity Beyond that are quality improvement initiatives that: Identify potential problems Identify activities to improve processes 8 4
Receiving Decontamination area Prevent debris from adhering and potential risk that debris will not be removed during cleaning Instruments opened and disassembled Cannulated instruments flushed Possible delay before can be put into washer Items sprayed with enzyme to prevent adherence of debris ANSI/AAMI ST79: 2010 & 2012 & 2012, Section 7 AORN Perioperative Standards and Recommended Practices, 2013 RP Care of Instruments, Rec.V 9 Manual Cleaning IFU detergent Measured concentration Automated concentration mechanism/pump Manual - Temperature - thermometer Time - timer 5
Automated cleaning Washer disinfector/decontaminator Doser check and documentation 11 Automated cleaning equipment washer-disinfector Daily maintenance check and documentation Screens, Washer arms/spray nozzles Free of debris Present Spin Direction Racks aligned Drains Lights 12 ANSI/AAMI ST79: 2010 & 2012 & 2012, Section 7 6
Efficacy testing Standard Weekly, preferably daily 13 Cleaning equipment Ultrasonic tested and documented Sonic check transducers in multiple locations Degassed 14 7
Quality Improvement Sterile Processing Post cleaning QA initiatives Protein tests ATP testing Inspection Function testing 15 16 8
Set Assembly Printed or electronic content list Check off and signed Missing elements, etc., identified 17 Sterilization 4 levels of testing Efficacy Load Release Qualification Product Testing ANSI/AAMI ST79: 2010 & 2012 & 2012, Section 10 9
Sterilization Physical monitors Parameter check and sign off Sterilization Chemical indicators Outside and inside Air removal test (Bowie-Dick) daily Sterilization Biological indicators Efficacy testing, Load release, Qualification Testing, Product Testing ANSI/AAMI ST79: 2010 & 2012 & 2012, Section 10 AORN Perioperative Standards and Recommended Practices, 2013 RP Sterilization Recommendation 19 Efficacy Daily spore kill Daily air removal for dynamic air removal sterilizers Load Release Non implant Implant ANSI/AAMI ST79: 2010 & 2012 & 2012, Section 7 AORN Perioperative Standards and Recommended Practices, 2013 RP Sterilization Recommendation VII 10
Qualification testing Installation Repair Location change Product testing Testing product under facility resources Your equipment, your load, your utilities, etc Reason why so important to receive loaners 24 hrs ahead 21 Reprocessing Volumes ~ 520 set assemblies/day ~150 peel packs/day ~ 40,000 instruments handled/day ~ 115 surgeries on average/day ~ 46 steam sterilization loads/day ~ 21 hydrogen peroxide loads/day ~ 1 EtO load/day 22 11
Controlling the Chaos OR Rounds First Case Auditing Decontamination Pre-assembly Post-assembly Sterilization Quality monitoring Equipment Biological indicators Cannulas and complex instruments 23 Auditing Our Processes Review sterilization records Daily Check biological indicators Each shift Audit Sterilization loads Every load Audit assemblies OR 1 set from 1 st case CS 10-15 per shift First Case Rounds 24 12
First Case Rounds Audit Form 25 Courtesy Johns Hopkins Hospital Pre-Assembly Audit Courtesy Johns Hopkins Hospital 13
Post Assembly Audit Courtesy Johns Hopkins Hospital Sterilization Audit Form Courtesy Johns Hopkins Hospital 14
Set Assembly Auditing Operating Room First cases Additional Central Sterile Percentage per employee Percentage of production 29 Courtesy Johns Hopkins Hospital Reporting the Data Total first cases Total set assemblies with no issues from first cases Break down of errors Process or system error Additional errors reported Audits performed by CSP Total sterilization deviations 30 15
Sterilizer Deviations 186 Total Cycles Nov 17- Nov 23 Linking Error 4 Missing Documentation Aborted Load Ran/Chose Wrong Cycle 1 1 2 Deviations Load Opened in Error 3 0 5 94.1% Accuracy Rate Courtesy Johns Hopkins Hospital Total First Case Audits for October 2013 500 450 400 350 300 250 200 150 100 50 0 430 319 84% 77% 81% 144 122 115 111 97 36 29 JHOC WBG ZAYED Total 1st Cases Total 1st Case Audits No Issues Courtesy Johns Hopkins Hospital 16
1 st Case Rounds Set Quality Data October 2013 500 450 430 400 350 300 319 Total 1st Cases 250 200 150 100 50 86.5% 43 95% 20 Reported Issue 0 WBG ZAYED Courtesy Johns Hopkins Hospital Interventions Standardized procedures Minimize distractions Re-training Back up inventory Automated Stocked daily Onsite repair Second sign-off on problematic sets Sterilization zones Unsterile/sterile Restricted area 34 17
Developing Central Sterile Training Create a career ladder Instrument Processor I, II, and III Require certification Create new job descriptions Quality assurance Trainer/Educator 35 Collaboration OR/CS Task group Infection Control Practioner Operating Room Central Sterile CS Open House Transparency Report defects and interventions Back up processes Automated peel pack storage 36 18
THE BEST 37 EVIDENCE-BASED REFERENCES Association for the Advancement of Medical Instrumentation, Arlington VA. ANSI/AAMI ST79: 2010 & 2012 & 2012 Comprehensive guide to sterilization and sterility assurance in healthcare facilities, Section 7. Association of perioperative Registered Nurses (AORN), Denver, CO. Perioperative Standards and Recommended Practices, 2013 RP Sterilization RP Care of Instruments 38 19