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EBMT 2010 quality management meeting slides

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EBMT 2010 quality management meeting slides. 4 presentations in one PDF from the plenary sessions.

EBMT 2010 quality management meeting slides. 4 presentations in one PDF from the plenary sessions.

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  • 1. 08/04/2010 DISCLOSURE 2nd EBMT QUALITY THIS SPEAKER MANAGEMENT MEETING DECLARES THAT HE HAS NO CONFLICT AN INTRODUCTION TO RISK MANAGEMENT OF INTEREST RELATED Marc Czarka, MD, FBCPM Managing Partner HM3A TO THIS LECTURE (Healthcare Market Authorization and Access Associates) 1 2 WHAT’S RISK ? it’s very simple TALKING ABOUT RISK IS, OF COURSE, ONE OF THE RISK THE FIRST SPEAKER THE RISKIEST THINGS ONE WILL LOOK UP CAN DO: THERE ARE SO wikipedia.org/historical_background/ wikipedia.org/historical_background/ “the definition of risk” MANY EXPERTS ABOUT ! J.D.Remington, HSE, UK 3 4 WHAT’S RISK ? • EXPECTED VALUE OF ONE OR MORE RESULTS OF ONE OR MORE FUTURE EVENTS • MEASURED BY ITS LIKELYHOOD AND ONCE RISK WAS CONSEQUENCE WHICH MAY BE POSITIVE IN THE HANDS OR NEGATIVE OF "OTHERS" • GENERAL USAGE FOCUSES ON POTENTIAL HARM – INCURRING A COST (DOWNSIDE RISK) – FAILING TO ATTAIN SOME BENEFIT (UPSIDE RISK) Wikipedia 5 6 1
  • 2. 08/04/2010 AGAINST THE GODS AGAINST THE GODS • HISTORY OF MATHEMATICAL • I RECOMMEND READING IT AS THE ANALYSIS OF RISK RISK IS LIMITED TO • LED TO THE DEVELOPMENT OF – LIST PRICE: $19.95 INSURANCE AND FINANCIAL – PRICE ON AMAZON.COM: $13.57 & MARKETS ELIGIBLE FOR FREE SUPER SAVER SHIPPING ON ORDERS OVER $25 • VAST INDUSTRIES NOW DEPEND ON – YOU SAVE: $6.38 (32%) COMPLEX RISK MANAGEMENT TECHNIQUES INCLUDING THE • THEN AFTER YOU FINISH WITH THIS HEALTHCARE INDUSTRY! ONE CONTINUE WITH TALEB'S BLACK SWAN 7 8 BLACK SWAN AGAINST THE GODS • TALEB HIGHLIGHTS THE DANGER OF THE UNEXPECTED GROWING BODY OF EVIDENCE THAT • IT WILL HAPPEN – EVEN IF WE HAVE A REVEALS REPEATED PATTERNS OF COMFORTABLE MODEL PREDICTING ONLY MINOR IRRATIONALITY, INCONSISTENCY, CHANGES • AFTER SUCH A "BLACK SWAN" CATCHES US BY AND INCOMPETENCE IN THE WAYS SURPRISE, WE USE OUR FLAWED HINDSIGHT TO HUMAN BEINGS ARRIVE AT DECIDE HOW WE COULD HAVE PREDICTED THE DISASTER USING A BETTER MODEL DECISIONS AND CHOICES • WE NEED BETTER STRATEGIES TO LIVE IN A WHEN FACED WITH UNCERTAINTY WORLD WHERE TRULY RANDOM, Peter L. Bernstein, 1996 UNPREDICTABLE EVENTS OCCUR 9 10 MOST OF US VIEW RISK AS EITHER RISK CULTURE ……ACCEPTABLE …..OR UNACCEPTABLE That’s if we have a choice ………….. 11 12 2
  • 3. 08/04/2010 RISK CULTURE RISK APPETITE POTENTIAL ISSUES • MISALIGNMENT BETWEEN CULTURE AND POLICIES (POTENTIAL NON- COMPLIANCE AND/OR UNDUE RISK) • BLAMING CULTURE VS. LEARNING CULTURE 13 14 RISK APPETITE RISK PERCEPTION • IN WESTERN SOCIETIES, RISK APPETITE IS • REMEMBER: FOR THE INDIVIDUAL, – VERY LOW IN HEALTHCARE, PERCEPTION IS REALITY…! – VERY HIGH IN FINANCIAL MATTERS… • MAY DIFFER GREATLY FROM TRUE • IN HEALTHCARE, WE OBSERVE A "ZERO-RISK" SOCIETAL TREND RISK – "EYE OF THE BEHOLDER" PHENOMENON • THE SHIFT OF THE EMA, IN THE EU, FROM DG ENTREPRISE TO DG SANCO IS • SUBJECTIVE JUDGMENT ABOUT THE ANOTHER MOVE IN THE SAME DIRECTION CHARACTERISTICS AND SEVERITY OF WITH A RENEWED FOCUS ON PATIENT A RISK SAFETY 15 16 RISK PERCEPTION FROM PUBLIC RISK PERCEPTION EXPERTS PUBLIC RISK RISK ASSESSMENT PERCEPTION OBJECTIVE AND RUMOUR ANALYTICAL SUBJECTIVE RATIONAL HYPOTHETICAL EMOTIONAL Morgan, 1993 17 18 3
  • 4. 08/04/2010 RISK PERCEPTION THE SIAMESE TWINS AND COMMUNICATION • RISKS AND UNCERTAINTY ARE INHERENT TO ANY ENTREPRISE – THERE IS NO • EXPERTS ARE GOOD AT REWARD WITHOUT TAKING RISK COMMUNICATING DATA • RISK (MANAGEMENT) HAS TWO FACES • MANY OTHERS, IN THE PUBLIC, ARE – PROTECTING AGAINST VALUE DESTRUCTION GOOD AT COMMUNICATING – ENSURING VALUE CREATION OPPORTUNITIES EMOTIONS… ARE NOT MISSED • UNDERSTANDING AND MANAGING RISK IS KEY FOR CREATING AND SAFEGUARDING VALUE 19 20 BROAD CATEGORIES ESSENCE OF RISK MANAGEMENT OF RISK FOR BERNSTEIN, IT • MARKET RISK LIES IN MAXIMIZING AREAS WHERE • FINANCIAL RISK WE HAVE SOME CONTROL OVER THE • TECHNOLOGY RISK OUTCOME WHILE MINIMIZING AREAS • PEOPLE RISK WHERE WE HAVE ABSOLUTELY NO • STRUCTURE/PROCESS RISK CONTROL OVER THE OUTCOME • HEALTH AND SAFETY RISK AND THE LINKAGE BETWEEN EFFECT AND CAUSE IS HIDDEN FROM US 21 22 RISK MANAGEMENT PROCESS: MORE THAN RISK MANAGEMENT JUST A REGULATORY REQUIREMENT THOUGHT SEQUENCE WHAT SHOULD THE ORGANISATION ACHIEVE ? WHAT COULD IMPEDE THE ACHIEVEMENT ? HOW LIKELY IS IT THAT SUCH AN EVENT OCCURS ? WHAT WOULD THE IMPACT BE ? HOW CAN WE RESPOND TO UNWANTED EVENTS ? 23 24 4
  • 5. 08/04/2010 ISO 31000:2009 ISO 31000:2009 • PROVIDES PRINCIPLES AND GENERIC GUIDELINES ON RISK MANAGEMENT • NOT SPECIFIC TO ANY INDUSTRY OR SECTOR • CAN BE APPLIED THROUGHOUT THE LIFE OF AN ORGANIZATION, AND TO A WIDE RANGE OF ACTIVITIES, INCLUDING STRATEGIES AND DECISIONS, OPERATIONS, PROCESSES, FUNCTIONS, PROJECTS, PRODUCTS, SERVICES AND ASSETS • CAN BE APPLIED TO ANY TYPE OF RISK, WHATEVER ITS NATURE, WHETHER HAVING POSITIVE OR NEGATIVE CONSEQUENCES • UTILIZED TO HARMONIZE RISK MANAGEMENT PROCESSES IN EXISTING AND FUTURE STANDARDS • PROVIDES A COMMON APPROACH IN SUPPORT OF STANDARDS DEALING WITH SPECIFIC RISKS AND/OR SECTORS, AND DOES NOT REPLACE THOSE STANDARDS 25 26 KEY QUESTIONS KEY TASKS 1. WHAT MIGHT GO WRONG? THE SYSTEMATIC APPLICATION OF MANAGEMENT POLICIES, 2. WHAT IS THE PROBABILITY IT WILL GO WRONG? PROCEDURES AND PRACTICES TO 3. WHAT ARE THE CONSEQUENCES THE TASKS OF (SEVERITY)? • IDENTIFYING, 4. WHAT CAN BE DONE TO REDUCE THE • ANALYZING, RISKS? • EVALUATING, RISK 5. IS THERE ACCEPTANCE OF THE RESIDUAL • TREATING AND RISK? • MONITORING 27 28 RISK ASSESSMENT RISK ASSESSMENT • RISK ASSESSMENTS MEASURE THE RISK, THE POTENTIAL LOSS, AND THE PROBABILITY THAT THE LOSS WILL OCCUR • ONCE MORE, FOR THE FORMULA FOLKS, RISK (R) = PROBABILITY (P) * LOSS VALUE (L) 29 30 5
  • 6. 08/04/2010 RISK ASSESSMENT RISK ASSESSMENT PROCESS PROCESS • SPONSOR RISK ENUMERATION • SCOPE ACTION PLAN RISK • TEAM AND CLASSIFICATION EXECUTION AND RATING • START THE CYCLICAL PROCESS CONTROL REPORT IDENTIFICATION 31 32 RISK ASSESSMENT RISK ASSESSMENT • YOU DO IT EVERY DAY AND DON’T EVEN • PART OF ANY RISK ASSESSMENT IS THINK OF IT THAT WAY DETERMINING APPROPRIATE CONTROLS • "IF I DON’T GET MY WIFE A WEDDING’S • THERE CAN BE ALTERNATE CONTROLS TO BIRTHDAY PRESENT, SHE’S GOING TO KILL A DIAMOND RING LIKE ME" – DINNER OUT • RISK = LOSS (LIFE) * PROBABILITY – A VACUUM CLEANER (DEFINITELY GOING TO HAPPEN = 1) – AN E-CARD • IN THIS EXAMPLE, AN APPROPRIATE • SOME CONTROLS MAY NOT BE AS CONTROL IS BUYING A GIFT EFFECTIVE, AND ASSESSMENTS SHOULD RECOMMEND EFFECTIVE CONTROLS 33 34 RISK MANAGEMENT RISK MANAGEMENT • ACCOMPLISHED BY – BALANCING RISK EXPOSURE AGAINST MITIGATION COSTS AND – IMPLEMENTING APPROPRIATE COUNTERMEASURES AND CONTROLS MITIGATE THE RISK OF ACCIDENTS MITIGATE THE RISK OF INJURY 35 36 6
  • 7. 08/04/2010 RISK MANAGEMENT OPTIONS RISK MATRIX TRANSFER TREAT • FACED WITH RISK, ORGANIZATIONS HAVE FOUR OPTIONS (4Ts): Impact – TERMINATE THE ACTIVITY GIVING RISE TO RISK high AVOID - TERMINATE – TRANSFER RISK TO ANOTHER PARTY intermediate TREAT – REDUCE RISK BY USING OF APPROPRIATE CONTROL MEASURES OR MECHANISMS low TOLERATE (TREAT) low intermediate high Probability – ACCEPT THE RISK (WHICH MEANS TOLERATE THE RESIDUAL RISK) Keep risk in mind Take calculated action Call for action 37 38 time RESIDUAL RISK • RISKS THAT STILL REMAIN AFTER COUNTER- MEASURES & CONTROLS HAVE BEEN DESIGNED • FINAL ACCEPTANCE OF RESIDUAL RISK SHOULD TAKE INTO ACCOUNT: CONTEXT ANALYSIS RISK ASSESSMENT RISK MANAGEMENT – REGULATORY COMPLIANCE Identify Impact of threats is – ORGANIZATIONAL POLICY – SENSITIVITY AND CRITICALITY OF RELEVANT ASSETS Analyze Within acceptable limits – ACCEPTABLE LEVELS OF POTENTIAL IMPACTS Evaluate At an acceptable cost – UNCERTAINTY INCORPORATED IN THE RISK ASSESSMENT DYNAMIC PROCESS : MONITOR AND REVIEW – COMMUNICATE AND CONSULT APPROACH ITSELF – COST AND EFFECTIVENESS OF IMPLEMENTATION • ACCEPTANCE OF RISK SHOULD ALWAYS BE REGULARLY REVIEWED YOU NEED A PLAN ! 39 40 RISK MANAGEMENT PLAN MISTAKES? • GOAL: DESCRIBING HOW RISK MANAGEMENT WILL BE STRUCTURED AND PERFORMED ON A • TALEB HAS PUBLISHED "THE SIX MISTAKES PROJECT EXECUTIVES MAKE IN RISK MANAGEMENT" IN THE OCTOBER 2009 ISSUE OF THE HBR • OUTPUT: A DOCUMENT (OR SET OF DOCUMENTS • OUR WORLD IS INCREASINGLY BEING SHAPED BY AND TEMPLATES) WITH PROCEDURES FOR LOW-PROBABILITY, HIGH-IMPACT EVENTS THAT MANAGING RISK THROUGHOUT A PROJECT ARE ALMOST IMPOSSIBLE TO FORECAST "BLACK • TOPICS IN A RMP WILL INCLUDE SWANS" – METHODOLOGY • CONFIRMS THAT RISK MANAGEMENT IS NOT – ROLES AND RESPONSIBILITIES – BUDGET AND TIMING ABOUT FORECASTING BUT IMPACT REDUCTION – RISK CATEGORIES OF THREATS WE DON’T UNDERSTAND… – RISK PROBABILITY AND IMPACT – RISK DOCUMENTATION – TRACKING 41 42 7
  • 8. 08/04/2010 SIX MISTAKES FOCUS ON HEALTHCARE • MANAGERS MAKE SIX COMMON MISTAKES • WHICH RISK AND FOR WHOM? WHEN CONFRONTING RISK: – THEY TRY TO ANTICIPATE EXTREME EVENTS – FINANCIAL? – THEY STUDY THE PAST FOR GUIDANCE – HEALTH? – THEY DISREGARD ADVICE ABOUT WHAT NOT TO DO – FOR THE PATIENT? – THEY USE STANDARD DEVIATIONS TO – FOR THE HEALTHCARE PROVIDER? MEASURE RISK – THEY FAIL TO RECOGNIZE THAT – FOR THE HOSPITAL? MATHEMATICAL EQUIVALENTS CAN BE PSYCHOLOGICALLY DIFFERENT, AND – FOR THE PUBLIC OR PRIVATE INSURER? – THEY BELIEVE THERE'S NO ROOM FOR REDUNDANCY WHEN IT COMES TO EFFICIENCY 43 44 FOCUS ON HEALTHCARE ONE EXAMPLE: SURGICAL SAFETY 45 46 HAMMURABI'S CODE OLD URBAN LEGENDS? OF LAWS (1780 B.C.) • WE'VE ALL HEARD STORIES ABOUT SURGICAL IF A PHYSICIAN MAKES A LARGE INSTRUMENTS, SPONGES, EVEN NEEDLES BEING LEFT INSIDE A PATIENT INCISION WITH THE OPERATING KNIFE, • AT TIMES, THE WRONG PATIENT HAS BEEN AND KILLS THE PATIENT (IF HE IS A FREE WHEELED INTO THE OPERATING ROOM MAN), OR OPENS A TUMOR WITH THE • TALES ABOUND ABOUT SOMEONE GETTING THE OPERATING KNIFE, AND CUTS OUT THE WRONG LIMB AMPUTATED, OR THE WRONG KIDNEY REMOVED EYE, HIS HANDS SHALL BE CUT OFF. • THERE ARE EVEN INCIDENCES OF PATIENTS LAW # 218 CATCHING FIRE WHILE BEING CAUTERIZED 47 48 8
  • 9. 08/04/2010 SURGICAL CARE AND SAFETY FOCUS AREAS • SURGICAL CARE ESSENTIAL COMPONENT • INFECTION PREVENTION OF HEALTH CARE FOR OVER A CENTURY • SURGICAL SAFETY UNRECOGNIZED AS • ANESTHESIA SAFETY PUBLIC HEALTH ISSUE • SAFE SURGICAL TEAMS • LACK OF DATA ON SURGERY AND • MEASUREMENT OUTCOMES • FAILURE TO USE EXISTING SAFETY KNOW- HOW 49 50 HOW DOES AVIATION DO IT? HOW DOES AVIATION DO IT? • SURVEILLANCE • CULTURE CHANGE • VARIATION MITIGATION – CHECK-COUNTER CHECK – REGULATIONS AND RULES – REGULATORS – CHECKLISTING 51 52 SURGICAL SAFETY CHECKLIST SURGICAL SAFETY CHECKLIST • CHECKLIST IDENTIFIES THREE PHASES OF AN OPERATION IN THE NORMAL FLOW OF WORK: – BEFORE THE INDUCTION OF ANAESTHESIA ("SIGN IN") – BEFORE THE INCISION OF THE SKIN ("TIME OUT") AND – BEFORE THE PATIENT LEAVES THE OPERATING ROOM ("SIGN OUT") • IN EACH PHASE, A CHECKLIST COORDINATOR MUST CONFIRM THAT THE SURGERY TEAM HAS COMPLETED THE LISTED TASKS BEFORE IT PROCEEDS WITH THE OPERATION • IMPLEMENTATION MANUAL: DESIGNED TO HELP ENSURE THAT SURGICAL TEAMS ARE ABLE TO IMPLEMENT THE CHECKLIST CONSISTENTLY 53 54 9
  • 10. 08/04/2010 STUDY RESULTS PROCESS MEASURES BASELINE CHECKLIST P-VALUE OBJECTIVE AIRWAY 64.0% 77.2% <0.001 EVALUATION ABX AT 0-60 MINS EXCEPT DIRTY 56.1% 82.6% <0.001 CASES VERBAL PT/SITE CONFIRMATION 54.4% 92.3% <0.001 TWO IVS /CENTRAL LINE IF EBL≥500 58.1% 63.2% 0.32 PULSE OXIMETER 93.6% 96.8% <0.001 SPONGE COUNT 84.6% 94.6% <0.001 ALL SIX SAFETY New England Journal of Medicine 360:491-9. (2009) INDICATORS DONE 34.2% 56.7% <0.001 55 56 RESULTS – ALL SITES CHANGES BY INCOME CLASSIFICATION BASELINE CHECKLIST P VALUE CASES 3733 3955 - CHANGE IN CHANGE IN DEATH 1.5% 0.8% 0.003 COMPLICATIONS DEATH ANY COMPLICATION 11.0% 7.0% <0.001 HIGH INCOME 10.3% -> 7.1%* 0.9% -> 0.6% SSI 6.2% 3.4% <0.001 LOW AND MIDDLE 11.7% -> 6.8%* 2.1% -> 1.0%* INCOME UNPLANNED REOPERATION 2.4% 1.8% 0.047 * p<0.05 57 58 STUDY CONCLUSION FRANCE – JANUARY 2010 IMPLEMENTATION OF THE CHECKLIST • THE "SAFE SURGERY SAVES LIVES" WAS ASSOCIATED WITH PROGRAM IS COMPULSORY SINCE CONCOMITANT REDUCTIONS JANUARY 2010 IN ALL OPERATING IN THE RATES OF DEATH THEATRE ON FRENCH TERRITORY AND COMPLICATIONS AMONG • THE HIGH HEALTH AUTHORITY PATIENTS AT LEAST 16 YEARS OF AGE WANTS TO WHO WERE UNDERGOING – INCREASE PATIENT SECURITY NONCARDIAC SURGERY IN A DIVERSE GROUP OF HOSPITALS – IMPROVE THE QUALITY OF CARE New England Journal of Medicine 360:491-9. (2009) 59 60 10
  • 11. 08/04/2010 FOCUS ON BMT FOCUS ON BMT • JACIE AND HUMAN TISSUE AUTHORITY • THE RISK WAS ASSESSED AND DEEMED REQUIRE THAT ALL DONORS ARE TO REQUIRE CORRECTIVE ACTIONS AS IT ASSESSED FOR PUT BOTH DONORS AND RECIPIENTS AT – KEY INFECTIOUS DISEASE MARKERS RISK – TRAVEL HISTORY AND • THEREFORE A STANDARD DONOR – RELEVANT MEDICAL HISTORY ASSESSMENT FORM WAS PRODUCED TO • OFTEN KEY TESTS/ASSESSMENTS WERE ENSURE ALL RELEVANT MEDICAL HISTORY BEING MISSED AND NOT PROPERLY IS RECORDED RECORDED 61 62 CORRECTIVE ACTION RISK MANAGEMENT IN SCT • A STEM CELL SPILLAGE OCCURS, CAUSED BY THE GIVING SET BECOMING DISCONNECTED FROM THE BAG OF CELLS, DURING THE INFUSION • THIS IS CLEARLY A SERIOUS INCIDENT FOR A TRANSPLANT PATIENT 63 64 RISK MANAGEMENT IN SCT RISK MANAGEMENT IN SCT • THE RISK MATRIX IS USUALLY COMPLETED • HOWEVER THIS IS A HIGH RISK INCIDENT FROM THE POINT OF VIEW OF THE WIDER FOR TRANSPLANT AS IT HAS A HIGH HOSPITAL PROBABILITY OF OCCURRING AGAIN IN • HENCE, SCORED AS LOW RISK AS IT HAS THIS POPULATION AN INTERMEDIATE RISK TO THE PATIENT – IF THIS IS AN AUTOLOGOUS TRANSPLANT WITH 20 BAGS OF CELLS AND ONE IS LOST, THIS IS OF LOW RISK TO (NOT ALL OF THE CELLS WERE LOST) AND THE PATIENT A LOW PROBABILITY OF HAPPENING – IF THIS IS AN ALLOGENIC TRANSPLANT WITH A SINGLE AGAIN BASED ON THE WIDER HOSPITAL BAG OF CELLS ANY SPILLAGE WOULD BE OF HIGH RISK TO THE PATIENT PATIENT POPULATION 65 66 11
  • 12. 08/04/2010 RISK MANAGEMENT IN SCT RISK MANAGEMENT IN SCT • THE FOLLOWING CORRECTIVE ACTIONS WERE • THEREFORE THIS EVENT HAS TO BE PUT INTO PLACE: INVESTIGATED AND CORRECTIVE ACTIONS – CHECK STEM CELL ADMINISTRATION SOP HAS CORRECT PUT IN PLACE PROCEDURE AND UPDATE – RETRAIN NURSES IN ADMINISTRATION OF STEM CELLS • THIS IS THE ROLE OF DISCUSSION/ – TAPE THE GIVING SET TO THE BAG OF CELLS INVESTIGATION OF ADVERSE EVENTS BY – PIERCE THE BAG OF CELLS OVER A STERILE TRAY, SO THE QUALITY MANAGEMENT SYSTEM THE CELLS COULD BE RETRIEVED IF THE SPILLAGE OCCURS AT THIS POINT • THERE IS STILL A RESIDUAL RISK AS THERE IS ALWAYS THE POSSIBILITY OF HUMAN ERROR/EQUIPMENT FAILURE BUT THIS IS DEEMED TO BE ACCEPTABLE RISK 67 68 RISK MANAGEMENT? HOLISTIC APPROACH TO RISK PEOPLE AND COMPLIANCE TO BEHAVIORS POLICIES AND STANDARDS STANDARD ARCHITECTURE OPERATING AND TECHNOLOGY PROCEDURES 69 70 A GOOD PROCESS AND A LAST THOUGHT MEASURE IT IS UNWISE TO BE TOO SURE OF ONE'S OWN WISDOM. IT IS HEALTHY TO BE COMMUNICATE REMINDED THAT THE STRONGEST MIGHT WEAKEN IMPROVE ANALYZE AND THE WISEST MIGHT ERR. GANDHI 71 72 12
  • 13. What is JACIE The Role of Quality A set of agreed standards to ‘promote Management within JACIE quality medical and laboratory Standards practice in haematopietic progenitor cell transplantation’ JACIE standards transplantation’ The speaker declares that there is no conflict Version4 of interest in relation to this talk Inspections every 4 years with interim Nina Som SCT Quality Manager audit after 2 years. University Hospitals Bristol NHS Foundation Trust Voluntary process in most countries Who can apply? Who can inspect? Any clinical, collection or processing Peer review process, all inspectors facility involved in volunteers transplantation/therapies using Clinical inspector must be a Doctor cellular products Collection inspector can be a Nurse Minimum transplant requirements for Processing inspector can be a clinical centres: Scientist Allogeneic 10 new patients per year. All must be suitably qualified and Autologous 5 new patients per year. completed inspector training What is Quality Management? Why QM in HSCT? ‘An integrated programme of quality assessment, assurance, control and It is a requirement of the improvement’ JACIE Standards improvement’ Version 4 JACIE standards! A way to solve problems that were previously accepted as an unavoidable part of the service provided.
  • 14. Quality Management & JACIE Implementing QM in HSCT QM can exist without JACIE, however Identify persons responsible for JACIE cannot be achieved without implementing QM QM Start small and build on success QM must be an active useful part of the programme function Get advice from similar centres who QM & JACIE both focused on have already achieved accreditation continuous service/system improvement Benefits of QM -1 Benefits of QM - 2 Meet not only JACIE standards but SOP’s are a valuable training tool and local/national standards and laws standardise procedures Have an active problem solving Adverse events and near miss events approach dealt with proactively High quality services provided to all Systems transparent to both staff and users and improve staff working lives users And Finally…………. Finally…………. Any Questions
  • 15. 2nd Quality Management Meeting Vienna, Austria EBMT 2010 The European Group Blood and MarrowMarrow Transplantation The European Group for for Blood and Transplantation The European Group for Blood and Marrow Transplantation
  • 16. Applicant and the Inspector’s experience of the Quality Management System Pierre-Emmanuel DONOT Dr Catherine FAUCHER Vienna March 24th 2010 The European Group for Blood and Marrow Transplantation
  • 17. The quality management system for the applicant : • The first thing you start… • …that is nearly impossible to see… • …and that you’ll never finish ! • The quality management system : • A whole structure, built for continualy improve the way we work. The European Group for Blood and Marrow Transplantation
  • 18. The QMS for the inspector : a lot of work done…but not enough time Need to come back with evidences Deviations documentation Quality management meetings minutes Adverse events workflow and document control Quality indicators reviews The European Group for Blood and Marrow Transplantation
  • 19. B 4 Quality management (V2 march 2007) Quality manual Audit Reporting of errors, accidents and adverse reactions (AEs) The European Group for Blood and Marrow Transplantation
  • 20. Inspectors guidelines (1) Audit Requirements must perform audit must use results of audits to achieve improvement. Audit results and improvement strategies must be reviewed with documentation in accordance with the QMP Evidences Evidence of regular audits or reviews Evidence of change of practice and re-audit The European Group for Blood and Marrow Transplantation
  • 21. Inspectors guidelines (2) AE reporting requirements a system for detecting, evaluating, documenting and reporting errors, accidents, etc AEs must be reviewed by the Programme Director. Description available to physicians, collection/processing If applicable, report to the appropriate regulatory agency Document deviations from key SOP (donor, administration of conditioning, HPC) planned or unplanned evidence Evidence of a system for detecting and reporting errors, accidents and AE s Evidence that AEs are reviewed by PD Evidence that the system is used - Note number of AEs The European Group for Blood and Marrow Transplantation
  • 22. Common problems with Clinical Programme • Different units not functioning as a single programme - (lack of common training, common SOPs, close and regular interaction) • Training of medical staff not documented • Quality management problems – Adverse event reporting not adequate (e.g. adverse events not reviewed by Programme director) – No regular audits or infrequent audits The European Group for Blood and Marrow Transplantation
  • 23. and The quality management program (V4) • B.4.1.1 : « There shall be a Clinical Program Quality Management Program that incorporates the information from clinical, collection, and processing facility quality management ». • « The Quality Management Program consists of a description of a strategy (QM Plan) and the associated policies and procedures wich drive the operation of the QM program » The European Group for Blood and Marrow Transplantation
  • 24. Inspection of the CLB clinical program adult (auto) March 2007 What we already had : • A quality « spirit » : – Because our top management was totally aware of this necessity. – Because we had experienced the french national certification – Because, of course, of the great amount of work of the quality team ☺ The European Group for Blood and Marrow Transplantation
  • 25. The Quality structure in the Lyon Anticancer Center Quality Management System = Quality Management Program + Quality Management Tools The European Group for Blood and Marrow Transplantation
  • 26. Visit preparation : applicant • Of course, you send all the documentation needed by JACIE but for the day of the visit, is there a way to make your quality management system understandable by someone who doesn’t know your programme ? The European Group for Blood and Marrow Transplantation
  • 27. Visit preparation : inspector Try to understand the ORGANISATIONAL CHART of key personnel and functions, interactions between the three parts of the program. search for AUDIT plan look at the way to perform REPORTING OF AE read the SOP of SOP verify the DOCUMENT CONTROL organisation HOW to prepare the questions to the quality manager? reading thoroughly the Quality management plan /manual The European Group for Blood and Marrow Transplantation
  • 28. Inspector : interview of the quality manager Quality management plan /manual ORGANISATIONAL CHART of key personnel and functions? AUDITS? REPORTING OF AE? SOP of SOP? DOCUMENT CONTROL? The European Group for Blood and Marrow Transplantation
  • 29. The European Group for Blood and Marrow Transplantation
  • 30. Audit plan • On the day of the visit, we didn’t have a formalized audit plan. The European Group for Blood and Marrow Transplantation
  • 31. Audits • Every SOP’s was written in a way you can easily make an audit. • But, during the first year, we focused on the Med A form because we wanted to improve our patient data system. • The only audit we made was about the risks and benefits explanation The European Group for Blood and Marrow Transplantation
  • 32. Adverse Events • On the day of the inspection, the AE workflow was not clearly identified. AE Quality Program electronic annual Director declaration meeting Quality Team The European Group for Blood and Marrow Transplantation
  • 33. The European Group for Blood and Marrow Transplantation
  • 34. The European Group for Blood and Marrow Transplantation
  • 35. Document control • For the inspection, two documentation control systems were existing, one using paper, and the one electronic. • We were putting in place the Electronic Document Control software • However the most importants procedures were already revised once on the day of the visit. The European Group for Blood and Marrow Transplantation
  • 36. Inspector report : interview of the quality manager Quality management plan /manual ORGANISATIONAL CHART of key personnel and functions? Very clear AUDITS? were not planned, as the inspection was done just after the initiation of QMP REPORTING OF AE? not clear if they were reviewed by Programme Director SOP of SOP? Very clear DOCUMENT CONTROL? Not clear because coexistence of 2 systems The European Group for Blood and Marrow Transplantation
  • 37. Inspector vision: other interviews to help assessing the QMP Quality management plan /manual Personal training and maintenance? interactions between the clinic/lab/apheresis facilities data management quality meetings? SOP knowledge by the transplant team? The European Group for Blood and Marrow Transplantation
  • 38. The Quality Manual • Description of every processes involved in the JACIE program. • Moreover, several quality points seemed to be described : – The document control – The Direction meetings – The adverse events review and workflow – Indicators – Training – Emergency SOP’s The European Group for Blood and Marrow Transplantation
  • 39. The Management Review • At the beginning, once a month • 12 months 3 months : twice a month • 3 months visit day : once a week • And…after the inspection : twice a year… ☺ The European Group for Blood and Marrow Transplantation
  • 40. The European Group for Blood and Marrow Transplantation
  • 41. After the visit • As the inspectors pointed out the main deficiencies of our Quality Management Plan, we dedicated the first following year to : – Build the replies to the inspection report – Improve our own Quality Management system. • All the staff was pleased to take the recomendations and advices of the inspector as a way to improve the daily work. • They did not felt to be judged but that their work was recognized and they were asked to go further. The European Group for Blood and Marrow Transplantation
  • 42. Quality System Process Management Patient and Culture and Patient Participation Development, improvement and control Client Participation Behavior Within Quality Systems Vienna 2010 Communication, Report and Inspection 2nd EBMT Quality Management Meeting J. Besteman VUmc Amsterdam, the Netherlands Participation Ladder Question high Patient defines Partnership (Influence patient) Who has patient participation built into their Advise quality system, to improve the quality of Consult care? low Inform high (Influence low professional) Question Question What are the results and benefits of patient What is needed to make patient participation participation? successful? 1