2010 quality management meeting slides (4 in 1)
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08/04/2010
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2nd EBMT QUALITY MANAGEMENT MEETING
AN INTRODUCTION TO RISK MANAGEMENT
Marc Czarka, MD, FBCPMManaging Partner HM3A
(Healthcare Market Authorization and Access Associa tes)
DISCLOSURETHIS SPEAKER
DECLARES THAT HE HAS NO CONFLICT OF INTEREST RELATED
TO THIS LECTURE2
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TALKING ABOUT RISK IS, OF COURSE, ONE OF
THE RISKIEST THINGS ONE CAN DO: THERE ARE SO MANY EXPERTS ABOUT !
J.D.Remington, HSE, UK
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WHAT’S RISK ?
THE RISK THE FIRST SPEAKER
WILL LOOK UPwikipedia.org/wikipedia.org/historical_backgroundhistorical_background/ “the definition of risk”/ “the definition of risk”
it’s very simple
WHAT’S RISK ?• EXPECTED VALUE OF ONE OR MORE
RESULTS OF ONE OR MORE FUTURE EVENTS
• MEASURED BY ITS LIKELYHOOD AND CONSEQUENCE WHICH MAY BE POSITIVE OR NEGATIVE
• GENERAL USAGE FOCUSES ON POTENTIAL HARM– INCURRING A COST (DOWNSIDE RISK)– FAILING TO ATTAIN SOME BENEFIT (UPSIDE
RISK)5Wikipedia 6
ONCE RISK WAS IN THE HANDS OF "OTHERS"
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AGAINST THE GODS
• HISTORY OF MATHEMATICAL ANALYSIS OF RISK
• LED TO THE DEVELOPMENT OF INSURANCE AND FINANCIAL MARKETS
• VAST INDUSTRIES NOW DEPEND ON COMPLEX RISK MANAGEMENT TECHNIQUES INCLUDING THE HEALTHCARE INDUSTRY!
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AGAINST THE GODS
• I RECOMMEND READING IT AS THE RISK IS LIMITED TO – LIST PRICE: $19.95 – PRICE ON AMAZON.COM: $13.57 &
ELIGIBLE FOR FREE SUPER SAVER SHIPPING ON ORDERS OVER $25
– YOU SAVE: $6.38 (32%) • THEN AFTER YOU FINISH WITH THIS
ONE CONTINUE WITH TALEB'S BLACK SWAN
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BLACK SWAN
• TALEB HIGHLIGHTS THE DANGER OF THE UNEXPECTED
• IT WILL HAPPEN – EVEN IF WE HAVE A COMFORTABLE MODEL PREDICTING ONLY MINOR CHANGES
• AFTER SUCH A "BLACK SWAN" CATCHES US BY SURPRISE, WE USE OUR FLAWED HINDSIGHT TO DECIDE HOW WE COULD HAVE PREDICTED THE DISASTER USING A BETTER MODEL
• WE NEED BETTER STRATEGIES TO LIVE IN A WORLD WHERE TRULY RANDOM, UNPREDICTABLE EVENTS OCCUR
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AGAINST THE GODS
GROWING BODY OF EVIDENCE THAT REVEALS REPEATED PATTERNS OF IRRATIONALITY, INCONSISTENCY,
AND INCOMPETENCE IN THE WAYS HUMAN BEINGS ARRIVE AT DECISIONS AND CHOICES
WHEN FACED WITH UNCERTAINTY Peter L. Bernstein, 1996
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……ACCEPTABLE
…..OR UNACCEPTABLE
That’s if we have a choice …………..
MOST OF US VIEW RISK AS EITHER RISK CULTURE
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RISK CULTURE POTENTIAL ISSUES
• MISALIGNMENT BETWEEN CULTURE AND POLICIES (POTENTIAL NON-COMPLIANCE AND/OR UNDUE RISK)
• BLAMING CULTURE VS. LEARNING CULTURE
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RISK APPETITE
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RISK APPETITE
• IN WESTERN SOCIETIES, RISK APPETITE IS – VERY LOW IN HEALTHCARE, – VERY HIGH IN FINANCIAL MATTERS…
• IN HEALTHCARE, WE OBSERVE A "ZERO-RISK" SOCIETAL TREND
• THE SHIFT OF THE EMA, IN THE EU, FROM DG ENTREPRISE TO DG SANCO IS ANOTHER MOVE IN THE SAME DIRECTION WITH A RENEWED FOCUS ON PATIENT SAFETY
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RISK PERCEPTION
• REMEMBER: FOR THE INDIVIDUAL, PERCEPTION IS REALITY…!
• MAY DIFFER GREATLY FROM TRUE RISK – "EYE OF THE BEHOLDER"PHENOMENON
• SUBJECTIVE JUDGMENT ABOUT THE CHARACTERISTICS AND SEVERITY OF A RISK
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RISK PERCEPTION FROM PUBLIC
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Morgan, 1993
RISK PERCEPTION
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RISK ASSESSMENT
OBJECTIVEANALYTICAL
RATIONAL
RISK PERCEPTION AND RUMOURSUBJECTIVE
HYPOTHETICALEMOTIONAL
EXPERTS PUBLIC
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RISK PERCEPTION AND COMMUNICATION
• EXPERTS ARE GOOD AT COMMUNICATING DATA
• MANY OTHERS, IN THE PUBLIC, ARE GOOD AT COMMUNICATING EMOTIONS…
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THE SIAMESE TWINS
• RISKS AND UNCERTAINTY ARE INHERENT TO ANY ENTREPRISE – THERE IS NO REWARD WITHOUT TAKING RISK
• RISK (MANAGEMENT) HAS TWO FACES– PROTECTING AGAINST VALUE DESTRUCTION– ENSURING VALUE CREATION OPPORTUNITIES
ARE NOT MISSED
• UNDERSTANDING AND MANAGING RISK IS KEY FOR CREATING AND SAFEGUARDING VALUE
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BROAD CATEGORIES OF RISK
• MARKET RISK• FINANCIAL RISK• TECHNOLOGY RISK• PEOPLE RISK• STRUCTURE/PROCESS RISK• HEALTH AND SAFETY RISK
ESSENCE OF RISK MANAGEMENT
FOR BERNSTEIN, IT LIES IN MAXIMIZING AREAS WHERE
WE HAVE SOME CONTROL OVER THE OUTCOME WHILE MINIMIZING AREAS WHERE WE HAVE ABSOLUTELY NO
CONTROL OVER THE OUTCOME AND THE LINKAGE BETWEEN EFFECT
AND CAUSE IS HIDDEN FROM US
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RISK MANAGEMENT PROCESS: MORE THAN JUST A REGULATORY REQUIREMENT
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RISK MANAGEMENT THOUGHT SEQUENCE
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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 ?
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ISO 31000:2009
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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 ORGANIZATI ON,
AND TO A WIDE RANGE OF ACTIVITIES, INCLUDING STRATE GIES AND DECISIONS, OPERATIONS, PROCESSES, FUNCTIONS, PROJECTS, PRODUCTS, SERVICES AND ASSETS
• CAN BE APPLIED TO ANY TYPE OF RISK, WHATEVER ITS NA TURE, 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 DOE S NOT REPLACE THOSE STANDARDS
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KEY QUESTIONS
1. WHAT MIGHT GO WRONG?2. WHAT IS THE PROBABILITY IT WILL GO
WRONG?3. WHAT ARE THE CONSEQUENCES
(SEVERITY)?4. WHAT CAN BE DONE TO REDUCE THE
RISKS?5. IS THERE ACCEPTANCE OF THE RESIDUAL
RISK?
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KEY TASKS
• IDENTIFYING, • ANALYZING, • EVALUATING, • TREATING AND • MONITORING
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THE SYSTEMATIC APPLICATION OF MANAGEMENT POLICIES, PROCEDURES AND PRACTICES TO THE TASKS OF
RISK
RISK ASSESSMENT
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RISK ASSESSMENT
• RISK ASSESSMENTS MEASURE THE RISK, THE POTENTIAL LOSS, AND THE PROBABILITY THAT THE LOSS WILL OCCUR
• ONCE MORE, FOR THE FORMULA FOLKS,
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RISK (R) = PROBABILITY (P) * LOSS VALUE (L)
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RISK ASSESSMENT PROCESS
• SPONSOR• SCOPE• TEAM• START THE CYCLICAL PROCESS
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RISK ASSESSMENT PROCESS
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RISK ENUMERATION
RISK CLASSIFICATION
AND RATING
CONTROL IDENTIFICATIONREPORT
ACTION PLAN AND
EXECUTION
RISK ASSESSMENT
• YOU DO IT EVERY DAY AND DON’T EVEN THINK OF IT THAT WAY
• "IF I DON’T GET MY WIFE A WEDDING’S BIRTHDAY PRESENT, SHE’S GOING TO KILL ME"
• RISK = LOSS (LIFE) * PROBABILITY (DEFINITELY GOING TO HAPPEN = 1)
• IN THIS EXAMPLE, AN APPROPRIATE CONTROL IS BUYING A GIFT
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RISK ASSESSMENT
• PART OF ANY RISK ASSESSMENT IS DETERMINING APPROPRIATE CONTROLS
• THERE CAN BE ALTERNATE CONTROLS TO A DIAMOND RING LIKE– DINNER OUT– A VACUUM CLEANER– AN E-CARD
• SOME CONTROLS MAY NOT BE AS EFFECTIVE, AND ASSESSMENTS SHOULD RECOMMEND EFFECTIVE CONTROLS
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RISK MANAGEMENT
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MITIGATE THE RISK OF ACCIDENTS MITIGATE THE RISK OF INJURY
RISK MANAGEMENT
• ACCOMPLISHED BY – BALANCING RISK EXPOSURE AGAINST
MITIGATION COSTS AND – IMPLEMENTING APPROPRIATE
COUNTERMEASURES AND CONTROLS
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RISK MANAGEMENT OPTIONS
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• FACED WITH RISK, ORGANIZATIONS HAVE FOUR OPTIONS (4Ts):– TERMINATE THE ACTIVITY GIVING RISE TO RISK– TRANSFER RISK TO ANOTHER PARTY– REDUCE RISK BY USING OF APPROPRIATE
CONTROL MEASURES OR MECHANISMS (TREAT)
– ACCEPT THE RISK (WHICH MEANS TOLERATE THE RESIDUAL RISK)
RISK MATRIX
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Impact
Probabilitylow
low
intermediate
intermediate high
high
Keep risk in mind
Take calculated action
Call for action
AVOID - TERMINATE
TREATTRANSFER
TOLERATE
TREAT
RESIDUAL RISK• RISKS THAT STILL REMAIN AFTER COUNTER-
MEASURES & CONTROLS HAVE BEEN DESIGNED• FINAL ACCEPTANCE OF RESIDUAL RISK SHOULD
TAKE INTO ACCOUNT:– REGULATORY COMPLIANCE– ORGANIZATIONAL POLICY– SENSITIVITY AND CRITICALITY OF RELEVANT ASSETS– ACCEPTABLE LEVELS OF POTENTIAL IMPACTS– UNCERTAINTY INCORPORATED IN THE RISK ASSESSMENT
APPROACH ITSELF– COST AND EFFECTIVENESS OF IMPLEMENTATION
• ACCEPTANCE OF RISK SHOULD ALWAYS BE REGULARLY REVIEWED
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CONTEXT ANALYSISCONTEXT ANALYSIS RISK MANAGEMENTRISK MANAGEMENT
time
RISK ASSESSMENTRISK ASSESSMENT
DYNAMIC PROCESS : MONITOR AND REVIEW DYNAMIC PROCESS : MONITOR AND REVIEW –– COMMUNICATE AND CONSULTCOMMUNICATE AND CONSULT
YOU NEED A PLAN !YOU NEED A PLAN !
Impact of threats is
�Within acceptable limits
�At an acceptable cost
�Identify
�Analyze
�Evaluate
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RISK MANAGEMENT PLAN• GOAL: DESCRIBING HOW RISK MANAGEMENT
WILL BE STRUCTURED AND PERFORMED ON A PROJECT
• OUTPUT: A DOCUMENT (OR SET OF DOCUMENTS AND TEMPLATES) WITH PROCEDURES FOR MANAGING RISK THROUGHOUT A PROJECT
• TOPICS IN A RMP WILL INCLUDE– METHODOLOGY– ROLES AND RESPONSIBILITIES– BUDGET AND TIMING– RISK CATEGORIES– RISK PROBABILITY AND IMPACT– RISK DOCUMENTATION– TRACKING
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MISTAKES?
• TALEB HAS PUBLISHED "THE SIX MISTAKES EXECUTIVES MAKE IN RISK MANAGEMENT" IN THE OCTOBER 2009 ISSUE OF THE HBR
• OUR WORLD IS INCREASINGLY BEING SHAPED BY LOW-PROBABILITY, HIGH-IMPACT EVENTS THAT ARE ALMOST IMPOSSIBLE TO FORECAST "BLACK SWANS"
• CONFIRMS THAT RISK MANAGEMENT IS NOT ABOUT FORECASTING BUT IMPACT REDUCTION OF THREATS WE DON’T UNDERSTAND…
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SIX MISTAKES
• MANAGERS MAKE SIX COMMON MISTAKES WHEN CONFRONTING RISK: – THEY TRY TO ANTICIPATE EXTREME EVENTS– THEY STUDY THE PAST FOR GUIDANCE– THEY DISREGARD ADVICE ABOUT WHAT NOT
TO DO– THEY USE STANDARD DEVIATIONS TO
MEASURE RISK– THEY FAIL TO RECOGNIZE THAT
MATHEMATICAL EQUIVALENTS CAN BE PSYCHOLOGICALLY DIFFERENT, AND
– THEY BELIEVE THERE'S NO ROOM FOR REDUNDANCY WHEN IT COMES TO EFFICIENCY
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FOCUS ON HEALTHCARE
• WHICH RISK AND FOR WHOM?– FINANCIAL?– HEALTH?– FOR THE PATIENT?– FOR THE HEALTHCARE PROVIDER?– FOR THE HOSPITAL?– FOR THE PUBLIC OR PRIVATE INSURER?
FOCUS ON HEALTHCARE
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ONE EXAMPLE: SURGICAL SAFETY
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HAMMURABI'S CODE OF LAWS (1780 B.C.)
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IF A PHYSICIAN MAKES A LARGE INCISION WITH THE OPERATING KNIFE,
AND KILLS THE PATIENT (IF HE IS A FREE MAN), OR OPENS A TUMOR WITH THE
OPERATING KNIFE, AND CUTS OUT THE EYE, HIS HANDS SHALL BE CUT OFF.
LAW # 218
OLD URBAN LEGENDS?
• WE'VE ALL HEARD STORIES ABOUT SURGICAL INSTRUMENTS, SPONGES, EVEN NEEDLES BEING LEFT INSIDE A PATIENT
• AT TIMES, THE WRONG PATIENT HAS BEEN WHEELED INTO THE OPERATING ROOM
• TALES ABOUND ABOUT SOMEONE GETTING THE WRONG LIMB AMPUTATED, OR THE WRONG KIDNEY REMOVED
• THERE ARE EVEN INCIDENCES OF PATIENTS CATCHING FIRE WHILE BEING CAUTERIZED
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SURGICAL CARE AND SAFETY
• SURGICAL CARE ESSENTIAL COMPONENT OF HEALTH CARE FOR OVER A CENTURY
• SURGICAL SAFETY UNRECOGNIZED AS PUBLIC HEALTH ISSUE
• LACK OF DATA ON SURGERY AND OUTCOMES
• FAILURE TO USE EXISTING SAFETY KNOW-HOW
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FOCUS AREAS
• INFECTION PREVENTION• ANESTHESIA SAFETY• SAFE SURGICAL TEAMS• MEASUREMENT
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HOW DOES AVIATION DO IT?
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HOW DOES AVIATION DO IT?
• SURVEILLANCE• CULTURE CHANGE• VARIATION MITIGATION
– CHECK-COUNTER CHECK– REGULATIONS AND RULES– REGULATORS– CHECKLISTING
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SURGICAL SAFETY CHECKLIST
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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
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STUDY RESULTS
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New England Journal of Medicine 360:491-9. (2009 )
PROCESS MEASURESBASELINE CHECKLIST P-VALUE
OBJECTIVEAIRWAY EVALUATION
64.0% 77.2% <0.001
ABX AT 0-60 MINS EXCEPT DIRTY CASES
56.1% 82.6% <0.001
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% <0.001ALL SIX SAFETY INDICATORS DONE 34.2% 56.7% <0.001
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RESULTS – ALL SITES
BASELINE CHECKLIST P VALUE
CASES 3733 3955 -DEATH 1.5% 0.8% 0.003ANY COMPLICATION 11.0% 7.0% <0.001
SSI 6.2% 3.4% <0.001UNPLANNED REOPERATION 2.4% 1.8% 0.047
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CHANGES BY INCOME CLASSIFICATION
CHANGE IN COMPLICATIONS
CHANGE IN DEATH
HIGH INCOME 10.3% -> 7.1%* 0.9% -> 0.6%
LOW AND MIDDLE INCOME 11.7% -> 6.8%* 2.1% -> 1.0%*
* p<0.05
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STUDY CONCLUSION
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IMPLEMENTATION OF THE CHECKLIST WAS ASSOCIATED WITH
CONCOMITANT REDUCTIONS IN THE RATES OF DEATH
AND COMPLICATIONS AMONG PATIENTS AT LEAST 16 YEARS OF AGE
WHO WERE UNDERGOINGNONCARDIAC SURGERY
IN A DIVERSE GROUP OF HOSPITALSNew England Journal of Medicine 360:491-9. (2009 )
FRANCE – JANUARY 2010
• THE "SAFE SURGERY SAVES LIVES" PROGRAM IS COMPULSORY SINCE JANUARY 2010 IN ALL OPERATING THEATRE ON FRENCH TERRITORY
• THE HIGH HEALTH AUTHORITY WANTS TO– INCREASE PATIENT SECURITY– IMPROVE THE QUALITY OF CARE
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FOCUS ON BMT
• JACIE AND HUMAN TISSUE AUTHORITY REQUIRE THAT ALL DONORS ARE ASSESSED FOR – KEY INFECTIOUS DISEASE MARKERS – TRAVEL HISTORY AND – RELEVANT MEDICAL HISTORY
• OFTEN KEY TESTS/ASSESSMENTS WERE BEING MISSED AND NOT PROPERLY RECORDED
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FOCUS ON BMT
• THE RISK WAS ASSESSED AND DEEMED TO REQUIRE CORRECTIVE ACTIONS AS IT PUT BOTH DONORS AND RECIPIENTS AT RISK
• THEREFORE A STANDARD DONOR ASSESSMENT FORM WAS PRODUCED TO ENSURE ALL RELEVANT MEDICAL HISTORY IS RECORDED
CORRECTIVE ACTION
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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
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RISK MANAGEMENT IN SCT
• THE RISK MATRIX IS USUALLY COMPLETED FROM THE POINT OF VIEW OF THE WIDER HOSPITAL
• HENCE, SCORED AS LOW RISK AS IT HAS AN INTERMEDIATE RISK TO THE PATIENT (NOT ALL OF THE CELLS WERE LOST) AND A LOW PROBABILITY OF HAPPENING AGAIN BASED ON THE WIDER HOSPITAL PATIENT POPULATION
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RISK MANAGEMENT IN SCT
• HOWEVER THIS IS A HIGH RISK INCIDENT FOR TRANSPLANT AS IT HAS A HIGH PROBABILITY OF OCCURRING AGAIN IN THIS POPULATION – IF THIS IS AN AUTOLOGOUS TRANSPLANT WITH 20 BAGS
OF CELLS AND ONE IS LOST, THIS IS OF LOW RISK TO THE PATIENT
– IF THIS IS AN ALLOGENIC TRANSPLANT WITH A SINGLE BAG OF CELLS ANY SPILLAGE WOULD BE OF HIGH RISK TO THE PATIENT
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RISK MANAGEMENT IN SCT
• THEREFORE THIS EVENT HAS TO BE INVESTIGATED AND CORRECTIVE ACTIONS PUT IN PLACE
• THIS IS THE ROLE OF DISCUSSION/ INVESTIGATION OF ADVERSE EVENTS BY THE QUALITY MANAGEMENT SYSTEM
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RISK MANAGEMENT IN SCT• THE FOLLOWING CORRECTIVE ACTIONS WERE
PUT INTO PLACE:– CHECK STEM CELL ADMINISTRATION SOP HAS CORRECT
PROCEDURE AND UPDATE– RETRAIN NURSES IN ADMINISTRATION OF STEM CELLS– TAPE THE GIVING SET TO THE BAG OF CELLS– PIERCE THE BAG OF CELLS OVER A STERILE TRAY, SO
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
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RISK MANAGEMENT? HOLISTIC APPROACH TO RISK
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PEOPLE AND BEHAVIORS
STANDARD OPERATING PROCEDURES
COMPLIANCE TO POLICIES AND
STANDARDS
ARCHITECTURE AND TECHNOLOGY
A GOOD PROCESS
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MEASURE
ANALYZEIMPROVE
COMMUNICATE
AND A LAST THOUGHT
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IT IS UNWISE TO BE TOO SURE OF ONE'S OWN WISDOM.
IT IS HEALTHY TO BE REMINDED THAT THE
STRONGEST MIGHT WEAKEN AND THE WISEST MIGHT ERR.
GANDHI
The Role of Quality The Role of Quality Management within JACIE Management within JACIE
StandardsStandardsThe speaker declares that there is no conflict The speaker declares that there is no conflict of interest in relation to this talkof interest in relation to this talk
Nina SomNina SomSCT Quality ManagerSCT Quality Manager
University Hospitals Bristol NHS Foundation TrustUniversity Hospitals Bristol NHS Foundation Trust
What is JACIEWhat is JACIE
A set of agreed standards to A set of agreed standards to ‘‘promote promote quality medical and laboratory quality medical and laboratory practice in practice in haematopietichaematopietic progenitor progenitor cell transplantationcell transplantation’’ JACIE standards JACIE standards Version4Version4
Inspections every 4 years with interim Inspections every 4 years with interim audit after 2 years.audit after 2 years.
Voluntary process in most countriesVoluntary process in most countries
Who can apply?
Any clinical, collection or processing facility involved in transplantation/therapies using cellular productsMinimum transplant requirements for clinical centres:
�Allogeneic 10 new patients per year.�Autologous 5 new patients per year.
Who can inspect?
Peer review process, all inspectors volunteers
Clinical inspector must be a DoctorCollection inspector can be a Nurse
Processing inspector can be a ScientistAll must be suitably qualified and completed inspector training
What is Quality Management?What is Quality Management?
‘‘An integrated programme of quality An integrated programme of quality assessment, assurance, control and assessment, assurance, control and improvementimprovement’’ JACIE Standards JACIE Standards Version 4Version 4
A way to solve problems that were A way to solve problems that were previously accepted as an previously accepted as an unavoidable part of the service unavoidable part of the service provided.provided.
Why QM in HSCT?
It is a requirement of the JACIE standards!
Quality Management & JACIE
QM can exist without JACIE, however JACIE cannot be achieved without QMQM must be an active useful part of the programme functionQM & JACIE both focused on continuous service/system improvement
Implementing QM in HSCT
Identify persons responsible for implementing QM
Start small and build on successGet advice from similar centres who have already achieved accreditation
Benefits of QM -1
Meet not only JACIE standards but local/national standards and laws
Have an active problem solving approachHigh quality services provided to all users and improve staff working lives
Benefits of QM - 2
SOP’s are a valuable training tool and standardise procedures
Adverse events and near miss events dealt with proactivelySystems transparent to both staff and users
And FinallyAnd Finally……………………..
Any QuestionsAny Questions
The European Group for Blood and Marrow TransplantationThe European Group for Blood and Marrow Transplantation
2nd Quality
Management
Meeting
Vienna, Austria
EBMT 2010
The European Group for Blood and Marrow Transplantation
The European Group for Blood and Marrow Transplantation
Applicant and the Inspector’sexperience of the QualityManagement System
Pierre-Emmanuel DONOTDr Catherine FAUCHERVienna March 24th 2010
The European Group for Blood and Marrow Transplantation
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
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
Quality manual
� Audit
� Reporting of errors, accidents and adverse reactions (AEs)
B 4 Quality management
(V2 march 2007)
The European Group for Blood and Marrow Transplantation
� 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
Inspectors guidelines (1)
Audit
The European Group for Blood and Marrow Transplantation
�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
Inspectors guidelines (2)
AE reporting
The European Group for Blood and Marrow Transplantation
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
and The quality management program (V4)
• B.4.1.1 : « There shall be a Clinical Program Quality Management Program that incorporatesthe 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
Inspection of the CLB clinicalprogram 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
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
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 makeyour quality management system understandable by someone who doesn’tknow your programme ?
The European Group for Blood and Marrow Transplantation
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
Inspector : interview of the quality managerQuality 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
The European Group for Blood and Marrow Transplantation
Audit plan
• On the day of the visit, we didn’t have a formalized audit plan.
The European Group for Blood and Marrow Transplantation
Audits
• Every SOP’s was written in a way you caneasily 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
Adverse Events
• On the day of the inspection, the AE workflow was not clearly identified.
AEelectronic
declaration
QualityTeam
ProgramDirector
Qualityannual
meeting
The European Group for Blood and Marrow Transplantation
The European Group for Blood and Marrow Transplantation
The European Group for Blood and Marrow Transplantation
Document control
• For the inspection, two documentation control systems were existing, one usingpaper, and the one electronic.
• We were putting in place the ElectronicDocument Control software
• However the most importants procedureswere already revised once on the day of the visit.
The European Group for Blood and Marrow Transplantation
Inspector report : interview of the quality managerQuality 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
Inspector vision: other interviews to help assessing the QMPQuality 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
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
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
The European Group for Blood and Marrow Transplantation
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 workwas recognized and they were asked to go further.
1
Patient Participation
Within Quality SystemsVienna 2010
2nd EBMT Quality Management Meeting
J. Besteman VUmc Amsterdam, the Netherlands
Quality System
ProcessManagement
Development, improvementand control
Patient and Client Participation
Culture and Behavior
Communication, Report and Inspection
Participation Ladder
low(Influence professional)
high
Informlow
Consult
Advise(Influence patient)
Partnership
Patient defineshigh
Question
Who has patient participation built into their quality system, to improve the quality of care?
Question
What are the results and benefits of patient participation?
Question
What is needed to make patient participation successful?
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