ebmt 2010 quality management meeting slides

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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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• 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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• 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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• 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


Applicant and the Inspector’sexperience of the QualityManagement System

Pierre-Emmanuel DONOTDr Catherine FAUCHERVienna March 24th 2010


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 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


Quality manual

� Audit

� Reporting of errors, accidents and adverse reactions (AEs)

B 4 Quality management

(V2 march 2007)


� 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


�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


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


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 »


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 Quality structure in the Lyon Anticancer Center

Quality Management System =

Quality Management Program+

Quality Management Tools


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 ?


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


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?


Audit plan

• On the day of the visit, we didn’t have a formalized audit plan.


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


Adverse Events

• On the day of the inspection, the AE workflow was not clearly identified.

AEelectronic

declaration

QualityTeam

ProgramDirector

Qualityannual

meeting


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.


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


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 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 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…☺


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?

ebmt 2010 quality management meeting slides

Health & Medicine

analysis of risk risk

whats risk

risk managementof

risk cultureacceptable

definition of risk

type of risk

risk management processes

risk societal trend