EBMT 2010 Quality Management Meeting, Vienna slides from the plenary sessions.

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
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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
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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
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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)
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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
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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
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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
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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
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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
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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
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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