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© 2008 Universitair Ziekenhuis Gent
JACIE: the experience of a medical director
Annual BHS Meeting
JACIE Session
Prof. Dr. Tessa Kerre
Hematology Dept Ghent University Hospital
January 24th 2013
2 2 © 2008 Universitair Ziekenhuis Gent
Once upon a time…
3 3 © 2008 Universitair Ziekenhuis Gent
Once upon a time…
4 4 © 2008 Universitair Ziekenhuis Gent
The JACIE experience of a medical director
How it all begun
Overview of the Ghent University Hospital Program
The evil: the challenges/obstacles/pitfalls
The good: the keypersons
The katharsis: the inspection
The happy end
The sequel!
5 5 © 2008 Universitair Ziekenhuis Gent
How it all begun
2004: small group of MD’s and QCs (ped+hem+red cross)
2006: rejuvenation with bigger group: once a month
once a week once a month
2010: QC resigns
5/2010: new QC
9/2011: JACIE submission file sent in
4/2012: preliminary program of JACIE inspection
1 week before inspection: definitive program of JACIE
inspection
5/2012: JACIE inspection
6 6 © 2008 Universitair Ziekenhuis Gent
The JACIE experience of a medical director
How it all begun
Overview of the Ghent University Hospital Program
The evil: the challenges/obstacles/pitfalls
The good: the keypersons
The katharsis: the inspection
The happy end
The sequel!
Stem cell transplant program
Program Director
Principal investigator variable
SCT PHO
Medical director SCT hematology
Medical director
Donor Management
HSC Processing Medical director
Collection Bone Marrow, hematology Medical director
Collection Apheresis
Medical director
Quality coordinator
PHO/SCT Hematology/SCT Nephrology/hemodialysis
Collectio Bone marrow PHO Medical director
Quality coordinator
Quality coordinator
Quality coordinator
Quality coordinator
Quality coordinator
PHO : pediatric hemato-oncology SCT : stem cell transplantation
Donor management hematology Medical director
Donorbeheer PHO Medical director
Cell therapy
Hematology
Pediatrics
Nephrology
Clinical Biology
Bank management
Bank director
Bank management
Bank director
Collection Apheresis
Hematology/SCT PHO/SCT
Hematopoietic stem cell processing
Stem cell transplantation program
Program Director
Quality coordinator
Foto NLoo
• Quality Management Plan (QMP)
• Yearly meeting: QMP report
• Yearly meeting: outcome analysis
• Final responsibility JACIE accreditation
Overview stem cell transplantation program
Hematology
Pediatrics
Nephrology
Clinical Biology
• Common document management
• Common registration non-conformaties
• Common SOP Internal auditing
• Common SOP education
• Common workflows
• Common definitions
Hematology
Pediatrics
Nephrology
Clinical Biology
Stem cell transplantation program
Program Director
Quality coordinator
Overview stem cell transplantation program
Hematology
Pediatrics
Nephrology
Clinical Biology
Stem cell transplantation program
Program Director
Quality coordinator
Overview stem cell transplantation program
Monthly stem cell transplant meeting
• Donor searches
• Aphereses and bone marrow harvests
• Cell processing procedures
• Conditioning
• Transplant planning
• Transplant follow-up
Stem cell transplant program
Program Director
SCT PHO
Medical director SCT hematology
Medical director
PHO/SCT Hematology/SCT
Quality coordinator
Quality coordinator
Hematology
Pediatrics
Collection, Bone marrow, hematology Medical director
Collection, Bone marrow, PHO Medical director
Donor management hematology Medical director
Donor management PHO Medical director
Bank managament
Bank director
Quality coordinator
Clinical Unit – Adults: Hematology Layout in the program
PHO : pediatric hemato-oncology SCT : stem cell transplantation
Hematology/SCT: 9K12
Hospitalisation
Hematology/SCT: 9K12
Poli /secretarial offices
Hematology/SCT: 3K12
Day Clinic: BAS
Hospitalisation
Clinical Unit – Adults: Hematology Location
Stem cell transplant program
Program director
SCT hematology
Medical director
Hematology/SCT
Quality coordinator
Collection, Bone marrow, hematology Medical director
Donor management hematology Medical director
Quality coordinator
Lucien Noens
Tessa Kerre
Eva Steel
Liesbet Cabooter
Lucien Noens
Clinical Unit – Adults: Hematology Location
Bank managament Bank manager
Ghent University Hospital
Sector Bloed Ademhaling Spijsvertering
Hematology department
Stem cell transplant program HEM
Medical director
donor management
MD, hematologist
Nurses
nursing consulent
hematology/ nurse
specialist hematology
Medical director
bone marrow harvest
Coordinators
Clinical trials
Quality coordinator
Medical director
SCT
MD, hematologist
hematologist
In training
Head nurse Logistics/
Secretarial offices
Stem cell transplant coordinator
Clinical Unit – Adults: Hematology Local organogram
Ghent University Hospital
Sector Bloed Ademhaling Spijsvertering
Hematology department
Stem cell transplant program HEM
Medical director
donor management
MD, hematologist
Nurses
nursing consulent
hematology/ nurse
specialist hematology
Other services with
personnel
dedicated to the
department
Psychologist
•Physical therapist
•Psychologist
•Social workers
•Cleaning
personnel
Other general
services without
personnel
dedicated to the
program
• Tip-ploeg
• Dalkia
•….
Medical director
bone marrow harvest
Coordinators
Clinical trials
Quality coordinator
Medical director
SCT
MD, hematologist
hematologist
In training
Head nurse Logistics/
Secretarial
offices/cleaning
personnel
Stem cell transplant coordinator
Clinical Unit – Adults: Hematology Local organogram
Ghent University Hospital
Sector Bloed Ademhaling Spijsvertering
Hematology department
Stem cell transplant program HEM
Medical director
donor management
MD, hematologist
Nurses
nursing consulent
hematology/ nurse
specialist hematology
Other services with
personnel
dedicated to the
department
Psychologist
•Physical therapist •Psychologist
•Social workers
•Cleaning
personnel
Other general
services without
personnel
dedicated to the
program
• Tip-ploeg
• Dalkia
•….
Medicxal director
bone marrow harvest
Coordinators
Clinical trials
Quality coordinator
Medical director
SCT
MD, hematologist
hematologist
In training
Head nurse Logistics/
Secretarial
offices/cleaning
personnel
Stem cell transplant coordinator
Clinical Unit – Adults: Hematology Local organogram
MDs in consult: - Cardiology - Nephrology - Pneumology - Gastro-enterology - …
Departments where SCT patients are treated: - Radiotherapy - Intensive Care - Emergency department - ….
18 18 © 2008 Universitair Ziekenhuis Gent
Activity Numbers 2011 Numbers 2012
Donor management autologous 38
Donor management allogeneic (RD) 12
Donor management allogeneic (UD) 9
Bone marrow harvests 2 2
Autologous stem cell transplantations 26 28
Allogeneic stem cell transplantations
(RD) 13 9
Allogeneic stem cell transplantations
(UD) 14 17
Overview of the program
19 19 © 2008 Universitair Ziekenhuis Gent
The JACIE experience of a medical director
How it all begun
Overview of the Ghent University Hospital Program
The evil: the challenges/obstacles/pitfalls
The good: the keypersons
The katharsis: the inspection
The happy end
The sequel!
20 20 © 2008 Universitair Ziekenhuis Gent
The evil
The Work!
The administration
Yourself
Getting everyone involved AND enthusiastic
SAE reporting (IML)
Outcome analysis
21 21 © 2008 Universitair Ziekenhuis Gent
The evil: The Work
FACT = JACIE means a lot of work take your time!
The standards: read, read, read, then put away
Find your own system: logical tree (may take a while:
take your time, this is important!): start from reality! –
what is according standards, what not?
Write SOPs, guidelines tree
Regularly check standards, start early with check list
22 22 © 2008 Universitair Ziekenhuis Gent
The evil: The Work
23 23 © 2008 Universitair Ziekenhuis Gent
The evil: The Work
24 24 © 2008 Universitair Ziekenhuis Gent
The evil: the administration
FACT = JACIE will increase the adminstrative burden
The trick is to make it as easy as possible for the people actually doing the work (and having only little time left as it is):
Make the documents easily trackable and found (online/search list)
Prepare paperwork as much as possible and present it to the responsible person
Eg HSC collection, preSCT, …
Create weekly short meeting to plan everything and remind people of what they have to do/ fill in
Remind people of their responsabilities
Be patient: it takes time to get people involved (don’t assume people are unwilling or contrite)
Don’t focus on the negative, but on the positive!
25 25 © 2008 Universitair Ziekenhuis Gent
The evil: the administration
Quarterly meeting within local program (clinical)
SAE’s
Audits: results of passed audits and planned audits
Changes to documents that are necessary/planned
New processes/documents + reading lists
26 26 © 2008 Universitair Ziekenhuis Gent
The evil: the administration
27 27 © 2008 Universitair Ziekenhuis Gent
The evil: the administration
28 28 © 2008 Universitair Ziekenhuis Gent
The evil: yourself!
Don’t try to make it perfect/complicated/awesome from
the first time!
More work!
Frustrating: nobody will read your marvellous SOPs and
guidelines conclusion: they are not that marvellous
Think pragmatic! The goal is not that all documents are
perfect, but that you have a good system, complient with
the standards, that people use and follow!
Sometimes it is necessary to put your pride aside for a
while!
29 29 © 2008 Universitair Ziekenhuis Gent
The evil: getting everyone involved and enthusiastic
Create a small group of enthusiastic people that are also
INVOLVED in daily practice = core group
Be enthusiastic yourself! –it will be sometimes hard to
REMAIN it!
Begin with small, easily reachable goals that impact
patient care: if people see that things change for the
better for the patients, they will be more easily
convinced
Make the SOPs and guidelines found, read, used and
followed!
30 30 © 2008 Universitair Ziekenhuis Gent
The evil: outcome analysis
Long process
Quality indicators (set standards, based on literature and historic numbers in own center)
Collection apheresis: number of HSC after apheresis and processing: minimal/ideal set beforehand: %<min (expected <10%): all patients that were below: explanations?
Number of HSC for SCT: min/ideal: all patients that were below: explanations? Outcome?
Neutrophil engraftment (<30d) – thrombocyte engraftment (<25d)
%aGVHD, %cGVHD
SCT survival D+100, 1year
Outcome analysis table
Yearly Outcome analysis meeting with whole program: trend analysis
31 31 © 2008 Universitair Ziekenhuis Gent
The evil: outcome analysis
Mobilisation – apheresis – processing
Apheresis – processing affiliated hospital 1
Apheresis – processing affiliated hospital 2
Processing affiliated hospital 3
BM register – processing
BM harvest – processing
Autologous until 1 year post SCT / > 1 year
Allogeneic SCT until 1 year post SCT / > 1 year
DLI
32 32 © 2008 Universitair Ziekenhuis Gent
The beasts: outcome analysis
33 33 © 2008 Universitair Ziekenhuis Gent
34 34 © 2008 Universitair Ziekenhuis Gent
The evil: SAE reporting (IML)
For many groups: challenge
Hospital wide online system: very good
Also a good system to adapt procedures that are not
perfect
35 35 © 2008 Universitair Ziekenhuis Gent
The evil: SAE reporting (IML)
36 36 © 2008 Universitair Ziekenhuis Gent
The evil: SAE reporting (IML)
37 37 © 2008 Universitair Ziekenhuis Gent
The evil: SAE reporting (IML)
Some examples
Home Nurse didn’t want to give and did not administer growth
factor for stem cell mobilisation: form was adapted (specification
that the dose is high but correct, in case of questions
hematologist-on-call should be contacted)
Information from affiliated hospitals was incomplete (information
necessary for EBMT/ourselves) incident report new
procedure: form needs to be filled in before procedure can be
started: big improvement!
38 38 © 2008 Universitair Ziekenhuis Gent
The evil: SAE reporting (IML)
Some examples
Stem cell storage at -85°C or liquid N2, dependent on timing for
transplant
patient was already in conditioning when processing facility
contacted clinical unit that the HSC were in -85°C for too
many years (nl <6 m): viability testing was acceptable and
more than enough cells according to protocol could be
infused new procedures to prevent this in the future
Check storage duration/type and viability testing before
conditioning
Systematic alert if planned duration time of SC storage is
almost overdue (and change to other storage type if
applicable)
39 39 © 2008 Universitair Ziekenhuis Gent
The JACIE experience of a medical director
How it all begun
Overview of the Ghent University Hospital Program
The evil: the challenges/obstacles/pitfalls
The good: the keypersons
The katharsis: the inspection
The happy end
The sequel!
40 40 © 2008 Universitair Ziekenhuis Gent
The good
Quality coordinator
Administrative coordinator
Nurse specialists
The patients
Everyone
41 41 © 2008 Universitair Ziekenhuis Gent
The good: quality coordinator
Necessary qualities for a good QC:
Well organized, good insight
Social abilities: you have to work with, stimulate, interact with
and go against many different characters
Strong character (against people that are higher in hierarchy)
Invaluable for program director / medical director: peace
of mind, knowing that someone has it all covered
42 42 © 2008 Universitair Ziekenhuis Gent
The good: administrative coordinator
Administrative burden is very high
Dedicated person that prepares documents and
presents them to the responsible person
Weekly meetings: follow-up donor searches, planning of
aphereses, stem cell transplant, follow-up
Agenda sent beforehand
Overview
Tasks of all people involved listed
If applicable: documents at hand so they can be filled in/signed
43 43 © 2008 Universitair Ziekenhuis Gent
The good: nurse specialists
2 nurse specialists in Ghent
More involved in clinical care (nurse consultation)
Outcome analysis / data coordination
44 44 © 2008 Universitair Ziekenhuis Gent
The good: the patients
Patients have better outcome = our ultimate goal
Master thesis project to evaluate impact in our hospital
Organisation improves: people see the positive effects
of JACIE
Gratwohl et al, JCO, 2011
45 45 © 2008 Universitair Ziekenhuis Gent
The good: everyone!
Team aspect is very important: everyone is important for
the success of the program: cleaning personnel, QC,
nurses, MDs, pharmacists, consulting MDs, …
Briefing / educating / involving EVERYBODY is crucial!
As the date of inspection approaches:
Atmosphere changes
Initial suspicion/distrust/negative attitude disappears and is
replaced by a positive group feeling!
Healthy stress
Common goal
46 46 © 2008 Universitair Ziekenhuis Gent
The JACIE experience of a medical director
How it all begun
Overview of the Ghent University Hospital Program
The evil: the challenges/obstacles/pitfalls
The good: the keypersons
The katharsis: the inspection
The happy end
The sequel!
47 47 © 2008 Universitair Ziekenhuis Gent
The inspection
21/5-22/5/2012 (1.5 d): program was sent 1 week before
Combined inspection of collection, clinical (both adult and
pediatric) and processing
Welcome by program director, QCs and medical directors,
head of department: presentation + pictures
Guided tour of several places (inspection starts here!)
Inspectors stay at their respective facility (always
accompanied by responsible MD/QC) during 1.5 days
End of day 2: closure meeting
Reception
48 48 © 2008 Universitair Ziekenhuis Gent
The inspection
Within 3 months: inspection report
19/6/2012, 15u28: inspection report received
Center has 6 months time to answer all questions
9/2012: all answers sent in
49 49 © 2008 Universitair Ziekenhuis Gent
The JACIE experience of a medical director
How it all begun
Overview of the Ghent University Hospital Program
The evil: the challenges/obstacles/pitfalls
The good: the keypersons
The katharsis: the inspection
The happy end
The sequel!
50 50 © 2008 Universitair Ziekenhuis Gent
The happy end
51 51 © 2008 Universitair Ziekenhuis Gent
The happy end
52 52 © 2008 Universitair Ziekenhuis Gent
The JACIE experience of a medical director
How it all begun
Overview of the Ghent University Hospital Program
The evil: the challenges/obstacles/pitfalls
The good: the keypersons
The katharsis: the inspection
The happy end
The sequel!
53 53 © 2008 Universitair Ziekenhuis Gent
The sequel
The biggest challenge after the inspection: to keep
spirits high, stimulate team
54 54 © 2008 Universitair Ziekenhuis Gent
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