JACIE: the experience of a medical director - bhs.be · SCT PHO Medical director SCT hematology...

© 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…


Once upon a time…


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!


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



How it all begun





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


Program Director

Quality coordinator


Hematology

Pediatrics

Nephrology

Clinical Biology


Program Director

Quality coordinator


Monthly stem cell transplant meeting

• Donor searches

• Aphereses and bone marrow harvests

• Cell processing procedures

• Conditioning

• Transplant planning

• Transplant follow-up


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 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


Poli /secretarial offices


Day Clinic: BAS

Hospitalisation

Clinical Unit – Adults: Hematology Location


Program director

SCT hematology

Medical director

Hematology/SCT

Quality coordinator

Collection, Bone marrow, 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





Medical director

donor management

MD, hematologist

Nurses

nursing consulent

hematology/ nurse


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


Secretarial

offices/cleaning

personnel







Medical director

donor management

MD, hematologist

Nurses

nursing consulent

hematology/ nurse


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


Secretarial

offices/cleaning

personnel



MDs in consult: - Cardiology - Nephrology - Pneumology - Gastro-enterology - …

Departments where SCT patients are treated: - Radiotherapy - Intensive Care - Emergency department - ….


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



How it all begun





The happy end

The sequel!


The evil

The Work!

The administration

Yourself

Getting everyone involved AND enthusiastic

SAE reporting (IML)

Outcome analysis


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


The evil: The Work


The evil: The Work


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!



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






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!


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!


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


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


The beasts: outcome analysis



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







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!



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)



How it all begun





The happy end

The sequel!


The good

Quality coordinator

Administrative coordinator

Nurse specialists

The patients

Everyone


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


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


The good: nurse specialists

2 nurse specialists in Ghent

More involved in clinical care (nurse consultation)

Outcome analysis / data coordination


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


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



How it all begun





The happy end

The sequel!


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


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



How it all begun





The happy end

The sequel!


The happy end


The happy end



How it all begun





The happy end

The sequel!


The sequel

The biggest challenge after the inspection: to keep

spirits high, stimulate team


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JACIE: the experience of a medical director - bhs.be · SCT PHO Medical director SCT hematology...

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