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www.ebmt.org#EBMT2015
"If I was starting again, what would I do differently?"
Case 2: Mara Magri, Quality OfficerHaematopoietic stem cell Transplant Program, Papa Giovanni XXIII, Bergamo ITALY
24 March 2015
2
Haematopoietic Transplant Programme
Bergamo -Italy
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
Hematology and Bone Marrow Transplant Unit
A. Rambaldi
Bone Marrow Collection
Facility
F. Lussana
HPC Processing
Facility
ATMP Factory
M. Introna
Clinical Unit
Inpatient Clinic
HPC Transplant Center
Outpatient Unit
A. Grassi
Laboratory for haematological
disease diagnosis
O. Spinelli
3
UNI EN ISO Certification
Our experience
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
JACIE Accreditation
Certification of HPC collection facility and of Tissue establishment by National Competent Authority
ATMP Laboratory Accreditation by National Competent Authority
Different standards but similar approach
4
Two kinds of mistake
1. evident from the very beginning of accreditation process
2. discovered during the inspection thanks to the inspectors and their different point of view
just like a diet!!!
Some mistakes are easy to fix but others are not....
Why?
I did not really understand or accept them…
my adjustment is only a patch for the summary report
Mistakes during Accreditation/Certification process
Quality Officer experience
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
5
Well!!! ….. We have finished!!!
Now we can go back to our normal life .......
BUT
Sometimes we need to change our life style or our way of thinking just like after a diet
Changes must be operative if we want them
to be durable and efficient
Post inspection Mistakes
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
before after after some time
6
Pre-inspection
• Preparation and organization of the documents
• Timetable planning and management
• Communication, duties and relationship among Programme areas
Post-inspection
• Continual improvement of the quality management system
Dangerous areas
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
7
WRITE.... WRITE.... AND WRITE ONCE MORE
Really too much
Lack of experience
how can I demonstrate this activity? Ok I will write it
Lack of self-confidence
Surely the inspector will ask me the SOP for this……
JACIE doesn't ask to write everything, but only some SOPs detailed in the Manual. We are free to write what we really need to write
Preparation and Organization of documents
Mistake # 1
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
8
OK now we have the Quality Officer and he/she will write what we need!!!!
REMEMBER
Good SOPs are written by people who daily do the activities described in the document
Consequences:
- SOP far from the real daily activity
- SOP that nobody will read and use
Preparation and Organization of documents
Mistake # 2
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
ONE MAN BAND
9
Preparation and Organization of documents
Mistake # 3
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
Consequence• are you sure that it suits to your
process?
• SOPs photocopy or totally impersonal
The grass is always greener on the other side
ShortcutCould you please send me your SOP for…….?
10
The attachments Exhibition
Example
The organigramme attached to
• SSFEmat
• MQTrapCSE
• IOEmatDeg 25
• IOEmatDeg 24
• IODOE 05
Consequence
Am I able to change the obsolete version everywhere?
Preparation and Organization of documents
Mistake # 4
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
11
Is your timeframe realistic ?
The time from application to accreditation will depend on:
1. The size and complexity of the programme
2. The amount of time and staff that can be dedicated to JACIE
Timetable planning and management
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
Start Accreditation
Process
Documentpreparation
Submit pre -inspectiondocuments
Submitapplication
Inspection
6/12 months 1 months 3 months
2/9 months
12
Timetable planning and management
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
Activity Goals Responsibilities Indicators
Formalizzazione del Programma di Trapianto di CSE
Istituzione formale del Programma di Trapianto di CSE, nomina del Direttore e dei Responsabili
Direzione dell’Azienda Direzione del Programma
Presentazione del Programmaalla Direzione dell’A.O. e richiesta di istituzione del Programma
Comunicazione di Istituzione del Programma
Analisi dei processi del Programma: definizione delle attività, delle risorse, delle responsabilità e stesura del cronoprogramma
• Analisi delle attività, dei processi secondo gli standard JACIE/ISO
• Stesura del piano di azione
• Direttore del Programma• Direzione dell’Ospedale• Responsabile della Qualità
aziendale• Gruppi di lavoro interni al
Programma
• Verbali degli incontri e redazione del piano di azione
Implementazione del pianodi azione
Inizio del processo di Certificazione / Accreditamento fino alla visita ispettiva
• Direttore del Programma• Responsabile della Qualità
aziendale• Gruppi di lavoro interni al
Programma
Verbali dei lavori di gruppo Produzione della
documentazione di qualità Richiesta di Certificazione/
Accreditamento
UNI EN ISO Inspection ISO Certification
• Ente terzo• Direzione del Programma• Personale del Programma
ISO Certificate
JACIE Inspection JACIE Accreditation• Team ispettivo JACIE• Direzione del Programma• Personale del Programma
JACIE Certificate
Expected in 2006 Obtained in 2008
13
Communication, duties and relationship
Mistake # 1
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
REMEMBER
Quality Manager is responsible for
• Implementing
• Maintaining
• And developing the QMS
NOT for operational management
NOT for drafting of the whole documentation
JACIE Accreditation is not a personal goal of the Quality Manager
14
Keep on board
Set up communications and education regarding JACIE
Establish “Quality Management “ on the agenda of staff meetings
Communication, duties and relationship
Mistake # 2
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
Staff members must read and know JACIE standards before writing SOPs
REMEMBERHospital Policy may be different
ConsequenceLack of evidence for JACIE standards
15
Hypertrophy of staff meetings, for demonstrating we work as a single Programme
REMEMBER
Programme Staff have so many
meetings to attend therefore they have
to prioritise and Quality Manager
meetings may get the lowest priority
Do not exceed
Communication, duties and relationship
Mistake # 3
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
16
• Inadequate document control (SOPs not reviewed annually, deviations from SOPs not documented)
• No evidence of regular audits or reviews
• No more information about JACIE developments circulating among the team
• Lack of interaction among the Programme areas (Clinical Unit, Collection facility end Processing laboratory)
• Lack of Continuing education and performance evaluation
• No deviation management
Consequence
All of your hard work in achieving accreditation will become redundant and you will find yourself back at the beginning when applying for reaccreditation
Continual improvement of the quality management system - mystakes
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
17
REMEMBER
JACIE accreditation does not end here - it is a continuous process
Naturally people may be less motivated after accreditation award but it is extremely important that you maintain JACIE within the Programme.
This will make your interim audit and reaccreditation process easier.
Continual improvement of the quality management system - mistakes
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo
18
JACIE inspection site - visit for renewal Accreditation 27-28 April 2015
Avoided mistakes
• Preparation and organization of the documents
Partially avoided mistakes
• Continual improvement of the quality management system
Repeated mistakes
• Timetable planning and management
• Communication, duties and relationship among Programme areas
Conclusions
Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo