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www.ebmt.org #EBMT2015 "If I was starting again, what would I do differently?" Case 2: Mara Magri, Quality Officer Haematopoietic stem cell Transplant Program, Papa Giovanni XXIII, Bergamo ITALY 24 March 2015

If I was starting again, what would I do differently? · "If I was starting again, what would I do differently?" Case 2: Mara Magri, Quality Officer ... Presentazione del Programma

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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

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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

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Thanks

Case 2: Hematopoietic stem cell Transplant Program, HPG23, Bergamo

To all my colleagues of

The Hematology and Bone Marrow Transplant Unit

Papa Giovanni XXIII, Bergamo

before after after some time