"If I was starting again, what would I do differently?"

Transcription

1 "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 #EBMT2015

2 Haematopoietic Transplant Programme Bergamo -Italy Hematology and Bone Marrow Transplant Unit A. Rambaldi Laboratory for haematological disease diagnosis O. Spinelli Clinical Unit Inpatient Clinic HPC Transplant Center HPC Processing Facility ATMP Factory M. Introna Bone Marrow Collection Facility F. Lussana Outpatient Unit A. Grassi 2

3 Our experience UNI EN ISO Certification 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 3

4 Mistakes during Accreditation/Certification process Quality Officer experience 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 4

5 Post inspection Mistakes 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 before after after some time 5

6 Dangerous areas 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 6

7 Preparation and Organization of documents Mistake # 1 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 7

8 Preparation and Organization of documents Mistake # 2 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 ONE MAN BAND 8

9 Preparation and Organization of documents Mistake # 3 Shortcut Could you please send me your SOP for.? Consequence are you sure that it suits to your process? SOPs photocopy or totally impersonal The grass is always greener on the other side 9

10 Preparation and Organization of documents Mistake # 4 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? 10

11 Timetable planning and management 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 6/12 months 1 months 3 months Start Accreditation Process Document preparation Submit application Submit pre - inspection documents 2/9 months Inspection 11

12 Timetable planning and management 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 Programma alla 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 piano di 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 JACIE Inspection ISO Certification JACIE Accreditation Ente terzo Direzione del Programma Personale del Programma Team ispettivo JACIE Direzione del Programma Personale del Programma ISO Certificate Expected in 2006 Obtained in 2008 JACIE Certificate 12

13 Communication, duties and relationship Mistake # 1 JACIE Accreditation is not a personal goal of the Quality Manager REMEMBER Quality Manager is responsible for Implementing Maintaining And developing the QMS NOT for operational management NOT for drafting of the whole documentation 13

14 Communication, duties and relationship Mistake # 2 Keep on board Set up communications and education regarding JACIE Establish Quality Management on the agenda of staff meetings Staff members must read and know JACIE standards before writing SOPs REMEMBER Hospital Policy may be different Consequence Lack of evidence for JACIE standards 14

15 Communication, duties and relationship Mistake # 3 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 15

16 Continual improvement of the quality management system - mystakes 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 16

17 Continual improvement of the quality management system - mistakes 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. 17

18 Conclusions JACIE inspection site - visit for renewal Accreditation 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 18

19 Thanks To all my colleagues of The Hematology and Bone Marrow Transplant Unit Papa Giovanni XXIII, Bergamo before after after some time 19