Il mondo dell’EFI: Report dei Commissioners

Carlo Carcassi & Andrea Bontadini & Luca Mascaretti

Cattedra di Genetica Medica, Università degli Studi - Cagliari.Laboratorio di Tipizzazione Tissutale, Immunogenetica e Immunologia dei

Trapianti

5°°°°WINTER SCHOOL AIBT3 – 5 dicembre 2015

EFI Accreditation Strengths

• Acknowledged clinical and technical expertise in H&I– EFI owners of clinically relevant standards

– EFI inspectors expertise is valued by labs

• Over 260 accredited labs

• 18 years experience

• Only organisation applying same standards for H&I laboratory services across more than 30 countries

EFI BOARD (EXECUTIVE COMMITTEE)

1. STANDARDS AND QUALITY ASSURANCE COMMITTEE

2. ACCREDITATION COMMITTEE

3. EXTERNAL QUALITY CONTROL COMMITTEE

4. EDUCATION COMMITTEE

5. SCIENTIFIC COMMITTEE

The Accreditation Committee members are:

A Harmer (UK), Chair

EK Petershofen (Germany), Co-ChairCommissioner Region 99A (Outside Europe and Commissioners labs)

S. Martin (UK)Commissioner Region 99B (Outside Europe and Commissioners labs)�L Mascaretti (Italy), General-SecretaryCommissioner Region 7B (Italy)

A Bishara (Israel)Commissioner Region 8A (Albania, Armenia, Bulgaria, Cyprus, Greece, The Former Yugoslav Republic of Macedonia (FYROM), Romania, Serbia, Turkey, Montenegro and Israel)

A Bontadini (Italy)Commissioner Region 7C (Italy)

C Carcassi (Italy)Commissioner Region 7A (Italy)

I Fae (Austria)Commissioner Region 5B (Austria, Bosnia and Herzegovina, Croatia, Czech Republic, Hungary, Poland, Slovakia, Slovenia, Kosovo and Russia)

…

EFI ACCREDITATIONS

314

31

55

78

108

137152

162 169180

191203

216

238257 257 262 267 263 262

0

50

100

150

200

250

300

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

COMMISSIONERS

REGION REGION NAME NAME

01 Nordic Region Dr. Bjarne Møller

02 Benelux Dr. Christien Voorter

03a UK + Ireland Dr. Ann-Margaret Little 03b UK + Ireland Dr. Martin Howell

04a Germany Dr. Matthias Marget 04b Germany Dr. Sabine Scherer 04c Germany Prof. Christian Seidl 05a Central Europe Dr. Blanka Vidan-Jeras 05b Central Europe MSc. Ingrid Faé

COMMISSIONERS

REGION REGION NAME NAME

06a+11a France+Switzerl. Dr. Françoise Hau 06b+11b France+Switzerl. Dr. Dominique Masson

07a Italy Prof. Carlo Carcassi 07b Italy Dr. Luca Mascaretti 07c Italy Dr. Andrea Bontadini 07d Italy Dr. Maria Edvige Fasano

COMMISSIONERS

REGION REGION NAME NAME

08a SE/Europe/Israel/Arm. Dr. Amal Bishara 08b SE/Europe/Israel Dr. Milena Ivanova

09a+10a Spain + Portugal Dr. Guadalupe Ercilla 09b+10b Spain + Portugal Dr. José Vicario 99a Outside Europe Dr. Eduard Petershofen 99a Commissioners labs. Dr. Eduard Petershofen 99b Commissioners labs. Dr. Susan Martin

REGION ACCREDITED LABORATORIES

01 Scandinavia 12

02 Benelux 13

03 UK + Ireland 20

03a 12 03b 8

04 Germany 39

04a 15 04b 13 04c 11

05 Central Europe 18 05a 8 05b 10

06+11 France + Switzerland. 36 06a+11a 18 06b+11b 18

REGION ACCREDITED LABORATORIES

07 Italy 53 07a 16 07b 13 07c 13 07d 11

08+99 SE Europe/Israël/Arm 27 08a+99a 16 08b+99b 11

09+10 Spain + Portugal 22 09a+10a 10 09b+10b 12

REGION ACCREDITED LABORATORIES

99 Commissioners labs & South Africa,China 22 99a Commissioners lab; 01,02,03,08,09,99 8

99a South Africa, China 2 99b Commissioners lab; 04,05,06,07 12

Total 261

Region code

Labnr Date last accreditation

City Contactperson Director/Co-director

07a07-IT-082.918

08/12/14Messina Dr. Vincenza Giuffrida Dr. Vincenza Giuffrida director, Dr. Patrizia Zappia co-director

07a07-IT-001.999

12/12/14Milano Dr. Elena Longhi

Dr. Massimo Cardillo, Co-Dir. Dr. Loretta Crespiatico, Dr. Elena Longhi,

07a07-IT-061.939

08/01/15Foggia Dr. Giuseppe Cappucci Dr. Lazzaro di Mauro, Dr. Giuseppe Cappucci

07a07-IT-090.910

01/02/15Modena Dr. Pietro Miceli Dr. Pietro Miceli, Dr. Marina Stefani

07a07-IT-031.969

27/02/15Udine Dr. Valeria Miotti Dr. Valeria Miotti

07a07-IT-042.958

01/04/15Padova Dr. Maria Paola Albergoni Dr. Maria Paola Albergoni

07a07-IT-069.931

06/04/15Cuneo Dr. Giuseppe Menardi Dr. Giuseppe Menardi, Dr. Laura Perotti, Dr. Maristella Prucca

07a07-IT-026.974

15/04/15Roma Pofessor Paola Grammatico Prof. Paola Grammatico, Dr. Alessandra Moscetti (co-director)

07a07-IT-018.982

20/04/15Genova Dr. Lucia Garbarino Dr. Lucia Garbarino,Dr. Nicoletta Sacchi

07a07-IT-050.950

20/05/15Catania Dr. Grazia Sortino Dott.ssa Grazia Sortino, Dott.ssa Maria Azzaro

07a07-IT-065.935

20/05/15Lucca Dr. Marco Fabbri Dr. Marco Fabbri, Dr. Annalisa Martinucci

07a07-IT-045.955

01/06/15Milano Dr. Claudia Lombardo Dr. Claudia Lombardo, Dr. Arabella Mazzocchi

07a07-IT-073.927

10/06/15 Piemonte Dr. Anna Maria Mangione Dr. Anna Maria Mangione

07a07-IT-048.952

30/06/15Pisa Dr. Maria Luciana Mariotti Dr. Maria Luciana Mariotti, Dr. Silvia Fornaciari, Dr. Michele Curcio

07a07-IT-015.985

13/08/15Roma Dr. Maria Paola Perrone Dr. Maria Paola Perrone, Dr. Luca Laurenti

07a07-IT-016.984

13/08/15Bari Dr. Donata Mininni Dr. Donata Mininni

07a07-IT-014.986

16/09/15Torrette di Ancona Dr. Patrizia Scalari Dr. Patrizia Scalari, Dr. Alessandra Zoli

07a Carlo Carcassi

Region code Labnr Date last accreditation

City ContactpersonDirector/

Co-director

07b 07-IT-004.996 09/04/15 Ferrara Dr. A. Balboni Dr. Loredana Melchiorri, Dr. Alessandra Balboni,

07b 07-IT-010.99012/03/15

Milano Dr Benedetta MazziDr. Benedetta Mazzi

07b 07-IT-012.988 28/06/15 Firenze Dr. Giovanni Rombolà Dr. Giovanni Rombolà, Prof. Berardino Porfirio

07b 07-IT-025.97501/09/15

Roma Professor A. PiazzaProf. Antonina Piazza

07b 07-IT-027.97323/08/14

VeronaDr. Elisabetta Guizzardi

Dr. Elisabetta Guizzardi, Dr. Anna Rosa Gandini, Dr. Elena Nicolis

07b 07-IT-030.970 20/05/15 Parma Dott. Paola Zanelli Dott. Paola Zanelli

07b 07-IT-034.966 04/10/15 Alessandria Dr. Lia Mele Dr. Lia Mele

07b 07-IT-037.96317/07/15 Reggio

Calabria Dr. Giuseppa RomeoDr. Giuseppa Romeo, Dr. Marina Francone

07b 07-IT-049.951 30/05/15 Treviso Dr. Elisabetta Durante Dr. Elisabetta Durante

07b 07-IT-055.94505/04/15

Bolzano Dr. Cinzia VecchiatoDr. Cinzia Vecchiato

07b 07-IT-058.94208/07/15

Napoli Dr. Caterina FuscoDr. Caterina Fusco,Co-Direct:Dr. Roberta Penta de Vera d 'Aragona

07b 07-IT-074.92615/02/15

Piacenza Dr. Agostino RossiDr. Agostino Rossi, Dr. Angela Rossi,Dr. Diego Ferrarese (technical supervisor)

07b 07-IT-088.91209/07/14

Roma Dr. Patrizia ChiusoloDr. Patrizia Chiusolo

07b 07-IT-032.96815/04/15

Cremona

Dr. Luisa Pecoroni and Dr. Ilaria Colombini

Dr. Luisa Pecoroni and Dr. Ilaria Colombini

07b 07-IT-036.96406/07/15 Mestre-

Venezia Dr. Maria Irene FezziDr. Maria Irene Fezzi

07b 07-IT-043.95730/03/15

Matera Dr. SantospiritoDr. Eustachio Vincenzo Santospirito, Dr. Rosa Colucci

07b 07-IT-054.946 25/01/15 Bergamo Dr. Laura Castellani Dr. Laura Castellani

07b 07-IT-002.998 Torino Maria Edvige Fasano Dr. Elena Garino

07b Luca Mascaretti

Region code

Labnr Date last accreditation

City Contactperson Director/Co-director

07c 07-IT-013.987 08/07/14 Pavia Dr. A. Pasi Dr. Annamaria Pasi, Dr. Ilaria Sbarsi

07c 07-IT-017.983 20/12/15 Pesaro Dr. Sonia Nesci Dr. Sonia Nesci

07c 07-IT-021.979 09/04/14 Varese Dr. Claudia Rinaldini Dr. Claudia Rinaldini, Dr. Davide Rossi

07c 07-IT-024.976 01/09/15 L'Aquila Dr. Franco Papola Dr. Franco Papola

07c 07-IT-028.972 13/06/15 Vicenza Dr. Cinzia Tagliaferri Dr. Cinzia Marina Tagliaferri

07c 07-IT-044.95601/02/15

PalermoDr. Raimondo Marcenò & Dr. Valentina Cappuzzo Dr. Raimondo Marcenò, Dr. Cappuzzo, Dr. Rosalba Bavetta

07c 07-IT-046.954 08/09/15 Brescia Dr. Graziella Carella Dr. Graziella Carella, Dr. Alberto Malagoli

07c 07-IT-052.948 14/11/14 Roma Dr. Marco Andreani Dr. Marco Andreani & Dr. Manuela Testi

07c 07-IT-060.940 20/08/14 Napoli Professor Claudio Napoli Professor Claudio Napoli, Dr. Marianna Resse

07c 07-IT-062.938 28/01/15 Ragusa Dr. Roberto Distefano Dr. Pietro Bonomo (SIMT Dr. Roberto Distefano (Lab HLA)

07c 07-IT-077.923 26/05/15 Napoli Prof. Luigi del Vecchio Prof. Luigi del Vecchio

07c 07-IT-084.916 02/10/14 Catanzaro Dr. Elena Focarelli Dr. Elena Focarelli Barone

07c 07-IT-056.944 13/08/14 Milano Dr. Giorgia Cornacchini Dr. Giorgia Cornacchini

07c 07-IT-057.943 05/12/14 Monza Dr. Marina Poggio Dr. Marina Poggio

07c 07-IT-064.936 26/05/15 Livorno Dr. Riccardo Luti Dr. Riccardo Luti, Dr. Fabrizio Niglio

07c 07-IT-080.920 16/08/15 Nuoro Dr. Pier Paolo Bitti Dr. Pier Paolo Bitti

07c 07-IT-089.911 05/10/14 Perugia Dr. Rita Tognellini Dr. Rita Tognellini, Dr. Brunella Malagigi

07c 07-IT-022.978 09/06/15 Trento Dr. Nadia Ceschini Dr. Nadia Ceschini, Dr. Paolo Gottardi

07c Andrea Bontadini

REGION ACCREDITED LABORATORIES INSPECTORS

01 Scandinavia 12 6 (+ 1) 02 Benelux 13 8 (+) 03 UK + Ireland 20 12 (+ 1) 04 Germany 39 17 (+ 1) 05 Central Europe 18 8 (+) 06+11 France + Switzerl. 36 14 (+ 1) 07 Italy 53 12 (+ 3) 08+99 SE Europe/Israël/Arm 27 14 (+) 09+10 Spain + Portugal 22 11 (+ 2) 99 South Africa,China,France 2 99 Commissioners labs 20

Total 262 102 (+ 9)

Ispettori EFI

Marco Andreani Andrea Bontadini Carlo CarcassiMaria E. Fasano Luca Laurenti Luca Mascaretti Benedetta Mazzi Valeria Miotti Sonia Nesci Franco Papola Antonina Piazza Cinzia Vecchiato

Michele CurcioLucia Garbarino 14.12.2015 UdineElena Longhi 14.12.2015 Modena

Ispettori EFI italiani

REGIONS1 Denmark, Finland, Iceland, Norway, Sweden, Estonia, Latvia,

Lithuania2 Benelux (Belgium, Netherlands, Luxembourg)3 United Kingdom, Ireland, Scotland4 Germany5 Austria, Bosnia, Croatia, Czech Rep., Herzegovina, Hungary,

Kosovo, Poland, Slovenia, Slovakia, Russian Federation

6+11 France, Switzerland

7 Italy

8+99 Albania, Armenia, Bulgaria, Cyprus, Greece, The Former Yugoslav Republic of Macedonia (FYROM),Moldavia, Romania, Serbia, and Montenegro, Turkey, Israël

9+10 Spain, Portugal99 Outside Europe , Commissioners labs

11

1

9107

6

2

11

4

5

5

25

5 58

888

8

3

3

2

1

88

55

8

5

5

51

11

99

1

EFI Accreditation Regions

Procedure Manual

Contains all the details of the Accreditation Programme

•Regional Commissioner •Appointment and Term •is proposed by the chairperson of the AC

•is approved and appointed by the EFI Executive Committee

•the term of office is for 3 years with up to two 3 years reappointments by the program chairperson contingent upon approval by the EFI Executive Committee (within the first six months, the activities will be supervised by the previous commissioner).

•Qualification •is an active inspector

•is a member of EFI •must belong to an EFI accredited laboratory from the region.

• Responsibilities

• attends meetings of the Accreditation Committee (AC)

• promotes the accreditation program in his/her region

• evaluates and decides on the accreditation applications that have been assigned to

him/her and administers the process in a timely fashion

• nominates candidate inspectors from his/her region

• reviews the inspectors’ report and prepares the commissioner’s report

• keeps for each assigned laboratory a file with all relevant correspondence and

reports for the previous three years

• performs duties as deemed appropriate by the Chairperson or by the AC

Regional Commissioner

Organising and Preparing the Inspection

• The commissioner, the laboratory and the inspectors have to agree on the date of inspection. After the AO has been informed it sends the documents (Application packet, Current EFI Standards, EFI Checklist, Latest Commissioner Report, any additional information that has resulted from the commissioner’s review of the application packet) to the inspectors.

• Prior to the on-site inspection, the inspectors must review all documents and discuss with the commissioner any potential problems that may need to be investigated in the laboratory.

Laboratory Application

• Packet A/C received by EFI Office and EFI Commissioner

• Commissioner reviews packet– Determine whether sufficient information in packet

to proceed to inspection– May ask for additional documents to be sent

• Commissioner arranges inspection– Invites 2 inspectors

Agreeing to an inspection• Invitation to inspect comes from the

Commissioner• Respond to Commissioner quickly

– allow them to invite other inspectors

• Once agreed the inspection date must be kept– Withdrawal only acceptable in exceptional

circumstances• Illness• Bereavement

• Unavoidable travel disruption– notify Commissioner immediately

Invitation to Inspect• Dates agreed by inspectors and

laboratory• Confirmed by the EFI Office• Office send out packets to inspectors

– Application packet– Current EFI Standards

– EFI Checklist– Latest Commissioner Report

Number of weeks from packet C being received by Inspector to date of inspection

0

2

4

6

8

10

12

1 to 2 3 to 5 6 to 8 9 to12 13 to15 16 to 23

Number of weeks

Nu

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er o

f la

bs

0

100

200

300

400

500

600

B C D E F G H I J K L M N

Deficiencies in 2013Quality Assurance Nucleic acid AnalysisHematopoietic SCT

Number of standards found per lab

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5

10

15

20

25

1 to 5 6 to 10 11 to 15 16 to 20 21 to 30 31 to 40

Number of standards found

Nu

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Common Quality Deficiencies 2012-13

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5

10

15

20

25

2012 1stsemester

2012 2ndsemester

2013 1stsemester

2013 2ndsemester

C6.1.1C8.2C5.1

Top 3 findings 2013

• C6.1.1– Labs must participate in EPT programmes to

cover all accredited laboratory applications

• C8.2– Labs must have mechanisms in place for

continuous monitoring of all test systems used

• C5.1– All procedures in use must be detailed in a

procedure manual...reviewed annually ...changes initialled & dated

Summary of most common standards found Jan-Jun 2014

0

1

2

3

4

5

6

7

8

9

C6.1 C7.1 C1.2 C5.1 /2

C8.2 D1.4 L4.2 C1.1.1 C.2.2.2 C6.2 L3.3 L9.3

Standard

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L4.2.3 test each lot and shipment of commercial kits against at least one DNA sample of known type.

EFI Standard Finding Corrective Action

C5.400 Appropriate interpretations Add the appropriate interpretation in all the reports prepared

C5.400Interpretation of results is sometimes missing on reports and is replaced by an accompanying letter

Add a conclusive comment on reports when necessary and mention that a letter is associated when necessary. Send an example.

EFI Standard Finding Corrective Action

C5.400 Appropriate interpretations Add the appropriate interpretation in all the reports prepared

C5.400Interpretation of results is sometimes missing on reports and is replaced by an accompanying letter

Add a conclusive comment on reports when necessary and mention that a letter is associated when necessary. Send an example.

C1.600 Pre-amplification area must have physical and/or biochemical barriers to exclude/prevent DNA contamination

The inspectors recommend an isolated pre-PCR area

C1.600 Paperwork was observed being taken from a post- to a pre-PCR area.

Modify workflow or working areas to avoid post- to pre-PCR transfer. Provide updated policy.

Number of days from Inspection to the inspectors report being sent to commissioner

0

2

4

6

8

10

12

1 to 5 6 to10 11 to15 16 to 20 21 to 25 26 to 30 31 to 35

Number of days

Nu

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er o

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REGION XX - XXXX- XXXXX

ACCREDITED LABS: 13

Q: 1. Is there a conflict of interest?

Q: 2. Problems with interpretation of Standards

Q: 3. Any other comments?

ACCREDITED LABS: 13

Q: 1. Is there a conflict of interest?

Q: 2. Problems with interpretation of Standards

Q: 3. Any other comments?

EFI-Nr TownA / C Inspection

LSC Question

Region By

Region

A/C

B1/B2

Expiry

Date

99-XX-001.999 XXXXXXX C – 23/03/2015

EFI Standard

Finding Corrective Action

B3.2.1 High resolution typing of selected HSCT donors is subcontracted to Histogenetics. No subcontract nor EFI accreditation certificate of the subcontracted lab is present.

Provide documented subcontract with Histogenetics and EFI accreditation certificate of Histogenetics.

B3.2.3 On reports the portion of the testing done by the subcontracted lab is not indicated.

Indicate portion of testing done by subcontracted lab and identity of subcontracted lab on the report. Provide an example to commissioner.

Ispettori e esperienza maturata

Ispettori e ispezioni effettuate

?

Nuova modalità online: https://www.efi-accreditation.org/

Nuova modalità di programmazione delle visite per i laboratori italiani

Grazie a voi e grazie soprattutto a Valeria