EN ISO accreditation for blood gases

Transcription

1 EN ISO accreditation for blood gases Michel Vaubourdolle SFBC Accreditation WG chairman EFLM ISO/A WG chairman Head of Department of Laboratory Medicine* and Pathology University Hospitals Paris-East, Saint-Antoine, AP-HP * laboratory accredited by COFRAC with NF EN ISO 15189, and standards POCT Symposium Antwerp, 23 October 2014

2 POCT ISO accreditation European level EFLM WG ISO/A State of accreditation for POCT in Europe French level Mandatory accreditation including POCT Our experience in Saint Antoine hospital Laboratory accredited for POCT blood gases Practical aspects POCT Symposium - Antwerp, 23 October

3 European level: EFLM ISO/A WG Role of EFLM ISO/A WG Link Harmonize Guidelines Assessors Labs EA Accreditation bodies Scientific societies EFLM Specialists in laboratory medicine POCT Symposium - Antwerp, 23 October

4 EFLM survey -POCT «Medical labs» responsible for POCT: 18/26 69% POCT Symposium - Antwerp, 23 October

5 POCT, OTC and self-testing «Medical labs» responsible for POCT: 18/26 Regulation by Health Minister, regional government or professional chamber «Medical labs» responsible for POCT at physicians level: 6/18 (Belgium, Croatia, Ireland, Slovenia, Spain) Labs with POCT submitted to accreditation or in progress to accreditation: 13/18 72% 69% 33% Use of EN ISO standard: 16/18 Netherlands use also CCKL, Croatia and Sweden EN ISO or (Sweden) None : Switzerland No data : Spain «Medical labs» responsible for Patients self-testing: 0/26 0,4% «Medical labs» responsible for tests OTC: 0/26 0% 89% POCT Symposium - Antwerp, 23 October

6 French reform of Medical Biology Harmonization of private and public practices Choice of medical biology vs. industrial biology Reorganization of territorial distribution : multisites labs with proximity medicalized antennas Proven quality by mandatory accreditation Two health territories 13 labs Two health territories 3 multisites labs POCT Symposium - Antwerp, 23 October

7 French accreditation project Who?All biologists in public and privates medical biology Labs What?New regulation for Medical Biology : mandatory accreditation using NF EN ISO and NF EN ISO 2270 Where?In all medical labs for all tests performed When?2013 to prove the real engagement 2020 to complete achievement Why? Proven quality, international recognition, increase in biology medicalization How? Working hard, now and together COFRAC Accreditation body Scientific Societies SFBC HAS Health high authority Medical Biologists Lab directors POCT Symposium - Antwerp, 23 October

8 Role of National Societies Example -Guidelines for accreditation of medical laboratories Vol.1-3 SFBC WG ALBM Published in Ann. Biol. Clin. Now in French In English ASAP Scope: all requirements of the two standards and Agreement of accreditation body COFRAC Consensus work from specialists in laboratory medicine Volume 1: preanalytical analytical Volume 2: postanalytical POCT Volume 3: quality management, support processes POCT Symposium - Antwerp, 23 October

9 Issues for POCT accreditation TnIc ED POC Coordinator Hb Dig. ICU POCT Unit BNP MICU ACT OR BG ICU ph NICU From to Objectives Remote control Operators competency assessment A posteriori biological validation Unified procedures One POC coordinator Mandatory accreditation NF ISO EN POCT Symposium - Antwerp, 23 October

10 University hospital group in eastern Paris Saint Antoine Hospital

11 The Saint-Antoine Hospital University hospital of eastern Paris Hospital beds capacity : 700 Medical staff : 900 ISO accredited laboratory POCT Symposium - Antwerp, 23 October

12 Saint-Antoine and POC Testing For over 10 years, the service of biochemistry has closely supervised POCT Blood Gas (GDS) Cardiac markers (TnIc, BNP) Hemoglobin Glycated hemoglobin

13 Accreditation project (2008) Voluntary accreditation following the publication of the ISO (2006) standard Creation of a working group "accreditation EBMD" consisting of members of the quality unit: RAQ (Quality manager) 2 biochemists Scope : 3 blood gas POCT sites to be accredited : Maternity (obstetrical bloc) Digestive OR (transplantations) Medical ICU Maternity Digestive OR Medical ICU

14 Process approach Identify in laboratory process map the specific elements involved for POCT Specify the items to manage and quality indicators to follow Include in QMS of accredited lab POCT Symposium - Antwerp, 23 October

15 Risk analysis POCT Symposium - Antwerp, 23 October

16 Blood gas POCT devices in 2008 Maternity Analyzer : GEM 4000 (IL) Syringes (cord blood) and capillaries (scalp) Tests : GDS, Ht, lactate Users : clinicians, midwives, nurses Will be removed at the department closure (2012) Medical ICU Analyzer : GEM 4000 Tests : GDS, CO-Oxymetry, Ht, lactate, Na +, K +, Ca ++, glucose Users : clinicians, internal and external students, nurses Digestive OR Analyzer: GEM 3000 (IL) Tests: GDS, Ht, lactate, Na +, K +, Ca ++, glucose Users: clinicians, nurses Will be replaced by GEM 4000 (2013)

17 Implementation of standards and regulatory requirements lso standards requirements : Divided into chapters and paragraphs identical to I SO Chapter 4 (quality management system) Chapter 5 (technical requirements) Content : specific requirements and cross-references to ISO French regulatory requirements : Ordinance january 10, 2010 SH REF 02 from COFRAC : september Moving to a mandatory accreditation COFRAC Requirement answer implementation : Verification of compliance of our organization with those implement for other laboratory tests (ISO 15189) Quality report written to summarize POCT organization

18 POCT quality plan POCT «Quality manual» For laboratory staff and POCT units Same chapters distribution as for laboratory quality manual Description of quality organization Specificities related to POCT

19 Implementation POCT specific management requirements 1. Management committee for POCT 2. Justification data for POCT and instrument choice 3. Agreement protocol between laboratory and clinical units (responsibilities) 4. Appropriate management of the documentation system 5. Record management 6. POCT management review

20 1. Committeefor POCT supervision Appointment of a committee leader With laboratory, POC units and administration representatives Annual meeting Defined missions for the committee and its leader (chap à 5) Follow up of POCT projects Filling of annual activity report for management review

21 2. Justification data for POCT and instrument choice For POCT blood gas devices previously installed (maternity and medical ICU) Retrospective compilation of folder from: Mails, s... Preliminary study : feasibility, logistics, result turn around time... Publications in partnership with clinical units Analyzer evaluation reports (GEM3000 and GEM4000) For POCT digestive OR location set up in 2010 Data collection by working group and small meeting with the staff of the digestive OR

22 3. Agreement protocol Organized in laboratory through 2 documents: First general document dedicated to quality and regulation Valid for large groups of clinical units Document with low potential changing, tacitly renewed Signed by department managers

23 3. Medical and biological user contract 2 nd document for each device Practical document form Reviewed annually

24 3. Medical and biological user u ser contract Signed by laboratory and POC units managers Clearly defines responsibilities for each analyzer

25 4. Documentation system management Laboratory : POC Coordinator Folder with Global POCT management processes POCT recordings POCT quality plan Quality manual Laboratory : Instrument responsible One folder by POC unit Records Archives On POC site: One folder For clinical unit Who must be contacted How to run a test What to do in case of failure POCT quality plan For laboratory Instrument data sheet. Installation compliance sheet Intsrument operation and maintenance Certified staff list for both clinical units and laboratory Agreement protocol Summarized sheets technical validation Bibliography Safety data sheets Notebook transmission

26 5. Records management (chap. 4.13) Record Identifications (laboratory, POC units) Management Audit

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28 6. POCT management review Annual review Prepared by CEEBMD Presentation during management review Requirements specified in chapter 4.15 (input elements)

29 6. POCT Management review Quality indicators Blood gas activity Patient number and recruitment modifications Instruments unavailability Number of gas results reported, unavailability period Pre analytical good practices (sampling) Number of rejected patient samples Number of non-conformities Proficiency survey Comparisons with lab analyzers

30 Main technical requirements No major difficulties ISO / ISO except some specificities: 1- POC devices installation conformity (environment) 2-Analytical method verification/validation 3-Staff training and habilitation (POCT units laboratory) 4-Metrological control management 5-Biological validation of results

31 1. POC device installation compliance (environment) -chap. 5.2 Compliance form checklist Supplier requirements Room temperature Reagents storage Power supply Ventilation Laboratory requirements Safety Confidentiality of results

32 2. Method verification/validation Risk assessment Initial evaluation of analytical performances Performances gathered in form SH FORM 43 (COFRAC). POCT specific: initial and recurrent comparison of POC devices results vs. laboratory results Comparison done on EQA samples and, if necessary, on blood samples

33 3. Staff training and operators competency assessment Clinical team: Trainings and habilitations Different operators categories Medical: clinicians, interns and students Nonmedical: nurses Common grid for all users Operator identification code By laboratory device manager (enabling disabling). In collaboration with POC device manager (staff turnover). Difficulties Many persons Three different teams over 24h Turnover (nurses, students, interns) Competency following

34 3. Staff training and operators competency assessment

35 3. Staff training and operators competency assessment Operators competency follow-up 18 months maximum duration Authorization criteria > 15 blood gas done < 5 % of blood gas rejected QUIZZ GemWebPlus > 80% right answers Practical exam 1 BG determination

36 4. Management of POC metrological control Reduced metrological constraints Centrifuges: none Pipettes: none Refrigerated chamber: none No reagents storage on site Environmental conditions management: Sensors connected to a lab-centralized system

37 5. Result validation (French regulation) Immediate use of patient results by clinicians Retrospective validation of results by a specialist in laboratory medicine Results integration into the patient file (HIS) and possible consultation on results server The POCT nature of the result is mentioned into the reports (paper/server) Verification (every 6 months) of data integrity from the analyzer to the electronic report

38 Review Checklist: follow-up grid for a POC device Allows to ensure that key processes are managed and evaluated annually It includes QMS elements Technical elements Check the proper monitoring of the analyzer and assist in the preparation of the management review

39 Review Checklist: evaluation grid and clinical needs follow-up

40 ISO COFRAC audits (3 audits since 2010) Audit by 2 COFRAC assessors 1 assessor for quality management 1 assessor for technical requirements, specialized for POCT In each POC unit Visit of the 2 COFRAC assessors Interview of POC operators (medical and non-medical) Observation of blood gas testing POCT : 5 non conformities 1 specific ISO non specific ISO 15189/22870 with 1 critical

41 Audit results 3 POC non critical non conformities Non conformities descriptions ISO Non-conformity answers Quality manager for POCT was not defined (2010) Indicated into quality manual and POCT quality plan No proficiency controls for CO-Oximetry (2010) Proficiency control program (Asqualab) starting January 2011 No periodical evaluation of clinical needs, cost/benefice study, clinical efficiency and improvements(2012) Introduction of need revaluation grid each year

42 POCT Symposium - Antwerp, 23 October

43 Conclusions POCT management under lab responsibility Consensus inside hospital Recognition of a laboratory medical service and expertise Respect of skills and competences (clinical/biological) Good appreciation from clinical units Regulation of new devices installation management of expenses and activity POCT and ISO accreditation Recognition of laboratory technical competency and quality management Motivation of laboratory team Confidence in results quality POCT Symposium - Antwerp, 23 October

44 Acknowledgements Dr Bénédicte BENETEAU-BURNAT Hospital Blood Gas coordinator Dr Ludmia TAIBI Biochemist Dr Pascal PERNET Hospital POC coordinator For the daily management of this quality system POCT Symposium - Antwerp, 23 October