Patient Safety and Accreditation of Medical Laboratories in France Friday, April 12, 2013

1. Patient Safety and Accreditation of Medical Laboratories in France Friday, April 12, 2013 Bernard GOUGET Member, Committee Health Care Section b.gouget@fhf.fr Fédération Hospitalière de France

2. What was the project about?The European Network for Patient Safety (EUNetPaS) project established a network of all 27 EU Member States, international organisations, and stakeholders in the field of healthcare (healthcare professionals, patients, institutions, and scientists) to encourage and enhance collaboration in the field of patient safety. It was coordinated by HAS (the French National Authority for Health). • Project’s objectives • The objectives of the project were: • To promote coherence at the EU level through recommendations and common tools • To promote a patient safety culture based on no-blame reporting • To promote education and information on patient safety • To create a permanent collaboration network on patient safety • Project’s outcomes • Outcomes of the project include a tool to measure patient safety culture, guidelines for education and training, a virtual library of European reporting and learning systems, recommendation on medication safety and an establishment of national Patient Safety Platforms in 13 EU Member States.

3. PromotingQuality and Patient safetyThe need for common tools and terminology • Patient safety is now on the healthcare agenda in most western countries • Patient safety is a somewhat nebulous concept to many, and there is a need for a simple conceptual framework so that patient safety may be placed in context with respect to other healthcare activities Definition: • Patient safety is a discipline in the health care professions that applies safety science methods toward the goal of achieving a trustworthy system of health care delivery

4. Patient safety in context • Patient safety is an important component of risk management, clinical governance, and quality improvement. • The quality improvement systems provide a basis for introducing the necessary changes for patient safety from reaction to prevention

5. The HPST law(hospital, patient, health and territories) The law was passed in July 2009 to reorganize the French health care system . The main objectives were: - to modernize the hospitals, giving them more financial means to carry out their mission and to reorganize their territorial and internal organization, - to promote research and education, - to guarantee a better access to care, - to reorganize the provision of care through a coordination between the hospitals and cities within a regional organization, - and to promote public health.

6. The Med Lab is increasingly integrated with patient care • The increasing demand for: • Transparency and Accountability, • Accessibility, • Integrated diagnostics • Professional excellence, • Patient outcomes and Customer satisfaction, • and better cost management has underpinned the development of systems for quality assurancewith an increasing focus on accreditationand several forms of external review mechanisms .

7. The French context • 10 000 medical biologists • 16,5/100 000 inhabitants vs 5,8 in UE • 7000 private sector / 3000 hospital • Medical Lab demogaphy is decreasing • ¾ pharmaceutical ; ¼ medical background • 41 000 people are working the the private sector • 3800 private labs • 1200 Hospital labs • There is a movement for concentrating laboratories, increasingly pursued by investment funds.

8. MedicalBiology in France : Economic aspects • 1,8% routine health care expenses • 2,4% Consumption of care and medical goods • ( 4,3 BM € private sector, 2,2 BM € public ) • 9,7% Consumption of ambulatoryhealth care • -1,6% decrease in reimbursements FR grossdomesticproduct (GDP):2033,7 BM€

9. History of the French reform of the medicallabs • 2009: HPST: Art 69 de la loi n° 2009-879 du 21 juillet 2009 portant réforme de l'hôpital et relative aux patients, à la santé et aux territoires • 2010: Ordonnance Janvier 13 2010 (REGULATION) • 2011: Proposition de loi de M. Jean-Pierre Fourcade modifiant certaines dispositions de la loi n° 2009-879 du 21 juillet 2009 portant réforme de l'hôpital et relative aux patients, à la santé et aux territoires (n° 65, 2010-2011), censurées par le Conseil constitutionnel. • 2012: l'Assemblée nationale le 26 janvier 2012, Une proposition de loi de Mme Valérie Boyer, M. Jean-Luc Préel et plusieurs de leurs collègues portant réforme de la biologie médicale (n° 3989, AN XIIIème législature), reprenant le même texte, a été adoptée • 2012: Sénat fev 2012, sans toutefois être inscrite à l'ordre du jour avant la fin de la législature. • 2013: 10 avril Commission Mixte Paritaire > Ratification Jeudi 11 Avril 2013 Sénat ( LAW)

10. Four major objectives of the new law • to ratify the 2010 ordinance regarding laboratory medicine • to enhance the medicalization of the profession. • to define the organization of laboratory medicine • and slow the Intrusive process of the finance industry • to ensure the quality of medical biology tests.

11. Medicalization of the profession • In order to be recognized as a medical biologist, it is necessary to hold a pharmacist or medical degree and a degree in specialized studies in laboratory medicine. • The conduct of the preanalyticalphase of a laboratory medicine test is secured by guidance from the practice of providers ( nurses) authorized to participate in it. • Adjustments have also been made at various points, especially regarding the question of the practice of healthcare providers coming from the European Union and not holding a medical biology degree • Consistent with the fact that laboratory medicine is a medical discipline rather than a technical one, the practice is ended of exceptions to the pricing rules by common law acts, called "rebates (discounts)", excludingcooperationbetweenpublic institutions.

12. Territorial organization of the medicallabs • Articles define the organization of laboratory medicine on 3 territories • One article seeks to slow the Intrusion of the finance industry by restoring the principle of majority ownership of company capital by medical biologists practicing within companies. • Regional health agencies are responsible for regulating the provision of public and private laboratory medicinein the regions where they operate, in order to guarantee that local laboratory medicine is sustained. JIQH 2009 – La Villette 23 & 24 novembre 2009 Page 12

13. Multisite labs Site 2 Site 2 Site 4 Site 4 • Rule : Only one multisite lab in one hospital or hospital group • Accreditation consequences • 1 responsible • Multisite quality management • Homogenization of pre-examination procedures Territorial multisite laboratory « Star » model with unique central lab « Network » model with multiple connected labs Site 3 Site 3 Site 1 Site 1

14. POCT TnIc ED • Objectives • Remote control • Training-Habilitation • A posteriori biological validation • Unified procedures • One POC coordinator • Mandatory accreditationNF ISO EN 22870 BNP MICU BG ICU POC Coordinator pH NICU ACT OR Hb Dig.ICU

15. Optimiser le maillage territorial (6)Groupements validés par l’ARS pour le SROS Biologie Données RTC 2010 ARS 4 sites 2 PT 38 MB B:0.21 6 sites ? PT 39 MB B:0.28 2 sites 2 PT 31 MB B:0.23 4 sites ? PT 47 MB B:0.24 2 sites 1 PT 21 MB B:0.25

16. Mandatoryaccreditation • .One article sets a double objectiveregardinglaboratoryaccreditation, • It ensures that medical biologists have an optimal organization in place and are proven to be competent to conduct testing: • As of November 2016, medical laboratories will not be able to operate without an accreditation covering 50% of medical biology tests. • As of November 1, 2018, medical laboratories will not be able to operate without an accreditation covering 70% of medical biology tests. • As of November 1, 2020, medical laboratories will not be able to operate without an accreditation covering 100% of medical biology tests. • The accreditation in principle cover all families of tests. JIQH 2009 – La Villette 23 & 24 novembre 2009Page 16

17. French accreditation project • NF EN ISO 15189 • NF EN ISO 228 70

18. and the mandatory accreditation for medical labs • based on ISO 15189 and ISO 22870 standards • the whole activity of the laboratory is concerned • Need for adaptations at the accreditation bodylevel and at the laboratory level Page 18

19. The Cofrac • Unique national accreditation body recognized by law • In compliance withthe European Regulation n° 765/2008 dated 9 July 2008 : • accreditation is a public authority activity • the national accreditation body operates on a not-for-profit basis • all interested parties are involved in the work of the national accreditation body • the national accreditation body fulfils the requirements of ISO/IEC 17011, particularly in terms of independence , impartiality, transparency, competence of its personnel • Passed with success the peer evaluation organized by EA and is signatory to the EA-MLA Page 19

20. Board of Administrators Internal Audit Commission General Director Quality Manager Horizontal services: accounting, human resources, communication,.. Laboratories Section Inspection Section Healthcare Section Certifications Sections Lead assessors and technical assessors The Cofrac Page 20

21. The Healthcare Section • This section is totally dedicated to human health issues • The section committee participates in the elaboration of the strategy for accreditation of medical laboratories as well as in the working of the documents useful to evaluation and accreditation • The technical commission for accreditationstudies evaluation reports and looks at the candidatures of technical evaluators and experts • These two instances are composed of: • representatives from the ministry of Health, its permanent offices in regions, the High Authority of Health, medical biologists, patients, prescribers, accredited medical laboratories. Page 21

22. The evaluators • Accreditation is based upon evaluations undertaken by peers • Selecting a candidate to become a technical evaluator consists in validating his capability to evaluate as well as the adequacy of his technical competence to our needs • The selected technical evaluators are working in medical laboratories accredited or on the way to be accredited. Page 22

23. The evaluators • The evaluators (lead and technical) used by Cofrac fill a declaration of confidentiality and absence of conflicts of interest. • If justified, a medical laboratory may refuse to be evaluated by a proposed evaluator. • The evaluators are trained and supervised periodically. Page 23

24. I S1 S2 S3 R 12 months 15 months I: Initial evaluation R: Reevaluation Sn: Surveillance visit Ext: Extension evaluation S6 S4 5 years S5 The accreditation cycle Ext 12 months 12 months 12 months 15 months 15 months 15 months Page 24

25. The accreditationprocess • Multisite accreditation has to be put in place • Only one dossier • Unique quality management system • Organization taking into account the multisite reality • Flexible scope • Specific evaluation of the preanalysis activity carried out by medical auxiliaries (nurses, ...) • Specific evaluation for point of care testing Page 25

26. The accreditationprocess The 3 steps are: • analysis and formalization of the demand • evaluation (documentary and on site) of the competences of the medical laboratory • decision on the basis of the evaluation report Page 26

27. On site evaluation Key points : • Examination of the relevance and adequacy of the arrangements in place, both at the organisational and technical levels • Verification of the good application of the arrangements • Evaluation of the technical competence (through interviews and observations) as well as of the quality of the results (through internal or external controls) Page 27

28. On site evaluation • Outcome: • general impressions aiming to conclude on the confidence in the quality of the exams • strengths • possibilities for improvements • Eventual findings • All conclusions and findings are presented during the closing meeting • The laboratory may accept/refuse the finding reported by the evaluator Page 28

29. On site evaluation • Critical non conformity: non conformity that has an impact on the reliabilityof the results or on the capability of the management system to maintain the quality level of the exam. • Non critical non conformity: non conformity that has no direct and immediate impact on the quality of the exams • For each non conformity, an action plan is required from the laboratory. Page 29

30. The decision process • The evaluation reports are studied collegially by accreditation commissions, • The decision is taken by the Cofrac General Director, • An appeal procedure permits contestation of the decision by the laboratory. Page 30

31. The decision process • In case of initial evaluation or extension evaluation • if it exists critical non conformities not under control: negative decision or negative until verification (documentary or on site) of the effectiveness of the corrective actions • the non conformities must be cleared up within 6 months at a maximum • after expiration of this delay, the laboratory gets: - 15 days to transmit documentary proofs, - 3 months to have a complementary evaluation. Page 31

32. The decision process • In case of surveillance visit or re-evaluation • If it exists critical non conformities not under control: positive decision only if they are cleared up within 3 months at a maximum • after expiration of this delay, the laboratory gets: - 15 days to transmit documentary proofs, - 3 months to have a complementary evaluation. • the non critical non conformities must be cleared up within 6 months at a maximum. Page 32

33. Information • Information about accreditation decisions have to be transmitted to several public entities • When there is a major risk for the health of the patients, the regional permanent office of the ministry of health is immediately informed. Page 33

34. Accreditation manual • Document grouping accreditation requirements together with those coming from the regulation • The manualcontainsexplanatory notes and recommendations • Aim : to facilitate common understanding of the rules by laboratories and evaluators. Page 34

35. Accredited laboratories * dont 18 non LBM (structures ACP, structures médico-légales, …)

36. Bilan statistique (mars 2012/janvier 2013) Etude réalisée sur 2000 écarts (en 2012/2013)relevés sur des évaluations réalisées selon la norme NF EN ISO 15189 & SH REF 02 * Données du bilan 2011/2012 36 Réunion d'harmonisation des Evaluateurs Techniques- Section Santé Humaine - Cofrac – 2013

37. Bilan statistique (mars 2012/janvier 2013) Etude réalisée sur 2000 écarts (en 2012/2013)relevés sur des évaluations réalisées selon la norme NF EN ISO 15189 & SH REF 02 * Données du bilan 2011/2012 37 Réunion d'harmonisation des Evaluateurs Techniques- Section Santé Humaine - Cofrac – 2013

38. Requirements of ISO 15189

39. 39 Réunion d'harmonisation des Evaluateurs Techniques- Section Santé Humaine - Cofrac – 2013

40. 40 Réunion d'harmonisation des Evaluateurs Techniques- Section Santé Humaine - Cofrac – 2013

41. 41 Réunion d'harmonisation des Evaluateurs Techniques- Section Santé Humaine - Cofrac – 2013

42. 42 Réunion d'harmonisation des Evaluateurs Techniques- Section Santé Humaine - Cofrac – 2013

43. Thankyou ! Page 43