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
• What was the project about? The European Network for Patient Safety (EUNet. Pa. S) 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.
Promoting Quality and Patient safety The 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
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
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.
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 assurance with an increasing focus on accreditation and several forms of external review mechanisms.
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 private sector • 3800 private labs • 1200 Hospital labs • There is a movement for concentrating laboratories, increasingly pursued by investment funds.
Medical Biology 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 ambulatory health care • -1, 6% decrease in reimbursements FR gross domestic product (GDP): 2033, 7 BM€
History of the French reform of the medical labs • 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)
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.
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 preanalytical phase 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)", excluding cooperation between public institutions.
Territorial organization of the medical labs • 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 medicine in 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
Multisite labs • Rule : Only one multisite lab in one hospital or hospital group • Accreditation consequences – 1 responsible – Multisite quality management – Homogenization of preexamination procedures Territorial multisite laboratory « Star » model with unique central lab « Network » model with multiple connected labs
POCT – Objectives Tn. Ic ED BNP MICU BG ICU POC Coordinator p. H NICU Hb Dig. ICU ACT OR • Remote control • Training-Habilitation • A posteriori biological validation • Unified procedures – One POC coordinator – Mandatory accreditation NF ISO EN 22870
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
Mandatory accreditation • . One article sets a double objective regarding laboratory accreditation, • 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 2009 Page 16
French accreditation project HAS COFRAC – NF EN ISO 15189 – NF EN ISO 228 70 High authority of Health Accreditation body Scientific Societies SFBC Medical Biologists Lab directors 17
and the mandatory accreditation for medical labs based on ISO 15189 and ISO 22870 standards Ø the whole activity of the laboratory is concerned Ø Need for adaptations at the accreditation body level and at the laboratory level Page 18
The Cofrac § Unique national accreditation body recognized by law § In compliance with the 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
The Cofrac 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 Page 20
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 accreditation studies 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
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
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
The accreditation cycle Ext I S 1 S 2 12 months I: Initial evaluation R: Reevaluation Sn: Surveillance visit Ext: Extension evaluation S 3 R 12 months 15 months S 6 5 years S 4 15 months S 5 Page 24
The accreditation process § 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
The accreditation process 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
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
On site evaluation Ø Outcome: § general impressions aiming to conclude on the confidence in the quality of the exams – strengths – possibilities for improvements § Eventual findings Ø All conclusions and findings are presented during the closing meeting Ø The laboratory may accept/refuse the finding reported by the evaluator Page 28
On site evaluation § Critical non conformity: non conformity that has an impact on the reliability of 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 Ø For each non conformity, an action plan is required from the laboratory. Page 29
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
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
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
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
Accreditation manual § Document grouping accreditation requirements together with those coming from the regulation § The manual contains explanatory notes and recommendations § Aim : to facilitate common understanding of the rules by laboratories and evaluators. Page 34
Accredited laboratories 31/12/09 31/12/10 31/12/11 31/12/12 28/02/13 156 153 185 206 212* (156) (197) (319) (510) (581) - 11 14 13 15 dont structures accréditées selon la norme NF EN ISO 15189 - 59 129 182 190 dont structures accréditées selon la norme NF EN ISO 22870 - - 2 2 2 Nb de structures accréditées (nb de sites) dont structures hospitalières * dont 18 non LBM (structures ACP, structures médico-légales, …)
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 Total Maîtrise avant passage en commission (critique) 619 ( 30 %) 580 39 (2%) 22 (56 %) 270 16 (6 %) 7 (44 %) 1380 (70 %) 1234 146 (10%) 65 (44%) 568 (66 %) Technique Critique 286 (34%)* Qualité Non critique 500 68 (12%) 32 (47 %) * Données du bilan 2011/2012 Réunion d'harmonisation des Evaluateurs Techniques- Section Santé Humaine - Cofrac – 2013 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 Total Maîtrise avant passage en commission (critique) 619 ( 30 %) 580 39 (2%) 22 (56 %) 270 16 (6 %) 7 (44 %) 1380 (70 %) 1234 146 (10%) 65 (44%) 568 (66 %) Technique Critique 286 (34%)* Qualité Non critique 500 68 (12%) 32 (47 %) * Données du bilan 2011/2012 Réunion d'harmonisation des Evaluateurs Techniques- Section Santé Humaine - Cofrac – 2013 37
Requirements of ISO 15189
Réunion d'harmonisation des Evaluateurs Techniques- Section Santé Humaine - Cofrac – 2013 39
Réunion d'harmonisation des Evaluateurs Techniques- Section Santé Humaine - Cofrac – 2013 40
Réunion d'harmonisation des Evaluateurs Techniques- Section Santé Humaine - Cofrac – 2013 41
Réunion d'harmonisation des Evaluateurs Techniques- Section Santé Humaine - Cofrac – 2013 42
Thank you ! Page 43
GBEA Quality aspects Directive approach Accreditation 15189 – 22870 Process approach Technical requirements QMS + technical requirements = competence Management No Yes Recognition National International Evaluation Inspection Double audit quality + technical (colleagues biologists) Organism Government DDRASS Unique national accreditation body COFRAC
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