1. TAIEX Workshop on the Accreditation of Medical and Clinical Laboratories (55902) “ROLE AND VALUE OF THE MEDICAL LABORATORIES ACCREDITATION” Aliki Stathopoulou Kyiv, 5-6 February 2015

2. Medical laboratories were becoming more sophisticated:  Automated analysis equipment was being introduced  Quality Control was present but non-standardized  Each European country had its own accreditation process  College of American Pathologists were accrediting laboratories by checklists  Proficiency testing was non-standardized Prior to 1980

3.  Automated equipment was becoming more reliable, more available  College of American Pathologists (CAP) was accrediting laboratories consistent with American law (Clinical Laboratory Improvement Amendments - CLIA)  Proficiency Testing was becoming more standardized  Non medical laboratories (and some medical) were being accredited to Guide 25 and after 2000 according to ISO 17025.  There was a need for a new Quality standard for medical laboratories By 1994…

4. A New Technical Committee was proposed  ISO Committee Name: ISO TC 212  Committee Title: in Vitro diagnostics and Quality  Secretariat Country: United States  Secretariat Organization: CLSI  Number of countries 33 (All continents represented) International Organization for Standardization (ISO)

5. The creation of a new Quality standard for medical laboratories took 7 years to develop  Name: Medical Laboratories – Particular Requirements for Quality and Competence  Number: ISO 15189  First year Published: 2003  Revised and Republished: 2007, 2012 ISO 15189: A new standard

6. Influences in the Development of ISO 15189 ILAC Guide 25 ISO 17025:1999 ISO 9000:2000 ISO 15189 Particular Requirements for Quality and Competence CLSI QSE CAP checklists

7. Accreditation to ISO 15189 places five additional critical criteria on medical laboratories which include:  providing advice on the type of sample, and testing that may be required;  interacting with clinical staff by placing a responsibility on the laboratory to liaise with clinicians who refer patient samples for testing about the quality of their service;  providing opinions on results of testing in relation to diagnosis and patient care;  collecting samples or if not, providing information on collection procedures, sample containers and sample volumes; and  ethical practice – first duty is to the patient, not to the ‘customer’. ISO 15189: A new standard

8. Twenty three countries around the world adopted the standard within a year of publication (2004).  By 2009 the standard was adopted by medical laboratories in 44 countries.  By 2013 the standard was adopted by medical laboratories in over 60 countries.  ISO 15189 is one of the fastest growing international quality standards in the world. Why ISO 15189:2003 became so significant

9. Medical laboratory services are essential in the diagnosis and assessment of the health of patients. Their services encompass arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent result validation, interpretation, reporting and advice. Medical laboratory services should therefore meet the needs of all patients, clinical personnel responsible for patient care and any other interested parties. Accreditation Accreditation: A tool to demonstrate the competence of medical laboratories and ensure the delivery of timely, accurate and reliable results. Why is ISO 15189: 2012 a special standard

10. ISO 15189 is very comprehensive TECHNICAL QUALITY TECHNICAL QUALITY MANAGE- MENT MANAGE- MENT ERROR AND IMPROVEMENT ERROR AND IMPROVEMENT PHYSICAL LAB PHYSICAL LAB STAFF Laboratory Quality Laboratory Quality CUSTOMER Monitor Detect Correct Prevent Audit Pre-examination Examination Post-examination Sample Security Safety Job Description Training Competency Proficiency Review Patients Family Clinicians Public Health Community

11.  Accreditation of medical laboratories, to ISO 15189, demonstrates the quality and reliability of medical laboratories services. Medical laboratory’s aim is not only to provide accurate results, BUT to do so on the right patient, within a meaningful timeframe, as regards clinical management, using appropriate laboratory procedures and with a respect for ethics, confidentiality and the safety of the patient.  While ISO 15189:2012 is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines such as physiology, medical imaging and medical physics, could also find it useful and appropriate.  Bodies engaged in the recognition of the competence of medical laboratories, will be able to use ISO 15189:2012 as the basis for their activities. Why is ISO 15189:2012 a special standard

12. Links between ISO 15189 and related standards ISO 23640:2011 Evaluation of stability of in vitro diagnostic reagents ISO 15189 Particular Requirements for Quality and Competence Sample collectionSafety ISO 15190:2003 Requirements for safety ISO 22870:2006 Requirements for quality and competence Point of Care ISO/TS 22367:2008 Reduction of error through risk management and continual improvement Risk

13. Benefits of Accreditation According to the EC REGULATION No 765/2008 “The particular value of accreditation lies in the fact that it provides an authoritative statement of the technical competence of bodies whose task is to ensure conformity with the applicable requirements”. To ensure continued compliance, accredited laboratories are regularly reassessed to check that they are maintaining their standards of technical expertise. These laboratories will also be required to participate in regular proficiency testing programs (known as external quality assurance programs or EQAS) as an on-going demonstration of their competence.

14. Benefits of Accreditation For Healthcare Regulators The need to drive up the quality of care for patients, whilst delivering efficiency and productivity, is a key principle for regulators of healthcare services. Accreditation can be used as a tool to support the commissioning or specification of medical laboratory services that are technically competent, safe and reliable, and that continually improve the experience for patients by:  providing an independent assurance of quality and safety that supports world-class decisions on how to deliver better care and value for patients;  providing a mechanism for measuring quality improvement;  supporting consistency in the quality of care; and  encouraging innovation

15. Benefits of Accreditation For Patients Accreditation requires that the laboratory assesses the value and relevance of the testing in relation to the patient’s clinical management. It demonstrates that medical laboratories comply with an international standard, confirming that:  there is consistency in the quality of care;  comparability of tests results;  the service has up-to-date-technologies and its procedures and techniques reflect current best practice; and  staff providing the service are competent to undertake the tasks they perform.

16. Benefits of Accreditation For Medical Laboratories Accreditation provides proof that a laboratory complies with best practice. It also offers authoritative assurance of the technical competence of a laboratory to undertake specified analysis or measurements according to validated methods. Accreditation:  provides an opportunity for external perspectives on the laboratory’s practice;  can prevent the unnecessary duplication of information gathering on performance often required by regulatory bodies;  encourages the sharing of best practice;  stimulates innovation;  reduces risk; and  provides international recognition.

17. International Recognition Through a system of international agreements, accredited laboratories receive a form of international recognition which allows their data to be more readily accepted in overseas markets. Such international agreements, called mutual recognition arrangements (MRAs), are crucial in enabling test data to be accepted between different economies. Over 70 accreditation bodies have signed a multi-lateral mutual recognition agreement called the ILAC Arrangement.

18. Accreditation vs Certification The ISO 9001 standard is widely used in manufacturing and service organisations to evaluate their system for managing the quality of their product or service. Certification of an organisation’s quality management system against ISO 9001 confirms the compliance of the management system to this standard. ISO 15189 accreditation on the other hand provides recognition of the medical laboratory’s competence including both the management system and technical practice. Whilst medical laboratories may be certified to ISO 9001, such certification does not make any statement about the technical competence of a laboratory.

19. According to this joint communiqué, Medical laboratories accredited to ISO 15189:2007 are recognized as meeting the management system principles of ISO 9001:2008. It was issued to address the misconception in the market that medical laboratories accredited to ISO 15189:2007 do not operate a recognized management system. Accredited medical laboratories that are part of a larger organization certified to ISO 9001 should only need to be assessed once according to ISO 15189, and these results accepted as meeting the principles of the management system requirements (ISO 9001:2008). This recognition will reduce redundant, costly and time- consuming audits and, at the same time, enable medical laboratories to better meet their customers’ needs.

20. Thank you!