1	Global Trends In Laboratory Improvement On the Horizon of Worldwide Standardization Through Accreditation Greg Cooper CLS, MHA Manager, Clinical Standards and Practices Bio-Rad Laboratories Quality Systems Division
2	Standardization of Laboratory Practice Global community Patient mobility Need for harmonization of outcomes regardless of testing location E.g. diabetes E.g. anti-coagulant maintenance
3	Harmonization Through Accreditation Certification ISO 17025 General requirements for the competence of testing and calibration laboratories Verifies that all the components are in place Accreditation Verifies that all the components are in place and that the laboratory is competent to perform procedures ISO 15189 Medical Laboratories – Particular requirements for quality and competence
4	ISO 15189 Signatories Argentina, Australia, Austria, Belgium Brazil, Canada, Chile, China, Czech Republic Denmark, Finland, France, Germany, Iran, Ireland Israel, Italy, Japan, Korea, Luxembourg, Mexico The Netherlands, New Zealand, Norway, Portugal, Singapore Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
5	Why Do International Labs Seek Accreditation? Money Competitive edge Medical tourism Thailand – cardiac care, sexual reassignment surgery Costa Rica – cosmetic surgery Mexico – cancer treatments Clinical trials Professional benchmarking Government requirement Tied to reimbursement, not tied to reimbursement
6	Accreditation/Lab Practice Standards Worldwide (Some Examples) European Continent ~50% of countries on European continent require laboratory practice standards ~22% considering practice standards ~40% see accreditation as a positive Only a small percentage are accredited as of 2005 ~17% require accreditation with enforcement North American Continent US Any location testing human samples for diagnosis, prognosis or treatment must be accredited privately or by the US Government. Unique requirements, not ISO based Canada One province requires accreditation based on ISO 15189 Remaining provinces soon
7	Accreditation/Lab Practice Standards Worldwide (Some Examples) Australia/New Zealand Labs certified based on ISO 17025 Will be accredited next 3-5 years based on ISO 15189 Asia/Pacific Emerging interest China, India (NABL), Malaysia (MOH), Singapore, Taiwan (MOH), Thailand (MOH and Med Tech Society) Overall theme More and more labs see accreditation as a means to be financially and professionally successful Need direction, guidance, advice, education Need a economical approach for accreditation
8	Perceived Barriers to Accreditation COST To implement an accredited quality system Lack of a phased approach Accreditation schemes focus on and are designed for larger facilities Participation in EQA (proficiency testing) LACK OF MANAGEMENT COMMITMENT LACK OF EXPERTISE IN QUALITY SYSTEMS LIMITED STAFFING
9	Characteristics of International Laboratories Diagnostic Laboratories Share Many Things in Common Technology and Science of Diagnostics: a common denominator Resource Limitations Financial Human (staff turnover) Qualified and Trained personnel Facility Space Environment Emerging Interest in Quality Systems Final CLIA Rule (US) reflects a quality system format ISO 15189
10	What is Important to Know About International Laboratories Uncommon Characteristics (Country specific) Highly trained and educated staff (Masters and PhD) UK, Australia, New Zealand, Canada “Hang Out A Shingle” laboratory Asia-Pacific and China US and European trained Medical Technologists and Pathologists Specialization UK, Australia, New Zealand, Canada Focus on robotics and automation Japan, Korea Direct Access Testing –Predominant India Decentralized Testing Pharmacies – France Emergency Care – Much of Europe
11	Summary Currently there is a patchwork of laboratory standards leading to mixed laboratory outcomes While many laboratories worldwide have interest in ISO 15189, laboratories in the Asia/Pacific region seem to have the most interest. It is hoped that all countries will adopt ISO 15189 as the basis for accreditation Accreditation requirements must be enforced by governments or professional societies
12	US Update Establishment of Manufacturer’s Recommendations for User Quality Control of in vitro Diagnostic Devices; Proposed Guideline (EP22)
13	Subcommittee Members Greg Cooper, Chairholder (Bio-Rad) Fred D. Lasky, PhD (Genzyme Diagnostics) Dai J. Li, MD, PhD, FACB (FDA Center for Devices and Radiological Health/OIVD) George S. Makowski, PhD, DABCC,FACB (University of Connecticut Health Center) James H. Nichols, PhD, DABCC, FACB (Baystate Medical Center) Curtis A. Parvin, PhD (Washington University School of Medicine) George M. Plummer (Dade Behring, Inc.) Adam Manasterski, PhD (Centers for Disease Control and Prevention)
14	EP22 - Scope Intended for manufacturers of in vitro diagnostic test systems & may be used by national certifying bodies at their discretion. Provides guidance for the establishment of manufacturer’s recommendations for user quality control for in vitro diagnostic test systems. Provides guidance on the maintenance of & disclosure of information to users regarding the scope & effectiveness of recommended QC procedures.
15	EP22 – Intended Use This document will be used by IVD manufacturers that choose to include QC recommendations in their labeling. If a manufacturer makes no such recommendation, this document does not apply.
16	EP22 - Exclusions This document will not: Address risk mitigation activities that may be performed by clinical laboratories beyond manufacturer’s recommendations. Describe or recommend risk assessment/mitigation procedures to be performed by IVD manufacturers.
17	EP22 – Exclusions (continued) This document will not: Provide a list of specific validation tests or test types, acceptable performance limits, or sample sizes needed to support a manufacturer’s QC recommendations. Prescribe specific QC requirements for a laboratory such as QC rules, QC frequency or QC materials. Compare or contrast any alternative QC recommendations to the use of traditional QC materials.
18	Progress Three meetings to-date Preliminary draft completed 30 June 2006 Subcommittee finalizing draft via web conferences (July/August)
19	Progress Participant perspectives Manufacturers Laboratory professionals Certifying and regulatory bodies
20	Questions?