1. Laboratory of Immunobiochemistry and ISO 17025 Accreditation Sandra Menzies, M.S., Consumer Safety Officer Laboratory of Immunobiochemistry, CBER, FDA

2. 2 LIB-ISO 17025 History of Scientific Evidence New standards initiated by FBI experience Frye v. Unites States, 1972  Expertise must be generally accepted by the scientific community Daubert v. Merrill Dow Pharmaeuticals, Inc., 1993  Federal Rules of Evidence  Judge determines expert’s testimony: Reliable foundation Relevant to the task Frederic Whithurst, Ph.D.  FBI Expert Witness and Whistleblower  O.J. Simpson Murder Trial  World Trade Center Bombing 1997 OIG Findings  Evaluation of 51 cases ID by Dr. Whithurst  improper report preparation,  insufficient documentation of results,  scientifically flawed reports,  inadequate records, and  unqualified examiners

3. 3 LIB-ISO 17025 FDA History Oct. 1998 FDA’s Senior Science Council (SSC) began to assess lab accreditation Nov. 1999 FDA Leadership Council and the Commissioner endorsed a proposal from the SSC  each FDA Center and ORA independently pursue accreditation of official testing activities according to individual center needs and activities

4. 4 LIB-ISO 17025 Accreditation Approval that a group has met specific requirements after undergoing an inspection by an accreditation body. Inspectors are experts in the field in which accreditation is sought. Accreditation is based on procedures that standardize the accreditation bodies (ISO/IEC 17011).

5. 5 LIB-ISO 17025 Laboratory Accreditation Formal recognition that a testing laboratory is competent to carry out the tests identified within the scope of accreditation Accreditation ensures that: Results are: Accurate, Reproducible, and Traceable. Testing laboratories are: Competent and Credible to specific tests.

6. 6 LIB-ISO 17025 Standards Organization American Society for Testing and Materials (ASTM) International American National Standards Institute (ANSI) International Organization for Standards (ISO)

7. 7 LIB-ISO 17025 International Organization for Standards (ISO) ISO based on Greek word isos meaning “equal” Established in October 1947 Identifies the global need for international standards A non-governmental organization A federation of national standards bodies within 157 countries The world’s leading developer of International Standards  18,536 International standards and standard-type documents (as of 12/31/10) CBER selected ISO 17025 to provide the framework for its laboratory testing program.

8. 8 LIB-ISO 17025 ISO 17025 ISO 17025:2005 “General requirements for the competence of testing and calibration laboratories”  Management requirements  Technical requirements ISO 17025 formerly called Guide 25 Allows for recognition of testing laboratory results worldwide Provides accreditation of defined, validated methods

9. 9 LIB-ISO 17025 Management of a Laboratory Quality System (LQS) Management Review Document Control Customer Service Internal Audits Nonconformity & Corrective Action/ Preventative Action Record Control

10. 10 LIB-ISO 17025 Testing Life-cycle Develop Testing Plans Select & Validate Test Methods Ensure Sample Handling (Receipt → Disposal) Assure Quality of Test Results Assure Reporting of Results

11. 11 LIB-ISO 17025 Technical RequirementsTestMethods Environmental Control Qualification of Equipment Competency of Personnel Validations Measurement Uncertainty Purchase Service & Supplies

12. 12 LIB-ISO 17025 CBER History Nov. 2001 FDA recommended that CBER be accredited to ISO 17025 Sept 2006 Re-organization of CBER’s lot release testing program and establishment of Division of Product Quality (DPQ) March 2009 Upon determination that allergenic lot release will remain with LIB, LIB initiated LQS development June 2010 DPQ assessed for ISO 17025 Accreditation by A2LA. Oct. 2010 DPQ granted ISO 17025 Accreditation (Future) ISO 17025 Accreditation assessment of LIB

13. 13 LIB-ISO 17025 Laboratory Quality System Organization Chart Laboratory of Immunobiochemistry Division of Bacterial, Parasitic and Allergenic Products OVRR, CBER, USFDA Ronald L. Rabin, M.D. Chief, Laboratory of Immunobiochemistry Cherry Valerio Operational Manager Aaron Chen Operational Personnel Ekaterina Dobrovolskaia Operational Personnel Mona Febus Operational Personnel Sandra Menzies, MS Quality Manager Susan Huynh Document Administrator

14. 14 LIB-ISO 17025 LIB’s Scope of Accreditation Competition ELISA  Grass pollens  Mites  Bermuda Radial Immunodiffusion Assay (RID) or Sandwich ELISA  Ragweed  Cat hair and Cat pelt

15. 15 LIB-ISO 17025 LIB’s LQS Status 63 procedures developed and issued  addresses all areas of the quality system  12 of these documents are undergoing changes 7 documents developed but not issued Equipment maintenance contracts for:  Pipettes  Balances Method Validation  Ragweed RID – completed  Competition ELISA –testing is on-going  Cat RID – validation protocol in development

16. 16 LIB-ISO 17025 LIB’s LQS Status – In process Authorization of personnel Equipment qualification  Freezers, refrigerators, cold rooms  Comparing RID viewing calipers  Air handlers  Chemical hoods

17. 17 LIB-ISO 17025 Recent Internal Audit First Quarter 2011 and focused on:  Document Control  Testing Plans  Purchasing of Services and Supplies  Control of Records  Personnel  Accommodation and environmental conditions  Reporting of results Several minor findings.

18. 18 LIB-ISO 17025 Summary LIB’s continues to develop a LQS that is accreditable to ISO 17025 Future goals:  Complete the LQS development  Undergo an LQS internal audit  Accreditation assessment A LQS will provide management with an assurance that data generated by LIB are accurate, reproducible, and traceable.