Preparing for Accreditation

1. Jerry L. Parr Catalyst Information Resources, L.L.C. TNRCC Trade Fair May 7, 2002 Preparing for Accreditation

2. NELAC Accreditation: Start to Finish 1. Deciding to apply 2. Understanding the requirements 3. Getting ready 4. Accreditation process

3. Key Documents • NELAC Standards • Assessor Training Manual • National Standards for Water PT • NELAC PT Tables • State Requirements • State Fields of Testing

4. STEP 1: Deciding to Apply • Your state’s requirements • Improve data quality • Customer expectations • Marketing advantage

5. NELAC Improves Data Quality • Implementation of a Quality System • Improved documentation • Standardized policies and procedures • Ethics program • Improved technical procedures

6. Customer Expectations • EPA • SDWA • OSWER • OIG • DOD • Industry

7. Marketing Considerations • Recognized standard of excellence • Use of logo • Reciprocity = geographic expansion

8. The Application • 20 detailed items • Certificate of compliance • Fields of testing • Quality manual • Fee • State options

9. Legal name of lab Address Owner (and address) Location Name and phone of TD, QAO, contact Hours of operation Primary AA Fields of testing Methods employed (with analytes) Lab type Required Elements in Application

10. Certificate of Compliance • Attest to compliance to NELAC standards • Signed by Technical Director & QA Director

11. Fields of Testing • Area: • Chemistry, Microbiology, WET, Radiochemistry, Field Activities • Program • SDWA, CWA, RCRA, CAA (TSCA, FIFRA, CERCLA) • Changes to be made in 2002 • Method/Analyte • Change to technology? • Include analyte group?

12. STEP 2 - Understanding the Requirements • Proficiency Testing • Quality System • Personnel Qualifications

13. PT Program Review • Two PT samples per year per field of testing where available • Purchase from any approved supplier • Uniform acceptance criteria • Pass 2 out of last 3

14. NELAC QUALITY SYSTEM • Elements documented in quality manual • Policies and objectives and commitment to accepted laboratory practices and quality of testing services • Annual internal audit and management review

15. NELAC Quality Manual • Policies and operational procedures established to meet NELAC standard. • Probably most significant up-front investment • Must address all QS elements • Template available from Catalyst

16. Elements of a Quality System • Personnel • Physical facilities • Equipment and reference materials • Measurement traceability and calibration • Test methods and SOPs • Method verification (Appendix C)

17. Elements of a Quality System (2) • Sample handling • Records and storage of records • Laboratory report format and content • Subcontracting • Complaint procedures • Essential QC Procedures (Appendix D) • Chemical, WET, Micro, Radiochemistry, Air

18. Sample Handling • Sample tracking • Sample acceptance • Sample receipt • Sample storage • Legal chain of custody • Sample disposal

19. Calibration • Traceability of calibration • Reference standards • General requirements • Analytical support equipment • Instrument calibration

20. QA/QC • Document control • Acceptable permitting departures from documented policies, procedures, & specifications • Corrective action • Complaint handling • Preventive action • Internal audits • Developing acceptance criteria when no method or regulatory requirement exists

21. Data Review and Reporting • Data review • Reporting analytical results • Electronic reporting • Record retention • Records transfer • Data integrity • Data security

22. Test Methods • May be copies of published methods • Must address 23 elements

23. Essential Quality Control Required activities, acceptance criteria and corrective action for: D.1 Chemistry D.2 WET Testing D.3 Microbiology D.4 Radiochemistry D.5 Air

24. Chemistry QC • Method Blanks • LCS • MS • Surrogates • Detection Limits • Selectivity Major revision in 2001 Standards

25. Detection Limit Determination • Appropriate (e.g., MDL) • Limited exceptions (e.g., temperature) • Each Matrix (see Glossary) • Link to Quantitation Limit • Redo if “significant change” • Link to instrument calibration

26. Demonstration of Capability • All methods • 4 replicates at 10 X DL • Compare X and s to acceptance criteria • Limited exceptions • “Work cell” provision • Certification statement Exception in 2001 standards for methods in use before July 1999

27. Analyst Proficiency One of the following at least once per year: • Single blind • DOC • PT sample • 4 LCS • Sample analyzed by another

28. STEP 2 - Understanding the Requirements Proficiency Testing Quality System • Personnel Qualifications

29. Technical Director • Full time employee • Oversee all lab operations • QA/QC • Data being generated • Sufficient qualified personnel • “One or more” may be appointed

30. TD for Chemical Analysis • Bachelor’s degree in chemical, environmental, biological sciences, physical sciences, or engineering • 24 college semester credit hours in chemistry • 2 years of experience in environmental analysis • Master’s or Ph.D. may be substituted for 1 year experience

31. TD for Inorganic Analysis (non metals) • Associate’s degree in chemical, physical or environmental sciences or • 2 years college education and • 16 semester credit hours in chemistry • 2 years of experience

32. TD for Microbiology • Bachelor’s degree in microbiology, biology, chemistry, environmental sciences, physical sciences, or engineering • 16 semester credit hours in general microbiology and biology • 2 years of experience • Master’s or Ph.D. may be substituted for 1 year experience

33. Exception for Microbiology • Associate’s degree in science (or 2 years college) with 4 hours in general microbiology and 1 year experience in environmental analysis • Limited to fecal coliform, total coliform, & standard plate count

34. Grandfather Clause • Does not meet educational requirements • Is the TD on date laboratory “applies” or “becomes subject to” NELAC standards AND has been TD for one year (new for 2001) • Can be TD at any other comparable laboratory • Limited to first year of program

35. Exceptions Full-time employee: • Of drinking water or sewage treatment facility with valid treatment plant operator’s certificate appropriate for that facility is approved to serve as director of accredited lab devoted to samples taken within facility • Of industrial waste treatment facility with 1 year supervised experience is approved as director of accredited lab devoted to samples taken within facility

36. Quality Assurance Officer • May be TD or deputy TD if limited staff • Responsible for quality system management & implementation • Focal point for QA/QC • Documented training and/or experience in QA/QC • Knowledge of the test methods • Arrange for or conduct internal audits annually • Notify lab management of deficiencies in quality system & ensure corrective action • No educational or experience requirements

37. STEP 3 - Getting Ready Organizational Decisions Technical Director Quality Assurance Officer Data Generation PT Sample Data Method Performance Data Documentation Quality Manual SOPs Administrative Information

38. Organizational Options • Multiple TD(s), QAO • Singe TD, QAO • TD = QAO

39. Quality Assurance Officer • Title is optional • Direct access to management • May be technical director • Specific job functions

40. Recommendations for TD/QAO • Have TD and QAO as 2 positions, if organization will allow • Have single TD, if qualifications allow • Have deputy TDs for contingency/growth • Consider grandfather clause

41. Summary of Data Needed • 2 PT samples results • Detection limits • Demonstration of capability (not required for methods already in use, but a good idea)

42. Administrative Information • Laboratory organization • Personnel training • Equipment & reference materials • Standards & reagents • Other

43. Laboratory Organization • Organization chart • Identification of major units • Lines of responsibility

44. Personnel Records • Job descriptions • Documentation of education/technical background • Documentation for each employee relating to quality manual • Training records • Analyst proficiency

45. Equipment & Reference Materials • Name of equipment • Manufacturer & serial number • Date received/placed into serviced • Current location • Condition when received • Copy of manufacturer’s instructions • Dates of calibration • Details of maintenance • History • Calibration certifications

46. Standards and Reagents • Certificate of analysis • Date of receipt • Manufacturer/vendor • Storage conditions • Expiration dates • Other information (e.g., sample disposal records)

47. STEP 4: The Assessment Process

48. Understand the Assessment Process • Assessors (i.e. auditors) • Frequency • Pre-Assessment • On-site Assessment (i.e. the Audit) • Assessment Report • Corrective Action • Closure

49. Steps to Take • Review assessor training manual • Review checklist • Internal/contractor review • Preliminary record submittal • SOPs • Data package • Other information • Review due process rules

50. Your Rights Before the On-Site • Checklist(s) • Confidentiality notice • Conflict of interest form • Assessor credentials • Mutually agreeable date