Environmental Laboratory Accreditation

1. Environmental Laboratory Accreditation Richard H. Sheibley, Chief Laboratory Accreditation Program Department of Environmental Protection

2. Act of June 29, 2002 P.L. 596, No. 90 Title 27 Sections 4101-4113 Environmental Laboratory Accreditation Act

3. Key Provisions Act 90Section 4103 – Laboratory Requirements • An environmental laboratory must be accredited under this act • All testing and analysis of environmental samples shall be performed by an accredited environmental laboratory • Testing shall be performed pursuant to the act, the environmental statutes and departmental conditions

4. Key Provisions Act 90Who is Affected? “Environmental Laboratory” A facility engaged in the testing or analysis of environmental samples.

5. Key Provisions Act 90Who is Affected? “Environmental sample” A solid, liquid, gas or other specimen taken for the purpose of testing or analysis as required by an environmental statute.

6. Key Provisions Act 90Who is Affected? “Environmental statute” A statute administered by the Department relating to the protection of the environment or of public health, safety, and welfare.

7. Laboratory Accreditation Advisory Committee Eleven Members Provide Technical Assistance Public Meetings

8. Regulation Development Process Preliminary Draft – October 2002 LAAC Review – October through February 10/17, 12/16, 2/13 Ad Hoc Work Group 11/26, 1/9, 3/5

9. Regulation Development Process(continued) Advisory Committees • SRBC Water Quality Advisory Committee • State Board for Certification of Water and Wastewater Systems Operators • Certification Program Advisory Committee for Water and Wastewater Systems Operators (CPAC)

10. Regulation Development Process(continued) Advisory Committees • Small Business Compliance Advisory Committee • Small Water Systems Technical Assistance Center Advisory Board

11. Regulation Development Process(continued) DEP Program Input Water Supply Water Quality Underground Storage Tanks Land Recycling Mining Oil and Gas

12. Dual Accreditation Program State Accreditation • Created by Regulation Chapter 252 NELAP – VOLUNTARY • NELAC standards incorporated by reference

13. Chapter 252Environmental Laboratory Accreditation Regulations

14. General Provisions • Definitions • Batch • Drinking water, non-potable water, solid and chemical materials • Laboratory notebook • Laboratory control sample • Quality manual

15. General Provisions • Definitions (continued) • Analyst • Laboratory Supervisor • Technical staff • Standard operating procedure

16. General Provisions • Purpose • Scope

17. General Requirements • NELAP Equivalency • Accreditation by Rule • Drinking Water • Field measurements • Dissolved Oxygen • Residual disinfectant concentration • Alkalinity

18. General Requirements • Accreditation by Rule (continued) • Field measurements • Temperature, flow • Settleable solids • Field radioactivity • Total halogen – waste oil

19. Application, Fees,Supporting Documentation • Application • Initial • Ownership transfer • Renewal

20. Out-of-State Laboratories • Primary Accreditation • Secondary Accreditation • Same Fees As In-State Laboratories

21. General Standards for Accreditation • Laboratory Supervisor • Responsibilities • Qualifications • Grandparent Provision • Personnel Requirements • Demonstrate Capability • Documentation

22. General Standards for Accreditation • Physical Facilities • Adequate for Testing & Analysis • No Affect on Testing & Analysis

23. General Standards for Accreditation • Equipment, Supplies, Reference Materials • Maintain Records • Properly Maintained • Calibrated

24. pH Meter • Electrode • Scale Graduations • Thermometer or Probe • Standardize • 3 buffers, 4, 7, & 10 • 2 buffers 4 & 7 OR 7 & 10 • Maintain Records

25. ID Method Effective Date Scope Equipment & Supplies Reagents & Standards Quality Control Calibration Analytical Procedure Calculations Corrective Action Reporting Results Methodology

26. QUALITY ASSURANCEANDQUALITY CONTROL

27. Document Control Ethics Sample Handling Sample Acceptance Departures from SOP Quality Control Reporting Results Basic RequirementsQuality Manual

28. Essential Quality Control • Chemistry • Toxicity Testing • Microbiology • Radiochemistry

29. Chemistry & Radiochemistry • Initial Calibration • Continuing Calibration Verification • Sample Duplicates • Detection Limits • Selectivity

30. Toxicity Testing • Positive & Negative Controls • Sensitivity • Test Organisms • Equipment • Test Conditions

31. Microbiology • Positive & Negative Controls • Autoclaves & Ovens • Miscellaneous Equipment • Reagent Water • Media • Test Variablilty

32. Proficiency Test Studies ONE SUCCESSFUL PROFICIENCY TEST STUDY PER YEAR

33. On-Site Assessments • Sample Receipt to Final Report • Data & Procedural Review • Learning Process • Confirmation Doing It RIGHT • Correct Deficiencies • Continuous Improvement

34. Miscellaneous Provisions • Expiration of Application • Denial, Revocation, Suspension • Use of Accreditation • Record Keeping • Subcontracting • Reporting & Notification

35. QUESTIONS?

36. USEFUL INFORMATION • www.dep.state.pa.us Choose Subjects / Lab Certification • Rsheibley@state.pa.us 717-705-2425 Bureau of Laboratories Evan Press Building – Room 100 P. O. Box 1467 Harrisburg, PA 17105-1467 Phone 717-787-4669 FAX 717-783-1502