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

Transcription

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

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

3 Key Provisions Act 90 Section 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 3

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

5 Key Provisions Act 90 Who 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. 5

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

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

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 8

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) 9

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

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

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

13 Chapter 252 Environmental Laboratory Accreditation Regulations 13

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

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

16 General Provisions Purpose Scope 16

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

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

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

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

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

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

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

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

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

26 QUALITY ASSURANCE AND QUALITY CONTROL 26

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

28 Essential Quality Control Chemistry Toxicity Testing Microbiology Radiochemistry 28

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

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

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

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

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

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

35 QUESTIONS? 35

36 USEFUL INFORMATION Choose Subjects / Lab Certification Rsheibley@state.pa.us Bureau of Laboratories Evan Press Building Room 100 P. O. Box 1467 Harrisburg, PA Phone FAX