1. Louisiana Environmental Laboratory Accreditation Program (LELAP) Paul Bergeron LELAP Supervisor Joint Emergency Services Training Center Zachary LA April 29, 2010 _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 1

2. Why Accreditation? Many state agencies, not just LDEQ, make policies based on data from laboratories. Consequently, objections to policies are pursued by challenging the quality of the data. Accreditation is a mechanism for establishing that a laboratory has a system for producing data of known and documented quality. _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 2

3. Scope of Accreditation EPA and DEQ have policies concerning how different media or matrices are affected by human activity. Laboratories specialize in the ability to measure compounds and parameters in the matrices according to recognized methods. Accredited laboratories receive a scope of accreditation which identifies the matrix, method, and analyte on which the accreditation is based. _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 3

4. Accreditation and Certification—what’s the difference? Accreditation is used to verify that laboratories have an appropriate quality management system and can properly perform test methods and calibration parameters according to their scopes of accreditation. Certification is reserved for personnel and products as having adequate credentials or meeting certain requirements. Accredited laboratories do receive and must display a certificate. _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 4

5. Accreditation in Louisiana The only state in the US with two NELAP Recognized Accrediting Bodies (Louisiana Department of Environmental Quality and Louisiana Department of Health and Hospitals) The only state in the US offering full accreditation for stack testers _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 5

6. LDEQ Overview LELAP was created in 1994 by legislation Program began accepting applications in 1998; since then, number of applications has leveled off to 5-10 year Interim accreditation ended in 2001 Program officially became a NELAP accrediting authority in 2001 and a NELAP accrediting body in 2008 following the formation of TNI _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 6

7. NELAP v. LELAP NELAP does not fully accredit stack testers; LELAP accredits stack testers NELAP requires records to be retained for 5 years; LELAP requires records to be retained for 10 years _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 7

8. NELAP v LELAP NELAP requires two rounds of passing proficiency test results for the addition of a method to the scope of accreditation; LELAP requires one round NELAP gives laboratories the option to perform supplemental proficiency tests; LELAP requires remedial proficiency tests for failed routine proficiency tests _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 8

9. NELAP v LELAP If proficiency test samples are not available, NELAP requires the maintenance of a total quality management system; LELAP requires an analytical data package NELAP addresses the use of experimental proficiency tests; LELAP does not address experimental proficiency tests _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 9

10. NELAP v LELAP NELAP requires the technical director of a chemistry laboratory to have 24 semester hours of chemistry in addition to a bachelor of science degree; LELAP requires a bachelor of science degree or 4 years of equivalent experience in a related field NELAP requires all containers of prepared, standards, and reference materials to bear an identifier and expiration date; LELAP requires all purchased chemicals, solutions, and standards to be labeled with the date of receipt, expiration date, and date the container is opened. _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 10

11. NELAP v LELAP NELAP requires a laboratory to state that the final report shall not be reproduced except in full without the written approval of the laboratory; LELAP requires a laboratory to state that the report shall not be reproduced in full or in part without the written approval of the customer NELAP does not require quality assurance data to be included with final reports; LELAP requires that the report include appropriate quality assurance documents. _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 11

12. At Present… 185 accredited facilities 10 applicants are pending, 7 are first-time 1 facility was suspended in 2009 92 facilities accredited by primary accreditation, 74 facilities by secondary accreditation (recognition), 19 have both _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 12

13. Primary and Secondary Accreditation _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 13

14. Instate versus Out-of- State _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 14

15. Accreditation by Program _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 15

16. NELAP Accreditation _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 16

17. Accreditation Application Electronic copy available on website Must include application fee Must include copy of Quality Assurance Manual and list of SOPs Must include proficiency test results _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 17

18. Proficiency Testing List of approved providers is available at website LELAP no longer approves providers for gas proficiency tests The requirement for gas proficiency tests is suspended until such providers are accredited by the American Association for Laboratory Accreditation (A2LA) _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 18

19. Analytical Data Packages Submitted in lieu of proficiency test results when there are no approved proficiency test samples Defined as including all analytical method, technical information, and quality assurance results If facility is not performing the method, it must provide data as specified by the reference method calibration or quality control requirements at a minimum _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 19

20. Confidential Business Information See LAC 33:I.503 Must be declared before an assessment begins Materials granted CBI status will be locked with restricted access Request must be renewed every two years _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 20

21. Test Categories Metals Microbiology Biomonitoring Classical Wet Chemistry (nutrients, minerals, ions, demands, and coliforms) o Minor conventional parameters _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 21 Organics (semi-volatiles, volatiles, pesticides, herbicides, and PCB’s) Dioxins and Furans Radiochemistry Asbestos Geotechnical Soil Testing Air Pollutants

22. Minor Conventional Parameters BOD 5, Hexane- Extractable Material, TSS, Fecal & Total Coliform, and Residual Chlorine ONLY _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 22

23. Accreditation by Test Categories _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 23

24. Accreditation by Category and Location _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 24

25. NELAP Accreditation by Category and Location _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 25

26. NELAP Primary and Secondary Accreditation by Category for Out-of-State Laboratories _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 26

27. ASSESSMENT TEAMS Assessment teams are comprised of assessors from LELAP. Most assessments require at least two assessors. _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 27

28. _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS Pre-Assessment Materials 28 Includes checklists, standard operating procedures, and data packages Facilities are requested to complete and return the checklist prior to assessment Offsite reviews reduce travel time to assessor and visiting time for laboratory

29. Scope Amendments _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 29 Request must be submitted in hard copy, accompanied by one round of proficiency test results (state) or two (NELAP) No addition amendments are allowed during the assessment process

30. Schedules Renewal Application—every 3 years Assessments—every two years Stack tester assessments include home base and field assessments Field assessments may be static (demonstration only) and combined with home base. Proficiency Tests and Analytical Data Packages—Twice a year~6 months apart _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 30

31. Schedules Assessment Reports due 30 days after the NELAP assessment; due 60 days after the state assessment Corrective Action Plans—due 30 days after receipt of the assessment report Responses to the Corrective Action Plan – due 30 days after receipt of the NELAP Corrective Action Plan Correction of Findings Identified During Assessment—6 months after receipt of the assessment report _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 31

32. Schedules Test Category Fee after Initial Assessment—due 30 days from receipt of invoice Decision on NELAP accreditation for initial applicant—due 9 months after application is received Re-application to Obtain NELAP accreditation—laboratory must wait 6 months Regain Full NELAP Accreditation after Suspension—6 months to correct cause _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 32

33. Schedules Regain Full NELAP or State Accreditation after Revocation---laboratory may reapply after cause is corrected Notice to LELAP of change of key accreditation criteria—due 30 days after change is effective Notice to laboratory clients of change of accreditation status—due 10 days from official notice of the action _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 33

34. Questions? _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 34

35. LELAP Location within LDEQ Headquarters Office of Environmental Services Permit Support Services Division Notifications and Accreditations Section _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 35

36. LELAP physical location… 602 North Fifth Street Baton Rouge LA 70802 Paul Bergeron, Supervisor Phone 225-219-1244 Email Paul.Bergeron@LA.GOV _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 36

37. LELAP has the following staff… _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 37 Paul Bergeron Supervisor Cindy Gagnon Assessor Dr. Jacqueline Prudente Assessor Dr. Alicia Ryan Assessor Elizabeth West Assessor (Shreveport) Charles Leonard, CIH Assessor Beverly Cupit Administrative Coordinator

38. LELAP has implemented “regionalization” An assessor is based in the Northwest Regional Office to conduct assessments for laboratories located in north and central Louisiana, the Texarkana area, and northern Mississippi _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 38

39. LELAP is implementing other aspects of the Ten Point Plan Ethics and Integrity—assessors receive annual training Transparency—LELAP FAQs are posted on website Front-loading—a/k/a “Accreditation 101” Investment in Small Business—LELAP encourages small laboratories to participate on the TNI small laboratory sub-committee _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 39

40. LELAP is implementing other aspects of the Ten Point Plan Investment in Community Organizations and Local Governments—LELAP continues to support LWEA and its members Investment in Green Government and Applied Research—documents will be accepted and sent electronically; method modification will continue to be approved according to regulations Investment in Technology and e-Commerce—LELAP is making improvements to its database; fees can be paid electronically, contact the LDEQ Financial Services Division _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 40

41. LELAP is implementing “Streamlining for Efficiency” Records are being transferred to the Electronic Data Management System (EDMS) Scopes are available on EDMS and will be available on the website _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 41

42. “Streamlining for Efficiency” The LELAP Quality Assurance Plan and the standard operating procedures are being revised to increase efficiency of accreditation activities Regulation changes will be proposed to reduce or combine assessments _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 42

43. Benefits of “Streamlining for Efficiency” Assessment time in laboratory will be reduced if the laboratories provide the documentation upfront Provide requested documents such as checklists to the assessor prior to the assessment Have training records, internal audits and annual management reviews ready for the assessor to review _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 43

44. Benefits of “Streamlining for Efficiency” Costs to Laboratories and Overtime Will be Reduced Contractor assessors have been eliminated Streamlining with the use of checklists Limiting the scope of the assessment Rotating/target certain areas for assessment _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 44

45. Benefits of “Streamlining for Efficiency” Exit Debrief will be Reduced by Limiting Extraneous Discussion Submitting copy of the assessor’s checklist with previously noted and discussed findings, seriousness, and lab objections A hard copy of the post assessment requirements may be presented to labs A teleconference may also be conducted _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 45

46. Assessment Cycle Focus First Assessment—Overview to determine if compliant quality system has been implemented Second Assessment—Focus on methods _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 46

47. Assessment Cycle Focus Third Assessment—Focus on data review Fourth Assessment—Back to overview, determine if quality system is functioning in laboratory _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 47

48. Assessment Cycle Focus Minimum Quantitation Levels (MQLs)— assessors are looking for implementation of new MQLs in EPA Region 6-based work New technologies—LELAP will address nanotechnology, metals speciation, etc. as the need arises _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 48

49. Assessment Cycle Focus Other assessments will be conducted as needed Laboratory relocations Complaints received by LELAP Addition of new test category or technology to scope _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 49

50. Other items… LELAP Recognition by the NELAP Board was finalized by November 2009 The application for accreditation has been revised Checklists have been posted on the website _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 50

51. Reminders… Use accredited laboratories for subcontracted work Submit analytical data packages if there are no proficiency test samples available _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 51

52. Reminders… Notify LELAP of changes affecting the condition of your laboratory accreditation (new name, address, etc.) Fees are due by July 1 of each year or as stated on invoice _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 52

53. Reminders… Provide requested documents such as checklists to the assessor prior to the assessment Have training records, internal audits and annual management reviews ready for the assessor to review _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 53

54. Reminders… Submit a satisfactory corrective action plan for findings identified during the assessment Expect a teleconference or meeting if the plan is predominantly “not approved” _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 54

55. Reminders… Implement the corrective action plan when it is approved! Monitor the implementation to establish its effectiveness Be prepared to provide documentation of implementation by the next assessment _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 55

56. Questions… _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 56

57. Laboratory Issues and Challenges An Open Forum Paul Bergeron, LDEQ Joint Emergency Services Training Center Zachary, LA April 29, 2010 _________________________________________ LOUISIANA DEPARTMENT OF ENVIRONMENTAL QUALITY : FOR ALL YOUR ENVIRONMENTS 57