The Overhaul of California ELAP: The Laboratory/ELTAC Perspective

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Presentation transcript:

The Overhaul of California ELAP: The Laboratory/ELTAC Perspective Andy Eaton, PhD, BCES Technical Director ELTAC Chair The Overhaul of California ELAP: The Laboratory/ELTAC Perspective Added Monrovia and South Bend to the slide.

What Do I Need in an ELAP Program as a Lab Level playing field Quality systems based approach in all labs to improve the odds of defensible data Good communication of changes in the program so I can respond Responsiveness from the program to my needs

Historical Issues That Were Vexing to the Lab Community THE OLD ELAP Inconsistent evaluations Opinions instead of standards No consistent review of PTs No timeliness in response (or in audits) No communication of program changes Etc….

A New and Vigorous ELTAC Environmental Laboratory Technical Advisory Committee (ELTAC) The ERP recommended reinvigorating this entity, which had actually existed for a number of years but was at cross purposes with ELAP. ELAP wanted to use ELTAC as a resource to help re-invent and improve the program.

Who the Heck is ELTAC? A mix of commercial, public health, municipal and state agency (non voting) representatives Selected by ELAP to represent various industry sectors, but also tasked with trying to put aside inherent biases and support ELAP Voting and non-voting members

Current ELTAC Voting Members are Diverse Name category representing Mindy Boele muni CWEA-small Jill Brodt commercial small Stephen Clark bioassay Ronald Coss CWEA-large Huy Do CASA-large Andy Eaton-Chair multistate Miriam Ghabour large Bruce Godfrey ACIL- large & small Anthony Gonzales public health Rich Gossett small specialty David Kimbrough medium Mark Koekemoer Allison Mackenzie

ELTAC Was REALLY Busy In the First 18 Months

Topics ELTAC Has Been Involved With Lab Accreditation Standard – Controversial to say the least… Proficiency Testing Evaluation Approach – ELTAC generally speaks with one mind Fields of Testing Worksheets for CA – lots of input and some consensus Adding new methods for compliance (CA) – consensus on approach Fee structure – punted to stakeholder group

More Topics ELTAC Has Been Involved With Check Lists - In our bailiwick, then out of our bailiwick Enforcement approach – also controversial Communications approaches – consensus on recommendations CA DLRs – just weighing in directly on that subject now that CA is considering a lower RL for ClO4 Implementation of the Standard and New Regulations

ELTAC and the Lab Accreditation Standard – Now TNI2016 (sort of) Discussions on this took the better part of a year and there was no consensus. Small lab issues were the greatest area of concern (CA has a LOT of small labs) Smaller muni labs concerned with the large number of requirements. Many wanted something simpler. Even some commercial labs (non TNI) were worried. Ultimately the State Agency Partners called the shots with the State Board. Essentially TNI2016.

Proficiency Testing Evaluation Approach Historically ELAP did minimal tracking of PTs. So if a lab didn’t participate there was no penalty… But also for methods like VOAs, they did not evaluate individual analytes on their own, but relied on 80% of ALL analytes to “pass”. This was a problem for labs that only do short lists like BTEX. ELTAC strongly recommended evaluation by analyte (duh…). But there are still issues with determining availability of PT samples for some analytes.

Fields of Testing Worksheets for CA The former FOT set up in CA was not very lab friendly for applications and also not all inclusive of allowable methods ELAP asked for ELTAC to come up with alternative models to make it more logical. ELAP embraced the changes, but … The MUR (whenever…) complicates it It overlaps extensively with fee issues. We are now moving towards FOAs (analytes) and not worrying about FOTs per se.

Adding New Methods or Lowering Reporting Limits ELTAC developed a “Proposed Framework for State Agency Requests to ELAP for New Analytical Methods and Lowered Reporting Limits” More interagency cooperation encouraged Multi-step process (see next slides) designed to ensure that methods are validated and reporting limits are achievable. ELTAC as a technical resource is the backstop of the process This is ultimately a critical role for ELTAC.

Flow Chart for New Methods Process ELAP Request from State Workgroup to ELAP Chief ELAP submits to ELTAC ELTAC ELTAC establishes technical committee to evaluate feasibility ELTAC gets list of relevant CA certified labs from ELAP ELTAC reaches out to labs with “scope” of needs ELTAC reviews lab responses

Flow Chart for New Methods Process (Continued) ELTAC If labs are deemed capable, a summary will be prepared for ELAP. ELAP ELAP must then offer accreditation for that analyte/reporting limit. Labs must obtain accreditation to perform testing for compliance. If capability is deemed to NOT be there, a summary of the required development and timeline will be provided to ELAP. ELAP goes back to State Agencies with status and needs.

Fee Structure It was originally envisioned that ELTAC would be the primary resource for discussion of fee structures. But instead ELTAC members are participants in a broader stakeholder group. Work in process, but things are moving fast. ELAP Fees have gone up significantly in past two years to account for budget shortfalls, so the plan now is to have a sustainable fair fee structure.

Historical Issues That Were Vexing to the Lab Community THE NEW ELAP Inconsistent evaluations Training contract implemented to train auditors Opinions instead of standards Training contract implemented; there is a standard No consistent review of PTs ELAP is still learning… No timeliness in response (or in audits) Anecdotally this is still a bit problematic No communication of program changes Improved, but more is always needed.

Last But Not Least - Assessments ELAP does not have in-house capability for assessing any mass spec methods. This will lead to requirements for 3rd party assessments for as many as half the labs in CA. ELTAC weighing in on criteria for approving 3rd parties to: Make it easier for smaller labs to have a choice Ensure that TNI/ISO/DOD labs don’t need an additional assessment

Eurofins Eaton Analytical, Inc. CALIFORNIA CECs Any Questions? Andy Eaton andyeaton@eurofinsus.com 626.386.1125 Eurofins Eaton Analytical, Inc. www.eurofinsus.com