By: Allison Mackenzie, CEO
The arduous journey to fix laboratory accreditation in California and improve the reliability of all regulatory data quality produced by CA accredited labs reached another significant milestone last month. On May 3rd the State Water Resources Control Board (State Water Board) held an informational workshop regarding the California Environmental Laboratory Accreditation Program (ELAP). The State Water Board received public comments on the Program’s progress and also the final recommendations in the Year 2 Final Report by the ELAP Expert Review Panel. As the CEO of Babcock Laboratories and a member of the Environmental Laboratory Technical Advisory Committee (ELTAC), I was among those who attended this workshop and provided comments. This article highlights some of the Expert Review Panel’s final report recommendations and what labs can expect during the next leg of the journey.
The Panel’s final report included the recommendation that ELAP move without delay to adopt the The NELAC Institute (TNI) 2016 Standard. Additionally, the Panel also recommended that “ELAP adopt the 58 ELTAC proposed modifications as implementation guidance rather than as modifications to the underlying standard” in part because “adopting a modified standard would isolate California from invaluable training resources available from the national program.” Babcock Laboratories supports this recommendation by the Panel because we believe that full adoption of the TNI 2016 Standard will provide meaningful reform for California ELAP.
The reason that full adoption of the TNI 2016 Standard is important is because the purpose of a quality systems-based laboratory standard is to ensure the competency of a laboratory to produce data of known and documented quality. All labs—public and private— produce data for decision making purposes affecting public health and safety and therefore must be held to the same standard, regardless of lab size. This is yet another reason why ELAP should adopt the 58 modifications as implementation guidance rather than as modifications. Creation of a California-only accreditation standard will impede and delay the process of regaining confidence in all of the results generated by labs.
The Panel also recommended that ELAP “develop an implementation process that facilitates laboratory participation.” More specifically, the Panel suggested ELAP use a combination of time-based, documentation-based, and requirement-based phasing. Again, Babcock Laboratories agrees with this recommendation and believes this phasing process should take no more than three years to implement once the Standard is adopted. Moreover, Babcock Laboratories has called on ELAP to include a training component in its on-site assessments (OSAs) over the course of the implementation period. This will allow laboratories, especially laboratories unfamiliar with the Standard, the opportunity to improve their quality systems.
In terms of expanding resources, the Panel strongly urged ELAP to “immediately begin accepting third-party assessments.” Babcock Laboratories agrees with this recommendation because third-party assessments will help reduce the current backlog and provide expertise for assessment of complex fields of testing (FOTs).
Third-party assessments also make sense from a practicality standpoint. The ELAP staff have made great strides in the past two years and gained significantly in knowledge and experience. That said, the ability of the program to attract and retain the technical competence necessary to conduct audits and assessments of all methods and fields of testing in three major regulatory programs has proved insufficient. The financial resources and the number of years necessary to train, develop, and retain a competent accreditation staff is impractical and, arguably, not in the best interest of the State Water Board and the California tax payers.
To make the use of third-party assessment possible, ELAP must provide some financial relief to laboratories that need to utilize the services of third-party assessors. Laboratory fees in California have tripled in the last three years. The additional cost cannot simply be thrown on top of existing laboratory accreditation fees, which are excessive by any reasonable comparison. With ELAP no longer burdened to provide for the on-site audit and assessment portion, the cost to use third-party assessment services should be considered in setting the California accreditation fees for labs compelled to use it.
A final recommendation from the Panel that is worth noting is its suggestion that ELAP immediately initiate and use “software to improve the processing efficiency of information being evaluated for laboratory accreditation.” ELAP staff are spending countless hours manually reviewing the Proficiency Testing reports of the 750 CA accredited laboratories. This is an important task as each laboratory must demonstrate the ability to analyze and report every analyte for every test method for which the laboratory maintains accreditation. It is a minimum requirement of any credible demonstration of competence. It is also a task that virtually every other state accreditation system has automated. In our final comments to the State Water Board, Babcock Laboratories called on ELAP to prioritize the purchase and implementation of available software to make this important task efficient and cost effective.
Overall, it appeared at the May workshop that the State Water Board is in agreement withthe Panel’s final report recommendations. This is encouraging, as it means laboratories can begin implementing the TNI Standard ahead of formal State regulation adoption. California will be set up for laboratory accreditation success and data quality reliability.
The next ELTAC meeting will take place on July 13th, where the committee will discuss the next big issue—laboratory accreditation fees.