Coverage of new ELAP regulations supported by LabWorks, waterLIMS™
Christine Sotelo, Chief of CA ELAP
By Christine Sotelo
Chief of CA ELAP
The California Environmental Laboratory Accreditation Program (ELAP) is on a path of improvement, and we are honored to be working collaboratively with CWEA and its members on this journey.
Five years ago, the State Water Resources Control Board inherited ELAP. At that time, the program was widely viewed as the worst environmental laboratory accreditation program in the nation. ELAP was failing its stakeholders and failing to effectively evaluate laboratory competency.
Laboratories who interacted with ELAP all had similar poor experiences; decisions on accreditation status were left to the whim of the assessors, on-site assessments were inconsistent in nature and frequency, complaints lodged with the program were never addressed, and it was nearly impossible to get ELAP to return a call or email. On top of this, the relationship between ELAP and its Environmental Laboratory Technical Advisory Committee (ELTAC) was broken because ELAP did not listen or respond when it made suggestions.
ELAP was also failing to meet its regulatory obligations to inspect, accredit, monitor, and enforce requirements for its laboratories. Assessments were backlogged for years, monitoring labs through annual review of proficiency testing results was not taking place at all, and ELAP was years behind on updating its methods so that agencies could request that the data they relied upon was produced using the most technically relevant methods. The final straw came when the Water Boards’ Office of Enforcement confirmed that ELAP had failed to investigate a laboratory fraud case despite being provided sufficient evidence to warrant an investigation. ELAP’s inability to remove a fraudulent laboratory from the population was a sobering realization about the ineffectiveness of the program and resulted in the transfer of the program to the Water Boards.
Since moving to the Water Boards, ELAP has undergone a monumental transformation. We standardized our processes by implementing an internal quality management system that creates accountability and predictability for staff and stakeholders. Decisions made by ELAP staff are no longer arbitrary and adhere to documented procedures based on state laws and regulations. Half of ELAP’s staff has turned over during this time and new staff have been trained under this quality management system.
A major aspect of the transformation was a reorganization to become a complete, whole accreditation program. For example, we created a new Proficiency Testing Unit to monitor and evaluate results from proficiency testing studies from every laboratory, which is approximately 20,000 results per year. A robust enforcement unit was also established and currently works diligently to educate laboratories and take appropriate action until problems are resolved, including working with local law enforcement when there is criminal activity involved. Thanks to this units’ efforts, the above mentioned fraud case has since been resolved and resulted in a criminal conviction.
Another key piece to this transformation has been building strong relationships with stakeholders, which included putting processes in place to support better and more productive interactions with laboratories and other agency programs. In the past, ELAP did not talk to the California regulatory agencies that use the data produced from accredited laboratories.
Now we meet regularly with executive and program staff to identify current and future accreditation needs of the programs. ELTAC was also revitalized with new by-laws that clearly define processes for communication between the program and the committee. With this guidance, ELTAC and ELAP have been successfully working together to move the program forward so that it meets the needs of the regulatory programs the data is produced for.
The program has made great strides, but there remains one more major item to accomplish – the adoption of new regulations that include a quality management system requirement (QMS) for accreditation. While ELAP, its regulatory agency partners, and the laboratories all agree that a QMS requirement is necessary, the laboratory community is divided over how rigorous it should be. Even though the proposal to the State Board may not include the QMS option supported by CWEA, ELAP is listening and appreciates the open dialogue that has been embraced during this process.
Whatever the State Board decides, we look forward to working with the laboratory community on implementing the new standard, including providing tools and training to assist in the transition. ELAP also looks forward to continuing to work as partners in service of a shared mission to protect the environment and public health of California’s communities.
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