Article written by Gregg Frazier and Michael Haller of Analytical Products Group, Inc. and published in the Florida Specifier
Florida Remediation Conference Presentation
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Complete article from Edition 23 APG eNewsletter
The current laboratory accreditation system does not meet the implied promise of ensuring that accredited laboratories produce accurate data. Private corporations and environmental consulting firms must use alternative methods of laboratory verification to protect their corporation and customers.
This article will address the problems associated with current laboratory accreditation systems and actions that data users can take to ensure data quality objectives are achieved.
Environmental lab accreditation in the U.S.
The United States does not have a mandatory national accreditation system. Laboratory accreditation is only mandated by the U.S. government for drinking water laboratories and this accreditation is the responsibility of the individual states. Some states have additional laboratory accreditation programs for wastewater, hazardous waste and air monitoring. The requirements for these additional programs vary from state to state.
The National Environmental Laboratory Accreditation Program implements standards adopted by the National Environmental Laboratory Accreditation Conference. This conference is an organization of federal and state officials that represent 12 accrediting authorities in 11 states that have similar accreditation programs. Accreditation reciprocity is maintained throughout these 12 accrediting authorities. The main aspects of NELAC accreditation process are a quality system audit based on ISO 17025 and proficiency testing to provide continuing oversight.
Laboratory audits
Laboratory audits are required to validate laboratory capability, competency and that sufficient systems are in place to ensure data integrity. The audit frequency varies from state to state. These routine laboratory audits are generally scheduled in advance thereby giving laboratories the opportunity to optimize their performance. The state of Florida operates on a two-year audit schedule as prescribed by NELAC.
The following are quotes from several of Florida’s audits of accredited laboratories:
"On several occasions the results of quality control sample was not within expected range of 90%-100% and samples were not reanalyzed as specified in the laboratory SOP and the sample results were reported without the proper qualifier code."
"At the time of inspection, the temperature of three out of four incubators used for verification of positive colonies, sterility check of media and incubation of positive and negative controls was below required 35±5ºC."
"Analytical results were often reported without applicable data qualifiers."
"The laboratory did not follow Standard Operating Procedures to ensure that the reported data is free from transcription and calculation errors and that quality control measures are reviewed and evaluated before data is reported."
"The laboratory did not have records of Standard Receipt and Traceability."
The auditing system accomplished its objective, the state identified these significant issues and most likely the issues were quickly resolved. However, the data users of these accredited laboratories received less than what is implied by the accreditation promise.
As of April 2004, Florida had 18 laboratories that had not been audited within the past five years. Florida was chosen as an example because it maintains one of the most respected laboratory accreditation programs in the country.
The laboratory audit used as a part of the environmental accreditation process may eliminate the very worst laboratories but does not ensure laboratories in the program provide the quality of data needed by the corporate or environmental consulting communities.
Proficiency testing
Environmental proficiency testing, or PT, requires laboratories to analyze single blind samples of certified analytes and report the results to an independent third party for evaluation. This evaluation is then reported to the laboratories and their accrediting authorities. These PTs are intended to monitor laboratory performance during the periods between audits.
The NELAC program will be used as an example, although PT requirements vary from state to state. The NELAC program requires that laboratories complete two single blind proficiency tests for each program (CWA, SDWA, and RCRA) and analyte per year. The proficiency testing program has two critical flaws. The tests are single blind and the laboratory knows they are being tested. Therefore the best instruments and technicians can be used for the evaluation. Even as a single blind test, the laboratory is allowed to receive a non-acceptable evaluation one out of three times. This allows poor laboratories to generate unacceptable PT data for 12 months before loss of accreditation becomes an issue.
The second flaw with the PT programs is the evaluation criteria used to determine the laboratory’s acceptability. The majority of regressions used to evaluate the data are based on the performance of a small number of laboratories in the 1990s. Accreditation limits are designed to help ensure 95% of the laboratories participating pass, not to ensure the quality of data meets users’ expectations. As an example, if you submit a sample containing 200 ppb of 1,1,1-Trichloroethane to a laboratory, using EPA regressions, an acceptable result would be between 128 ppb and 264 ppb. This wide range does not support the needs of today’s data users.
The above discussion illustrates that accreditation does not equal quality. Corporations and consulting groups that depend upon accreditation systems are at significant risk. These groups must develop tools to identify laboratories that can meet their data quality objectives.
Gregg Frazier and Mike Haller are general manager and quality manager, respectively, of Analytical Products Group, Inc. in Belpre, Ohio. Prior to joining APG Frazier and Haller held various positions in private industry and consulting.
Editor’s note: This column is the first of a two-part series.
Continue to Part II
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