Laboratory Improvement through Accreditation

Oral Presentation

Prepared by M. McGarvey, A. Alger
PA DEP, PO BOX 1467, 2575 Interstate Dr, Harrisburg, PA, 17202, United States


Contact Information: mmcgarvey@pa.gov; 717-346-8618


ABSTRACT

Achieving laboratory accreditation standards and audits can be challenging for some laboratories. This presentation will discuss experiences from the Pennsylvania Department of Environmental Protection’s (PADEP) Bureau of Laboratories’ (BOL) National Environmental Laboratory Accreditation (NELAP) process and the PADEP Laboratory Accreditation Program (LAP) approach to laboratory improvement through accreditation. These insights will assist other public and private laboratories to create a culture where accreditation and audit findings can be used for laboratory improvements. The partnership between LAP and the private environmental laboratories developed through audit findings and LAP's compliance assistance with the laboratories’ corrective actions will be discussed. Examples include compliance assistance through memos for reporting to for the Safe Drinking Water Act, FAQ for Corrective Action Reports, and On-site Assessment Guidance.
This session will tell the PA DEP story of why and how our laboratory is NELAP accredited. Prior to 2009, the PA DEP BOL was accredited for drinking water only by the US EPA Region III. In 2007, the laboratory leadership changed. Prior to 2007, the previous leadership embraced the notion of NELAP accreditation but it did not happen, simply stating, “We were not ready.” The PA BOL had lost connection with and the confidence of its clients, the environmental programs. Based upon results from a state-conducted survey, new leadership understood the laboratory was not sustainable without NELAP accreditation. Laboratories reporting compliance data to the Commonwealth of Pennsylvania were required of the Laboratory Accreditation Act of 2002 to be accredited. We could not provide quality data, be in compliance, and gain the confidence of our agency without meeting the national accreditation standard. Our data was robust and valid and we had a terrific team of chemists, microbiologist, and assessors. We needed NELAP accreditation to prove we could not only improve our quality but document it, defend it, continue laboratory improvement to meet our clients’ needs, and be in compliance with Pennsylvania law.
The assessment process, implementation of a quality system, management requirements, documents and records, internal assessments, findings, recommendations, and lessons learned will be presented. Lessons learned from the LAP and the BOL will be discussed regarding enforcement actions against non-compliant labs implemented for lab improvement, resources used, and in some cases, the assistance of third party consultants to achieve compliance.