Medical Laboratory Professionals Week is traditionally a week for daily festivities at the Bureau of Clinical Laboratories (BCL), but this year’s celebration was extraordinary. On April 25, the laboratory received word that the laboratory in Prattville was approved for ISO/IEC 17025 accreditation from the American Association for Laboratory Accreditation (A2LA Certificate # 5521.01).
The current defined scope of accreditation is for biological testing of dairy products and frozen desserts using FDA PetrifilmTM and standard plate count methods to determine aerobic and coliform bacteria. Having this accreditation supports the Bureau of Environmental Services’ Manufactured Food Program to improve food safety in Alabama by protecting the public from foodborne illness and injury.
BCL Director Sharon Massingale, Ph.D., was overjoyed with this achievement, because ISO/IEC 17025 accreditation has been a goal since 2015 when an FDA grant was announced. However, she said both personnel and personal challenges caused delays, in addition to complying with changing regulations for accreditation. Resignations, retirements and other human resource issues made reaching this long-standing goal elusive. This was compounded by the multiple high priority demands of completing the new lab facility and moving operations to Prattville, plus the crucial priority of uninterrupted COVID-19 testing. The year-long illness and passing of Dr. Massingale’s beloved husband, Herman, was another contributing factor.
As COVID-19 testing slowed, the focus again turned to accreditation and plans were revamped as funding was extended. A core group was formed, and a gap analysis of actions needed was made. Regular monthly progress meetings to brainstorm improvements were held, and finally the notification of accreditation came.
Dr. Massingale wrote, “While the BCL has always taken testing seriously and has always tried to raise the bar for safety and accuracy, ISO/IEC 17025 accreditation reaffirms our commitment to quality.”
A laboratory’s fulfillment of the requirements of ISO/IEC 17025 means the lab meets both the technical competence requirements and management system requirements that are necessary for it to consistently deliver technically valid test results and calibrations. Having an ISO certification raises the bar for testing standards and assures providers that their specimens and samples have been rigorously tested to ensure high quality conditions. The work is not over once accreditation is obtained; the lab must continue to document, monitor for traceability and ensure ethical standards.
ISO/IEC 17025 is the single-most important internationally accepted standard for test and measurement of products. Accreditation bodies use the standard specifically to assess relevant factors of a laboratory’s ability to produce precise, accurate test and calibration data. The BCL used A2LA as its accreditation body as it is a well recognized accreditor of calibration laboratories in the United States. The BCL will seek ISO 17025 accreditation for other programs in the future at the Prattville and Mobile campuses.
Accreditation core team members, shown from left, are Dr. Aretha Williams, Angelica Webb, Jamie Hodges, Pam Pruett and Dr. Sharon Massingale. Not shown is Ron Dawsey, Bureau of Environmental Services director.