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Cause Analysis in the Clinical Laboratory

Home » Clinical » Cause Analysis in the Clinical Laboratory

March 7, 2025 by A2LA

A2LA has been offering accreditation for over forty years. We currently hold Centers for Medicare and Medicaid Services Deemed-Status and are a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement to provide clinical laboratory accreditation to the requirements of ISO 15189 and CLIA. A2LA is the only accreditation body in the world to achieve and maintain both formal recognitions.

How do recognitions ensure quality results from our accredited laboratories?

One core example is regarding handling laboratory nonconformities. We do not categorize nonconformities as major or minor; all nonconformities, by definition, are cases of not meeting the given standard or requirements for accreditation. Therefore, it is not unreasonable to expect that all nonconformities, whether considered major or minor, be addressed with cause analysis investigations leading to corrective actions. As a policy, we require our laboratories to resolve the nonconformities by providing records of their cause analyses, corrective actions, and objective evidence of implementation that the nonconformities have been resolved. We do not accept just a plan of corrective action as we want to ensure implementation and that the laboratory has incorporated the proposed corrective action(s).

Our process instills a culture of continuous improvement, risk assessment, and preventative action. We see trends in our reports where the number of nonconformities declines as the laboratories undergo renewal assessments. They can better identify the cause of nonconformities and execute a plan to better establish preventative actions. The ISO principles for corrective action and cause analyses to promote continuous improvement in the clinical laboratory community and assuring improvements in patient data. ISO 15189 is written specifically for clinical laboratories.

ISO 15189 and CLIA are influential throughout the clinical community.

Laboratories incorporating the requirements of ISO 15189 and CLIA can provide prescriptive technical requirements and a core quality management system for clinical laboratories. CLIA and ISO 15189 share a common goal to ensure that clinical laboratories are held accountable and produce accurate and reliable test results. ISO 15189 brings a robust focus on meeting the needs of the customer and can increase efficiency through the consistency of an overall system.

For more information, contact A2LA at info@A2LA.org or call 301.644.3248.

CLIA,  Clinical,  ISO 15189 A2LA,  Accrediation,  accreditation,  accreditation body,  Clinical,  ISO 15189,  laboratory accreditation,  third-party accreditation body

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