US Clinical laboratory accreditation agencies have redoubled their efforts to continually provide quality assessments and support to laboratories, in response to a recent US Government Accountability Office (GAO) report that called into question the status of CLIA-prescribed oversight of laboratories.  In its report, Clinical Lab Quality: CMS and Survey Organization Oversight Should be Strengthened, which was released in June, the GAO asserts that sufficient data is lacking to determine the quality of laboratory testing and makes several recommendations for improving the accreditation and survey processes for laboratories.  With its extensive library of voluntary consensus standards and guidelines, CLSI supports both laboratories and accrediting bodies in meeting the shared goal of excellence in patient care.

Congress commissioned the GAO audit to investigate laboratory quality in response to widespread problems in 2004 at Maryland General Hospital’s (MGH) clinical laboratory.  The CMS-approved private accrediting organizations, including the College of American Pathologists (CAP), COLA, and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), responded to the situation at MGH by revising their inspection standards and contend that they are committed to the continuous improvement of the accreditation programs.  These improvements include increasing the education and training of surveyors, and improving the communication among agencies. 

In support of its mission to develop best practices in medical testing and to promote their use, CLSI has partnered with accrediting bodies in several ways. “CLSI provides resources developed through a consensus process that help laboratories improve their processes and meet accreditation requirements at the same time.  The guidelines serve as a tool for labs and for the agency surveyors who are looking to maintain consistency across the accreditation process,” says Glen Fine, CLSI Executive Vice President.

CLSI’s consensus standards and guidelines support clinical laboratory professionals seeking to meet accreditation requirements, and numerous CLSI documents are referenced in the CAP Laboratory Accreditation Program Inspection Checklists, for example.  The CLSI website provides an index of CLSI documents referenced in CAP checklists that can be explored at a glance.  These documents can be used as educational and reference tools for the laboratories as well as the surveyors.  Similarly, CLSI has partnered with COLA to provide documents that complement COLA’s accreditation program and online education program on quality management systems. 

Ultimately, accreditation organizations strive to develop consistent standards and methods for identifying a laboratory’s opportunities for improvement, while at the same time allowing a laboratory’s unique characteristics and its culture to remain strong.  The mission of CLSI is tightly aligned with these common goals through the timely development of voluntary consensus standards and guidelines that focus on the significant issues impacting laboratorians.
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