Advocacy - Lab Advocate
On April 1, 2016, the Centers for Medicare and Medicaid Services (CMS) issued Memorandum S&C: 16-18-CLIA, which makes a number of policy changes to the Clinical Laboratory Improvement Amendments (CLIA). The primary focus of the document is CMS’ decision to accept primary source verification (PSV) as evidence of laboratory compliance with the CLIA personnel qualifications. This has been a long sought change by the laboratory community as a means of reducing the regulatory burden of CLIA. Utilizing a PSV report allows the laboratory to demonstrate an individual’s credentials without having to obtain and store the documents themselves.
One area of concern for AACC is CMS’ decision not to allow professional certification to demonstrate fulfillment of the CLIA personnel requirements. Although AACC supports the agency’s broader PSV decision, the association has urged the agency to create a pathway for accrediting bodies to serve in a PSV capacity if they collect and verify the information CMS requires.
A second issue addressed in the memo pertains to the role of nurses performing laboratory testing. CMS stated that an individual with a bachelor’s degree in nursing meets the personnel requirements for high complexity testing and a person with an associate’s degree in nursing is able to perform moderate complexity testing. The agency did not provide any rationale for the policy change. AACC objects to CMS making this decision arbitrarily without public input and urges the agency to suspend its action until a proposed rule is published and comments evaluated.