On Friday January 12, CMS released a "Request for Information," notifying the public that it is considering a major update to CLIA regulations. CLIA is a public health law that is implemented via lengthy regulations written by CMS. In general, the regulations are quite dry: specifying requirements such as years of experience for staff and management, and specifying that controls, records, and accuracy of tests must be appropriate. Much implementing detail is left to customs, guidelines, and standards of practice even after both the statute and regulations are considered.
The CMS request for information is here, and is open until for sixty dates, until mid March. See coverage at Modern Healthcare here, JDSupra(by ReedSmith) here, and 360DX here.
A limited number of topics are being posted. One is the equivalency or not of various associates' and bachelors' degrees, such as those in Nursing versus those in biology or lab science. Another is penalties for abuses of proficiency testing. Another is the methodology for crossmatch histocompatibility in transplant science.
The home page for CLIA statute and regulations is here. The earliest version of CLIA covered labs billing CMS and labs with interstate businesses (e.g. federal authorities under the Interstate Commerce Clause). This was CLIA 1967, and followed "scandals" in areas like PAP testing. CLIA 88 broadened authorities to all labs. CLIA statute is only a few pages long, defining laboratory testing and laboratories, giving CMS the authority to establish standards, inspect, regulate, etc. CLIA regulations are very dry and procedural, walking through staffing, proficiency testing, and quality systems for non waived testing in about a dozen historical areas (microbiology, virology, chemistry, toxicology, cytology, etc.) For example, at 493.1254, for maintenance checks of equipment developed in-house, "the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and reporting."
