CMS is requesting information from the public on potential changes to longstanding Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel, histocompatibility, and related policies, which have not been comprehensively updated since 1992. With regard to personnel requirements, CMS seeks information that will enable it to revise the regulations to “better reflect current knowledge, changes in the academic context and advancements in laboratory testing,” particularly with regard to nursing and physical science degrees, competency assessment, laboratory training and experience requirements, and documentation. Regarding CLIA histocompatibility requirements, CMS asks for comments regarding potential updates to crossmatching requirements (including whether virtual crossmatching should be an acceptable alternative to physical crossmatching) and other rules that may not reflect current laboratory practice.
In addition, CMS requests feedback regarding CMS’s flexibility to impose alternative sanctions for laboratories issued a Certificate of Waiver (CoW) that are determined to have participated in prohibited proficiency testing (PT) referral. CMS also seeks comments on appropriate sanctions when a laboratory has referred its PT samples to another laboratory and has reported the other laboratory’s result as their own. Furthermore, CMS invites input on existing and potential new CLIA-related fees.
CMS will accept comments until March 12, 2018. CMS will consider submitted comments in a future related rulemaking.