Coming like a shot out the the blue, the Centers for Medicare and Medicaid Centers may have opened up a real hornet’s nest in asking for public input on who should be allowed to perform testing in U.S. laboratories as defined by the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
CLIA sets specific education and experience requirements for personnel allowed to perform moderate and high complexity testing. Unchanged with minor exceptions for more than 25 years, CLIA personnel requirements have been the subject of intense debate since they were finalized in 1992. Now with highly sophisticated molecular and genetic testing becoming more mainstream, the issue of who is allowed to perform such testing takes on even greater importance. That’s why its critically important that CMS receive feedback from as many knowledgeable industry personnel as possible.
To many lab professionals, CMS already went a step too far when it previously issued guidance decreeing that a bachelor’s degree in nursing is determined to be equivalent to a bachelor’s degree in biological science for purposes of the educational requirements for moderate and high complexity testing. Now the agency is seeking public comment on whether CLIA regulations should be modified (1) to expressly reflect that a nursing degree is equivalent to a biological science degree; or (2) to add nursing degrees as a separate qualifying degree to the current list of qualifying degrees.
The request for public comment (including evidence, research, and trends) appeared in the Federal Register last month with CMS seeking information in drafting proposals, in consultation with the Centers for Disease Control and Prevention (CDC), to update the existing CLIA regulations through future rule making. The agency is seeking input on the following specific CLIA areas:
- Personnel and histocompatibility requirements;
- Flexibility to impose alternative sanctions for labs issued a Certificate of Waiver (CoW) determined to have participated in proficiency testing (PT);
- Appropriate sanctions in situations where it is determined that a lab has referred its PT samples to another lab and has reported the other lab’s result as their own;
- Updating fees for determination of program compliance and additional fees for labs established under CLIA regulations;
- Collecting other fees CMS is authorized to collect such as fees for revised certificates, post survey follow-up visits, complaint investigations, and activities related to imposition of sanctions; and
- Other areas of CLIA which should be reviewed and potentially updated
Comments to are due by March 9 (refer to file code CMS-3326-NC) Electronic comments should be submitted to http://www.regulations.gov or send by regular mail to: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3326-NC, P.O. Box 8016, Baltimore, MD 21244-8016.