Lab Regulatory News

After Two Decades, CMS Wants to Update CLIA Lab Regulations

IN THE FIRST EFFORT OF ITS kIND in more than two decades, the federal Centers for Medicare and Medicaid Services has published a request for information (RFI) in the Federal Register as a first step to revise the CLIA rules it promulgated in 1992.

Over the years, CMS has made some minor changes to the rules issued under the Clinical Laboratory Improvement Amendments of 1988. However, it appears CMS is ready to consider significant revisions to personnel regulations, proficiency testing (PT) referral, histocompatibility regulations, and fees that labs pay to keep the CLIA program running.

Clinical laboratory executives welcomed the RFI that was published on Jan. 9, saying the rules were outdated long ago. But they also said that some sections of the RFI were confusing and that, in other sections, the request does not go far enough.

Comments from clinical lab directors and pathologists are due by March 8. To view the eight-page RFI published in the Federal Register on Jan. 9, follow this link: https://tinyurl.com/ydcve85k.

The following is a short synopsis of the request for information. THE DARk REPORT will have a more detailed analysis of the RFI in the next issue (Feb. 12).

PT Referral Questions

On the issue of proficiency testing referral, CMS is seeking comments on applying discretion for situations in which it determines that a laboratory has referred its PT samples to another laboratory and has reported the other laboratory’s PT results as its own; and under what circumstances it should use its discretion. CMS gained discretion in issuing sanctions in cases of intentional PT referral under the Taking Essential Steps for Testing Act of 2012 (the TEST Act). In some cases, that discretion may replace the automatic revocation of the lab’s CLIA certificate and subsequent imposition of the two-year ban of the lab’s owner or operator, the RFI said.

Under the RFI, CMS is seeking comments on what discretion it would have for the most egregious violation (called a Category violation), encompassing cases of repeat PT referral, regardless of circumstances; and cases in which a lab reports another lab’s PT results as its own.

Significant Penalties

In a Category 1 violation, CMS can revoke the laboratory’s CLIA certificate for at least a year; ban the owner and operator from owning or operating a CLIA-certified laboratory for at least one year; and may impose a civil money penalty.

Also, CMS seeks comments on alternative sanctions it could issue for proficiency testing referral by laboratories with a Certificate of Waiver (CoW) that have participated in PT referral. Currently, CoW laboratories that participate in PT are not exempt from the ban against proficiency test referral.

The RFI said, “Therefore, our only recourse in cases of proficiency testing referral found at CoW laboratories are principal sanctions (that is, revocation, suspension, or limitation).”

CMS requested comments on whether to use alternative sanctions to create parity for all types of labs involved in PT referral.

CMS is considering revisions to the CLIA histocompatibility requirements that would reflect current knowledge, changes in transplant medicine, and advancements in laboratory testing, including the use of virtual crossmatching instead of a physical crossmatch to determine compatibility between an organ donor and recipient. A physical crossmatch (also referred to as a serologic crossmatch) is a mixing of specimens from donor and recipient to check for compatibility. Clinicians in transplantation medicine view CMS’ current regulations on crossmatching to be a barrier to modernized decision-making on organ acceptability based on risk assessment, the RFI said.

Now that virtual crossmatching is a viable alternative to physical crossmatching, the RFI is seeking comments on what criteria and decision-making algorithms for virtual crossmatching would be an appropriate substitute for physical crossmatching.

CLIA Compliance Fees

The RFI also is seeking comments on CLIA compliance fees for laboratories holding a Certificate of Compliance (CoC), fees for laboratories holding a Certificate of Accreditation (CoA), fees for revised certificates, follow-up visits, complaint investigations, and activities related to the imposition of sanctions.

Among Clinical Labs’ Most Pressing Issues: an Urgent Need for Flexibility in Hiring Lab Techs

FOR LAB DIRECTORS AND ADMINISTRATORS, the personnel requirements under CLIA may be the most troubling because labs need flexibility to hire and retain clinical laboratory scientists and technicians with a variety of skills and degrees.

If new rules prohibit the hiring of individuals who lack the proper credentials, labs may be unable to find adequate staff to fill jobs, given that most of the nation’s aging lab workforce is approaching retirement age.

Under the personnel requirements section in the CMS request for information (RFI), the agency asks for comments on CLIA revisions that address issues related to nursing and physical science, along with staff competency. Current rules say a bachelor’s degree in nursing is equivalent to a bachelor’s degree in biological science for moderate- and high-complexity testing personnel. CMS is considering whether a nursing degree should be considered a separate qualifying degree to run moderate- and high-complexity tests.

At the same time, the RFI said, the term “physical science degree” is difficult to define because physical science is a broad discipline involving non-living systems that have nothing to do with lab testing. CMS seeks comment on whether any physical science degree should be considered appropriate for qualifying to meet the CLIA education requirements.

On personnel competency, the RFI said qualifications for general supervisors may be less stringent than those for technical consultants. The difference in degree requirements to qualify to assess competency presents staffing challenges in labs, the RFI said.

As a result, the RFI requested comments on whether general supervisors with associates’ degrees should perform competency assessment for moderate complexity testing personnel in labs that do moderate- and high-complexity tests.

The RFI also requested comments on what should be considered appropriate laboratory training, experience, and skills when determining the qualifications for personnel to meet CLIA requirements, and what comprises appropriate documentation to verify training, experience, and skills.

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