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Staffing Special Report: CMS Proposes Changes to CLIA Laboratory Personnel Requirements

by Glenn S. Demby | May 17, 2023 | CLIA-nir, Essential, National Lab Reporter

An overview and analysis of the recently proposed changes and how they could affect your medical laboratory.

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The year was 1992, and it was the last time that the Centers for Medicare & Medicaid Services (CMS) made significant changes to Clinical Laboratory Improvement Amendments of 1988 (CLIA) lab personnel requirements. While all agree that updates are in order, there are serious concerns that CMS’s recently proposed changes may be diluting the qualifications necessary to ensure high-quality, safe testing.

CLIA Laboratory Personnel Requirements

CLIA establishes criteria that labs must meet to perform moderate complexity, high complexity, and other nonwaived testing. Subpart M of the CLIA regulations lays out the qualifications that individuals must possess to qualify for positions related to testing at such labs, including laboratory director (LD), clinical consultant (CC), technical supervisor (TS), technical consultant (TC), general supervisor (GS), testing personnel (TP), cytology general supervisor (CGS), and cytotechnologist (CT). Qualifications for personnel at labs that perform high complexity testing are generally stricter than those at moderate complexity testing labs.

On July 22, 2022, CMS issued a proposed rule (CMS-3326-P) purporting to “update the CLIA personnel requirements to better reflect current knowledge, changes in the academic context, and advancements in laboratory testing.” To accomplish that objective, CMS is essentially proposing to water down the credentials required for the LD, TS, and TP roles.¹

The Nursing Degree Controversy

Under current rules, individuals must have a degree in lab science to qualify for these positions. CMS wants to modify this rule to enable people without scientific degrees to perform these roles at high complexity labs. But the most controversial part of the proposal is the addition of nursing degrees to the list of degrees that qualify a person to perform moderate and high complexity testing. If the rule becomes final, a bachelor’s degree in nursing would be considered equivalent to a bachelor’s degree in biological science, which is currently accepted as meeting the educational requirements for moderate complexity TC, moderate complexity TP, and high complexity TP. CMS also says that it is considering whether to make a nursing degree a separate qualifying degree, as opposed to the equivalent of a biological science degree, to meet educational requirements for moderate and high complexity TP and TC.

According to CMS, nurses perform most point-of-care testing in many different settings and scenarios, such as bedside, surgery centers, and end-stage renal disease facilities. “We do not have any reason to believe that nurses would be unable to accurately and reliably perform moderate and high complexity testing with appropriate training and demonstration of competency,” the agency says. Allowing nursing degree holders to perform high and moderate complexity testing “would decrease the burden on laboratories by allowing one individual to fulfill multiple responsibilities while still maintaining the laboratory’s ability to perform accurate and reliable testing,” CMS reasons in a Fact Sheet on the rule.²

Diluting Lab Director Qualifications

CMS is also proposing to expand CLIA qualifications for the LD role. The LD position is particularly critical because of the key functions that LDs aren’t allowed to delegate and must personally perform, including:³

Ensuring that lab testing systems provide quality service in every aspect of test performance

Evaluating the lab’s physical and environmental conditions

Verifying that the lab is safe for workers

Reviewing new test procedures

Under current CLIA rules, individuals must possess an MD or board-certified PhD to serve as LDs at high complexity labs. CMS is proposing to allow those with a “professional doctorate” or “master’s equivalency” to qualify for those positions.

Current CLIA Personnel Requirements for Non-Waived Testing Labs

Position	Moderate Complexity Lab	High Complexity Lab
Laboratory Director (LD)	1. Licensed MD/DO/DPM, AND either be certified in anatomic or clinical pathology, OR have lab training or experience consisting of at least one year directing or supervising non-waived tests, OR have earned at least 20 CME credits in lab practice addressing director responsibilities, OR have training equivalent to 20 CME credits obtained during medical residency 2. Doctoral degree in lab science AND certified by a Department of Health and Human Services (HHS)-approved board, OR at least one year experience directing or supervising non-waived testing 3. Master’s degree in lab science AND at least one year lab training or experience in non-waived testing AND at least one year experience supervising non-waived testing 4. Bachelor’s degree in lab science AND two years lab training or experience in non-waived testing AND two years experience supervising non-waived testing	1. Licensed MD/DO/DPM AND either be certified in anatomic or clinical pathology, OR have at least one year of lab training during medical residency, OR 2 years experience directing or supervising high complexity testing 2. Doctoral degree in laboratory science AND certified by an HHS-approved board OR, prior to February 24, 2003, served as director of a lab performing high complexity testing AND two years lab training or experience AND two years experience supervising or directing high complexity testing
Testing Personnel (TP)	1. Licensed MD/DO/DPM 2. Doctoral, master’s, bachelor’s, or associate’s degree in lab science or medical technology 3. High school graduate or equivalent AND completed medical laboratory procedures course (50-week) course AND held the occupational specialty of Medical Laboratory Specialist 4. High school graduate or equivalent AND documentation of training demonstrating the skills required for analyzing patient specimens	1. Licensed MD/DO/DPM 2. Doctoral, master’s, bachelor’s, or associate’s degree in lab science or medical technology 3. Education or experience equivalent to an associate’s degree AND graduated from a clinical lab training program OR have three months experience in each specialty of high complexity testing performed NOTE: Must also provide documentation of training at the present facility for testing personnel
Clinical Consultant (CC)	1. Licensed MD/DO/DPM 2. Doctoral degree in lab science AND either be board certified in specialty/subspecialty of service OR have at least one year experience directing or supervising non-waived laboratory testing	1. Licensed MD/DO/DPM 2. Doctoral degree in lab science AND either be board certified in specialty/subspecialty of service OR have at least one year experience directing or supervising non-waived laboratory testing
Technical Consultant (TC)	1. Licensed MD/DO/DPM AND either be certified in anatomic or clinical pathology, OR have at least one year lab training or experience in non-waived testing in the specialty/subspecialty of service 2. Doctoral or master’s degree in lab science or medical technology AND at least one year lab training or experience in non-waived testing in the specialty/subspecialty of service 3. Bachelor’s degree in lab science or medical technology AND two years lab training or experience in non-waived specialty/subspecialty of service	NA
Technical Supervisor (TS)	NA	Depends on specialty or subspecialty Microbiology subspecialties – bacteriology, mycobacteriology, mycology, virology, and parasitology: 1. Licensed MD/DO/DPM or PhD AND either be certified in clinical pathology, OR have at least one year lab training or experience in high complexity microbiology with a minimum of six months in subspecialty of service. 2. Master’s degree in lab science or medical technology AND two years lab training or experience in high complexity microbiology with a minimum of six months in subspecialty of service 3. Bachelor’s degree in laboratory science or medical technology AND four years lab training or experience in high complexity microbiology with a minimum of six months in subspecialty of service Immunology, chemistry, hematology, or radiobioassay: 1. Licensed MD/DO/DPM or PhD AND either be certified in clinical pathology, OR have at least one year lab training or experience in the high complexity testing specialties performed 2. Master’s degree in lab science or medical technology AND two years lab training or experience in high complexity testing specialties performed 3. Bachelor’s degree in lab science or medical technology AND four years lab training or experience in the high complexity testing specialties performed Immunohematology: Licensed MD/DO/DPM AND either be certified in clinical pathology, OR have at least one year lab training or experience in immunohematology testing

Note: The requirements listed here have been simplified for easier comparison between position and for length. Please see the CLIA regulations for an in-depth listing of requirements. Source: https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-M.⁴

The Lab Industry Pushback

Key clinical and professional organizations have voiced strong objections to the idea of treating a nursing degree as the equivalent of a degree in clinical lab science, noting that most of the point-of-care tests currently performed by nurses are CLIA-waived tests. Allowing nurses to do high complexity testing is a quantum leap that “recklessly disregards patient health,” according to the American Society for Clinical Pathology (ASCP).⁵

“This would mean that individuals with a nursing degree would not be required to meet any coursework or clinical training requirements under CLIA,” notes the ASCP in an earlier statement. “Nursing degrees typically require a fraction of the scientific coursework (about one-quarter) and laboratory training required by CLIA of laboratory testing professionals.”⁶

The American Hospital Association (AHA) has also called on CMS to withdraw the rule, noting that “the types of laboratory tests classified by CMS as high complexity require a level of knowledge, training, and result interpretation that we believe exceeds the typical nurses training—even at the doctoral and masters’ levels.” The AHA adds that “high complexity tests also require extensive expertise in the technical aspects of clinical laboratory testing, such as complex and consistent sample preparation, which is critical to proper test completion and accurate interpretation of results, but is not taught in nursing programs.”⁷

While expressing doubt that a nursing degree by itself is ample qualification for performing, supervising, or directing nonwaived CLIA lab testing, the American Association for Clinical Chemistry (AACC) has suggested that nurses may still be able to “demonstrate testing competency” via:⁸

Passing a curriculum of required laboratory-specific continuing education courses, and/or

Passing a competency exam—e.g., ASCP, MLS, MLT, or equivalent—for certifying staff to work in clinical labs as instrument operators and testing personnel.

AACC has also come out against the proposed expansion of the qualifying education credentials for LDs at high complexity test labs.

Takeaway

CMS has yet to publish a final rule, even though public comments have long since closed on the proposed rule. However, a final rule may come at any time. If it does, the revised CLIA personnel requirements could officially take effect as early as 90 days from the date of publication.

The new, less restrictive personnel requirements won’t impact your lab unless it is CLIA certified to perform moderate or high complexity testing. Also, keep in mind that CLIA requirements are minimum standards that don’t preclude labs from following more stringent rules if they do not contradict the CLIA regulations. Result: Depending on the provisions of the final rule, you may not have to alter your current personnel qualifications even after the new CLIA requirements take effect.