CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

KEY UPDATES TO CLIA PERSONNEL RULES FOR LABORATORIES PERFORMING NONWAIVED TESTS

Lab Director Requirements

A laboratory director of a nonwaived lab who holds a doctor of medicine (MD) or doctor of osteopathy (DO) degree must also be certified in anatomic pathology or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology. Unlike prior qualifications, board eligibility is no longer sufficient. If a physician serving as laboratory director does not hold the aforementioned board certification, they must have at least one year of experience directing or supervising nonwaived laboratory testing (two years in the case of high-complexity laboratories) and at least 20 continuing medical education or continuing education units covering clinical laboratory director responsibilities in order to qualify as a laboratory director.

Nonphysician directors of laboratories performing high-complexity tests must have:

• A doctoral degree in chemical, biological, clinical, or medical laboratory science or medical technology
• At least two years of laboratory training or experience
• At least two years of experience directing or supervising high-complexity testing
• At least 20 continuing education hours in laboratory practice that cover director responsibilities.

For laboratories performing moderate-complexity tests, a nonphysician director may hold a doctoral, master’s, or bachelor’s degree in the aforementioned disciplines. Qualifying doctoral degrees do not include MD, DO, doctor of podiatry, doctor of veterinary medicine, or honorary degrees. Moderate-complexity laboratory directors with a master’s or bachelor’s degree must also demonstrate at least one to two years of training and at least one to two years of supervisory experience in nonwaived laboratory testing and must obtain at least 20 continuing education credit hours in laboratory practice that cover nonwaived lab director responsibilities. Moderate-complexity laboratory directors with a doctoral degree do not have a training and supervisory experience requirement but must meet the 20 continuing education hours obligation.

Laboratory directors may obtain the required laboratory experience through a medical residency or fellowship, or by providing services in a facility that meets the definition of a laboratory under 42 CFR § 493.2 (i.e., excluding facilities that only collect, prepare, or courier specimens without performing testing). Experience at forensic labs, research labs that test but do not report patient test results, and drug testing labs certified by the Substance Abuse and Mental Health Services Administration do not meet this requirement.

Finally, as a new requirement, nonwaived lab directors must be onsite at least once every six months, with an interval of at least four months between the two annual onsite visits.

• What’s the impact? The final rule emphasizes the need for lab directors to either earn advanced degrees or demonstrate specific experience in clinical laboratory settings. Directors serving remote labs also must be onsite at least twice a year.

Educational Qualifications

Under prior nonwaived laboratory director qualification standards, individuals with a degree in a physical science could qualify for various laboratory positions. However, under the new rule, CMS eliminated the physical science degree as an acceptable qualification for positions requiring a bachelor’s degree. CMS did not define “physical science degree” but instead stated that it now recognizes only degrees in biological or chemical sciences, or in clinical or medical laboratory technology.

• What’s the impact? Individuals with a physical science degree or otherwise lacking a qualifying degree must meet additional educational requirements to perform testing services and hold supervisory roles in nonwaived laboratories. Instead of automatic qualification based on a degree, qualification will be determined based on an “educational algorithm” that evaluates completion of required courses in laboratory science.

• Are any individuals eligible for grandfathering? Individuals who were already employed in qualifying positions as of December 28, 2024, will be “grandfathered in” and will not need to meet the new educational requirements as long as they remain employed without interruption.

Requirement that Nurses Obtain Additional Training for High-Complexity Testing

One of the most debated aspects of the proposed rule was whether individuals with a bachelor of science in nursing (BSN) should be allowed to perform high-complexity testing. CMS initially proposed to allow BSN holders to perform high-complexity tests without additional training; however, after receiving more than 19,000 comments in opposition via a form letter, CMS changed course. The agency concluded that nursing education, while extensive in clinical training, does not provide sufficient depth in laboratory science concepts, such as quality control and proficiency testing, which are crucial for high-complexity tests.

• What does this mean for nurses? Nurses holding a BSN can still perform high-complexity testing, but only if they complete additional training, such as coursework in biological or chemical sciences and clinical lab science, equivalent to what is required for an associate degree in laboratory science or medical technology.

New Pathway for Technical Consultant Qualifications

Historically, CLIA rules allowed a laboratory director or technical supervisor to delegate performance of competency assessments for high-complexity test personnel to a general supervisor. However, CLIA rules also historically required that a technical consultant perform competency assessments, without delegation, for moderate-complexity test personnel. This meant that an individual with an associate degree – the minimum education requirement for general supervisors – was permitted to perform high-complexity competency assessments, but that same individual could not perform moderate-complexity competency assessments. Thus, the education requirements for individuals performing competency assessments on high-complexity personnel, which could be delegated to a person with an associate’s degree, were less stringent than for moderate-complexity personnel competency assessments, because a technical consultant must have at least a bachelor’s degree in a qualifying field of study.

Under the new rule, CMS created a route for individuals with an associate degree in laboratory science or medical technology plus four years of clinical training or experience to qualify as technical consultants for moderate-complexity testing. This change expands the pool of qualified professionals able to perform competency assessments in both moderate- and high-complexity settings.

• What does this mean for technical consultants? Most technical consultants will now be able to perform competency assessments on all laboratory personnel, for both moderate- and high-complexity testing. However, the qualifications for blood gas analysis (which measures the levels of oxygen and carbon dioxide in the blood) remain more stringent. To qualify as a technical consultant for blood gas analysis, an individual must have a bachelor’s degree in laboratory science, respiratory therapy, or a related field, plus additional training in blood gas analysis.

Permanent Qualification for Military-Trained Laboratory Technicians as Testing Personnel

The final rule solidifies a permanent pathway for individuals to qualify as testing personnel in moderate- and high-complexity laboratories if they have completed a medical laboratory procedures course of at least 50 weeks and have held the military enlisted occupational specialty of medical laboratory specialist (laboratory technician). Previously, military laboratory specialists/laboratory technicians could only qualify for high-complexity testing if they were grandfathered in before 1995.

• What does this mean for military personnel? Military-trained laboratory personnel will now be able to perform moderate- and high-complexity testing without being subject to a grandfathering provision, allowing more veterans to enter civilian laboratory roles.

Expanded Definition for Midlevel Practitioner

CMS expanded the “midlevel practitioner” definition to include nurse anesthetists and clinical nurse specialists. Previously, this definition was limited to nurse midwives, nurse practitioners, and physician assistants. In each case, the individual must be licensed by the state in which they practice, if such licensing is required.

• What’s the impact? A laboratory holding a CLIA certificate for provider-performed microscopy may have a director or testing personnel who is a licensed midlevel practitioner. As we continue to see a shortage of healthcare professionals, the expanded definition for midlevel practitioners will permit a larger and more diverse group of professionals serve in these positions.

IMPACT ON LAB STAFFING AND THE FUTURE

As laboratories increasingly integrate technology such as artificial intelligence and automation into their workflows to address staffing shortages, they will need professionals who are not only equipped to adapt to new technologies but also accustomed to traditional testing methods. Clinical laboratories have experienced the same workforce shortages, burnout, and job satisfaction challenges as other sectors of the healthcare industry. The final rule’s changes hopefully will strike a balance between addressing staffing shortages by expanding qualification standards for certain roles and protecting patient safety and ensuring sufficient scientific expertise by limiting those who can serve in supervisory roles such as lab directors.

For more information on clinical laboratory personnel and operation requirements, please contact Greg Fosheim or Ashley Ogedegbe.