CMS SOM App. C, Tag D6078

The laboratory director must be qualified to manage and direct the laboratory

personnel and performance of high complexity tests and must be eligible to be an

operator of a laboratory within the requirements of subpart R.

Interpretive Guidelines §493.1443

Ensure that the laboratory director is not prohibited from owning, operating, or directing

a laboratory.

NOTE: Refer to section 353(i)(3) of the PHS Act as amended by the TEST Act, which

now states, "No person who has owned or operated a laboratory which has had its

certificate revoked may, within 2 years of the revocation of the certificate, own or operate

a laboratory for which a certificate has been issued under this section (see §493.1840),

except that if the revocation occurs pursuant to paragraph (4) the Secretary may substitute

intermediate sanctions under subsection (h) instead of the 2-year prohibition against

ownership or operation which would otherwise apply under this paragraph.

(a) The laboratory director must possess a current license as a laboratory director

issued by the State in which the laboratory is located, if such licensing is required;

and

Interpretive Guidelines §493.1443(a)

The term “State” as used in this provision, includes the District of Columbia, the

Commonwealth of Puerto Rico, the Commonwealth of Northern Mariana Islands, the

U.S. Virgin Islands, Guam and American Samoa.

(b) The laboratory director must--

(b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice

medicine or osteopathy in the State in which the laboratory is located; and

(b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American

Board of Pathology or the American Osteopathic Board of Pathology; or

(b)(2)(i) Be a doctor of medicine, a doctor of osteopathy, or doctor of podiatric

medicine licensed to practice medicine, osteopathy, or podiatry in the State in which

the laboratory is located; and

(b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity

testing; and

(b)(2)(iii) Have at least 20 CE credit hours in laboratory practice that cover the

director responsibilities defined in § 493.1445; or

Interpretive Guidelines §493.1443(b)(2)(ii) and (iii)

The type of experience required under this regulation is clinical in nature. This means

directing or supervising personnel who examine and perform tests on human specimens

for the purpose of providing information that is used in diagnosing, treating, and

monitoring a patient’s condition. This experience may include the laboratory director

personally examining and performing tests on patient specimens. Patient or medically

oriented experience, which is defined as the ordering of tests and interpreting and

applying the results of these tests in diagnosing and treating a patient’s illness is

unacceptable to meet the requirement for laboratory training or experience.

NOTE: See §493.2 for the definition of continuing education (CE) credit hours and

experience directing or supervising.

(b)(3)(i)(A) Hold an earned doctoral degree in a chemical, biological, clinical or

medical laboratory science or medical technology from an accredited institution; or

(b)(3)(i)(B) Hold an earned doctoral degree; and

(b)(3)(i)(B)(1) Have at least 16 semester hours of doctoral level coursework in

biology, chemistry, medical technology (MT), clinical laboratory science (CLS), or

medical laboratory science (MLS); or

(b)(3)(i)(B)(2) An approved thesis or research project in

biology/chemistry/MT/CLS/MLS related to laboratory testing for the diagnosis,

prevention, or treatment of any disease or impairment of, or the assessment of the

health of, human beings; and

(b)(3)(ii) Be certified and continue to be certified by a board approved by HHS; and

(b)(3)(iii) Have at least 2 years of:

(b)(3)(iii)(A) Laboratory training or experience, or both; and

(b)(3)(iii)(B) Laboratory experience directing or supervising high complexity testing;

and

(b)(3)(iv) Have at least 20 CE credit hours in laboratory practice that cover the

director responsibilities defined in §493.1445; or

Interpretive Guidelines §493.1443(b)(3)

An individual with a doctoral degree that does not meet the definition at 493.2 may

qualify under 493.1443(b)(3)(i)(B).

“Certified” means the individual has completed all the designated board’s requirements,

including the examination. Currently approved boards are:

ABB - American Board of Bioanalysis,

ABB - Public Health Microbiology certification,

ABCC - American Board of Clinical Chemistry,

ABFT - American Board of Forensic Toxicology (limited to individuals with a

doctoral degree)*,

ACHI - American College of Histocompatibility and Immunogenetics (formerly

known as American Board of Histocompatibility and Immunogenetics (ABHI)),

ABMGG - American Board of Medical Genetics and Genomics (formerly ABMG

- American Board of Medical Genetics),

ABMLI - American Board of Medical Laboratory Immunology,

ABMM - American Board of Medical Microbiology,

DMLI - Diplomate in Medical Laboratory Immunology,

American Society for Clinical Pathology (ASCP) Board of Certification (BOC)

NRCC - National Registry for Certified Chemists – Clinical Chemist or

Toxicological Chemist certifications only (limited to individuals with a doctoral

degree)*,

*NOTE: ABFT and NRCC also certify non-doctoral individuals; however, the director

of high-complexity testing must have a doctoral degree.

(b)(4) Notwithstanding any other provision of this section, an individual is

considered qualified as a laboratory director of high complexity testing under this

section if they were qualified and serving as a laboratory director of high complexity

testing in a CLIA-certified laboratory as of December 28, 2024, and have done so

continuously since December 28, 2024.

Interpretive Guidelines §493.1443(b)(4)

The grandfathering provision will allow individuals already qualified and employed as a

laboratory director of high complexity testing as of the effective date of the final rule

December 28, 2024, to continue to be qualified under the new provisions provided the

individuals remain continuously employed in their position after the effective date of

December 28, 2024. To be considered to be “continuously employed,” in their position,

the individual may have no more than 6 months of break in employment in their position

in a two-year period.

The responsibility is on the individual to provide documentation showing their eligibility

to meet this provision.

(b)(5) For the subspecialty of oral pathology, be certified by the American Board of

Oral Pathology, American Board of Pathology, or the American Osteopathic Board

of Pathology.