CMS SOM App. C, Tag D6171

(b) Meet one of the following requirements:

(b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine

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

laboratory is located; or

(b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical,

biological, clinical or medical laboratory science, or medical technology from an

accredited institution;

(b)(2)(ii) Be qualified under the requirements of § 493.1443(b)(3) or §493.1449(c)(4)

or (5); or

Interpretive Guidelines §493.1489(b)(2)(ii)

Individuals may qualify under §493.1489(b)(2)(ii). Individuals qualifying at these cross

references, § 493.1443(b)(3) or § 493.1449(c)(4) or (5), only need to meet the education

requirements for the equivalent degrees.

For the education equivalent qualification requirements at § 493.1443(b)(3), the

individual must have an earned doctoral degree, 16 semester hours of earned doctoral

level coursework or an approved thesis in biology/chemistry/MT/CLS/MLS.

For the education equivalent qualification requirements at § 493.1449(c)(4), the

individual must meet either § 493.1449(c)(4)(i)(B)(2) or (c)(4)(i)(C)(2). The individual

must have an earned bachelor’s degree, 16 semester hours of earned graduate level

coursework in biology/chemistry/MT/CLS/MLS.

For the education equivalent qualification requirements at § 493.1449(c)(5), the

individual must have at least 120 semester hours or equivalent.

EXCEPTION: Individuals with a Bachelor of Nursing degree may qualify as testing

personnel for high complexity glucometer testing only.

This limited exception allows qualified individuals with a Bachelor of Nursing degree to

perform high complexity glucometer testing. The exception is strictly limited to high

complexity glucometer testing only.

Bachelor of Nursing degree holders working under this exception are explicitly

prohibited from performing any other types of high complexity testing procedures unless

they meet the personnel requirements for high complexity testing personnel. Nurses who

have the appropriate science coursework in chemical, biological, clinical or medical

laboratory science, or medical technology, may qualify under § 493.1489(b)(2)(ii) or §

493.1489(b)(3) – (5).

Laboratories should maintain documentation that specifically identifies which personnel

are authorized to perform which tests. These individuals should be listed on the Form

CMS-209 and have competency testing performed.

(b)(3)(i) Have earned an associate degree in a laboratory science or medical

laboratory technology from an accredited institution or—

(b)(3)(ii) Have education and training equivalent to that specified in paragraph

(b)(2)(i) of this section that includes—

(b)(3)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution

that, at a minimum, includes either—

(b)(3)(ii)(A)(1) Twenty-four (24) semester hours of medical laboratory technology

courses; or

(b)(3)(ii)(A)(2) Twenty-four (24) semester hours of science courses that include—

(b)(3)(ii)(A)(2)(i) Six (6) semester hours of chemistry;

(b)(3)(ii)(A)(2)(ii) Six (6) semester hours of biology; and

(b)(3)(ii)(A)(2)(iii) Twelve (12) semester hours of chemistry, biology, or medical

laboratory technology in any combination; and

(b)(3)(ii)(B) Have laboratory training that includes:

(b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or

accredited by the ABHES or the CAAHEP (this training may be included in the 60

semester hours listed in paragraph (b)(3)(ii)(A) of this section); or

(b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty

in which the individual performs high complexity testing; or

(b)(4) Successful completion of an official U.S. military medical laboratory

procedures training course of at least 50 weeks duration and having held the

military enlisted occupational specialty of Medical Laboratory Specialist

(Laboratory Technician); or

Interpretive Guidelines §493.1489(b)(4)

Ensure that the military discharge paperwork (i.e., DD Form 214) reflects the

occupational specialty and includes weeks of training. The occupational specialty must be

related to the laboratory and must be at least 50 weeks long.

(b)(5) Notwithstanding any other provision of this section, an individual is

considered qualified as a high complexity testing personnel under this section if they

were qualified and serving as a high complexity testing personnel in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since

December 28, 2024.

Interpretive Guidelines §493.1489(b)(5)

The grandfathering provision will allow individuals already qualified and employed high

complexity testing personnel 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.

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

in a two-year period.

(b)(6) For blood gas analysis—

(b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or

(b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular

technology from an accredited institution; or

(b)(6)(iii) Have earned an associate degree related to pulmonary function from an

accredited institution.

Interpretive Guidelines §493.1489(b)(6)

This requirement applies only to performance of blood gas analysis procedures which are

categorized as high complexity.

NOTE: Some blood gas systems are categorized as moderate complexity tests.

Therefore, only moderate complexity personnel requirements are applicable to them. To

determine which tests are categorized as waived or nonwaived (i.e., moderate or high

complexity tests), refer to the “FDA CLIA Complexity Database” at

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm.

Test systems, assays, and examinations not yet classified are considered high complexity.

(b)(7) For histopathology, meet the qualifications of §493.1449(b) or (f) to perform

tissue examinations.

Interpretive Guidelines §493.1489(b)(7)

The tests in histopathology include both gross examination (macroscopic), and

microscopic examination of the slide(s) with evaluation and diagnostic interpretation, and

diagnostic findings reported.

In the case of gross examinations, the technical supervisor may delegate to individuals

qualified under §493.1489 the responsibility for the physical examination/description,

including color, weight, measurement and other characteristics of the tissue; or other

mechanical procedures for which a specific written protocol has been developed. The

technical supervisor is ultimately responsible for the diagnosis related to the gross

examination and must sign the examination report. The technical supervisor is not

required to provide direct on-site supervision but is responsible for the accuracy of all test

results reported. All physical examinations/descriptions of tissue including color, weight,

measurement and other characteristics of the tissue; or other mechanical procedures

performed in the absence of the technical supervisor by individuals qualified under

§493.1489 should be reviewed within 24 hours by the technical supervisor. All

microscopic tissue examinations must be performed by individuals qualified under

§493.1449(b), (f) or (g), as appropriate.