CLIA Personnel Requirements Under 42 CFR Part 493, Subpart M
Short answer
CLIA personnel requirements are in 42 CFR Part 493, Subpart M ("Personnel for Nonwaived Testing"). The roles a lab needs depend on the most complex testing it does. Waived-only labs have no Subpart M personnel requirements. Provider-performed microscopy (PPM) labs need a laboratory director and testing personnel. Moderate complexity labs need a laboratory director, technical consultant, clinical consultant, and testing personnel. High complexity labs need a laboratory director, technical supervisor, clinical consultant, general supervisor, and testing personnel. Labs that do cytology also need a cytology general supervisor and cytotechnologists. Each person must hold any state license the state requires and meet the education, training, and experience in their section. Qualifications changed under the CMS final rule published December 28, 2023 (88 FR 90039 and following), which took effect December 28, 2024.
Required CLIA personnel by test complexity
PPM: Laboratory director. Condition § 493.1355; qualifications § 493.1357; responsibilities § 493.1359.
PPM: Testing personnel. Condition § 493.1361; qualifications § 493.1363; responsibilities § 493.1365.
Moderate: Laboratory director. Condition § 493.1403; qualifications § 493.1405; responsibilities § 493.1407.
Moderate: Technical consultant. Condition § 493.1409; qualifications § 493.1411; responsibilities § 493.1413.
Moderate: Clinical consultant. Condition § 493.1415; qualifications § 493.1417; responsibilities § 493.1419.
Moderate: Testing personnel. Condition § 493.1421; qualifications § 493.1423; responsibilities § 493.1425.
High: Laboratory director. Condition § 493.1441; qualifications § 493.1443; responsibilities § 493.1445.
High: Technical supervisor. Condition § 493.1447; qualifications § 493.1449; responsibilities § 493.1451.
High: Clinical consultant. Condition § 493.1453; qualifications § 493.1455; responsibilities § 493.1457.
High: General supervisor. Condition § 493.1459; qualifications § 493.1461; responsibilities § 493.1463.
High (cytology): Cytology general supervisor. Condition § 493.1467; qualifications § 493.1469; responsibilities § 493.1471.
High (cytology): Cytotechnologist. Condition § 493.1481; qualifications § 493.1483; responsibilities § 493.1485.
High: Testing personnel. Condition § 493.1487; qualifications § 493.1489; responsibilities § 493.1495.
One person can hold more than one role if they qualify for each. For example, the laboratory director may also act as the technical consultant (moderate) or as technical supervisor, clinical consultant, general supervisor, and testing personnel (high) (§§ 493.1411, 493.1445(a)).
What changed on December 28, 2024
The current eCFR text reflects the 2023 final rule:
Degree fields: Qualifying degrees are now listed as "chemical, biological, clinical or medical laboratory science, or medical technology." The current Subpart M text does not include "physical science."
Doctoral degree defined (§ 493.2): A doctoral degree is "an earned post-baccalaureate degree with at least 3 years of graduate level study that includes research related to clinical laboratory testing or advanced study in clinical laboratory science, medical laboratory science, or medical technology." MD, DO, DPM, DVM, and honorary degrees do not count as doctoral degrees under this definition.
Coursework and semester-hour pathways: People with degrees in other fields can qualify by meeting specific semester-hour combinations. Examples: bachelor's degree equivalency of 120 semester hours, including 48 hours of science or medical laboratory courses (§ 493.1405(b)(5)(i)(B)), and 16 semester hours of doctoral or graduate coursework, or a thesis or research project, for doctoral and master's routes.
Director CE: Most director pathways now require at least 20 CE credit hours in laboratory practice covering director responsibilities.
Director onsite visits: Moderate and high complexity directors must be onsite at least once every 6 months, with at least 4 months between the two minimum visits, and must stay available by phone or electronically (§§ 493.1407(c), 493.1445(c)).
Grandfathering: Several roles include a "notwithstanding" clause. Someone qualified and serving in the role in a CLIA-certified lab as of December 28, 2024, who has served continuously since then, still qualifies (for example §§ 493.1405(b)(6), 493.1443(b)(4), 493.1461(c)(4), 493.1483(b)(3), 493.1489(b)(5)).
Blood gas analysis: There are specific pathways for respiratory therapy and cardiovascular technology degrees (§§ 493.1423, 493.1461(d), 493.1489).
For a detailed walkthrough, see CLIA Personnel Rule Changes (2024). For what CMS has proposed next, see CLIA Proposed Rule 2026: Personnel and Virtual Access.
Qualifications by role (summary of current eCFR)
Every role must also hold any license required by the state where the lab is located. This is a summary only. Always check the full section.
PPM laboratory director (§ 493.1357) and PPM testing personnel (§ 493.1363)
A physician, a dentist, or a midlevel practitioner. For a PPM director, the midlevel practitioner must be authorized by the state to practice independently. PPM testing personnel who are midlevel practitioners work under a physician's supervision or practice independently if the state allows it.
The PPM director may direct no more than five laboratories (§ 493.1359).
Moderate complexity laboratory director (§ 493.1405)
Must meet one of these: 1. MD or DO licensed in the state, and board certified in anatomic and/or clinical pathology (ABP or AOBP). 2. MD, DO, or DPM licensed in the state, with at least 1 year directing or supervising nonwaived testing and at least 20 CE hours. 3. Earned doctoral degree (in a qualifying lab science, or any doctorate plus 16 semester hours of doctoral coursework or a qualifying thesis or research project), current certification by an HHS-approved board, at least 1 year directing or supervising nonwaived testing, and 20 CE hours. 4. Master's degree in a qualifying science (or an equivalency pathway), with 1 year of nonwaived lab training or experience, 1 year of supervisory nonwaived experience, and 20 CE hours. 5. Bachelor's degree in a qualifying science (or 120-semester-hour equivalency), with 2 years of nonwaived lab training or experience, 2 years of supervisory nonwaived experience, and 20 CE hours. 6. Grandfathered: serving as of Dec. 28, 2024, and continuously since.
Technical consultant, moderate (§ 493.1411)
Must meet one of these: - MD or DO with AP/CP board certification. - MD, DO, or DPM with 1 year of nonwaived training or experience in the specialty. - Doctoral or master's degree in a qualifying science (or equivalency) with 1 year in the specialty. - Bachelor's degree in a qualifying science (or equivalency) with 2 years in the specialty. - An associate degree pathway, and other pathways, as listed in the section.
Clinical consultant, moderate (§ 493.1417) and high (§ 493.1455)
Qualified as a director under § 493.1405(b)(1)–(3) (moderate) or § 493.1443(b)(1)–(3) (high, with (b)(5) for oral pathology), or
An MD, DO, or DPM licensed in the state.
Testing personnel, moderate (§ 493.1423)
Must meet one of these: - MD or DO licensed in the state. - Doctoral, master's, or bachelor's degree in a qualifying science, medical technology, or nursing. - Equivalency pathways. - Associate degree in a qualifying science, medical laboratory technology, or nursing. - 50-week military Medical Laboratory Specialist course. - High school diploma or equivalent plus documented training covering specimen handling, procedures, instrument use, maintenance and calibration, reagents, QC, factors affecting results, and verifying results before reporting.
High complexity laboratory director (§ 493.1443)
Must meet one of these: 1. MD or DO licensed in the state with AP/CP board certification. 2. MD, DO, or DPM licensed in the state with 2 years directing or supervising high complexity testing and 20 CE hours. 3. Earned doctoral degree (qualifying science or coursework or thesis pathway), current HHS-approved board certification, 2 years of lab training or experience and 2 years directing or supervising high complexity testing, and 20 CE hours. 4. Grandfathered: serving as of Dec. 28, 2024, and continuously since. 5. Oral pathology: board certification by ABOP, ABP, or AOBP.
Technical supervisor, high (§ 493.1449)
Requirements depend on the specialty or subspecialty (for example microbiology subspecialties, chemistry, hematology, immunohematology, cytology, histopathology, histocompatibility, clinical cytogenetics).
An MD or DO certified in both anatomic and clinical pathology can supervise all specialties except histocompatibility and clinical cytogenetics (§ 493.1449(b)).
Other pathways combine an MD, DO, DPM, doctoral, master's, or bachelor's degree with set amounts of high complexity experience in the specialty.
General supervisor, high (§ 493.1461)
Must meet one of these: - Qualified as a high complexity director or technical supervisor. - MD, DO, or DPM, or a doctoral, master's, or bachelor's degree in a qualifying science, with 1 year of high complexity training or experience. - Qualified as testing personnel under § 493.1489(b)(3) with 2 years of high complexity training or experience. - Other listed pathways, including grandfathering and blood gas pathways.
Cytology general supervisor (§ 493.1469) and cytotechnologist (§ 493.1483)
Cytology general supervisor: qualified as a technical supervisor under § 493.1449(b) or (e), or a qualified cytotechnologist with at least 3 years of full-time (2,080 hours per year) cytotechnologist experience within the previous 10 years.
Cytotechnologist: graduated from a CAAHEP-accredited cytotechnology school, or certified by an HHS-approved certifying agency, or grandfathered (serving as of Dec. 28, 2024, and continuously since).
Testing personnel, high (§ 493.1489)
Must meet one of these: - MD, DO, or DPM licensed in the state. - Doctoral, master's, or bachelor's degree in a qualifying science. - Associate degree in a laboratory science or medical laboratory technology, or an equivalent of 60 semester hours (24 hours of MLT courses, or 24 science hours including 6 chemistry and 6 biology) plus an ABHES- or CAAHEP-accredited training program or 3 months of documented training in each specialty. - 50-week military Medical Laboratory Specialist course. - Grandfathered.
Core responsibilities
Laboratory director (§§ 493.1407, 493.1445): Responsible for the overall operation and administration of the lab, including hiring competent personnel, test system quality, QC, proficiency testing, and making sure staff are competent and stay competent. The director may delegate duties to qualified people but stays responsible for them. Must meet the onsite-visit requirement and may direct no more than five laboratories.
Technical consultant / technical supervisor (§§ 493.1413, 493.1451): Technical and scientific oversight. Selects and verifies test methods, sets up QC and PT, identifies training needs, and evaluates the competency of testing personnel.
Clinical consultant (§§ 493.1419, 493.1457): Advises the lab's clients on choosing tests and interpreting results for patient care, and makes sure reports include the information needed for interpretation.
General supervisor (§ 493.1463): Day-to-day supervision of testing personnel and result reporting. Responsible for proper performance when the director and technical supervisor are not available.
Testing personnel (§§ 493.1425, 493.1495): Follow the lab's procedures, perform QC, document results and corrective actions, and identify problems.
Cytology roles (§§ 493.1471, 493.1485): Supervision and slide examination under the cytology standards.
SLC personnel documentation checklist
Use this to build an audit-ready personnel file for every person listed on your CLIA certificate or staffing roster:
Role assignment: a written list of who holds each Subpart M role, by specialty and subspecialty, with the director's signature
Current state license for each person, if the state requires one
Diploma and/or transcripts showing the degree and field. For equivalency pathways, transcripts showing semester hours by subject
Board certification (pathology board or HHS-approved board), where the pathway requires it
Documented training and experience (letters, prior-employer verification) showing years, complexity level, and specialty
Director CE records: 20 CE credit hours covering director responsibilities, where required
Records of director onsite visits (dates at least 4 months apart, at least every 6 months)
Training records for high-school-pathway moderate complexity testing personnel, covering each § 493.1423(b)(6) item before they test patient specimens
Competency assessments for testing personnel and supervisors, as your director defines and documents them
Grandfathering evidence (proof the person was serving as of Dec. 28, 2024, and continuously since), if you rely on it
Delegation-of-duties records signed by the director
A count of how many labs the director currently directs (no more than five)
Need a qualified laboratory director?
Finding a director who meets § 493.1405 or § 493.1443 is often the hardest personnel requirement to satisfy. Sound Lab Consultants can provide laboratory directors, including New York Certificate of Qualification (CQ) holding directors. See Laboratory Director Services.
CDC resources on CLIA
CDC's overview of the CLIA program: CDC explains that CLIA applies to every U.S. site that tests human specimens to assess health or to diagnose, prevent, or treat disease. It also explains that CDC supports the program alongside CMS and FDA.
CDC on CLIA test complexity categories: CDC explains how FDA scores tests as moderate or high complexity using seven criteria. It also notes that lab-developed or modified tests default to high complexity, and that moderate and high complexity standards differ only in personnel requirements.
CDC's CLIAC page: CDC manages the Clinical Laboratory Improvement Advisory Committee, which advises HHS on laboratory quality and on revising CLIA standards.
FAQs
What are the CLIA personnel requirements? They are the roles, qualifications, and responsibilities in 42 CFR Part 493 Subpart M. The required roles depend on whether a lab performs PPM, moderate, or high complexity testing.
Do waived labs need to meet Subpart M? No. Subpart M is titled "Personnel for Nonwaived Testing." It covers PPM, moderate, and high complexity testing.
Can one person fill several CLIA roles? Yes, if they meet the qualifications for each role. The director may serve as technical consultant (moderate) or as technical supervisor, clinical consultant, general supervisor, and testing personnel (high).
Is "physical science" still a qualifying degree? The current eCFR text of Subpart M lists chemical, biological, clinical or medical laboratory science, and medical technology. It does not list physical science. People with other degrees may qualify through the semester-hour equivalency pathways.
Does an MD count as a "doctoral degree" under CLIA? Not under § 493.2. The doctoral degree definition excludes MD, DO, DPM, DVM, and honorary degrees. Physicians qualify through their own separate pathways.
How often must a CLIA laboratory director be onsite? For moderate and high complexity labs: at least once every 6 months, with at least 4 months between the two minimum visits. The director must also be available by phone or electronically.
What if my staff qualified before December 28, 2024? Several roles let people who were qualified and serving as of December 28, 2024, and have served continuously since, keep qualifying. Keep documentation that proves continuous service.
How many labs can one director direct? No more than five laboratories (§§ 493.1359, 493.1407(d), 493.1445(d)).
Sound Lab Consultants serves clinical laboratories nationwide. Mailing address: PO Box 2135, Chandler, AZ 85244.
Sources: eCFR, 42 CFR Part 493 Subpart M and § 493.2 (current text); CMS Clinical Laboratory Improvement Amendments program. This page summarizes federal regulations. State and accreditation requirements may add to them.