CAP_Personnel_Requirements_Final.pdf

CAP Personnel Requirements by Testing Complexity

Director* Clinical Consultant/

Technical Consultant Technical Supervisor** General Supervisor Testing Personnel

Waived Testing***

MD, DO, or DPM licensed to practice in the jurisdiction where the laboratory is located¹; or qualified as director of a moderate or high complexity laboratory

Not Applicable Not required Not required No specific requirements outlined in CLIA-88, however each laboratory must ensure waived testing personnel meet facility-defined minimum requirements and have documented training

Moderate Complexity***

1. MD or DO with current medical license in State of laboratory's location¹ AND Board-certified in Anatomic and/or Clinical Pathology; OR

2. MD, DO or DPM with current medical license in State of laboratory's location¹ and laboratory training/experience consisting of:

a. 1 year directing or supervising non-waived tests, OR

b. 20 CME credit hours in laboratory practice commensurate with director responsibilities, OR

c. Equivalent laboratory training (20 CME's) obtained during medical residency

OR

3. Doctorate in chemical, physical, biological or clinical laboratory science with board certification OR 1 year experience directing or supervising non-waived testing

A clinical consultant is only required if the director is not a physician or a board-certified doctoral scientist.

The clinical consultant must be a doctor of medicine, doctor of osteopathy or doctor of podiatric medicine and possess a license to practice medicine, osteopathy or podiatry in the State in which the laboratory is located¹; or a doctoral scientist certified by an HHS-approved Board.

A technical consultant is only required if the laboratory director is not qualified as a high complexity director.

The technical consultant must be qualified as a high complexity laboratory director.

Not required Not required 1. MD or DO with current medical license in State of laboratory's location¹; OR

2. Doctorate in clinical laboratory science, chemical, physical or biological science;

OR

3. Master's in medical technology, clinical laboratory, chemical, physical, or biological science; OR

4. Bachelor's in medical technology, clinical laboratory, chemical, physical or biological science; OR

5. Associate degree in chemical, physical or biological science or medical laboratory technology; OR

6. High school graduate or equivalent and successfully completed military training of 50 or more weeks and served as a medical laboratory specialist;

OR

7. High school diploma or equivalent and appropriate training/experience as specified in 493.1423

High Complexity

1. MD or DO with current medical license in State of laboratory's location¹ AND Board-certified in Anatomic and/or Clinical Pathology; OR

2. MD, DO or DPM with current

Not Applicable 1. MD or DO with current medical license in State of laboratory's location and Board-certified in Anatomic and/or Clinical Pathology;

OR

2. MD or DO with current medical

1. Qualify as Director for high-complexity testing; OR

2. Qualify as Technical Supervisor for high-complexity testing; OR

3. Doctorate in clinical

1. MD or DO with current medical license in State of laboratory's location¹; OR

2. Doctorate in clinical laboratory science, chemical, physical or biological science;

* The Director may fulfill multiple roles listed here. While CLIA may allow for non-physician or non-doctoral degreed individuals to direct Waived and Moderate Complexity laboratories, CAP does not. CAP accredited laboratories must be directed by a physician or doctoral degreed individual. Refer to CLIA88 for grandfather provisions.

** CLIA requires at minimum a bachelor degreed individual for technical supervisor of most laboratory sections. CLIA requires special qualifications for technical supervisor in certain specialties (Transfusion Medicine, Cytopathology, Cytogenetics, Histopathology, Oral Pathology, Histocompatibility) (493.1449). For these specialties, required qualifications include being a physician and/or doctoral scientist, and having specified training/experience. Refer to CLIA for further details. For these specialties, the technical supervisor may be referred to as the section director.

*** Laboratories with an annual test volume exceeding 500,000 must be directed by a high-complexity-qualified director, even if only waived and/or moderately complex tests are performed + Military and VA personnel may be licensed in any US State medical license in State of laboratory's location¹ and 1 year laboratory training during medical residency; OR

3. MD, DO or DPM with current medical license in State of laboratory's location¹ and 2 years experience directing/supervising high-complexity testing; OR

4. Doctorate degree in chemical, physical, biological or clinical laboratory sciences and board certification license in State of laboratory's location¹ and 1 year training and experience in high-complexity testing in the respective specialty; OR

3. Doctorate in clinical laboratory science, chemical, physical or biological science and 1 year training and experience in the respective specialty; OR

4. Master's in medical technology, clinical laboratory science, or chemical, physical or biological science and 2 years training and experience in high-complexity testing in the respective specialty; OR

5. Bachelor's in medical technology, clinical laboratory science, or chemical, physical or biological science and 4 years training and experience in high-complexity testing in the respective specialty laboratory science or chemical, physical or biological science and 1 year training and experience in high-complexity testing; OR

4. Master's in clinical laboratory science, medical technology or chemical, physical or biological science and 1 year training and experience in high-complexity testing; OR

5. Bachelor's in clinical laboratory science, medical technology or chemical, physical or biological science and 1 year training and experience in high-complexity testing; OR

6. Associate degree in medical laboratory technology (or pulmonary function) and 2 years laboratory (or blood gas analysis) training or experience, or both, in high-complexity testing

OR

3. Master's in medical technology, clinical laboratory, chemical, physical, or biological science; OR

4. Bachelor's in medical technology, clinical laboratory, chemical, physical or biological science; OR

5. Associate degree in chemical, physical or biological science or medical laboratory technology; OR

6. Education and training equivalent to an associate degree in a laboratory science or medical laboratory technology; OR

7. Anyone hired after April 24, 1995 must have an associate degree

***Laboratories with an annual test volume exceeding 500,000 must be directed by a high-complexity-qualified director, even if only waived and/or moderately complex tests are performed

*The Director may fulfill multiple roles listed here. While CLIA may allow for non-physician or non-doctoral degreed individuals to direct Waived and Moderate Complexity laboratories, CAP does not. CAP accredited laboratories must be directed by a physician or doctoral degreed individual. Refer to CLIA88 for grandfather provisions.

**CLIA requires at minimum a bachelor degreed individual for technical supervisor of most laboratory sections. CLIA requires special qualifications for technical supervisor in certain specialties (Transfusion Medicine, Cytopathology, Cytogenetics, Histopathology, Oral pathology, Histocompatibility) (493.1449). For these specialties, required qualifications include being a physician and/or doctoral scientist, and having specified training/ experience. Refer to CLIA for further details. For these specialties, the technical supervisor may be referred to as the section director.