CLIA PERSONNEL REQUIREMENTS
WAIVED TESTING
DIRECTOR:
1. Licensed physicianTESTING PERSONNEL:
1. Minimum: High school graduate with documented on the job training for tests performed.PHYSICIAN PERFORMED MICROSCOPY
DIRECTOR:
1. Licensed physician - MD or DO, Podiatrists, Dentists qualified in pathology.TESTING PERSONNEL
1. Physician2. Nurse midwives - documented training for tests performed
3. Physician Assistants (degreed) - documented training for tests performed
4. Nurse practitioners - documented training for tests performed
MODERATE COMPLEXITY TESTING (NON-WAIVED TESTING)
DIRECTOR:
1. Laboratory director license if required by State2. Licensed MD, DO AND Certified in anatomic or clinical pathology OR Lab training or experience consisting of: 1 year directing or supervising non-waived lab OR 20 CME credits in lab practice relevant to director responsibilities (effective in August 93) OR Training equivalent to 20 CME credits during medical residency.
3. Doctoral degree in laboratory science AND Board certified OR 1 year experience directing or supervising non-waived lab.
4. Master's degree in lab science AND 1 year lab training or experience AND 1 year of supervisory experience.
5. Bachelor's degree in lab science AND 2 years lab training or experience AND 2 years of supervisory experience.
6. Prior to Feb 28, 1992, qualified under state law or Medicare lab regulations as Director.
TECHNICAL CONSULTANT:
1. License, if required by State2. Licensed MD, DO AND Certified in anatomic or clinical pathology OR Lab training or experience consisting of: 1 year laboratory training or experience in designated specialty/ subspecialty areas of service.
3. Doctoral or Master's degree in laboratory science AND 1 year laboratory training or experience in designated specialty/subspecialty in areas of service.
4. Bachelor's degree in lab science AND 2 years laboratory training or experience in designated specialty/subspecialty in areas of service.
NOTE: "Training or experience" can be acquired concurrently in specialties and subspecialties.
CLINICAL CONSULTANT:
1.Licensed MD or DO.2.Qualified laboratory director (See director's column).
TESTING PERSONNEL:
1. Licensed by State, if required.2. Licensed MD or DO.
3. Doctoral, Master's, Bachelor's or Associate's degree in laboratory science.
4. High School graduate and 50 weeks military training as Medical Lab Specialist.
5. High School graduate or equivalent AND Documentation of training appropriate to testing performed. TO INCLUDE: specimen collection, labeling, preparation, etc.; implement laboratory procedures; perform tests assigned; conduct preventive maintenance, troubleshooting, calibration; knowledge of reagent stability and storage; implement quality control procedures; knowledge of factors influencing test results; validate patient test results with QC before reporting.
HIGH COMPLEXITY TESTING
DIRECTOR:
1. Laboratory director license if required by State.2. Licensed MD, DO AND Certified in anatomic or clinical pathology OR 1 year of laboratory training during medical residency OR 2 years of experience directing or supervising high complexity lab.
3. Doctoral degree in laboratory science AND Board certified OR (until Feb. 1994), 2 years laboratory training/experience AND 2 years experience directing or supervising high complexity lab.
4. Prior to Feb. 28, 1992, qualified under state law or Medicare lab regulations as Director.
TECHNICAL SUPERVISOR:
Specific qualifications are required for each specialty or subspecialty.For all specialties/subspecialties except for histocompatibility and cytogenetics:
1. Licensed MD of DO AND Certified in anatomic AND clinical pathology.
For subspecialties of bacteriology, mycobacteriology, mycology, virology, parasitology:
1.Licensed MD, DO AND certified in clinical pathology OR 1 year training or experience in high complexity microbiology with a minimum of 6 months in the appropriate subspecialty.
2.Doctoral degree in laboratory science AND 1 year training or experience in high complexity microbiology with a minimum of 6 months in the appropriate subspecialty.
3.Master's degree in laboratory science AND 2 years training or experience in high complexity microbiology with a minimum of 6 months in the appropriate subspecialty.
4.Bachelor's degree in laboratory science AND 4 years training or experience in high complexity microbiology with a minimum of 6 months in the appropriate subspecialty.
For diagnostic immunology, chemistry, hematology, radiobioassay:
Same educational/experiential requirements as above EXCEPT no 6 month subspecialty requirement.
For pathology and its subspecialties, cytology, histopathology, cytogenetics, immunohematology:
There are specific requirements for each specialty or subspecialty (See Regulation).
CLINICAL CONSULTANT:
1 .Licensed MD or DO.2. Qualified laboratory director.
GENERAL SUPERVISOR:
1. Licensed by State, if required.2. Qualified Director
3. Qualified Technical Supervisor
4. MD, DO, Doctoral, Master's or Bachelor's degree in lab science AND 1 year lab training/experience in high complexity testing.
5. Associate’s degree AND 2 years lab training or experience.
6. Individuals who have successfully completed the HHS examination before it was discontinued in 1987 AND will have 6 years experience in the position of general supervisor by January 1994.
7. Individuals with 60 semester hours, which include either 24 semester hours of medical laboratory technology or science courses that include 6 semester hours of biology and 12 semester hours of chemistry, biology, medical laboratory technology or any combination of the three PLUS completion of either an accredited clinical laboratory or medical laboratory training program or 3 months of documented training in each specialty in which the individual performs high complexity testing.
8. Individual who does not have a degree or have a baccalaureate degree that is in science but meets the equivalency route for associate degree and has at least 2 years of laboratory training or experience in high-complexity training.
9. Individual qualified as a general supervisor under the March 14, 1990 federal regulations.
10. High school graduate, or equivalent, who has 10 years of laboratory training or experience in high-complexity testing (with at least 6 of those years in a supervisory capacity, within the last 10 years) and working as a general supervisor on or before September 1, 1992.
For blood gases: If not qualified above, Bachelor's or Associate's degree in respiratory therapy AND 1 or 2 years of training or experience.
For cytology, see regulation.
TESTING PERSONNEL (HIGH):
1. Licensed MD or DO2. Doctoral, Master's, Bachelor's or Associate's degree in laboratory science.
3. Previously qualified as technologist.
4. Completed an accredited or 50 week U.S. military medical laboratory training program.
5. High school graduate with appropriate training performing high complexity tests on or before April 25, 1995. (No additional training or education will be required). Test results reported by this individual who does not meet the educational standards found in #1-4 must have all test results they report reviewed by a supervisor within 24 hours and before release. For blood gases: Must meet qualifications of 1 - 4 above or have Bachelor's degree in respiratory therapy Associate's degree related to pulmonary function.