EDUCATION REQUIREMENT – MODERATE COMPLEXITY TESTING
Clinical Laboratory Improvement Amendment 1988 (CLIA ’88)
493.1423, Subpart M – D6064, D6065, D6066, & D6069
493.1423 – D6064: Standard; testing personnel qualifications:
Each individual performing moderately complex testing must –
- Possess a current license issued by the State in which the laboratory is located, if such licensing is required; and
Interpretive Guidelines 493.1423
The laboratory director is responsible for ensuring the testing personnel have the appropriate education and experience, and receive the appropriate training for the type and complexity of testing performed. The experience required is clinical in nature. This means, examination of and test performance on human specimens for purposes of obtaining information for the diagnosis, treatment, and monitoring of patients, or for providing information to others who will do the diagnosing and treating of the patient’s condition. (Use D6029) (e11) Ensure that prior to testing patients’ specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results;)
Each individual must have documentation of training applicable to the types and complexity of testing performed. This training should be such that the individual can demonstrate that he/she has the skills required for proper performance of preanalytic, analytic, and postanalytic phases of testing. For example, if the individual performs a rapid Strep test, he/she should be able to demonstrate the skills for:
- Proper specimen handling prior to testing, e.g., assuring the specimen is properly labeled and received and tested within appropriate timeframes, the swab is received at the proper temperature, and the ampule on the swab containing transport media is broken;
- Proper test performance according to the laboratory’s policies and manufacturer’s instructions, e.g., using reagents that are not outdated, are at the proper temperature, and of the same lot number, accurate timing of all steps in the procedure, proper performance of quality control procedures; and
- Proper reporting of patient test results in accordance with the laboratory’s policies, e.g., notifying the person authorizing to receive test results of a positive result, not reporting the test result if quality control fails.
Training may include, but is not limited to, attendance at:
- Seminars given by experts in the field, e.g., a lecture about antibiotic resistance given by the infection control officer of a local hospital;
- On-site or off-site instrument trainings given by a manufacturer, e.g., a week-long training course given at the manufacturer’s headquarters, or training by a manufacturer’s technical representative on an instrument purchased by a laboratory;
- Technical training sessions, workshops, or conferences given by a professional laboratory organization, e.g., CAP, ASMT, AACC, and ASCT;
- Technical education classes or specialty courses that include hands-on test performance, e.g., parasitology, bacteriology, cytology, given by CDC, a State Health Department, or professional laboratory organizations;
- A formal laboratory training program; or
- Inservices offered by a local hospital laboratory staff, pathologist, or medical technologist to a physician’s office personnel.
Documentation may consist of, but is not limited to, letters from training programs or employers, attestation statements by the laboratory director, a log sheet initialed by the attendees indicating attendance at a training session/inservice, certificates from organizations providing the training session, workshop, conference, specialty course.
493.1423 – D6065: Standard; testing personnel qualifications:
- Meet on of the following requirements:
(b1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master’s, or bachelor’s degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or
Interpretive Guidelines 493.1423(b)(1)
See 493.2 for the definition of and guidance for accredited institution.
(b2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or
(b3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medial Laboratory Specialist (Laboratory Technician); or
Interpretive Guidelines 493.1423(b)(3)
Equate similar military courses with different titles. Evaluate the course length and content to assure that it provides effective training for testing personnel. Refer to A Guide to the Evaluation of Educational Experience in the Armed Services. American Council on Education, Washington, D.C.
(b4) Have earned a high school diploma or equivalent; and
Interpretive Guidelines 493.1423(b)(4)
Personnel qualifying under this requirement must have a high school diploma or GED.
How does the laboratory assure that personnel receiving orientation and training have the necessary skills for properly performing assigned responsibilities?
493.1423 – D6066: Standard; testing personnel qualifications:
(b4ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens.
493.1423 – D6069: Standard; Testing personnel qualifications:
- Each individual performs only those moderate complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual’s education, training or experience, and technical abilities.
Comprehensive Accreditation Manual for Hospitals (CAMH Update 2, September 2012 – effective January 1, 2013)
Human Resources (HR)
Standard HR.01.02.05 – The hospital verifies staff qualifications.
Elements of Performance for HR.01.02.05
C, 3., D – The hospital verifies and documents that the applicant has the education and experience required by the job responsibilities. – M, R.
A, 6. – The hospital uses the following information from HR.01.02.05, Elements of Performance 1-5, to make decisions about staff job responsibilities: – R
- Required licensure, certification, or registration verification
- Required credentials verification
- Education and experience verification
- Criminal background check
- Applicable health screenings
Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing (CAMLAB Update 2, September 2012 – effective January 1, 2013)
Human Resources (HR)
Standard HR.01.02.05 – The laboratory verifies staff qualifications.
Elements of Performance for HR.01.02.05
C, 3., D – The laboratory verifies and documents that the applicant has the education and experience required by the job responsibilities. # – M, R.
A, 6. – The laboratory uses the following information to make decisions about staff job responsibilities:
- Verified licensure, certification, or registration required by law or regulation or the laboratory
- Verified education and experience
# – Education and experience requirements are described in the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) under Subpart M: “Personnel for Nonwaived Testing,” 493.1351-493.1495. A complete description of the requirement is located at http://www.cdc.gov/clia/Regulatory/default.aspx