Final5
CLIA. Part II: Perplexity about Personnel and ComplexityFinal5
CLIA. Part II: Perplexity about Personnel and ComplexityAs discussed in Part 1 of this series, the long awaited Final CLIA Rule was published in the Federal Register on January 24, 2003. The Final Rule did away with the use of the terms high complexity and moderate complexity and established one set of "quality assessment" standards for non-waived tests. Now instead of separate quality requirements for moderate and high complexity testing, there is only one set for non-waived testing. Readers may now have the impression that there is only one set of personnel requirements for non-waived testing as well. NOT TRUE! Personnel qualifications still are related to test complexity, thus you have every right to be "perplexed" or confused.
Laboratories still need to meet the personnel requirements identified for moderate and high complexity testing. The only change in the Final Rule is for the director qualification in the high complexity category.
This discussion provides a review the current personnel qualifications for testing under CLIA and identifies the appropriate sections in the CLIA regulations for each position. Details for each position, including specific responsibilities and requirements for directors in specialty and subspecialty areas, can be found in the most current codified edition (12/29/01), which contains all changes subsequent to the initial requirements identified in the February 28, 1992 Federal Register: http://www.phppo.cdc.gov/clia/regs/toc.asp The latest qualifications (01/24/03) for high complexity test director are available at: http://www.phppo.cdc.gov/clia/regs/toc.asp
Waived Testing (§493.15). For a laboratory performing only waived testing, there are no personnel requirements. These tests may be performed by anyone, although the Centers for Medicare and Medicaid Services (CMS) expect personnel to following manufacturers' instructions and apply good laboratory practices.
Moderate and High Complexity Testing (Subpart M, §493.1403-1495). For a laboratory performing moderate complexity testing, qualified individual(s) need to be identified for four positions: Director, Technical Consultant, Clinical Consultant, and Testing Personnel. High complexity testing requires that individual(s) be identified for five positions: Director, Technical Supervisor, Clinical Consultant, General Supervisor, Testing Personnel.
Note that the position titles for each complexity level do not have to correspond to working titles used within the laboratory. The specific education and experience qualifications for each title vary according to the complexity of testing as well. A Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), Doctor of Podiatric Medicine (D.P.M.), or Ph.D with the appropriate experience can fill all the required positions for both complexity levels.
Director (§493.1403-1407): The director is responsible for all aspects of laboratory operation and administration. The director may delegate the duties to qualified individuals, but ultimately remains responsible for ensuring that all duties are properly performed. The director must be accessible, but is not required to be on-site when laboratory testing is performed. The director's qualifications range from a licensed doctor of medicine, osteopathy, or podiatry to an individual having a bachelors degree in medical technology/clinical laboratory science or in the chemical, physical, or biological science. Each qualification requires specific training and/or experience in laboratory testing.
Technical Consultant (§493.1409-1413): The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity methods. The technical consultant establishes the quality standards of the laboratory through selecting and monitoring the laboratory's methods/instrumentation and evaluating and documenting the competency of the personnel. The technical consultant must be accessible, but is not required to be on-site when laboratory testing is performed. Qualifications for this position range from a licensed medical doctor or doctor of osteopathy certified in anatomic and/or clinical pathology to an individual having a bachelors degree in medical technology/clinical laboratory science or in the chemical, physical, or biological science. Each qualification requires specific training and/or experience in laboratory testing.
Clinical Consultant (§493.1415-1419): The clinical consultant is the liaison between the laboratory and its customers. The "customers" consisting of both physicians who order tests and "lay" people, patients, who have full access to all medical records. This individual must be qualified to consult with and give opinions concerning the diagnosis, treatment, and management of patient care and be available to provide clinical consultation to the laboratory's clients. The clinical consultant is not required to be on-site when laboratory testing is performed. The clinical consultant must be a licensed medical doctors or doctors of osteopathy, doctors of podiatric medicine or individuals having a doctorate in the chemical, physical, biological or clinical laboratory science and appropriate certification.
Testing Personnel (§493.1423-1425): Testing personnel are responsible for specimen processing, test performance, and reporting test results. For moderate complexity testing, personnel qualifications range from doctors of medicine, osteopathy or podiatry to an individual with a high school diploma or equivalent and specific, appropriate training/experience that includes having documented training prior to analyzing patient specimens.
Director (§493.1443-1445): The director is responsible for all aspects of laboratory operation and administration including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. The director may delegate the duties to qualified individuals, but remains responsible for ensuring that all duties are properly performed. The director must be accessible, but is not required to be on-site when laboratory testing is performed.
For high complexity testing, the director's qualifications include:
- M.D., or D.O. with a current medical license in the state of the laboratory's location and certified in anatomic and/or clinical pathology by ABP or AOBP or equivalent qualifications;
- M.D., D.O. or D.P.M. with a current medical license in the state the laboratory is located and one year laboratory training during medical residency;
- M.D., D.O., or D.P.M. with current medical license in State of laboratory's location and 2 years experience in directing/supervising high complexity testing;
- Doctorate in chemical, physical, biological or clinical laboratory science and board certification;
- Doctorate in a chemical, physical, biological, or clinical laboratory science from an accredited institution and serving as director of a laboratory performing high complexity testing (these individuals must also have two years of laboratory training or experience, or both; and two years of experience directing or supervising high complexity testing);
- ON OR BEFORE 2/28/92 serving as a laboratory director and previously qualified or could have qualified as a laboratory director under laboratory regulations published March 14, 1990 (55 FR 9538);
- ON OR BEFORE 2/28/92 qualified as director by the State in which the laboratory is located.
With the January 24, 2003 Final Rule, experienced directors without board certification, (5) above, will be "grandfathered". As of February 24, 2003, new doctoral degreed directors of high complexity testing will need board certification as identified in (4). The number of approved boards for both and doctoral-degree directors and clinical consultants was expanded and is available at: http://www.cms.gov/clia/dirclcon.asp
Technical Supervisor (§493.1447-1451): The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical and scientific oversight for each of the specialties and subspecialties of service in which the laboratory performs high complexity tests or procedures. The technical supervisor establishes the quality standards of the laboratory through selecting and monitoring the laboratory's methods/instrumentation and evaluating and documenting the competency of the personnel. The technical supervisor must be accessible, but is not required to be on-site when laboratory testing is performed.
The technical supervisor's qualifications range from a licensed medical doctor or doctor of osteopathy certified in anatomic and/or clinical pathology to an individual having a bachelors degree in medical technology/clinical laboratory science or in the chemical, physical, or biological science. Each qualification requires specific training and/or experience.
Clinical Consultant (§493.1455-1457): The clinical consultant is the liaison between the laboratory and its customers. This individual must be qualified to consult with and give opinions concerning the diagnosis, treatment and management of patient care. The clinical consultant must be available to provide clinical consultation to the laboratory's clients, but is not required to be on-site when laboratory testing is performed. The qualifications for this position include only licensed medical doctors, doctors of osteopathy, doctors of podiatric medicine, and individuals having a doctorate in the chemical, physical, biological or clinical laboratory science and appropriate certification.
General Supervisor (§493.1459-1463): The laboratory must have one or more general supervisors who, under the direction of the laboratory director and supervision of the technical supervisor, provides day-to-day supervision of testing personnel and reporting of test results. In the absence of the director and technical supervisor, the general supervisor must be responsible for the proper performance of all laboratory procedures and reporting of test results. The general supervisor must be accessible (on-site) when laboratory testing is performed. The general supervisor's qualifications include:
- Laboratory director of high complexity testing;
- Technical supervisor of high complexity testing;
- M.D., D.O. or D.P.M. with current medical license in the state where laboratory is located and 1 year training/experience in high complexity testing;
- Doctorate in clinical laboratory science or chemical, physical or biological science and 1 year training/experience in high complexity testing;
- Masters degree in clinical laboratory science, medical technology or chemical, physical or biological science and 1 year training/experience in high complexity testing;
- Bachelors degree in medical technology, or chemical, physical or biological science and 1 year training/experience in high complexity testing;
- Associate degree in a laboratory science or medical laboratory technology and have at least 2 years of laboratory training or experience, or both, in high complexity testing;
- Education and training equivalent to an associate degree in a laboratory science or medical laboratory technology and have at least 2 years of laboratory training or experience, or both, in high complexity testing (Education -- 60 semester hours including either 24 semester hours of medical laboratory technology courses or 24 semester hours of science courses (6 hours of chemistry; 6 hours of biology; and 12 hours in chemistry, biology or medical laboratory technology, or any combination; and Training -- either completion of an approved/accredited clinical laboratory or medical laboratory training program, which may be included in the 60 semester hours specified above or three months of documented laboratory training in each specialty in which the individual performs high complexity testing);
- For blood gas analysis, earned an associate degree related to pulmonary function and have at least 2 years of laboratory training or experience, or both, in blood gas analysis;
- On or before 2/28/92 qualified or could have qualified as a general supervisor under 42 CFR 493.1433 laboratory regulations published March 14, 1990 (55 FR 9538);
- On or before 9/1/92, served as a general supervisor of high complexity testing and as of April 24, 1995, have at least 2 years of clinical laboratory training or experience, or both, in high complexity testing (either before or after completing the accredited or military medical laboratory training) and meet 1 of the following:
- Have graduated from an approved or accredited medical laboratory or clinical laboratory training program.
- Be a high school graduate or equivalent and have successfully completed at least a 50 week official U.S. military medical laboratory procedures course and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician).
- On or before 9/1/92, served as a general supervisor of high complexity testing, and have high school diploma or the equivalent; and have at least 10 years of laboratory training or experience, or both, in high complexity testing, including at least 6 years of supervisory experience between 9/1/82 and 9/1/92.
Testing Personnel (§493.1487-1495): The testing personnel are responsible for specimen processing, test performance and for reporting test results. Qualifications for testing personnel include:
- M.D., D.O., or D.P.M. with current medical license in the state where laboratory is located;
- Doctorate in clinical laboratory science or chemical, physical or biological science;
- Masters degree in medical technology, clinical laboratory science or chemical, physical or biological science;
- Bachelors degree in medical technology/clinical laboratory science or chemical, physical or biological science
- Associate degree in a laboratory science, or medical laboratory technology
- Education and training equivalent to an associate degree in a laboratory science, or medical laboratory technology (Education -- 60 semester hours including either 24 semester hours of medical laboratory technology courses or 24 semester hours of science courses (6 hours of chemistry; 6 hours of biology; and 12 hours in chemistry, biology or medical laboratory technology, or any combination; and Training -- either completion of an approved/accredited clinical laboratory or medical laboratory training program, which may be included in the 60 semester hours specified above or at least three months of documented laboratory training in each specialty in which the individual performs high complexity testing);
- ON OR BEFORE 2/28/92 qualified or could have qualified as a technologist under 42 CFR 493.1433 laboratory regulations published March 14, 1990 (55 FR 9538);
- On or before April 24, 1995, with a high school degree or equivalent and either have graduated from an approved or accredited medical laboratory or clinical laboratory training program or have successfully completed at least a 50 week official U.S. military medical laboratory procedures course and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician).
Sharon Ehrmeyer, Ph.D., MT(ASCP) is Professor of Pathology and Laboratory Medicine and Director of the Medical Technology Program at the University of Wisconsin in Madison, Wisconsin. Dr. Ehrmeyer is active in the American Society for Clinical Laboratory Science, the American Association for Clinical Chemistry (she is secretary for its Critical and Point of Care Testing Division), and the American Society for Clinical Pathology where she serves on the Board of Governors. Dr. Ehrmeyer gives numerous presentations on laboratory regulations (CLIA, JCAHO, CAP and COLA), point of care testing and various quality issues. Her research interests focus on clinical laboratory quality and the impact of government regulations on laboratory and POCT practices.
