January 28, 2002 - ASM Comments on Qualification Requirements for Directors of Laboratories Performing High Complexity Testing

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments to the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) on CMS-2094-P, Medicare, Medicaid and CLIA Programs: Qualification Requirements for Directors of Laboratories Performing High Complexity Testing, Proposed Rule, published in the Federal Register (Volume 66, Number 294) on December 28, 2001. The ASM is the largest educational, professional, and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents more than 42,000 microbiologists, including scientists and science administrators working in a variety of areas, including biomedical, environmental, and clinical microbiology. Many ASM members have primary involvement in the clinical laboratory area including individuals licensed and certified to direct laboratories and individuals who perform such testing.

The ASM supports certification as a critical and vital measure of laboratory qualifications. The certification process is an appropriate way to evaluate experience, training, knowledge and overall competency. The American Board of Medical Microbiology (ABMM) established in 1959, and the American Board of Medical Laboratory Immunology (ABMLI), established in 1975, were created to test the expertise of microbiologists seeking to direct public health or clinical microbiology laboratories. Board certified "Diplomates" are adjudged capable to direct public health and clinical microbiology laboratories within their specialty certification. Both the ABMM and the ABMLI use a two-step examination process for certification consisting of a Part I written examination (200 multiple choice questions) and a Part II oral examination. This process challenges candidates to respond to practical and theoretical problems encountered by the laboratory director based on their knowledge and experience.

Certification of Diplomate status is awarded to those individuals who successfully complete both the Part I and Part II examinations. Successful candidates of the ABMM certification process are certified as Diplomates in one of four specialty areas: Medical and Public Health Microbiology, Medical and Public Health Mycology, Medical and Public Health Parasitology or Medical and Public Health Virology. The rigorous certification process for both ABMM and ABMLI board certification requires appropriate training and experience prior to application for certification. For example, a candidate must possess an earned doctorate and complete a minimum of five (5) years of experience, or a combination of postdoctoral training and experience as defined by the ABMM or ABMLI. In addition, both Boards require continued re-certification which enhances the knowledge and skills of the laboratory director. Re-certification, which occurs every three years, is accomplished by participating in continuing education programs and ongoing professional activities such as teaching and publishing. The ASM is concerned that the proposed regulation, and in particular, the third alternative, opens the door for laboratories conducting high complexity testing to be directed by individuals who are not certified. ASM notes that the original intent of CLIA '88 was to improve the quality and accuracy of testing in clinical laboratories. The ASM supports the standards set forth in the ABMM and ABMLI certification process because they ensure a level of expertise necessary for laboratory directors to oversee accurate and safe laboratory testing, according to sound scientific practices. Alternative one and two in the proposed regulation closely parallel the education, training and competency standards set forth in the ABMM and ABMLI certification process.

ASM has the following specific comments on the three proposed alternatives for qualification requirements:

Alternative 1:

An individual who holds an earned doctoral degree and is certified by an HHS-approved board on or after January 1, 2003, is qualified.

The ASM views doctoral degree and certification as the "Gold Standard" for laboratory directors. This alternative assures that the individual has specified education and training and has completed the appropriate certification process, which measures competency. Thus, the ASM supports this alternative.

Alternative 2:
An individual who is or has been the director of a laboratory performing high complexity testing before January 1, 2003, and holds an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution; and has 2 years of laboratory training or experience, or both; and 2 years experience directing or supervising high complexity testing will be qualified.

The second alternative gives credit for experience as a laboratory director before January 2003, allowing an individual who has held a position for some time to be "grandfathered" in. The combination of experience as a laboratory director, plus an earned doctoral degree, two years of training and two years of other laboratory experience directing or supervising high complexity testing, is acceptable for those who have been laboratory directors previously. As in the ABMM and ABMLI re-certification process, participation in continuing education programs and ongoing professional activities should be encouraged. In addition, all new positions should be filled with ABMM or ABMLI certified individuals.

Alternative 3:

An individual who holds an earned doctoral degree but has never been the director of a laboratory performing high complexity testing must have at least 6 years of laboratory training or experience, or both; including 2 years of experience directing or supervising high complexity testing.

The problem with qualifying someone on the basis of "experience" is that there is no way to measure the quality of that experience or the quality of the laboratory in which the experience is acquired without an examination process. Performance of high complexity testing requires the rigorous training and competency attested by board certification. Alternative three does not encourage an individual to get the appropriate training and experience needed for certification; it continues the status quo as opposed to seeking to improve the status of the laboratory; and, it does not foster the development of education or training programs to provide for the proper training of individuals who could eventually become certified. If Alternative three is approved, the ASM recommends that this alternative include a "sunset provision" of two years, i.e. until December 31, 2005, to allow sufficient time for an individual to get certified; and/or, mandate that laboratory training is under the supervision of a certified laboratory director in the area in which the person is receiving experience, or under the supervision of a board certified clinical pathologist, plus three years directing or supervising high complexity testing. The ASM opposes Alternative three as it is currently proposed in the regulation.

The ASM appreciates the opportunity to comment as CMS and CDC decide the appropriate mix of education, training and experience required for directors of high complexity testing laboratories. We are pleased to provide any additional information or consultation you may need as this process moves forward.