Edward Baker, MD, MPH
Assistant Surgeon General &
Director, Public Health Practice Program Office
Mailstop K-36
Centers for Disease Control and Prevention
Atlanta, Georgia 30333

Dear Dr. Baker:

Thank you for your October 30, 1998 response regarding our request that you implement the Clinical Laboratory Improvement Advisory Committee’s (CLIAC’s) recommendation regarding non board-certified PhD clinical consultants. Specifically, CLIAC urged CDC to grandfather individuals with a doctoral degree, who were board-eligible on or before February 28, 1992, to serve as Clinical Consultants. We are pleased that the CDC is considering this request.

AACC continues to support the concept set forth in the CLIA regulations, namely that doctoral scientists serving as the Clinical Consultants should be board-certified. However, we recognize that there are many qualified--by virtue of their training and experience--non board-certified PhDs, who do not meet this standard. We believe it is essential that CDC grandfather these individuals, as it has individuals in other personnel categories, such as Testing Personnel and high complexity General Supervisors. Failing to recognize the expertise of these individuals may:

  • increase laboratory administration costs by inefficiently allocating staff responsibilities to ensure that a certified individual provides such services;
  • require some laboratories to hire outside Clinical Consultants, even though they have qualified and trained individuals on staff (who have provided such services in the past), but don’t meet the current board-certification requirements; or
  • limit job opportunities for those non board-certified individuals, who previously provided clinical consultant services, but now are prohibited from performing that duty.

Unfortunately, there is no reliable data describing the extent of this problem. From our own database, we can glean some insight into how widespread this problem could be. Approximately 2,000 of AACC’s members classify themselves as laboratory directors. Nearly 500 of these individuals are ABCC certified—the primary accrediting body for
doctoral level clinical chemists. Of the remaining 1500 laboratory directors, it is possible that some individuals are MDs, accredited by other organizations or certified, but they failed to inform us of their status. It would seem safe to assume that many of these individuals are not board-certified, but capably serving as laboratory directors.

It’s important to note that only those individuals board-eligible as of February 28, 1992 would be grandfathered. Therefore, those individuals who became laboratory directors after the publication of the initial CLIA rule would, in fact, need to become certified to serve in this capacity. Thus, AACC urges you to adopt the CLIAC Clinical Consultant recommendation and provide relief to those highly trained and experienced laboratorians hindered by the current regulations, while also reducing the administrative and financial burdens on their facilities.

By way of background, AACC is the principal association of clinical chemists--professional laboratory scientists--including MDs, PhDs and medical technologists. AACC’s members develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations and work in hospitals, independent laboratories and the diagnostics industry nationwide. The AACC's objectives are to further the public interest and educational activities and help maintain high professional standards.

If we may be of any assistance, please call me at (405) 271-3571 or Vince Stine, Director, Government Affairs at (202) 835-8721.



K. Michael Parker, PhD


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