09/30/98

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:

In December 1993, the American Association for Clinical Chemistry (AACC) recommended to the Centers for Disease Control and Prevention (CDC) that CLIA’s Clinical Consultant standards be modified to deem PhDs who were board-eligible on or before February 28, 1992, as qualified to serve as Clinical Consultants. The Clinical Laboratory Improvement Advisory Committee (CLIAC) unanimously endorsed our proposal. Five years later, AACC continues to support this recommendation.

Therefore, we were dismayed to learn that at the September 16-17 CLIAC meeting that CDC may not adopt this recommendation. AACC is concerned that without this change, some highly trained individuals--who have been successfully providing consultation services for many

years—may either lose their jobs or find their responsibilities severely restricted because they are not board-certified. It’s important to note that these same individuals have been performing the Clinical Consultant responsibilities under CLIA for six years without anyone raising this as a quality problem.

Although no comprehensive number exists on how many laboratorians are affected by this provision, if AACC’s membership is a good indicator, it could be quite substantial. AACC has nearly 2,000 members serving as laboratory directors. We estimate that less than half of them are board-certified. Yet many of them are currently directing hospital and commercial laboratories performing high complexity testing. We believe it is important that these individuals be permitted to continue performing their jobs.

AACC continues to be a strong supporter of board-certification. Although we do not want to weaken the certification requirements, it is unfair to disenfranchise these highly qualified laboratory professionals. That is why we recommended that this change only apply to those PhDs who were board-eligible on or before the February 28, 1992 promulgation date of CLIA’88 rule. This change would be consistent with previous CDC decisions to ensure that quality personnel did not lose their jobs by grandfathering such individuals (e.g., high complexity general supervisors and testing personnel).

One rationale mentioned for not grandfathering anyone into the Clinical Consultant position was that no such position existed under CLIA’67. We do not agree with this argument. Although the position did not exist, the functions performed by the Clinical Consultant certainly did exist—and were most often performed by the laboratory director. Similarly, no Testing Personnel position existed under CLIA’67. The functions included under that new category had usually been performed by individuals classified as either a Technologist or Technician. Yet, CDC grandfathered them into the new position. Therefore, the precedent to grandfather qualified professionals into new positions exists and there should be no barrier to board-eligible PhDs qualifying as Clinical Consultants.

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 (708) 216-4725 or Vince Stine, Director, Government Affairs at (202) 835-8721.

Sincerely,

Stephen Kahn, PhD, DABCC

President

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