Letter to Dr. Carter Regarding Draft “Study of the Need to Regulate Medical Laboratory Scientists and Medical Laboratory Technicians”

September 28, 2010

Elizabeth A. Carter, Ph.D.
Executive Director for the Virginia Board of Health Professions Perimeter Center
9960 Mayland Drive, Suite 300
Richmond, Virginia 23233

Dear Dr. Carter:

On behalf of the members of the American Clinical Laboratory Association (ACLA), I am writing to provide our comments on the draft “Study of the Need to Regulate Medical Laboratory Scientists and Medical Laboratory Technicians (the Study),” which is intended to better understand the scopes of practice of these practitioners and issues related to the need for adequate safeguards for the public’s protection. ACLA is an association of national, regional and local laboratories located throughout the United States; several of our members have laboratories in Virginia and would be affected by all proposed personnel regulations.

The clinical laboratory industry is a dynamic, ever-changing landscape of new technologies and sophisticated diagnostic equipment . Regulation needs to keep pace with the responsibilities and demands of the evolving clinical laboratory practice. Clinical laboratories are regulated by the federal Clinical Laboratory Act Amendments (CLIA) of 1988. Under CLIA, laboratory directors and pathologists are granted the authority to select, assign and qualify individuals as part of their direction of the laboratory. Current federal regulations stipulate that the laboratory director “employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results.” CLIA also establishes a “systems’ approach of accreditation and proficiency testing to ensure laboratory adherence to standards by testing the quality of laboratory performance as a whole rather than testing the individuals who perform laboratory testing.

The Study is a comprehensive and contemporary analysis and review of medical laboratory personnel in the United States and is a valuable reference document. We have only a few concerns with the content. In documenting the potential for harm of the lack of regulation, the study cites an ASCP 2005 policy statement and a CMS study of waived testing laboratories. Waived testing laboratories are physician office laboratories, not subject to CLIA, performing basic testing procedures that have been determined not to require CLIA oversight because the potential for harm to the patient from incorrect results is small. Most personnel performing waived testing are NOT medical technologists. Applying personnel standards to “waived” physician office laboratories would reduce the incorrect test result rate at a significant and probably unreasonable cost. In addition, the Study states that MLSs develop and modify laboratory procedures. This is not done haphazardly, but under the direction and supervision of a technical supervisor and/or the laboratory director.

The Board of Health Professions is conducting this review of the need for regulation of laboratory personnel at the request of Delegate John M. O’Bannon who has proposed legislation requiring the registration of “medical laboratory scientists” and “medical laboratory technicians.” In general, and for the reasons stated above, we believe CLIA provides the appropriate system of regulation to provide the flexibility to keep pace with the evolving, dynamic laboratory practice while insuring the quality of the services performed. Establishing by statute strict personnel requirements for Virginia laboratories will constrain that flexibility, exacerbate existing workforce shortages and place Virginia laboratories at a distinct disadvantage in the competition for qualified personnel.