American Association for Clinical Chemistry
Better health through laboratory medicine
04/28/98

Coalition to Preserve Safe Patient Testing

April 28, 1998

The Coalition to Preserve Safe Patient Testing and Public Citizen urges you to oppose H.R. 2250, the Clinical Laboratory Improvement Act Amendments of 1997. This legislation, if enacted, would exempt physician office laboratories (POLs) – 56 percent of all laboratories in the United States – from any federal oversight. This means that nearly 90,000 physician office laboratories could perform tests for AIDS, cancer, genetic abnormalities and other diseases and conditions without having to follow any standards for quality or accuracy. We strongly object to this policy recommendation.

Congress passed the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) primarily in response to patients’ concerns regarding the accuracy of POL and Pap smear testing. This law, which has been phased in over the past few years, establishes minimum standards for laboratories performing patient testing. One of the basic tenets of the law is that all testing facilities, regardless of location, should follow accepted laboratory quality practices when performing patient testing. Our coalition members continue to support this principle and believe that CLIA ’88 is essential to improving overall laboratory performance.

Two studies recently published in the Journal of the American Medical Association clearly indicate the need for regulating POLs. The studies, conducted by the California state Department of Health and the Centers for Disease Control and Prevention (CDC), evaluated the proficiency testing (PT) performance of laboratories (proficiency testing is a method for determining a laboratory’s testing accuracy). Both studies found that laboratory testing performed by POLs and other previously unregulated facilities is not as accurate as testing performed by previously regulated laboratories, such as hospital and commercial facilities. In fact, the California study shows that POLs have three times the unsatisfactory rate than other laboratories.

It’s important to note, however, that a study by the State of Wisconsin indicates that POLs’ PT performance is improving as a result of CLIA. This supports previous reports, which suggest that the scores of laboratories participating in PT improve as they learn from their mistakes. We are confident, therefore, that as long as POLs remain subject to the CLIA standards, their testing accuracy will continue to improve.

Similarly, the inspection data from the Health Care Financing Administration (HCFA), one of the federal agencies responsible for administering CLIA, indicates that POLs are cited for more deficiencies than other facilities. During the first cycle of inspections (1992-95), nearly one-third of POLs were cited for failing to perform quality control standards—37 percent higher than non-POLs. However, as a result of CLIA, the number of POLs cited for not following the quality control standards during the second inspection cycle (1995-97) was reduced to 13 percent. Although this was still 23 percent higher than non-POLs, it is certainly a step in the right direction.

We believe that the initial data from the CLIA program indicate that the program is meeting its chief objective—to improve the overall quality and accuracy of laboratory testing. The primary beneficiaries of these gains are the patients, who are diagnosed and treated based on more accurate results. If

H.R. 2250 were enacted, it would exempt POLs from these quality and accuracy standards and potentially reverse this advancement in patient care. Therefore, we urge you to oppose H.R. 2250 or any other legislative measures to exempt POLs from CLIA.

If you have any questions regarding CLIA ’88, would like a copy of the State of California, CDC or State of Wisconsin studies, or would like to meet with us to discuss this issue, please don’t hesitate to contact one of our coalition representatives.

American Association for Clinical Chemistry

American Association of Bioanalysts

American Clinical Laboratory Association

American Medical Technologists

American Society for Clinical Laboratory Science

American Society for Microbiology

American Society of Clinical Pathologists

Association of State and Territorial Public Health

Laboratory Directors

Clinical Laboratory Management Association

International Society for Clinical Laboratory Technology

Public Citizen