Representative Neil Abercrombie
1233 Longworth HOB
Washington, DC 20515

Dear Representative Abercrombie:

The American Association for Clinical Chemistry (AACC) urges you to oppose H.R. 528, the Clinical Laboratory Improvement Act Amendments of 1999. This legislation, if enacted, would exempt physician office laboratories (POLs) - 58 percent of all laboratories in the United States - from any federal oversight. This means that more than 92,000 POLs 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 bill.

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. AACC continues to support this principle and believes that CLIA ’88 is essential to improving overall laboratory performance.

Last year, the Journal of the American Medical Association published two studies, which clearly demonstrated the need for regulating POLs under CLIA’88. The studies, conducted by the California Department of Health Services 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 are three times more likely to fail a PT testing event than other laboratories.

The good news, however, is that a study by the State of Wisconsin indicates that POLs’ PT performance is improving as a result of CLIA’88. This supports previous reports, which suggest that 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, early inspection data from the from the Health Care Financing Administration (HCFA), one of the federal agencies responsible for administering CLIA, documented quality problems in POLs. During the first cycle of inspections (1992-95), more than 20 percent of POLs were cited for failing to perform daily quality control procedures. However, as a result of CLIA, the number of POLs not performing this quality practice during the third inspection cycle (1998-present) has been reduced to eight percent.

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 patients, who are diagnosed and treated based on more accurate results. If H.R. 528 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. 528 or any other legislative measures to exempt POLs from CLIA.

By way of background, AACC is the principal association of 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 to help maintain high professional standards.

If you have any questions or 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


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