09/02/97

Senator Barbara Box
United States Senate
Washington, DC 20510

Dear Senator Boxer:

The Coalition to Preserve Safe Patient Testing 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) – 55 percent of all laboratories in the United States – from any federal oversight. This means that 86,000 physician practices 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) 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, safe laboratory practices when performing patient testing. Our groups continue to support this principle and believe that CLIA ’88 has helped improve overall laboratory performance.

 

Some argue that regulating POLs is unduly burdensome. However, the inspection data from the Health Care Financing Administration (HCFA), the federal agency responsible for administering CLIA, indicates that POLs have a much higher inspection deficiency or citation rate than other facilities. The inspection data also indicates that CLIA is helping remedy these problems and that the quality of POL testing is improving under CLIA. During the last two year inspection cycle, the number of POLs cited for failing to perform quality control was reduced by half, from 33 percent to 16 percent, respectively. However, there is still much work to be done.

 

Also, previous concerns that CLIA would hinder patients’ access to laboratory services have been unfounded. A June 1995 HHS Office of the Inspector General (OIG) report: CLIA’s Impact on the Availability of Laboratory Services, stated that "the number of physicians with access to an in-office laboratory has remained unchanged since 1988." Therefore, the physician’s ability to provide testing for his/her patients has not been compromised. In addition, rural residents continue to have access to laboratory testing equivalent to their urban counterparts. The OIG data demonstrates that CLIA has not diminished patients’ access to laboratory services.

 

We request that you oppose a POL exemption from CLIA ’88. If you have any questions regarding CLIA ’88, 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
  • Association of State and Territorial Public Health
  • Laboratory Directors
  • Clinical Laboratory Management Association
  • International Society for Clinical Laboratory Technology
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