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Date:  September 7, 1995
For Release:  Immediately
Contact:  HCFA Press Office (202) 690-6145

Surveys Show Improvement in Physician Office Labs

Out of 2,186 physician office labs which have undergone two surveys, serious deficiencies were found in only 129 of the labs, a decrease of 26 percent. In addition, the total number of deficiencies found in the second survey decreased 23 percent. And there was a 51 percent drop in the average number of deficiencies per lab (from 5.5 to 2.7 deficiencies per physician lab surveyed).

HCFA Administrator Bruce C. Vladeck said the data indicate that the CLIA law is having a positive effect.

"Our approach to CLIA has been educational, giving labs feedback about quality problems of which they were often unaware," Vladeck said. "CLIA is helping labs make quality improvements, leading to more accurate test results and better patient care."

The new data come from laboratories, including the physician office labs, that had undergone a second round of CLIA inspections by mid-August 1995. CLIA requires the inspections, along with other quality standards, for all clinical labs that perform tests of moderate or high complexity.

Other labs, including 59 percent of physician office labs, are exempt from regular surveys. These include 35 percent of doctor office labs that do only simple tests, and 24 percent of these labs that limit moderate complexity testing to certain tests performed as part of a patient exam.

About 152,000 clinical labs are registered under CLIA, of which about 89,000 are in doctors' offices.

"With physician office labs making up 59 percent of the nation's clinical laboratories, improving the quality of testing is very important to patient care," Vladeck said. "Erroneous test results can lead to improper diagnoses and treatment, which may ultimately cause unnecessary injuries and deaths. 'False positive' and 'false negative' lab results also produce higher costs, both for the patient and the health care system as a whole."

Prior to 1988, only a subset of laboratories --mostly large commercial labs -- were subject to federal regulation. For most physician office labs, there was no quality oversight at all. The current version of CLIA was adopted in 1988 (superseding prior law) to assure that all labs meet minimum quality standards, based on the complexity of tests they perform. CLIA's purpose is to help laboratories improve their testing accuracy, protecting patients in whatever setting the testing occurs.

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NOTE: Tables presenting the preliminary data are available from the HCFA Press Office, (202) 690-6145