Impact of CLIA on physician office laboratories in rural Washington State.

BACKGROUND

Despite physician concerns to the contrary, the United States Health Care Financing Administration (HCFA) estimated that its regulations implementing the Clinical Laboratory Improvements Act of 1988 (CLIA) would cause few physician office laboratories to either close or reduce testing.

METHODS

A survey requesting information about tests performed before and after the implementation of CLIA was developed and mailed to all members of the rural practice section of the Washington Academy of Family Physicians.

RESULTS

There were significant changes in the complexity of laboratory tests performed before and after implementation of CLIA. Among independent family physicians' office laboratories, waived-status laboratories (i.e., those performing only the simplest and lowest risk tests) increased from 1% to 34%, laboratories performing tests of moderate complexity declined from 76% to 53%, and laboratories performing high-complexity tests declined from 23% to 13%. The shift to waived status was more pronounced among solo and small group physicians in smaller communities.

CONCLUSIONS

HCFA seriously underestimated the impact of CLIA on rural physician office laboratories.