Senate Panel Backs Stricter Medical Lab Rules

A Senate panel on Wednesday approved legislation designed to tighten standards for medical laboratory testing, including pap smear tests to detect cervical cancer in women.

The measure, approved by the Labor and Human Resources Committee on a voice vote, would require annual inspection and licensing of all laboratories that perform clinical lab testing, including those in physicians’ offices.

Similar legislation passed the House Energy and Commerce Committee on Tuesday. Senate and House floor action is expected in the fall, following the congressional recesses.

The bill also would:

--Establish a means for testing the proficiency of individual lab technicians and judging the overall performance of laboratories. Labs also would be required to limit the workload--tests performed per day--for employees reading pap smears.

Would Bill Patients

--Require laboratories to bill patients directly for tests performed, rather than through the physicians, to ensure that doctors choose laboratories based on quality and not cost.

--Establish tougher, uniform quality assurance standards for all lab testing.

The regulations would be enforced by the Health and Human Services Department.

Sen. Barbara A. Mikulski (D-Md.), who along with Sen. Brock Adams (D-Wash.) was a chief sponsor, said after the committee acted: “There are too many labs out there where overworked, undersupervised technicians are making too many errors--errors that mean the difference between life and death. We cannot allow this practice to continue.”

20% to 40% Inaccurate

Mikulski and Adams held a hearing in January in which testimony was given that as many as 20% to 40% of pap smear test results are inaccurate, resulting in undiagnosed cases of cervical cancer.

The testimony indicated that the cause of the inaccuracies was unregulated medical labs and “pap mills”--huge labs that process thousands of tests a day with virtually no quality assurance standards.

“Now, when someone uses a lab, whether it’s for a pap smear, a cholesterol test or a pregnancy test, they will know that the results will be accurate and reliable,” Mikulski said.