A bill on its way to the president requires that all clinical medical laboratories, including those in physicians' offices, be certified by the Secretary of Health and Human Services or private accrediting bodies appointed by him.
The bill, "Clinical Laboratory Improvement Amendments of 1988," passed the Senate Tuesday night. Sen. Orrin Hatch, R-Utah, was principal co-sponsor of the bill, designed to reduce the staggering laboratory error rate.The errors have been most apparent in Pap smears, a test for the early detection of cervical and uterine cancer. Erroneous results have skyrocketed, causing extensive grief to many misdiagnosed women.
"I am very happy to see something done about this situation," Hatch said. "The act is a balance between quality assurance and public and private sector control."
This is the first time physician office labs will have to obtain certification and ensure their employees have proficiency in testing.
The act, however, has been endorsed by the American Medical Association and by many Utah physicians, who agreed with Hatch that quality testing is important.
Several initially opposed the bill, seeing it as another interference from big government. They relaxed their resistance when Hatch was able to amend the bill to allow the secretary to approve private accrediting bodies to certify the labs.
Exempted from certification are those labs that perform tests that have an "insignificant risk" of an erroneous result, or for which the secretary has determined that there's no reasonable risk of harm to the patient if performed incorrectly.
If signed by the president, the law will require the secretary to set standards to ensure consistent performance by the certified labs. The laboratories will have to maintain quality assurance and quality control-programs, maintain records and equipment and employ qualified people.
The bill requires that the labs be tested quarterly for compliance with proficiency standards. It also grants the secretary the authority to make both announced and unannounced inspections.
If a lab fails to comply with the standards, its personnel must undergo training.
The bill gives the secretary the authority to require a laboratory to take corrective action if it is in substantial non-compliance with the licensing provisions. The secretary can also impose civil fines and/or seek injunctive relief when a lab is engaging in practices that present an imminent and serious risk to human health.
The results of the proficiency testing will be available to the public. Each year the secretary will publish annual lists of laboratories that have been subject to various sanctions or penalties.