U.S. Proposes Tougher Rules for Clinical Labs

WASHINGTON — The federal government proposed tougher uniform standards Tuesday for clinical laboratories in an effort to ensure the accuracy of Pap smears and other tests.

The rules proposed by the Department of Health and Human Services, published in the Federal Register, apply to the 12,000 labs that are federally regulated either because they do work under Medicare or Medicaid or engage in interstate commerce.

The practical effect is to cover virtually all commercial labs, except those in physicians’ offices.

The 90-day public comment period outlined in Tuesday’s notice also solicits comments on whether the uniform standards should apply to physicians’ office labs once they are covered by federal standards beginning in 1990.

Standards Can Vary

Under current law, labs must participate in an approved program of proficiency testing to receive Medicare or Medicaid funds. The standards can vary from state to state and between groups that conduct the proficiency exams, such as the College of American Pathologists and the American Assn. of Bioanalysts.

“At present, there are no uniform or minimally acceptable federal standards for proficiency testing programs,” said William Roper, head of HHS’ Health Care Financing Administration.

The new standards proposed include:

--A uniform national proficiency testing program developed by the Centers for Disease Control with specific standards for such things as throat and urine cultures and glucose and cholesterol tests.

--Options for required proficiency testing for Pap smears and tougher rescreening requirements for negative Pap smears, especially those performed for women in high-risk categories.