WASHINGTON -- Strict new regulations governing medical tests at hundreds of thousands of physician laboratories around the country, slated to take effect last year, will be delayed at least another year, raising fears that patients will continue to be subject to inaccurate and life-threatening tests.
"We're talking about people's lives here, we're not talking about issuing a postage stamp to honor a tree," said Sen. Barbara A. Mikulski, D-Md., co-sponsor of the Clinical Laboratory Improvement Amendments of 1988, annoyed that the Health Care Financing Administration has said it would not complete regulations until early 1992.
Although some of the tough new lab regulations -- ranging from personnel, quality assurance and proficiency testing -- are being put into effect in 12,000 commercial labs this year, according to officials, the HCFA has yet to complete a key regulation that would bring 300,000 to 600,000 smaller labs under federal review for the first time.
CLIA 1988 -- which was supposed to be effective Jan. 1, 1990 -- came in the wake of congressional testimony and news reports about the growing number of inaccurate lab results, particularly Pap smears. Upward of 40 percent of Pap smears results are inaccurate, resulting in undiagnosed cases of cervical cancer, according to testimony.
As much as 75 percent of Pap smears are conducted at commercial labs, while smaller labs account for 10 percent to 25 percent of Pap smears, according to congressional staffers and health experts.
Maryland has 215 commercial labs and as many as 2,000 physician labs, according to Tori Leonard, spokeswoman with the state Department of Health and Mental Hygiene.
"We're concerned that no matter where you go, your lab is in a system," said an aide to Senator Mikulski. "[Patients] assume their doctor has a good lab facility. But they die when he does not."
As a result of delays, said the aide, "people are dying or not getting good information" from labs.
Chris Berg, a Washington attorney whose wife, Patricia, died last June of cervical cancer after a now-closed commercial lab in Rockville misread a Pap smear, said such regulations are needed quickly. "The system didn't do what it was supposed to do and [my wife] died as a result of it," he said. "The women ought to have better guarantees that the Pap smears are being read and read correctly."
The Maryland senator said she expects to meet this week with Health and Human Services Secretary Louis W. Sullivan, who oversees the HCFA, to press for a speedier resolution to the lab regulations.
One HCFA official said one reason for the delay is that the administration has received some 60,000 comments to the proposed regulation and must answer each one. "There is considerable work to be done by analyzing these comments [and] coming up with a final regulation," said Thomas G. Morford, director of the HCFA's health standards quality bureau.
Meanwhile, the Office of Management and Budget said it would review the costs of the regulation, noting in the Bush administration's budget that user fees and other spending to comply with the regulations could "cost the private sector billions of dollars."
Some congressional observers say such a review will further delay -- or even scuttle -- the regulations. "It looks like one more monkey wrench," said Senator Mikulski.