ANNAPOLIS -- Recent reports of the dangerously slipshod performance of many private medical laboratories -- particularly those that evaluate Pap tests for cervical cancers -- are generating a flurry of bills to strengthen state regulation of such labs.
One bill has been introduced and several are being drafted by legislators disturbed about recent reports that lab tests fail to detect one-quarter to one-third of cases in which cancerous or precancerous cells are present in Pap test slides.
The American College of Obstetricians and Gynecologists estimates that Pap results are wrong 20 to 40 percent of the time when cancer or a precursor condition is present. A report in The Wall Street Journal in November attributed the inaccuracies to physician carelessness and to the shoddy performance of high-volume "Pap mills."
At labs around the country, the Journal reported, overworked, underpaid technicians are analyzing many more Pap slides than they can handle accurately. Some lab technicians visually evaluate 200 or more patient slides per day, according to the Journal report -- more than four times the number recommended by medical experts.
Cervical cancer, considered highly curable if caught early, kills about 7,000 of the 60,000 American women who get it each year. Some of those deaths occur because of erroneous lab results, medical experts say.
Last week on Capitol Hill, where at least three congresssional committees are investigating the problem, Sen. Barbara A. Mikulski (D-Md.) called on Gov. William Donald Schaefer to toughen regulations, suggesting that lab accuracy should be tested yearly. Also, Mikulski said she may seek federal legislation to regulate labs.
The Schaefer administration has not taken a position on increased regulation, but state health department officials are working with legislators who want to see the law strengthened.
"It's a national problem, and we understand from the state health department that it's a problem here in Maryland," said Del. Joan Pitkin (D-Prince George's). Pitkin said she is readying a bill that, among other things, calls for unannounced proficiency tests by the state. Pap smears would be sent to labs for analysis, and the labs would then be graded on their level of accuracy.
Currently, New York is the only state that does such testing, and it closes labs with high error rates that fail to take corrective action.
There are 72 labs in Maryland that do Pap testing and nine out-of-state labs that hold permits to do testing for Maryland physicians. Dr. John DeBoy, chief of the laboratory division of the state Department of Health and Mental Hygiene, said the state inspects labs once a year.
DeBoy said that he does not know of any instance in which the state has found "major deficiencies" that have required closing a lab.
"We do not have these Pap mills in Maryland," DeBoy said. He added, however, that he does not necessarily think that the lab error rate is lower in Maryland than nationally, and he said he supports stronger regulation.
Other provisions of Pitkin's bill, which are also contained in a bill sponsored by state Sen. Ida G. Ruben (D-Silver Spring), would limit the number of Pap slides a technician could examine to 60 per day and would require that technicians take a five-minute break every hour.
One of principal reasons for lab errors is that many technicians are pushed to get through a high volume of tests daily -- with some paid on the basis of the number of slides they examine. Some lab workers even take slides home to screen, a practice that Pitkin's bill would outlaw.
Analyzing Pap smears is tedious work: the technician should microscopically examine several hundred cells on each slide. Abnormalities can easily be missed if the technician is tired, rushed or overworked.
Pitkin and Ruben want the law to state that a lab must keep Pap smears for at least two years so that a patient can recover the slide for diagnostic reasons as well as for purposes of filing a lawsuit.
Pitkin and other legislators are proposing that the state take a more aggressive role in regulating labs in physicians' offices, which are now largely unmonitored. Many doctors find that they can augment their incomes by doing simple hematology or urinalysis tests in their offices, although these office labs do not perform Pap tests.
Under current law, the state licenses, monitors and inspects only those office labs used in group practices of four or more physicians. Labs in smaller practices do not have to be licensed.
DeBoy said a health department survey showed that 4,000 of the state's 11,000 physicians do lab work in their offices but that only 100 office labs are licensed.