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New laws in Maryland closely monitor laboratories


Charles Campbell was better protected against unreliable labs than most Americans. Maryland laboratories have been closely monitored for years and tougher standards to minimize error and fraud went into effect in the late 1980s.

Parts of the Maryland inspection and licensing law, including annual tests for people who read Pap smears, served as a model for the federal lab improvement law that took effect in 1992.

Labs in Maryland must be inspected by a major accrediting organization or by the state. In a double check, state regulators reserve the right to investigate accredited labs either because of complaints or problems unearthed by accrediting teams.

Of 2,800 labs, including 2,300 in doctors' offices, Maryland regulators find major problems at a dozen labs each year. Of those, roughly two end up closing. In 1994, Tyco Clinical Laboratories in Catonsville closed after being convicted of Medicare fraud and violating quality standards.

The public seldom complains about labs, but complaints that do come in show that doctors and patients must be vigilant about the labs they use.

One lab diagnosed a high Bilirubin level for a patient in late 1993, but as far as the doctor could see, the patient wasn't jaundiced. A retest confirmed the error. Maryland regulators concluded it was an isolated incident but cited the lab, MetPath Inc., for failing to document the error, how it occurred and what it did to prevent a recurrence.

In another complaint, an angry consumer complained that MetPath lost his blood sample and billed him anyway: ". . . it will be a cold day in hell before I let another one of your employees stick a needle in my arm," he wrote. "I wasted time and effort, in addition to my blood, in dealing with your lab, and I still do not know if I'm even healthy."

In state inspections, the goal is to maintain quality.

Earlier this year, a state inspector found expired reagents -- liquids mixed with blood to obtain a reaction -- still being used by testers at National Health Laboratories in Chevy Chase. National Health merged with Hoffman Roche Laboratories this spring to become Laboratory Corporation of America Holdings (LabCorp) and is now the largest medical laboratory in the country.

LabCorp vice president Bill Bucher says the old reagents would have been picked up by internal quality assurance before they were used. "It posed no health care concern to patients," he says.

State inspectors also found MetPath using expired material to assess Pap smears and tissue samples in a 1991 inspection, the latest available, of the company's Rockville lab. Along with that problem, regulators found spilled blood, test machines poorly maintained, and no record of how many Pap smears were being read by each cytotechnologist, the person trained to examine cells on a slide.

MetPath's Rockville lab is being sued by a woman who says it failed to spot her cancer on a Pap smear. (It was later diagnosed by Maryland Medical Labs.) It is one of at least several suits in the late 1980s and early 1990s by Maryland women who developed cervical cancer after the Rockville lab cleared their Pap smears. At least one woman died.

MetPath, owned by Corning Inc. and headquartered in Teterboro, N.J., is the second-largest medical lab in the country and performs 70 million tests annually.

In Maryland several years ago, consumer complaints about MetPath led one managed-care company, HealthPlus, a division of New York Life, to drop its contract with the lab. "It was a combination of quality issues, complaints and contracting issues," says Christopher Doherty, spokesman for HealthPlus.

HealthPlus acted after at least one subscriber quit because he was forced to use MetPath.

In a letter to the company, the subscriber, Scott Allen, said he was appalled by "filthy" conditions and a receptionist-blood taker who didn't wear gloves at a MetPath blood collection site in Alexandria, Va. MetPath fired the employee, state records show.

Al Reynolds, vice president and chief operating officer of MetPath, says he is surprised that quality was an issue in the HealthPlus contract.

"We're the choice of the vast majority of managed care," he says. "We did have contracting issues, but not quality."

Last spring MetPath acquired the dominant lab in Maryland, Maryland Medical Laboratories Inc., and moved its Rockville operations to Maryland Medical in Baltimore. The company is now the largest lab serving Maryland.

MetPath also is the largest provider of lab services to managed-care networks in Maryland, with three times as many tests as any other lab and six times the number of patients, the company says.

Maryland Medical, long considered a top-flight lab, is one of MetPath's largest sites.

The Baltimore facility is sophisticated enough that 99 percent of tests on Maryland residents can be analyzed here rather than at MetPath's main lab in New Jersey. Much of the facility's instrumentation has been upgraded, and the entire lab is being expanded as a result of the merger.

In about 20 percent of tissue cases, the pathologists seek a second opinion inside the lab. If they are not unanimous, the sample is sent outside, usually to a specialist at Johns Hopkins Hospital or the Armed Forces Institute of Pathology.

MetPath and Maryland Medical Laboratory "have strong quality control to detect errors. It's when we find an error that laboratory didn't know about, it's a problem," says Michael Wajda, chief lab regulator in Maryland. He says the operative question from inspectors when they visit labs is "Do we want our family's tests done here?"

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