Testing violations shut down health lab

State and federal officials see failures as danger to public

3,000 patients are offered retesting

Medical accrediting agency ordered to explain its methods

August 27, 2004|By Dennis O'Brien | Dennis O'Brien,SUN STAFF

Maryland health officials are reviewing the way many of the state's medical labs are regulated after finding such serious problems at a Rosedale facility that 3,000 patients are being offered retesting to check the accuracy of results for sexually transmitted diseases.

Inspectors discovered so many violations of state and federal regulations at Reference Pathology Services of Maryland that regulators ordered the operation to shut down and issued a scathing report.

One federal official concluded that the lab poses "an immediate jeopardy to the health of its patients and that of the general public."

Maryland officials have asked the accrediting agency that signed off on the independent lab's operations in 2003 - the College of American Pathologists (CAP) - for an explanation of its methods.

They say the same agency has accredited 150 medical labs in the state, including one at Maryland General Hospital where investigators found similar violations of testing procedures this spring - prompting the hospital to offer free HIV retesting to hundreds of patients.

Maryland officials met with CAP representatives in June and asked for details of the group's accrediting process. They are reviewing thick files of information that CAP supplied this week, said Carol Benner, chief of Maryland's Office of Health Care Quality.

"We'll be looking at their standards, their surveying process, to see if they're equal to ours," she said. "We've asked for samples of their reports, what their sanctions are, how they train their surveyors, the composition of their surveyor teams and what conflicts of interest there might be."

Benner said her review of CAP should be completed in about two weeks.

License requirement

Under state and federal law, medical labs seeking a Maryland license must either submit to a state inspection or seek accreditation from three independent agencies, including CAP.

Of roughly 2,000 labs in Maryland, Benner said, about 400 - mostly smaller operations - submit to a state review rather than pay costly accrediting fees.

The review of the Rosedale lab comes after state inspectors turned up several violations this spring at the facility, which is in the 9400 block of Philadelphia Road. The violations began as far back as October 2002 and continued at least until April. They include:

Failure to report sexually transmitted disease cases to local health departments.

Failure to report cervical cancer cases to a state cancer registry, which uses the information to determine how state cancer funds are spent.

Failure to conduct required controlled testing on equipment and materials to ensure they work properly. This failure to certify its equipment, officials said, is what casts doubt on the results of so many tests.

State inspectors also uncovered evidence that in roughly 6,000 cases, the lab reused filters in a cervical cancer test kit that should have been discarded after. CAP investigators reached the same conclusion, listing reuse of equipment as a reason for revoking Reference Pathology's accreditation in May.

In papers filed with the state, the lab's owner said the filters were not reused.

Dr. Jesus Socrates, the lab's medical director and a pathologist at Hanover Hospital in Hanover, Pa., declined to be interviewed, saying only that he was hired recently to correct problems at the lab.

He referred questions to the lab's owner, Timothy Frank, who did not return several phone calls this week.

Business for sale

There were no patients evident at the lab's offices yesterday. The modest one-story office could be accessed only by visitors who rang a doorbell and were admitted by a receptionist activating a buzzer lock.

Benner said the lab is for sale. If it is sold, she said, state regulators will prohibit the current management from having any role in its future operations.

Inspectors visited the lab in May and June after a whistle-blower - whose identity is being withheld - alerted state authorities and CAP to potential problems.

Benner said there's no way to know whether incorrect results were given to any of the 3,000 patients being offered retesting. She said those results are not yet available.

Experts say that even the prospect of inaccurate results on tests for a sexually transmitted disease can be emotionally draining.

"There can be a tremendous psychosocial effect on a person from the outcome when a test is positive," said Charlotte Gaydos, an infectious disease specialist at Johns Hopkins Medical School.

License suspended

After the inspections turned up deficiencies, Socrates, the lab's medical director, initially agreed to make improvements. But the lab failed to comply, and the state suspended its license June 30.

After negotiations, the lab agreed to close Sept. 5 and offer free re-tests to 3,000 patients for chlamydia, gonorrhea and human papillomavirus - the last a sexually transmitted disease that increases the risk for cervical cancer, Benner said.

It was not clear during what time period those patients were originally tested.

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