State insists on lab reports

Md.'s health secretary warns accrediting group refusing to release records

Facts on Md. General sought

Sabatini might revoke automatic approval for about 120 medical labs

April 27, 2004|By Walter F. Roche Jr. | Walter F. Roche Jr.,SUN STAFF

Maryland's top health official is threatening to revoke the automatic approval for about 120 medical laboratories across the state unless a national accrediting organization agrees to release its inspection reports on those facilities to state regulators.

In a letter sent yesterday to Peter Mockridge, head of the College of American Pathologists, state Health Secretary Nelson J. Sabatini gave the organization a Friday deadline to respond to his demand for the release of inspection reports.

He said the Illinois-based nonprofit has thus far refused to provide the state with copies of its inspection reports for Maryland General Hospital, a 243- bed facility cited recently by state and federal regulators for serious deficiencies in its laboratory operations.

During the period that state inspectors say there were serious problems in the hospital lab, CAP gave the facility its top rating.

According to Sabatini's letter, CAP officials told Carol Benner, head of the Maryland Office of Health Care Quality, in a voice mail message late last week that the organization would not release the Maryland General report "because the college does not have a relationship with the state of Maryland."

"I believe you may be mistaken about this and strongly suggest you review your position and contact us immediately," Sabatini wrote.

Until now, Maryland has automatically approved labs that are inspected and certified by CAP. If the state Department of Health and Mental Hygiene decides not to recognize CAP certification, medical laboratories would have to undergo state inspections, too.

Patty Flesher, an official in CAP's communications department, said late yesterday that the letter had been received.

"We are going to look into it and respond later this week," Flesher said.

Md. General Hospital

The letter from Sabatini is the latest development in a regulatory dispute triggered by problems at Maryland General that became public last month.

Maryland General was cited by the state for issuing about 460 HIV and hepatitis test results over a 14-month period despite instrument readings showing that the test results might be in error.

The hospital, an affiliate of the University of Maryland Health System, has agreed to provide new tests to more than 2,000 patients, and last week submitted a corrective action plan to the state.

The laboratory problems also led to the resignation of Maryland General's president and chief executive, Timothy D. Miller, and its top laboratory officials.

Sabatini has been highly critical of Maryland General and of the inspection system under which the Joint Commission on Accreditation of Healthcare Organizations and the pathologists group inspect and certify health facilities under a federally sanctioned process called "deeming."

Sabatini contends that the current system limits the ability of state inspectors to monitor hospitals as closely as they do nursing homes and other licensed health facilities.

Under the system, labs are deemed to be acceptable to the state if they have been accredited by the national agency. Maryland inspectors can conduct reviews of hospitals only in response to a specific complaint. It was a complaint from whistleblower Kristin Turner, a former lab worker, that sent state inspectors into Maryland General early this year.

Sabatini's warning

In a brief interview yesterday, Sabatini said that the refusal of the pathologists group to provide the inspection report from 2002 came as a surprise.

"So we told them, if they won't release their report, then we won't accept their certification," Sabatini said, adding that state inspectors would then take over the responsibility.

In the letter, Sabatini said that the state "for years accepted CAP accreditation in lieu of an on-site survey. ... This relationship not only implies but demands that CAP share its survey information with the licensing agency upon request.

"If CAP chooses to deny us access to its information, we will have no choice but to withdraw deemed status from all CAP- accredited laboratories in Maryland," the letter states.

According to information on its Web site, CAP accredits 123 laboratories in Maryland - including those operated by the American Red Cross, Anne Arundel Medical Center, the Greater Baltimore Medical Center, Harbor Hospital, John Hopkins Bayview and hospitals in Easton, Salisbury and Cheverly.

The highest rating

Last July, records show, the College of American Pathologists gave Maryland General its highest rating, "Accredited with Distinction," based on a review conducted in mid-April.

Subsequent state inspections found serious problems in the lab dating to August 2002. Former employees in the laboratory have since publicly disclosed a series of internal complaints dating to 2001.

In addition to the questionable HIV and hepatitis tests, state inspectors have found evidence of botched tests for Legionella bacteria and sexually transmitted diseases.

A worker's complaints

Turner, the former worker whose complaints prompted the Maryland General probe, has filed suit alleging that she became infected with hepatitis and the human immunodeficiency virus, which causes AIDS, when a laboratory analyzer, known as a Labotech, malfunctioned and spattered her with infected blood samples.

Adaltis USA, the manufacturer of the testing equipment, filed a response in U.S. District Court late last week denying Turner's claim that her infection was the result of a malfunction.

Maryland General also has asked that Turner's complaint be dismissed, contending that she lost her right to sue when she filed a workers compensation claim, which the hospital did not dispute.

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