Hospital report notes troubles

Inspectors found faulty quality assurance plan

Md. General still got high marks

April 30, 2004|By Walter F. Roche Jr. | Walter F. Roche Jr.,SUN STAFF

A report last year by a national accreditation agency on the error-plagued laboratory at Maryland General Hospital gave the facility generally high marks even though inspectors found that it had not been following a required quality assurance plan for a year before the review.

The "confidential" accreditation report, which was released yesterday by the state Department of Health and Mental Hygiene, was completed by the College of American Pathologists in April 2003. At the same time, state inspectors later learned, the testing facility was experiencing major problems and was issuing test results for HIV and hepatitis even though instrument readings indicated that the tests might be wrong.

The quality assurance plan, handwritten notes in the report state, was "not in effect for approx. 12 months. Plan written but not adhered to."

Eleven pages in the report were left blank, indicating that various sections of the laboratory had no deficiencies. In the immunology section, for instance, the accreditation inspector checked the box indicating "no deficiencies." State inspectors found major problems this year in the immunology area including questionable procedures for tests on sexually transmitted diseases.

State Health Secretary Nelson J. Sabatini said late yesterday that the Office of Health Care Quality was reviewing the accreditation report and could not comment on its contents. He also said it appeared that some documents relating to the inspection were not released.

"We think that there are things that are missing and we're going to be asking for those records," Sabatini said.

The accreditation report was sent to the state after Sabatini threatened to revoke the approval for 123 medical labs in Maryland that were approved by the same Illinois-based agency. The nonprofit College of American Pathologists had refused to release the report, contending that it was confidential.

Agency officials have stated that at the time of the April 2003 inspection, they did not have enough information to detect the widespread problems that were later uncovered.

Prompted by a whistleblower's complaint detailing serious testing problems, state inspectors found serious deficiencies this year in the laboratory at the 243-bed facility, which is an affiliate of the University of Maryland Medical System. State inspectors concluded the lab was understaffed and "rife with equipment malfunctions."

The hospital is in the midst of implementing a state-ordered corrective action plan, and the hospital president and two top lab officials have resigned in the aftermath of the critical state inspections. Maryland General also is facing a Medicaid fraud investigation by the state attorney general and a whistleblower lawsuit by the former head of its anesthesiology department.

The report by the accreditation agency was issued only weeks after a former lab technician, Kristin Turner, contends that she was infected with HIV and hepatitis when a blood analyzer malfunctioned and splattered her face with infected blood specimens. Turner has sued the hospital and the equipment manufacturer, Adaltis US Inc.

The report released yesterday, much of it handwritten and including spelling errors, includes positive comments about many of the lab operations though some problems were mentioned.

"Overall everyone was helpful and knowledgeable," a summary page states. "The lab has a very high personell (sic) turnover; however the lab appears to be headed in the right direction."

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