State orders Md. General to fix its lab

Baltimore hospital faces $10,000-a-day fines if it fails to correct problems

Test results issued despite errors

Equipment malfunctions, inadequate training and sample mishandling noted

April 03, 2004|By Walter F. Roche Jr. | Walter F. Roche Jr.,SUN STAFF

Citing a laboratory operation "rife with equipment failures" and other serious deficiencies, state health officials ordered Maryland General Hospital yesterday to take immediate corrective action or face fines of up to $10,000 a day.

Patients were put at risk because the lab was so poorly run that "suspect and possibly erroneous test results" were issued, according to the state report. It notes "lack of awareness" by top hospital officials of lab-related problems that the report said ranged from bacteriology to immunology to a failure of the hospital's "governing body" to act.

The report indicates that the testing problems in the city community hospital, an affiliate of the University of Maryland Health System, are far more widespread than had previously been indicated. A limited inspection in January triggered by a whistleblower's complaint showed that about 460 HIV and hepatitis C test results were issued despite indications that they might be invalid.

Last night a hospital official said that questionable HIV and hepatitis results might have been given to 2,169 patients and that letters will be sent offering them free re-tests.

Immediate steps ordered by the state include hiring quality-control professionals, restricting lab testing that the hospital does for other health care facilities such as nursing homes, and submitting evidence that all patients "who may have been affected by inaccurate testing have been notified and offered retesting."

The report, based on an inspection carried out March 16-24, cites questionable test results for HIV, hepatitis B and C and sexually transmitted diseases such as chlamydia and gonorrhea. In several cases, inspectors found the hospital used chemical reagents for a variety of routine tests after they had passed their expiration date.

Hospital spokesman Lee Kennedy said the 243-bed facility takes the inspectors' findings seriously and is moving to comply.

"This type of performance is unacceptable. We are committed to addressing these matters and delivering the quality of care that our patients demand and deserve," Kennedy said.

"For the past three weeks, we have been working virtually round the clock to ensure that Maryland General's laboratory operations going forward are sound and operating in accordance with all appropriate regulations."

Many deficiencies

Other deficiencies identified in the report include a lack of sufficient staffing and failure to adequately train lab personnel. The lab problems were so bad that even when two tests on the same samples provided opposite results, the hospital failed to investigate the cause, according to the report, compiled by state regulators, the federal Centers for Medicare and Medicaid Services and the Joint Commission on the Accreditation of Healthcare Organizations.

The report also confirms that the hospital mishandled tests conducted for Legionella bacteria on five patients at a Northwest Baltimore nursing home. The hospital previously acknowledged the test results were issued despite being invalid and has offered retests.

In a letter to hospital President Timothy Miller, Carol Benner, director of the state Office of Health Care Quality, wrote, "The deficiencies which are enclosed with this letter are serious in nature and require immediate corrective action. ... If the hospital fails to correct these serious deficiencies, the department may impose a civil money penalty of $10,000 per instance or $10,000 per day."

The inspection report shows that lab problems continued even as state officials were conducting their inspections. On Jan. 14 of this year, a few days after state inspectors arrived at the hospital, a technician misread a test result as positive for HIV, when it was negative.

`I'm very disturbed'

"Quite frankly, I'm very disturbed," said State Health Secretary Nelson J. Sabatini in a telephone interview late yesterday. "It shows pervasive problems."

He said the pattern of problems at Maryland General, which date to inspections conducted in 2002, indicate a systemic problem with hospital health care inspections done by a combination of government and private organizations.

"When is the last time you heard that the federal government really did something? ... When did they go out and tell somebody that they had to shut down?" Sabatini said. "Test results are being lost. It shows the inadequacy of the whole process to assure quality. It's the full employment act for bureaucrats."

According to the state report, the problems in Maryland General's lab date back more than a year. But even when facility officials promised corrective action, a subsequent state survey showed many of the promised actions had not been taken.

"From at least August of 2002 to February of 2004 the laboratory was rife with equipment failure and malfunctions, training and communication problems with staff, and lost or mishandled specimens," the report states.

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