BALTIMORE — Maryland General Hospital has filed its plan to correct problems at its laboratory that led to hundreds of patients getting suspect results on HIV and hepatitis tests.
The hospital filed the plans last week with the Maryland Office of Health Care Quality and the Centers for Medicare and Medicaid Services, according to a news release from Maryland General.
Among actions Maryland General has taken is not accepting new laboratory contracts with health care facilities. Maryland General also is evaluating current contracts with an eye toward reducing the number of clients for which it provides testing.
Other corrective actions include:
• Submitting monthly progress reports to the state agency.
• Hiring a full-time lab quality assurance professional.
• Hiring a lab technical supervisor approved by the state agency.
• Requiring lab staff to undergo a training and competency program.
The discovery of widespread procedural and management problems at Maryland General’s laboratory illustrates the need for closer monitoring by state and federal regulators of all state hospitals and laboratories, state health secretary Nelson Sabatini said.
“The system is broken and needs overhaul,” Mr. Sabatini said. “In the case of Maryland General Hospital, the state’s regulatory system was not equipped to adequately address problems that only came to light after a complaint was filed.”
Unlike nursing homes, which are inspected by the state, hospitals in Maryland and most states are regulated primarily by accreditation agencies.
In Mr. Sabatini’s view, the hospital system is largely reactive. The state conducts comprehensive inspections of nursing homes once a year. State law requires an investigation of any complaint within 48 hours. In contrast, Mr. Sabatini said the state is not allowed to inspect hospitals except to investigate a complaint.
“I’d like to see the state adopt more regulations allowing for much more aggressive oversight, to make sure hospitals put in place systems that guarantee quality care,” Mr. Sabatini said. “I don’t believe the current system is something we can be proud of.”
Mr. Sabatini said state and federal inspectors are dependent on reports from whistleblowers, such as the former lab worker whose e-mail to state authorities early this year led to the discovery of widespread problems at Maryland General’s laboratory.
Other lab workers have said they complained two years ago about problems at the lab to hospital administrators and to state authorities, but got little or no response. The health secretary acknowledged the earlier complaint but said it was too general and state inspectors did not find serious problems when they conducted a survey.
The difficulty of detecting deficiencies at the Maryland General lab is symptomatic of a wider problem, the health secretary said.
“The only way we can go in and really be aggressive is in response to a complaint — and it has to be very, very precise and specific,” Mr. Sabatini said. “Absent that, the state and federal government have to assume that if an institution is accredited, there are no problems there.”
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