Second hospital hearing is today

Regulatory issues raised at Md. General are focus

System seen as flawed, sluggish

Whistleblower protection, coordination are concerns

July 07, 2004|By Julie Bell | Julie Bell,SUN STAFF

When Maryland General Hospital gave more than 450 patients lab-test results despite indications they might be inaccurate, it did more than spur state and federal investigations.

The hospital's actions sparked a congressional hearing into the nature of hospital accreditation and regulation, reigniting a debate over whether regulators and accrediting organizations are too collegial, lenient and slow to act.

"This is an issue much bigger than Maryland General," U.S. Rep. Elijah E. Cummings, a Baltimore Democrat who pushed for hearings, said at a recent news conference in front of the city hospital.

The broad questions raised by the case of Maryland General, and a regulatory response widely acknowledged to be sluggish and flawed, will be in the spotlight again today at the second of two congressional hearings before a House Government Reform subcommittee in Washington.

At issue in part will be whether new protections are needed for hospital whistleblowers and how to ensure that the private and government agencies involved in ensuring patient safety talk with each other - and act - immediately.

The hearing comes as the General Accounting Office, the investigative arm of Congress, is putting the finishing touches on a report expected to suggest a number of improvements in the way hospital accreditation is handled.

At the same time, state Health Secretary Nelson J. Sabatini is calling for legislative changes that would give his inspectors clear authority to go into hospitals, even if they haven't received a complaint. In the case of Maryland General, the state received a complaint in 2002 but failed to uncover the problems or pass the complaint on to accreditors.

Nonetheless, Sabatini said, there is a hole in the system. Currently, hospitals or laboratories accredited by certain private agencies, such as the College of American Pathologists (CAP), are deemed to be eligible for Medicare and in compliance with applicable state licensing regulations. CAP, for example, reaccredited Maryland General's laboratory after an inspection in April last year without finding the problems that state regulators - tipped off by a whistleblower - later found were in full throttle at the time.

"Right now, I have no basis to go into a hospital except to investigate a complaint, and absent that complaint, I have to assume they're in compliance with all the licensing requirements," Sabatini said yesterday.

State Sen. Paula C. Hollinger, chairwoman of the Education, Health and Environmental Affairs Committee, said she is concerned about the same problem. The state formerly inspected hospitals regularly. But the General Assembly decided years ago that the process duplicated what accrediting organizations were doing and did away with the inspections, she said.

"Now we have an example of a ramification" of changing the law, she said, "and it's not a very pretty picture."

Even if state law isn't changed back, Sabatini said he is working with CAP to come up with more rigorous accreditation standards for Maryland hospital laboratories, as well as a CAP process that would allow state inspectors to go along.

Sabatini, who has a scheduling conflict, is sending Carol Benner, head of the state Office of Health Care Quality, to testify at today's hearing. Also testifying will be Dr. Mary E. Kass, president of the American College of Pathologists; Edmond Notebaert, president of Maryland General's parent, the University of Maryland Medical System; and a representative from Adaltis USA, the manufacturer of a lab-sample machine that Maryland General employees allege repeatedly malfunctioned.

The most emotionally riveting testimony, however, likely will come from Kristin S. Turner. The former Maryland General laboratory worker says she contracted HIV and hepatitis C in a blood-splashing accident that she claims was caused by a faulty specimen-testing machine. Her lawsuit against Adaltis USA is pending.

But she is also backs changes in how hospitals are accredited. "It's really important to talk about what can be done differently," she said.

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