Md. General in compliance, regulators say

Lab, hospital now meet standards for Medicare

Review sees key problems fixed

Site probed for months after faulty testing found

September 28, 2004|By Julie Bell | Julie Bell,SUN STAFF

Maryland General Hospital's laboratory, under scrutiny for months after workers there sent out hundreds of possibly inaccurate lab test results, has corrected major problems, federal regulators have found, and is again in compliance with conditions for participating in Medicare.

Regulators who inspected the hospital as a whole last month found that it, too, met the standards for participation in Medicare, despite some violations: a dirty kitchen floor, failure to keep a current nursing care plan for three of 51 patients sampled and a "very messy, disorganized and dirty" pharmacy that was largely cleaned up by the next day.

But overall, the Baltimore hospital considers the compliance findings good news.

"I am confident that Maryland General is today operating at the highest standards and with a stronger commitment to quality patient care than ever before," hospital Chief Executive Officer Colene Y. Daniel said in a statement last night. "As a result of the challenges confronting Maryland General's laboratory, our entire hospital has over the last few months been subject to as thorough and intense a review process as any hospital in the nation."

Daniel said the hospital has "taken giant steps over the last six months, and the hard work and focus on constant improvement will continue."

Maryland General and the state knew the hospital was back in compliance with Medicare's conditions weeks ago, but the hospital refused to release the most recent inspection reports. The state provided them yesterday in response to a request under the Public Information Act.

The hospital's laboratory was never kicked out of Medicare. But it stood to lose its ability to collect Medicare payments if it hadn't corrected the problems regulators found this year after laboratory workers alerted authorities.

Among the most serious findings were that workers had sent out HIV and hepatitis test results to more than 450 people even after equipment indicated those results might be inaccurate.

Inspectors' findings spawned a state Medicaid fraud investigation, subpoenas from the federal Health and Human Services' Office of the Inspector General and congressional hearings. More recently, departing state Health Secretary Nelson J. Sabatini has said his department is preparing legislation to reform laboratory oversight.

The College of American Pathologists, one of the private inspection agencies the government has been relying on to catch problems in laboratories, has also instituted reforms, including providing a toll-free number for laboratory whistleblowers to call anonymously.

The hospital, part of the University of Maryland Medical System, responded as well, retaining an outside consultant to run the laboratory, hiring more lab workers and bringing in Daniel to replace CEO Timothy D. Miller, who resigned. It also offered retesting to those who had HIV and hepatitis tests. The hospital has said the retesting confirmed that the original tests were overwhelmingly accurate.

The federal Centers for Medicare & Medicaid Services (CMS) informed the hospital in an Aug. 20 letter that it was back in compliance with Medicare's conditions. The agency is charged with ensuring hospitals and laboratories are properly inspected and eligible for Medicare and Medicaid payments.

For the most part, however, CMS relies on selected private accrediting agencies to inspect both, while it relies on state health department inspectors to double-check the private agencies' work. In this case, both the state and the federal government presumed Maryland General Hospital's laboratory was in compliance because it had been inspected and granted accreditation by one of those private agencies - the College of American Pathologists.

After the whistleblowers sparked state regulators to go in and look for themselves, they found numerous violations that have now been addressed. The college also reinspected, then suspended accreditation for two areas of the laboratory.

But late last month, the college lifted the suspensions. It left the two areas on probation, where they are likely to remain until after another, unannounced inspection. That one will take place once Park City Solutions, the consultant running the laboratory, leaves and turns the lab back over to Maryland General to run.

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