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Children's Hospital scrutinized

Patient's case spurs questions, leads to review by Mass., US

Federal and state health officials are launching a broad review of clinical services and other activities at Children's Hospital in Boston in response to a recent episode involving a child's medical treatment that raised questions about the hospital's "capacity to render adequate care," according to a letter that federal regulators sent to the hospital.

Hospital executives and state and federal officials declined to describe the episode, which is under investigation by the state Department of Public Health. According to the letter from the federal agency that regulates Medicare and Medicaid, the state investigation has revealed violations of federal standards in the areas of "medical staff," "nursing services" and governance issues. The agency provided a copy of the letter to the Globe under a Freedom of Information Act request.

On Sept. 4, Richard Shaw, chief of the Boston branch of the Center for Medicare & Medicaid Services, wrote to hospital president Dr. James Mandell that his agency was concerned about deficiencies "of such serious nature as to substantially limit your hospital's capacity to render adequate care."

Such sweeping federal reviews typically follow significant problems. One serious patient-care incident Children's has recently reported to the state involved the death of an epilepsy patient who suffered a seizure on May 11 while undergoing long-term monitoring of seizures, in which electrodes placed inside the skull map the location of seizures within the brain.

State officials slated that occurrence for further investigation, but yesterday state and federal officials declined to say whether it was that probe that triggered the federal review.

Children's officials said they would make public their plan to correct any problems found in the state investigation and emphasized the high-quality care at the hospital.

"We want to assure the public that Children's is a safe and outstanding place for children and their families," said spokeswoman Michelle Davis in a statement.

The federal review will scrutinize the hospital's compliance with all the major standards that hospitals are required to meet to serve Medicare and Medicaid patients, in areas as wide-ranging as emergency services, radiology, pharmacy and laboratory services, medical record-keeping, personnel policies, and even organ transplant procurement.

If Children's does not correct the problems already found or any others found later, it could lose the right to collect payments from Medicaid, the federal-state program that insures the poor and covers 17 percent of Children's patients. Medicare, which covers the elderly and a few pediatric diagnoses, accounts for 1.5 percent of Children's patients.

Earlier incidents that triggered similar investigations of Boston-area hospitals include the death of Globe columnist Betsy Lehman from a chemotherapy drug overdose at Dana-Farber Cancer Institute in 1994 and two maternal deaths at Newton-Wellesley Hospital in 1997, said Roseanne Pawelec, spokeswoman for the state Department of Public Health, which conducts the probes on behalf of the federal agency.

Such reviews have occurred about 15 to 20 times in the past 10 years in Massachusetts, and typically result in hospitals making changes to clinical standards and other systems to address problems and improve patient care. For instance, new dosage safeguards were introduced at Dana-Farber, and at Newton-Wellesley the hospital significantly increased its supervision of medical residents, or doctors in training.

If the state finds Children's at fault in the May death of the epileptic patient, it would be Children's second public rebuke from health officials for the care of a neurosurgery patient.

Children's was rocked two years ago when state officials found that "systems problems" there contributed to the death of toddler Taylor McCormack, who suffered fatal brain damage while she waited overnight for surgery. Her neurosurgeon did not answer his pager when residents sought his help, key laboratory tests were not noted in her medical record, and she was not properly monitored, state officials found.

In the death of the epileptic patient this spring, the child suffered a seizure that lasted 30 minutes even after clinicians administered medication in an effort to stop it, according to the hospital's report to the state. The patient was intubated -- a procedure to assist with breathing -- and sent to surgery to remove the electrodes, but suffered irreversible brain damage over the next 36 hours and died.

Typically, in seizure monitoring, patients' antiseizure medication is reduced so doctors can observe the seizures under controlled hospital conditions, to help diagnose the condition or prepare the patient for surgery to remove parts of the brain affected by seizures.

In the state investigation of the unspecified episode that triggered the Medicare review, Children's was found to be in violation of several federal standards in areas relating to medical staff, nursing services, and governance. The letter does not specify what the violations were. Children's is the nation's largest pediatric medical center and the main pediatric teaching hospital of Harvard Medical School. It is a pioneer in cutting-edge surgeries and therapies, and often provides free care to poor children from across the United States and around the world. It is the state's largest provider of medical services to low-income children.

Taylor McCormack's father, Pembroke state trooper John McCormack, was angry yesterday to learn that Children's had been cited again for care problems. "Here they promised the public, they promised my family and they promised the DPH changes, and here we go again," he said. "They should be held accountable and responsible."

Alice Dembner of the Globe staff contributed to this report. Anne Barnard can be reached at abarnard@globe.com.

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