The event that triggered increased government oversight of MD Anderson Cancer Center was the death of a 23-year-old leukemia patient who received a contaminated blood product, according to a new report.

The report, issued Monday by the Centers for Medicare and Medicaid Services, notes the patient, a woman, died two days after receiving a transfusion tainted with a bacterial infection commonly acquired in hospitals but rarely found in blood transfusions. She had had serious complications prior to the transfusion, the report noted.

The report was released two weeks after CMS made public its letter notifying MD Anderson it had found the Houston cancer center in violation of serious hospital requirements based on on-site inspections following an “adverse event” in December. The letter informed MD Anderson it will come under more aggressive government oversight until the deficiencies are fixed.

At the time, MD Anderson would not tell the Chronicle whether the event was a patient death.

The chain of events came as a shock because of MD Anderson’s sterling reputation for patient care and safety. High marks in those areas historically have contributed to it being ranked the No.1 cancer center in U.S. News & World Report’s annual survey of best hospitals.

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It was also the second death involving a blood transfusion recently at a high-profile Houston hospital. In late November, an emergency room patient died at Baylor St. Luke’s Medical Center after a transfusion of the wrong blood type, given because of a labeling error.

The nearly back-to-back events in the same city took many hospital observers aback. One Harvard expert said he hasn’t seen any national data, but couldn’t imagine that adverse events prompting Centers for Medicare and Medicaid Services reports happens more than half a dozen times a year in the nation’s more than 5,000 hospitals.

MD Anderson Friday sent CMS its corrective plan of action and asked for reinstatement of an important condition of Medicare participation that was lifted as part of the agency’s findings. The agency is expected to be back in July for a follow-up inspection, before any such reinstatement can be made.

“MD Anderson has taken swift and decisive actions in order to ensure compliance with Medicare Conditions of Participation and to address the (report),” Dr. Peter Pisters, the cancer center’s president, wrote in response to the report.

MD Anderson remains a participant in Medicare and Medicaid programs, but it is currently under federal and state authority — instead of the Joint Commission, its accrediting agency — until it demonstrates it is in compliance with the rules of the Centers for Medicare and Medicaid Services.

Pisters wrote that the efforts include “review of and revisions to relevant policies, review of documentation processes in all areas of the hospital that may be involved in blood component transfusions, internal review of the patient charts discussed with the surveyors, implementation of an audit process and educational sessions for physicians and staff involved in blood component transfusions and the engagement of experienced consults.”

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Pister’s letter referred to “alleged deficiencies” discovered during the inspection and noted its plan was submitted “without conceding the events for which MD Anderson was cited occurred or were violations of Medicare Conditions of Participation.”

MD Anderson officials would not discuss details of the patient death, citing federal privacy laws.

Details in the CMS report note the patient had a history of acute lymphoblastic leukemia, a rare cancer that begins in the bone marrow before moving into the blood. The disease, diagnosed annually in about 5,000 Americans, is more favorably treated in children than adults. The report doesn’t say when the patient was first diagnosed.

She was admitted to MD Anderson Sept. 25 for a third stem-cell transplant, according to the report. Complications included viral-induced bladder inflammation and the placement of a tube that allows direct drainage from the kidney. She needed daily blood transfusions.

An infusion she received the evening of Dec. 6 was later found to be contaminated with the bacteria Serratia marcescens , the report noted. Her condition worsened and she died in the intensive care unit Dec. 8.

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Serratia m is responsible for 1.5 percent of hospital acquired infections, according to one journal report. But MD Anderson officials said they’ve only identified it in one of 28,800 blood bacterial surveillance cultures, or about .003 percent.

MD Anderson reported the event to the Food and Drug Administration, which referred the matter to the CMS after its own investigation reported no citations. In conjunction with the Texas Department of State Health Services, CMS conducted investigations from March 29-April 5 and May 13-17.

The resulting report, which concerned other patient records in addition to the one who died as a result of the compromised blood, revealed major shortcomings in nursing services, pathology services, patient information and consent rights and oversight responsibility.

Among the findings: no oversight ensured blood transfusions were administered in accordance with policies and procedures; vital signs were not monitored or obtained during transfusions; there was a failure to ensure that hand-off communication was performed when a patient with an infectious disease was transferred from a patient unit to the operating room; and many patients had no recently signed informed consent documents.

MD Anderson Chief Operating Officer Rosanna Morris said the cancer center reached agreement with Centers of Medicare and Medicaid Services that consent documents for continuing patients who receive procedures such as transfusions routinely may be no older than six months.

In the aftermath of the death, MD Anderson is touting a “first-of-its-kind” hemovigilence unit to provide real-time surveillance of all patients undergoing or recently provided a blood transfusion and more quickly respond, document and report any concerns or reactions. Officials said it also has initiated additional pre-transfusion testing of blood products.

The hospital is also instituting ongoing education and online training regarding blood transfusions that reinforces procedures and expectations for patient monitoring and documentation. Under the revised policy, nursing staff will take the patient’s vital signs prior to the transfusion, 15 minutes into it, hourly throughout and at its completion.