After a Patient Death, Top Cancer Center Issues Corrective Plan

Nick Mulcahy

Disclosures

June 25, 2019

UPDATED June 26, 2019 // The University of Texas MD Anderson Cancer Center in Houston has taken "swift and decisive actions" to address a "statement of deficiencies" from the Centers for Medicare & Medicaid Services (CMS), says the cancer center's top executive.

The announcement was made public at the same time that CMS revealed that a 23-year-old woman with pre–B-cell acute lymphoblastic leukemia (ALL) died at MD Anderson after receiving a blood transfusion contaminated with a rare bacteria.

Earlier this year, CMS found serious problems with MD Anderson's patient care after conducting two investigations of operations at the center in April and May 2019.

The wide-ranging federal scrutiny was triggered by the case of the now deceased young woman with ALL, who is identified as "patient #34" by MD Anderson and CMS. The center reported her death to federal authorities at the end of 2018.

Subsequent CMS investigations found deficiencies in nursing care, laboratory services, patients' rights, quality assurance, and institutional oversight.

"These deficiencies have been determined to be of such a serious nature as to substantially limit your hospital's capacity to render adequate care," CMS said in its June 3 letter to MD Anderson.

According to a report in the Houston Chronicle at the time, the letter is similar to ones that CMS sent earlier this year to Baylor St. Luke's Medical Center in Houston following investigations there after an emergency department patient died as a result of a transfusion of the wrong blood type, given because of a labeling error.

Also at that time, MD Anderson acknowledged that "in rare instances, severe reactions occur [from blood transfusions]. The transfusion of blood and blood products from human to human carries inherent risks — from mild to severe."

The case of patient #34 involved a transfusion of pooled platelets contaminated with Serratia marcescens, a gram-negative bacillus associated with a range of infections and illnesses. She died on December 8, 2018, a day after the transfusion.

According to CMS, "there was no blood consent in the medical chart to administer the platelets."

The young woman had undergone stem cell transplant in October 2018 and suffered from a number of complications, including severe BK cystitis. She was hospitalized at MD Anderson at the time of the transfusion.

Corrective Plan

In a letter to CMS dated June 21, which was released to the public June 24, MD Anderson President Peter Pisters, MD, said that the cancer center has a "plan of correction," which involves a series of remedial actions to be implemented no later than July 10.

Among other things, MD Anderson will provide training for all 4300 of its practitioners on its "new informed consent policy," writes Pisters.

"MD Anderson respectfully submits that Patient #34 did have an executed informed consent for administration of blood components in accordance with MD Anderson's then-current informed consent policy," he states.

In addition to consent policy training, the new corrective plan includes "educational sessions for physicians and staff involved in blood component transfusions and the engagement of experienced consultants."

The plan also calls for a review of "documentation processes in all areas of the hospital that may be involved in blood component transfusions."

Pisters also says that MD Anderson, by enacting its corrective plan, was not "conceding" that the events "for which MD Anderson was cited occurred or were violations of Medicare Conditions of Participation." This refers to CMS's rules and regulations for involvement with their programs and related matters, such as reimbursement.

A Plea for "Deemed Status" to Return

Earlier this month, CMS removed MD Anderson's "deemed status" — which means the cancer center lost its status as having met all applicable Medicare conditions of participation.

In its letter to CMS, the cancer center states it believes it complies with Medicare conditions. "Accordingly, MD Anderson requests...that you reinstate its deemed status," writes Pister.

He also points out that MD Anderson was ranked as the top cancer center by US News and World Report for 2018 and has been ranked first for 14 of the 17 years that the survey has been conducted.

However, the center has seen a string of negative events over the past 2 years. These include large budget shortfalls, the cutting of 1000 staff, the resignation of its controversial top executive, and an aborted, big-data cancer management collaboration.

The center was also fined $4.3 million in 2018 for violations of the Health Insurance Portability and Accountability Act (HIPAA). The fine was imposed after an employee lost a laptop and thumb drives containing unencrypted electronic protected health information of more than 33,500 individuals.

Editor’s note: An earlier version of the story reported that patient #34 had an adverse event after the blood transfusion. The story has been updated to reflect her death.

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