HOUSTON – A federal investigation into the University of Texas MD Anderson Cancer Center is complete after a blood transfusion ended in one patient's death. As a result, the hospital has issued a plan of correction.
What triggered the federal investigation?
A 23-year-old, female leukemia patient died at the hospital Dec. 8, 2018, after a contaminated blood transfusion.
The hospital reported the event to the Food and Drug Administration, as required, and the case was referred to the Health and Human Services Centers for Medicare and Medicaid.
Federal investigators with the Dallas CMS office conducted the probe in conjunction with state health investigators.
What do we know about the investigation itself?
Federal and state health employees conducted two weeklong investigations on-site at MD Anderson, one in March and the other in May.
The investigators arrived unannounced and reviewed policies, procedures and documentation related to blood transfusions, including an examination of 34 patients since last December and interviews with staff.
In June, investigators published a 99-page "statement of deficiencies" outlining a series of failures at the hospital that needed correction.
What deficiencies did the investigation find?
The "statement of deficiencies" found federal health requirements out of compliance in the following categories:
The full, 99-page report, including detailed accounts of problematic care for unidentified patients, can be found below:
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MD Anderson Transfusion Deficiency Report (PDF)
MD Anderson Transfusion Deficiency Report (Text)
How did MD Anderson respond to the investigation?
Hospital administration and staff "cooperated fully" with the investigation, "welcomed" and "take seriously" the feedback and produced a 94-page plan of correction.
That plan details how the center "has corrected all alleged deficiencies, has implemented training and monitoring and taken steps for sustained compliance ... to ensure safe, quality care for patients."
What are some of those corrections?
Among the changes made at MD Anderson are the following:
You can find the full, 94-page "plan of correction" here:
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MD Anderson Plan of Correction (PDF)
MD Anderson Plan of Correction (Text)
What else did the hospital say?
Here's MD Anderson's full statement following the release of the 99-page "statement of deficiencies":
"More than 140,000 people from around the world turned to our experts last year for their cancer care. Their trust in MD Anderson pushes us to set the highest standards and to continually improve and strive for excellent patient outcomes.
"Late last year, MD Anderson self-reported a blood transfusion-related adverse event to the Food and Drug Administration (FDA). Based on the self-reported information, the FDA conducted a full review of the lab and no citations were provided. Per policy, the FDA referred the case to the Centers for Medicare and Medicaid Services (CMS).
"CMS in conjunction with the Texas Department of State Health Services conducted surveys of MD Anderson from March 29-April 5 and May 13-17. MD Anderson cooperated fully with CMS and has responded to its reports with our improvement plans.
"It is important to note that there have been no changes to our participation in Medicare and Medicaid programs. Patient coverage should be the same as it was prior to the surveys. MD Anderson is not on a pathway to termination from Medicare and Medicaid programs.
"While it is unfortunate that the CMS surveys resulted from an adverse patient event, we recognize and embrace the opportunity to further enhance and improve our patient care efforts and robust safety measures. We take this feedback seriously, and we already have implemented changes into our clinical practice.
"MD Anderson transfuses as many as 200,000 blood products each year. Those transfusions carry inherent risks, and, for our patients, many who are very sick with weakened immune systems, those risks are more significant. While we have policies and procedures in place to protect our patients, in rare instances severe reactions occur.
"In addition to ongoing educational information and online training regarding blood transfusion reactions, as well as ongoing training to reinforce blood administration procedures and expectations for patient monitoring and documentation, we have created additional layers of safeguards to protect patients during blood transfusions – exceeding the already high standards set forth by the FDA and the accepted standard of care.
"One of those safeguards is a first-of-its-kind Hemovigilance Unit to provide real-time surveillance of all patients undergoing or recently provided a blood transfusion. The unit, to be launched soon, will be staffed full time by advanced practice providers and nurses who will monitor for reactions and will partner with our physicians and nursing staff to quickly respond, to document and to report any concerns or reactions.
"MD Anderson’s faculty and staff are among the most skilled, professional and highly-trained in the country, and we have made intentional, strategic and patient-focused decisions to further improve patient outcomes. Additionally, more than 70 regulatory, professional and accrediting bodies regularly review MD Anderson’s processes.
"To our patients and their loved ones, we want to reinforce our unwavering commitment to provide them with the safest and highest quality care. We are grateful to them for entrusting us with their care, and we consider it our responsibility and honor to join them in their fight to end cancer."