HOUSTON – A joint investigation by state and federal health inspectors found serious “deficiencies” at The University of Texas MD Anderson Cancer Center and placed the hospital under state and federal authority.
Here’s what happened:
December 2018: MD Anderson “self-reported a blood transfusion-related adverse event to the Food and Drug Administration (FDA),” the hospital said. The hospital did not confirm that the adverse event was a patient death.
The FDA referred the case, per department policy, to the Health and Human Services Centers for Medicare and Medicaid Services.
March 2019: CMS and Texas Department of State Health Services employees conducted a weeklong investigation, or “survey,” at MD Anderson.
May 2019: CMS and Texas Department of State Health Services employees conducted a second weeklong investigation at MD Anderson.
The hospital “cooperated fully,” it said.
June 3, 2019: CMS sent two letters to MD Anderson outlining the results of the investigations. One letter was addressed to MD Anderson’s CEO, Peter Pisters. The other is addressed to Elizabeth Wagar, MD Anderson’s laboratory director.
Survey No. 1 results: The first letter, to MD Anderson’s CEO, outlines “Medicare Conditions of Participation” that are out of compliance:
- Governing body
- Patient rights
- Quality assurance and performance improvement
- Nursing services
- Laboratory services
The report detailing the specific deficiencies is not public, but the letter said: “These deficiencies have been determined to be of such a serious nature as to substantially limit your hospital’s capacity to render adequate care and prevent it from being in compliance with all the applicable Medicare Conditions of Participation.”
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CMS MDAnderson Letter 1 (PDF)
CMS MDAnderson Letter 1 (Text)
Survey No. 2 results: The second letter, to MD Anderson’s laboratory director, outlines “Clinical Laboratory Improvement Amendments (CLIA) conditions” the laboratory did not meet:
- Facility administration
- Immunohematology
- General laboratory systems
- Laboratory director, high complexity testing
- Technical supervisor, high complexity testing
- Personnel, high complexity testing
The report with a detailed list of all “deficiencies” has not been made public. The laboratory “must submit a plan of correction” to state and federal inspectors for the “deficiencies” by June 18, the second letter said.
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CMS MDAnderson Letter 2 (PDF)
CMS MDAnderson Letter 2 (Text)
MD Anderson's response: The hospital acknowledged self-reporting the “adverse event” in December and said it “cooperated fully” with and “welcomed” the investigations.
In regards to the laboratory: “MD Anderson transfuses as many as 200,000 blood products each year, and we have policies and procedures in place to protect our patients; however, in rare instances, severe reactions occur. The transfusion of blood and blood products from human to human carries inherent risks — from mild to severe.”
Additionally, “We welcome the review and feedback,” the hospital said in a statement. “It affords us the opportunity to further strengthen and supplement our efforts. ... MD Anderson constantly strives to ensure the highest standards of patient care, and we are unwavering in our commitment to serve those who entrust us with their care.”