Shared from the 11/5/2019 Houston Chronicle eEdition

Serious deficiencies found at MD Anderson

Federal report details ‘immediate jeopardy,’ two more seemingly preventable deaths

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Melissa Phillip / Staff file photo

CMS scrutiny of MD Anderson dates to the death in December of a leukemia patient who received a contaminated blood product.

MD Anderson Cancer Center deficiencies discovered during a recent government inspection jeopardized the health of patients, according to a new federal report that uncovered two more seemingly preventable deaths at the elite Houston hospital.

The inspection by the Centers for Medicare & Medicaid Services, a more comprehensive look at MD Anderson practices in the aftermath of a death previously investigated, found deficiencies in nine of 23 areas surveyed, including three so serious as to constitute “immediate jeopardy,” a finding so serious it can threaten ahospital’s CMS funding.

“Deficient practices of CMS conditions of participation were determined to pose an immediate jeopardy to patient health and safety and placed all patients in the facility at risk for the likelihood of harm, serious injury and possibly subsequent death,” said the report, made available last week.

The report contains 268 pages of deficiencies and infractions, both mundane and life-threatening. It provides limited details on the two new deaths.

The report, based on an inspection in August, says CMS removed the immediate jeopardy findings before auditors left because MD Anderson provided an acceptable correction plan.

The report findings nevertheless represented a black mark for MD Anderson, whose sterling reputation is buttressed by routine No. 1 rankings in U.S. News & World Report’s annual survey of best cancer hospitals. It is unclear whether the findings might affect future rankings, which emphasize patient care and safety.

MD Anderson has not previously had to undergo a comprehensive CMS inspection investigating possible deficiencies in care, cancer center officials said.

MD Anderson is one of three Texas Medical Center hospitals — Baylor St. Luke’s Medical Center and Ben Taub Hospital are the others — that this year came under greater federal and state scrutiny because of preventable deaths. Such oversight is the result of CMS removing a hospital’s “deemed status.”

St. Luke’s deemed status was reinstated by CMS in August, removing the increased oversight it had undertaken in the aftermath of a death late last year involving a blood transfusion error in the emergency room. CMS inspections at St. Luke’s early in 2019 found deficiencies in six areas, including three that constituted “immediate jeopardy.” The agency cleared St. Luke’s of serious deficiencies after a follow-up inspection in June.

Ben Taub, whose emergency department was the site of two 2019 deaths involving patients found unresponsive in a waiting room restroom following a lack of timely treatment, is waiting for CMS’ report following the comprehensive inspection the agency conducted there in September.

Rosanna Morris, MD Anderson’s chief operating officer, said CMS officials told cancer center officials Friday they plan to clear the hospital of the serious deficiencies and reinstate its deemed status. The agency conducted its follow-up inspection of MD Anderson last week.

CMS would need to make such reinstatement of MD Anderson’s deemed status official in a new report, which typically follows the inspection by at least a month. Morris said CMS auditors suggested this one might take less time.

One national expert said a plan by itself shouldn’t instill confidence in people that the deficiencies are gone.

“The proof will be in the pudding,” said Dr. Thomas Tsai, a Harvard surgeon and professor in health policy and management who conducts research on the quality of U.S. care. “This stuff is really basic, but it’s also really hard. The issue is one of implementation — how do you make sure you bring the same level of focus and rigor on every patient, every minute, every day?”

Tsai said he wasn’t surprised by the findings at MD Anderson, citing the estimated 210,000 to 440,000 deaths annually caused by medical error. He said “it’s not like they’re all concentrated at small hospitals — big hospitals have the same or different set of problems.”

“The scary thing is that it probably happens at a lot of hospitals around the country,” he added.

CMS scrutiny of MD Anderson dates to the death last December of a 23-year-old leukemia patient who received a contaminated blood product. In a report made public in June, CMS documented the lack of monitoring of vital signs during the transfusions.

Not monitoring patients and notifying doctors of changes in condition remained an issue in the new report. Nursing staff failed to provide patient care and treatment according to policy and doctor’s orders and to notify the doctor of changes in condition for all 29 of the patients reviewed, the report said.

The failure to notify the doctor of changes in condition marked one of the new deaths. The report noted six instances when a nurse didn’t notify the doctor that the patient’s vital signs had exceeded the parameter set for such notification. The role the failure played in the August 2019 death is unclear because the report notes only that the patient became unresponsive and died a few days later.

As described in the report, the other new death seemed clearly the result of errors in care. It described the May 2019 death of a 54-year-old brain cancer patient who had “an untoward reaction” to overdoses of anesthetic drugs injected into her scalp prior to scheduled radiation treatment.

Citing federal patient privacy laws, MD Anderson declined comment Monday on the two new cases.

Tsai said the case was curious because there is standard follow-up treatment to overdose reactions to anesthetic drugs.

The areas of deficiency included nursing, pharmacy, outpatient services, food services, patient rights, infection control and surgical services. The last three posed the immediate jeopardy threat, according to the report.

Tsai described the lion’s share of the deficiencies as “death by a thousand cuts,” structural and process problems rather than outcomes. They included a lack of infection control practices necessary to keep equipment and linens sanitized and free of contamination; improper cleaning and reporting of chemotherapy spilled during infusions; and the failure to ensure patient confidentiality by leaving medical records unsecured and potentially accessible.

The MD Anderson corrective plan, also made public last week, focuses on policy revision and education and training. The plan also notes the creation of what it calls a “first-of-its-kind” hemovigilance unit to provide real-time surveillance of all patients undergoing or recently provided a blood transfusion.

In a letter to CMS, MD Anderson President Dr. Peter Pisters requested the plan lead to reinstatement of the cancer center’s deemed status.

“MD Anderson has taken swift and decisive actions in order to ensure compliance,” wrote Pisters. “To the extent MD Anderson may have deviated from (CMS) conditions of participation in the past, the corrective actions detailed in the plan ensure no such deviation will occur in the future.”

He added that the cancer center was not “conceding that the events for which MD Anderson was cited occurred or were violations.” todd.ackerman@chron.com twitter.com/chronmed

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