CMS Sanctioned Three Houston Hospitals, Labs

Each hospital had a patient death following mistakes in handling blood products or lab tests

CEO SUMMARY: At MD Anderson Cancer Center and Baylor St. Luke’s Medical Center, blood transfusion errors led to two patients’ deaths in separate incidents last fall. Then, this spring, a patient died in the emergency department of Ben Taub Hospital following “an ineffective process in patient monitoring and communication of critical lab values.” State and federal inspectors found deficiencies at all three hospitals.

THREE PROMINENT HOUSTON HOSPITALS WERE SANCTIONED IN DIFFERENT WAYS by the federal Centers for Medicare and Medicaid Services (CMS) following patient deaths at each hospital. CMS identified the clinical laboratories as having a role in each patient’s death.

It’s unusual for CMS to identify such serious deficiencies in patient care at three major hospitals in such a short period of time. News reporting identified each hospital where a patient died as:

  • Baylor St. Luke’s Medical Center,
  • Ben Taub Hospital, and
  • University of Texas MD Anderson Cancer Center.

All three health systems were placed under state and federal authority as a result of CMS revoking their “deemed status,” The Houston Chronicle reported.

Labeling Error Causes Death

The first reported patient death happened at 661-bed Baylor St. Luke’s Medical Center in November. A 75-year-old female died in the emergency room when a labeling error caused her to be transfused with the wrong type of blood, the Chronicle reported.

Then, in December, a 23-year-old female patient with leukemia died at 681-bed MD Anderson Cancer Center as a result of being transfused with blood tainted with a bacterial infection.

Her death led to increased oversight by CMS and the Texas Department of State Health Services. Following its inspections of the hospital, CMS revoked the cancer center’s deemed status.

Critical Lab Values

In April, at 650-bed Ben Taub Hospital, a third patient died due to a failure to communicate critical lab values, according to reporting in the Chronicle.

On June 27, the Chronicle reported that Ben Taub Hospital was placed under federal and state authority after a patient at the Ben Taub Emergency Center died when staff failed to follow federal patient care and safety requirements.

Ben Taub Hospital is part of Harris Health System, a public safety net hospital network in the Texas Medical Center where MD Anderson and Baylor St. Luke’s also are located.

Having two deaths due to similar patient-safety deficiencies related to transfusions in two large hospitals in the same city is extremely unusual.

“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 happen more than half a dozen times a year in the nation’s more than 5,000 hospitals,” the Chronicle reported.

On June 14, Modern Healthcare reported that surveys by CMS and the Texas Department of State Health Services found MD Anderson wasn’t complying with CMS’ conditions of participation regarding its governing body; quality assessment and performance improvement program; patient rights; and nursing and laboratory services.

CMS Investigators Identified 122 Incidents of Mislabeled Blood at Baylor St. Luke’s

OVER FOUR MONTHS LAST YEAR, inspectors from the federal Centers for Medicare and Medicaid Services (CMS) found 122 incidents in which the staff at Baylor St. Luke’s Medical Center in Houston labeled blood incorrectly, according to The Houston Chronicle.

In a report CMS issued in February, CMS investigators found that in November, the medical center’s clinical laboratory failed to notice that a blood sample had arrived with another patient’s blood in it.

As a result of that failure, a 75-year-old woman was mistaken for a patient who had been in the emergency room just before her and was given the wrong blood, according to the Chronicle.

The 75-year-old ER patient died the next day due to cardiac arrest.“That fatal mistake followed a pattern of blood labeling errors at St. Luke’s Medical Center last year,” the Chronicle reported.

Pattern of Labeling Errors

CMS cut off funding for heart transplants at St. Luke’s following a yearlong joint investigation by the Chronicle and ProPublica which documented numerous errors that led to patient deaths and surgical complications following heart surgery.

The recent patients’ deaths occurred at about the same time the Chronicle-ProPublica reports were published.

The medical center made the CMS report public in March and has since worked to fix those errors and eliminate the deficiencies, CMS cited.

In its review of the 75-year-old patient’s death, CMS found that an internal hospital committee had previously identified problems with the way staff labeled blood samples, but the unsafe practices continued, the Chronicle reported.

The hospital also had a “short-staffed nursing crew that lacked training in how to detect adverse reactions during transfusions and a hospital laboratory with too few workers on staff to always catch potentially fatal labeling mistakes,” the CMS report showed.

In May, Baylor St. Luke’s Medical Center President Doug Lawson, PhD, posted a letter on the hospital’s website explaining the steps staff were taking to correct the deficiencies. “Over the next few weeks, we will meet with CMS in a full-scale review of our hospital, our organization, and our operations, painstakingly reviewing every policy and practice we have. I expect the CMS reviews to reveal additional areas of improvement,” he wrote.

Along with the letter, Lawson posted the CLIA deficiencies reports and the medical center’s correction plan. The hospital is accredited by DNV GL Healthcare.

Tragic Consequences

The CMS survey showed that the female patient had experienced serious complications and then died on Dec. 8, two days after receiving a transfusion tainted with the bacteria Serratia marcescens, the Chronicle reported. S. marcescens is a gram-negative bacillus that occurs naturally in soil and water. It is associated with common infections, septicemia, and meningitis, Science Direct reported. It is commonly acquired in hospitals but rarely found in blood transfusions.

The event has tainted MD Anderson’s stellar reputation for patient care and safety. In a letter to CMS on June 21, MD Anderson President Peter Pisters, MD, said U.S. News & World Report ranked the hospital as the top cancer center in 2018, and that it has been ranked first in 14 of the publication’s 17 annual surveys.

‘Swift and Decisive Actions’

In the same letter, Pisters noted that MD Anderson has taken “swift and decisive actions” in an effort to ensure compliance with Medicare’s conditions of participation and to address CMS’ statement of deficiencies.

MD Anderson included a corrective plan of action and asked for reinstatement of its deemed status. Inspectors are expected to return to the hospital this month before making a decision on the reinstatement. The Joint Commission accredits MD Anderson.

In a statement MD Anderson issued June 25, the cancer center said it reported late last year to the Food and Drug Administration (FDA) an incident involving contaminated platelets that contributed to a patient’s death.

The FDA conducted a review of the lab and did not issue any citations, but under its policies FDA referred the case to CMS.

“CMS in conjunction with the Texas Department of State Health Services conducted surveys of MD Anderson from March 29 to April 5 and from May 13 to 17,” the statement said. MD Anderson cooperated with CMS and has submitted improvement plans.

“It is important to note that there have been no changes to our participation in Medicare and Medicaid programs. MD Anderson transfuses as many as 200,000 blood products each year,” the statement added. “Those transfusions carry inherent risks, and, for our patients, many who are very sick with weakened immune systems, those risks are more significant.”

‘An Ineffective Process’

In an e-mail to staff about the problems at Ben Taub Hospital, Harris Health CEO George Masi disclosed the death, explaining that the patient died as a result of “an ineffective process in patient monitoring and communication of critical lab values.” No other details were available at the time THE DARK REPORT went to press.

Harris Health did not report the death to CMS. Instead, the federal agency learned about the death through a complaint, the Chronicle reported.

On June 4 and 5, the Texas Health and Human Services Commission investigated the complaint and found deficiencies in patient rights and emergency services, CMS said in a letter to Harris Health. DNV GL Healthcare accredits the Harris Health System.

Loss of Deemed Status

Each hospital is still feeling the effects of the deaths and is responding to deficiencies cited in reports that CMS issued after investigations into all three events.

The entire Harris Health System, Baylor St. Luke’s Medical Center, and MD Anderson Cancer Center, were all placed under state and federal authority as a result of CMS revoking the deemed status for each one, the Chronicle reported.

Even though all three health systems will continue as participants in the Medicare and Medicaid programs, all three also will remain under government authority until they demonstrate compliance with CMS’ conditions of participation, the Chronicle stated.

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