Blistering report details serious safety lapses at St. Luke's

2019-05-18 | The Honolulu Star-Advertiser

May 17-- May 17--When government inspectors descended on Baylor St. Luke's Medical Center in March, they found a once-renowned hospital system beset with problems threatening the health and safety of patients.

It was a place where some people were given medications not ordered by their doctors, where objects had been mistakenly left in patients after surgery, and where sewage backed up into a kitchen stocked with moldy vegetables.

It was also a place where transvaginal ultrasound probes, the type used to examine a fetus during an early pregnancy, were not always disinfected properly before being used in subsequent patients, and where staff members weren't always following protocols needed to prevent air from seeping into the blood of patients receiving dialysis, a potentially fatal complication.

In area after area, from infection control to quality assurance, from the kitchen to the executive suite, inspectors found that hospital administrators didn't have adequate processes in place to ensure the staff always followed safety standards and learned from serious mistakes.

Those findings were detailed in a 203-page deficiency report from the Texas Department of State Health Services and the Centers for Medicare and Medicaid Services, which was delivered to hospital leaders last month and made public Friday.

The report follows months of scrutiny by federal regulators and comes one year after the start of an investigation by the Houston Chronicle and ProPublica that revealed a high rate of deaths and complications following heart transplants at St. Luke's. Subsequent stories uncovered other concerns related to surgical outcomes, hospital management and nursing care.

The Medicare agency cut off funding for heart transplants at St. Luke's in August, prompting officials at the hospital and its affiliated Baylor College of Medicine to bring in new cardiac surgeons to lead the program and begin an ongoing effort to regain federal certification.

But the government scrutiny of St. Luke's broadened a few months later, when a patient died in the emergency room after staff used the wrong blood type during a transfusion. The error was so severe that it led the St. Luke's board of directors to replace three top executives in January, including the hospital's CEO. The officials did not respond to requests for comment at the time.

The fatal mistake followed a pattern of blood labeling errors at St. Luke's, according to a report from the Medicare agency made public in February. The review prompted the government to order a top-to-bottom inspection of the hospital.

That inspection spanned more than two weeks in late March and early April, after new hospital leaders had already begun implementing reforms, and covered every aspect of care at the 850-bed facility. The hospital, long regarded as one of the best in the nation for heart surgery, is owned by Catholic Health Initiatives, a behemoth national nonprofit hospital chain, and co-managed by Baylor.

In a letter posted on the hospital's website Friday, hospital CEO Doug Lawson pledged to make additional changes needed to regain the trust of patients.

"The conditions described in the CMS report did not occur overnight, nor were they the result of any single factor," Lawson wrote. "We take the issues CMS identified seriously and we owe it our patients and their families to correct them immediately -- and we have already started to do so through our internal quality program."

Some of the deficiencies -- those related to infection control, patient safety and food services -- were so serious that federal regulators concluded they "placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death" and ordered the hospital to make immediate fixes while the inspection was still ongoing.

The hospital complied, avoiding the immediate loss of Medicare funding. This week, having been presented with the complete deficiency report, the hospital submitted a detailed plan of correction that Lawson said should bring St. Luke's into compliance with federal standards.

When the Chronicle and ProPublica first detailed problems with the heart transplant program last year, St. Luke's executives said any issues had been corrected and stressed that they did not affect the hospital as a whole. Executives also took out full-page newspaper advertisements touting the hospital's quality. Lawson's more recent comments acknowledged the depth of the hospital's troubles and promised to address them.

"(T)his is a challenging time for our hospital," Lawson wrote Friday. "While we cannot change the past, we can continue to do everything possible to provide the highest quality, safest possible care and to do so with compassion. I remain confident that Baylor St. Luke's will emerge stronger than ever."

Reporters requested an interview with Lawson or other hospital leaders following the release of the report, but David Gonzalez of Pierpont Communications, a Houston public relations firm, said they were not available.

Serious problems

The government report details a litany of problems at St. Luke's and some of its outpatient treatment facilities.

In one instance, regulators noted that a cart of medical equipment had been removed from the room of a patient with a rare flesh-eating bacteria infection, with no evidence that the cart had been disinfected and no documentation of where the cart had been taken. Infections can spread if caregivers touch a cart that carries bacteria and then come in contact with another patient.

Later, an inspector observed a nurse touching a contaminated dialysis machine without gloves. When confronted, the nurse replied, "I thought because we clean it really good we do not wear gloves."

In 2018, St. Luke's recorded worse-than-average infection rates in several areas, according to the report. When an inspector asked an administrator why the hospital wasn't tracking staff compliance with several prevention protocols, the director said it "was because of lack of resources" in infection control.

Hospital administrators didn't have adequate follow-up processes in place to ensure staff continued to learn from serious mistakes, regulators wrote, as was the case in 2018 after surgical objects -- a sponge, a surgical towel and a cervical instrument -- were mistakenly left inside three different patients during a three-month span.

Medical experts consider accidentally leaving an instrument or sponge inside a patient during surgery a "never event," meaning the error is so egregious that it should never happen.

Regulators found that some nurses weren't following hospital policy for the safe administration of medications, including one who gave an additional dose of anti-psychotropic drugs to calm a patient who'd been yelling -- without first consulting a doctor.

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In some instances observed by inspectors, nursing staff failed to take steps necessary to protect frail patients from the risk of falls. In others, staff failed to ensure patients fully understood the risks before asking them to consent to a procedure.

Even the facility -- a 65-year-old building at the heart of the Texas Medical Center -- posed a potential danger to patients, according to the inspectors, with sewage backed up in the kitchen, malfunctioning dishwashers, moldy ceiling tiles, water leaks creating slip hazards and paint chipping from walls in operating rooms.

At a 2016 groundbreaking, Baylor St. Luke's leaders said a new hospital tower to replace its aging facility would be completed by 2019, but construction contracts were later canceled. This year, hospital leaders announced the new facility is now "scheduled for completion in the fall of 2024."

Regaining trust

In response to the findings, the hospital submitted a 129-page plan of correction, including fixes to the hospital's kitchen equipment, and several policy, staffing and training changes aimed at correcting each of the deficiencies.

Specifically, the hospital reported that it conducted training to ensure the safe use of dialysis machines, changed the process to ensure doctors track the administration of psychotropic drugs and increased oversight of all hospital departments, including dietary services, infection control and surgery.

"Many significant improvements already have been completed across the hospital," Lawson wrote, adding, "we are confident remaining findings will be implemented in the coming weeks."

Vivian Ho, a health-care economist at Rice University, said the hospital's new leadership team now must work to regain the trust of the community.

"I'm concerned that this news could cause them to lose patients, and reduced patient volume means lower revenues and affects their ability to provide quality care," Ho said. "It becomes a vicious cycle."

Ho, who's also a professor at Baylor College of Medicine, which helps manage St. Luke's, said she hopes hospital administrators succeed in turning things around.

"Robust local competition leads to better care for patients," Ho said. "We can't afford to lose this hospital in Houston."

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This story is the result of a collaboration between the Chronicle and ProPublica, an independent nonprofit newsroom based in New York. ProPublica Deputy Managing Editor Charles Ornstein contributed to this report.