St. Christopher's Hospital for Children did not do enough to determine why nine of its patients died after heart surgery, according to a sweeping report by state investigators.
The findings stem from a surprise three-day inspection of the North Philadelphia hospital one month after the Inquirer reported in February that the death rate among newborn heart-surgery patients there was nearly triple the national average.
The 140-year-old hospital, owned by Tenet Healthcare Corp. of Dallas, stopped performing nonemergency heart surgery in late January pending an internal review. It has yet to resume these procedures, nearly eight months later, but submitted a plan of correction that the state approved.
Every death in surgery should be scrutinized to "learn and potentially prevent that death from happening the next time," said Jeffrey Jacobs, chief of cardiac surgery at Johns Hopkins All Children's Hospital in St. Petersburg, Fla., and a leader of a national effort to publicize surgical records.
In a separate, 244-page report, state investigators also criticized St. Christopher's for administering 10 times the proper dose of chemotherapy to an 11-month-old cancer patient, a potentially fatal error that went undetected for five days.
Last year, hospital officials said simply that the error was caused by an inaccurate calculation. The new report elaborates, finding numerous clinicians failed to notice signs of the overdose.
Michael Cohen, president of the Institute for Safe Medication Practices, a Horsham-based nonprofit that works with clinicians, said the state report shows this mistake was exceptional.
"We get error reports every day. Very few are this serious," Cohen said.
Cohen said the state report shows St. Christopher's has now implemented important safeguards against such errors.
The state Department of Health reports identified shortcomings both with the quality of care at St. Christopher's and the hospital's procedures for studying and improving its performance.
Investigators also reported that the hospital's operating-room records did not match information it sent to a national group working to improve pediatric heart surgery.
When investigators asked the hospital for its heart-surgery data on March 16, a St. Christopher's employee provided an internal document stating that a 2014 review had "identified inconsistencies" between operating-room records and what was given to the Society of Thoracic Surgeons, which publicly reports on the quality of heart surgery in hospitals across the nation.
The third day of the March visit, state investigators met with an unnamed St. Christopher's employee who said the heart-surgery team did not participate in a hospital-wide quality program, instead doing its "own thing," the report said.
Jacobs, the St. Petersburg surgeon - who is also professor of surgery and pediatrics at Johns Hopkins University - said he could not discuss a specific hospital. However, he said that accuracy is paramount to the Society of Thoracic Surgeons' National Database, which he oversees.
"Patients and their families have the right to know the outcomes of the treatment they're going to receive," Jacobs said.
After the Pennsylvania investigators learned of the inconsistent St. Christopher data, they asked for proof that heart procedures were being "measured, analyzed and tracked."
The response, inspectors wrote: "None was provided."
On 10 other occasions, the investigators used the same phrase to describe the hospital's reply to requests for information.
Most from poor families
Most of the hospital's heart patients come from poor families, so responsibility for their care lies in part with the agency that oversees Medicaid insurance plans, the state Department of Human Services.
David Kelley, chief medical officer at the agency's office of medical assistance programs, said that having a process to scrutinize patient deaths is essential to correcting problems.
Kelley said: "You want to have that process in place to figure out, 'Is there something we could have done to prevent that bad outcome?' "
The hospital did not admit fault but agreed to revise its quality goals and to review data monthly "to ensure consistent, reliable data collection." After a subsequent visit in June, state officials found the hospital was "in substantial compliance" after submitting what the agency calls a plan of correction.
Hospital officials declined the Inquirer's request to discuss the state findings. Asked if they reviewed the cases after the state visit, hospital spokeswoman Kate Donaghy said in an email: "The cases were reviewed and we cannot comment further."
The heart-surgery program remains shut down except for emergency operations.
"We have not yet resumed elective cases as we continue to thoroughly evaluate our options," Donaghy wrote.
Kelley said children in need of heart operations are being steered to Children's Hospital of Philadelphia and Nemours/Alfred I. duPont Hospital for Children in Wilmington.
The state investigation found that, for the cases of the nine dead children it reviewed, the hospital had failed to provide evidence that it had tried to find out precisely what killed them.
In one case, a baby died at the hospital after an accident with a life-support machine that occurred more than two months after surgery.
Hospital employees provided records indicating that "massive amounts of air" were observed in tubes delivering blood to the child, a dangerous condition. But four years after the fact, there was no record that anyone had tried to find out what happened.
"There was no documented evidence provided to show that this event was critically analyzed to determine the root cause, including how air got into the machine, or other contributing factors, in order to prevent recurrence," the state report said.
In an interview with state investigators, one employee said the hospital did not know whether the episode was due to the machine operator having recently come back from maternity leave or due to a machine malfunction.
The report does not identify the child by name, but the date of treatment and other details match those of La'Kel Alford-Robbins, whose parents recently settled a lawsuit against St. Christopher's.
The baby's father, Leonard Alford, declined to reveal the settlement amount but said what he really wanted was an apology. Told of the state investigation, he said neither that nor the financial settlement would help him get over La'Kel's death.
"It was never about the money," said Alford, who lives in Northeast Philadelphia.
"Our clients are happy that this is resolved," said family lawyer Joe H. Tucker Jr.
Tucker's firm also represented a whistle-blower who operated a heart-lung bypass machine at St. Christopher's. He alleged that the hospital had provided deficient care to 10 heart-surgery patients who died or suffered neurological complications.
In a third case, Tucker's firm won a $1.3 million jury verdict on behalf of one of the 10 patients.
In that case, baby Adrian Wilson underwent a difficult heart operation called the Norwood when he was 2 days old. Adrian initially appeared to be faring well, according to medical records cited during the trial, but he died less than three weeks later.
The jury found an anesthesiologist gave the baby an excessive amount of calcium.
Separate from the report on heart surgeries, a second state report detailed what one hospital official termed a potentially lethal chemotherapy overdose, administered to a boy named Isaac Harrison just before his first birthday.
The medicine, called etoposide, is not normally administered to children, so clinicians had to calculate the proper dose manually.
But the child was given 10 times the proper dose, due to an oncologist's "typographical error," the report said.
The error was missed by multiple staff members. Three other unnamed oncologists were involved in drawing up the baby's chemo treatment plan, and multiple pharmacists prepared the drugs.
Those pharmacists had not worked with chemo frequently, but the job fell to them because the "normal chemo" pharmacist was not on duty, employees told investigators.
The medicine was so "highly concentrated" that it clogged up tubes through which it was administered on three occasions over five days, the report stated.
Yet the hospital was unable to provide evidence that physicians or pharmacists were notified on the first two occasions, even though nurses had to flush out the tubes to keep the chemotherapy flowing.
Records revealed that of the six nurses who administered or verified the medication, two were not certified to give chemotherapy. Three other nurses who administered different cancer medications also were not certified to do so, the report found.
Last spring, at least 350 nurses signed a petition challenging the hospital's practice of temporarily reassigning them to other areas.
"The children that come to our hospital deserve safe staffing and experienced nurses at their bedside on every unit and shift!" the petition stated.
The Inquirer began a review of heart surgery at St. Christopher's last year after the hospital was the only one that did not participate in a first-ever state evaluation of such programs.
By analyzing insurance claims data, the newspaper found that between 2009 and 2014, one in four babies who were less than a month old had died after complex, highly risky heart operations performed at St. Christopher's. That is nearly triple the death rate at Children's Hospital of Philadelphia, the other city hospital that operates on children born with severe heart defects.