A liver transplant surgeon at Memorial Hermann-Texas Medical Center frequently altered patients' records in a national database, potentially preventing them from receiving transplants, according to CMS documents obtained by the Houston Chronicle.
During an April 4 inspection of the Houston-based hospital, federal regulators reviewed the records of 14 patients in the liver transplant program, 12 of whom had their records improperly changed in the United Network for Organ Sharing database. The surgeon — who was not named in the inspection report though has been identified by the hospital as Steve Bynon, MD, — often altered records to create restrictive donor criteria for patients, typically around the time a patient became ill. Patients were not notified when such changes were made.
According to the inspection documents, Dr. Bynon admitted to changing information in the database, dismissing federal rules. He is quoted as saying he took a "shortcut" to "ensure patients were safely transplanted," while other hospital officials told surveyors he made the changes because his patients were sick.
In one case, when a patient who was on the transplant waiting list was hospitalized in November with sepsis, the surgeon altered the donor acceptance criteria so the patient would only be able to receive an organ from a donor under 6 years old who weighed between 70 and 200 pounds, according to the Chronicle's report. Less restrictive criteria were put back in months later.
When patients become too sick, it's not unusual for them to be inactivated from a transplant wait list. Such instances require a formal review process and that programs formally classify a candidate as indicative in the national transplant system — both processes that were not followed in these cases.
Dr. Bynon is facing lawsuits from the families of multiple patients who claim their loved one died due to the inappropriate changes. The surgeon and his attorney did not respond to the Chronicle's request for comment.
In a statement to Becker's, Memorial Hermann said it removed Dr. Bynon from his leadership position days after the Organ Procurement and Transplantation Network informed hospital officials in March of inappropriate changes in the UNOS database.
The hospital's liver and kidney transplant programs have been on pause since April. In its statement, Memorial Hermann said inappropriate changes to donor acceptance criteria are limited to the liver transplant program, but that officials decided to voluntarily halt the kidney program as well since it shares the same leadership structure.
Memorial Hermann has submitted a corrective plan in response to deficiencies cited by regulators and is taking steps to "ensure these issues cannot happen again," it said in a statement.
"These changes include limiting access to UNet, expanded documentation requirements, two-person validation processes for data entry and additional enhanced protections. The Transplant Quality Manager performs an audit, and the Transplant Oversight Committee reviews the process."
CMS and officials with Texas Health and Human Services conducted a recent inspection and found "[the hospital staff] had taken appropriate corrective action and are fully compliant," the hospital said.
Meanwhile, federal health officials continue to investigate. Memorial Hermann has said it is planning to reactivate its kidney transplant program under a new leadership structure, though it has not specified a date or shared information on plans to reactivate liver transplants.