The federal Centers For Medicare And Medicaid have accepted a corrective action plan for both Mount Carmel West Hospital and Mount Carmel St. Ann's.
Mount Carmel Health System announced on February 1 that it was placed in “immediate jeopardy” by CMS, putting the hospitals at risk of losing federal funding. Mount Carmel sent CMS a "plan of correction" three days later.
According to documents acquired by WOSU, Ohio Department of Health surveyors outlined a number of policy deficiencies and failed safeguards that contributed to "excessive" dosing of ICU patients – including that employees were able to override safety checks from an automated medication dispensing system, and that the hospital maintained insufficient guidelines for fentanyl doses in palliative care.
The department determined the facility “failed to prevent patients from receiving an overdose” from medications such as fentanyl, a powerful painkiller.
"Based on an interview and record review," the document says, "the hospital failed to ensure a system was in place to monitor and prevent large doses of central nervous system medications from being accessed from the automated medication dispensing system."
In their plan to CMS, Mount Carmel lays out corrective actions the hospitals intend to follow. The hospital writes that "preparation and execution of this plan of correction does not constitute an admission or agreement of the facts alleged or conclusions set forth."
Mount Carmel is not commenting at this time.
Mount Carmel Health is currently under internal and external investigation for what the hospital calls "excessive" and "potentially fatal" painkiller doses prescribed by now-fired doctor William Husel.
Husel was removed from patient care duty in November and fired in December. The hospital announced last month that at least 34 patients had received higher-than-normal doses during his five-year tenure.
All the patients died after receiving the drugs, though the hospital says the drugs were not the cause of death in some of the cases. Husel's medical license was suspended by the State Medical Board last month.
As of Tuesday, at least 15 wrongful death lawsuits have been filed against Mount Carmel and Husel by the families of Husel's patients, who came under Husel's care in the ICU. Many of the suits accuse Mount Carmel of failing to properly review the painkiller doses.
The Ohio Department of Health, working on behalf of CMS, concluded its review of Mount Carmel on Jan. 16, 2019. The next day, the hospital was notified that they were in “immediate jeopardy” for not complying with pharmaceutical services guidelines, as written by the Medicare Condition of Participation.
In their report, ODH surveyors write that they reviewed an automated medication dispensing system override report at Mount Carmel. That report shows that 24 of the original 27 patients identified had medications dispensed from that machine while it was in "override" mode – meaning medication approval wouldn’t have to go through the usual channels.
During an interview on January 16, an unnamed physician stated that there was no “lock out” on the automated medication dispensing system, meaning there were no safeguards to prevent staff from overriding the system and getting more medications out of it.
Many of the patients involved were reportedly near-death, and on life support. The document states that fentanyl was not a listed medication for “palliative ventilator withdrawal” and as such, there was no written policy on how much fentanyl would be appropriate to make a patient comfortable.
Corrective actions laid out by Mount Carmel include limiting the availability of opioids in automated medication dispensing systems, reducing number of medications available through an override of the system, and reviewing high risk medication overrides every day.
At least 23 nurses, pharmacists and other employees have been placed on leave since the hospital's investigation began, and the Chief Pharmacy Officer left the hospital last week.
The new report draws further scrutiny to previous statements made by Mount Carmel administrators. In January, Mount Carmel CEO Ed Lamb attributed the doses to individual employees who "did not meet our standard of care."
"The actions that created this tragedy were instigated by this physician and carried out by a small number of good people who made poor decisions," Lamb said in a video to employees. "They ignored the safeguards we had in place.”
Several Mount Carmel employees, speaking to WOSU on conditions of anonymity, argued the hospital's policies were not clear enough to justify punishing staff members who followed doctors' orders.
The Franklin County Prosecutor's Office is currently investigating.
This story will be updated with more information.
If you are a Mount Carmel staffer who has information to share, or you believe your loved one or family member was impacted by this case, contact WOSU at firstname.lastname@example.org.