Inspection finds Mount Carmel St. Ann’s not in compliance with Medicare standards

File photo - Mount Carmel West (WBNS-10TV)

A federal health agency tasked with overseeing patient safety inside the nation’s hospitals has found that Mount Carmel St. Ann’s is still not in compliance with some federal Medicare standards.

The discovery has occurred in the wake of the patient overdosing scandal in which 35 patients are believed to have received excessive doses of pain medication between 2014 and 2018.

In a letter dated April 2, the Centers for Medicare and Medicaid Services wrote to Mount Carmel St. Ann’s:

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“On February 1, 2019, we informed you that we had removed Mount Carmel St. Ann’s deemed status in response to the January 24, 2019 substantial allegation (complaint) survey conducted by the Ohio Department of Health (ODH). The survey revealed that your hospital was not in compliance with the Medicare Condition of Participation of Pharmaceutical Services. In our notice to you dated February 22, 2019, we advised you that your hospital remained under the survey jurisdiction of the ODH, as a result of the followup survey on February 12, 2019, and that they would return to your hospital to determine compliance with all of the Medicare Conditions of Participation.

The January 24, 2019 survey conducted by the ODH found noncompliance with the following Condition of Participation:

42 CFR §482.25 Pharmaceutical Services.

The followup survey conducted by the ODH on February 12, 2019, found ongoing noncompliance with the following Condition of Participation: 42 CFR §482.25 Pharmaceutical Services.

The additional survey completed on March 15, 2019 by the ODH found that your hospital does not meet the following Condition of Participation: 42 CFR §482.41 Physical Environment.

We have determined that the deficiencies are significant and limit your hospital's capacity to render adequate care and ensure the health and safety of your patients. In addition, a number of deficiencies were found in other Medicare requirements. Enclosed is a complete listing of all deficiencies cited.”

In a letter dated April 3, the Centers for Medicare and Medicaid Services said Mount Carmel St. Ann's was in compliance for pharmaceutical services.

Mount Carmel St. Ann’s now must submit a plan of correction if it hopes to avoid losing its federal Medicare funding.

All patients embroiled in the dosing scandal died and all were under the care of Dr. William Husel, who the hospital fired in December after an internal investigation. Thirty-four of the patients were at Mount Carmel West. One of the patients - Robert Lee - was at Mount Carmel St. Ann’s where he died in 2017, his family says after receiving a fatal dose of fentanyl. Lee had suffered cardiac arrest but been revived before receiving the dose of pain medication.

The hospital had said that 29 of the patients received potentially fatal doses and that the other six received doses that went beyond providing comfort but were likely not the causes of their deaths. The hospital has since acknowledged in recent months that at least five of the patients could have seen their conditions improve with treatment.

The hospital has made a series of corrections including restricting the use and dosages of certain pain medications like fentanyl and requiring that nurses and doctors must get pharmacy approval before administering pain medications when removing a ventilator. Most of the patients involved received doses of pain medication when their ventilators were being removed.

Records provided to 10 Investigates from The Centers for Medicare and Medicaid Services show that Lee had suffered cardiac arrest on October 12, 2017 and that his wife had agreed to not resuscitate “in the event the heart stopped,” a nurse practitioner noted on October 12, 2017, around 4:30 p.m.

The next day, at 7:19 a.m., a physician’s progress note from Physician A — believed to be Dr. Husel — stated that the family was in full agreement to withdraw care.

Ed Lamb, president and CEO of Mount Carmel Health System, sent 10TV the following statement:

Mount Carmel has made and continues to make changes throughout our system to prevent the improper actions that may have led to the deaths of patients under Dr. William Husel's care. We remain committed to cooperating fully with all authorities and regulators as they investigate this matter, including the Centers for Medicare & Medicaid Services (CMS) and the Ohio Department of Health (ODH). As expected, CMS and ODH recently conducted another survey that included all areas of Mount Carmel St. Ann's and its associated facilities. One of the results was that pharmacy services is now in full compliance at Mount Carmel St. Ann's.

As part of this more expansive survey, CMS identified other areas that need improvement—particularly as it relates to the physical environment of the facilities. We immediately began correcting items identified by CMS surveyors while they were still on site, and will submit a formal plan that addresses every finding. As of today, all items have been corrected or are in the process of being corrected. Once our plan is accepted, we expect CMS to return for a follow-up visit to assess and confirm that all appropriate actions are complete and effective.

In the meantime, nothing changes our ability to treat patients covered by Medicare or Medicaid.

There is nothing more important to Mount Carmel than the safety of our patients and their trust in us. We continue to learn from these events, and we are confident that we have processes in place to ensure the safety of our patients and their families.