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What is in Mount Carmel's "Plan of Correction"?

We recently obtained a copy of Mount Carmel's "Plan of Correction," which details, among other things, the following information:

  • How Dr. Husel, the nurses, and pharmacists were able to access such inappropriate doses of pain medication for patients;
  • Mount Carmel's violations of federal regulations; and
  • Mount Carmel's policy changes and new training regimen

In summary Mount Carmel is acknowledging that, in most cases, the medication was obtained using some type of system override, roughly half of the time without pharmacy approval. Even when pharmacy approval was given, it was often after the fact and did not appear to challenge the use of the medication. Mount Carmel also acknowledges the "usual adult dose" of Fentanyl (25-100 mcg) as being far less than the amounts used by Dr. Husel in these cases. They also note the usual dose of Versed and Dilaudid are much lower, and those are the only drugs listed in the "palliative ventilator withdrawal" policy. In other words, Fentanyl was not intended to be used in the scenarios in which Dr. Husel used it, in these cases, even at appropriate amounts. 

They also acknowledged that there was no limitation on how many times physicians could override the system to obtain medications, and the chief pharmacy officer had no explanation for why this continued to happen, for so long.

The report details the actions Mount Carmel has already taken, and will continue to take, to address the issues identified by the government, which put patient safety in jeopardy. The main issues identified by the government (as well as some of the more pertinent "fixes") are:

(1) Accessing these medications from the automated medication system using override function;

  • Physicians can no longer do a medication override for inpatients, including limited availability for Fentanyl, which is now solely available at a max of 250 mcg in the ER
  • Reduced number of medications available for override by 55%
  • Greatly limited the ability of nurses to override for medication
  • New training materials about the high risk medications and limitations on use of medications
  • Daily review of all medication overrides

(2) Not following the guidelines for use of high-risk medications, like Fentanyl;

  • Fired Dr. Husel and put 20 other staff on leave
  • Created new pharmacist documentation and escalation policy relating to high risk pain meds
  • Revised chain of command to include reporting of pharmacists who vary from appropriate care
  • Chain of command issues will be reviewed daily by hospital leadership
  • Data regarding high risk pain medication use will be reviewed monthly by various patient safety groups at Mount Carmel

(3) Not following the policy for palliative ventilator withdrawal;

  • Revised policy to mandate only using the standard orders for medication set forth in the policy, and requires physician who wants to use medications beyond the standard orders, to get approval from the VP of Medical Affairs or Medical Director
  • New training program on this policy as well as creation of new documentation requirements for ventilator withdrawal

(4) Improperly using verbal/telephone orders for medication; and

  • Revised verbal order policy to clarify when they may be used
  • Multiple new training programs on use of verbal/phone orders and communication relating to palliative ventilator withdrawal
  • Verbal and phone order data will be reviewed monthly by various patient safety groups

(5) Pharmacy improperly approving of large doses of opioids, like Fentanyl.

  • New documentation and escalation policies for any concerning orders of opioids
  • New training regarding chain of command relating to concerning orders
  • All high risk opioid orders must be signed off by pharmacy leader, to be reviewed daily
  • Pharmacist education on maximum single and cumulative doses of high risk pain medication, and rejection of orders that exceed those limitations.

While there are still a lot of unanswered questions relating to this tragedy, this at least provides answers to some of the basic questions of how these inappropriate orders were allowed to occur, and how they are preventing anything like this from ever happening again.

The attorneys at Leeseberg & Valentine are working hard to get answers and obtain justice for the victims' families of the Mount Carmel tragedy. If you received a call from Mount Carmel notifying you that your loved one may have been given an inappropriate and potentially lethal dosage of pain medication, please contact our office today to see if we can be of assistance to you.

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