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Based on observation, interview and policy review, the Critical Access Hospital (CAH) failed to have in stock and immediately accessible sufficient amounts of Dantrolene (medication used to reverse malignant hyperthermia (MH), a rare life-threatening condition causing a severe high body temperature trigged by exposure to drugs used in emergency situations).

The failure of the CAH to maintain sufficient amounts of Dantrolene required for emergency use placed all patients at risk for serious injury, serious harm, serious impairment or death should Malignant Hyperthermia (an often-fatal side effect that can occur from the administration of the medication Succinylcholine Chloride, a paralytic medication used during rapid sequence intubation) occur during placement of an endotracheal tube (a tube placed in the airway to help a patient breath). Refer to C0203.

Findings Include:

Document review on 11/04/19 at 4:30 PM of the facility policy, "Checking Drug Outdates Policy and Procedure" revised 10/12/18 stated, On the first of the month all medications in the following areas are to be checked for outdates by the night shift RN/LPN. ... Pharmacy-Ambulance Box and all other meds in the pharmacy are checked by the Pharmacy supervisor.

Recommendations by the Malignant Hyperthermia Association of the United States (MHAUS) standard of treatment is: to treat an MH episode, an initial dose of dantrolene at 2.5 mg/kg is recommended, with a suggested upper limit of 10 mg/kg. If a patient of average weight (approximately 70 kg) were to require dantrolene at the upper dosing limit, then at least 700 mg of dantrolene would be needed. A minimum required stock of Dantrolene is 36-20mg vials.

During a facility tour on 11/04/19 at 9:00 AM, The MH kit contained 36 vials of Dantrolene, however 18 of the vials were expired. The practice of using Succinylcholine Chloride to paralyze muscles during emergency rapid sequence intubation (RSI) was confirmed by the Associate Director of Nursing (ADON) during this tour.

During an interview on 11/04/19 at 9:40 AM, Staff E, Pharmacy Manager removed the 18 expired vials of Dantrolene from the malignant hypothermia kit and ordered replacements. Staff E, Pharmacy Manager started to research for a generic replacement for the Dantrolene and failed to order the replacements.

Based on observation, interview, and policy review, the Critical Access Hospital (CAH) failed to maintain sufficient amounts of Dantrolene (medication used to reverse malignant hyperthermia (MH), a rare life-threatening condition causing a severe high body temperature triggered by exposure to drugs used in emergency situations) and failed to replace outdated Dantrolene. Failure by the facility to provide sufficient useable amounts of Dantrolene has the potential to negatively impact all patients requiring administration of Succinylcholine (a paralytic used during rapid sequence intubation) for rapid sequence intubation (RSI) resulting in worsening of the patients' condition or even death.

An IJ was formally determined to exist on 11/05/19 at 4:15 PM under 42 CFR 485.618 Emergency Services. Staff A, Administrator, Staff D, Acute Care Ward/ Emergency Room Director of Nursing (ACW/ER DON), Staff E, Pharmacy Manager, and the CMO were notified of the IJ on 11/05/19 at 4:30 PM.

The IJ was removed on 11/05/19 at 6:30 PM, when the CAH submitted an acceptable Plan of Removal that included:

1. All Succinylcholine Chloride was removed from all areas of the hospital, including the emergency room (ER) and operating room (OR) on 11/05/19 at 5:30 PM by facility Director of Nursing (DON) and Pharmacy Registered Nurse (RN).

2. The Chief Medical Officer (CMO), all medical staff, and the RN shift leader of the acute care ward (ACW) were notified on 11/05/19 at 5:30 PM that Succinylcholine Chloride was removed from all areas of the hospital and would not be available until a total of 36 vials of Dantrolene were restocked.

3. The CMO determined on 11/05/19 at 5:30 PM alternate medications consisting of Rocuronium or Vecuronium (muscle relaxers) would be available for use during the time the Succinylcholine Chloride was unavailable, and the DON confirmed the availability of the medications. Sufficient amounts of Dantrolene were ordered with scheduled delivery on 11/06/2019.

4. All facility policies regarding medication outdates were reviewed and updated to included specific medication kits stored in the pharmacy on 11/05/19 at 5:30 PM. Physicians and staff with the authority to dispense, order or administer medications received the updates.

Staff A, Administrator and the DON were notified of the IJ removal on 11/05/19 at 6:30 PM.

Findings Include:

Review of the facility policy, "Checking Drug Outdates Policy and Procedure" revised 10/12/18 showed, "On the first of the month all medications in the following areas are to be checked by the night shift RN/LPN ... All other meds in pharmacy are checked by the Pharmacy supervisor."

Recommendations by the Malignant Hyperthermia Association of the United States (MHAUS) standard of treatment is: to treat an MH episode, an initial dose of dantrolene at 2.5 mg/kg is recommended, with a suggested upper limit of 10 mg/kg. If a patient of average weight (approximately 70 kg) were to require dantrolene at the upper dosing limit, then at least 700 mg of dantrolene would be needed. A minimum required stock of Dantrolene is 36-20mg vials.

Observation during the tour of the pharmacy MH kit on 11/04/19 at 9:30 AM revealed a total of 36 vials of Dantrolene with 18 of the 36 vials expired. The ADON confirmed that Succinylcholine Chloride is used during RSI.

During an interview with Staff E, the pharmacy Registered Nurse (RN) stated, "We keep 36 vials of Dantrolene, but we just discovered that 18 of them expired 11/01/19."

During a joint interview on 11/04/19 at 9:30 AM with the Assistant Director of Nursing (ADON), Staff E, pharmacy RN, and Staff A, Administrator it was agreed that the facility did not have a sufficient amount of Dantrolene available to treat MH should a case occur.