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Based on observation, interview, record review, and review of facility documents, the facility failed to meet the Conditions of Participation for Emergency Services by failing to ensure appropriate medications used for life-saving measures were immediately available putting all patients at risk who require emergency services (Refer to C-203 regarding medication availability in the Emergency Department).

Findings include:

An Immediate Jeopardy (IJ) was identified and notification to the facility was made on 10/21/19 at 4:18 PM regarding the presence of succinylcholine chloride (a rapid acting muscle relaxant medication used for emergency intubations) in the Emergency Department (ED). It was further determined the facility failed to have the medication dantrolene used to treat Malignant Hyperthermia (MH), (a potentially fatal condition that can occur from the use of succinylcholine).

The Malignant Hyperthermia Association of the United States (MHAUS) states the nationally accepted standard is for 720 total milligrams (mg) of dantrolene to be stocked in a facility that uses succinylcholine chloride for emergency purposes.

IJ was formally determined to exist on 10/21/19 at 12:00 PM under 42 CFR 485.618 Emergency Services at C-0200. The Chief Executive Officer (CEO) was notified of the identified IJ on 10/21/19 at 4:18 PM, and of the need for a Plan of Removal to be put in place immediately to remove the IJ.

A final Plan of Removal was submitted to the Centers for Medicare & Medicaid Services (CMS) and Regional Office (RO) on 10/22/19 at 1:30 PM.

The following is the facilities official plan of removal for the Immediate Jeopardy identified at Cass Lake Indian Health Service (IHS) Hospital due to the presence of Succinylcholine in the facility and the absence of dantrolene:

1. The Pharmacy and Therapeutics (P&T) committee of the hospital approved the immediate removal of succinylcholine chloride from the formulary and shelves on 10/22/19 at 10:00 AM.

2. Immediate reeducation and notification of nursing staff, pharmacy staff and providers began on 10/21/19 to inform the staff of the medication removal and alternative medications available for use in the event of the need to intubate a patient.

3. The current stock of succinylcholine chloride was removed from the Rapid Sequence Intubation (RSI) kit and the Omnicell's of the hospital and the pharmacy removed the medication from the hospital's order sets on 10/21/19 at 4:00 PM.

4. The facility determined if RSI was necessary, the facility would provide Ketamine, Amidate (Etomidate), Lidocaine, Atropine, Versed (Midazolam), or Norcuron (Vecuronicum) to maintain sedation and/or paralysis.

The facility's "Plan of Removal" was validated by on site surveyors through an additional inspection and review of documentation to ensure the removal plan was implemented. The validation of the facility's "Plan of Removal" was provided to CMS and the RO on 10/22/19 at 2:50 PM, at which time the CEO was notified that the IJ was considered removed.

Based on observation, interview, record review, and documentation review, the facility failed to ensure medications used for life-saving measures were immediately available putting all patients at risk who require emergency services.

The failure of the Critical Access Hospital (CAH) to recognize the potential occurrence of life-threatening reactions to the administration of succinylcholine chloride (a rapid acting muscle relaxant medication used for emergency intubations) during rapid intubation of patients, and the failure to maintain a supply of dantrolene onsite to counteract Malignant Hyperthermia (MH), (a potentially fatal condition that can occur from use of succinylcholine) had the potential to affect all patients presenting to the CAH for emergency treatment and represented an immediate jeopardy situation. (Cross reference C-0200 for further information.)

Findings include:

Observation of the facility's Emergency Department's (ED) trauma room on 10/21/19 at 12:00 PM, in the presence of the Acting Pharmacy Director and day shift ED registered nurse (RN)1 revealed six vials of succinylcholine chloride, two vials were in the crash cart and four vials were in the Omnicell (a locked cabinet for medications) for use in Rapid Sequence Intubation (RSI. Inspection of the ED trauma room's crash cart revealed dantrolene was not available for treatment of MH. According to the Malignant Hyperthermia Association of the United States (MHAUS) website recommendation, the appropriate amount on hand should be 36, 20 milligram (mg) vials of generic dantrolene (total dose of 720 mg) or three 250 mg vials of ryanodex (total dose of 720 mg). When questioned, the Acting Pharmacy Director stated there were no vials of dantrolene on hand in the hospital and she was not aware of the need for dantrolene on site. Additionally, ED RN1 was not aware of what dantrolene was, or indication for use.

During a joint interview with the Acting Pharmacy Director, primary ED Physician's Assistant (PA), and RN1 on 10/21/19 at 1:50 PM, they were referred to the national standard of care as outlined in the Malignant Hyperthermia Association of the United States (MHAUS) website recommendation, which states in part, " ...in a small percentage of cases MH appears to be triggered by succinylcholine alone ...Facilities that stock and have the potential to administer any triggering agent, including succinylcholine ...should have dantrolene immediately available (i.e., the ability to administer dantrolene within 10 minutes of the first sign of (MH) in the event that a patient in that facility develops MH."

During an interview with the Acting Pharmacy Director on 10/21/19 at 1:50 PM, she stated the hospital is unable to order dantrolene intravenous (through the hospital formulary), she can only order the oral route.

During an interview with ED RN1 on 10/21/19 at 1:50 PM, he stated succinylcholine was used on a patient in October 2019 and no dantrolene was available for use if needed.

During an interview with the ED PA1 on 10/21/19 at 2:00 PM, he stated he was aware of MH but was not aware that if using succinylcholine, the hospital should have dantrolene on site. He also confirmed a patient was given succinylcholine in October 2019.

Review of Patient (P) 1's ED medical record revealed that P1 was brought into the ED via ambulance on 10/12/19 at 10:36 AM unresponsive. P1 was given succinylcholine 125 mg intravenous at 11:03 AM and P1 was intubated at 11:05 AM. P1 was transferred from the hospital to a higher level of care at 12:40 PM.

During an interview with the Medical Director on 10/21/19 at 3:15 PM, he stated he was not aware that succinylcholine was used at the hospital. He further stated he was not an ED physician and does not perform RSI.

The Quality Manager, the hospital Accreditation Specialist and the Chief Executive Officer (CEO) were unable to provide a facility policy related to RSI, the use of succinylcholine chloride during RSI, or the need for the availability of dantrolene in the Emergency Department.

During a joint interview with the CEO and QM on 10/21/19 at 5:00 PM, the CEO stated the RSI policy " ... had been in draft form and waiting to be approved ..." prior to 10/21/19.

Review of the drug manufacturer's package insert (drug information sheet) for succinylcholine chloride injection, USP, revised 02/2019, revealed, "Succinylcholine is a depolarizing skeletal muscle relaxant . . . indicated . . . to facilitate tracheal intubation [insertion of an artificial breathing tube] . . . [and] has been associated with acute onset of malignant hyperthermia, a potentially fatal hypermetabolic state of skeletal muscle. . . . Malignant hyperthermia frequently presents as intractable spasm of the jaw muscles . . . which may progress to generalized rigidity, increased oxygen demand, tachycardia [rapid heart rate], tachypnea [rapid breathing] and profound hyperpyrexia [fever]. . .. Intravenous dantrolene sodium is recommended as an adjunct to supportive measures in the management of this problem."

Review of the drug manufacturer's package insert for dantrolene sodium, revised 01/2019, revealed, "Dantrolene Sodium for Injection is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Dantrolene Sodium for Injection should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized."

Based on observation, document review, and interview, the facility failed to demonstrate compliance with the requirements found at 42 CFR 485.623(d), Life Safety and Fire, and the related National Fire Protection Association (NFPA) standard 101-2012 edition during the survey conducted from 10/21/19 to 10/24/19.

Please refer to the citations at K-271, K-311, K-324, and K-911.

Based on observation, record review, and interview, the facility failed to demonstrate compliance with the requirements of the National Fire Protection Association (NFPA) standard 101-2012 edition.

Please refer to the citations at K-271, K-311, K-324, and K-911 cited during the survey conducted 10/21/19 through 10/24/19.