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Based on observation, interview, and review of facility documents and policies, the facility failed to meet the Conditions of Participation for Pharmaceutical Services by failing to ensure appropriate medications used for life-saving measures had not passed their expiration date putting all patients at risk who require surgical services (Refer to A-505 regarding expired medication).

Findings Include:

An Immediate Jeopardy (IJ) was identified and notification to the facility was made on 11/21/19 at 12:50 PM regarding the presence of the expired medication dantrolene used to treat Malignant Hyperthermia (MH), (a potentially fatal condition that can occur from the use of succinylcholine, a rapid acting muscle relaxant medication used for emergency intubations). The 36 vials of dantrolene had an expiration date of 09/2019.

The Malignant Hyperthermia Association of the United States (MHAUS) states the nationally accepted standard is for 36 vials of dantrolene, to equal 720 total milligrams (mg), to be stocked in a facility that uses succinylcholine chloride for surgical purposes.

IJ was formally determined to exist on 11/18/19 at 1:30 PM under 42 CFR 482.25 Pharmaceutical Services at A-0490. The Chief Operating Officer (COO) was notified of the identified IJ on 11/21/19 at 12:50 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 and accepted on 11/21/19 at 3:45 PM.

The following is the facility's official plan of removal for the Immediate Jeopardy identified at Summit Surgical due to the presence of the expired dantrolene medication:

On November 18, 2019 the following steps were taken:

1. 36 vials of dantrolene were obtained from Hutchinson Regional Medical Center at 2:30 PM and were placed on the malignant hyperthermia cart.

2. The 36 vials of expired dantrolene were removed from the malignant hyperthermia cart on November 18, 2019 at 2:30 PM and placed with other outdated drugs in the specified area of the pharmacy labeled "outdated medications."

3. At 3:00 PM the malignant hyperthermia cart supply list was changed to a malignant hyperthermia "checklist" to be utilized on a monthly basis to check supplies and medications in the malignant hyperthermia cart.

4. The Operating Room (OR) Supervisor was educated on the updated policy and the malignant hyperthermia checklist. The OR Supervisor will be responsible for checking the cart on a monthly basis.

5. The malignant hyperthermia policy was revised to include information as follows:

a. The documentation that all patients are assessed for a history of, or family history of malignant hyperthermia (this was being done but had not been previously included in the policy).
b. The information pertaining to an anesthesia consult being conducted prior to the day of surgery if there is a patient or family history of malignant hyperthermia.
c. The statement that outdated medications will be replaced prior to the expiration date.

6. A skills competency fair had been scheduled for November 21, 2019 prior to the arrival of the surveyors. The competency fair and education program was carried out. As has been done annually the malignant hyperthermia cart and protocol was reviewed at the fair as well as the step-by-step procedure in the event of malignant hyperthermia. The COO did review at the competency fair that expired dantrolene was on the malignant hyperthermia cart and expectation of checking the cart was stressed.

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 the State Survey Agency on 11/21/19 at 3:45 PM, at which time the COO was notified that the IJ was considered removed.

Based on observation, interview, record review, and documentation review, the facility failed to ensure medication used for life-saving measures were not expired and were immediately available putting all patients at risk who require emergency services.

The failure of the Acute Care Hospital to maintain an unexpired supply of dantrolene onsite to counteract Malignant Hyperthermia (MH), (a potentially fatal condition that can occur from use of succinylcholine chloride) had the potential to affect all patients presenting to the Hospital for emergency treatment or surgery and represented an immediate jeopardy situation. (Cross reference A-0489 for further information.)

Findings Include:

Observation of the facility's Malignant Hyperthermia (MH) cart on 11/18/19 at 1:30 PM, revealed 36 vials dantrolene medication. All 36 vials of dantrolene had an expiration date of 09/2019.

According to 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 Chief Operating Officer (COO) on 11/18/19 at 2:00 PM, she confirmed the dantrolene was " ...outdated ..." and would replace the medication immediately. The COO stated the Operating Room (OR) supervisor was the staff responsible to check the MH cart, which included checking for outdated medications and supplies. She also stated the facility did not have a "formal checklist and no specific staff member checked the MH cart on a routine basis ..."

The expired dantrolene was replaced on 11/18/19 at 2:30 PM.

During a telephone interview the OR supervisor on 11/20/19 at 1:20 PM, stated she was the staff person responsible to check the MH cart for expired items and medications and could not explain why the expired medication was in the cart. The OR supervisor stated that prior to 11/18/19, the facility did not have a formal checklist in place to document when the check was done.

Review of the facility policy titled, "Malignant Hyperthermia Cart," revised 6/2013 stated, " ...the surgical department will have a cart stocked for the treatment of malignant hyperthermia at all times, will be maintained by the surgery personnel, and will be inspected once a month for inventory, expired drugs, etc..." The policy was updated on 11/21/19 to reflect " ...The malignant hyperthermia cart will be inspected once a month for inventory, expired drugs, etc. and marking the presence on the cart checklist. Items will be replaced prior to expiration by the person responsible for checking the cart ..."