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Based on observation and interview, 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. This failure put all patients who require emergency intubation at risk for preventable complications. (Refer to C-203 regarding medication availability in the Emergency Department).

Findings include:

An Immediate Jeopardy (IJ) was identified on 11/18/19 at 11:20 AM, during an inspection of the Emergency Department (ED) with Register Nurse (RN) 1 and the Administrator. Observations conducted in the ED revealed 2 Rapid Sequence Intubation (RSI) kits located in the ED. Each RSI Kit contained two 200 mg/10 ml vials of Succinylcholine Chloride (a rapid acting muscle relaxant used for emergency intubations). It was further determined the facility failed to have the medication Dantrolene used to treat Malignant Hyperthermia (MH), (an often fatal condition that can potentially occur from the use of Succinylcholine) available in the facility for emergency response.

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 11/18/19 at 3:05 PM under 42 CFR 485.618 Emergency Services at C-0200. The Administrator was notified of the identified IJ on 11/18/19 at 3:35 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 Center for Medicare & Medicaid Services (CMS) State Survey Agency (SSA) on 11/18/19 at 5:30 PM.

The following is the facilities official plan of removal for the Immediate Jeopardy identified at San Luis Valley Health Conejos County Hospital due to the presence of Succinylcholine in the facility and the absence of Dantrolene:

1. All Succinylcholine Chloride medications were removed from the RSI kits and pharmacy of the facility on 11/18/19 at 3:00 PM by the Pharmacy Director and all pharmacy staff were notified of the removal of the medication from the hospital's formulary.

2. The Director of Nursing updated the RSI kit content list, ED charge sheets, and educational materials related to emergency medications on 11/18/19 at 3:30 PM

3. The electronic medication order sets for ED RSI were updated to eliminate the option for Succinylcholine Chloride on 11/18/19 at 4:20 PM

4. On 11/18/19 at 4:25 PM, the Chief Medical Officer (CMO) sent email correspondence regarding the removal of Succinylcholine Chloride to all hospital providers (14) and nursing staff (23). The hospital will validate all providers and nurses have received and acknowledge this correspondence prior to the beginning of their next shift.

5. Hospital policies titled, "Adult Rapid Sequence lntubation" and "Mechanical Ventilation" were updated to reflect the removal of the medication from use on 11/18/19 at 4:25 PM.

6. The hospital's quality assurance team initiated monitoring of the facility's pharmacy formulary to ensure Succinylcholine Chloride has not been added back to the formulary.

7. The removal plan was determined to be fully implemented on 11/19/19 at 9:20 AM.

Supporting documentation submitted with the "Plan of Removal" on 11/18/19 at 5:30 PM included copies of the new ED supply lists, the new ER and Pharmacy policies related to "Adult Rapid Sequence lntubation" and "Mechanical Ventilation", a written QA plan for audits, copies of medication order sheets, and the email correspondence regarding the removal of Succinylcholine Chloride to all hospital providers (14) and nursing staff (23).

The "Plan of Removal" was approved by the Center for Medicare & Medicaid Services (CMS), State Survey Agency (SSA) on 11/18/19 at 10:52 PM.

All steps delineated in the Plan of Removal were validated by on-site surveyors as follows:

On 11/19/19 at 8:45 AM observation of all medication storage areas validated all Succinylcholine vials were removed from the facility and unavailable for use.

On 11/19/19 at 9:00 AM review of policies revealed new ER and Pharmacy policies related to RSI medications were signed by the Administrator and the CMO.

On 11/19/19 at 9:05 AM review of the initial Quality Assurance (QA) audit and review of the written plan for ongoing audits, and interview with the QA Coordinator, validated the QA process for the removal plan.

On 11/19/19 at 9:10 AM interviews with the Administrator, ED Medical Director, ED providers, DON, and staff nurses revealed staff education regarding new ER and Pharmacy policies was initiated and confirmed hospital staff had been notified and educated on the new ER and Pharmacy policies regarding RSI.

The facility's "Plan of Removal" was validated by on site surveyors via an additional inspection and review of documentation to ensure the plan of removal was implemented. Validation of the implementation of plan of removal was provided to the SSA 11/19/19 at 9:20 AM, at which time the Administrator was notified that the IJ was considered removed.

Based on observation, interview, and medical record review, the facility failed to ensure it maintained a supply of medication to reverse a potentially life-threatening side effect of another medication used by the facility during emergencies. Failure to anticipate the need for care of medication side-effects during medication administration had the potential to negatively impact all patients requiring rapid sequence intubation (RSI) or presenting to the facility for emergency care.

Findings include:

On 11/18/19 at 11:15 AM, observation of the facility's Emergency Department (ED) revealed 2 Rapid Sequence Intubation (RSI) kits located in the ED. Each RSI Kit contained two 200 mg/10 ml vials of Succinylcholine Chloride (a rapid acting muscle relaxant used for emergency intubations). However, the observations further revealed there was no evidence the facility stocked Dantrolene (a medication used to counteract a possible side-effect of Succinylcholine Chloride called Malignant Hyperthermia (MH), a life-threatening medical crisis which causes high fever and skeletal rigidity).

On 11/18/19 at 11:20 AM, interviews were conducted with the Administrator and Registered Nurse (RN)1. RN1 stated the Succinylcholine Chloride was stocked for use in emergency Rapid Sequence Intubation (RSI, a procedure used when a patient requires immediate insertion of an endotracheal tube to maintain an airway and/or provide supplemental oxygen). When questioned, the Administrator stated the facility did not stock Dantrolene and the Administrator and RN1 were not unaware of the need for Dantrolene to be immediately available as an intervention for MH. The Administrator confirmed with Pharmacy Director there was no Dantrolene stocked in the facility. In addition, RN1 stated Succinylcholine Chloride had been administered to Patient (P) 23 on 11/10/19.

An interview with the Pharmacy Director on 11/18/19 at 12:50 PM revealed the facility did not stock Dantrolene Sodium in a MH cart, Omnicell (secure drug unit), or in the pharmacy of the facility. The Pharmacy Director stated Dantrolene Sodium was not available in the hospital until 11/18/19 at 12:30 PM and was not in the hospital's stock of medications prior to the beginning of the recertification survey or initial tour of the ED.

An interview conducted with the Administrator on 11/18/19 at 2:00 PM revealed Dantrolene was previously stocked in the facility and was taken out of the hospital's medication stock on approximately 09/01/18. In addition, the Administrator stated 2 patients have been administered Succinylcholine Chloride from 09/01/18 to 11/18/19.

Interview with the ED Physician (EDP) 2 on 11/18/19 at 2:40 PM revealed the EDP2 was aware Succinylcholine was available in the RSI Kits of the hospital. However, EDP2 was not aware Dantrolene was not available in the hospital. In addition, EDP2 stated he had not administered Succinylcholine Chloride in the past 5 years and prefers to use an alternative medication (rocuronium). EDP2 further stated he has performed RSI twice in the last 6 months.
Review of the ED medical record of P23 revealed P23 was admitted to the ED of the facility on 11/10/19 at 4:27 AM with a diagnosis of severe respiratory distress. P23 was administered Succinylcholine Chloride on 11/10/19 at 8:07 AM during intubation in the ED, and transport of the patient out of the facility via ambulance at 9:40 AM, or one hour 33 minutes following administration of Succinylcholine. P23 did not have the potential side effect of Malignant Hyperthermia prior to leaving the facility but was put at risk.

The Malignant Hyperthermia Association of the United States (MHAUS) recommendations are: "Any facility using a trigger for malignant hyperthermia (potent volatile anesthetics and/or succinylcholine) must assure there is a sufficient supply of dantrolene sodium for injection available within 10 minutes." In addition, MHAUS guidelines state, " ...the one-hour period immediately following (use of Succinylcholine) is a critical time."