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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 at risk who require emergency services at this facility.(Refer to C-203 regarding medication availability in the Emergency Department).

Findings include:

An Immediate Jeopardy (IJ) was identified on 07/22/19 at 10:05 AM, during an inspection of the Emergency Room (ER) medication supply room with Staff 2, the Director of Nursing (DON) related to the presence of the 46 vials of the medication 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 07/22/19 at 3:15 PM under 42 CFR 485.618 Emergency Services at C-0200. The Chief Executive Officer (CEO) was notified of the identified IJ on 07/22/19 at 3:26 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) and Regional Office (RO) on 07/25/19 at 11:33 AM.

The following is the facilities official plan of removal for the Immediate Jeopardy identified at Cimarron Memorial Hospital due to the presence of Succinylcholine in the facility and the absence of Dantrolene:

1. "Succinylcholene (sic) removed from pharmacy on 07/22/19 at 3:30 PM and was secured and made unavailable for use. Providers have formulated a plan to use Fantanyl (sic), Ketamine and Propofol if needed for RSI (Rapid Sequence Intubation).

2. Emergency Department and Pharmacy Department policies were written and put in place for Rapid Sequence Intubation (RSI) and use of Succinylcholine with the immediate availability of Dantrolene in the event of malignant hyperthermia." This policy was approved by the Chief of Staff and the CEO verbally on 07/22/19 at approximately 6:00 PM. The CEO signed this policy on 07/23/19 at 11:49 AM and the Chief of Staff replied by email giving his confirmation of approval on 07/23/19 at 1:52 PM.

3. The Pharmacy manager was notified on 07/23/2019 at 10:30 AM of the immediate need for Dantrolene. The hospital Pharmacist was notified of need for IV Dantrolene on 07/23/2019 10:35 PM (sic). On 07/23/19 at 10:00 AM the facility ensured 36 vials of Dantrolene 20 mg/ml (milligrams per milliliter) was ordered and expected to arrive in 3 to 5 business days. In addition, the pharmacy manager ordered 25 vials of Sterile Water without bacteriostatic agent 100 ml on 07/25/19 at 9:00 AM with an expected arrival on 07/26/2019.

4. QA (Quality Assurance) audits of the ER areas, medication rooms, pharmacy and crash carts to ensure Succinylcholine was secured and made unavailable for use until Dantrolene has been received. The audit will be reported monthly at the QA meeting. The weekly audit will be done for one month. At such time it will be determined if the safety measures have been followed. If it is deemed that safety measures are in place and followed, the audits will be done monthly and reported at the monthly QA meeting. At this time the QA Director will delegate the auditing to the Pharmacy Manager and the QA Director will do random audits to ensure compliance and report this at the monthly QA meeting. This audit will be done on a monthly basis for 6 months. At this time, it will be discussed in medical staff meeting and determined at that time if safety measures have been followed then the audit will be done quarterly and reported at the quarterly QA meeting. During this audit it will also be audited for compliance of training of Succinylcholine and Dantrolene use. All audits will be logged in with the date, time, and audit areas noted. In order to ensure this will never happen again, QA will immediately notify the DON and the CEO if it is determined safety measures are not being followed.

5. In-service education regarding the new Emergency Department and Pharmacy policies started with current nursing and pharmacy staff on 07/23/19 at 10:00 AM. Nursing and pharmacy staff has been made aware that oncoming nurses and providers must go through in-service education before providing care to patients. On 07/24/19 at 7:00 AM 56% of staff has completed training prior to providing patient care.

6. Hospital providers have been notified and educated on the Nursing and Pharmacy Policy on Rapid Sequence Intubation (RSI) and use of Succinylcholine with the immediate availability of Dantrolene and other agents in the event of malignant hyperthermia.

7. On 07/25/2019 at 10:47 AM the Director of Nursing has verified that all necessary medications and supplies necessary to respond to Malignant Hyperthermia are present in the hospital or have been ordered.

8. Final plan of correction was implemented on 7/25/19 at 10:50 AM."

Supporting documentation submitted with the "Plan of Removal" on 07/25/19 at 11:33 AM included a list of medications and supplies required for treatment of Malignant Hyperthermia, the new ER and Pharmacy policies related to the use of Succinylcholine Chloride to include the stocking of Dantrolene in recommended quantity, a written QA plan for audits, copies of Pharmacy order sheets for Dantrolene and Sterile Water, and the Nursing Inservice attendance record and the education provided.

The "Plan of Removal" was approved by the Center for Medicare & Medicaid Services (CMS), State Survey Agency (SSA), and Regional Office (RO) on 07/25/19 at 1:06 PM.

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

On 07/24/19 at 9:15 AM observation of the Pharmacy and all medication storage areas validated all Succinylcholine vials were secured and unavailable for use.

On 07/25/19 at 1:30 PM review of policies showed new ER and Pharmacy policies related to RSI medications were signed by the Staff 1, CEO and Staff 9, Medical Director.

On 07/25/19 at 12:45 PM review of Pharmacy orders showed Dantrolene and bacteriostatic-free Sterile Water were on order.

On 07/25/19 at 1:50 PM review of the initial, completed audit, review of the written plan for ongoing audits, and interview with the Staff 11, QA Coordinator, validated the QA process for the removal plan.

On 07/25/19 at 1:40 PM interview with the Staff 2, DON and review of the in-service documentation revealed 58% of staff had completed education regarding new ER and Pharmacy policies and confirmed no staff would be allowed to care for patients until this education was completed.

On 07/25/19 at 1:40 PM interview with the hospital providers, Staff 10, Nurse Practitioner and Staff 9, Medical Director revealed all facility providers had been notified and educated on the new ER and Pharmacy policies regarding RSI.

On 07/25/19 at 1:47 PM, interviews with Staff 2, DON and Staff 17, Laboratory Manager, and observation showed all necessary medications and supplies to respond to Malignant Hyperthermia were present in the facility or on order.

The facility's "Plan of Removal" was validated by on site surveyors via an additional inspection and review of documentation to ensure the removal plan was implemented. Validation the plan was implemented was provided to CMS, SSA, and the RO on 07/25/19 at 1:55 PM, at which time the CEO 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 presenting to the facility for emergency care.

Findings include:

Observation of the facility's medication room and interview with Staff 2, the Director of Nursing (DON), on 07/22/19 at 10:05 AM, showed the facility stocked 45 vials of Succinylcholine Chloride (a rapid-acting muscle relaxant used to prevent a patient from struggling against the intubation process). The DON stated the Succinylcholine 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 DON stated the facility did not stock the medication Dantrolene (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). Staff 2, DON reported being unaware of the need for Dantrolene to be immediately available as an intervention for MH. Staff 2, DON, stated, "We usually ship a patient like that right out, they're here for about 10 minutes."

Staff 15, Pharmacy Manager (PM), on 07/22/19 at 10:10 AM, confirmed that no Dantrolene was stocked in the facility.

During a telephone interview with Staff 6, Pharmacist, on 07/22/19 at 11:15 AM, verified there was no Dantrolene stocked in the facility and reported being unaware of the need for Dantrolene to be immediately available as an intervention for MH.

During an interview with Staff 10, Nurse Practitioner, on 07/22/19 at 11:45 AM, stated was unaware of the need for Dantrolene to be immediately available as an intervention for MH.

During a telephone interview with Staff 9, Medical Director, on 07/22/19 at 11:55 AM, reported being unaware of the need for Dantrolene to be immediately available as an intervention for MH.

During an interview and observation with the Staff 15, PM on 07/24/19 at 9:15 AM, Staff 15 reported being unaware of the need for Dantrolene to be immediately available and secured the 46 vials of Succinylcholine Chloride located in the pharmacy immediately to prevent the use of the medication due to the failure of the facility to stock Dantrolene.

Review of a medication report for the previous 12 months revealed two patients had received Succinylcholine Chloride administration, Patient (P) 1 and P2.

Review of the ER medical record of P1 revealed Succinylcholine Chloride administration on 07/16/19 at 9:10 PM during intubation in the ER, and transport of the patient out of the facility via ambulance at 10:34 PM, or one hour 24 minutes following administration of Succinylcholine. This patient did not have the potential side effect of Malignant Hyperthermia prior to leaving the facility but was put at risk.

Review of the ER medical record of P 2 revealed Succinylcholine Chloride administration on 01/14/19 at 10:47 AM during intubation in the ER, and transport of the patient out of the facility via ambulance at 11:27 AM, or 40 minutes following administration of Succinylcholine. This patient did not have the adverse side effect of Malignant Hyperthermia but was put at risk.

Malignant Hyperthermia Association of the United States (MHAUS) guidelines state, " ...the one-hour period immediately following (use of Succinylcholine) is a critical time."


A request for policies related to use of Succinylcholine Chloride and/or RSI procedures was made The facility had no policies or procedures in place for the use of Succinylcholine Chloride or interventions for adverse side effects in place.

Based on observation, interview, and review of facility documents and policies, it was determined the facility failed to meet the Condition of Participation for Physical Plant and Environment when the facility failed to ensure the routine inspection and certification of the facility's medical gas system. The failure to ensure the routine inspection and certification of the medical gas system resulted in an Immediate Jeopardy condition identified under the Life Safety Recertification Survey. This had the potential to affect all currently admitted patients that required, or potentially required, the use of oxygen.

The facility also failed to ensure preventative maintenance of medical equipment used for patient care in the hospital was inspected. This had the potential to affect all patients who receive care at the facility.

Findings include:

1. Based on interview and review of facility documents, the facility failed to ensure the piped, medical gas system used throughout the facility was routinely inspected and certified by a medical technology inspector. This deficient practice, which resulted in an Immediate Jeopardy condition, was identified to exist on 07/22/19 at 5:10 PM by a Life Safety Code (LSC) Surveyor with the Oklahoma State Department of Health during the performance of the facility's LSC inspection. During an interview with the LSC Surveyor on 07/23/19 at 3:40 PM, the LSC Surveyor confirmed validation of the facility's corrective action and the removal of the immediate jeopardy. (Cross-reference C-0231)

2. Based on observation, interview, and review of facility policy, the facility failed to ensure a laboratory blood bank refrigerator, a laboratory specimen refrigerator, and the Harvey Hydroclave MC10 used for the sterilization of medical equipment, is inspected as required. (Cross-reference C-0222.)

Based on observation, interview, and review of equipment maintenace documents, the facility failed to ensure all equipment was identified as currently inspected and tested for performance and safety. This had the potential to allow faulty equipment to be used for storing blood products, laboratory specimens, and the sterilization of medical equipment resulting in a potential for negative outcomes for all patients receiving care in the facility.

Findings include:

Observations conducted on 07/22/19 at 2:29 PM revealed a blood bank refrigerator located in the laboratory section of the hospital had an expired inspection sticker showing a due date for reinspection was 05/2019 and a specimen refrigerator with an expired inspection sticker showing the due date for reinspection as 05/2019. In addition, observations conducted on 07/22/19 at 4:05 PM revealed a Harvey Hydroclave MC10 used to sterilize medical equipment had an expired inspection sticker showing the due date for reinspection to be 05/2019.

An interview with the Director of Maintenance (DOM) was conducted on 07/23/19 at 3:40 PM. The DOM confirmed the blood bank refrigerator, the specimen refrigerator, and the Harvey Hydroclave MC10 stickers for inspection were past due and had not been inspected as required.

Review of the facility's policy titled, "Preventative Maintenance Policy", not dated, revealed, "A program will be maintained in the Maintenance Office to provide a schedule for servicing equipment needing scheduled maintenance work." In addition, the policy documented, "All tags showing inspection and maintenance dates will be on the machines and checked by the Maintenance staff annually." The policy further documented, "Equipment will be maintained to ensure an acceptable level of safety and quality."

Based on interview and review of the facility systems inspection documents, it was determined the facility failed to ensure Life Safety Code (LSC) requirements were met. An Immediate Jeopardy (IJ) was identified during the LSC survey of the hospital on 07/22/19 due to the facility's failure to ensure the medical gas system of the hospital was properly inspected and certified. This failure affected multiple care areas of the hospital, including inpatient rooms and the emergency department. This failure had the potential to affect all patients receiving services at the facility.

On 07/23/19, the facility had taken measures to abate the IJ related to the failure to inspect the medical gas system.

Findings include:

On 07/22/19 at 5:10 PM, an interview was conducted with the Life Safety Code (LSC) surveyor conducting the LSC survey of the hospital. The LSC surveyor identified an IJ on 07/22/19, due to the facility's failure to ensure the piped, medical gas system of the hospital was annually inspected and certified by a medical technology inspector.

On 07/23/19 at 3:40 PM, an interview was conducted with the Director of Maintenance (DOM). The DOM stated the facility had taken measures to ensure a certified medical technology inspector would conduct an inspection of the medical gas system on 07/29/19. In addition, the DOM stated one patient was identified who currently is requiring oxygen. The DOM stated the patients was placed on portable oxygen concentrators and nurses were required to conduct respiratory assessments of the patient every hour until the medical gas system of the hospital was certified.

The LSC surveyor stated deficient practice was identified at K-908 of the 2012 LSC.

Based on observation, staff interview, and policy review, the facility failed to ensure outdated and/or mislabeled medications were removed from the medication room and medication cart to prevent administration to a patient. Failure to remove expired and mislabeled medications from the facility inventory provided the potential for staff to use medications that were no longer viable or were deemed unusable by the manufacturer and had the potential to negatively affect the patient care provided by the facility.

Findings include:

Observation in the nurse's station medication room and medication cart on 07/23/19 from 9:55 AM to 10:20 AM revealed the following:

1. One Humulin R (regular insulin) open multidose vial dated as opened 8/17/18.
2. One Lantus (long-acting insulin) open multidose vial dated as opened 12/31/18.
3. One Humulin N (medium-acting insulin) open multidose vial unlabeled for date, time and initials.
4. Ten Pneumococcal Vaccine pre-filled single-dose syringes, expiration date 09/2018.
5. One Influenza Vaccine open multidose vial, expiration date 06/30/19.
6. Fifteen ampules of Demerol 75 mg, expiration 07/01/19.
7. One Nubain multidose vial, expiration 07/01/19.
8. One Ketamine open multidose vial unlabeled for date, time and initials.

During a joint interview with Staff 13, Registered Nurse (RN) and Staff 14, Licensed Practical Nurse (LPN) on 07/23/19 at 10:20 AM, they agreed the medications noted above were either outdated or unlabeled. Staff 14, LPN stated open multi-dose vials are considered good for use for 30 days following their opening. Staff 13, RN stated the Pharmacy Manager is responsible for checking all medications for outdates but added that all nursing staff should be checking dates and labels of medications.

During an interview with the Staff 15, Pharmacy Manager (PM), 07/24/19 at 9:15 AM, the PM verified it was considered the responsibility of the PM to check all areas of patient care for medication stock either outdated or improperly labeled. The PM stated, "I missed those meds."

Review of the facility policy titled, "Monthly Inspection of the Nursing Stations," last revised 06/11, showed, "The pharmacist, or pharmacy technician, will be responsible for recorded periodic inspections of the nursing stations floor stock inventories and patient medication storage at least monthly. These inspections are undertaken to assure that complete and in-date supplies of floor stock medications and emergency drug trays are on hand at all places ..."

Review of the facility policy titled, "Outdated Drugs," last revised 06/11, showed, "It is the responsibility of the pharmacy to make sure that all medications used in the hospital are in date and of acceptable quality. The Pharmacy will remove all medications which will expire by the end of or before the end of the current month. 'Out of Date' checks will be made near the end of the preceding month so as to be sure that the out dated drugs will not be available for use."

Review of the facility policy titled, "Multiple Dose Vials," last revised 06/11, showed, "If a multiple dose vial is used, the date of the initial opening and the initials of name of the individual opening the vial will be written on the vial when the vial is opened. No multiple dose vials will be used beyond 28 days after entry of the vial."