HospitalInspections.org

Based on observation and interview, the Critical Access Hospital (CAH) failed to ensure medications used for life-saving measures are kept at the CAH and are readily available for treating emergency cases.

The cumulative effects of this deficient practice resulted in an Immediate Jeopardy (IJ) (a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment or death) situation.

Findings Include:

The Critical Access Hospital (CAH) failed to ensure it maintained a supply of medication to reverse a potential life-threatening side effect of Succinylcholine Chloride available for use by the CAH during emergencies. (Succinylcholine chloride, a rapid-acting muscle relaxant, used when a patient requires immediate insertion of an endotracheal tube to maintain an airway and/or provide supplemental oxygen; one potential side effect of succinylcholine chloride is a condition known as Malignant Hyperthermia (MH), a life-threatening medical crisis which causes high fever and skeletal rigidity and if not treated quickly with the appropriate dose of a reversal agent) (Refer to C-0884)

Based on observation, document review, and interview, the Critical Access Hospital (CAH) failed to ensure it maintained a supply of medication to reverse a potential life-threatening side effect of Succinylcholine Chloride available for use by the facility during emergencies (a rapid-acting muscle relaxant medication, used when a patient requires immediate insertion of an endotracheal tube to maintain an airway and/or provide supplemental oxygen) Failure to anticipate the need for and maintain a supply of medications needed to treat potential side-effects during Succinylcholine Chloride administration has the potential to cause serious injury, serious harm, serious impairment or death to patients presenting to the facility for emergency care.


Findings Include:


Review of the national standard of care as outlined in the Malignant Hyperthermia Association of the United States (MHAUS) website recommendation, revealed, in part, " ...in a small percentage of cases Malignant Hyperthermia (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 observation of the facility's Emergency Department (ED) on 12/06/19 at 10:30 AM with the Chief Nursing Officer (CNO), it was determined that succinylcholine chloride was stored for use in their Rapid Sequence Intubation (RSI) kit. (succinylcholine chloride, a rapid-acting muscle relaxant, used when a patient requires immediate insertion of an endotracheal tube to maintain an airway and/or provide supplemental oxygen; one potential side effect of succinylcholine chloride is a condition known as Malignant Hyperthermia (MH), a life-threatening medical crisis which causes high fever and skeletal rigidity and if not treated quickly with the appropriate dose of a reversal agent).

During an interview on 12/06/19 at 10:30 AM, the CNO stated they did not have the required reversal agents for succinylcholine chloride to treat MH on hand in the facility.

A review of the undated facility document titled, "RSI Pathway" revealed no reference to the use of a reversal agent i.e., dantrolene or Ryandodex, for treatment of MH that could be triggered by succinylcholine chloride usage.

During an interview on 12/06/21 at 12:35 PM, the CNO verified that the CAH does not have a Malignant Hypothermia (MH) kit containing the required reversal agents. The CNO stated, that they do not have a policy regarding reversal agents, but they have a pathway to follow.


On 12/07/21 at 1:37 PM, the Chief Executive Officer (CEO) and Chief Nursing Officer (CNO) were notified that an immediate jeopardy (IJ) (a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment or death) existed related to C-0884 - §485.618(b) Standard: Equipment, Supplies, and Medication used in treating emergency cases are kept at the CAH and are readily available for treating emergency cases. It was determined that the medication, succinylcholine chloride, (a paralytic agent) was stocked in the CAH's Rapid Sequence Intubation (RSI) kit (a procedure used in an emergency to place a tube in a patient's airway to assist them to breathe and administer oxygen and medications). It was determined that the facility failed to stock any of the required reversal agents required for succinylcholine chloride i.e., dantrolene or Ryandodex, which is used to treat Malignant Hyperthermia (MH), a potentially fatal condition that can occur from the use of succinylcholine chloride.

The hospital submitted an acceptable IJ plan of removal that was validated by the onsite surveyors. The Plan of Removal was accepted on 12/10/21 at 10:34 AM.


The plan of removal included the following:

I. Patients/clients who have suffered or are likely to suffer a serious adverse outcome because of the noncompliance:

a. F.W. Huston Medical Center lacked reversal agents to be administered in the case of a Malignant Hyperthermia reaction following the administration of Succinylcholine Chloride. Any patient requiring emergency rapid sequence induction for endotracheal intubation in the emergency room since February 2019 had the potential to be negatively affected by the lack of reversal agents. No patients suffered harm because of the noncompliance, due to the lack of administration of Succinylcholine Chloride.

II. Actions the facility will take:

a. Systems, Policies, and Procedures:

i. On 12/6/2021, the facility's full supply (10 vials) of Succinylcholine Chloride was removed from the locked medication boxes within the locked pharmacy. The supply was immediately transported by a nurse to the [pharmacy name and location], which provides medication for use in the hospital. Succinylcholine will no longer be available for administration at F.W. Huston Medical Center.

ii. On l 2/7/2021, Succinylcholine Chloride was removed from the Adult Rapid Sequence Intubation Pathway, which guides staff through the process.

iii. On 12/7/2021, Succinylcholine Chloride was removed from the Adult Rapid Sequence Intubation Medication Reference, a tool which guides staff through locating medications, and the dosing, onset, duration, and cautions of medications potentially used in the intubation process.

iv. On l2/7/2021, Succinylcholine Chloride was removed from the Rapid Sequence Intubation Kit (RSI Kit). The photograph of the kit, which is used for a reference and training tool, has been updated to exclude the Succinylcholine previously pictured.

v. On 12/7/2021, Succinylcholine Chloride was removed from the RSI Airway Kit Inventory Tracking Log, which is used to document amounts of each medication used and wasted.

vi. As of 12/7/2021, the only paralytic agent available for use with rapid sequence induction for endotracheal intubation at F.W. Huston Medical Center is rocuronium (Zemuron). All above-mentioned guides and tools reflect this medication as being the only paralytic agent available. Our hospital had physostigmine available as a reversal agent for rocuronium. As of 12/9/21, sugammadex (Bridion) is available as the preferred reversal agent for rocuronium as recommended by the American Association of Nurse Anesthesiology (AANA) position statement and practice document "Airway Management: Use of Succinylcholine or Rocuronium" and the frequently utilized clinical tool UpToDate topic: "Neuromuscular blocking agents (NMBAs) for rapid sequence intubation in adults outside of the operating room." Per up To Date: "When rocuronium is used, sugammadex should be immediately available for rapid reversal of neuromuscular blockade whenever possible."

b. Education/Training:

i. On 12/6/2021, an email was sent by the Chief Nursing Officer and Director of Advanced Practice Providers to all hospital nurses and E.R. medical providers of F.W. Huston Medical Center, which included the following: "Succinylcholine will no longer be available for rapid sequence induction in intubation. Rocuronium is our paralytic agent available should it be needed. The RSI kit has been modified to no longer include succinylcholine. The succinylcholine has been removed from the pharmacy and is no longer available."

ii. On 12/7/2021, the above-mentioned e-mail was printed and placed on the Communication Clipboard by the Chief Nursing Officer for all nurses to sign as reviewed and acknowledged during their next shifts. Attached to the email are colored printouts of the revised versions of above-mentioned guides:

1. Adult Rapid Sequence Intubation Pathway
2. Adult Rapid Sequence Intubation Medication Reference
3. Photograph of contents of Rapid Sequence Intubation Kit (RSI Kit)
4. RSI Airway Kit Inventory Tracking Log

iii. All E.R. medical providers and hospital nurses have or will receive verbal in-servicing on the lack of availability of Succinylcholine Chloride for use with rapid sequence intubation, provided by either Chief Nursing Officer or Nurse Consultant/QAPI Coordinator (writer). Written education has been or will be signed as reviewed and acknowledged prior to or upon arrival for next shift by each individual.

iv. As of 12/7/2021, 100% of E.R. medical providers and hospital nurses were provided notice of the change via electronic mail.

v. As of 12/9/2021, 23 of 24 (96%) E.R. medical providers and hospital nurses received verbal education about the change in medication availability and pathway for rapid sequence intubation, provided by either the Chief Nursing Officer or Nurse Consultant/QAPI Coordinator. Eighteen of 24 (75%) have received and acknowledged written education. Efforts are ongoing.

vi. The expected completion date of all verbal education is 12/10/2021. The anticipated completion date of all written education is 12/15/2021. All E.R. medical providers and hospital nurses will be prohibited from working another shift prior to receipt and acknowledgement of both verbal and written education regarding the removal of Succinylcholine Chloride from the RSI kit.

vii. All new-hire hospital nurses will be oriented to the RSI kit with current contents, excluding Succinylcholine Chloride, via the Orientation Checklist, effective immediately.

viii. [Named], Pharmacy Consultant and supplier of medications for the hospital, has been notified verbally and in writing, of the prohibition of Succinylcholine Chloride within F.W. Huston Medical Center's pharmacy.

c. Monitoring, Audits, QAPI, and Facility Assessment:

i. The Nurse Consultant/QAPI Coordinator will be monitoring daily through 12/15/2021 for compliance with providing verbal and written education to all E.R. medical providers and hospital nurses. Weekly monitoring, beyond 12/15/2021, will occur until all current healthcare workers are educated. Compliance percentage will be reported through Quality Dashboard and QAPI Committee meetings until 100% is achieved.

ii. The Chief Nursing Officer will monitor compliance of RSI kit orientation for new hire hospital nurses monthly. Ongoing compliance will be reported through Quality Dashboard and QAPI Committee meetings until 100% compliance is achieved for 12 consecutive months.

iii. The medication related to noncompliance is no longer available within the organization. There is no plan to make it accessible in the future, as an alternate paralytic agent is available if needed for rapid sequence induction for endotracheal intubation.

iv. The RSI Medications Log, which is signed by both the on-coming and off-going Registered Nurses during each shift change, has had the column for capture of the Succinylcholine medication lock number, removed. The bottom of the form now includes the following statement in all caps:

SUCCINYLCHOLINE IS PROHIBITED.
ROCURONIUM IS THE ONLY PARALYTIC AVAILABLE.

v. The verification of no access to Succinylcholine Chloride within the facility has been added to the F.W. Huston Medical Center Quality Dashboard for hospital and E.R. The verification audit will be performed by the Chief Nursing Officer and/or Nurse Consultant/QAPI Coordinator weekly, for routine reporting to the QAPI Committee, and to the Board of Directors. All medication packing receipts accompanying medications received from the supplier pharmacy will be reviewed to verify that no Succinylcholine Chloride has been accepted. Verification will continue until 100% compliance is achieved for 12 consecutive months.

vi. Signage has been placed in the hospital pharmacy, notifying all nurses that Succinylcholine Chloride will no longer be stocked within the facility. Placement and integrity of signage will be verified by the Chief Nursing Officer and/or Nurse Consultant/QAPI Coordinator weekly and as needed, for reporting to the Quality Dashboard, QAPI Committee, and Board of Directors. Ongoing compliance will be reported until 100% compliance is achieved for 12 consecutive months.