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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, 42 CFR 485.618, 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:

Observation of the facility's Emergency Department (ED) medication room on 11/11/19 at 10:00 AM, in the presence of the day shift ED Registered Nurse (RN)1 revealed four vials of succinylcholine chloride in a locked Rapid Sequence Intubation (RSI) kit. Inspection of the ED medication room and pharmacy revealed dantrolene was not available.

During interview with the Chief Nursing Officer (CNO) on 11/11/19 at 10:15 AM, she stated RSI was performed recently in the emergency room and succinylcholine chloride was used as a paralytic medication for intubation. When asked if the hospital stocked the medication dantrolene, the CNO stated she did not know what dantrolene was used for, and did not think the hospital had the medication available for use.

An Immediate Jeopardy (IJ) was identified and notification to the facility was made on 11/11/19 at 4:10 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 11/11/19 at 3:50 PM under 42 CFR 485.618 Emergency Services at C-0200. The Chief Executive Officer (CEO) was notified of the identified IJ on 11/11/19 at 4:10 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 by the State Survey Agency on 11/12/19 at 12:43 PM.

1. The Chief of Staff (COS) and CEO on 11/11/19 approved the immediate removal of succinylcholine chloride from the Rapid Sequence Intubation (RSI) kit and pharmacy.

2. Immediate reeducation and notification of nursing staff, pharmacy staff and providers began on 11/11/19 to inform staff of the removal of succinylcholine. and Rocuronium will be used for RSI procedures.

3. The medical staff voted on 11/11/19 to remove succinylcholine from the hospital formulary. Rocuronium will be used for RSI.

4. The CNO will monitor for any presence of succinylcholine and evaluate all intubation cases and for four months through May 12, 2010 and report findings to the Quality Assurance Performance Improvement Committee.

The facility's "Removal Plan" 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 "Removal Plan" was provided to the State Survey Agency on 11/12/19 at 1:22 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 chloride) had the potential to affect all patients presenting to the CAH for emergency treatment and represented an immediate jeopardy situation.

Findings include:

Observation of the facility's Emergency Department (ED) medication room on 11/11/19 at 10:00 AM, in the presence of the day shift ED Registered Nurse (RN)1 revealed four vials of succinylcholine chloride in a locked Rapid Sequence Intubation (RSI) kit. Inspection of the ED medication room and pharmacy revealed dantrolene was not available.

During an interview with RN1 on 11/11/19 at 10:00 AM, he stated he has worked in the hospital ED for years. RN1 stated the RSI kit is kept in the medication room [ED] for staff to use when a patient requires intubation. RN1 stated succinylcholine chloride was used on a patient who needed RSI a few months ago, but he was not sure of the date. RN1 stated he had never heard of the medication dantrolene and did not know the medication's use.

During interview with the Chief Nursing Officer (CNO) on 11/11/19 at 10:15 AM, she stated RSI was performed recently in the emergency room and succinylcholine chloride was used as a paralytic medication for intubation. When asked if the hospital stocked the medication dantrolene, the CNO stated she did not know what dantrolene was used for, and did not think the hospital had the medication available for use.

Review of the "Hospital Formulary" last revised on 09/11/18, provided by the CNO, revealed dantrolene was not included in the hospital formulary. The CNO confirmed during an interview on 11/11/19 at 10:15 AM that the hospital did not have dantrolene available.

During an interview with the ED physician, who was the Chief of Staff (COS), on 11/11/19 at 11:00 AM, he stated, "I have performed RSI on patients at the hospital but not very often. The COS stated the facility used succinylcholine when performing RSI, but he wasn't sure of the specific side effects of the medication. The COS stated he did not know that dantrolene should be available when succinylcholine is being used. The COS stated, "[name of pharmacy consultant] did not provide the hospital information on the need to have dantrolene with succinylcholine use."

During a telephone interview with the Pharmacy Consultant on 11/11/19 at 12:15 PM, when asked if he was familiar with dantrolene and if the hospital stocked dantrolene, he stated, "Yes, I know what dantrolene is used for. We [hospital] do not perform surgery and there is no general anesthesia used at this time [at the hospital] so we would never use the med [medication dantrolene]. The med [medication dantrolene] is very expensive and no reason to stock [it] if not used."

Review of Patient (P) 12's ED medical record revealed that P12 was brought into the ED via ambulance on 09/25/19 at 12:03 PM in respiratory distress. P12 was given succinylcholine chloride 100 milligram (mg) intravenous at 12:32 PM and successful intubation occurred at 12:38 PM. P12 was transferred from the hospital to a higher level of care at 1:17 PM.

The CNO and 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 ED. During a joint interview with the CNO and CEO on 11/11/19 at 4:10 PM, they were referred to the national standard of care as outlined in the Malignant Hyperthermia (MH) Association of the United States 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."


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, interview, and policy review, the facility failed to implement infection control measures by breaching the packaging of supplies hung on the walls and oxygen tanks in three of three emergency department bays (Bay 1, 2, and 3). This deficient practice had the potential to adversely affect on all patients receiving care in the emergency services rooms, by increasing the possible exposure to supplies that were not stored in an appropriate manner.

Finding include:

Observation on 11/11/19 at 10:30 AM of emergency department treatment Bays 1, 2, and 3 showed the following supplies had a packaging breach, in that staff had placed a hole in the package so that the package could be hung on a hook on the wall:

Bay One;
1) Disposable nebulizer with tee, tubing, mouth piece and reservoir;
2) Mask, aerosol elongated adult;

Bay Two;
3) Soft touch adult nasal oxygen cannula with 7' (2.1 meter) crush resistant tubing, which was observed over the oxygen liter meter on a portable oxygen tank;

Bay Three;
4) Adult medium concentration oxygen, tubing 7' (2.1 meter) oxygen tubing; and,
5) Non-rebreather high concentration oxygen mask, adult, 7' crush resistant oxygen tubing, latex free.

In an interview on 11/11/19 at 10:35 AM, the Chief Nursing Officer said, "We should not breach the packaging of the supplies as they would no longer be sterile. The supplies should have been hung on the outside edge of the packaging so the Command hooks would not poke holes in the packaging.

In an interview on 11/12/19 at 10:01 AM, the Infection Control Nurse said, "The stuff on the wall is not supposed to be opened in the center where the materials are. The nurse was supposed to hang them by the edge of the package and not hang them by placing a hole in the sealed packaging.

Review of the facility's policy titled, "Multiple Use and Single Use Supplies," dated 11/12/19, provided by the Chief Nursing Officer, showed, "It is [hospital] policy that single use/patient supplies will be used for sterile and invasive procedures."

Review of the facility's undated policy titled, "Stocking Hospital Supplies," provided by the Chief Nursing Officer, showed, "Check remaining supplies to ensure packaging is intact. If packaging is not intact, replace with a new product. Ensure any supply that does not have a manufacture's expiration date: packaging and supply are intact and free of discoloration. In the event tat the packaging or supply is not intact or shows discoloration, remove supply from the stock and replace ... "

Based on interview, and review of the facility's "Emergency Preparedness Plan (EPP)," the facility failed to develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. This failure had the potential to affect all patients who received emergency and outpatient services at the facility and any staff on duty.

Findings include:

1. Review of the facility's "EPP" revealed the plan did not contain all of the Emergency Preparedness components that are required to be included in the EPP and that the plan was to be based on the Hazard and Vulnerability Assessment (HAV). The HAV was last conducted in 2015.

2. The facility failed to review and revise the comprehensive emergency preparedness program on an annual basis. Refer to E0004

3. The facility failed to review and revise the hazard and vulnerability assessment (HAV) on an annual basis. Refer to E0006

4. The facility failed to include policies and procedures to outline the types of services the facility would be able to provide in the event of an emergency and failed to develop a delegation of authority and successions plan. Refer to E0007

5. The facility failed to develop a plan to provide medical and pharmaceutical supplies in the event of an emergency. Refer to E0015

6. The facility failed to ensure the evacuation plan component included a process for tracking patients and staff in an emergent situation. Refer to E0018

7. The facility failed to develop a system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. Refer to E0023

8. The facility failed to develop a plan for arrangement with other facilities or other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to facility patients. Refer to E0025

9. The facility failed to review and updated the communications plan on an annual basis. Refer to E0029

10. The facility failed to have a written policy and/or procedure for sharing information and medical documentation for patients under their care in the emergency communication plan component of the "EPP". Refer to E0033

In an interview on 11/12/19 at 12:05 PM, the Administrator said she had just started in her position in June and had not reviewed or revised the EPP nor determine whether the plan addressed all of the required components.

Based on interview, and review of the facility's "Emergency Preparedness Plan (EPP)," the facility failed to review and revise the comprehensive emergency preparedness program on an annual basis. This failure had the potential to affect all of the patients that receive emergency and outpatients services at the facility and any staff on duty.

Findings include:

A review of the facility's "EPP", revealed the facility had not reviewed or revised the EPP since March of 2018.

In an interview on 11/12/19 at 12:05 PM, the Administrator said she had just started in her position in June and had not addressed the EPP updates and annual policy review.

Based on interview, and review of the facility's "Emergency Preparedness Plan (EPP)," the facility failed to review and revise the hazard and vulnerability assessment (HAV) on an annual basis. This failure had the potential to affect all of the patients who received emergency and outpatient services at the facility and any staff on duty.

Findings include:

A review of the facility's "EPP", revealed the facility had not reviewed or revised the HAV assessment on an annual basis. The HAV assessment was last conducted in 2015.

In an interview on 11/11/19 at 12:05 PM, the Administrator stated the facility had conducted an HAV in 2015. The Administrator stated that the EPP had been a work in progress and still had some missing elements.

Based on interview, and review of the facility's "Emergency Preparedness Plan (EPP)," the facility failed to include policies and procedures to outline the types of services the facility would be able to provide in the event of an emergency and failed to develop a delegation of authority and successions plan. This failure had the potential to affect all the patients who received emergency and outpatient service at the facility and any staff on duty.

Findings include:

A review of the facility's "EPP", revealed the facility had not developed policies and procedures to address the type of services the facility had the ability to provide in an emergency and continuity of operations, including a delegations of authority policy.

In an interview on 11/12/19 at 12:05 PM, the Administrator stated that the EPP plan did not include policies to guide the types of services the facility would be able to provide in the event of an emergency and did not have a delegation of authority and succession plans within the facility.

Based on interview, and review of the facility's "Emergency Preparedness Plan (EPP)," the facility failed to develop a plan to provide medical and pharmaceutical supplies in the event of an emergency. This failure had the potential to affect all of the patients who received emergency and outpatient services at the facility, and any staff on duty.
Findings include:

A review of the facility's "EPP", revealed the facility had not developed a plan to provide medical and pharmaceutical supplies in the event of an emergency.

In an interview on 11/12/19 at 12:05 PM, the Administrator stated that she was unable to find documentation in the EPP that addressed medical supplies and pharmaceutical supplies.

Based on interview, and review of the facility's "Emergency Preparedness Plan (EPP)," the facility failed to ensure the evacuation plan component included a process for tracking patients and staff in an emergent situation. This failure had the potential to affect all of the patients who received emergency and outpatient services at the facility, and any staff on duty.

Findings include:

A review of the facility's "EPP", revealed the evacuation plan component did not include a process for identifying how patients and staff would be tracked in the event of an emergency evacuation.

In an interview on 11/12/19 at 12:05 PM, the Administrator stated that she would have a list of patients from the daily census and could use the facility time and attendance to track employees but did not have a policy in the EPP that included a process for tracking patients and staff in an emergent situation.

Based on interview, and review of the facility's "Emergency Preparedness Plan (EPP)," the facility failed to develop a system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. This failure had the potential to affect all of the patients who received emergency and outpatient services at the facility, and any staff on duty.

Findings include:

A review of the facility's "EPP, revealed the facility had not developed policies and procedures to guide in the preservation of patient information, protect confidentiality of patient information, and secure and maintain availability of records, in the event of an emergency.

In an interview on 11/12/19 at 12:05 PM, the Administrator stated that the facility had not developed the necessary policies and procedures to meet this requirement.

Based on interview, and review of the facility's "Emergency Preparedness Plan (EPP)," the facility failed to develop a plan for arrangement with other facilities or other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to facility patients. This failure had the potential to affect all of the patients who received emergency and outpatient services at the facility, and any staff on duty.

Findings include:

A review of the facility's "EPP", revealed the facility had not made arrangements with other facilities or other providers to receive patients in the event of an emergency.

In an interview on 11/12/19 at 12:05 PM, the Administrator stated that the facility had general transfer agreements with other hospitals but did not have agreements with other facilities in the event of an emergency, and the EPP plan did not contain policies to address this need.

Based on interview, and review of the facility's "Emergency Preparedness Plan (EPP)," the facility failed to review and updated the communications plan on an annual basis. This failure had the potential to affect all of the patients who received emergency and outpatient services.

Findings include:

A review of the facility's "EPP", revealed no documentation to indicate the communication plan component had been reviewed and updated on an annual basis. The facility's "EPP" revealed the facility had not reviewed or revised the EPP since March of 2018.

In an interview on 11/12/19 at 12:05 PM, the Administrator stated that she had just started in her position in June and had not addressed the updates and policy review for the EPP.

Based on interview, and review of the facility's "Emergency Preparedness Plan (EPP)," the
facility failed to have a written policy and/or procedure for sharing information and medical
documentation for patients under their care in the emergency communication plan component of the "EPP". This failure had the potential to affect all of the patients who received emergency and outpatient services at the facility, and any staff on duty.

Findings include:

A review of the emergency communication plan component of the facility's "EPP" revealed it did not have a written policy or procedure for sharing information and medical documentation with another provider in an emergent event.

In an interview on 11/12/19 at 12:05 PM, the Administrator stated that she had been unable to locate a policy or procedure for the sharing of patient information.