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Based on record review, review of the facility's policy, and staff interview, the Critical Access Hospital (CAH) failed to determine if all patients admitted to the CAH had an advanced directive or provide information and/or assistance if so desired by the patients about how to obtain an Advanced Directive for two of the 20 patients' records reviewed (Patient 1 and Patient 2); and failed to post a notice informing patients that the CAH does not have a Doctor of Medicine or a Doctor of Osteopathy present in the hospital 24 hours per day, seven days per week or how the CAH will meet the medical needs of any patient with an emergency medical condition. This deficient practice has the potential to place patients at risk for unmet or unknown medical care needs, wants and/or desires.

Findings Include:

A review of the CAH's policy titled, "Advance Directives for Health Care" effective Jan 2015 showed, "PROCEDURES: 1) When admitting a patient, the hospital admissions or the admitting personnel, shall provide to all inpatient, as well as observation patients, 18 years of age and older, a copy of the Advance Directive Acknowledgment form. Admitting personnel will assist each patient in reading and appropriately initialing the statements on the Advance /directive Acknowledgement. Admitting personnel will ensure that the patient sign the acknowledgment form indicating that assistance was offered. Admitting personnel witnessing the signature shall sign their name to the form in the appropriate space. The completed advance Directive acknowledgment form will be placed on the patient's medical chart by admitting personnel." §489.102(b)(1) states, "the CAH should also consider providing the advance directive notice at the time of registration, to outpatients (or their representatives) who are in the emergency department, who are in an observation status, or who are undergoing same-day surgery." Their policy does not address patients admitted to the ED.

Review of the requirements of 42 CFR 489.20(w), showed all CAH's that do not have a Doctor of Medicine or a Doctor of Osteopathy present in the hospital 24 hours per day, seven days per week, must post a notice stating such, and must indicate how the CAH will meet the medical needs of any patient with an emergency medical condition, as defined in 42 CFR 489.24(b).

Review of Patient 1's medical record showed admission to the Emergency Department on 02/17/19 at 3:27 PM and discharged the same date at 4:37 PM with a diagnosis of left foot contusion. The medical record reviewed on 01/02/19 at 10:25 AM showed no evidence that Patient 1 was offered an opportunity to accept or decline assistance to develop an advanced directive if desired.

Review of Patient 2's medical record showed admission to the Emergency Department on 01/27/19 at 8:59 AM and discharged the same date at 10:37 AM with a diagnosis of acute low back pain. The medical record showed no evidence that Patient 2 was questioned about having an advanced directive or was offered an opportunity to accept or decline assistance to develop an advanced directive if desired.

An observation of the CAH's Emergency Department (ED) waiting room and patient entranceways on 04/01/19 at 9:45 AM showed there was no posting to alert patients entering the ED that this facility does not have a Doctor of Medicine or Doctor of Osteopathy present 24 hours per day, seven days per week or how they will accommodate all patients entering the facility with emergency service's needs.

In an interview during medical record review on 04/01/19 at 1:40 PM, Staff D, Registered Nurse (RN) stated, "We have a new template and advanced directive questions are not always addressed." It was later clarified in an interview with Staff D on 04/01/19 at 1:40 PM that depending on who registers the patients, ED patients are not always asked about Advanced Directives.

In an interview on 04/01/19 at 9:50 AM, during observation of the facility's ED with Staff B, Director of Nursing (DON) and Staff E, Registered Nurse (RN), they were unaware that a notice must be posted to notify patients entering their facility that they do not have a Doctor of Medicine or a Doctor of Osteopathy present 24 hours per day, 7 days per week and their plan to accommodate all patient's emergency service needs.

Based on observation, interview and review of the facility's documentation, 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 which, has the potential to put all patients at risk who may require emergency services at this facility. (Refer to C-203 regarding drugs availability in the Emergency Department (ED).

Findings Include:

An Immediate Jeopardy (IJ) (A situation in which noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) was identified on 04/01/19 at 11:45 AM during observation of the Emergency Department (ED) trauma room. It was determined that the medication Succinylcholine Chloride was stocked in the ED for use as a general anesthetic for an emergent rapid sequence intubation to assist a patient to breath. It was further determined that the facility failed to stock the correct amount/dosage of the medication Dantrolene used to treat Malignant Hyperthermia (MH), an often-fatal condition that can potentially occur from the use of Succinylcholine Chloride. The facility had six 20 mg vials of Dantrolene available for treatment of Malignant Hyperthermia. The required amount to keep on hand should be 36 20 mg vials of Generic Dantrolene (total dose of 720 mg) or three 250 mg vials of Ryanodex (total dose of 720 mg).

IJ was formally determined to exist on 04/02/19 at 1:00 PM under 42 CFR 485.618 Emergency Services at C200. The Facility Administrator and Regional Administrator were notified of the Immediate Jeopardy on 04/02/19 at 1:19 PM and requested the facility complete a Plan of Removal of the IJ.

A final Plan of Removal was submitted by the Regional Administrator on 04/02/19 at 5:13 PM, the plan was approved on 04/02/19 at 5:53 PM.

The following is the final facility's Plan of Removal for the Immediate Jeopardy at Sedan City Hospital due to the presence of Succinylcholine in the facility and an inadequate supply of Dantrolene.

Steps that were taken by the facility to correct this situation include:

1. Sedan City Hospital administration and medical staff members met on 04/02/19 at 1:30 PM to discuss the immediate removal of Succinylcholine and Dantrolene from use within the hospital. Administration met with all of the medical staff providers currently scheduled to provide care in the hospital to discuss the issue and all agreed that the succinylcholine and dantrolene medications would be removed immediately from the crash cart and drug room in the hospital and that Rocuronium will be used as the agent for Rapid Sequence Intubation.

2. A registered nurse working at the directive of the Director of Nursing took the succinylcholine and dantrolene medications out of the crash cart, placed them in a locked drug room in a sealed paper bag marked DO NOT USE.

3. The Director of Nursing will be responsible for either returning the medication to the manufacturer or disposing of appropriately in accordance with accepted industry standards.

4. The updated Rapid Sequence Intubation/Deep Sedation policy has been updated, under the PROCEDURE heading discussing the appropriate choice of agents, specifically that Rocuronium is the agent of choice to be administered within the hospital and that all providers have been emailed the updated policy and education on the appropriate dosage, administration, and potential side effects of using Rocuronium. Read receipts have been added to the email information sent to the providers on 04/02/19 at 4:41 PM.

5. On 04/02/19 at 5:53 PM, the Plan of Removal submitted by Sedan City Hospital was approved.

6. On 04/03/19 at 2:20 PM, the facility's Plan of Removal was validated by on-site surveyors via an additional inspection of the ED Trauma room crash cart and medication room to ensure that Succinylcholine and Dantrolene were no longer available in facility.

Based on observation, review of the facility's policy, website review and interview, the facility failed to ensure it maintained a supply of medication to reverse a potential 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 Emergency Department's (ED) trauma room on 04/01/19 at 11:45 AM, in the presence of the Chief Nursing Officer (CNO), showed the presence of the drug Succinylcholine Chloride for use in Rapid Sequence Intubation (RSI) (used when a patient requires immediate insertion of an endotracheal tube to maintain an airway and/or provide supplemental oxygen). Succinylcholine Chloride is used as a rapid-acting muscle relaxant on patients requiring rapid intubation to prevent the patient from struggling against the intubation process. One potential side effect of Succinylcholine Chloride is a condition called 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 Dantrolene can be fatal. Inspection of the ED trauma room's crash cart showed six 20 milligram (mg) vials of Dantrolene available for treatment of Malignant Hyperthermia. The appropriate amount on hand should be 36 20 mg vials of Generic Dantrolene (total dose of 720 mg) or three 250 mg vials of Ryanodex (total dose of 720 mg). When questioned, the CNO stated there were no other vials of Dantrolene on hand in the facility.

Review of the facility's policy titled, "RAPID SEQUENCE INTUBATION/DEEP SEDATION" effective date April 2015, did not address the use of Succinylcholine Chloride during RSI, or the need for the availability of Dantrolene in the Emergency Department.

During the joint interview with the CNO, Hospital Administrator, and Regional Administrator on 04/02/19 at 1:19 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 showed, " ...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 this joint interview with the CNO, Hospital Administrator, and the Regional Administrator, it was agreed by all parties the facility did not have enough Dantrolene available to treat MH.

Based on document review and interview, the Critical Access Hospital's (CAH) staff failed to ensure the facility's policies were reviewed at least annually by the CAH's professional healthcare staff (an advisory group) including at least one physician or Doctor of Osteopathy (DO) and one or more physician assistants, nurse practitioners or clinical nurse specialists on staff. This deficient practice has the potential to affect all patients in the facility.

Findings Include:

A review of the Critical Access Hospital's numerous meeting minutes over the past year showed that an advisory group meeting for policy review was not included.

A review the facility's policy and procedure manuals showed no documentation that the policy and procedures had not been reviewed on an annual basis.

In an interview on 04/03/19 at 10:00 AM, during policy review, Staff A, Administrator, confirmed that the facility's policies had not been reviewed/revised by any of the CAH's staff members on a yearly basis. Staff A explained that the staff had reviewed some policies, but had not documented the date of the review.

Based on document review and interview, the Critical Access Hospital's staff failed to provide evidence that their health care policies were evaluated, reviewed and/or revised as part of the annual program evaluation. This deficient practice has the potential to affect all patients in the facility.

Findings Include:

Review of the facility's "Annual Evaluation Fiscal Year 2018" included the following statements: "The purpose of the evaluation is to determine whether the utilization of services was appropriate, the established policies were followed, and any changes are needed. The Policies and Procedures established by the Board are being reviewed, and therefore will only be included in this report for reference and clarification purposes." The evaluation was a comparison of Fiscal Year 2017 and 2018 and included average length of stays, average daily censuses, number of procedures, etcetera. The evaluation did not include an evaluation of policies and if any changes were needed.

Review of the facility's "Nursing Department Table of Contents Policy and Procedures" with an effective date of January 2015 and was signed by the Governing Board, Chief of Staff and Administrator during September 2007. The 2007 signatures indicated that the Policy and Procedures had been reviewed, approved and the annual review was completed. The policies had not been reviewed in over 4 years.

Review of the facility's "Infection Control Policy and Procedure Manual" had a blank signature page for when the Governing Board, Chief of Staff and Administrator would sign giving their approval and that the annual review was completed

In an interview on 04/03/19 at 10:00 AM, during policy review, Staff A, Administrator, confirmed the majority of policies were outdated and had not been reviewed/revised on an annual basis. Staff A explained that the facility's staff had recently reviewed various policies but did not document the date of the review.

Based on document review and interview, the Critical Access Hospital's (CAH) staff failed to develop an annual program evaluation that determined the utilization of services was appropriate, the established policies were followed and if any changes were needed. This deficient practice had the potential to affect all patients in the facility.

Findings include:

Review of the facility's "Annual Evaluation Fiscal Year 2018" included the following statements: "The purpose of the evaluation is to determine whether the utilization of services was appropriate, the established policies were followed, and any changes are needed. The Policies and Procedures established by the Board are being reviewed, and therefore will only be included in this report for reference and clarification purposes." The evaluation was a comparison of Fiscal Year 2017 and 2018 and included average length of stays, average daily censuses, number of procedures, etcetera. The evaluation did not include an evaluation of the appropriate utilization of services, if established policies were followed and if any changes were needed.

Review of the facility's "Nursing Department Table of Contents Policy and Procedures" had an effective date of January 2015 and was signed by the Governing Board, Chief of Staff and Administrator during September 2007. The signatures indicated that the Policy and Procedures had been reviewed, approved and the annual review was completed.

Review of the facility's "Infection Control Policy and Procedure Manual" had a blank signature page for when the Governing Board, Chief of Staff and Administrator would sign giving their approval and that the annual review was completed

In an interview on 04/03/19 at 10:00 AM, during policy review with Staff A, Administrator confirmed that the majority of policies were outdated and had not been reviewed/revised on an annual basis. Staff A did not state a reason why the annual review was not occurring.

Based on interview and review of the facility's documentation, the facility failed to ensure compliance for the Condition of Participation (CoP) for the Emergency Preparedness Plan (EPP) as evidenced by the failure to 1) document a review and update the EPP annually; 2) develop policies based on a facility and community Risk Assessment, and documentation the policies were reviewed and updated annually; 3) address facility's patient population, type of services that can be provided and a plan to continue operations during an emergency; 4) to establish policies and procedures based on a facility and community risk assessment and communication plan; 5) establish policies and procedures to address subsistence needs for staff and patients during an emergency or disaster; 6) to establish policies and procedures to address a means to shelter in place in the facility; 7) to establish policies and procedures to address preserving patient information, protecting confidentiality of patient information, and securing and maintaining availability of patient records in the event of an emergency; 8) to establish policy and procedures to address for the use of volunteers in an emergency; 9) develop a communication plan that has a primary and alternate means for communicating with staff and emergency management agencies; 10) develop a method for sharing information and medical documentation for patients under the facility's care. These failures had the potential to affect the all facility in-patients and/or swing bed patients, and/or out-patients receiving care in the facility, and potentially hindered the facility's ability to prepare for potential emergency situations and keep patients safe during an emergency event.

Findings Include:

1. The facility failed to ensure the Emergency Preparedness Plan (EPP) was evaluated and updated on an annual basis. Refer to tag E0004.

2. The facility failed to provide an all-hazards risk assessment that was reviewed and updated annually. Refer to tag E0006.

3. The facility failed to address their patient population, the type of services they could provide during an emergency and succession plan. Refer to tag E0007

4. The facility's failed to ensure that their Communication's Plan was reviewed and updated annually. Refer to tag E0013.

5. The facility's staff failed to establish policies and procedures to address subsistence needs for staff and patients during an emergency or disaster situation. Refer to tag E0015.

6. The facility's staff failed to establish policies and procedures to address sheltering in place for an emergency. Refer to tag E0022.

7. The facility's staff failed to establish policies and procedures to address preserving patient information, protecting confidentiality of patient information, and securing and maintaining availability of patient records in the event of an emergency. Refer to tag E0023.

8. The facility's staff failed to establish policies and procedures for the use of volunteers in the event of an emergency. Refer to tag E0024.

9. The facility's staff failed to develop and maintain an emergency preparedness communication plan that must be reviewed and updated at least annually. Refer to tag E0029.

10. The facility's staff failed to develop a method for sharing information and medical documentation for patients under their care with other health providers. Refer to tag E0033.

During an interview on 04/01/19 at 2:30 PM, Staff A, Administrator, confirmed the policies and procedures were outdated and had not been updated and reviewed on an annual basis. Staff A explained that various policies had been reviewed, but documentation of the date reviewed did not occur.

Based on document review and interview, the Critical Access Hospital's (CAH) staff failed to ensure that their Emergency Preparedness Plan was reviewed and updated annually. This deficient practice has the potential to place staff at risk for being unprepared during an emergency situation, placing patients at risk for harm.

Findings Include:

A review on 04/01/19 of the facility's Emergency Preparedness Plan showed no evidence that the plan had been reviewed and updated on an annual basis. The current written plan, "Sedan City Hospital Emergency Preparedness Organizational Management Plan" was dated 02/18/16 and the plan had not been reviewed or updated since that time. The plan showed, "The Disaster Preparedness Plan is reviewed at least annually and revised as often as needed."

During an interview on 04/01/19 at 2:30 PM, Staff A, Administrator, explained that Staff A was not aware that the Emergency Preparedness plan needed to be reviewed and updated on an annual basis.

Based on document review and interview, the Critical Access Hospital's (CAH) staff failed to provide an all-hazards risk assessment for their Emergency Preparedness Plan that was reviewed and updated annually. This deficient practice has the potential to place staff at risk for being unprepared during an emergency situation, placing patients at risk for harm.

Findings Include:

A review of the facility's Emergency Preparedness Plan showed no documented evidence that their risk-assessment was based on an all-hazards approach specific to the geographic location of the facility that encompasses all potential hazards or was updated annually. The written plan, "Sedan City Hospital Emergency Preparedness Organizational Management Plan" was dated 02/18/16.

A review on 04/01/19 of the facility's community and facility-based risk assessment, "HVA Sedan City Hospital" dated 2010, showed that it was not current and had not been updated annually.

During an interview on 04/01/19 at 2:30 PM, Staff A, Administrator, confirmed the plan and risk assessment had not been updated for three years and nine years respectively. Staff A did not have an explanation of why the updates/reviews had not occurred.

Based on document review and interview, the Critical Access Hospital's (CAH) staff failed to provide an Emergency Preparedness Plan that addressed their patient population, the type of services they could provide and succession plans. This deficient practice has the potential to place patients at risk for unmet medical needs.

Findings Include:

A review of the facility's Emergency Preparedness Plan showed no documented evidence that addressed their patient population, the types of services that could be provided in an emergency and succession plans.

During an interview on 04/01/19 at 2:30 PM, Staff A, Administrator, explained that the facility's patient demographic was elderly and indigent. Staff A confirmed that the patient population, type of services they could provide, and a succession plan was not included in the Emergency Preparedness Plan.

Based on document review and interview, the Critical Access Hospital's (CAH) staff failed to ensure that their Emergency Preparedness policies and procedures, based on a facility and community risk assessment and communication plan, were reviewed and updated annually. This deficient practice has the potential to place patients at risk for care that is provided by unprepared staff in an emergency situation.

Findings include:

A review of the facility's Emergency Preparedness Plan and related policies and procedures showed they were not developed and based on a current facility and community-based risk assessment utilizing an all-hazards approach. A review of policies and procedures showed no documented evidence they were updated annually. The risk assessment that was provided for review was dated 2010. Due to the risk assessment being outdated, the Emergency Preparedness policies that were provided were based on outdated risk assessment information. The policies that were provided for review were outdated (2015) except for one titled "Hospital Evacuation" was dated 11/01/18.

During an interview on 04/01/19 at 2:30 PM, Staff A, Administrator, confirmed the policies and procedures were outdated and had not been updated and reviewed on an annual basis. Staff A explained that various policies had been reviewed, but documentation of the date reviewed did not occur.

Based on document review and interview, the Critical Access Hospital's (CAH) policies and procedures failed to address all subsistence needs (food and pharmaceutical supplies) for staff and patients during an emergency or disaster situation. This deficient practice has the potential to place patients, staff and potential patients at risk for unmet subsisitne needs during an emergency situation.

Findings Include:

A review of the facility's Emergency Preparedness Plan showed no documented evidence that the facility's policies and procedures addressed all subsistence needs for staff and patients during an emergency or disaster. Such needs would include the safe and sanitary storage of provisions and pharmaceutical supplies. Further, there were no policies to address the provision of sewage and waste disposal.

During an interview on 04/01/19 at 2:30 PM, Staff A, Administrator, confirmed their policy and procedures did not address the safe and sanitary storage of provisions and pharmaceutical supplies.

Based on document review and interview, the Critical Access Hospital's (CAH) Emergency Preparedness Plan failed to address a means to shelter in place in the event of an emergency. This deficient practice has the potential to place patients and staff at risk for harm.

Findings Include:

A review of the facility's Emergency Preparedness Plan showed no documented evidence that the facility's staff had developed policies and procedures that addressed a means to shelter in place for patients, staff and volunteers who remained at the facility during an emergency.

During an interview on 04/01/19 at 2:30 PM with Staff A, Administrator, it was explained that the facility had no policies and procedures that addressed sheltering in place during an emergency and sheltering in place was not covered in the Emergency Preparedness Plan. Staff A was not aware that a means to shelter in place needed to be included in the Emergency Preparedness Plan in the form of a policy or procedure.

Based on document review and interview, the Critical Access Hospital's (CAH) Emergency Preparedness Plan failed to address preserving patient information, protecting confidentiality of patient information, and securing and maintaining availability of patient records in the event of an emergency. This deficient practice has the potential to place patients in the facility at risk for a breech in confidentiality and loss of medical information.

Findings Include:

A review of the facility's Emergency Preparedness Plan showed no documented evidence that the facility's staff had established policies and procedures to address preserving patient information, protecting confidentiality of patient information, and securing and maintaining availability of patient records in the event of an emergency.

During an interview on 04/01/19 at 2:30 PM Staff A, Administrator, explained policies and procedures had not been developed that addressed securing and maintaining availability of patient records, patient information, or protecting confidentiality of patient information in the event of an emergency. Staff A was not aware that policies regarding the protection of patient information during an emergency needed to be a part of the Emergency Preparedness Plan.

Based on document review and interview, the Critical Access Hospital's (CAH) Emergency Preparedness Plan failed to address the use of volunteers in an emergency and other emergency staffing strategies. This deficient practice has the potential to place patients and staff at risk for unmet needs during an emergency situation..

Findings Include:

A review of the facility's Emergency Preparedness Plan showed no documented evidence that the facility's staff had developed policies and procedures that addressed the use of volunteers (healthcare professionals and non-medical) or other emergency staffing ideas.

During an interview on 04/01/19 at 2:30 PM, Staff A, Administrator, confirmed there were no policies and procedures that addressed the use of volunteers during an emergency situation. Staff A was not aware that a use of volunteers policy needed to be part of the facility's Emergency Preparedness Plan.

Based on document review and interview, the Critical Access Hospital's (CAH) staff failed to develop a written emergency communication plan that complies with Federal, State and local laws that had been reviewed and updated at least annually. This deficient practice has the potential to place patients at risk for harm during an emergency situation.

Findings Include:

A review of the facility's Emergency Preparedness Plan showed no documented evidence that the facility's staff had developed a written emergency communication plan. The Plan included one paragraph that was titled "Communications" that addressed recalling hospital employees and that the command post will notify external authorities concerning the nature of emergencies. The plan did not address how the CAH would comply with Federal, State and local laws. The plan was not updated annually.

During an interview on 04/01/19 at 2:30 PM, Staff A, Administrator, explained there was not a comprehensive written facility emergency communication plan.

Based on document review and interview, the Critical Access Hospital's (CAH) staff failed to develop an emergency communication plan that complies with Federal, State and local laws, that includes a method for sharing information and medical documentation for the facility's patients with other health providers, that had been reviewed and updated at least annually. This deficient practice has the potential to place patients at risk for unmet medical care needs during a emergency situation.

Findings Include:

A review of the facility's Emergency Preparedness Plan showed no evidence of an emergency preparedness communication plan that included a process for sharing health information and medical documentation for their patients in order to provide continuity of care. The plan included a paragraph titled "Patient Management Information" but did not address the sharing of patients' health information.

During an interview on 04/01/19 at 2:30 PM Staff A, Administrator, explained that a method for sharing patient information and documentation was not addressed in the Emergency Preparedness Plan for the facility.