HospitalInspections.org

Based on interview and document review, the critical access hospital (CAH) failed to ensure community education regarding advance directives had been completed. This deficient practice had the potential to affect all current and future patients of the CAH.

Findings include:

Information at entrance was provided by the facility on advance directives, "at the time of admission all patients who are 18 years of age or older will be offered written information about their rights to make decisions concerning medical care and to prepare an adult healthcare declaration/advance directive." The admission binder included a pamphlet with a question and answer sheet about healthcare directives.

During an interview on 1/28/25 at 3:04 p.m., the director of inpatient services, registered nurse (RN)-D stated as part of the admission process, patients were asked about any healthcare directives. RN-D stated if patients wanted information about advance directives it would be provided upon request. RN-D verified there had not been any community education regarding healthcare directives.

The policy Self Determination and Advance Healthcare Directive dated 5/20/23, did not include how the CAH would provide community education on advance directives to the community.

Based on observation, interview and document review, the critical access hospital (CAH) failed to ensure needles, syringes and medications were secured and inaccessible to patients receiving services in clinic procedure rooms.

Findings include:

During a tour on 1/29/25 at 8:11 a.m., of the Raiter Clinic procedure room one and two were found to have unsecured medications, needles and syringes in drawers without locking mechanisms. Unsecured medications in treatment room one included:
--one 10ML [milliliters] bottle of lidocaine ( a local anesthetic that works by blocking nerve signals in your body) 2% [percent]
--one 10 ML bottle of lidocaine 1%
--one 20ML bottle of xylocaine (interchangeable with Lidocaine) with epinephrine (also known as adrenaline, is both a neurotransmitter and a hormone. It plays an important role in your body ' s "fight-or-flight" response).
--one bottle of Monsels (used as an astringent and hemostatic)
unsecured medication in treatment room two included:
--two 10ML bottles of lidocaine 2%
--one 20 ML bottle lidocaine 1% with epinephrine
--one 10 ML bottle of lidocaine 1%
--one 20ML bottle of xylocaine with epinephrine.

During an interview on 1/29/25 at 9:20 a.m., the clinic manager registered nurse (RN-B) confirmed medications, needles and syringes were not being stored in a secured area in procedure rooms one and two. As a policy, the regular exam rooms did not have needles, syringes or medications stored in them. RN-B stated it should be the same way in the treatment rooms, and indicated it was a concern that patients could access those items if left unsecured in the treatment rooms. RN-C stated it would be easy to add a lock to the drawer to secure treatment room medications and administration supplies so that patients could not access them.

The hospital policy section CMH (Community Memorial Hospital Association) Raiter Family Clinic Medication Storage and Handling Policy dated 2/7/23, instructed all medications were to be stored out of reach and view of patients and other non-employees and directed that the Raiter Family Clinic medication room was to be used for primary storage for clinic medications as it was accessible only through an employee badge reader.

Based on observation, interview, and document review, the critical access hospital (CAH) failed to ensure an adequate system for monitoring, tracking, and maintaining appropriate humidity and temperature levels within acceptable standards for 4 of 4 operating rooms.

Findings include:

During a tour of the surgical area on 1/27/25 at 9:50 a.m., surgical director, registered nurse (RN)-A stated all four of the operating rooms (ORs) were monitored for humidity and temperature by the maintenance department. RN-A stated the ORs were kept at 30-60 % humidity and the temperatures were kept at 70 degrees Fahrenheit (F). RN-A stated maintenance would notify surgery if the humidity and temperature were out of those ranges. In the ORs, the humidity was not displayed, there were however, wall thermostats with a red line indicating the temperature range.

During an interview on 1/30/25 at 8:25 a.m., director of building and grounds (DBG)-A stated the ORs were on an electronic system. DBG-A stated the computer system would constantly track humidity and temperature. If the humidity or temperature went out of range, it would alarm in the maintenance office. DBG-A stated the humidity was supposed to be between 30-60 % and the temperature at 70 degrees F. DBG-A stated either Monday or Tuesday of the present week he saw a temperature for 78 degrees F but did not call anyone or take any corrective measure. DBG-A stated the surgery department would call him if the temperatures were too hot or too cold. DBG-A thought the humidity and temperatures for the OR suites were recorded daily at 5:00 a.m.. DBG-A stated the humidity and temperatures were recorded daily however, he was not sure if anyone reviewed them and indicated he had not been sending any reports to the surgery director. A review of the alarm parameters on the computer system revealed the humidity range was set to alarm below 10 % and above 75%. The temperature alarm parameters were set to alarm below 45 degrees F and above 78 degrees F.

During an interview on 1/30/25 at 9:18 a.m., RN-A stated he had not been reviewing humidity and temperature logs. RN-A stated the standards according to the Association of periOperative Registered Nurses (AORN) for humidity and temperature for humidity in the OR would be 30-60 % and 68-75 degrees F. RN-A stated there would be a fire risk when humidity was too low and an increased risk for infection if the OR was too warm. If the temperature was too low/too high, there was also a risk for hypothermia/hyperthermia for the patient.

A review of the humidity and temperature logs for January 2025, revealed the following:

OR 1 humidity outside of the 30-60 % range 29 times with the lowest reading at 19 % and highest at 28 %
OR 2 humidity outside of the 30-60 % range 29 times with the lowest reading at 11.8 % and highest at 21.1 %
OR 3 humidity outside of the 30-60 % range 21 times with the lowest reading at 19.8 % and highest at 31.9 %
OR 4 humidity outside of the 30-60 % range 24 times with the lowest reading at 18.6 % and the highest at 34.1

OR 1 temperature outside of the 68-75 degrees F range 28 times with the lowest reading at 62.02 F never reaching 68 degrees F
OR 2 temperature outside of the 68-75 degrees F range 29 times with the lowest reading at 64.44 F never reaching 68 degrees F
OR 3 temperature outside of the 68-75 degrees F range 28 times with the lowest reading at 62.28 F reaching 68 degrees
F one time
OR 4 temperature outside of the 68-75 degrees F range 27 times with the lowest reading at 61.66 F reaching 68 degrees F twice

A review of the humidity and temperature logs for December 2024, revealed the following:

OR 1 humidity outside of the 30-60 % range 20 times with the lowest reading at 18.2 %
OR 2 humidity outside of the 30-60 % range 31 times with the lowest reading at 12.5 % and highest at 21.6 %
OR 3 humidity outside of the 30-60 % range 9 times with the lowest reading at 21.3 %
OR 4 humidity outside of the 30-60 % range 15 times with the lowest reading at 18.2 %

OR 1 temperature outside of the 68-75 degrees F range 30 times with the lowest reading at 59.9 degrees F
OR 2 temperature outside of the 68-75 degrees F range 31 times with the lowest reading at 64.5 degrees F never reaching 68 degrees F
OR 3 temperature outside of the 68-75 degrees F range 24 times with the lowest reading at 62.42 degrees F
OR 4 temperature outside of the 68-75 degrees F range 27 times with the lowest reading at 61.66 degrees F

During an interview on 1/30/25 at 10:50 a.m., quality director (QD)-A and risk compliance specialist (RCS)-D both verified the humidity and temperatures needed to be monitored, reported when out of range, and actions taken to correct as needed. Both verified the humidity and temperature monitoring occurred daily at 6:00 p.m..

On 1/31/25 at 9:17 a.m., an email communication was received from Siemens main branch dispatcher (S)-C to the state surveyor which identified the following:

OR 1 humidity parameters 10 -75 %, alarms set. Temperatures 45 - 78 degrees F with alarms set.
OR 2 humidity parameters 10 -80 %, alarms set. Temperatures 45 - 80 degrees F with alarms set.
OR 3 humidity parameters 10 -80 %, alarms set. Temperatures 45 - 75 degrees F with alarms set.
OR 1 humidity parameters 10 -80 %, alarms set. Temperatures 45 - 80 degrees F with alarms set.

The email identified manufacturer's recommendations to be as follows:

Relative humidity range 20-60 % and temperature range 68-75 F.

A policy on humidity and temperature for the OR was requested however not received.

Based on interview and document review, the critical access hospital (CAH) was not in compliance with 485.627 Condition of Participation for Organizational Structure due to failure of the governing body to assume full legal responsibility for ensuring the CAH had an effective organizational structure therefore they were unable to meet this condition. The organizational chart identified there was not a medical director. The physicians reported to the Vice President of Clinics and Physician Services. The nursing staff reported to The Chief Operating Officer (COO). This deficient practice had the potential to affect any patient who received services from the CAH.

A condition level deficiency was issued.

Findings include:

The facility organization chart identified, the governing board was listed at the top of the organizational chart, with the CEO next. A dotted line connected the medical staff to the CEO/administrator. The physicians reported to a vice president (VP) of clinics and physician services, who reported to the chief operating officer (COO), who reported to the CEO/administrator.

During an interview on 1/30/25 at 8:43 a.m., the CEO/administrator stated the CAH did not have a medical director. The CEO stated they had a chief of staff, a postion that was created in 2023 and hired in 2024. The chief of staff was elected annually and could serve one or two terms. The CEO described their job as administrative and their primary function was to run the medical staff meetings. The CEO verified the COO was not a nurse but was over the nursing departments (inpatient, emergency services, surgical services). The CEO verified over the years the CAH has had a nurse who was over nursing areas and had the title of Chief Nursing Officer (CNO). The CEO stated the section chiefs did not report to the chief of staff but directly to the CEO which was shown on the organization chart as a dotted line. All physicians however were listed as reporting to the VP of Clinics and Physician Services.

During an interview on 1/31/25 at 10:35 a.m., the VP of clinics and physician services stated the hiring and performance appraisals were completed by her. Any physician care complaints would go through the quality department. The VP of clinics and physician services stated they were not a physician.

The VP of clinics and physician services job description dated 7/2023, identified the VP was responsible for strategic relationships with the CAH providers and was to establish and maintain relationships that would drive business results. In addition, to implement strategies that would align with the organization's initiatives and goals. The job descriptions duties and responsibilities included:
-Manages provider performance including all disciplinary actions.
-Leads the organization's provider recruitments.
-Makes recommendations for provider terminations.
-Serves a a key voice for the providers by creating a flow of information between the providers and Community Memorial Hospital.

Education and/or experience included a "Minimum of a Bachelor's Degree in Health care Administration, business or related field."

During an interview on 1/31/25 at 10:42 a.m., the CEO verified the medical staff and section chiefs did not report to the chief of staff. Any complaints regarding care provided by the physicians would go to the section chiefs. Any complaints involving the section chiefs would go to another physician in that department.

On 1/31/25 at 11:15 a.m., the CEO provided pages 43 through 46 of the medical staff bylaws and again reiterated the CAH did not have a medical director. Pages 43-46 outlined the chief of staff's duties. "The Chief shall serve as the chief administrative officer of the Medical Staff to":

a. act in coordination and cooperation with the CEO/Administrator in all matters of mutual concern within the Facility;
b. call, preside at, and be responsible for the agenda of all general meetings of the Medical Staff;
c. serve as chair of the Medical Staff Executive Committee;
d. be responsible in conjunction with Administration, for the enforcement of Medical Staff Bylaws, Rules and Regulation, for implementation of sanctions where these are indicated, and for the Medical Staff's compliance with procedural safeguards in all instances where corrective action has been requested or initiated;
e. appoint committee Members to all standing, special and multidisciplinary Medical Staff committees except the Medical Staff Executive Committee;
f. represent the views, polices, needs and grievances of the Medical Staff to the Board of Directors and to the CEO/Administrator;
g. receive and interpret the polices of the Board of Directors to the Medical Staff and report to the Board of Directors on the performance and maintenance of quality with respect to the Medical Staff's delegated responsibility to provide medical care;
h. be the spokesperson for the Medical Staff in it's external professional and public relations;
i. attend the monthly Board of Directors meetings;
j. Serve as an ex-officio Member, with vote, of all other Medical Staff Committees;
k. Review credentialing files of new appointments; and
l. Perform such other duties commensurate with the office or as may from time to time be reasonably requested by the Medical Staff Executive committee or the Board."

On 1/31/25 at 1:00 p.m., a request was made to interview the chief of staff, they did not return the call.

A job description for the chief of staff was requested however, was not provided.

During an interview on 1/31/25 at 12:36 p.m., the CEO was not available the COO stated there was not a medical director. The COO stated their were section chiefs however, the CAH did not have an organizational chart for the medical staff.

The COO's job description dated 8/2023, identified they were responsible for the smooth and efficient operation of key departments throughout the CAH. Essential duties and responsibilities included:
-Maintains good communication with all department heads and medical staff.
-Establish and maintain medical provider relationships, seeking opportunities to engage the medical staff in dialogue around organizational strategy and key issues facing the medical staff and the organization.

Supervisory responsibilities included the following: clinical informatics, DME/sleep program, emergency services, imaging services, inpatient services, laboratory, marketing/public relations, occupational therapy, pharmacy, physical therapy, speech pathology, surgical services, the VP of clinical and physician services, the VP of human resources and support services.

Education and/or experience identified a minimum of a Bachelor's Degree in Healthcare Administration, Business or related field.

Other related deficiencies can be reviewed under the Condition of Participation for Organizational Structure C-0966 and under the Standard: Nursing Services C-1046.

Based on interview and document review, the critical access hospital (CAH) failed to implement its policy and procedure for reporting changes in the medical director to the State agency. The organizational chart identified there was not a medical director. The physicians reported to the Vice President of Clinics and Physician Services. This deficient practice had the potential to affect any patient who received services from the CAH.

Findings include:

The facility organization chart identified, the governing board was listed at the top of the organizational chart, with the CEO next. A dotted line connected the medical staff to the CEO/administrator. The physicians reported to a vice president (VP) of clinics and physician services, who reported to the chief operating officer (COO), who reported to the CEO/administrator.

During an interview on 1/30/25 at 8:43 a.m., the CEO/administrator stated the CAH did not have a medical director. The CEO stated they had a chief of staff, a position that was created in 2023 and hired in 2024. The chief of staff was elected annually and could serve one or two terms. The CEO described their job as administrative and their primary function was to run the medical staff meetings. The CEO verified the COO was not a nurse but was over the nursing departments (inpatient, emergency services, surgical services). The CEO verified over the years the CAH has had a nurse who was over nursing areas and had the title of Chief Nursing Officer (CNO). The CEO stated the section chiefs did not report to the chief of staff but directly to the CEO which was shown on the organization chart as a dotted line. All physicians however, were listed as reporting to the VP of Clinics and Physician Services. The CEO stated he was not aware of the need to report changes in the medical director to the state agency and therefore did not report the appointment of the chief of staff, again stating they did not have a medical director. The chief of staff was appointed by the board on 9/16/24, the CEO stated this appointment was not made to the state agency.

During an interview on 1/31/25 at 10:35 a.m., the VP of clinics and physician services stated the hiring and performance appraisals were completed by her. Any physician care complaints would go through the quality department. The VP of clinics and physician services stated they were not a physician.

The VP of clinics and physician services job description dated 7/2023, identified the VP was responsible for strategic relationships what the CAH providers and was to establish and maintain relationships that would drive business results. In addition, to implement strategies that would align with the organization's initiatives and goals. The job descriptions duties and responsibilities included:

-Manages provider performance including all disciplinary actions.
-Leads the organization's provider recruitments.
-Makes recommendations for provider terminations.
-Serves a a key voice for the providers by creating a flow of information between the providers and Community Memorial Hospital.

Education and/or experience included a "Minimum of a Bachelor's Degree in Health care Administration, business or related field."

During an interview on 1/31/25 at 10:42 a.m., the CEO verified the medical staff and section chiefs did not report to the chief of staff. Any complaints regarding care provided by the physicians would go to the section chiefs. Any complaints involving the section chiefs would go to another physician in that department.

On 1/31/25 at 11:15 a.m., the CEO provided pages 43 through 46 of the medical staff bylaws and again reiterated the CAH did not have a medical director. Pages 43-46 outlined the chief of staff's duties. "The Chief shall serve as the chief administrative officer of the Medical Staff to:

a. act in coordination and cooperation with the CEO/Administrator in all matters of mutual concern within the Facility;
b. call, preside at, and be responsible for the agenda of all general meetings of the Medical Staff;
c. serve as chair of the Medical Staff Executive Committee;
d. be responsible in conjunction with Administration, for the enforcement of Medical Staff Bylaws, Rules and Regulation, for implementation of sanctions where these are indicated, and for the Medical Staff's compliance with procedural safeguards in all instances where corrective action has been requested or initiated;
e. appoint committee Members to all standing, special and multidisciplinary Medical Staff committees except the Medical Staff Executive Committee;
f. represent the views, polices, needs and grievances of the Medical Staff to the Board of Directors and to the CEO/Administrator;
g. receive and interpret the polices of the Board of Directors to the Medical Staff and report to the Board of Directors on the performance and maintenance of quality with respect to the Medical Staff's delegated responsibility to provide medical care;
h. be the spokesperson for the Medical Staff in it's external professional and public relations;
i. attend the monthly Board of Directors meetings;
j. Serve as an ex-officio Member, with vote, of all other Medical Staff Committees;
k. Review credentialing files of new appointments; and
l. Perform such other duties commensurate with the office or as may from time to time be reasonably requested by the Medical Staff Executive committee or the Board."

On 1/31/25 at 1:00 p.m., a request was made to interview the chief of staff, they did not return the call.

A job description for the chief of staff was requested but not provided.

On 1/31/25 at 12:36 p.m., the CEO was not available the COO stated there was not a medical director. The COO stated their were section chiefs however, the CAH did not have an organizational chart for the medical staff.

The COO's job description dated 8/2023, identified they were responsible for the smooth and efficient operation of key departments throughout the CAH. Essential duties and responsibilities included:
-Maintains good communication with all department heads and medical staff.
-Establish and maintain medical provider relationships, seeking opportunities to engage the medical staff in dialogue around organizational strategy and key issues facing the medical staff and the organization.

Supervisory responsibilities included the following: clinical informatics, DME/sleep program, emergency services, imaging services, inpatient services, laboratory, marketing/public relations, occupational therapy, pharmacy, physical therapy, speech pathology, surgical services, the VP of clinical and physician services, the VP of human resources and support services.

Education and/or experience identified a minimum of a Bachelor's Degree in Healthcare Administration, Business or related field.

Based on interview and document review, the critical access hospital (CAH) failed to have a nurse responsible for the overall management and evaluation of nursing care, including nursing performance appraisals to meet the needs of patients. This deficient practice had the potential to affect any patient who received nursing services from the CAH.

Findings include:

During an interview on 1/30/25 at 1:15 p.m., the director of inpatient services, registered nurse (RN)-D stated there was not a process for performance reviews for RNs who were not in management. RN-D stated they had in the past however, not since the hospital made the switch from having a chief nursing officer (CNO) to having three nurse directors: one each for surgery, emergency, and inpatient departments. RN-D stated she did a touch-base with the inpatient RNs about once a year.

During an interview on 1/31/25 at 8:32 a.m.., the vice president of human resources and support services (HR)-A stated employee reviews were completed by exception, meaning if there was not a problem, a review would not be completed. HR-A stated it was up to the department "manager" whether they completed one or not. HR-A stated it was decided to be this way after looking at five years worth of employee reviews that had satisfactory as the status quo, and the hospital leadership felt the employee review was not an effective process. HR-A stated his suggestion to the "managers" was to meet with their employees monthly. HR-A stated the expectations were set for employees and if expectations were not being met, such as overdue education or medication errors, it was expected the investigatory process would be utilized to address the issue. The chief operating officer (COO) was the person supervising and doing the employee reviews for the "nurse managers".

During an interview on 1/31/25 at 9:27 a.m., the COO confirmed he was not a nurse and supervised the nurse directors, met weekly with them to discuss any concerns and would pull in quality leadership and create collaborative work groups as needed. The COO stated they did not sign off on nursing clinical policies; all policies belonging to the CNO had been transferred over to the ownership of the nurse leaders to review and revise as there was no longer a CNO. The COO stated nurse leaders would seek out peers in the industry for advice and for what best practice was, and if the nurse leaders could not agree, they would pull in other resources such as the Minnesota Hospital Association (MHA). Although the COO stated he did not get into the details of the policies, his expectation was that the nurse leaders were reviewing them for best practice annually. The COO stated it was unlikely CNOs in other facilities read every single policy they signed off. Although the COO stated he did not have clinical knowledge, he did not feel it was a challenge to manage nursing without being a nurse or having clinical background. COO stated he could obtain resources for nurse leaders to use and indicated he was ultimately responsible for the nursing staff.

During a follow-up interview on 1/31/25 at 9:46 a.m., RN-D stated her intention was to meet with her nursing staff for more frequent check-ins, however, with the CAH's growth in census and acuity of patients, she had not been able to keep up with that. RN-D did meet with employees as needed if she noted they were not completing their education, or if there was an error or issue, and she completed annual reviews for any non-contract employees she supervised. RN-D's performance review was completed by the COO.

During an interview on 1/31/25 at 11:34 a.m., the emergency department director, registered nurse (RN)-C stated she utilized her peers for clinical insight and support when looking at best practice, including peers outside the CAH. RN-C stated she and the other two nurse directors made the final decisions on best practice, and policy and procedures were signed off by their medical staff.

Review of the CAH's organization chart identified the directors of inpatient services, surgical services and emergency services reported to the COO. The COO reported to the chief executive officer (CEO). The organization chart did not identify a CNO. Neither the COO nor the CEO had a nursing background.

Review of the CAH's RN job description dated 9/2024, section D identified staff participation was essential to quality improvement, and the RN would participate in annual performance reviews.

Based on observation, interview, and document review, the critical access hospital (CAH) failed to ensure reusable laryngoscope blades were packaged and stored per the manufacturer's recommendation. This deficient practice had the potential to affect any patient who required emergency intubation. In addition, the facility failed to ensure a water management program was in place to address waterborne pathogens such as legionella. This deficient practice had the potential to impact all patients who received care at the CAH.

Findings include:

LARYNGOSCOPE BLADES

During an observation on 1/27/25 at 10:46 a.m., two emergency department (ED) crash carts were observed. The top drawer of the green adult crash carts contained a laryngoscope handle and several reusable laryngoscope blades unpackaged on a washcloth. The pediatric crash cart had a laryngoscope handle, and reusable blades stored in plastic zip lock bags.

During an interview on 1/31/25 at 9:47 a.m., central sterile processor (CSP)-L identified the process for used laryngoscope blades after use from any of the emergency carts was to have the blade returned to sterile processing. The blades were sent through the washer in sterile processing, moved to the clean side, placed in the steam autoclave machine in a "peel pouch" and returned to the proper department (nursing, emergency department, surgery). CSP-L stated laryngoscope blades were re-processed because of patient contact when the blades were used.

During an interview on 1/31/25 at 10:15 a.m., the emergency department medical director (EDMD) stated they did not know why the laryngoscope blades were not being stored in autoclaved packaging. After use, the blades were expected to be sent to sterile processing and then stored in the autoclaved packaging, so staff would know 100% they were clean and safe to use on the next patient.

During an interview and observation on 1/31/25 at 10:31 a.m., RN-H opened the top drawer of the crash cart on the medical/surgical unit. The drawer contained multiple laryngoscope blades in a shallow plastic tray which were not in sealed packages, one laryngoscope handle, and four c-size batteries. RN-H was not sure if the blades should have been in sealed packages. RN-H called respiratory therapist (RT)-G to the floor to see if she knew if the blades should have been in a sealed pack. RT-G stated anesthesia brought their own glide scopes to codes, the ones in the drawer were used for back up.

During an interview and observation on 1/31/25 at 10:36, RN-I opened the top drawer of the crash cart in the intensive care unit (ICU). The drawer contained multiple laryngoscope blades, some were in sealed packages and some were not. RN-I stated she did not know why some of the blades were not in packages, which indicated they were not sterile, and she thought they should have been sterile when used on a patient.

During an interview on 1/31/25 at 10:40 a.m., RN-D stated the expectation was the blades were to be sterilized through sterile processing. The anesthesiologists did bring their own glide scopes however, if there was a code overnight the physician would probably have to do the intubation and use the supplies in the cart. RN-D stated it was an infection control concern and was important to help prevent infections.

During an interview on 1/31/25 at 11:28 a.m., the emergency department director (EDD) registered nurse (RN-C) stated the ED staff cleaned laryngoscope blades in quat [short for the cleaning solution quaternary ammonium compound cleaning] in the ED and indicated they had thought blades could not be sterilized. RN-C stated they did not have a policy for cleaning the blades in quat however, they planned to stop doing that immediately and would be changing the process to send the blades to sterile processing.

During an interview on 1/31/25 at 1:25 p.m., surgical director, registered nurse (RN)-A opened the surgical emergency cart. The top drawer had various sizes of laryngoscope blades none of which were in "peel pouches". Certified registered nurse anesthetist (CRNA)-K stated they would not use the airway drawer and said for any emergency intubation they would use the airway backpack. CRNA-K opened the backpack, all of the laryngoscope blades were in "peel pouches". RN-A removed all of the laryngoscope blades from the surgical emergency cart stated he would be sending them to sterile processing for reprocessing and packaging.

Cleaning and Processing of Instruments dated 4/24/23, identified used instruments would be transported to the cleaning room, each instrument would be manually scrubbed after soaking to remove gross contamination, after scrubbing, instruments would be put into the appropriate container before starting the washer, instruments were steam sterilized according to the manufacturer's instructions.

WelchAllyn Fiber optic laryngoscope blade assemblies and directions for use dated 2014, identified the following:

Point of use: separate blade assembly from the handle and place the blade assembly into suitable containment for subsequent reprocessing.

Preparation for decontamination: disassemble the blade, select a neutral pH enzymatic cleaner.

Manual cleaning: immerse the blade and components in the neutral pH enzymatic cleaner, clean with soft bristle brush, thoroughly rinse.

Drying: dry all components with clean cloth or allow to air dry.

Sterilization: gravity autoclave sterilization or pre-vacuum autoclave sterilization or Steris AMsco V-PRO low temperature sterilization or STERRAD hydrogen peroxide gas plasma sterilization.

WATER MANAGEMENT

During an interview on 1/28/25 at 1:04 p.m., the infection preventionist (IP) stated the director of of building and grounds (DBG) was responsible for the water management plan. The IP indicated they had completed a risk infection prevention assessment and legionella was on their radar for 2025. They had been planning to reach out and work with the DBG to ensure the CAH's water management and legionella policies and practices were place.

During an interview on 1/29/25 at 2:50 p.m., the director of building and grounds DBG stated since they had resumed their position in August, they had not performed any water management activities for legionella. At the time of the interview, they did not know where the water plan was located, and indicated they would have to follow-up with the plan later.

Records were requested for water management activities performed at the CAH, none were provided other then previous testing results. The document from Special Pathogens Laboratory indicated the facility had tested areas on the 2nd floor of the CAH for legionella on 5/14/22. Testing was resulted on 5/23/22 and values were negative for legionella.

During an interview on 1/31/25 at 12:37 p.m., the director of quality confirmed the facility did not have any water management maintenance records to show legionella prevention activities had been/were being done at the facility.

The CAH policy Water Management Program was dated as revised in the future: 7/18/25. The policy indicated the director of buildings and grounds and the director of infection prevention were responsible for the maintenance of the program and indicated data would be submitted to the infection control meetings quarterly.

Based on interview and document review, the critical access hospital (CAH) failed to identify and incorporate the high-risk low volume use of behavioral and medical restraint use into their quality assurance and improvement (QAPI) program.

Findings include:

The undated document Quality Improvement Plan Community Memorial Hospital Association subheading CMH [Community Memorial Hospital] Quality Improvement Indicators did not include restraint use as an indicator.

During an interview on 1/27/25 at 11:59 a.m., the Director of the Emergency Department (DED) RN-C stated they were not collecting and reviewing data on patients placed in restraints. Restraints were not part of their QAPI.

During an interview on 1/31/2025 at 9:27 a.m., the chief operating officer (COO) (who is responsible for nursing services) stated nursing services had not identified restraint use as a high-risk care area, nor had they identified issues or incorporated restraint use into the nursing QAPI plan.

During an interview on 1/31/25 at 10:15 a.m., the emergency department medical director (EDMD) stated they had not been aware of the concerns regarding restraint use at the facility. EDMD indicated restraint use should have been a part of QAPI. EDMD stated It would been ideal if the facility developed case review criteria like they had for the stroke program and reviewed each restraint event to ensure criteria was met. As part of the improvement process, the EDMD indicated they also needed to look at and revise current restraint orders/documentation, education, and policies to ensure they supported best practice for restraint use.

During a follow-up interview on 1/31/25 at 10:53 a.m., the EDD, RN-C stated as a result of the survey process they had determined the facility needed to incorporate restraint use into nursing QAPI and in addition the facility needed to assess, review and make revisions on their restraint policy, orders, education, and electronic medical record documentation to ensure they were using and meeting best practice standards for restraint use.

The CAH policy Restraints dated 5/20/23, did not include direction for QAPI and safety review of restraint use in the CAH.

Based on interview and document review, the critical access hospital (CAH) failed to ensure the plant services area had on going participation in the CAH's quality assessment and performance improvement (QAPI) plan.

Findings include:

The undated document Quality Improvement Plan Community Memorial Hospital Association indicated all individuals, departments, and professions would be included in QAPI. Department managers were identified as responsible for selecting, executing and reporting quality improvement project finding at assigned times to the Quality and Safety Council.

During an interview on 1/29/25 at 2:50 p.m., director of building and grounds (DBG)-A stated they did not have a QAPI project in 2024, and indicated they were in the process of selecting a project to work on for 2025.

During an interview on 1/31/25 at 12:37 p.m., the director of quality improvement confirmed the maintenance department did not have a QAPI project for 2024, and had yet to submit a project for 2025.

Based on interview and document review, the critical access hospital (CAH) failed to evaluate the discharge planning process, including a periodic review of a sample of patient discharge plans including patients who were readmitted within 30 days to ensure the discharge plans were adequate for patient's post-discharge needs.

Findings include:

During an interview on 1/31/25 at 9:34 a.m., the director of inpatient services, registered nurse (RN)-D, who supervised the social worker who was unavailable for interview, stated there was not a review process in place for discharge planning nor an ongoing review of a sample of patient discharge plans. RN-D stated it would have been important to review those things to identify any gaps in planning care after discharge.

The CAH's policy, Interprofessional Patient Care Conference/Daily Meeting dated 11/17/23, did not address evaluating the discharge planning process.

Based on interview and document review, the critical access hospital (CAH) failed to ensure integrated education, polices, procedures, orders, and medical documentation was in place to ensure restraint application was implemented at the least restrictive intervention level and care was consistent with current standards of practice. In addition, the CAH failed to ensure restraint education was competency based and included patient-centered, trauma informed care. The CAH further failed to ensure patients consistently received their Bill of Rights upon admission. These deficient practices had the potential to impact all patients who received care at the CAH.

As a result of these failures, these deficient practices resulted in a condition level deficiency for (P14, P17, P18, P35, P26, P27, P28, P29). The hospital was found out of compliance with the Condition of Participation Patient Rights at 42 CFR 482.13.

A condition-level deficiency was issued.

Findings include:

See C-2553 Based on interview and document review, the critical access hospital (CAH) failed to ensure the CAH restraint and seclusion policies and procedures were clearly defined and presented in a manner to ensure the correct restraint application, assessment, observation, and documentation was performed for 4 out of 5 patients (P26, P27, P28, P29) reviewed for the use of restraints for violent behavior management.

See C-2551 Based on interview and document review, the critical access hospital (CAH) failed to ensure integrated education, polices, procedures, orders, and medical documentation was in place to ensure restraint application was implemented at the least restrictive intervention level when utilized for behavioral or medical management. This deficient practice impacted 4 out of 5 patients (P26, P27, P28, P29) reviewed for restraint use and had the potential to impact all patients who received care at the CAH.

See C-2560 Based on interview and document review, the critical access hospital (CAH) failed to ensure restraint education was comprehensive and competency based. This deficient practice had the potential to impact all patients within the CAH who required restraint application for medical or behavioral care management.

See C-2561 Based on interview and document review, the critical access hospital (CAH) failed to ensure restraint education for nursing staff and providers included patient-centered, trauma informed competency- based training and education. This deficient practice had the potential to impact all patients receiving services at the CAH.

See C-2502 Based on interview and document review, the critical access hospital (CAH) failed to protect and promote patient rights by issuing a patient bill of rights to 4 of 20 patients (P14, P17, P18, P35) reviewed for patient rights.

Based on interview and document review, the critical access hospital (CAH) failed to protect and promote patient rights by issuing a patient bill of rights to 4 of 20 patients (P14, P17, P18, P35) reviewed for patient rights.

Findings include:

P14's medical record identified an admission on 12/13/24, with discharge on 12/19/24. P14's medical record lacked evidence P14 received the patient bill of rights.

P17's medical record identified an admission on 1/23/25, with discharge on 1/28/25. P17's medical record lacked evidence P17 received the patient bill of rights.

P18's medical record identified an admission on 1/19/25, with discharge on 1/27/25. P18's medical record lacked evidence P18 had received the patient bill of rights.

P35's medical record identified an admission on 1/24/25, with discharge on 1/28/25. P35's medical record lacked evidence P35 had received the patient bill of rights.

During an interview on 1/30/25 at 11:30 a.m., the director of inpatient services, registered nurse (RN)-D stated the patient bill of rights was on a clipboard, along with other admission documents, the admitting nurse carried into the patient room and went over with the patient on admit. RN-D stated there was not a place for the patient to sign receipt of the bill of rights on these admission papers however, there was on their general admission consent. The general admission consent was completed by registration and the patient may or may not have received the patient bill of rights at the time they signed that. Patients being admitted to a swing bed did have an acknowledgement form with the patient bill of rights. RN-D stated the difference may have been the forms had not been reviewed in a while.

During an interview on 1/30/25 at 12:15 p.m., the director of quality improvement (QD)-A confirmed the above patient records did not have acknowledgement of receiving the patient bill of rights.

Patient Admission Procedure dated 7/31/23, identified its purpose was to introduce the patient to the hospital routine; to inform the patient of their rights and responsibilities, to provide a holistic and systematic approach to a health assessment. The procedure did not address giving the patient the patient bill of rights.

Based on interview and document review, the critical access hospital (CAH) failed to ensure integrated education, polices, procedures, orders, and medical documentation was in place to ensure restraint application was implemented at the least restrictive intervention level when utilized for behavioral or medical management. This deficient practice impacted 4 out of 5 patients (P26, P27, P28, P29) reviewed for restraint use and had the potential to impact all patients who received care at the CAH.

Findings include:

On 1/30/25 at 10:12 a.m., the emergency department director, registered nurse (RN-C) provided a copy of the restraint orders and nurse flowsheet from the electronic medical record (EMR):
There were two restraint orders to select from. Each order auto-populated a second associated order:
--Order one: Apply restraints - which auto populated the order: assess restraints q [every] 15 minutes stat [immediately].
--Order two: Apply soft restraints - which auto populated the order: assess soft restraints q 2 hours.
The CAH provided copy of the EMR nursing flowsheet for nursing restraint documentation included the following headers and data fields:
Behavior---
--behavior requiring restraints
--Restraint alternatives tried
--Actions taken related to restraints
Restraints (occurrence)
--Restraint location
--Restraint type
--restraint status
--assessment of limb
Patient care
---Patient care performed
---Reason Restraints discontinued.
Instructions in the restraint occurrence field listed:
--Velcro limb: insert an occurrence for each limb restrained and document status and site assessment every 15 minutes until restraint discontinued.
--Foam/soft limb: insert an occurrence for each limb restrained and document status and site assessment every 2 hours until restraints discontinued.

During an interview on 1/30/25 at 10:12 a.m., RN-C confirmed the orders did not identify the type of restraint (behavioral or medical), the indication for restraint used, the duration/expiration of order, or the level of restraint to be applied. RN-C confirmed nurse documentation fields did not identify if behavioral or medical restraints were implemented, nor did it provide a place to document ongoing assessment of patient response to restraints. RN-C stated staff selected the harm to self or others and Velcro restraints when behavioral restraints were used, however staff were not documenting in the flowsheet as it instructed every 15-minutes when velcro restraints were used. RN-C stated if the doctor ordered soft restraints, then the order for assessment was every two hours and did not match the flow sheet instruction for every 15-minute assessments.

P26:

P26's electronic medical record (EMR) nursing chief complaint entry indicated P26 arrived at the emergency department (ED) on 8/5/24 at 2:36 a.m., with confusion. The provider history and physical notes indicated the provider saw P26 at 2:39 a.m. The chief complaint was altered mental status, and the final diagnoses included hepatic encephalopathy and anemia/gastrointestinal bleed. The note included "soft restraints necessary secondary to her climbing out of bed".

Restraint orders were placed at 2:39 a.m.: apply soft restraints, assess soft restraints q 2 hours. The orders lacked identification if the restraints were behavioral or medical, the level of restraints to be used, the expiration of the order or the rationale for implementation.

A registered nurse's (RN) progress note at 2:40 a.m., identified safety precautions taken included the following: call light in reach, bed low, siderails up, room free of clutter, curtain open, instructed to call for help, non-skid shoes/slippers, and parent/companion in room.

At 2:45 a.m., RN progress note identified Velcro restraints were applied to right upper arm and left upper arm because patient was at risk for self-harm. Restraint alternatives tried were documented as well as limb warm, not swollen, and pulse present.

P26's EMR reflected the phrase "assess restraints every 15 minutes" and was time stamped on 8/5/24 at 3:00 a.m., 3:15 a.m., 3:30 a.m., and at 3:45 a.m. by an RN. The record lacked data at these times to indicate what type of assessment, or what the results of the assessments were.

On 8/5/24 3:55 a.m., a RN entry indicated Velcro restraints were discontinued (limb warm, not swollen, pulse present) for right and left upper arms. Reason for restraint discontinued: "condition improved."

On 8/5/24 4:00 a.m., RN progress note indicated restraints were removed in the computerized tomography (CT) room and remained off. Patient "remains calm".

The EMR lacked evidence of the following: level of restraint, duration of restraint order, type/intent of restraint utilized: behavior or medical management, assessment of P26's responses, rationale for the use/continued use of restraints, or what level of observation had occurred while P26 was restrained.

During an interview on 1/30/25 at 7:23 a.m., RN-F stated P26 had erratic behavior at home and their spouse had to call the ambulance to assist with getting P26 to the hospital. When P26 arrived, based on P26's symptoms and history of high ammonia levels, recent surgery and encephalopathy, there was an urgency to get an assessment completed and to make sure P26 was not critical. Restraints were used, because P26 had behaviors that were putting them at risk for injury and staff needed to quickly determine what P26's medical status was. RN-F reviewed the chart, and R26 had restraints on for less than an hour. RN-F stated staff were expected to watch closely and get patients out of restraints as soon as it was safe to do so.

P27:

P27's EMR nursing chief complaint entry indicated R27 arrived at the ED on 7/29/24 at 11:34 a.m., acting erratic. Patient was placed on hospital stretcher, four-point restraints applied. The provider history and physical notes identified the provider saw P27 at 11:46 a.m., and identified P27 was brought in by police in "cuffs and switched over to soft restraints. Chief complaint was agitation, and final diagnosis was psychotic disorder secondary to gabapentin [a medication used to treat parietal seizures, nerve pain, and restless leg syndrome].

Provider Order placed on 7/29/24 at 11:46 a.m.,: apply soft restraints and assess soft restraints every two hours.

Provider note on 7/29/24 at 4:00 p.m., removed right wrist restraint.

Provider note on 7/29/24 at 4:40 p.m., leg restraints removed, out of restraints.

Treatments:

On 7/29/24 11:40 a.m., soft restraints applied. "Harm to self, Harm to others, pulls at LS devices, Agitated/hostile, Confused/disoriented". Alternatives were documented.
All extremities, Velcro limb, limbs documented as warm, not swollen, pulse present.
---7/29/24 12:17 p.m., "assess soft restraints every two hours" identifies removes and reapplied.
---7/29/24 1:29 p.m., right and left lower extremities removed and reapplied.
---7/29/24 1:42 p.m., right upper extremity removed and reapplied, left upper extremity "rotated".
---7/29/24 2:40 p.m., right and left upper extremities removed and reapplied.
---7/29/24 3:50 p.m., left upper extremity, right lower extremity, left lower extremity removed and reapplied.
---7/29/24 5:00 p.m., left upper extremity, right lower extremity, left lower extremity restraint discontinued.

Review of nurses' notes from 7/29/24 to 7/31/24 revealed:
7/29/24 5:00 p.m., left upper and bilateral lower limb restraints taken off
7/29/24 6:45 p.m., up in bathroom in room, slightly unsteady on feet. Unclear when right upper extremity restraint was removed.
7/31/24 11:33 a.m., ambulance transfer to inpatient mental health outside of CAH

P27's restraint order did not specify type, level of restraint, indications for use, or expiration time of order. The EMR indicated the equivalent of a medical restraint order had been entered for a behavioral restraint application. The EMR lacked evidence of a renewed order for continued restraint use after the initial order expired at four hours. In addition, the chart lacked evidence of care interventions being offered and RN assessment completion every two hours. In addition, the EMR lacked documentation of assessed response to restraints and circulation checks every 15 minutes.

P28:

P28's EMR nursing chief complaint entry indicated P28 arrived at the ED via police on 9/15/24 at 0:55 a.m., intoxicated, uncooperative, combative (screaming and kicking staff). The provider history and physical notes identified the provider saw P28 at 1:20 a.m., the chief complaint was alcohol intoxication/abuse. The final diagnosis was alcohol use.

Documentation entered 9/15/24 at 1:30 a.m., on the paper form Care Management With Restraints Flowsheet identified the following:
---Invasive device present, confusion, disorientation, cognitive impairment, inability to follow commands, lack of awareness of potential harm to self.
---Combativeness of such severity to pose an imminent threat of self-extubation of an invasive device necessary for medical management.
---"Danger to others, arrived and restraints started".
---Bilateral writs, ankle, four side rails
Additional entries included:
---1:00 a.m., skin care/repositioned, safety checks, resp status assessed, restraint type "BAS", meets protocol
---2:00 a.m., skin care/repositioned, safety checks, resp status assessed, restraint type "BAS", meets protocol
---3:00 a.m., skin care/repositioned, safety checks, resp status assessed, trial release, restraints discontinued

On 9/15/24 at 0056, the EMR indicated soft restraints applied, and identified P28's behavior indications for restraints: harm to self, others, agitated/hostile, and confused/disoriented.
Velcro restraints were applied to right upper extremity, right lower extremity, right upper extremity, and left lower extremity was listed as foam/soft limb and Velcro. Limbs documented as warm, not swollen, pulse present.

On 9/15/24 at 2:50 a.m., restraints were discontinued due to "condition improved".

Review of nurses notes on 9/15/24, included the following entries:
9/15/24 at 1:26 a.m., "Patient is intoxicated and aggressive. In 4-point restraints due to be physically and verbally aggressive."
9/15/24 at 2:19 a.m., "CMS intact on all extremities"
9/15/24 at 2:50 a.m., "Restraints removes from all extremities."

Restraint orders were placed on 9/15/24 at 5:46 a.m.: apply soft restraints, assess soft restraints every two hours. The order did not specify type, level of restraint, indications for use, or expiration time of order. The EMR indicated the equivalent of a medical restraint order had been entered for a behavioral restraint application.
The order time did not fall within policy guidelines which directed orders were to be obtained within 30 minutes of restraint application.

P29:

P29's EMR nurse chief complaint entry indicated P29 arrived at the ED with law enforcement on 6/18/24 at 4:45 a.m.
A nurse's note entered in the EMR indicated the provider was in with P29 on 6/18/24 at 10:11 a.m.

On 6/18/24 at 10:32 a.m., a nurse entry in the EMR identified P29 had exhibited behavior that was identified as harm towards others, towards self, agitated and hostile. P29 had restraints applied, the provider was notified, then evaluated and provided an order for the restrains.

The provider orders entered at 6/18/24 at 10:07 a.m., were: apply restraints, assess restraints every 15 minutes. The orders lacked identification of the type and level of restraints to be used, the expiration of the order or the rationale for implementation.

The restraint flowsheet documented velcro limb restraints were applied to right upper extremity and left lower extremity, foam/soft limb restraints were applied to right lower extremity and left upper extremity. The flow sheet identified interventions tried before restraints were to modify the lighting, reduce sensory stimulation, and put bed in lowest position.

P29's EMR reflected the phrase "assess restraints every 15 minutes" and was time stamped on 6/18/24 at 10:34 a.m., 11:20 a.m., 11:35 a.m., 1150 a.m., 12:05 p.m., 12:20 p.m., 12:35 p.m., 12:42 p.m., 1:00 p.m., 1:13 p.m., 1:30 p.m., 1:45 p.m., 2:00 p.m., 2:15 p.m. The record did not contain data at these times to indicate what type of assessment, or what the results of the assessments were.

On 6/18/24 at 2:25 p.m., P29's EMR identified a note indicating a nurse assisted P29 to the bathroom, assisted her with cleaning up and changing shorts. At 2:50 p.m., P29 was escorted back to bed and a nurse's note identified P29 no longer required restraints.

P29's EMR indicated P29 had remained in restraints beyond the expiration time of the initial restraint order at 2:07 p.m. The restraint flowsheet did not include restraint discontinuation documentation however, a nurse note entry made on 6/18/24 at 2:51 p.m., indicated P29 was assisted to the bathroom and cleaned up by nursing staff. Upon completion of task, restraints were no longer needed. Sequential notes indicated R29 was no longer in restraints.

P29's EMR lacked evidence of the following: on-going RN assessments, documented response and rationale for the use/continued use of restraints, one on one observation of P29 (or other level) while restrained, range of motion was performed, nutrition, elimination, and hydration needs were addressed and that every fifteen-minute assessment and documentation had been completed while P29 was in restraints.

During an interview on 1/30/25 at 9:59 a.m., RN-C reviewed the restraint policy and confirmed the policy did not clearly identify current best practice standards for the care of patients in behavioral or medical restraints, nor did the policy clearly outline care requirements for staff to use as a reference. RN-C identified the need to revise the policy and indicated they would need to do research before they could identify what was expected for best practice care and documentation.

During an interview on 1/30/25 at 11:24 a.m., ED paramedic (EDP-E) stated restraint education did not include education or competencies on patient-centered, trauma informed care, or the application of restraints. EDP-E stated they attempted other interventions prior to restraint application, and they typically checked on patients in restraints every 15 minutes. EDP-E was not certain what the required frequency of assessment and documentation was for patients in restraints or what the frequency of order renewal was. For behavioral restraints, they thought order renewal was every 24 hours however, they indicated they would have to check the policy to be sure.

During a follow-up interview on 1/30/25 at 11:49 a.m., EDP-E stated they had reviewed their restraint policy and felt it was confusing, it did not clearly direct the frequency of assessments and/or order parameters for patients in medical or behavioral restraints.

During an interview on 1/30/25 at 11:35 a.m., RN-F stated they had not received any education on patient-centered, trauma informed care or restraint application. RN-F stated they had reviewed the restraint policy and felt the policy did not give any clear guidance for behavioral and medical restraints. RN-F stated they used more behavioral restraints in the ED. RN-F confirmed the orders in Meditech did not indicate the type of restraint that was being ordered or how long an order was good for. Before restraint use, they always tried to de-escalate patients, used the least restrictive level of restraint, and documented every 15 to 30 minutes on the patient. Circulation was expected to be be checked every 15 minutes. When possible, they kept eyes on the patient. RN-F stated they did not know how frequently orders needed to be renewed and they would look to the policy for that information.

During an interview on 1/31/25 at 7:23 a.m., RN-G stated they had reviewed their restraint policy, and it was unclear what the frequency and content of nursing documentation needed to be. RN-G looked at the examples of nurse documentation fields and restraint orders and confirmed it was not clear what order was to be used for medical vs. behavioral restraints. RN-G stated providers may not know the difference between the two order choices, so restraints were probably not getting ordered correctly and staff and providers did know what type of restraints were implemented regardless of the order. Sometimes every 15-minute assessments were ordered and sometimes every two-hour assessment got ordered for behavioral restraints. RN-G confirmed between the orders, the policy and the nurse EMR documentation, it was not clear how frequently required assessments and documentation should occur for the different types of restraints.

A facility provided document titled Course Completion History showed ED staff and providers had completed the Relias restraint education module in 2024. The undated, Restraints and Seclusion Relias education module did not include specific direction for frequency of monitoring and documentation, nor did it include de-escalation techniques or trauma informed care. The facility policy was not included in the education.

Restraint competencies were requested however, it was confirmed the CAH did not have any documented restraint competencies on file for nursing staff or providers.

The facility policy Restraints dated 5/20/23, was reviewed and lacked clear distinction and direction for behavioral restraint and medical restraint application. The policy indicated the same restraint order could be used for re-applications of restraints as long as the order had not expired however, current standards of practice require a new order and face to face evaluation for each restraint event regardless of the expiration time of the original restraint order. In addition, the policy lacked integration and similar language with the CAH's restraint orders, education, and EMR documentation fields. In addition, the policy did not address assessment for patient centered trauma informed care or the need for restraint QAPI.

Based on interview and document review, the critical access hospital (CAH) failed to ensure the CAH restraint and seclusion policies and procedures were clearly defined and presented in a manner to ensure the correct restraint application, assessment, observation, and documentation was performed for 4 out of 5 patients (P26, P27, P28, P29) reviewed for the use of restraints for violent behavior management.

The CAH's policy Restraints dated 5/20/23, did not identify clinical references and/or resources used to formulate the restraint policy. The policy section III Definitions/Special Consideration Section I. General Information included line item 4. When restraints are used the condition of the patient must continually be assessed, monitored and re-evaluated. However, the policy failed to define the level of observation and/or staff actions required to meet "continually assessed, monitored and re-evaluated."

The policy section IV. Procedure sub part A. Care management of the Medical or Post-Surgical Patient included the following line items:
1. In acute medical and post-surgical care, a restraint may be necessary to ensure that the patient receives the medications, feeding, IV fluids, or temporarily limit mobility.
2. Consider alternative, less restrictive, interventions prior to the use of restraint.
3. The RN will complete and document in PCS and reassess at least every shift thereafter.
4. The physician will document the risks associated with the use of restraint outweigh the risk of not using a restraint. Points of consideration may include patient's behavior, fall potential, orientation, ability to follow directions and the safety to self and others." Addition examples included:
---confused, disoriented or extremely restless to the degree that he/she is not responsible for safe decision making and may accidentally or purposefully harm self/others.
---agitated, hostile, or abusive toward care givers in the form of strong verbal language or the overt actions of biting, scratching, hitting, kicking personnel
---attempting to ambulate without assistance when assistance is required for safety
---interfering with or pulling at life support devices
5. An order must be obtained within 30 minute of the restraint application and cosigned within 24 hours. May be obtained via phone. This order is reordered every 24 hours.
6. The use of restraints is ended at the earliest possible time.
7. Once a restraint is applied, the nurse must document:
---Reason for restraints: example "harm to self and/or others"
---Type of restraint applied
---Time applied
---Less restrictive interventions attempted
---With appropriate staff assistance the nurse will release the patient every 2 hours to give the patient the opportunity for motion, exercise, nutrition, hydration, and elimination for at least 10 minutes. (If in 4-point restraint, free one limb for 10 minutes at a time)
---Assess the need for restraint use and end use as soon as the patient is compliant with instructions for safety
---Restraints are monitored and documented every 2 hours until discontinued
---Address all problems and interventions in the care plan.

The policy section IV. Procedure sub part B. Behavior Management included the following:
1.The RN after assessment may initiate the use of a restraint in an emergency situation where the patient's behavior becomes aggressive or violent presenting an immediate, serious danger to self or other.
2. In emergency situations, the MD from the Emergency Room will validate the restraint order to allow time to determine the cause of the behavior while protecting the patient and/or others from injury.
3. The treating physician or the clinic specific on-call physician must be notified as soon as possible.
4. A face-to-face evaluation must be conducted by the ordering physician and documented within one (1) hour after the initiation of the restraint used in an emergency situation.
5. Each written order is limited to:
---4 hours for adults
---2 hours for patients 9-17 years of age
---1 hour for patients under 9 years of age
---Renewal of the restraint order may take place via the telephone after the MD is made aware of the most recent patient assessment results. This renewal period may not exceed the written order limit, listed above.
---Criteria for release from restraint: calm, quiet, asleep, follows instructions, absence of impulsive behavior, alert, no attempts to harm self/others and removal of drains, tubes, dressings, etc.
---If the nurse discontinues a restraint prior to the expiration of the original order, and the behaviors reoccur, the original order still applies. However, it may not exceed the length of time specified in the original order.
---The original order may be renewed in accordance with the above limits for up to a total of 24 hours. The patient must be seen face-to-face every 24 hours with corresponding documentation in the Physician Progress Notes.

The policy section IV. Procedure sub part B. Behavior Management failed to identify parameters for behavioral restraints that were outlined in section IV. Procedure sub part A. Care management of the Medical or Post-Surgical Patient for medical restraint management. Omissions included:
---Least restrictive alternatives to restraints should be tried first
---the frequency of RN assessments and documentation
---how frequently hydration, elimination and other care needs should be offered
---the content of required provider documentation including the indication for restraint use
---the time period with which an order must be obtained from the time of application of restraint (30 minutes for medical restraints)
---what the nurse must document once a restraint is applied
---how frequently restraints are monitored and documented on until discontinued

Section B. included: If the nurse discontinues a restraint prior to the expiration of the original order, and the behaviors reoccur, the original order still applies. However, it may not exceed the length of time specified in the original order. The policy did not identify an information source for this line item.

The policy section IV. Procedure sub part Section C. General Safety points to remember instructed staff:
2. Apply the safety device correctly. Follow the manufacturer's instructions for application. Maintain circulation and skin integrity. Use soft restraints on wrists and ankles (unless leather restraints are required); keep padding (foam or wash cloths), under leather restraints at all times.

The policy section IV. Procedure sub part Section G. Restraints are applied according to the manufacturer's Guidelines identified that limb restraints and belt restraints were utilized at the facility and instructed staff to follow the manufacturer's guidelines for restraint application.

Sub section C. and G. of the restraint policy referenced the following types of restraints: soft restraints, leather restraints, limb restraints, waist restraints and instructed staff to follow manufacturer's instructions for application, however manufacturer instructions were not included in/or attached to the policy for staff to reference. The policy did not clearly identify the intended use for each identified type of restraint. The velcro restraints used at the facility were not included in the policy.

The policy did not identify if mid-levels could provide assessments and orders for medical and/or behavioral restraints at the CAH.

During an interview on 1/30/25 at 9:59 a.m., the emergency department director registered nurse (RN-C) reviewed the restraint policy and confirmed the policy did not clearly identify "current best practice standards" for the care of patients in behavioral or medical restraints, nor did the policy clearly outline care requirements for staff to use as a reference. RN-C stated they would need to do research before they could identify what the policy should include for restraint "best practice."

P26:

P26's electronic medical record (EMR) nursing chief complaint entry indicated P26 arrived at the emergency department (ED) on 8/5/24 at 2:36 a.m., with confusion. The provider history and physical notes indicated the provider saw P26 at 2:39 a.m. The chief complaint was altered mental status, and the final diagnoses included hepatic encephalopathy and anemia/gastrointestinal bleed. The note included "soft restraints necessary secondary to her climbing out of bed".

Restraint orders were placed at 2:39 a.m.: apply soft restraints, assess soft restraints q 2 hours. The orders did not identify if the restraints were behavioral or medical, the level of restraints to be used, the expiration of the order or the rationale for implementation.

A registered nurse's (RN) note at 2:40 a.m., identified safety precautions taken included the following: call light in reach, bed low, siderails up, room free of clutter, curtain open, instructed to call for help, non-skid shoes/slippers, and parent/companion in room.

At 2:45 a.m., RN note identified Velcro restraints were applied to right upper arm and left upper arm because patient was at risk for self-harm. Restraint alternatives tried were documented as well as limb warm, not swollen, and pulse present.

P26's electronic medical record (EMR) reflected the phrase "assess restraints every 15 minutes" and was time stamped on 8/5/24 at 3:00 a.m., 3:15 a.m., 3:30 a.m., and at 3:45 a.m. by an RN. The record did not contain data at those times to indicate what type of assessment, or what the results of the assessments were.

8/5/24 3:55 a.m., a RN entry indicated Velcro restraints were discontinued (limb warm, not swollen, pulse present) for right and left upper arms. Reason for restraint discontinued: "condition improved."

8/5/24 4:00 a.m., RN note indicated restraints were removed in the computerized tomography (CT) room and remained off. Patient "remains calm"

The EMR\ lacked evidence of the following: level of restraint, duration of restraint order, type/intent of restraint utilized: behavior or medical management, assessment of P26's responses, rationale for the use/continued use of restraints, or what level of observation had occurred while P26 was restrained.

During an interview on 1/30/25 at 7:23 a.m., RN-F stated P26 had erratic behavior at home and their spouse had to call the ambulance to assist with getting P26 to the hospital. When P26 arrived, based on P26's symptoms and history of high ammonia levels, recent surgery and encephalopathy, there was an urgency to get an assessment done and to make sure P26 was not critical. Restraints were used, because P26 had behaviors that were putting them at risk for injury and we needed to quickly determine what P26's medical status was. RN-F stated they reviewed the chart, and R26 had restraints on for less than an hour. RN-F stated staff were expected to watch closely and get patients out of restraints as soon as it was safe to do so.

P27:

P27's EMR nursing chief complaint entry indicated R27 arrived at the ED on 7/29/24 at 11:34 a.m., acting erratic. Patient was placed on hospital stretcher, four-point restraints applied.
The provider history and physical notes identify the provider saw P27 at 11:46 a.m., and identified P27 was brought in by police in "cuffs and switched over to soft restraints. Chief complaint was agitation, and final diagnosis was psychotic disorder secondary to gabapentin.

Provider Order placed on 7/29/24 at 11:46 a.m., apply soft restraints and assess soft restraints every two hours.

Provider note on 7/29/24 at 4:00 p.m., removed right wrist restraint.

Provider note on 7/29/24 at 4:40 p.m., leg restraints removed, out of restraints.

Treatments:

7/29/24 11:40 a.m., soft restraints applied. "Harm to self, Harm to others, pulls at devices, Agitated/hostile, Confused/disoriented". Alternatives were documented.
All extremities, Velcro limb, limbs documented as warm, not swollen, pulse present.
7/29/24 12:17 p.m., "assess soft restraints every two hours" identifies removes and reapplied
7/29/24 1:29 p.m., right and left lower extremities removed and reapplied
7/29/24 1:42 p.m., right upper extremity removed and reapplied, left upper extremity "rotated"
7/29/24 2:40 p.m., right and left upper extremities removed and reapplied
7/29/24 3:50 p.m., left upper extremity, right lower extremity, left lower extremity removed and reapplied
7/29/24 5:00 p.m., left upper extremity, right lower extremity, left lower extremity restraint discontinued

Review of nurses' notes from 7/29/24, to 7/31/24, revealed the following:
7/29/24 5:00 p.m., left upper and bilateral lower limb restraints taken off.
7/29/24 6:45 p.m., up in bathroom in room, slightly unsteady on feet. Unclear when right upper extremity restraint was removed.
7/31/24 11:33 a.m., ambulance transfer to inpatient mental health outside of CAH.

P27's restraint order did not specify type, level of restraint, indications for use, or expiration time of order. The EMR indicated the equivalent of a medical restraint order had been entered for a behavioral restraint application. The EMR lacked evidence of a renewed order for continued restraint use after the initial order expired at four hours. In addition, the chart lacked evidence of care interventions being offered and RN assessment completion every two hours. The EMR also lacked documentation of assessed response to restraints and circulation checks every 15 minutes.

P28:

P28's EMR nursing chief complaint entry indicated P28 arrived at the ED via police on 9/15/24 at 0:55 a.m., intoxicated, uncooperative, combative (screaming and kicking staff). The provider history and physical notes identify the provider saw P28 at 1:20 a.m., the chief complaint was alcohol intoxication/abuse. The final diagnosis was alcohol use.

Documentation entered 9/15/24 at 1:30 a.m., on the paper form Care Management With Restraints Flowsheet identified the following:
---Invasive device present, confusion, disorientation, cognitive impairment, inability to follow commands, lack of awareness of potential harm to self.
---Combativeness of such severity to pose an imminent threat of self-extubation of an invasive device necessary for medical management.
---"Danger to others, arrived and restraints started".
---Bilateral writs, ankle, four side rails.
Additional entries included:
---1:00 a.m., skin care/repositioned, safety checks, resp status assessed, restraint type "BAS", meets protocol.
---2:00 a.m., skin care/repositioned, safety checks, resp status assessed, restraint type "BAS", meets protocol.
---3:00 a.m., skin care/repositioned, safety checks, resp status assessed, trial release, restraints discontinued.

On 9/15/24 at 0056, the EMR indicated soft restraints were applied, and identified P28's behavior indications for restraints: harm to self, others, agitated/hostile, and confused/disoriented.
Velcro restraints were applied to right upper extremity, right lower extremity, right upper extremity, and left lower extremity was listed as foam/soft limb and Velcro. Limbs documented as warm, not swollen, pulse present. On 9/15/24 at 2:50 a.m., restraints were discontinued due to "condition improved".

Review of nurse notes on 9/15/24, included the following entries:
9/15/24 at 1:26 a.m., "Patient is intoxicated and aggressive. In 4-point restraints due to be physically and verbally aggressive."
9/15/24 at 2:19 a.m., "CMS intact on all extremities"
9/15/24 at 2:50 a.m., "Restraints removes from all extremities."

Restraint orders were placed on 9/15/24 at 5:46 a.m.: apply soft restraints, assess soft restraints every two hours. The order did not specify type, level of restraint, indications for use, or expiration time of order. The EMR indicated the equivalent of a medical restraint order had been entered for a behavioral restraint application. The order time did not fall within policy guidelines which directed order should have been obtained within 30 minutes of restraint application.

P29:

P29's EMR nurse chief complaint entry indicated P29 arrived at the ED with law enforcement on 6/18/24 at 4:45 a.m.

A nurses note entered in the EMR indicated the provider was in with P29 on 6/18/24 at 10:11 a.m.

On 6/18/24 at 10:32 a.m., nurse entry in the EMR identified P29 had exhibited behavior that was identified as harm towards others, towards self, agitated and hostile. P29 had restraints applied, the provider was notified, then evaluated and provided an order for the restrains.

The provider orders entered at 6/18/24 at 10:07 a.m., were: apply restraints, assess restraints every 15 minutes. The orders did not identify the type and level of restraints to be used, the expiration of the order or the rationale for implementation.

Velcro limb restraints applied to right upper extremity and left lower extremity, foam/soft limb restraints applied to right lower extremity and left upper extremity. P29's record identified interventions tried before restraints were to modify the lighting, reduce sensory stimulation, and put bed in lowest position.

P29's EMR reflected the phrase "assess restraints every 15 minutes" and was time stamped on 6/18/24 at 10:34 a.m., 11:20 a.m., 11:35 a.m., 1150 a.m., 12:05 p.m., 12:20 p.m., 12:35 p.m., 12:42 p.m., 1:00 p.m., 1:13 p.m., 1:30 p.m., 1:45 p.m., 2:00 p.m., 2:15 p.m. The record did not contain data at these times to indicate what type of assessment, or what the results of the assessments were.

On 6/18/24 at 2:25 p.m., P29's EMR identified a note indicating a nurse assisted P29 to the bathroom, assisted her with cleaning up and changing shorts. At 2:50 p.m., P29 was escorted back to bed and a nurse's note identified P29 no longer required restraints.

P29's EMR indicated P29 had remained in restraints beyond the expiration time of the initial restraint order at 2:07 p.m.

P29's EMR lacked evidence of the following: on-going RN assessments, documented response and rationale for the use/continued use of restraints, one on one observation of P29 (or other level) while restrained, range of motion was performed, nutrition, elimination, and hydration needs were addressed and that every fifteen-minute assessment and documentation had been completed while P29 was in restraints.

During an interview on 1/30/25 at 11:24 a.m., ED paramedic (EDP-E) stated they tried other interventions prior to restraint application, and they typically checked on patients in restraints every 15 minutes. EDP-E was not certain what the required frequency of assessment and documentation was for patients in restraints or what the frequency of order renewal was. For behavioral restraints, they thought order renewal was every 24 hours, however they indicated they would have to check the policy to be sure.

During a follow-up interview on 1/30/25 at 11:49 a.m., EDP-E stated they had reviewed their restraint policy and felt it was confusing, it did not clearly direct the frequency of assessments and/or order parameters for patients in medical or behavioral restraints.

During an interview on 1/30/25 at 11:35 a.m., RN-F stated they had reviewed the restraint policy and felt the policy did not give any clear guidance for behavioral and medical restraints. RN-F stated they used more behavioral restraints in the ED. RN-F confirmed the orders in Meditech did not indicate the type of restraint that was being ordered. Before restraint use, they always tried to de-escalate patients, used the least restrictive level of restraint, and documented every 15 to 30 minutes. Circulation is expected to be checked every 15 minutes. When possible, they kept eyes on the patient. RN-F stated they did not know how frequently orders needed to be renewed however, they would look to the policy for that information.

During an interview on 1/31/25 at 7:23 a.m., RN-G stated they had reviewed their restraint policy, and it was unclear what the frequency and content of nursing documentation needed to be. RN-G stated providers may not know the difference between the two order choices, so restraints were probably not getting ordered correctly. Sometimes every 15-minute assessments were ordered and sometimes every two-hour assessments were ordered for behavioral restraints. The nurse area for documentation, instructed assess Velcro restraints every 15 minutes and foam soft limb restraints every two hours. Depending on how the doctor ordered the restraints, the assessment frequency may not match in both places. RN-G stated between the orders, the policy and the nurse designated documentation areas, it was not clear how frequently required assessments and documentation should occur for the different types of restraints.

During an interview on 1/31/2025 at 9:27 a.m., the chief operating officer (COO) (who is responsible for nursing services) stated they expected nursing to follow best practice and explained since they personally did not have a nursing or medical background, the approval of medical/nursing polices, and best practice was deferred to the nursing department directors at the CAH.

During an interview on 1/31/25 at 10:15 a.m., the emergency department medical director (EDMD) stated the restraint policy should have been written so that anyone can look at the policy and know how to care for a patient in restraints. The policy should have clearly outlined the frequency of required assessments, orders, and documentation for behavioral and medical restraints. Orders and documentation in the EMR [electronic medical record] should support best practices outlined in the policy.

During a follow-up interview on 1/31/25 at 10:53 a.m., RN-C stated as a result of the survey process they had determined the facility needed to incorporate restraint use into nursing QAPI and in addition the facility needed to assess, review and make revisions on their restraint policy, orders, education, and electronic medical record documentation to ensure they were using and meeting best practice standards for restraint use.

Based on interview and document review, the critical access hospital (CAH) failed to ensure restraint education was comprehensive and competency based. This deficient practice had the potential to impact all patients within the CAH who required restraint application for medical or behavioral care management.

During an interview on 1/30/25 at 11:24 a.m., emergency department paramedic (EDP-E) stated restraint education was part of their annual education however, they did not think they had received a hands-on restraint application competency within the last five years.

During an interview on 1/30/25 at 11:35 a.m., RN-F stated they did not recall the last time they had completed a restraint application competency and indicated the facility no longer completed hands on skills because education was primarily on the computer now.

During an interview on 1/31/25 at 7:23 a.m., RN-G stated they remembered doing a hands-on restraint application competency however, they could not recall how long ago.

During an interview on 1/31/25 at 10:15 a.m., the emergency department medical director (EDMD) stated providers did not receive hands on restraint education, nor did providers receive additional education on facility policy and ordering for medical and/or behavioral restraints. The EDMD stated providers who ordered restraints should have received additional education regarding restraints.

During an interview on 1/31/25 at 10:53 a.m., the director of the emergency department, registered nurse (RN-C) confirmed the facility had not completed a restraint competency within the last few years, nor was there documentation in the facility's personnel files of past restraint competency completion. However, the nurses did receive Relias computer restraint education this past year. RN-C stated they would work with their peer group to ensure the facility incorporated restraint competencies, policies, trauma informed care and documentation into education for nurses and providers regarding restraint use and application.

A CAH provided document titled Course Completion History showed that registered nurses and providers had completed the Relias computer restraint education module in 2024.

The undated Restraints and Seclusion Relias education module did not include specific direction for frequency of monitoring and documentation, nor did it include de-escalation techniques or trauma informed care. Section header Safe Restraint Application identified staff who were allowed to apply restraints should know and use safe techniques. The CAH's restraint policy was not included in the education.

Based on interview and document review, the critical access hospital (CAH) failed to ensure restraint education for nursing staff and providers included patient-centered, trauma informed competency- based training and education. This deficient practice had the potential to impact all patients receiving services at the CAH.

Findings include:

During an interview on 1/30/25 at 11:24 a.m., emergency department paramedic (EDP-E) stated restraint education was part of their annual education however, they had not received education or competencies based on patient-centered, trauma informed care.

During an interview on 1/30/25 at 11:35 a.m., registered nurse (RN-F) stated they had not received any education on patient-centered, trauma informed care.

During an interview on 1/31/25 at 7:23 a.m., RN-G stated they had not received any education on patient-centered, trauma informed care.

During an interview on 1/31/25 at 10:15 a.m., the emergency department medical director (EDMD) stated they had not received any education on patient-centered, trauma informed care and indicated they felt it would have been important for all staff and providers to receive patient-centered, trauma informed care.

During an interview on 1/31/25 at 10:53 a.m., the director of the emergency department, registered nurse (RN-C) confirmed the Relias computer education did not include patient-centered, trauma informed care content or competencies. RN-C stated they would work with their peer group to ensure the facility incorporated restraint competencies, policies, trauma informed care and documentation into education for nurses and providers regarding restraint use and application.

A CAH provided document titled Course Completion History showed that registered nurses and providers had completed the Relias restraint computer education module in 2024.

The undated Restraints and Seclusion Relias education module did not include educational content or competencies on patient-centered trauma informed care.