Cass Lake Indian Health Services Hospital

“EMERGENCY SERVICES CFR(s): The CAH provides emergency care necessary to meet the needs of its inpatients and outpatients. This Condition is not met as evidenced by: 25065 Based on review of the Critical Access Hospital’s (CAH) organizational chart, the list of department heads, the governing body bylaws, the medical staff bylaws, the governing body’s meeting minutes, the medical staff meeting minutes, and interviews, the CAH failed to meet the Condition of Participation of Emergency Services. The CAH failed to appoint a Director of Emergency Services, the Medical Staff failed to establish criteria for the qualifications of the Director of Emergency Services and the CAH failed to ensure the inpatient unit crash cart (a mobile medical unit stocked with essential medications, equipment, and tools needed to respond to medical emergencies like cardiac arrest or other life-threatening situations) was checked consistently and failed to ensure oxygen tanks were readily available for use in the emergency department. These deficient practices had the potential to affect all patients receiving services in the emergency department (ED) of the CAH and all staff working in the CAH’s ED. Findings include: 1. Review of the CAH’s organizational chart dated 08/20/25 indicated there was no documentation that emergency services was listed as a department of the CAH. Review of the list of department heads dated 08/19/25 indicated there was no documentation that a Director of Emergency Services was listed. Review of the “Bylaws of the Governing Body” dated 11/25/24 indicated the bylaws included no reference to emergency services as a department. Review of the “Medical Staff Bylaws of [name of CAH] effective 02/02/22 indicated no documentation of a reference to Emergency Services and the criteria for the qualifications of the Director of Emergency Services. Review of the “Executive Board Session of the Executive Committee Governing Board Meeting” minutes conducted from 05/16/24 to 06/05/25 (total of five meetings) indicated no documentation of a reference to Emergency Services and no documentation related to the vacancy of an ED Medical Director. Review of the Medical Staff monthly meetings from 09/05/24 through 06/05/25 indicated no documentation of a reference to Emergency Services and no documentation related to the vacancy of an ED Medical Director. During an interview on 08/21/25 at 10:55 AM, Area Chief Medical Officer (Area CMO) stated the CAH worked on creating a position for a physician to serve as the Director of Emergency Services. When informed by the surveyor that Emergency Services was not listed on the organizational chart, the list of department heads, in the Governing Body Bylaws and the Medical Staff Bylaws, and the governing body and medical staff meeting minutes, Area CMO stated he/she assumed emergency services was included under “medical services.” Area CMO stated the CAH never got to advertising for a Director of Emergency Services, but they have created a job description. He/She stated the job description was started to be worked on in the fall of 2024, but it just recently got approved. Area CMO stated final approval would be having the position placed on the organizational chart, and that has not been done as of the time of this interview. During an interview on 08/22/25 at 1:09 PM with Acting Health Systems Administrator (HSA), Quality Manager (QM), and Acting Clinical Director (Acting CD) present, HSA stated, regarding the position of Director of Emergency Services, the hiring manager decides they want to fill the position, they make the request, and the first step is they send the request and position description to the classifier (a centralized process). The classifier reviews the job and classifies the position giving it a GS (general scale) level. The classifier and hiring manager communicate to ensure the position meets OPM (Office of Personnel Management) standards. Once the position has been officially classified, the next step of hiring begins. The hiring manager contacts the human resource (HR) specialist to work on a job analysis. The HR specialist and hiring manager develop the job analysis and work on the recruitment strategy. HSA stated the ED Director position was in the classification process currently. He/She stated the position started the classification step in November/December 2024. With the federal hiring freezes, they were only able to advertise six positions at a time. HSA stated there was a position but they are not at the point that they can announce it and advertise for it. In addition, HSA stated HIS (Indian Health Services) moved to a centralized hiring processes in mid-June 2025, and all hiring processes stopped for three to four weeks to transition. Acting HSA stated they are slowly rolling it out, but the wait time was about six weeks to start the process written above. HSA confirmed there was no one officially designated as the Director of Emergency Services. 2. Cross reference C0884 - The CAH failed to ensure the inpatient unit crash cart (a mobile medical unit stocked with essential medications, equipment, and tools needed to respond to medical emergencies like cardiac arrest or other life-threatening situations) was checked consistently and failed to ensure oxygen tanks were readily available for use in the emergency department.”

“ORGANIZATIONAL STRUCTURE CFR(s): Organizational Structure This Condition is not met as evidenced by: 25065 Based on review of the Critical Access Hospital’s (CAH) organizational chart, the list of department heads, the governing body bylaws, the medical staff bylaws, the governing body’s meeting minutes, the medical staff meeting minutes, patient electronic medical records (EMRs), CAH policies, and interviews, the CAH failed to meet the Condition of Participation of Organizational Structure. This deficient practice had the potential to affect all patient receiving services in the CAH and all staff providing services in the CAH. Findings include: 1. Reference C0880 - The CAH failed to meet the Condition of Participation of Emergency Services. The CAH failed appoint a Director of Emergency Services, the Medical Staff failed to establish criteria for the qualifications of the Director of Emergency Services and the CAH failed to ensure the inpatient unit crash cart (a mobile medical unit stocked with essential medications, equipment, and tools needed to respond to medical emergencies like cardiac arrest or other life-threatening situations) was checked consistently and failed to ensure oxygen tanks were readily available for use in the emergency department. 2. Reference C0992 - The governing body failed to assume full legal responsibility for the total operation of the CAH and ensure that quality healthcare was provided in a safe environment. The governing body failed to designate a physician as Director of Emergency Services and a Director of Nursing (DON) after the previous DON separated employment. 3. Reference C1004 - The CAH failed to meet the Condition of Participation of Provision of Services. The CAH failed to meet the requirements related to patient care policies and required CAH services. 4. Reference C1100 - The CAH failed to meet the Condition of Participation of Clinical Records. The CAH failed to ensure the emergency department (ED) physician medication orders were documented to be given in the ED and not in the clinic and failed to ensure each patient EMR (electronic medical record) had documented evidence of a completed and signed informed consent.”

“PROVISION OF SERVICES CFR(s): §485.635 Condition of Participation: Provision of Services This Condition is not met as evidenced by: 17281 Based on observation, record review, policy review, and interviews, the Critical Access Hospital (CAH) failed to meet the Condition of Participation of Provision of Services. The CAH failed to meet the requirements related to patient care policies and required CAH services. These deficient practices had the potential to affect all patients receiving services in the CAH. Findings include: Cross Reference C1006 - The CAH failed to ensure the AMA (against medical advice) form was completed, signed by the patient, and in the electronic medical record (EMR) in accordance with the CAH policy for one (Patient (P) 9) of two transfer patient records reviewed from a total of 10 emergency department (ED) patient records reviewed from a total sample of 20 patients. Cross Reference C1016 - The CAH failed to ensure twelve (12) 1000 milliliter (ml) bags of expired intravenous (IV) fluids located in the inpatient unit clean supply room were not available for use. Cross Reference C1046 - The CAH failed to ensure: 1. A Director of Nursing (DON) was designated after the previous DON separated from employment and 2. A registered nurse (RN) met the qualifications required by the emergency department (ED) RN job description for one of four personnel records reviewed for qualifications. Cross Reference C1048 - The RN failed to assess, supervise and evaluate the care of each patient by failure to perform assessments and treatment related to suicide ideation (SI), pain, and vital signs for three (Patients (P) P2, P3, and P17) of 20 medical records reviewed from a total sample of 20 patients. Cross Reference C1049 - the CAH failed to ensure discharge prescriptions included the specific instructions for use when two allergy medications were prescribed for one (Patient (P) 4) of 10 emergency department (ED) medical records reviewed for complete physician prescription medication orders from a sample of 20 patient records reviewed. Cross Reference C1050 - The CAH failed to ensure the nursing care plan was developed to include the admitting condition in accordance with the CAH’s policies for three (Patients (P) 15, P16, and P20) of 10 patient medical records reviewed from a total sample of 20 patients.”

“CLINICAL RECORDS CFR(s): §485.638 Condition of Participation: Clinical Records This Condition is not met as evidenced by: 25065 Based on policy review, medical record reviews, and interviews, the Critical Access Hospital (CAH) failed to meet the Condition of Participation of Clinical Records. These deficient practices had the potential to affect all patients receiving services in the CAH. Findings include: Cross Reference C1104 - The CAH failed to ensure the emergency department (ED) physician medication orders were documented to be given in the ED and not in the clinic for two (Patient (P) 3, P4) of 10 patient ED EMRs reviewed from a total sample of 20 patients. Cross Reference C1110 - The CAH failed to ensure each patient electronic medical record (EMR) had documented evidence of a completed and signed informed consent for 18 (Patient (P) 1, P2, P3, P4, P6, P7, P8, P9, P11, P12, P13, P14, P15, P16, P17, P18, P19, P20) of 19 patient EMRs reviewed for informed consent from a total sample of 20 patients.”

“EQUIPMENT, SUPPLIES, AND MEDICATION CFR(s): Equipment, supplies, and medication used in treating emergency cases are kept at the CAH and are readily available for treating emergency cases. The items available must include the following: This Standard is not met as evidenced by: 17281 Based on observation, document review, policy review, and interview, the Critical Access Hospital (CAH) failed to ensure the inpatient unit crash cart (a mobile medical unit stocked with essential medications, equipment, and tools needed to respond to medical emergencies like cardiac arrest or other life-threatening situations) was checked consistently and failed to ensure oxygen tanks were readily available for use in the emergency department. This failure had the potential to affect all patients presenting to the emergency room for treatment and inpatients who require emergency treatment. Findings include: 1.Review of the CAH policy titled, “Emergency Equipment - Crash Carts, Medication Boxes and AED [automated external defibrillator]” revised on 04/2025 revealed, “ ...A Registered Nurse (RN) as designated by the Director of Nursing, Associate Director of Nursing, or the Supervisor, is responsible for checking the crash cart, oxygen cylinder levels, defibrillator, and documenting compliance on the crash cart checklist daily. ...” Review of the June 2025, July 2025, and August 2025 “Unit Crash Cart Check List” located on the inpatient unit crash cart revealed the area to indicate the cart was checked by nursing was blank on 06/10/25, 06/12/25, 06/23/25, 07/17/25, 08/02/25, 08/16/25, and 08/17/25. During an interview on 08/22/25 at 11:03 AM, the Acting Director of Nursing (DON) stated an RN working on the day shift was responsible to check the crash cart daily and document the check was done by initialing the crash cart checklist which is located on the unit crash cart. The Acting DON stated the crash cart should be checked every day even when the hospital does not have any patients on the unit. The Acting DON confirmed documentation the crash cart was checked every day was missing on 06/10/25, 06/12/25, 06/23/25, 07/17/25, 08/02/25, 08/16/25, and 08/17/25. 2. Review of the CAH policy titled, “Respiratory Therapy: Oxygen” revised on 01/23 revealed, “ ...Purpose: To deliver concentrations of oxygen in an accurate, safe, and clinically appropriate manner at Cass Lake Indian Health Services (CLIHS). ...” Observation in the emergency department on 08/19/25 at 11:20 AM, revealed four patient examination rooms, one room for mental health services, and one trauma room with the capacity to treat three trauma patients. Observation in the trauma room revealed piped in oxygen was available at each bed. Observation of four patient examination rooms and the mental health room revealed piped in oxygen was not available in these rooms and portable oxygen was not available. During observation and interview on 08/19/25 at 11:45 AM, the Acting Assistant Director of Nursing (ADON) stated oxygen cylinders normally were kept in each examination room, and she did not know why oxygen tanks were not available in the examination rooms or in the emergency department. The Acting ADON looked in each examination room and throughout the emergency department and could not locate any oxygen cylinders for use. The Acting ADON stated oxygen was also stored outside and with the surveyor walked out of the emergency department to a loading dock outside where oxygen cylinders were located. During an interview on 08/22/25 at 11:03 AM, the Acting DON stated the facility did not have a policy specifically directing where oxygen for use in the emergency department should be kept. The Acting DON stated oxygen should be available in each examination room or in the emergency department for easy access when needed.”

“MAINTENANCE CFR(s): The CAH has housekeeping and preventive maintenance programs to ensure that-- (1) All essential mechanical, electrical, and patient-care equipment is maintained in safe operating condition; This Standard is not met as evidenced by: 17281 Based on observation, manufacturer’s user manual review, and interview, the Critical Access Hospital (CAH) failed to develop a policy to monitor the temperature of three blanket warmers in use in the CAH. This failure had the potential for adverse effect to any patient who utilized a warming blanket in the CAH. Findings include: 1.Review of the undated manufacturer’s user manual titled, “Getinge Warming Cabinets” revealed, “ ...Operation- Burn hazard. Items heated to over 49 degrees C [Celsius] (120 degrees F [Fahrenheit]) can burn skin. Keep items that may contact skin at temperatures below 49 degrees C (120 degrees F). ...Ensure that blankets heated in the warming cabinet are unfolded before using them on patients. Placing folded blankets on patients increases the risk of burns. ...” Observation in the emergency department on 08/19/25 at 11:20 AM revealed two blanket warmer cabinets with blankets inside for use. The temperature displayed on the warming cabinet indicated an internal temperature of 46 degrees C. Observation in the walk in clinic on 08/20/25 at 10:20 AM revealed a blanket warmer cabinet with blankets inside for use. The temperature displayed on the warming cabinet indicated an internal temperature of 46 degrees C. During an interview on 08/19/25 at 11:25 AM, General Engineer (GE) 1 stated the hospital did not have a policy to identify the required temperature range for the blanket warmers in use in the hospital. GM1 stated he/she was unaware of who should be monitoring the blanket warmers in the hospital. During an interview on 08/22/25 at 11:03 AM, the Acting Director of Nursing (DON) confirmed the hospital did not have a policy at the time of the observations on 08/19/25 and 08/20/25 for monitoring the temperatures of the blanket warmers used in the CAH. The Acting DON confirmed the CAH was not monitoring the temperatures of the blanket warmers to ensure the temperature did not exceed the acceptable range.”

“LIFE SAFETY FROM FIRE CFR(s): §485.623(c) Standard: Life Safety From Fire (1) Except as otherwise provided in this section: (i) The CAH must meet the applicable provisions and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.) (ii) Notwithstanding paragraph (d)(1)(i) of this section, corridor doors and doors to rooms containing flammable or combustible materials must be provided with positive latching hardware. Roller latches are prohibited on such doors. This Standard is not met as evidenced by: 21011 Based on observation, record review, and interview, the facility failed to demonstrate compliance with the requirements of the National Fire Protection Association (NFPA) standard 101-2012 edition. Please refer to the citations at K353 cited during the survey conducted 8/19/25 through 8/22/25.”

“GOVERNING BODY OR RESPONSIBLE INDIVIDUAL CFR(s): The CAH has a governing body or an individual that assumes full legal responsibility for determining, implementing and monitoring policies governing the CAH’S total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment. This Standard is not met as evidenced by: 25065 Based on review of the Critical Access Hospital’s (CAH) organizational chart, the list of department heads, the governing body bylaws, the medical staff bylaws, the governing body’s meeting minutes, the medical staff meeting minutes, job descriptions, hospital employee list, emails and letters related to the Director of Nursing (DON) position, and the hospital process for hiring and interviews, the governing body failed to assume full legal responsibility for the total operation of the CAH and ensure that quality healthcare was provided in a safe environment. The governing body failed to designate a physician as Director of Emergency Services and a Director of Nursing (DON) after the previous DON separated employment. These deficient practices had the potential to affect all patient receiving services in the CAH and all staff providing services in the CAH. Findings include: 1.Director of Emergency Services: Review of the CAH’s organizational chart dated 08/20/25 indicated there was no documentation that emergency services was listed as a department of the CAH. Review of the list of department heads dated 08/19/25 indicated there was no documentation that a Director of Emergency Services was listed. Review of the “Bylaws of the Governing Body” dated 11/25/24 indicated the bylaws included no reference to emergency services as a department. Review of the “Medical Staff Bylaws of [name of CAH]” effective 02/02/22 indicated no documentation of a reference to Emergency Services and the criteria for the qualifications of the Director of Emergency Services. Review of the “Executive Board Session of the Executive Committee Governing Board Meeting” minutes conducted from 05/16/24 to 06/05/25 (total of five meetings) indicated no documentation of a reference to Emergency Services and no documentation related to the vacancy of an ED Medical Director. Review of the Medical Staff monthly meetings from 09/05/24 through 06/05/25 indicated no documentation of a reference to Emergency Services and no documentation related to the vacancy of an ED Medical Director. During an interview on 08/21/25 at 10:55 AM, Area Chief Medical Officer (Area CMO) stated the CAH worked on creating a position for a physician to serve as the Director of Emergency Services. When informed by the surveyor that Emergency Services was not listed on the organizational chart, the list of department heads, in the Governing Body Bylaws and the Medical Staff Bylaws, and the governing body and medical staff meeting minutes, Area CMO stated he/she assumed emergency services was included under “medical services.” Area CMO stated the CAH never got to advertising for a Director of Emergency Services, but they have created a job description. He/She stated the job description was started to be worked on in the fall of 2024, but it just recently got approved. Area CMO stated final approval would be having the position placed on the organizational chart, and that has not been done as of the time of this interview. During an interview on 08/22/25 at 1:09 PM with Acting Health Systems Administrator (HSA), Quality Manager (QM), and Acting Clinical Director (Acting CD) present, HSA stated, regarding the position of Director of Emergency Services, the hiring manager decides they want to fill the position, they make the request, and the first step is they send the request and position description to the classifier (a centralized process). The classifier reviews the job and classifies the position giving it a GS (general scale) level. The classifier and hiring manager communicate to ensure the position meets OPM (Office of Personnel Management) standards. Once the position has been officially classified, the next step of hiring begins. The hiring manager contacts the human resource (HR) specialist to work on a job analysis. The HR specialist and hiring manager develop the job analysis and work on the recruitment strategy. HSA stated the ED Director position is in the classification process currently. He/She stated the position started the classification process in November/December 2024. With the federal hiring freezes, they were only able to advertise six positions at a time. HSA stated there was a position but they are not at the point that they can announce it and advertise for it. In addition, HSA stated HIS (Indian Health Services) moved to a centralized hiring processes in mid-June 2025, and all hiring processes stopped for three to four weeks to transition. Acting HSA stated they are slowly rolling it out, but the wait time is about six weeks to start the process written above. HSA confirmed there was no one officially designated as the Director of Emergency Services. 2. Director of Nursing: Review of the CAH’s undated employee list indicated Acting Director of Nursing’s (Acting DON) position/title was listed as “SUPV NURSE (ADON) [supervisory nurse (assistant director of nursing]. Review of the “Department Heads: Locations and Phone Numbers,” dated 08/19/25, indicated Acting DON was listed as “Acting Director of Nursing.” Review of an email sent by Former Director of Nursing (Former DON) on 06/17/25 to Acting Health Systems Administrator (HSA) indicated his/her last day of employment would be 07/26/25. Review of the “Request For Personnel Action” effective 07/13/25 indicated Acting DON was “. . . Detailed from ADON[Assistant Director of Nursing] to DON [Director of Nursing] Supervisor. . .” Review of an email sent by Former DON to all employees dated 07/10/25 indicated effective 07/13/25 Acting DON would be Acting Director of Nursing and Acting Assistant Director of Nursing (Acting ADON) would be Acting Assistant Director of Nursing. Review of the CAH’s undated “Overview of the Federal Hiring Process at HIS [Indian Health Services]” indicated it included the process as stated below in the interview with HSA. During an interview on 08/22/25 at 1:09 PM with HSA, Quality Manager (QM), and Acting Clinical Director (Acting CD), HSA stated, regarding the position of DON, the hiring manager decides they want to fill the position, they make the request, and the first step is they send the request and position description to the classifier (a centralized process). The classifier reviews the job and classifies the position giving it a GS (general scale) level. The classifier and hiring manager communicate to ensure the position meets OPM (Office of Personnel Management) standards. Once the position has been officially classified, the next step of hiring begins. The hiring manager contacts the human resource (HR) specialist to work on a job analysis. The HR specialist and hiring manager develop the job analysis and work on the recruitment strategy. The DON position is in the classification process currently and started this step in November/December 2024. HSA stated with the federal hiring freezes, they were only able to advertise six positions at a time. He/she stated there is a position but they are not at the point that they can announce it and advertise for it. He/she stated they cannot advertise for the ADON position, because Acting DON encumbers the position Assistant Director of Nursing position currently. In addition, HSA stated IHS moved to a centralized hiring processes in mid-June 2025, and all hiring processes stopped for three to four weeks to transition. HSA stated they are slowly rolling it out, but the wait time was about six weeks to start the process written above. HSA confirmed there was no one officially designated as the Director of Nursing.”

“PATIENT CARE POLICIES CFR(s): (1) The CAH’s health care services are furnished in accordance with appropriate written policies that are consistent with applicable State law. This Standard is not met as evidenced by: 25065 Based on hospital policy review, medical record review, and interview, the Critical Access Hospital (CAH) failed to ensure the AMA (against medical advice) form was completed, signed by the patient, and in the electronic medical record (EMR) in accordance with the CAH policy for one (Patient (P) 9) of two transfer patient records reviewed from a total of 10 emergency department (ED) patient records reviewed from a total sample of 20 patients. This deficient practice had the potential to affect all ED patients receiving services in the hospital’s ED. Findings include: Review of the CAH policy titled “Against Medical Advice Release (AMA): Nursing,” last revised March 2024, indicated “. . . when a patient indicates a desire to leave Against Medical Advice (AMA) the Medical physician, Advanced Practice Registered Nurse and or Physician Assistant (provider) will explain the risks and benefits to the patient and or legal representative and will document within the patients [sic] Electronic Medical Record (EHR). . . The Registered Nurse (RN) and or the provider will document the patient’s refusal of treatment in the EHR under the “forms tab” using HIS [Indian Health Service] Form 338 - “Release from Responsibility for Discharge” which should be printed and signed by the patient and or their legal representative. d. If a patient refuses to sign the document or departs from the facility, two [initials of hospital] staff will document the patient’s actions and sign as witnesses on IHS form 338 and will document a progress note within the patient’s HER. e. The signed document will be scanned into EHR by Health Information Management staff per VistA Imaging scanning policy. . .” Review of P9’s EMR indicated P9 presented to the ED via ambulance on 12/06/24 at 6:13 PM (located in the provider’s note located under the “Notes” tab) with a chief complaint of sudden onset of acute shortness of breath and sub-sternal chest pain. Continued review of the provider’s note indicated “. . . Disposition: Attempted admission, however pt [patient] is refusing, Pt is leaving AMA.” Review of P9’s entire EMR indicated no documented evidence that an AMA form was completed and signed in the EMR, and there was no documentation P9 refused to sign an AMA. During an interview on 08/20/25 at 4:15 PM, Registered Nurse (RN) 1 stated, after reviewing P9’s EMR, there was no documentation of a completed AMA form in the EMR. RN1 stated the patient was required to sign an AMA form when they choose to leave against medical advice.”

“PATIENT CARE POLICIES CFR(s): [The policies include the following:] (iv) Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. This Standard is not met as evidenced by: 17281 Based on observation and interview, the Critical Access Hospital (CAH) failed to ensure the intravenous (IV) fluid supply on the inpatient unit did not contain expired IV solution for patient use. This failure had the potential to affect all patients admitted to the CAH who require fluid replacement. Findings include: Observation on the inpatient unit on 08/19/25 at 10:20 AM revealed twelve (12) 0.45% normal saline 1000 milliliter bags (ml) were stored on a shelf and ready for use. An expiration date of July 2025 were on the bags. During an interview on 08/19/25 at 10:20 AM, the Pharmacy Director (PD) stated pharmacy staff were responsible to check the in-patient unit supply room to ensure expired IV solutions were removed and not available for use. The PD confirmed the 12 bags of IV fluid were expired. During an interview on 08/22/25 at 11:03 AM, the Acting Director of Nursing (DON) stated it was his/her understanding the pharmacy was responsible to check for expired IV fluids. The Acting DON was unable to provide a CAH policy directing to check for expired IV fluids.”

“NURSING SERVICES CFR(s): Nursing services must meet the needs of patients. (1) A registered nurse must provide (or assign to other personnel) the nursing care of each patient, including patients at a SNF level of care in a swing-bed CAH. The care must be provided in accordance with the patient’s needs and the specialized qualifications and competence of the staff available. This Standard is not met as evidenced by: 25065 Based on review of job descriptions, hospital employee list, list of department heads, emails and letters related to the Director of Nursing (DON) position, and the hospital process for hiring, the Critical Access Hospital (CAH) failed to ensure: 1. A DON was designated after the previous DON separated from employment and 2. A registered nurse (RN) met the qualifications required by the emergency department (ED) RN job description for one (RN2) of four personnel records reviewed for qualifications. This deficient practice had the potential to affect all patients receiving services in the ED. Findings include: 1. Review of the CAH’s undated employee list indicated Acting Director of Nursing’s (Acting DON) position/title was listed as “SUPV NURSE (ADON) [supervisory nurse assistant director of nursing]. Review of the “Department Heads: Locations and Phone Numbers,” dated 08/19/25, indicated Acting DON was listed as “Acting Director of Nursing.” Review of an email sent by Former Director of Nursing (Former DON) on 06/17/25 to Acting Health Systems Administrator (HSA) indicated his/her last day of employment would be 07/26/25. Review of the “Request For Personnel Action” effective 07/13/25 indicated Acting DON was “. . . Detailed from ADON[Assistant Director of Nursing] to DON [Director of Nursing] Supervisor. . .” Review of an email sent by Former DON to all employees dated 07/10/25 indicated effective 07/13/25 Acting DON would be Acting Director of Nursing and Acting Assistant Director of Nursing (Acting ADON) would be Acting Assistant Director of Nursing. Review of the CAH’s undated “Overview of the Federal Hiring Process at HIS [Indian Health Services]” indicated it included the process as stated below in the interview with HSA. During an interview on 08/22/25 at 1:09 PM with HSA, Quality Manager (QM), and Acting Clinical Director (Acting CD), HSA stated, regarding the position of DON, the hiring manager decides they want to fill the position, they make the request, and the first step is they send the request and position description to the classifier (a centralized process). The classifier reviews the job and classifies the position giving it a GS (general scale) level. The classifier and hiring manager communicate to ensure the position meets OPM (Office of Personnel Management) standards. Once the position has been officially classified, the next step of hiring begins. The hiring manager contacts the human resource (HR) specialist to work on a job analysis. The HR specialist and hiring manager develop the job analysis and work on the recruitment strategy. The DON position was in the classification process currently since November/December 2024. HSA stated with the federal hiring freezes, they were only able to advertise six positions at a time. He/she stated there was a position but they are not at the point that they can announce it and advertise for it. He/she stated they cannot advertise for the ADON position, because Acting DON encumbers the position Assistant Director of Nursing position currently. In addition, HSA stated IHS moved to a centralized hiring processes in mid-June 2025, and all hiring processes stopped for three to four weeks to transition. HSA stated they are slowly rolling it out, but the wait time is about six weeks to start the process written above. HSA confirmed there was no one officially designated as the Director of Nursing. 2. Review of the CAH’s undated “Nurse (ER)” [emergency room] job description indicated “. . . Certified and assumes responsibility in maintaining current within their CPR [cardiopulmonary resuscitation], ACLS [advanced cardiac life support], PALS [pediatric advanced life support] certifications . . .” Review of RN2’s personnel file, with Nurse Educator (NE) and Acting DON assisting with personnel file reviews, indicated no documented evidence RN2 was certified in PALS. During an interview on 08/22/25 at 9:50 AM, NE stated RN2’s personnel file had no documented evidence RN2 was certified in PALS.”

“NURSING SERVICES CFR(s): A registered nurse or, where permitted by State law, a physician assistant, must supervise and evaluate the nursing care for each patient, including patients at a SNF level of care in a swing-bed CAH. This Standard is not met as evidenced by: 17281 Based on record review, policy review, and interview, the registered nurse (RN) failed to assess patients in accordance with Critical Access Hospital (CAH) policies and/or physician orders related to suicide ideation, pain, and vital sign assessments for three (Patient (P) 2, P3, and P17) of 19 patient records reviewed for RN assessment from a total sample of 20 patients. This deficient practice had the potential to affect all patients receiving services at the CAH. Findings include: Review of the CAH policy titled, “Suicide Prevention and Care” revised on 03/2025 revealed, “ ...Patients who present with suicide risk, including symptoms or warning signs, will receive a screening followed by a nursing assessment (including diagnosis, treatment, collaboration safety plan, and discharge follow-up included in planning). ...The licensed independent practitioner will assess the level of risk based on the patient’s level of care, access to lethal means, and previous suicide attempts ...The licensed practitioner will clearly document treatment and interventions in the EHR [electronic health record] for follow-up based on the risk level assigned. ...” Review of the CAH policy titled, “Nursing Pain Assessment and Management” revised on 04/2025 revealed, “ ...Pain screenings for all patients shall begin upon the patient presenting to CLIHS [Cass Lake IHS] upon admission to inpatient, triage and/or screening of the patient, the RN/LPN shall inquire as to the nature (aching, gnawing, squeezing, burning, shooting, etc.), location, and severity of the pain using an appropriate pain scale. The RN/LPN will also inquire what usually relieves the pain and what methods are used at home. The patient’s age, literacy, values and beliefs, emotional status, and cognitive function will determine which pain scale to utilize. The pain scale chosen will be used consistently to evaluate pain. ...Documentation will be entered into the patients Electronic Heath Record, under pain assessments, in the admission template and under the screenings tab in the admission assessment for patients admitted to the unit, during triage it should be entered on the vitals tab and in the ER Nurse flow sheet under pain reassessment. Documentation will include; the patient’s score, analgesics administered and adverse reactions, comfort measures, patient education, and the patient’s response to treatment. Patients will be evaluated by an RN 30 minute after the pain control method has been implemented to determine amount of pain control or relief achieved ....” Review of the CAH’s policy titled “Vital Sign Reporting,” last revised January 2023, indicated “. . . staff should monitor the patient’s baseline BP [blood pressure] after they have been sitting quietly in a resting position for 5 minutes or more. Likewise, the patient should be located in a warm, quiet environment, with their back supported and feet flat on the floor if in a sitting position. It is recommended that patients abstain for at least 30 minutes or more after smoking, exercising and or consuming food products when having their BP completed by [initials of CAH] staff . . . staff will monitor, evaluate, and report critical vital signs to the medical provider responsible for the patient’s care as soon as possible, but no longer then 5-10 [five to ten] minutes after the initial evaluation. RN’s [sic] [registered nurses] and or providers will assess the patients vital signs at time of triage; check in, admission, prior to discharge and/or transfer. Patient’s [sic] will [sic] be assessed and reassessed according to his or her plan for care, physician orders, medical diagnosis, comorbid conditions, treatments, and/or changes in the patient condition . . .” 1.Review of P2’s emergency room “Provider Note” dated 05/10/25 located in the electronic medical record (EMR) under the “Progress Note” tab revealed, “patient reports having suicide ideation. States [he/she] thinks about getting in front of truck. No attempts made. [He/she] is grieving the loss of a significant other who may have committed suicide after they broke up which is affecting [him/her]. ... Chronic problems: moderate recurrent major depression ...Assessment and Plan: will attempt to get [him/her] voluntarily placed for this.” Review of P2’s “Face Sheet” located in EMR the under the “Progress Note” tab revealed P2 was admitted to the CAH on 05/11/25. Review of the “Assessment for Suicide Risk” dated 05/11/25 located in the EMR under the “Progress Note” tab signed by the registered nurse and the medical provider revealed, “ ...High risk R/T [related to] significant other suicide recently and children have been taken away by child services and is currently displaced with no supportive services and using alcohol to overcome suicide of significant other. ...Security notified and stayed with the patient and observation by nursing every fifteen minutes from 4:15 AM until 7:45 AM.” Review of the emergency room “Nursing Flow Sheet” dated 05/11/25 at 7:15 AM located in the EMR under the “Progress Note” tab revealed, “Pt does have indicators for a high risk but no plan at this time. Dr [name] has taken over care of pt [patient] for remaining ER visit and doesn’t feel pt needs one to one at this time and has documented to be a low risk of self-harm though out ER visit.” Revie of P2’s entire EMR failed to reveal a subsequent suicide ideation assessment was conducted by nursing or the practitioner after 05/11/25 when P2 was identified at high risk of suicide ideation. During an interview on 08/22/25 at 11:03 AM, the Acting Director of Nursing (DON) stated the provider would make the decision to change from a high risk of suicide to a low risk. The Acting DON stated there should be documentation in the record of how the decision was made to change the suicide risk. The Acting DON stated the nurse completes the suicide risk assessment and the provider evaluates the patient and documents whether in agreement with the nursing assessment. The Acting DON stated nursing should have done another suicide risk assessment. The Acting DON confirmed P2’s EMR did not include documentation a suicide risk assessment was completed after P2’s suicide risk was downgraded to low risk. 2.Review of P3’s provider note located under the “Notes” tab in the EMR indicated P3 presented to the ED on 08/19/25 with a chief complaint of bilateral 1eg swelling and left-sided chest pain. Review of P3’s “Nursing Flowsheet” located under the “Notes” tab in the EMR indicated the nurse assessed and documented P3’s pain at a level of six out of ten on 08/19/25 at 1:17 PM. Review of the entire “Nursing Flowsheet” and EMR indicated P3 was not administered medication for pain or comfort measures, the pain was not reassessed, education regarding pain management was not documented, and P3 was discharged home at 4:00 PM in stable condition. During an interview on 08/20/25 at 2:11 PM, Acting Assistant Director of Nursing (Acting ADON) stated P3’s pain should have been addressed, P3’s pain should have been reassessed and education on pain management should have been provided and documented in accordance with the CAH’s policy. 3. Review of P17’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P17 was admitted to the CAH on 06/06/25 and discharged on 06/08/25. Review of the “Inpatient Nurse Admission Assessment” dated 06/06/25 at 6:04 PM located in the EMR under the “Progress Note” tab revealed, “ ...Reason for admission- pyelonephritis [bacterial infection of the kidneys] ...pain rating is : 5 [based on a pain score of 1-10 with 10 being the most severe] acceptable level of pain is 4 - onset, duration, and variations: r [right] flank, constant ...” Review of the “Medication/Treatment Record” located in the EMR under the “Progress Note” tab revealed, “ ...ketorolac tromethamine [nonsteroidal anti-inflammatory drug used for the short-term management of moderately severe, acute pain] 15 mg [milligram] IV [intravenous] push, given reason pain on 06/06/25 at 22:18 [10:18 PM].” Review of P17’s entire EMR failed to reveal pain medication was administered for the report of pain on 06/06/25 at 6:04 PM but was not administered until 10:18 PM on 06/06/25. During an interview on 08/22/25 at 11:03 AM, the Acting DON stated the pain assessment completed in the admission nursing assessment is used to give a better idea of the severity of a patient’s pain and their tolerance. A pain level of five when the patient has an acceptable level of four would require something to be done by nursing. The Acting DON stated the medical record should have a note regarding the patient’s pain and what action was taken per the CAH policy. The Acting DON confirmed the EMR did not include documentation P17 received an intervention for the reported pain on 06/06/25 at 6:04 PM until 10:18 PM. 4. Review of Review of P3’s “Nursing Flowsheet” located under the “Notes” tab in the EMR indicated the nurse assessed P3’s VS at 1:17 PM, an electrocardiogram was performed at 1:40 PM, two separate antibiotics were administered intravenously at 2:30 PM and 3:00 PM, and vital signs were assessed at 2:15 PM and 3:00 PM after the first intravenous antibiotic was completed. Further review of the documentation on the “Nursing Flowsheet” by the nurse indicated at 4:00 PM the second antibiotic was completed, the intravenous line was discontinued, and P3 was discharged. There was no documentation P3’s vital signs were assessed after the second antibiotic was completed and prior to discharge in accordance with the CAH’s policy. During an interview on 08/20/25 at 2:11 PM, Acting ADON stated P3’s vital signs should have been assessed prior to discharge, since P3 had received two antibiotics during his/her ED stay. 25065”

“NURSING SERVICES CFR(s): §485.635(d)(3) All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws. This Standard is not met as evidenced by: 25065 Based on policy review, medical record review, and interview, the Critical Access Hospital (CAH) failed to ensure discharge prescriptions included the specific instructions for use when two allergy medications were prescribed for one (Patient (P) 4) of 10 emergency department (ED) reviewed for complete physician prescription medication orders from a total sample of 20 patients reviewed. This deficient practice had the potential to affect all ED patients discharged with medication prescriptions. Findings include: Review of the CAH policy titled “Hospital Discharge Policy,” last revised June 2025, indicated “. . . Prior to discharge, the discharging provider must write orders for all outpatient Medications. . .” Review of P4’s ED provider note located under the “Notes” tab in the electronic medical record (EMR) documented by Certified Nurse Practitioner (CNP1) indicated P4 presented to the ED on 08/19/25 with a chief complaint of swelling in the upper lip after eating zucchini bread approximately 20 minutes prior to arrival at the ED. Review of the provider’s documentation of discharge prescriptions indicated a prescription for diphenhydramine (Benadryl - active ingredient for various uses, including allergy relief, sleep aids, and itch-stopping creams) capsule oral, 50 milligrams (mg), take one capsule by mouth as needed for allergic reaction and cetirizine (Zyrtec - antihistamine that relieves allergy symptoms) tablet 10 mg, take one tablet by mouth every day as needed for allergic reaction. There was no documentation that instructions included when to take each medication, since both medications were for allergic reactions. During an interview on 08/20/25 at 2:22 PM, CNP1 stated he/she verbally instructed P4 to take one Cetirizine tablet after P4 got home and another Diphenhydramine that night. CNP1 stated both medications were PRN (as needed) medications. CNP1 stated he/she did verbally give instructions to P4, but without documenting that he/she did give verbal instructions, no one reviewing the EMR would know that CNP1 had done so.”

“NURSING SERVICES CFR(s): A nursing care plan must be developed and kept current for each inpatient. This Standard is not met as evidenced by: 17281 Based on record review, policy review, and interview, the Critical Access Hospital (CAH) failed to ensure each patient had a nursing care plan developed and kept current for three (Patient (P) 15, P16, and P20) of 10 patients reviewed for nursing care plan from a total sample of 20 patients. This deficient practice had the potential to affect all inpatients receiving services in the CAH. Findings include: Review of the facility policy titled, “Inpatient -Care Plan” revised on 06/2025 revealed, “ ... Care plans for Critical Access Hospital (CAH) patients starts on admission to the hospital. The comprehensive patient care plan will include measurable objectives and time tables [sic] to meet swing bed/CAH patient’s medical, psychiatric, and psychosocial needs. ...” 1. Review of P15’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P15 was admitted to the CAH on 07/07/25 and discharged on 07/10/25. Review of the “Nursing Hospital Admission Data Sheet” dated 07/07/25 located in the EMR under the “Progress Note” tab revealed, “ ...Chief complaint- Increasing shortness of breath and not feeling well ...exacerbation of COPD [chronic obstructive pulmonary disease]. ... “ Review of the “Attending Inpatient Note” dated 07/07/25 located in the EMR under the “Progress Note” tab revealed, “ ...Active problems: community acquired pneumonia, exacerbation of COPD, anxiety, depression, hypertension, abnormal glucose levels, asthma, and gastroesophageal reflux disease. ...” Review of the “Nursing Care Plan” dated 07/08/25 located in the EMR under the “Progress Note” tab revealed, impaired gas exchange with a goal to maintain oxygen levels above 93 % and decrease number of episodes of shortness of breath with activity. Review of the “Nursing Care Plan” failed to reveal P15’s active problems of pneumonia, asthma, abnormal glucose levels, depression, anxiety, gastroesophageal reflux disease, and hypertension were included in the care plan. 2. Review of P16’s “Face Sheet” located in the EMR under the “Progress Note” tab revealed P16 was admitted to the CAH on 06/03/25 and discharged on 06/05/25. Review of the “Attending Inpatient Note” dated 06/03/25 located in the EMR under the “Progress Note” tab revealed active problems included pneumonia, insulin dependent diabetes mellitus, depression, anxiety, cigarette use, and tinnitus (condition where you hear sounds, such as ringing or buzzing, which are not caused by an external source). Review of the “Nursing Care Plan” dated 06/03/25 located in the EMR under the “Progress Note” tab revealed, “ ...Pneumonia- diagnosis of unknown origin with unstable blood sugars.” Review of the “Nursing Care Plan” failed to reveal P16’s active problems of depression, anxiety, cigarette use, and tinnitus were included in the care plan. 3. Review of P20’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P20 was admitted to the CAH on 08/04/25 and discharged on 08/ 07/25. Review of the “Attending Inpatient Note” dated 08/04/25 located in the EMR under the “Progress Note” tab revealed, “ ...Active problems: cellulitis of the right leg, pain, MS [multiple sclerosis], neurogenic bladder, diabetes mellitus, hypertension. ...” Review of the “Inpatient Care Plan” dated 08/04/25 located in the EMR under the “Progress Note” tab revealed an alteration in comfort due to actual pain and anxiety. Review of the “Inpatient Care Plan” failed to reveal P20’s active problems of cellulitis of the right leg, multiple sclerosis, diabetes mellitus, and neurogenic bladder were included in the care plan. During an interview on 08/22/25 at 11:03 AM, the Acting Director of Nursing (DON) stated all inpatients should have a care plan developed within 24 hours of admission and should include all the issues of why the patient was admitted. The Acting DON confirmed P15, P16, and P20’s care plan were not comprehensive to include all problems identified on admission.”

“RECORDS SYSTEM CFR(s): The records are legible, complete, accurately documented, readily accessible, and systematically organized. This Standard is not met as evidenced by: 25065 Based on medical record reviews and interviews, the Critical Access Hospital (CAH) failed to ensure the emergency department (ED) physician medication orders were documented to be given in the ED and not in the clinic for two (Patient (P) 3 and P4) of 10 patient ED EMRs reviewed from a sample of 20 patients. This deficient practice had the potential to affect all patients receiving services in the ED. Findings include: 1.Review of P3’s provider note located under the “Notes” tab in the electronic medical record (EMR) indicated P3 presented to the ED on 08/19/25 with a chief complaint of bilateral 1eg swelling and left-sided chest pain. Review of medications ordered by the physician indicated “Vancomycin [antibiotic used to treat serious bacterial infections, particularly those caused by drug-resistant, Gram-positive bacteria] 1 [one] gm [gram] in water 200 ml [milliliters] premix inj [injection] 200 ml IV [intravenous] infuse over 60 minutes in clinic now.” During an interview on 08/20/25 at 2:03 PM, Clinical Application Coordinator (CAC) stated they have been aware the ED medication orders were being shown as outpatient medications or clinic medications and not ED medications. CAC confirmed P3’s Vancomycin was administered in the ED and not in the clinic. 2.Review of P4’s ED provider note located under the “Notes” tab in the EMR indicated P4 presented to the ED on 08/19/25 with a chief complaint of swelling of the upper lip after eating zucchini bread approximately 20 minutes prior to arrival to the ED. Review of medications ordered by Certified Nurse Practitioner (CNP) 1 indicated “diphenhydramine [antihistamine used to treat allergies, cold symptoms, insomnia, and motion sickness] 50 mg/ml [milligrams per milliliter] inj, soln [solution], 50 mg/1 ml [50 milligrams per one milliliter] IV in clinic now” and “methylprednisolone [corticosteroid used to treat a wide range of inflammatory and autoimmune conditions] 125 mg inj. Soln 125 mg/1 vial [per one vial] in clinic now.” During an interview on 08/20/25 at 11:51 AM, CAC confirmed the manner of documentation by CNP1 looked like the medications were given in the clinic and not in the ED.”

“RECORDS SYSTEM CFR(s): For each patient receiving health care services, the CAH maintains a record that includes, as applicable-- (i) Identification and social data, evidence of properly executed informed consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient; This Standard is not met as evidenced by: 25065 Based on policy review, medical record reviews, and interview, the Critical Access Hospital (CAH) failed to ensure each patient’s medical record had documented evidence of a completed and signed informed consent for 18 (Patient (P) 1, P2, P3, P4, P6, P7, P8, P9, P11, P12, P13, P14, P15, P16, P17, P18, P19, and P20) of 19 patient EMRs reviewed for informed consent from a sample of 20 patients. This deficient practice had the potential to affect all patients receiving services at the CAH. Findings include: Review of the CAH policy titled “Informed Consent for Treatment,” last revised January 2023, indicated “. . . The Medical Physician, Advanced Practice Registered Nurse and or [sic] Physician Assistant (provider) is responsible for explaining to the patient the procedure, risks, available alternatives, and the intended outcome. The provider must obtain a written consent prior to any procedures, which require an informed consent . . .” Review of the policy indicated the policy did not address informed consent for treatment at the time of admission to the inpatient unit or the emergency department (ED). 1. Review of P1’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P1 was admitted to the CAH on 08/06/25. Review of the physician note titled, “General Encounter” dated 08/06/25, located in the EMR under the “Progress Note” tab revealed, “ ...Assessment/Plan: ...1. Exacerbation of COPD [chronic obstructive pulmonary disease]. Sinusitis, exhaustion 2. Admission to Inpatient Orders as noted on admit. ...” Review of P1’s entire EMR failed to reveal an informed consent form was located in the record. 2. Review of P2’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P2 was admitted to the CAH on 05/11/25 and discharged on 05/13/25. Review of the “Doctor’s Orders” located in the EMR under the “Order” Tab revealed P2 was admitted to the CAH on 05/11/25 for alcohol gastritis. Review of P2’s entire EMR failed to reveal an informed consent form was located in the record. 3.Review of P3’s provider note located under the “Notes” tab in the electronic medical record (EMR) indicated P3 presented to the ED on 08/19/25 with a chief complaint of bilateral 1eg swelling and left-sided chest pain. Review of P3’s entire EMR indicated there was no documented evidence P3 had signed an informed consent for treatment. 4.Review of P4’s “RN [registered nurse] Emergency Department Note” located under the “Notes” tab in the EMR indicated P4 presented to the ED on 08/19/25 with a chief complaint of swelling of the upper lip after eating zucchini bread approximately 20 minutes prior to arrival to the ED. Review of P4’s entire EMR indicated there was no documented evidence P4 had signed an informed consent for treatment. 5. Review of P6’s “Provider Note” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P6 presented to the emergency room on 06/10/25 with a chief complaint of unresponsive and drug overdose and admitted to the CAH on 06/11/25. Review of P6’s entire EMR failed to reveal an informed consent form was located in the record. 6. Review of P7’s “Triage Note” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P7 presented to the CAH emergency room on 03/01/25 with a chief complaint of possible miscarriage. Review of the “Provider Note” dated 03/01/25 located in the EMR under the “Progress Note” tab revealed a cervical exam and blood work was obtained and after consultation with a physician at an acute care hospital, the patient was being transferred for obstetrical care and vaginal ultrasound. Review of P7’s entire EMR failed to reveal an informed consent form was located in record. 7.Review of P8’s ED nurse’s note indicated P8 presented to the ED on 02/05/25 with a chief complaint of having a positive pregnancy test five days ago and now feels sharp pains in the lower back and pelvis area with spotting for the past two days. Review of P8’s entire EMR indicated there was no documented evidence P8 had signed an informed consent for treatment. 8.Review of P9’s ED provider note indicated P9 presented to the ED on 12/06/24 via ambulance with a chief complaint of sudden onset of acute shortness of breath and sub-sternal chest pain at a pain level of seven out of 10. Review of P9’s entire EMR indicated there was no documented evidence P9 had signed an informed consent for treatment. 9.Review of P11’s ED nurse’s note indicated P11 presented to the ED on 12/02/24 seeking medical clearance, so he/she could be admitted to a facility for alcohol detoxification. P11 was triaged and placed in a room in the ED and left before being medically screened. Review of P11’s entire EMR indicated there was no documented evidence P11 had signed an informed consent for treatment. 10.Review of P12’s ED nurse’s note documented for the first visit on 01/01/25 indicated P12 presented to the ED with a chief complaint of five days of worsening upper respiratory-like symptoms with noted fever and chills, cough, sore throat, and headache. P12 was discharged home on 01/01/25 at 2:13 PM in stable condition. Review of P12’s ED provider note for the second visit on 01/01/25 at 4:25 PM indicated P12 was called by the provider to come back to the ED after the provider reviewed the chest x-ray. P12 was administered antibiotics and was subsequently transferred to an acute care hospital. Review of the entire EMR for both ED visits indicated there was no documented evidence P12 had signed an informed consent for treatment for each ED visit. 11. Review of P13’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P13 was admitted to the hospital Swing bed on 05/23/25 and discharged on 08/28/25. Review of the “History and Physical” dated 05/23/25 located in the EMR under the “Progress Note” tab revealed P13 was admitted to the hospital Swing bed for continued wound care. ...” Review of P13’s entire EMR failed to reveal an informed consent form that was located in the record. 12. Review of P14’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P14 was admitted to the CAH on 06/05/25 and discharged on 06/09/25. Review of the “RN Inpatient Note” dated 06/05/25 located in the EMR under the “Progress Note” tab revealed, “ ...reason for admission/admitting diagnosis- cellulitis. ...” Review of P14’s entire EMR failed to reveal an informed consent form was located in the record. 13. Review of P15’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P15 was admitted to the CAH on 07/07/25 and discharged on 07/10/25. Review of the “Nursing Hospital Admission Data Sheet” dated 07/07/25 located in the EMR under the “Progress Note” tab revealed, “ ...Chief complaint- Increasing shortness of breath and not feeling well ...exacerbation of COPD [chronic obstructive pulmonary disease]. ... “ Review of P15’s entire EMR failed to reveal an informed consent form was located in record. 14. Review of P16’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P16 was admitted to the CAH on 06/03/25 and discharged on 06/05/25. Review of the “Attending Inpatient Note” dated 06/03/25 located in the EMR under the “Progress Note” tab revealed, “ ...presented to the ED [emergency department] via ambulance early this morning with shortness of breath and is being admitted for pneumonia. ...” Review of P16’s entire EMR failed to reveal an informed consent form was located in the record. 15. Review of P17’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P17 was admitted to the CAH on 06/06/25 and discharged on 06/08/25. Review of the “Inpatient Nurse Admission Assessment” dated 06/06/25 located in the EMR under the “Progress Note” tab revealed, “ ...Reason for admission- pyelonephritis [bacterial infection of the kidneys]. ...” Review of P17’s entire EMR failed to reveal an informed consent form was located in record. 16. Review of P18’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P18 was admitted to the CAH on 05/23/25. Review of the “Inpatient Nurse Admission Assessment” dated 05/23/25 located in the EMR under the “Progress Note” tab revealed, “ ...Reason for admission- cellulitis and alcohol withdrawal. ...” Review of P18’s entire EMR failed to reveal an informed consent form was located in the record. 17. Review of P19’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P19 was admitted to the CAH on 05/19/25 and discharged on 05/20/25. Review of the “History and Physical” dated 05/20/25 located in the EMR under the “Progress Note” tab revealed P19 was admitted to the mid back pain, shortness of breath, and cough. ...” Review of P19’s entire EMR failed to reveal an informed consent form was located in record. 18. Review of P20’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P20 was admitted to the CAH on 08/04/25 and discharged on 08/ 07/25. Review of the “Inpatient Nurse Admission Assessment” dated 08/04/25 located in the EMR under the “Progress Note” tab revealed, “ ...Reason for admission- cellulitis of the right leg. ...” Review of 20’s entire EMR failed to reveal an informed consent form was located in the record. During an interview on 08/21/25 at 10:55 AM, Area Chief Medical Officer (Area CMO) confirmed the policy titled “Informed Consent for Treatment” references consent for procedures. Area CMO stated he’s/she’s not aware of another policy that addresses consent for treatment at admission to the inpatient unit or the ED, and “I am aware that it’s needed.” During an interview on 08/21/25 at 11:35 AM, Registered Health Information Administrator (MRA - Medical records Administration) indicated the EMRs of P1, P2, P3, P4, P6, P7, P8, P9, P11, P12, P13, P14, P15, P16, P17, P18, P19, and P20 did not have an informed consent for admission to the ED or the inpatient unit.”

“ORGAN, TISSUE, & EYE PROCUREMENT CFR(s): Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its option to either donate or not donate organs, tissues, or eyes. The individual designated by the CAH to initiate the request to the family must be a designated requestor. A designated requestor is an individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation; This Standard is not met as evidenced by: 25065 Based on policy review, patient medical record review, and interview, the Critical Access Hospital (CAH) failed to ensure a patient’s electronic medical record (EMR) contained documentation of collaboration with the coroner to obtain approval to proceed with donation in accordance with the CAH’s policy for one (Patient (P) 10) of one patient death reviewed for eye and tissue donation from a total sample of 20 patients. This deficient practice had the potential to affect all patients who expire in the CAH. Findings include: Review of the CAH’s policy titled “Tissue and Eye Donation Policy,” last revised April 2025, indicated “. . . In all cases, the procurement agency Donation Coordinator will make the final determination of a patient’s donation options. E. In all cases in which the patient is determined by the Donation Coordinator to be a donation candidate, donor designation will be evaluated by the Donation Coordinator. The hospital and procurement agency honor authorization via donor designation in accordance with state law. If no donation intent exists, the next of kin will be given the opportunity to donate organs, tissues, and eyes. F. Only a procurement agency Donation Coordinator will discuss donation with the next of kin (determined by state law in which the death occurred) . . . Registered Nurse /Provider/ Designee Contact the Donation Coordinator (DC) after every death and before mentioning donation to the family. . . Call within one hour after the patient death . . . You will be given a reference number to be documented in the patient’s medical record as evidence of making the referral call. . . DC will lead the donor designation assessment for patient’s documented intent or refusal to donate . . . Once designation is determined, collaborate to develop communication plan with legal next of kin. b. If the patient’s death is under the medical examiner’s/coroner’s jurisdiction, collaborate to inform the examiner/coroner of the death and obtain approval to proceed with donation. Document date and time of the discussion along with the name of examiner/coroner name and decision in patient’s medical record. . .” Review of P10’s “Nursing Flow Sheet Emergency Room” located in the EMR and dated 12/01/24 by Acting Assistant Director of Nursing (Acting ADON) indicated P10 arrived by ambulance with cardiopulmonary resuscitation in progress. Review of P10’s provider note documented on 12/01/24 at 9:07 AM indicated “. . . asystole X [times] 4 [four] rhythm checks: very cold , stiff and pupils 8 mm [eight millimeters] and dilated - after passive rewarming with hot packs and Bear blanket and 15 minutes of work with epi [epinephrine - fast-acting hormone and medication used primarily to treat life-threatening medical emergencies such as anaphylaxis, cardiac arrest, and severe asthma attacks] X 3 [times three] ( 1 mg [milligram] each ) we ended the code . . .” Review of P10’s “Nursing Flow Sheet Emergency Room” located in the EMR indicated the nurse documented the time of death at 9:23 AM and that P10’s body was picked up at 11:39 AM by the funeral home to be transported to the coroner’s office. Review of P10’s “Documentation of Death Worksheet” indicated Acting ADON contacted the donation coordinator on 12/01/24 at 9:46 AM, the coroner’s office at 10:15 AM, and the funeral home at 10:30 AM, all on 12/01/24. Review of P10’s “Certificate of Removal / Transit Permit” indicated Acting ADON documented the removal of P10’s body on 12/01/24 at 11:23 AM with a bag with P10’s name and driver’s license and the name of the funeral home taking custody of the body. Review of P10’s “[name of CAH] Record of Death Checklist for Organ, Tissue, Eye Donation” documented by Acting ADON on “12/01/22 @ 0946” [12/01/22 at 9:46 AM] indicated the reference number obtained from the Donor Coordinator. Documentation indicated assessment in consultation with the donation coordinator determined P10’s tissue and eyes met criteria for donation. Review of the form indicated “. . . Organ, Tissue, and Eye Donation option Check one [includes a box to check before each of the following options]: Donor designation: Patient documented intent to donate. Donation Coordinator will review disclosure form with family. Donor Designation: Patient documented intent not to donate. Family Connection: Donation Coordinator will approach family via telephone. Donation pending. Family authorizes donation after a CDR/Donation Coordinator approach. Family declines donation after a CDR/Donation Coordinator approach. Next of kin, _____ name/relationship was offered option of donation by CDR/Donation Coordinator _____ on _____ date. There was no documentation of a check mark or x in any of the option boxes, the next of kin name and relationship was left blank, the name of the CDR/Donation Coordinator was written, and the date line had “12/01/22 @ 0946” written [12/01/22 at 9:46 AM]. Review of the entire EMR indicated no documentation of collaboration to inform the examiner/coroner to obtain approval to proceed with donation in accordance with the CAH policy. During an interview on 08/20/25 at 3:30 PM, Acting ADON stated, after reviewing P10’s EMR, verified there was no documentation after the discussion with the Donation Coordinator concluded P10’s eyes and tissue met the criteria for donation with the patient’s next of kin by the Donation Coordinator and communication with the coroner for approval to proceed with donation in accordance with the CAH policy. Acting ADON stated the year on the “[name of CAH] Record of Death Checklist for Organ, Tissue, Eye Donation” form should have been 2024 and not 2022.”

“COMP ASSESSMENT, CARE PLAN & DISCHARGE CFR(s): §485.645(d)(5) Comprehensive assessment, comprehensive care plan, and discharge planning (§483.20(b), and §483.21(b) and (c)(2) of this chapter), except that the CAH is not required to use the resident assessment instrument (RAI) specified by the State that is required under §483.20(b), or to comply with the requirements for frequency, scope, and number of assessments prescribed in §413.343(b) of this chapter). “ §483.20(b) Comprehensive assessments- (1) Resident assessment instrument. A facility must make a comprehensive assessment of a resident’s needs, strengths, goals, life history and preferences, using the resident assessment instrument (RAI) specified by CMS. The assessment must include at least the following: (i) Identification and demographic information. (ii) Customary routine. (iii) Cognitive patterns. (iv) Communication. (v) Vision. (vi) Mood and behavior patterns. (vii) Psychosocial well-being. (viii) Physical functioning and structural problems. (ix) Continence. (x) Disease diagnoses and health conditions. (xi) Dental and nutritional status. (xii) Skin condition. (xiii) Activity pursuit. (xiv) Medications. (xv) Special treatments and procedures. (xvi) Discharge planning. (xvii) Documentation of summary information regarding the additional assessment performed on the care areas triggered by the completion of the Minimum Data Set (MDS). (xviii) Documentation of participation in assessment. The assessment process must include direct observation and communication with the resident, as well as communication with licensed and nonlicensed direct care staff members on all shifts. (2) When required. Subject to the timeframes prescribed in §413.343(b) of this chapter, a facility must conduct a comprehensive assessment of a resident in accordance with the timeframes specified in paragraphs (b)(2) (i) through (iii) of this section. The timeframes prescribed in §413.343(b) of this chapter do not apply to CAHs. (i) Within 14 calendar days after admission, excluding readmissions in which there is no significant change in the resident’s physical or mental condition. (For purposes of this section, “readmission” means a return to the facility following a temporary absence for hospitalization or for therapeutic leave.) (ii) Within 14 calendar days after the facility determines, or should have determined, that there has been a significant change in the resident’s physical or mental condition. (For purposes of this section, a “significant change” means a major decline or improvement in the resident’s status that will not normally resolve itself without further intervention by staff or by implementing standard disease-related clinical interventions, that has an impact on more than one area of the resident’s health status, and requires interdisciplinary review or revision of the care plan, or both.) (iii) Not less often than once every 12 months. “ §483.21(b) Comprehensive care plans. (1) The facility must develop and implement a comprehensive person-centered care plan for each resident, consistent with the resident rights set forth at §483.10(c)(2) and §483.10(c)(3), that includes measurable objectives and timeframes to meet a resident’s medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment. The comprehensive care plan must describe the following: (i) The services that are to be furnished to attain or maintain the resident’s highest practicable physical, mental, and psychosocial well-being as required under §483.24, §483.25, or §483.40; and (ii) Any services that would otherwise be required under §483.24, §483.25, or §483.40 but are not provided due to the resident’s exercise of rights under §483.10, including the right to refuse treatment under §483.10(c)(6). (i) Any specialized services or specialized rehabilitative services the nursing facility will provide as a result of PASARR recommendations. If a facility disagrees with the findings of the PASARR, it must indicate its rationale in the resident’s medical record. (ii) In consultation with the resident and the resident’s representative(s)- (A) The resident’s goals for admission and desired outcomes. (B) The resident’s preference and potential for future discharge. Facilities must document whether the resident’s desire to return to the community was assessed and any referrals to local contact agencies and/or other appropriate entities, for this purpose. (C) Discharge plans in the comprehensive care plan, as appropriate, in accordance with the requirements set forth in paragraph (c) of this section. (2) A comprehensive care plan must be- (i) Developed within 7 days after completion of the comprehensive assessment. (ii) Prepared by an interdisciplinary team, that includes but is not limited to- (A) The attending physician. (B) A registered nurse with responsibility for the resident. (C) A nurse aide with responsibility for the resident. (D) A member of food and nutrition services staff. (E) To the extent practicable, the participation of the resident and the resident’s representative(s). An explanation must be included in a resident’s medical record if the participation of the resident and their resident representative is determined not practicable for the development of the resident’s care plan. (F) Other appropriate staff or professionals in disciplines as determined by the resident’s needs or as requested by the resident. (iii) Reviewed and revised by the interdisciplinary team after each assessment, including both the comprehensive and quarterly review assessments. (3) The services provided or arranged by the facility, as outlined by the comprehensive care plan, must- (i) Meet professional standards of quality. (ii) Be provided by qualified persons in accordance with each resident’s written plan of care. (iii) Be culturally-competent and trauma-informed. “ §483.21(c)(2) Discharge summary. When the facility anticipates discharge a resident must have a discharge summary that includes, but is not limited to, the following: (i) A recapitulation of the resident’s stay that includes, but is not limited to, diagnoses, course of illness/treatment or therapy, and pertinent lab, radiology, and consultation results. (ii) A final summary of the resident’s status to include items in paragraph (b)(1) of §483.20, at the time of the discharge that is available for release to authorized persons and agencies, with the consent of the resident or resident’s representative. (iii) Reconciliation of all pre-discharge medications with the resident’s post-discharge medications (both prescribed and over-the-counter). (iv) A post-discharge plan of care that is developed with the participation of the resident and, with the resident’s consent, the resident representative(s), which will assist the resident to adjust to his or her new living environment. The post-discharge plan of care must indicate where the individual plans to reside, any arrangements that have been made for the resident’s follow up care and any post-discharge medical and non-medical services. This Standard is not met as evidenced by: 17281 Based on record review, policy review, and interview, the Critical Access Hospital (CAH) failed to ensure the baseline care plan was developed to provide person-centered care for one (Patient (P) 13) of one sampled Swing bed patient reviewed from a total sample of 20 patients. This failure had the potential to affect any patient admitted to the CAH Swing bed program for care and services. Findings include: Review of the facility policy titled, “Inpatient -Care Plan” revised on 06/2025 revealed, “ ...A comprehensive patient care plan will be developed for each swing bed patient within 24 hours after the completion of the initial Registered Nurse (RN) admission assessment. The comprehensive patient care plan will include measurable objectives and time tables [sic] to meet swing bed/CAH patient’s medical, psychiatric, and psychosocial needs as identified in the RN admission assessment. ...” Review of P13’s “Face Sheet” located in the electronic medical record (EMR) under the “Progress Note” tab revealed P13 was admitted to the hospital Swing bed on 05/23/25 and discharged on 08/28/25. Review of the “Nursing Swing Bed Admission Data Sheet” located in the EMR under the “Progress Note” tab revealed, “ ...Patient admitted 23- May- 2025 at 15:35 [3:35 PM] ...Reason for admission- wound care sacral ulcer. ...” Review of the “History and Physical” dated 05/23/25 located in the EMR under the “Progress Note” tab revealed, “ ...Plan had been to discharge home today 05/23/25, however given the status of wounds and insufficient access to home health care over the long holiday weekend, transfer to swing bed for continued wound care. ...” Review of P13’s EMR failed to reveal a care plan was developed within 24 hours of the nursing admission assessment per the CAH policy. During an interview on 08/20/25 at 10:45 AM, Medical Record Administration (MRA) confirmed a care plan for P13’s Swing bed admission from 05/23/25 through 05/28/25 could not be found. During an interview on 08/22/25 at 11:03 AM, the Acting Director of Nursing (DON) stated all Swing bed inpatients should have a care plan developed within 24 hours of admission and should include issues of why the patient was admitted.”

“A Life Safety Code recertification survey was conducted by the Centers for Medicare & Medicaid Services (CMS) on 8/19/25. At this Federal Recertification Survey, Cass Lake Indian Health Services Hospital Existing Wing (Wing 1) was found to be not in compliance with the requirements for participation in Medicare/Medicaid at 42 CFR 485.623(d), Life Safety from Fire, and the related National Fire Protection Association (NFPA) standard 101 - 2012 edition. Cass Lake Indian Health Services Hospital was a single, two-story building with a basement built at different times and was of new and existing construction and different occupancy types organized into multiple zones. Zones were separated by 2-hour fire barriers. The building was constructed in 1937, 1983, 1999, 2001, 2015, 2020, and 2025. There were previously three additional buildings, but they have since been demolished as part of the new construction. For the purposes of this survey, the hospital will be divided into two wings: Wing 1 and Wing 2. Wing 1 will include existing construction prior to 2020: Zone 1A Existing Business Occupancy, Zone 1B Existing Business Occupancy, Zone 2 Existing Health Care Occupancy, Zone 3 Existing Health Care Occupancy, Zone 4A Existing Ambulatory Occupancy, Zone 8 Existing Health Care Occupancy, and Zone 9 Existing Business Occupancy. These zones generally cover the hospital, emergency department, and pharmacy. Wing 2 will include the new construction in 2020 and 2025: Zone 4B New Business Occupancy, Zone 5 New Ambulatory Occupancy, Zone 6 New Ambulatory Occupancy, Zone 7 New Ambulatory Occupancy, Zone 10 New Storage Occupancy, and Zone 11 New Mixed Occupancy. These zones generally cover the clinic, radiology and dental. Each wing is Type II(000). The building is fully sprinklered and there is supervised smoke detection located in the corridors, spaces open to the corridors and in resident rooms. The facility has 4 certified beds. At the time of the survey the census was 0. The requirement at 42 CFR, subpart 485.623(d) is NOT MET as evidenced by:”

“A Life Safety Code recertification survey was conducted by the Centers for Medicare & Medicaid Services (CMS) on 8/19/25. At this Federal Recertification Survey, Cass Lake Indian Health Services Hospital New Wing (Wing 2) was found to be not in compliance with the requirements for participation in Medicare/Medicaid at 42 CFR 485.623(d), Life Safety from Fire, and the related National Fire Protection Association (NFPA) standard 101 - 2012 edition. Cass Lake Indian Health Services Hospital was a single, two-story building with a basement built at different times and was of new and existing construction and different occupancy types organized into multiple zones. Zones were separated by 2-hour fire barriers. The building was constructed in 1937, 1983, 1999, 2001, 2015, 2020, and 2025. There were previously three additional buildings, but they have since been demolished as part of the new construction. For the purposes of this survey, the hospital will be divided into two wings: Wing 1 and Wing 2. Wing 1 will include existing construction prior to 2020: Zone 1A Existing Business Occupancy, Zone 1B Existing Business Occupancy, Zone 2 Existing Health Care Occupancy, Zone 3 Existing Health Care Occupancy, Zone 4A Existing Ambulatory Occupancy, Zone 8 Existing Health Care Occupancy, and Zone 9 Existing Business Occupancy. These zones generally cover the hospital, emergency department, and pharmacy. Wing 2 will include the new construction in 2020 and 2025: Zone 4B New Business Occupancy, Zone 5 New Ambulatory Occupancy, Zone 6 New Ambulatory Occupancy, Zone 7 New Ambulatory Occupancy, Zone 10 New Storage Occupancy, and Zone 11 New Mixed Occupancy. These zones generally cover the clinic, radiology and dental. Each wing is Type II(000). The building is fully sprinklered and there is supervised smoke detection located in the corridors, spaces open to the corridors and in resident rooms. The facility has 4 certified beds. At the time of the survey the census was 0. The requirement at 42 CFR, subpart 485.623(d) is NOT MET as evidenced by:”

“Sprinkler System - Maintenance and Testing CFR(s): NFPA 101 Sprinkler System - Maintenance and Testing Automatic sprinkler and standpipe systems are inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintaining of Water-based Fire Protection Systems. Records of system design, maintenance, inspection and testing are maintained in a secure location and readily available. a) Date sprinkler system last checked _____________________ b) Who provided system test ____________________________ c) Water system supply source __________________________ Provide in REMARKS information on coverage for any non-required or partial automatic sprinkler system. 9.7.5, 9.7.7, 9.7.8, and NFPA 25 This Standard is not met as evidenced by: 50099 Based on observation and interview, the facility failed to maintain the sprinkler system in accordance with NFPA 101, 2012 edition, Section 19.3.5.3, 9.7.5, NFPA 25, 2011 edition, sections 5.1, 5.1.1, 5.1.1.1, 5.1.1.2, 5.2.1.1.2, 5.2.1.1.4 and Table 5.1.1.2. This deficient practice could affect approximately 4 or less patients and staff. Findings include On 8/19/25 at 2:55PM, observation revealed that one sprinkler was loaded with dust in the Kitchen. This finding was confirmed by the Facilities Manager at the time of discovery.”

“Sprinkler System - Maintenance and Testing CFR(s): NFPA 101 Sprinkler System - Maintenance and Testing Automatic sprinkler and standpipe systems are inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintaining of Water-based Fire Protection Systems. Records of system design, maintenance, inspection and testing are maintained in a secure location and readily available. a) Date sprinkler system last checked _____________________ b) Who provided system test ____________________________ c) Water system supply source __________________________ Provide in REMARKS information on coverage for any non-required or partial automatic sprinkler system. 9.7.5, 9.7.7, 9.7.8, and NFPA 25 This Standard is not met as evidenced by: 50099 Based on observation and interview, the facility failed to maintain the sprinkler system in accordance with NFPA 101, 2012 edition, Section 18.3.5.3, 9.7.5, NFPA 25, 2011 edition, sections 5.1, 5.1.1, 5.1.1.1, 5.1.1.2, and Table 5.1.1.2. This deficient practice could affect approximately 4 or less patients and staff. Findings include 1) On 8/19/25 at 1:50PM, observation revealed that the ceiling tile near the sprinkler was missing in Room 1935 - EVS Closet. 2) On 8/19/25 at 3:20PM, observation revealed that the the sprinkler head was blocked by a box on a shelf in Room 3152 - Janitor Storage. These findings were confirmed by the Facilities Manager at the time of discovery.”