Summit Healthcare Regional Medical Center

“Subsistence Needs for Staff and Patients CFR(s): §403.748(b)(1), §418.113(b)(6)(iii), §441.184(b)(1), §460.84(b)(1), §482.15(b)(1), §483.73(b)(1), §483.475(b)(1), §485.542(b)(1), §485.625(b)(1) [(b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following: (1) The provision of subsistence needs for staff and patients whether they evacuate or shelter in place, include, but are not limited to the following: (i) Food, water, medical and pharmaceutical supplies (ii) Alternate sources of energy to maintain the following: (A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. (B) Emergency lighting. (C) Fire detection, extinguishing, and alarm systems. (D) Sewage and waste disposal. *[For Inpatient Hospice at §418.113(b)(6)(iii):] Policies and procedures. (6) The following are additional requirements for hospice-operated inpatient care facilities only. The policies and procedures must address the following: (iii) The provision of subsistence needs for hospice employees and patients, whether they evacuate or shelter in place, include, but are not limited to the following: (A) Food, water, medical, and pharmaceutical supplies. (B) Alternate sources of energy to maintain the following: (1) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. (2) Emergency lighting. (3) Fire detection, extinguishing, and alarm systems. (C) Sewage and waste disposal. This Standard is not met as evidenced by: 43814 Based on review of the facility Emergency plan, record review and staff interview, it was determined, the facility failed to develop and implement emergency preparedness policies and procedures, based on subsistence needs for staff and patients. Failure to develop subsistence needs for staff and patients during an emergency could cause harm to staff and patients if immediate needs like food, water, medical and pharmaceutical supplies and alternate sources of energy are not planned for and available. Finding include During observations while on tour Aug 15, 2024, it was revealed that the facilities did not have the needed amounts of water needed to sustain the staff patients and visitor the three days as described in their plan. The facilities plan involved off-site assistance for water sources. Employees # 1,#2 confirmed during the exit interview conducted on Aug 15, 2024, that the sustenance on hand was not nearly enough.”

“Clear Width of Exit and Exit Access Doors CFR(s): NFPA 101 Clear Width of Exit and Exit Access Doors 2012 EXISTING Exit access doors and exit doors are of the swinging type and are at least 32 inches in clear width. Exceptions are provided for existing 34-inch doors and for existing 28-inch doors where the fire plan does not require evacuation by bed, gurney, or wheelchair. 19.2.3.6, 19.2.3.7 This Standard is not met as evidenced by: 43814 Based on observation, the facility failed to provide a safe means of egress from multiple exit pathways to a public way. Failure to provide a clear and unimpeded means of egress could harm the patients and staff in a fire emergency. NFPA 101, Life Safety Code, 2012, Chapter 19, Section 19.2.1 “Every aisle, passageway, corridor, exit discharge, exit location, and access shall be in accordance with Chapter 7. Section 7.1.10.1 “ Means of egress shall be continuously maintained free of all obstructions or impediments to full instant use in the case of fire or other emergency.” Section 7.1.10.2.1 No furnishings, decorations, or other objects shall obstruct exits or their access there to egress there from or visibility thereof. Observations made while on tour on August 14-15, 2024, revealed wheeled chairs, beds, and other medical equipment blocking the exit egress on the second and third floors of patient care areas. Some of these areas even had the floors marked as storage. Staff believed they were allowed to store items in the hallways as long as they were all on one side of the hallway. During the exit conference on August 15, 2024, employees #1 and #2 confirmed the findings during the tour and exit conference.”

“Laboratories CFR(s): NFPA 101 Laboratories Laboratories employing quantities of flammable, combustible, or hazardous materials that are considered a severe hazard are protected by 1-hour fire resistance-rated separation, automatic sprinkler system, and are in accordance with 8.7 and with NFPA 99. Laboratories not considered a severe hazard are protected as hazardous areas (see K321). Laboratories using chemicals are in accordance with NFPA 45, Standard on Fire Protection for Laboratories Using Chemicals. Gas appliances are of appropriate design and installed in accordance with NFPA 54. Shutoff valves are marked to identify material they control. Devices requiring medical grade oxygen from the piped distribution system meet the requirements under 11.4.2.2 (NFPA 99). 19.3.2.2, 8.7, 8.7.4.1 (LSC) 9.3.1.2, 11.4.3.2, 15.4 (NFPA 99) This Standard is not met as evidenced by: 43814 Based on observation and records, the facility failed to maintain emergency plans and staff training for laboratory chemicals. Failure to create emergency plans and train the staff could have caused staff and patients to be overcome or injured by chemicals stored in the lab. NFPA 101: Life Safety Code, 2012 Edition - Chapter 19 Existing Health Care Occupancies 19.3.2.2 * Laboratories. Laboratories employing quantities of flammable, combustible, or hazardous materials that are considered as a severe hazard shall be in accordance with Section 8.7 and the provisions of NFPA 99, Health Care Facilities Code, applicable to administration, maintenance, and testing. NFPA 99: Health Care Facilities Code, 2012 Edition - Chapter 9 Heating, Ventilation, and Air Conditioning (HVAC). 9.3.1.2 Laboratories shall comply with NFPA 45, Standard on Fire Protection for Laboratories Using Chemicals. NFPA 99: Health Care Facilities Code, 2012 Edition - Chapter 15 Features of Fire Protection 15.4 Laboratories. Laboratories using chemicals shall comply with NFPA 45, Standard on Fire Protection for Laboratories Using Chemicals, unless otherwise modified by other provisions of this code. [101:8.7.4.1] NFPA 45: Standard on Fire Protection for Laboratories Using Chemicals, 2024 Edition - Chapter 8 Chemical Storage, Handling, and Waste Disposal. 8.3.4.2 * Incompatible materials shall be segregated to prevent accidental contact with one another. 8.3.4.4.1 * Proper management shall consist of the following elements: (1) Defining those materials present that are time sensitive (2) Defining each time-sensitive material’s inspection frequency (3) Defining proper or approved inspection methodologies to determine the relative hazard of the time-sensitive material (4) Defining pass/fail criteria for inspection results 8.3.4.4.2 Time-sensitive materials that pass inspection shall be permitted to be redated and retained for an additional defined inspection period. 8.3.4.4.3 All other material shall be safely discarded. NFPA 45: Standard on Fire Protection for Laboratories Using Chemicals, 2024 Edition - Chapter 12 Educational and Instructional Laboratory Operations. 12.2.1 * Where instructors are performing demonstrations or students are conducting experiments using hazardous materials, the instructor shall be required to perform a documented hazard risk assessment, provide a safety briefing to students, provide adequate personal protective equipment (PPE), and place a safety barrier (as required) between students and the demonstration or experiment to prevent personal injury. 12.2.2 * Instructors in teaching labs shall be trained and knowledgeable in fire safety procedures, emergency plans, the hazards present in the lab, the appropriate use of PPE, and how to properly conduct a hazard risk assessment. Findings include: Observations while on tour August 14-15, 2024, revealed that the chemicals being stored in the laboratory did not have any emergency plans or SDSs. In addition, there were no training documents confirming that the staff was trained in handling those chemicals during an emergency. The management stated that CAP (College of American Pathologists) inspectors had inspected the facility two weeks earlier, and the facility was cited, but no action had taken place to correct the problem. Employees #1 and #2 confirmed during the exit that the lab was missing emergency plan documents for dealing with the stored chemicals and staff training.”

“Sprinkler System - Installation CFR(s): NFPA 101 Spinkler System - Installation 2012 EXISTING Nursing homes, and hospitals where required by construction type, are protected throughout by an approved automatic sprinkler system in accordance with NFPA 13, Standard for the Installation of Sprinkler Systems. In Type I and II construction, alternative protection measures are permitted to be substituted for sprinkler protection in specific areas where state or local regulations prohibit sprinklers. In hospitals, sprinklers are not required in clothes closets of patient sleeping rooms where the area of the closet does not exceed 6 square feet and sprinkler coverage covers the closet footprint as required by NFPA 13, Standard for Installation of Sprinkler Systems. 19.3.5.1, 19.3.5.2, 19.3.5.3, 19.3.5.4, 19.3.5.5, 19.4.2, 19.3.5.10, 9.7, 9.7.1.1(1) This Standard is not met as evidenced by: 43814 Based on observations, the facility failed to add sprinklers in a room during a recent modification/room addition. Failure to have a sprinkler system throughout the facility could harm residents and/or staff during an emergency. NFPA 101 Life Safety Code, 2012, Chapter 19, Section 19.3.5.3 Where required by 19.1.6, buildings containing hospitals or limited care facilities shall be protected throughout by an approved, supervised automatic sprinkler system in accordance with Section 9.7, unless otherwise permitted by 19.3.5.5..” Chapter 9, Section 9.7.1.1, “ Each automatic sprinkler system required by another section of this Code shall be installed in accordance with NFPA 13 Standard for the Installation of Sprinkler Systems.” Findings include: Observations made while on tour August 14-15, 2024, revealed that a room was added in an outside mechanical room housing the UPS room. The room is fully enclosed and was built under an existing sprinkler system, but the system was not extended to it, resulting in it being without sprinkler heads. Employees #1 and #2 confirmed the above findings during the tour on August 14, 2024, and the exit conference on August 15, 2024.”

“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: 43814 Based on observation, the facility failed to display a current hydraulic plate on the sprinkler riser. Failure to require a current date on the riser hydraulic plate could result in errors during modifications and failure of the sprinkler system. NFPA 25 2011 Standard for the inspection, testing, and maintenance of water-based fire protection systems. 5.2.6* Hydraulic Design Information Sign. The hydraulic design information sign for hydraulically designed systems shall be inspected quarterly to verify that it is attached securely to the sprinkler riser and is legible. A.5.2.6 The hydraulic design information sign should be secured to the riser with durable wire, chain, or equivalent. (See Figure A.5.2.6.) Paragraph 5.2.6 requires that the hydraulic design information sign (also called a nameplate or placard) be inspected on a quarterly basis. NFPA 13 requires a hydraulic design information sign on hydraulically designed systems so that the design criteria and system demand can be readily determined. The hydraulic design information sign can provide useful information to the owner. If the design information sign is missing, the owner should contact a design professional to determine the demand for the system, which can be written on a new design information sign. The details are also documented on the approved plans and hydraulic calculations, but these plans can be misplaced and may not be available when the property changes owners. A hydraulic design information sign that is securely fastened to the riser can provide the details when these other data are missing (see Exhibit 5.21). If the sign becomes loose or is difficult to read, it must be repaired or replaced. Findings include: Observation while on tour August 14-15, 2024, revealed the sprinkler riser in the south mechanical room was missing the required hydraulic plate. The quarterly inspections did not identify the missing plate. Employees #1 and #2 confirmed during the tour that the sprinkler riser hydraulic plate in the south mechanical room was missing.”

“Electrical Systems - Essential Electric Syste CFR(s): NFPA 101 Electrical Systems - Essential Electric System Maintenance and Testing The generator or other alternate power source and associated equipment is capable of supplying service within 10 seconds. If the 10-second criterion is not met during the monthly test, a process shall be provided to annually confirm this capability for the life safety and critical branches. Maintenance and testing of the generator and transfer switches are performed in accordance with NFPA 110. Generator sets are inspected weekly, exercised under load 30 minutes 12 times a year in 20-40 day intervals, and exercised once every 36 months for 4 continuous hours. Scheduled test under load conditions include a complete simulated cold start and automatic or manual transfer of all EES loads, and are conducted by competent personnel. Maintenance and testing of stored energy power sources (Type 3 EES) are in accordance with NFPA 111. Main and feeder circuit breakers are inspected annually, and a program for periodically exercising the components is established according to manufacturer requirements. Written records of maintenance and testing are maintained and readily available. EES electrical panels and circuits are marked, readily identifiable, and separate from normal power circuits. Minimizing the possibility of damage of the emergency power source is a design consideration for new installations. 6.4.4, 6.5.4, 6.6.4 (NFPA 99), NFPA 110, NFPA 111, 700.10 (NFPA 70) This Standard is not met as evidenced by: 43814 Based on observation and staff interviews, the facility failed to ensure that a remote stop or kill switch for the generator was installed. This affected the entire facility and could result in a loss of power due to a generator malfunction during an emergency power outage. Failure to have an emergency stop on the generator could cause a fire or harm the residents and staff. Code reference: NFPA 110 2010 Edition; Standard for Emergency and Standby Power Systems 5.6.5.6 All installations shall have a remote manual stop station of a type to prevent inadvertent or unintentional operation, located outside the room housing the prime mover, where so installed, or elsewhere on the premises where the prime mover is located outside the building. A.5.6.5.6 For systems located outdoors, the manual shut-down should be located external to the weatherproof enclosure and should be appropriately identified. Findings include: During observations during a tour conducted on August 14-15, it was revealed that the facility’s generator did not have the required remote stop or kill switch. Per facility management, this switch is scheduled to be installed in a couple of months. Employees #1 and #2 confirmed during the exit conference that the facility failed to install a remote stop switch for the emergency diesel generator.”

“Electrical Equipment - Power Cords and Extens CFR(s): NFPA 101 Electrical Equipment - Power Cords and Extension Cords Power strips in a patient care vicinity are only used for components of movable patient-care-related electrical equipment (PCREE) assembles that have been assembled by qualified personnel and meet the conditions of 10.2.3.6. Power strips in the patient care vicinity may not be used for non-PCREE (e.g., personal electronics), except in long-term care resident rooms that do not use PCREE. Power strips for PCREE meet UL 1363A or UL 60601-1. Power strips for non-PCREE in the patient care rooms (outside of vicinity) meet UL 1363. In non-patient care rooms, power strips meet other UL standards. All power strips are used with general precautions. Extension cords are not used as a substitute for fixed wiring of a structure. Extension cords used temporarily are removed immediately upon completion of the purpose for which it was installed and meets the conditions of 10.2.4. 10.2.3.6 (NFPA 99), 10.2.4 (NFPA 99), 400-8 (NFPA 70), 590.3(D) (NFPA 70), TIA 12-5 This Standard is not met as evidenced by: 43814 Based on Observation, it was determined that the facility allowed the use of power strips but did not use the wall outlet receptacles for appliances. Failure to properly use power strips and outlets could lead to electrical overload or fire, which could harm the patients and staff. NFPA 101, Life Safety Code, 2012. Chapter 2, Section 2.1 The following documents or portions thereof are referenced within this Code as mandatory requirements and shall be considered part of the requirements of this Code. Chapter 2 “Mandatory References” NFPA 99 “Standard for Health Care Facilities, “ 2012 Edition. NFPA 99, Chapter 6, Section 6.3.2.2.6.2 , “All Patient Care Areas,” Sections 6.3.2.2..6.2 (A) through 6.3.2.2.6.2 (E) Receptacles (2)” Minimum Number of Receptacles.” “The number of receptacles shall be determined by the intended use of the patient care area. There shall be sufficient receptacles located so as to avoid the need for extension cords or multiple outlet adapters. Findings include: Observations made during the tour from August 14-15, 2024, revealed that the following locations had power strips plugged into equipment with heavy load-drawing appliances (refrigerators, microwaves, and large printers). 1. The case management office had a microwave in a power strip and two items plugged into an unprotected outlet splitter. 2. The refrigerator in the Biomed room was plugged into a power strip. During the exit conference conducted on August 14-15, 2024, Employees # 1 and #2 confirmed the improper use of power strips and multi-plug adaptors without surge protection.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 48110 Based on record reviews, staff interviews, and observations, it was determined the hospital failed to ensure the Governing Body evaluated hospital services. This deficient practice poses the risk of the Governing Body being unaware of the overall function and management of the hospital and the inability to improve patient care services. Findings include: Hospital document titled, “Bylaws of Summit Healthcare Association”, revealed: “ ...The Summit Healthcare Association is referred to in these Bylaws as the “Corporation.” ...3.2 The Governing Board shall have the ultimate responsibility and authority for the effective and appropriate performance of services performed by the Corporation ...3.3 The Governing Board maintains final responsibility and accountability for the development, implementation and oversight of the Corporation’s system-wide Compliance Program ....” The Condition level deficiency is the result of the standard deficiencies found in the following tags: Cross reference A-0057: The CEO failed to ensure the day-to-day operations of the facility. Cross reference A-0117: The facility failed to ensure patient or patient’s representative received a written copy of their patient rights. Cross reference A-0123: The facility failed to ensure patient received notices of their grievance resolution. Cross reference A-0286: The facility failed to ensure event reporting policies and procedures were followed. Cross reference A-0353: The facility failed to ensure the medical staff complied with medical staff rules and regulations when issuing verbal orders for medications. Cross reference A-0407: The facility failed to ensure verbal orders were used infrequently. Cross reference A-0441: The facility failed to ensure patient’s paper medical records were secured. Cross reference A-0454: The facility failed to ensure verbal orders were authenticated within 48 hours per hospital policy. Cross reference A-0467: The facility failed to ensure verbal order for medications were documented in the patient medical record. Cross reference A-0619: The facility failed to ensure: 1. Dishes used to serve patient meals were cleaned of residual food debris; 2. Kitchen staff wore hair nets; 3. The kitchen, kitchen carts, shelves, and equipment were cleaned and disinfected; 4. Staff did not have personal beverages out for consumption in the kitchen; 5. Clean serving dishes and equipment were protected from contamination and stored in sanitary manner; 6. Dry storage food was stored appropriately in a clean and sanitary storage room; 7. Refrigerated food was stored appropriately; 8. Refrigerator temperatures were monitored and interventions implemented for out of range readings; 9. Food temperatures were monitored and interventions implemented for out of range readings; 10. A person in charge during all hours of operation on the premises demonstrated skills and knowledge of foodborne disease prevention, application of the hazard analysis and critical control point principles, and knowledge of the FDA 2017 Food Code requirements. Cross reference A-0620: The facility failed to ensure the Director of Nutritional Services was qualified to provide services at the facility. Cross reference A-0622: The facility failed to ensure staff in the hospital cafeteria were qualified to provided services at the facility. Cross reference A-0631: The facility failed to ensure current diet manual was approved by the registered dietitian. Cross reference A-0653: The facility failed to ensure: 1. The utilization review plan was reviewed and approved by the governing body. 2. The utilization review committee met quarterly per hospital plan. Cross reference A-0701: The facility failed to ensure medications were secured to prevent unauthorized access. Cross reference A-0750: The facility failed to ensure clean and dirty supplies were separated, and patient supplies were not mixed with staff personal food items. Cross reference A-0775: The facility failed to ensure personnel members received annual infection control and prevention education. Cross reference A-0776: The facility failed to ensure personnel member performed proper hand hygiene prior to medication preparation, patient contact, and retrieving clean patient supplies. Cross reference A-0951: The facility failed to ensure opened sterile single use items were disposed. Cross reference A-1104: The facility failed to ensure patient’s medical record were properly filed and accessible to surveyors. The cumulative effect of these systemic deficient practices resulted in the facility’s failure to meet the requirement for the Condition of Participation for Governing Body.”

“MEDICAL RECORD SERVICES CFR(s): 482.24 The hospital must have a medical record service that has administrative responsibility for medical records. A medical record must be maintained for every individual evaluated or treated in the hospital. This Condition is not met as evidenced by: 48110 Based on review of policies and procedures, hospital documents, medical records and interviews, it was determined the hospital failed to ensure the each individual patient’s medical record was maintained and complete as demonstrated by the following Standard level citations: 0441: The facility failed to ensure patients’ paper medical records were secured. 0454: The hospital failed to ensure verbal orders were authenticated by a medical staff member within 48 hours per hospital policy. 0467: The Hospital failed to ensure staff document a verbal medication order in the patient medical record. The cumulative effect of these systemic problems resulted in the hospital not ensuring medical records were maintained and complete, leading to a failure to meet the requirements of the Condition of Participation for Medical Records.”

“FOOD AND DIETETIC SERVICES CFR(s): 482.28 The hospital must have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company may be found to meet this Condition of Participation if the company has a dietitian who serves the hospital on a full-time, part-time, or consultant basis, and if the company maintains at least the minimum standards specified in this section and provides for constant liaison with the hospital medical staff for recommendations on dietetic policies affecting patient treatment. This Condition is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure: (A0619) 1. dishes used to serve patient meals were cleaned of residual food debris; 2. kitchen staff wore hair nets; 3. the kitchen, kitchen carts, shelves, and equipment were cleaned and disinfected; 4. staff did not have personal beverages out for consumption in the kitchen; 5. clean serving dishes and equipment were protected from contamination and stored in sanitary manner; 6. dry storage food was stored appropriately in a clean and sanitary storage room; 7. refrigerated food was stored appropriately; 8. refrigerator temperatures were monitored and interventions implemented for out of range readings; 9. food temperatures were monitored and interventions implemented for out of range readings; and 10. a person in charge during all hours of operation on the premises demonstrated skills and knowledge of foodborne disease prevention, application of the hazard analysis and critical control point principles, and knowledge of the FDA 2017 Food Code requirements. (A0620) personnel records contained evidence that the Director of Nutritional Services was qualified to provide services at the facility. (A0622) personnel records contained evidence that staff in the hospital cafeteria were qualified to provide services at the facility. (A0631) current diet manual was approved by a registered dietitian. The Hospital failed to be in compliance with the Conditions of Participation for Food and Dietetic Services. The cumulative effect of the facility’s systemic practices pose patient safety risks related to an increased risk of foodborne disease. Additionally, these deficient practices negatively impact the delivery of quality patient care if there is no oversight provided for the facility kitchen and dietary services overall functioning and performance.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 48110 Based on review of the hospital records and interviews, it was determined that the Hospital failed to ensure: Cross reference: A-0043, A-0057 0750: The facility failed to ensure a separation of clean and dirty, and patient supply items not mixed with staff and patient food items. 0775: The Hospital failed to ensure documentation of annual infection control and prevention education were provided for personnel members. 0776: The facility failed to ensure Employee #28 performed hand hygiene prior to preparing medications for administration, before and after gloving and patient contact, and before retrieving clean patient supplies from a supply cart. 0951: The hospital failed to ensure sterile single use items were disposed after surgical procedures. The cumulative effect of these systemic deficient practices resulted in the facility’s failure to meet the requirement for the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship and provide a safe environment for patients to protect them from harm.”

“CHIEF EXECUTIVE OFFICER CFR(s): 482.12(b) The governing body must appoint a chief executive officer who is responsible for managing the hospital. This Standard is not met as evidenced by: 48110 Based on record reviews and staff interviews, it was determined the Chief Executive Officer (CEO) failed to manage the daily operation of the hospital. This deficient practice poses a risk to the health and safety of patients when leadership does not provide proper guidance, enforcement of policies and procedures, and provide resources to deliver care to meet the needs of patients. Cross reference A-0043 Findings include: Hospital document titled, “Summit Healthcare Job Description”, revealed: “ ...Chief Executive Officer ...General Position Summary: The Chief Executive Officer (CEO) directs all functions of the hospital in keeping with the overall policies established by the Governing Board ...Essential Functions/Major Responsibilities: ...Plans, coordinates, and controls the daily operation of the organization in conjunction with executives, directors, and managers ...Dispenses advice, guidance, direction, and authorization to carry out major plans, standards and procedures, consistent with established policies and Board approval. Meets with the other executives to ensure that operations are being executed in accordance with the organization’s policies ....” Employee #5 confirmed during an interview conducted on 07/24/2024 that the hospital experienced multiple interim chief executive officers in the last year. It was determined the CEO failed to manage the day-to-day operations of the hospital as demonstrated by the following: Cross reference A-0117: The facility failed to ensure patient or patient’s representative received a written copy of their patient rights. Cross reference A-0123: The facility failed to ensure patient received notices of their grievance resolution. Cross reference A-0286: The facility failed to ensure event reporting policies and procedures were followed. Cross reference A-0353: The facility failed to ensure the medical staff complied with medical staff rules and regulations when issuing verbal orders for medications. Cross reference A-0407: The facility failed to ensure verbal orders were used infrequently. Cross reference A-0441: The facility failed to ensure patient’s paper medical records were secured. Cross reference A-0454: The facility failed to ensure verbal orders were authenticated within 48 hours per hospital policy. Cross reference A-0467: The facility failed to ensure verbal order for medications were documented in the patient medical record. Cross reference A-0619: The facility failed to ensure: 1. Dishes used to serve patient meals were cleaned of residual food debris; 2. Kitchen staff wore hair nets; 3. The kitchen, kitchen carts, shelves, and equipment were cleaned and disinfected; 4. Staff did not have personal beverages out for consumption in the kitchen; 5. Clean serving dishes and equipment were protected from contamination and stored in sanitary manner; 6. Dry storage food was stored appropriately in a clean and sanitary storage room; 7. Refrigerated food was stored appropriately; 8. Refrigerator temperatures were monitored and interventions implemented for out of range readings; 9. Food temperatures were monitored and interventions implemented for out of range readings; 10. A person in charge during all hours of operation on the premises demonstrated skills and knowledge of foodborne disease prevention, application of the hazard analysis and critical control point principles, and knowledge of the FDA 2017 Food Code requirements. Cross reference A-0620: The facility failed to ensure the Director of Nutritional Services was qualified to provide services at the facility. Cross reference A-0622: The facility failed to ensure staff in the hospital cafeteria were qualified to provided services at the facility. Cross reference A-0631: The facility failed to ensure current diet manual was approved by the registered dietitian. Cross reference A-0653: The facility failed to ensure: 1. The utilization review plan was reviewed and approved by the governing body. 2. The utilization review committee met quarterly per hospital plan. Cross reference A-0701: The facility failed to ensure medications were secured to prevent unauthorized access. Cross reference A-0750: The facility failed to ensure clean and dirty supplies were separated, and patient supplies were not mixed with staff personal food items. Cross reference A-0775: The facility failed to ensure personnel members received annual infection control and prevention education. Cross reference A-0776: The facility failed to ensure personnel member performed proper hand hygiene prior to medication preparation, patient contact, and retrieving clean patient supplies. Cross reference A-0951: The facility failed to ensure opened sterile single use items were disposed. Cross reference A-1104: The facility failed to ensure patient’s medical record were properly filed and accessible to surveyors. The cumulative effect of these systematic problems resulted in the CEO’s inability to ensure the facility provided quality health care in a safe environment.”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 48110 Based on record reviews and staff interviews, it was determined the hospital failed to ensure the patient or patient’s representative received a written copy of their patient rights for seven of 20 patients (Patients #33, #35, #38, #39, #41, #45, #46). This deficient practice poses the potential risk that patients are not informed of their rights at the time of admission. Cross reference A-0043, A-0057 Findings include: Hospital policy titled, “Patient Bill of Rights and Responsibilities”, revealed: “ ...Procedure: Summit staff shall honor and adhere to the Patient Bill of Rights and Responsibilities ....Patients or patient representatives are informed of their rights and receive a written copy of the Patient Bill of Rights and Responsibilities with each visit to the healthcare facility ....” Hospital document titled, “Conditions of Admission, Notifications, Authorizations and Agreements”, revealed a check box for when patient has been given a copy of the Patient Bill of Rights and Responsibilities. Review of medical records conducted on 07/24/2024 and 07/25/2024 revealed the check box that Patients 33, #35, #38, #39, #41, #45, and #46 was given a copy of the Patient Bill of Rights and Responsibilities was not checked. Employee #13, Employee #17, and Employee #18 confirmed during an interview conducted on 07/24/2024 and 07/25/2024 that there was no documentation Patients 33, #35, #38, #39, #41, #45, and #46 received a copy of their patient rights.”

“PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION CFR(s): 482.13(a)(2)(iii) At a minimum: In its resolution of the grievance, the hospital must provide the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. This Standard is not met as evidenced by: 45706 Based on the review of policies and procedures, documents, and interviews, it was determined the Hospital failed to ensure policies and procedures were followed related to complaints and grievances. This deficient practice poses a potential risk of possible harm to patients if patient complaints and grievances are not being investigated, monitored, addressed, and managed in a timely manner. Cross reference A-0043, A-0057 Findings include: Policy titled, “Quality, Compliance, and Risk Management”, revealed: “...The association provides timely and appropriate follow-up to all patient complaints and grievances. All complaints are recorded in the Patient Feedback web-based program. The patient is provided with a formal written notice of resolution within thirty business days when possible. In the event the grievance is complex or requires extensive review, the formal notice should be completed timely, ideally less than thirty days, but occasionally may take longer than thirty working days. In this case, the patient is notified within seven days, including the reason for the delay and the anticipated time frame for resolution. The patient or his/her representative has the right to appeal a grievance determination. Appeals for grievance determinations are submitted to the Chief Quality Officer. Final determinations for appeals are made within 60 days of appeal notification....” Review of the patient complaints and grievances log revealed the facility did not follow their policy and procedure for (3) of (6) patients. The following documentation was not available for review: Patients #21 and 22 did not receive a formal notice indicating the investigation was finalized. Patients # 22 and 23 did not receive an acknowledgement letter from the facility that their complaint or grievance was being investigated. Employee #42 confirmed in an interview on 0724/2024 the facility did not follow their policy and procedure on complaints and grievances.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 45706 Based on review of policies and procedures, documents, medical records, and interview, it was determined the hospital failed to ensure that the hospital followed their policies and procedures related to event reporting. This deficient practice poses a potential risk to the health and safety of patients when potential system or individual performance problems may not be addressed. Cross reference A-0043, A-0057 Findings include: Policy titled, “Event Reporting Guidelines”, revealed: “...Event reports will be directed to the department leaders and Quality Management for follow up and corrective action, if required. The event data will be kept in the data base or moved to the Patient Safety Organization Module (PSOM) (Policy HW1481). Any serious injury resulting from an incident must be reported immediately to the Risk Manager or the Administrator on call. If the event is a Sentinel Event, the Chief Quality Officer or Quality Management Director should be notified. (See Sentinel event policy HW1153 and Sentinel Event Guidelines HW1153GL)....Follow-up of the event should be completed by the appropriate department director(s) within 30 days of the event....” Review of incident report dated 07/12/2023 for Patient #26 revealed the patient was given a double dose of Plavix medication. Patient #26’s double dose of Plavix resulted in injury caused by incorrect medication dosing error. Further review of the event report revealed the incident was not reviewed by the Risk Management Department. (Plavix (clopidogrel bisulfate) is a thienopyridine class of drug that inhibits platelet aggregation and thus inhibits aspects of blood clotting used to treat patients with acute coronary syndrome, myocardial infarction (MI), peripheral vascular disease and some stroke (ischemic type) patients). Review of incident reported dated 12/16/2023 for Patient #51 revealed medication error resulting patient adverse event of low blood pressure. The incident was reported on 12/16/2023, and the department director completed the investigation on 01/30/2024. Employee #5 confirmed in an interview on 07/24/2024 that the facility did not follow policy and procedure regarding Risk Management review of an event resulting in injury. Employee #7 confirmed on 07/25/2024 that the facility did not follow policy and procedure regarding department leader follow up of the event in the required time frame.”

“MEDICAL STAFF BYLAWS CFR(s): 482.22(c) The medical staff must adopt and enforce bylaws to carry out its responsibilities. The bylaws must: This Standard is not met as evidenced by: 45706 Based on the review of policies and procedures, hospital documents, medical records, and staff interviews, it was determined that the hospital failed to ensure Medical Staff complied with the Medical Staff Bylaws and Regulations when issuing verbal orders for medications. This deficient practice poses a risk to the health and safety of patients if verbal orders are not documented as stipulated by the Medical Rules and Regulations for the hospital. Cross reference A-0043, A-0057 Finding include: Policy titled, “Summit Healthcare Regional Medical Center Medical Staff Rules & Regulations, 03/2024” revealed: “...Verbal Orders are order for medications, treatments, interventions or other patient care that are transmitted as oral, spoken communications, delivered either face-to-face or via telephone....” Policy titled, “Provider and Healthcare Team Communication: Secure Texting of Protected Health”, revealed: “...To ensure appropriate guidelines and security measures are followed by members of the healthcare workforce when patient health information is shared among healthcare providers by means of short message services (SMS) text messaging, and address security risks presented by SMS text messaging...4. Texting of patient orders is prohibited, regardless of the platform used. Secure texting may NOT be used as a method to communicate patient orders. Patient orders should be entered directly by the Provider into the Electronic Medical Record. In instances where this is not possible, telephone communication should be used for placing or modifying patient orders....” Review of Patient #25’s medical record dated 02/10/2024 revealed a verbal order for 2mg Dilaudid was given to Employee #45 by the Provider on 02/10/2024 at 01:37 a.m. The verbal order was documented in the Qliq secure text messaging application. Employee #9 confirmed in an interview on 07/25/2024 that the facility did not follow their policy and procedure on documenting verbal orders in the Qliq application.”

“VERBAL ORDERS FOR DRUGS CFR(s): 482.23(c)(3)(i) If verbal orders are used, they are to be used infrequently. This Standard is not met as evidenced by: 48110 Based on record reviews and staff interviews, it was determined the hospital failed to ensure verbal orders were used infrequently to prevent medication errors. This deficient practice poses a risk to the health and safety of patients if verbal orders are misunderstood, misheard, or transcribed incorrectly, and result in patient adverse events. Cross reference A-0043, A-0057 Findings include: Hospital document titled, “Medical Staff Rules & Regulations”, revealed: “ ...2.11 Physician Orders ...i. Verbal orders should be used only to meet the care needs of the patient when it is impossible or impractical for the ordering practitioner to write the order or enter it into a computerized order entry system (if such system exists) without delaying of treatment. Verbal orders should be recorded directly onto an order sheet in the patient’s medical record or entered into the computerized order entry system, if applicable. The content of the verbal orders must be clearly communicated, and nationally accepted read-back verification practice to be implemented for every verbal order ....Whenever possible, the receiver of the order should write down the complete order or enter it into a computerized system, then read it back, and receive confirmation from the individual who gave the order. The physician should sign, date and time such orders within 48 hours ....Verbal orders are orders for medications, treatments, interventions or other patient care that are transmitted as oral, spoken communications, delivered either face-to-face or via telephone ....” Hospital document titled, “Incident Report” dated 12/16/2023 revealed a medication error involving Patient #51. Patient #51 presented to the hospital with 36 weeks gestation for induction of labor with history of chronic hypertension and superimposed preeclampsia. Patient #51 blood pressure 138/83 on 12/15/2023 at 1527 hours. A verbal order was given by a provider to a registered nurse (RN) for Nifedipine 30mg by mouth every 12 hours extended release, and the medication was entered into the electronic health record (EHR) system as instant release. Patient #51 was administered instant release Nifedipine 30mg at 1602 hours, and Patient #51 blood pressure dropped to 97/53 at 1701 hours, and 96/51 at 1738 hours. Patient #51 blood pressure increased to 155/105 at 2121 hours, and magnesium sulfate therapy was initiated. The RN went to give the next dose of Nifedipine and discovered the error in the documented verbal order given to the first RN. Review of Incident Report dated 11/11/2023 revealed an incident report was generated for a change in Patient #29 condition which was identified as a cerebral infarctation. Further review of the incident report identified Patient #29 night nurse for 11/10/2023 (Employee #44) acknowledged that the neurologist had given Employee #44 a verbal order to hold Losartan and HCTZ unless systolic blood pressure was greater than 200. Further review of the incident report revealed Employee #44 acknowledged that the verbal was not entered into the medical record. Review of Patient #29’s medical record dated 11/09/2023 through 11/11/2023 revealed the following: medication order for Losartan and HCTZ were placed by the Provider on 11/09/2023. On 11/10/2024 the Neurologist gave Employee #44 a verbal order to hold Losartan and HCTZ unless systolic blood pressure was greater than 200. Review of Patient #29’s medical record did not contain evidence that the verbal order to hold Losartan and HCTZ were documented. Employee #9 confirmed in an interview on 07/25/2024 that Patient #29’s medical record dated 11/10/2023 did not contain evidence the verbal order holding the blood pressure medications was documented. Employee #5 confirmed during an interview conducted on 07/23/2024 that verbal orders are frequently given at the Hospital. Employee #13 and Employee #17 confirmed providers are often on-site and have the ability to place orders the EHR. Employee #7 also confirmed verbal orders have resulted in miscommunication, and medication errors and patient adverse events.”

“PROTECTING PATIENT RECORDS CFR(s): 482.24(b)(3) The hospital must have a procedure for ensuring the confidentiality of patient records. Information from or copies of records may be released only to authorized individuals, and the hospital must ensure that unauthorized individuals cannot gain access to or alter patient records. Original medical records must be released by the hospital only in accordance with Federal or State laws, court orders, or subpoenas. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure patients’ paper medical records were secured. Failure to secure a patient’s protected health information poses a potential risk that a patient’s confidential and private health information may be available to unauthorized individuals. Cross reference A-0043, A-0057, A-0431 Findings include: The facility policy titled “Retention of Medical Records” was provided in response to a request for the facility’s policy and procedure to secure medical records. The policy did not address the securement of patient’s medical records. Observation on 07/22/2024 revealed three oversized file cabinets in an unlocked room in the IV infusion center. The file cabinets contained pressboard type files filled with patient’s paper medical records. Each filed contained sensitive information, demographics, and protected health information. The file cabinets were unlocked as was the room the cabinets were stored in and anyone walking into the room would have access to the records. Employee #6 confirmed on 07/22/2024 that patients’ medical records were not stored securely to prevent unauthorized access.”

“CONTENT OF RECORD: ORDERS DATED & SIGNED CFR(s): 482.24(c)(2) All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner or by another practitioner who is responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations. This Standard is not met as evidenced by: 48110 Based on record reviews and staff interviews, it was determined the hospital failed to ensure verbal orders were authenticated by a medical staff member within 48 hours per hospital policy. This deficient practice poses a risk to the health and safety of patients if medical staff members do not review and authenticate verbal orders in a timely fashion, and confirm there are no errors on communication and the accuracy of the orders. Cross reference A-0043, A-0057, A-0431 Findings include: Hospital policy titled, “Medical Orders”, revealed: “ ...Procedure: ...4. Writing medical orders: a. Verbal and telephone orders are written in the medical record by the authorized receiving person ....6. Signing-off (verifying) medical orders: ...b. The provider giving the order must sign the order with 48 hours ....” Hospital document titled, “Medical Staff Rules & Regulations”, revealed: “ ...2.11 Physician Orders ...d. Verbal Orders - Verbal and telephone orders can be taken only from a physician, a Physician Assistant (PA) under a physician’s direction, or a Registered Nurse, Nurse Practitioner, or Licensed Practical Nurse under a physician’s direction ....the physician should sign, date and time such orders within 48 hours ....” Patient #31’s medical record revealed a verbal order for restraint entered on 06/06/2024 by a registered nurse. The verbal order was signed by the physician who requested the order on 06/10/2024. Patient #42’s medical record revealed a verbal order for sodium chloride 0.9% 1000 milliliter intravenous fluid entered on 05/09/2024 by a registered nurse. The verbal order was signed by the physician who requested the order on 05/13/2024. Patient #43’s medical record revealed a verbal order for heparin 3840 units intravenous bolus entered on 06/21/2024 by a registered nurse. The verbal order was signed by the physician who requested the order on 06/26/2024. Employee #13 and Employee #17 confirmed during an interview conducted on 07/24/2024 that the verbal orders for Patients #31, #42, and #43 were not authenticated by the physician within 48 hours per the hospital policy and medical staff rules and regulations.”

“CONTENT OF RECORD: ORDERS,NOTES,REPORTS CFR(s): 482.24(c)(4)(vi) [All records must document the following, as appropriate:] All practitioner’s orders, nursing notes, reports of treatment, medication records, radiology and laboratory reports, and vital signs and other information necessary to monitor the patient’s condition. This Standard is not met as evidenced by: 48110 Based on review of policy and procedures, medical records, and interviews, it was determined the Hospital failed to ensure staff document a verbal medication order in the patient medical record. This deficient practice poses a risk to health and safety of patients if staff does not document the correct name of medication, dosage, or route of administration causing a potential adverse drug event. Cross reference A-0043, A-0057, A-0431 Findings include: Policy titled, “Medical Orders”, revealed: “...To provide direction for staff regarding receiving, accepting, writing, transcribing and signing-off medical orders...1. Medical orders for medications and treatments are written in the medical record. 2. Receiving Medical Orders: a. Persons authorized to receive and write verbal or telephone orders are: i. Registered Nurses (RN)...Verbal and telephone orders can be accepted only from a person licensed in Arizona to prescribe such medications and treatments. Orders can be accepted from: i. Physician....” Policy titled, “Medical Record”, revealed: “...Medical record entries, including handwritten and electronic, must be legible, complete, dated, timed and authenticated by the person responsible for providing or evaluating the services provided, and consistent with hospital policies...2. The medical record contains the following demographic information: All orders....” Review of Patient #29’s medical record dated 11/09/2023 through 11/11/2023 revealed the following: medication order for Losartan and HCTZ were placed by the Provider on 11/09/2023. On 11/10/2024 the Neurologist gave Employee #44 a verbal order to hold Losartan and HCTZ unless systolic blood pressure was greater than 200. Review of Patient #29’s medical record did not contain evidence that the verbal order to hold Losartan and HCTZ were documented. At shift change during the evening hours, the blood pressure medication was not addressed. Employee #9 confirmed in an interview on 07/25/2024 that Patient #29’s medical record dated 11/10/2023 did not contain evidence the verbal order holding the blood pressure medications was documented.”

“ORGANIZATION CFR(s): 482.28(a) Organization This Standard is not met as evidenced by: 37489 Baseds on policy and procedure, United States Food and Drug Administration publication, Food Code: 2017 Recommendations of the Unites States Public Health Service, observation, and interview, it was determined that the facility failed to ensure 1. dishes used to serve patient meals were cleaned of residual food debris; 2. kitchen staff wore hair nets; 3. the kitchen, kitchen carts, shelves, and equipment were cleaned and disinfected; 4. staff did not have personal beverages out for consumption in the kitchen; 5. clean serving dishes and equipment were protected from contamination and stored in sanitary manner; 6. dry storage food was stored appropriately in a clean and sanitary storage room; 7. refrigerated food was stored appropriately; 8. refrigerator temperatures were monitored and interventions implemented for out of range readings; and 9. food temperatures were monitored and interventions implemented for out of range readings; and 10. a person in charge during all hours of operation on the premises demonstrated skills and knowledge of foodborne disease prevention, application of the hazard analysis and critical control point principles, and knowledge of the FDA 2017 Food Code requirements. Failure to be in compliance with Federal and State licensure requirements for food and dietary personnel as well as food services standards, laws and regulations poses a high potential risk of harm to patients through environmental and foodborne illnes that may arise from the facility kitchen. Cross reference A-0043 Cross reference A-0618 Findings include: 1. The policy titled “Dishwashing by Hand” requires: “...To provide a system for cleaning and sanitizing dishes and utensils when the dish machine is not functioning properly or is out of operation....” The policy titled “Dish machine Temperature Checks” revealed: “...To ensure efficient and sanitary dishwashing....” The United States Food and Drug Administration publication, Food Code: 2017 Recommendations of the United States Public Health Service, Food and Drug Administration requires: “...4-6 CLEANING OF EQUIPMENT AND UTENSILS...4-601.11...Equipment, Food-Contact Surfaces, Nonfood Contact Surfaces, and Utensils...(A) EQUIPMENT FOOD-CONTACT SURFACES and UTENSILS shall be clean to sight and touch....” Observation on 07/22/2024 revealed stoneware type plates for plating patient food had dried on food debris. Employee #6 and 27 confirmed on 07/22/2024 that plates used for serving patient meals from the kitchen had dried on food debris. 2. Observation on 07/22/2024 and 07/23/2024 revealed multiple staff working in the kitchen without hair coverings. Employee #19 confirmed on 07/22/2024 that not all staff wear hair nets as this was not a requirement of the hospital. The United States Food and Drug Administration publication, Food Code: 2017 Recommendations of the United States Public Health Service, Food and Drug Administration requires: “...2-3 PERSONAL CLEANLINESS...2-301 Hands and Arms...2-301.11 Clean Condition...FOOD EMPLOYEES shall keep their hands and exposed portions of their arms clean...Hair Restraints ...2-402.11 ...(A) Except as provided in (B) of this section, FOOD EMPLOYEES shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed FOOD; clean EQUIPMENT, UTENSILS, and LINENS; and unwrapped SINGLESERVICE and SINGLE-USE ARTICLES. (B) This section does not apply to FOOD EMPLOYEES such as counter staff who only serve BEVERAGES and wrapped or PACKAGED FOODS, hostesses, and wait staff if they present a minimal RISK of contaminating exposed FOOD; clean EQUIPMENT, UTENSILS, and LINENS; and unwrapped SINGLE-SERVICE and SINGLE-USE ARTICLES....” The FDA Food Code 2017 requires kitchen staff to wear some type of hair covering or restrain to prevent food from being exposed to hair. 3. The facility policy titled “Nutritional Services-Cleaning and Sanitizing Surfaces, last reviewed 7/21” requires: “...All work surfaced in the Dietary Department will be cleaned and sanitized after daily use. All equipment will be cleaned and sanitized after each use. Equipment not in daily use should be covered with plastic and cleaned again just before using...Cleaning Work Surfaces...For light duty cleaning and sanitizing of work surfaces use Pro Quat 400 Sanitizer...Hobart Mixer...Hood...Ovens...Freezer...meat Slicer...Deep Fryer...Refrigerators...Dishwashing machine...Cleaning Patient Food Carts (Performed 3 times daily)...Empty cart of all food trays; clean and sanitize carts using Pro Quat 400 solution. Clean all inside and outside areas of cart....” The United States Food and Drug Administration publication, Food Code: 2017 Recommendations of the United States Public Health Service, Food and Drug Administration requires: “...6-5 MAINTENANCE AND OPERATION Subpart 6-501 Premises...PHYSICAL FACILITIES shall be maintained in good repair. 6-501.12 Cleaning, Frequency and Restrictions. (A) PHYSICAL FACILITIES shall be cleaned as often as necessary to keep them clean. 4-6 CLEANING OF EQUIPMENT AND UTENSILS...4-601.11 Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces, and Utensils. (A) EQUIPMENT FOOD-CONTACT SURFACES and UTENSILS shall be clean to sight and touch....(B) The FOOD-CONTACT SURFACES of cooking EQUIPMENT and pans shall be kept free of encrusted grease deposits and other soil accumulations. (C) Non FOOD-CONTACT SURFACES of EQUIPMENT shall be kept free of an accumulation of dust, dirt, FOOD residue, and other debris....” Observation on 07/22/2024 revealed empty, ready to use patient carts that were not clean and free of debris and spills. Additionally, multiple carts, shelves, and racks used for clean equipment storage and food preparation were dirty and contaminated with loose debris, thick spills, and dirty grime. A food preparation cart/table had a dirty, off-white non-slip covering on a lower shelf underneath an uncovered baking tray and cutting board with cooked pork loin being sliced. Clean serving trays and lids were noted on the non-slip covering along with loose debris and food splatter, as well as a broken wooden shelf and a cardboard box with dirty scissors and five spools of party ribbon in a clear plastic box inside the cardboard box. The shelving unit with the stand mixer was littered with debris, had a bottle of open coffee creamer on it, and a discarded plastic spoon. A wheeled cart in front of the stand mixer has dried on splatters and spills of an unknown substance along with spilled white granulated and powdery substance spilled on the shelf. Cleaning supplies were noted on a shelf that contained boxes of steam pan liners, resealable bags, several fabric aprons, and a Christmas decoration/elf costume hat. The shelving unit was coated with a dirty, grimy film. A wheeled cart with patient trays and serving trays was located immediately against a dirty sink and shelving unit that contained cleaning supplies, sponges , bottle brushes, window cleaner, an open Ajax powdered cleanser, pot and pan detergent, several gallon bottles of silverware cleaner, packing tape rolls, dish machine detergent and rinse agent, fryer cleaner, oil based stainless steel cleaner wipes, three boxes of nitrile gloves (one open), and an open can of “CELSIUS” energy drink in the middle of the items on the top shelf. Another metal shelving unit was noted to have corrosion and rust on the metal and a layer of grimy debris. The shelves contained loose kitchen serving utensils, plastic and stainless-steel food serving trays, measuring cups, a thermo carafe, and two boxes of open trash can liners. Employee #6 and 27 confirmed on 07/22/2024 that carts, trays, work surfaces, food preparation areas were not kept clean and sanitized between use and on a daily basis and that employee open beverage cans were found in undesignated areas where contamination could occur. 4. The United States Food and Drug Administration publication, Food Code: 2017 Recommendations of the United States Public Health Service, Food and Drug Administration requires: “...Food Contamination Prevention ...2-401.11 Eating, Drinking, or Using Tobacco ...(A) Except as specified in (B) of this section, an EMPLOYEE shall eat, drink, or use any form of tobacco only in designated areas where the contamination of exposed FOOD; clean EQUIPMENT, UTENSILS, and LINENS; unwrapped SINGLE-SERVICE and SINGLE-USE ARTICLES; or other items needing protection can not result....” Observation on 07/22/2024 revealed a wheeled cart with patient trays and serving trays was located immediately against a dirty sink and shelving unit that contained cleaning supplies, sponges , bottle brushes, window cleaner, an open Ajax powdered cleanser, pot and pan detergent, several gallon bottles of silverware cleaner, packing tape rolls, dish machine detergent and rinse agent, fryer cleaner, oil based stainless steel cleaner wipes, three boxes of nitrile gloves (one open), with an open can of “CELSIUS” energy drink in the middle of the items on the top shelf. The document titled “Navajo County Food Establishment Inspection Report” dated 06/04/2024 revealed: “ ...Observed employee’s drinks on prep tables ...Repeat ...Food Code Section: 2-401.11 E ....” Employee #6 confirmed on 07/22/2024 that staff had an open drink in the kitchen and not in a designated eating/drinking area as required. Additionally, Employee #6 confirmed that the county kitchen inspector also cited the same finding in June 2024. 5. The United States Food and Drug Administration publication, Food Code: 2017 Recommendations of the United States Public Health Service, Food and Drug Administration requires: “...4-6 CLEANING OF EQUIPMENT AND UTENSILS...4-601.11 Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces, and Utensils. (A) EQUIPMENT FOOD-CONTACT SURFACES and UTENSILS shall be clean to sight and touch....(B) The FOOD-CONTACT SURFACES of cooking EQUIPMENT and pans shall be kept free of encrusted grease deposits and other soil accumulations. (C) Non FOOD-CONTACT SURFACES of EQUIPMENT shall be kept free of an accumulation of dust, dirt, FOOD residue, and other debris....” Observation on 07/22/2024 revealed the dish room was cluttered with carts stacked with trays of open food, discarded food, and dirty dishes and serving trays. The room was disorganized and staff were unable to walk freely around the area. Dirty items were stacked and stored adjacent to wheeled shelves and carts that contained “clean” equipment and kitchen items. There were also dirty items stacked on the countertops adjacent to the sinks and in the sinks themselves. Dirty items were stacked on either side of the dish machine. A large fan in the dishwashing area was noted to have a thick heavy layer of oily lint covering the wire metal cage around the fan blades. Employee #6 and 27 confirmed on 07/22/2024 that there was currently no staff present to clean the dishes and serving equipment, discard expired food, clean carts and trays, or generally clean the dish room. Employee #6 confirmed that an open energy drink was inappropriately stored on top of the counter in the dishwashing area. Observation on 07/23/2024 again revealed no staff present to clean dirty patient carts, trays, and serving equipment after the normal breakfast period had concluded. Employee #27 confirmed on 07/23/2024 that there is a high staff turnover and that this position is difficult to fill. 6. The facility policy titled “Nutritional Services-Storage of Dry Foods, last reviewed 7/21” requires: “...Dry storage room must be kept clean, orderly, well ventilated and temperature controlled...All staple food items are stored on shelves six inches above the floor...Broken lots of bulk foods will be stored in tightly covered metal or plastic containers. Small boxes of cereal, dry mixes and similar products are to be placed into plastic bags, tightly secured with tape, labeled and dated....” The United States Food and Drug Administration publication, Food Code: 2017 Recommendations of the United States Public Health Service, Food and Drug Administration requires: “...Preventing Contamination from the Premises...3-305.11 Food Storage. (A) Except as specified in (B) and (C) of this section, FOOD shall be protected from contamination by storing the FOOD: (1) In a clean, dry location; (2) Where it is not exposed to splash, dust, or other contamination; and (3) At least 15 cm (6 inches) above the floor...6-5 MAINTENANCE AND OPERATION Subpart 6-501 Premises, Structures, Attachments, and Fixtures...PHYSICAL FACILITIES shall be maintained in good repair. 6-501.12 Cleaning, Frequency and Restrictions. (A) PHYSICAL FACILITIES shall be cleaned as often as necessary to keep them clean....” Observation on 07/22/2024 revealed the dry food storage room in cluttered and unsanitary conditions. The tiled floor was coated with a black sticky grime throughout the storage area and the surveyor and hospital staff members shoes stuck to the floor when walking through the tiled area. There were dry grains and cereals, white granular substances, and dried liquid spills on the floor that had not been cleaned. The room contained multiple chrome plated, wire welded shelving units that contained open boxes of every type of food that facility stocked, there was no organization to the type of food stored on each shelf. Boxes were torn open, some food boxes lying flat or upside down, unmarked silver foil bags of dry foods were scattered around the shelving units, underneath open boxes, there were spilled and dried sauces and oils that had accumulated on other canned goods on the shelves below the leaking containers, a one gallon open bottle of barbecue and wing sauce stored at room temperature that required refrigeration on the label, outdated sesame oil, three open bottles of balsamic vinegar glaze with lids cracked open and exposed to air, open bottles of agave syrup without open dates, a container of panko crumbs with a dried red spill over the top, an open, poly lined corrugated box with 25 pounds of milk chocolate chips open to air, a poly lined bulk 25 lbs. of chocolate chips, a large poly lined, open corrugated box containing powdered sugar with brown, clumpy debris on top of the sugar inside the open box, an open, large plastic storage container of powdered sugar that was not covered with a lid, a large container of granulated sugar with an unsecured lid laid at an angle across the top, multiple other storage containers for cereals and grains with broken, cracked and unsecured lids on the tops. There were multiple open, corrugated boxes placed on the grimy tile floor that contained bulk and individually packaged foods, canned goods, sauces, and oils. Trays underneath individual storage shelves were littered with debris and dust. The document titled “Navajo County Food Establishment Inspection Report” dated 06/04/2024 revealed: “ ...There was an accumulation of debris in the small and large walk-in refrigerator/freezer in the kitchen area and in the dry storage area. The director stated all areas will be cleaned and sanitized ...Food Code Section: 6-201.11 ....” Employees #6 and 19 confirmed on 07/22/2024 that the dry food was not stored in a clean and sanitary storage room, nor was food stored a minimum of six inches off the floor. Additionally, Employee #6 confirmed that this is a continued finding as cited by the Navajo County inspector in June 2024. 7. The facility policy titled “Nutritional Services-Storage of Fresh Foods, last reviewed 7/21” requires: “...All food will be protected from contamination while being stored, prepared, and served. All food shall be maintained at safe temperatures (41° Fahrenheit(F) or below for cold food or 140° F or above for hot food)...Containers of food must be stored above the floor on clean racks or shelves in such a manner as to be protected against contamination...Prepared food in the refrigerator shall be covered, labeled, and protected against contamination form food requiring washing or cooking...Temperature checks will be made and recorded daily....” The United States Food and Drug Administration publication, Food Code: 2017 Recommendations of the United States Public Health Service, Food and Drug Administration requires: “...3-305.14...Food Preparation. During preparation, unPACKAGED FOOD shall be protected from environmental sources of contamination...Preventing Contamination from Other Sources 3-307.11 Miscellaneous Sources of Contamination. FOOD shall be protected from contamination that may result from a factor or source not specified under Subparts 3-301 - 3-306.....” Observation on 07/22/2024 revealed a sheet pan with a cooked pork loin and a cutting board adjacent to the sheet pan with sliced pork loin unattended in the kitchen. The cooked meat was on top of a metal table that had multiple dirty and non-food items stored on the table as well including a dirty, off-white non-slip covering on a lower shelf with storage containers and lids, on top of a non-slip covering scattered with loose debris and food splatter, as well as a broken wooden shelf and a cardboard box with dirty scissors and five spools of party ribbon in a clear plastic box inside the cardboard box. Observation on 07/22/2024 in the walk-in refrigerator revealed containers of unlabeled dressings/sauce, uncovered noodles, an open unlabeled and uncovered pitcher of juice or tea, unlabeled cut tomatoes, cartons of eggs in corrugated boxes on the refrigerator floor, and multiple open corrugated boxes of various cold storage food items. Employee #27 confirmed on 07/22/2024 that there were unlabeled, uncovered, and food items on the floor of the walk-in refrigerator. Employee #6 confirmed on 07/22/2024 that there was uncovered pork loin unattended on an area with dirty items in the kitchen. 8. The facility policy titled “Nutritional Services-Storage of Fresh Foods, last reviewed 7/21” requires: “...All food shall be maintained at safe temperatures (41° Fahrenheit(F) or below for cold food or 140° F or above for hot food)...Temperature checks will be made and recorded daily....” The facility policy titled “Nutritional Services-Storage and Temperature Checks, last reviewed 7/21” requires: “...Frequent checks of the temperatures of all refrigerators and freezers are to be taken and recorded on a log with any necessary comments reported to the Dietary Director who will then notify the Maintenance Department for any needed repairs...All Dietary personnel should monitor temperatures, and be on alert for improper functioning of a freezer or refrigerator. The Maintenance Department should be notified immediately of any problems....” The “Temperature for Refrigerator Storage” log requires: “...Normal Range: Refrigerator Not Greater than 41 degree F/Freezer Not Greater than 0 degree F...If temperature is out of range contact Dietary/Maintenance....” A review of “Temperature for Refrigerator Storage” logs dated May, June, and July 2024 revealed that neither the refrigerator temperatures or freezer temperatures were recorded daily for the following days for any of the refrigerators or freezers. May 2024 05/01/2024 05/02/2024 05/03/2024 05/04/2024 05/05/2024 05/06/2024 05/07/2024 June 2024 06/02/2024 06/03/2024 06/22/2024 06/23/2024 06/25/2024 06/28/2024 06/29/2024 06/30/2024 July 2024 07/06/2024 07/07/2024 07/20/2024 07/21/2024 Additionally, the logs revealed that there was no action taken for out of range readings on the following dates. May 2024 05/09/2024 MOB 43°F 05/11/2024 small walk in 42°F 05/13/2024 small walk in 43°F 05/17/2024 MOB 43°F 05/18/2024 small walk in 42°F 05/19/2024 assist refrigerator 46°F 05/19/2024 small walk in 46°F 05/20/2024 small walk in 42°F 05/23/2024 small walk in 44°F 05/23/2024 MOB 42°F 05/26/2024 small walk in 46°F 05/26/2024 MOB 43°F 05/27/2024 small walk in 43°F 05/28/2024 small walk in 42°F 05/29/2024 small walk in 45°F 05/29/2024 assist refrigerator 44° 05/30/2024 small walk in 42°F The small walk-in freezer was logged at above 0° F every day recorded in May 2024 without action. Temperatures ranged from 3°F to 13°F. June 2024 06/01/2024 MOB 43°F 06/01/2024 small walk in 46°F 06/04/2024 small walk in 45°F 06/05/2024 small walk in 42°F 06/06/2024 MOB 44°F 06/06/2024 small walk in 45°F 06/07/2024 small walk in 43°F 06/08/2024 small walk in 44°F 06/09/2024 small walk in 44°F 06/10/2024 small walk in 44°F 06/11/2024 MOB 42°F 06/13/2024 small walk in 45°F 06/14/2024 small walk in 46°F 06/15/2024 small walk in 45°F 06/16/2024 small walk in 45°F 06/18/2024 small walk in 42°F 06/19/2024 small walk in 45°F 06/20/2024 small walk in 45°F 06/21/2024 small walk in 42°F 06/26/2024 small walk in 43°F The small walk-in freezer was logged at above 0° F every day recorded in June 2024 without action. Temperatures ranged from 2°F to 10°F. July 2024 07/01/2024 small walk in 44°F 07/02/2024 small walk in 44°F 07/03/2024 small walk in 43°F 07/04/2024 small walk in 42°F 07/05/2024 small walk in 43°F 07/11/2024 small walk in 43°F 07/12/2024 small walk in 43°F 07/13/2024 small walk in 47°F 07/14/2024 small walk in 43°F 07/17/2024 small walk in 42°F 07/18/2024 small walk in 44°F 07/19/2024 small walk in 42°F 07/23/2024 small walk in 44°F The small walk-in freezer was logged at above 0° F every day recorded in July 2024 without action. Temperatures ranged from 2°F to 11°F. Employees #6 confirmed on 07/23/2024 that staff did not document refrigerator and freezer temperatures daily as required on the above listed days. Additionally, that staff did not take action as required when refrigerator and freezer temperatures were out of normal range. 9. The facility policy titled “Nutritional Services-Storage of Fresh Foods, last reviewed 7/21” requires: “...All food shall be maintained at safe temperatures (41° Fahrenheit(F) or below for cold food or 140° F or above for hot food)...Temperature checks will be made and recorded daily....” A review of the “Patient Line Food Temperature” logs for the last three months was requested. No temperature logs for patient food in May 2024 were provided. The patient line food temperature logs for June 2024 revealed the following missing and/or incomplete temperature readings. 06/01/2024-no food temperatures logged 06/02/2024 incomplete breakfast and lunch temperatures, no dinner food temperatures logged 06/03/20241-no dinner food temperatures logged 06/04/2024- incomplete dinner food temperatures logged 06/05/2024- incomplete dinner food temperatures logged 06/06/2024- incomplete dinner food temperatures logged 06/07/20241-no dinner food temperatures logged 06/11/2024-no food temperatures logged 06/12/2024-no food temperatures logged 06/13/2024-no food temperatures logged 06/14/2024-no breakfast food temperatures logged 06/15/2024-no food temperatures logged 06/18/2024-no breakfast food temperatures logged 06/19/2024-no food temperatures logged 06/20/2024-no food temperatures logged 06/21/2024-no breakfast food temperatures logged 06/22/2024-no food temperatures logged 06/23/2024- incomplete food temperatures logged 06/30/2024-no food temperatures logged The patient line food temperature logs for July 2024 revealed the following missing and/or incomplete temperature readings. 07/07/2024-no food temperatures logged 07/08/2024-no food temperatures logged 07/11/2024-incomplete dinner food temperatures and lunch vegetables served at 130°F which was 10°F lower that the required 140-165 07/17/2024-no breakfast food temperatures logged 07/21/2024-incomplete dinner food temperatures logged Employee #6 confirmed on 07/23/2024 that staff did not record patient food temperatures as required as listed above. 10. The United States Food and Drug Administration publication, Food Code: 2017 Recommendations of the United States Public Health Service, Food and Drug Administration requires: “...Chapter 2 Management and Personnel ...Responsibility 2-101.11 Assignment. (A) Except as specified in (B) of this section, the PERMIT HOLDER shall be the PERSON IN CHARGE or shall designate a PERSON IN CHARGE and shall ensure that a PERSON IN CHARGE is present at the FOOD ESTABLISHMENT during all hours of operation ...Knowledge...2-102.11 Demonstration ...Based on the RISKS inherent to the FOOD operation, during inspections and upon request the PERSON IN CHARGE shall demonstrate to the REGULATORY AUTHORITY knowledge of foodborne disease prevention, application of the HAZARD Analysis and CRITICAL CONTROL POINT principles, and the requirements of this Code ...The PERSON IN CHARGE shall demonstrate this knowledge by: (A) Complying with this Code by having no violations of PRIORITY ITEMS during the current inspection; (B) Being a certified FOOD protection manager who has shown proficiency of required information through passing a test that is part of an ACCREDITED PROGRAM; or (C) Responding correctly to the inspector’s questions as they relate to the specific FOOD operation ....” Employee #19 was unable to demonstrate sufficient knowledge of foodborne disease prevention as the person in charge of the kitchen and dietary services during an interview on 07/22/2024, nor did Employee #19’s personnel file contain documentation that s/he had been certified as a food protection manager through an accredited program. Employees #31, 32, and 33’s personnel files did not contain evidence of training to satisfy the requirements of a person in charge that possessed the skills and knowledge required in the FDA Food Code 2017 to provide food services to patients. Employee #42 confirmed in an interview on 07/23/2024 that Employee #19’s personnel record was provided in its entirety and the record does not contain a signed job description or Manager Certification outlining Employee #19’s role as Director of Nutrition Services. Additionally, that Employees #31, 32, and 33’s personnel file did not contain evidence that the appropriate training, and skills and knowledge to provide food services.”

“DIRECTOR OF DIETARY SERVICES CFR(s): 482.28(a)(1) The hospital must have a full-time employee who- (i) Serves as director of the food and dietetic services; (ii) Is responsible for daily management of the dietary services; and (iii) Is qualified by experience or training. This Standard is not met as evidenced by: 45706 Based on the review of hospital documents and staff interviews, it was determined the Hospital failed to ensure personnel records contained evidence that the Director of Nutritional Services was qualified to provide services at the facility. This deficient practice poses a potential risk to the overall health and safety of patients at the facility if personnel members do not have the qualifications or skills necessary to provide patient care services. Cross reference A-0043 Cross reference A-0618 Findings include: Job Description titled, “Director of Plant Operations”, revealed: “...The following information is designed to outline the functions and position requirements of this job. It does not identify all tasks that may be expected, nor address the performance standards that must be maintained...Responsible for the overall operation of the Plant Services Department. This responsibility includes building and equipment maintenance, design and construction activities, central plant operations and grounds maintenance for the entire hospital complex, including satellite facilities and clinics. Leads, directs and manages all facility maintenance activities to include staffing, equipment processes and operating procedures in a reliable manner to minimize system failures and provide a safe, effective environment of care. This position enforces personnel policies and procedures and manages annual departmental operating budgets. Has a thorough understanding of regulatory and safety standards ...Essential Functions / Major Responsibilities: Plans, directs, and controls activities for the overall operation and maintenance of Summit Healthcare’s campus and facilities. Provides continuous assessment of construction, engineering, and maintenance operations scope, schedule and budget. Develops and directs the proper preventative and corrective maintenance of all building structures, electrical, mechanical and emergency systems. Analyzes cost and work schedules, set priorities and expedites operations and/or repairs for all projects. Establishes and maintains short and long term operating and maintenance objectives that support the hospital’s mission and business plan for the campus, including renovation, construction, engineering and space planning, Develops appropriate policies and procedures. Ensures that approved departmental policies, procedures and objectives are clearly understood and effectively applied within the department. Ensures that the organizational structure of the department is efficiently planned and adequately and competently staffed. Provides for direct supervision of Plant Services staff in the performance of assigned duties. Assures appropriate training of all department personnel. Conducts performance appraisals, verifies attendance and handles disciplinary actions of the Plant Services department staff. Recommends compensation changes and/or promotions for department personnel in accordance with hospital policy. Reviews and evaluates the results of departmental activities and takes appropriate actions as necessary. Prepares and adheres to an annual budget for the Plant Services department. Assures that an accurate inventory of all fixed and portable equipment comprising the Utility Management program(s), including service schedules and maintenance history, is maintained. Orders materials, equipment, parts, and supplies as needed. Attends construction meetings and communicates project updates with other departments. Serves on other hospital committees related to facility operations, as necessary. Responsible for developing and updating plans related to fire safety and utilities management. Administers and monitors vendor service contracts to ensure work is properly performed in a timely manner in accordance with the agreement(s). Assures compliance with all local, state and federal laws/regulations as they relate to healthcare facilities operation and management. Coordinates building code compliance and corrections. Ensures approval of governmental, regulatory and accrediting agencies. Follows all safety rules while on the job. Reports accidents promptly and corrects minor safety hazards....” Summit Healthcare Organizational Chart dated 07/10/2024 revealed Plant Manager, EVS, Security, Nutritional Services, BioMed, and Emergency Management were all listed under the role for Senior Director of Facilities. Employee #19’s personnel record revealed they are employed as a Director of Plant Operations with a hire date of 01/14/2019. A request for a signed job description outlining Employee #19’s role as Director of Nutritional Services was requested on 07/23/2024. None was provided. Employees #6 and 19 confirmed in an interview on 07/22/2024 that Employee #19 has been assigned to Director of Nutritional Services for approximately 3 months. Interview with Navajo County Public Health Services on 07/30/2024 revealed that the facility has an Establishment Permit to Operate that expires 01/31/2025 and must adhere to Navajo County Ordinances relating to Manager Certification. Navajo County Ordinance Reg. 1-5-102 states: “... Reg. l-5-102 Manager Certification a) All food establishments that store, prepare, package, serve, vend, or otherwise provide time/temperature control for safety food or food for human consumption must employ at least one (1) certified manager that is present and available during operational hours. b) The person in charge on-site must be a certified manager. c) A food establishment with fewer than ten (10) employees may satisfy Health Code Reg. l-5- 102(a) by having a written Department-approved food safety plan in place and provided that a separate certified manager for each food establishment is available for a minimum of eight (8) hours each day that the food establishment is in operation or open for business. d) Manager Certification must be current and valid....” The United States Food and Drug Administration publication, Food Code: 2017 Recommendations of the United States Public Health Service, Food and Drug Administration requires: “...Chapter 2 Management and Personnel ...Responsibility 2-101.11 Assignment. (A) Except as specified in (B) of this section, the PERMIT HOLDER shall be the PERSON IN CHARGE or shall designate a PERSON IN CHARGE and shall ensure that a PERSON IN CHARGE is present at the FOOD ESTABLISHMENT during all hours of operation ...Knowledge...2-102.11 Demonstration ...Based on the RISKS inherent to the FOOD operation, during inspections and upon request the PERSON IN CHARGE shall demonstrate to the REGULATORY AUTHORITY knowledge of foodborne disease prevention, application of the HAZARD Analysis and CRITICAL CONTROL POINT principles, and the requirements of this Code ...The PERSON IN CHARGE shall demonstrate this knowledge by: (A) Complying with this Code by having no violations of PRIORITY ITEMS during the current inspection; (B) Being a certified FOOD protection manager who has shown proficiency of required information through passing a test that is part of an ACCREDITED PROGRAM; or (C) Responding correctly to the inspector’s questions as they relate to the specific FOOD operation ....” Employee #19 was unable to demonstrate sufficient knowledge of foodborne disease prevention as the person in charge of the kitchen and dietary services during an interview on 07/22/2024, nor did Employee #19’s personnel file contain documentation that s/he had been certified as a food protection manager through an accredited program. Employee #42 confirmed in an interview on 07/23/2024 that Employee #19’s personnel record was provided in its entirety and the record does not contain a signed job description or Manager Certification outlining Employee #19’s role as Director of Nutrition Services.”

“COMPETENT DIETARY STAFF CFR(s): 482.28(a)(3) There must be administrative and technical personnel competent in their respective duties. This Standard is not met as evidenced by: 45706 Based on the review of hospital documents and staff interviews, it was determined the Hospital failed to ensure personnel records contained evidence that staff in the hospital cafeteria were qualified to provide services at the facility. This deficient practice poses a potential risk to the overall health and safety of patients at the facility if personnel members do not have the qualifications or skills necessary to provide patient care services. Cross reference A-0043 Cross reference A-0618 Findings include: Job Description titled, “Nutritional Services-Cook”, revealed: “...Responsible for preparing and serving large quantities of food for hospital patients, staff, and visitors, in accordance with county and state guidelines. Responsible for presentation of food and cleanup of equipment and area...Education and/or Experience: High School Diploma or equivalent (required). One year quantity cooking experience (required). Completion of approved sanitation or food handling course or evidence of similar training (preferred).... Job Description titled, “Nutritional Services-Food Service Worker”, revealed: “...Responsible for serving large quantities of food for hospital patients, staff, and visitors, in accordance to county and state guidelines. This position is also responsible for presentation of food and cleanup of equipment and area...Education and/or Experience: High School Diploma or Equivalent (required). One year related experience (preferred). Completion of approved sanitation or food handling course or evidence of similar training (preferred)....” Employee #31’s personnel record revealed s/he is employed by the facility as a cook with date of hire 06/05/2024. A request to review Employee #31’s evidence of a food handling course/certification and education were requested on 07/23/2024. Neither documents were available or provided. Employee #32’s personnel record revealed s/he is employed by the facility as a cook with date of hire 01/01/2023. A request to review Employee #32’s evidence of a food handling course/certification and education were requested on 07/23/2024. Neither documents were available or provided. Employee #33s personnel record revealed s/he is employed by the facility as a Food Services Worker with date of hire 05/31/2024. A request to review Employee #33’s evidence of a food handling course/certification and education were requested on 07/23/2024. Neither documents were available or provided. Document titled, “Navajo County Public Health Services Food Establishment Inspection Report” dated 06/04/2024 revealed: “...Observations and Corrective Actions: Not all employees have food handler cards. New management is in the process of obtaining all food handler cards. All food handlers shall obtain a food handler card within 30 days of employment....” Interview with Navajo County Public Health Services on 07/30/2024 revealed that the facility has an Establishment Permit to Operate that expires 01/31/2025 and must adhere to Navajo County Ordinances relating to Food Handlers Cards/Certification. Navajo County Ordinance Reg. 1-5-101.b states: “...A food worker certificate must be obtained by each food worker at a food establishment within thirty (30) days after the start of employment....” Employee #42 confirmed in an interview on 07/23/2024 that Employees #31, 32, and 33 did not have evidence of education and a food handlers card/certification in their personnel files.”

“THERAPEUTIC DIET MANUAL CFR(s): 482.28(b)(3) A current therapeutic diet manual approved by the dietitian and medical staff must be readily available to all medical, nursing, and food service personnel. This Standard is not met as evidenced by: 48110 Based on record review and staff interview, it was determined the hospital failed to ensure the current diet manual available to personnel members and medical staff was approved by a registered dietitian. This deficient practice poses a risk to the health and safety of patients if the unapproved diet manual utilized by hospital staff does not meet the nutrition needs of the patients. Cross reference A-0043 Cross reference A-0618 Findings include: Hospital current diet manual was requested on 07/22/2024, and Hospital document titled, “For access to the Nutrition care Manual of the Academy of Nutrition & Dietetics” was presented. Hospital document titled, “For access to the Nutrition care Manual of the Academy of Nutrition & Dietetics”, revealed log in information for clinical staff to access a web-based diet manual. The document revealed no documentation that it was approved by the Hospital registered dietitian. Employee #15 confirmed during an interview conducted on 07/24/2024 that the web-based diet manual had not been approved by the Hospital registered dietitian.”

“APPLICABILITY CFR(s): 482.30(a) Standard: Applicability. The provisions of this section apply except in either of the following circumstances: (1) A Utilization and Quality Control Quality Improvement Organization (QIO) has assumed binding review for the hospital. (2) CMS has determined that the UR procedures established by the State under title XIX of the Act are superior to the procedures required in this section, and has required hospitals in that State to meet the UR plan requirements under §§456.50 through 456.245 of this chapter. This Standard is not met as evidenced by: 48110 Based on record reviews and staff interviews, it was determined the hospital failed to ensure: 1. Current utilization review plan was reviewed and approved by the governing body. 2. The utilization review committee met quarterly per the hospital plan. This deficient practice poses the risk of governing body not knowing the hospital current practices, and cannot evaluate the services and treatments provided to patients. Cross reference A-0043 Findings include: Request for the Hospital utilization review plan was made on 07/22/2024. Hospital document titled, “Utilization Management Plan 2024” was presented. Review of Hospital document titled, “Utilization Management Plan 2024” revealed spaces for the signatures of chairmen of the Utilization Management Committee, Quality Improvement Council, and Medical Executive Committee, and the dates of their acceptance and approval were blank. Documentation that the above committees and Hospital’s governing body approved the 2024 Utilization Management Plan was requested. Hospital document titled, “Governing Board Meeting Minutes” dated 02/25/2021 was presented. Review of Hospital document titled, “Governing Board Meeting Minutes” dated 02/25/2021 revealed 2021 Utilization Management Plan was approved. Hospital document titled, “Utilization Management Plan 2021”, revealed: “ ...C. Meetings: The UR Committee will meet, at a minimum, quarterly. More frequent meetings shall be held when needed to complete agenda business in a timely manner ....UM PLAN APPROVAL ...The Utilization Management Plan shall be reviewed annually by the Utilization Management Committee and revised as necessary. The Quality Improvement Council, Medical Executive Committee of the Medical Staff, Chief Executive Officer, and Board of Trustees of the Hospital will approve any revision ....” The utilization management committee meeting minutes for the last 12 months were requested. The meeting minutes on 02/24/2023 and 10/19/2023 were presented. Employee #36 confirmed during an interview conducted on 07/25/2024 that the utilization review plan is to be reviewed and approved by the governing body annually. Employee #36 also confirmed the 2024 utilization review plan was not approved by the governing body, and the last approved plan was in February 2021. Employee #36 further confirmed the utilization management committee had not been meeting quarterly per their plan.”

“MAINTENANCE OF PHYSICAL PLANT CFR(s): 482.41(a) The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients are assured. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure: 1.. medications in the infusion center were secured to prevent unauthorized access; and 2. medications in interventional radiology were secured to prevent unauthorized access. Failure to secure or otherwise lock medications in areas that unauthorized individuals may gain access to these medications poses a potential risk of harm to patients as medications may be tampered with and/or misappropriated. Cross reference A-0043 Findings include: 1. and 2. The facility policy titled “Authorized Access to Medications” requires: “...Purpose...To define categories of personnel who have authorized access to secure medication storage areas...Definitions...Secure Area...1: A secure area means that drugs and biologicals are stored in a manner to prevent unmonitored access by unauthorized individuals. Drugs and biologicals must not be stored in areas that are readily accessible to unauthorized persons. Areas where patients and visitors are not allowed without the supervision or presence of a health care professional are considered secure. Areas restricted to authorized personnel only are generally considered “secure areas”...Policy...1. Medications and biologicals are stored in a secure environment. a. Controlled substances are locked. b. Both controlled substances and non-controlled medication are locked when a patient care area is not staffed. 2. Medications may be stored in the Pharmacy, Medication Room on Unit, Omnicell, and/or a locking bin within a patient ’ s room. a. Only multiuse medications (ex. inhaler, cream/ointment, insulin, ear drops, eye drops) may be stored in a locking bin within a patient ’ s room. 3. Only authorized personnel have access to secure areas where medications and biologicals are stored....” 1. Observation on 007/22/2024 revealed an alcove type “room” adjacent to the IV infusion treatment area that was fitted with cabinets, a single countertop, medication bins, and a medication refrigerator that contained medications. The room did not have a door, cabinets containing medications had locks but were not locked, the medication refrigerator had a lock but was not locked, and there were open bins of medications. Staff were not observed in the area at initial observation of this area. Employee #6 stated that the medications were not locked and secured to prevent unauthorized access during the observation. 2. Observation on 07/22/2024 revealed a small clear plastic box labeled “reversal meds” in an unlocked cabinet in the patient beds/bay area in interventional radiology. The box contained vials of Ondansetron, Promethazine, Flumazenil, Benadryl, Solumedrol. The medications stored in the unlocked cabinet also contained patient treatment supplies, patient food items including peanut butter and canned beverages, bandages, IV bags of saline, monitor wires, office supplies, and disposable plates and utensils. Employee #6 stated that the medications were not locked and secured to prevent unauthorized access during the observation.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure a separation of clean and dirty, and patient supply items not mixed with staff and patient food items. Failure to ensure staff maintain a clean and sanitary environment poses a potential risk that items used in providing patient care may be contaminated and spread infection. Cross reference A-0043, A-0057, A-0747 Findings include: The facility policy titled “Infection Prevention and Control Program” requires: “...The purpose of this policy is to identify and describe safe work practices to prevent the spread of infection and to maintain a safe and clean work place...System-Wide Practices...Standard Precautions will be used by all employees...All staff will observe proper hand hygiene...All staff receive education regarding the infection control program at time of hire and annually thereafter....” A facility policy on the separation of clean and dirty and patient care items and food was requested. None was provided. Observation on 07/22/2024 in the interventional radiology department revealed a countertop shelf with patient care supplies and food/cooking equipment on top, and below the shelf two dormitory style refrigerators, one for staff and another for patients. The top of the counter had the following items placed side by side and touching. hand sanitizer sharps container loose 2x2 gauze alcohol prep pads i-Stat Crea cartridges i-Stat machine 10 mL prefilled saline flush syringes tray with IV start kits and lab tubes two open boxes of gloves a bottle of hand lotion two canisters of disinfectant wipes a cup with pens, pencils, scissors, and various office supplies a power strip connecting the microwave and two refrigerators a microwave with an open box of nitrile exam gloves on top a salt shaker, pepper grinder, bottle of Nescafe instant coffee, and a coffee mug The refrigerator below the counter that was labeled “For Employees” revealed the following patient food, staff food, and patient supplies. Freezer compartment: Medication freezer packs two lean cuisine meals two boxed juice beverages Hunts snack pack pudding cup Top shelf: Four “juice box” type beverages that were out of date and expired 07/18/2024 an open bottle of liquid coffee creamer a squeeze tube of sour cream three boxes i-State Crea cartridges Lower shelf: two insulated lunch bags a bottle of liquid coffee creamer Door compartment: a capri sun juice drink a bottle of chocolate milk, bottle of Nesquik chocolate milk, a protein shake, a Vanilla Starbucks iced coffee, a jar of salsa, a bottle of taco sauce, two bottles of diet coke, two jars of peanut butter The second refrigerator labeled “for Patients” contained additional drinks, juice, soda and food items. Employee #6 confirmed on 07/22/2024 that both refrigerators contained patient food items, mixed with staff personal food items and patient care supplies. Additionally, s/he confirmed that staff did not separate the clean from dirty supplies, equipment, a staff microwave and food items on the shelf in the radiology department as required.”

“IC PROFESSIONAL TRAINING CFR(s): [The infection preventionist(s)/infection control professional(s) is responsible for:] (iv) Competency-based training and education of hospital personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the hospital, on the practical applications of infection prevention and control guidelines, policies, and procedures. This Standard is not met as evidenced by: 45706 Based on review of policy and procedures, personnel records and interviews, it was determined the Hospital failed to ensure documentation of annual infection control and prevention education were provided for personnel members. This deficient practice poses a risk to health and safety of patients if personnel members are not trained on hygiene standards and infection prevention. Cross reference A-0043, A0057, A0747 Findings include: Policy titled, “Infection Prevention and Control Program”, revealed: “...The Infection Prevention Specialist, in conjunction with the Infection Prevention Committee, is responsible for the following: Professional Development specialists to provide new employee and mandatory staff education of Infection Prevention practices....” Review of Employee #28’s personnel record revealed s/he is employed by the facility as a Seasonal Registered Nurse (direct employee of the hospital) with a signed job description dated 10/05/2023. Further review of the personnel record revealed Employee #28’s most recent training on Infection Control and/or hand hygiene was dated 04/12/2021. Employee #28 confirmed in an interview on 07/23/2024 s/he has been working seasonally at the facility for the past eight weeks. Employee #42 confirmed in an interview on 07/24/2024 that all employees, seasonal or full-time, are required to have annual Rapid Regulatory Training completed. Further interview revealed Rapid Regulatory training is offered in HealthStream (the online training platform). Rapid Regulatory training is a module consisting of all the annual training required by the facility. Some examples include: EMTALA, HIPAA, Infection Control, Bloodborne Pathogens, and Emergency Preparedness. Employee #42 confirmed in an interview on 07/24/2024 that Employee #42 does not have annual Infection Control Training as required by the facility.”

“IC PROFESSIONAL ADHERENCE TO POLICIES CFR(s): [The infection preventionist(s)/infection control professional(s) is responsible for:] (v) The prevention and control of HAIs, including auditing of adherence to infection prevention and control policies and procedures by hospital personnel. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure Employee #28 performed hand hygiene prior to preparing medications for administration, before and after gloving and patient contact, and before retrieving clean patient supplies from a supply cart. Failure to follow standard precautions in infection control, hand hygiene, and gloving practices poses an increased risk of infection to patients through cross contamination and contact transmission of pathogenic organisms. Cross reference A-0043, A0747 Findings include: The facility policy titled “Hand Hygiene” requires: “...Hand washing is generally considered the single most important procedure in preventing nosocomial infections. Therefore, effective and frequent hand hygiene is necessary to prevent the transmission of infectious agents...There are two types of hand washing: a. Hand washing with plain soap and running water...Alcohol hand rub...Conditions requiring hand washing include (but are not limited to): ...Before handing or preparing medications...Before contact with clean medical equipment, supplies, and linens...Before and after every patient contact...Before donning gloves...After donning gloves....” Observation on 07/23/2024 revealed Employee #28 providing patient care. Employee #28 was observed preparing medications for administration while in the medication room. S/he did not perform hand hygiene prior to mixing medications for IV administration. Medication was drawn from a vial and added to an IV solution bag. Employee #28 also touched the side of the needle that was later inserted in the IV solution bag with bare hands. Employee #28 entered a patient’s room to administer the prepared medications. Employee #28 washed his/her hands upon entering the room; however, touched the patient, scanned the patient’s arm band, touched the computer and keyboard without practicing hand hygiene between tasks. Employee #28 donned gloves without additional hand sanitizing, gathered the prepared medications and placed them on the patient’s bedside table. Employee #28 noted that the patient’s arm was bleeding and walked over to a supply cart in the patient’s room to retrieve supplies. Employee #28 took off his/her right-hand glove, unlocked the supply cart with the ungloved hand, gathered the supplies, shut the drawer, then used the gloved left hand to retrieve a new clean glove from the PPE supply and donned a fresh new right glove with the dirty hand without performing hand hygiene or adhering to standard precautions. Employee #6 confirmed on 0/23/2024 that Employee #28 did not adhere to hand hygiene policy and standard infection prevention practices.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 48110 Based on record reviews, observations, and staff interviews, it was determined the hospital failed to ensure sterile single use items were disposed after surgical procedures. This deficient practice poses a risk to the health and safety of patients if single use items are contaminated and/or reused, and increases the risk of infection and complications after surgery. Cross reference A-0043, A0747 Findings include: Hospital policy titled, “Surgical Services Environmental Sanitation”, revealed: “ ...Procedure: ...3. All items that come in contact with the patient and/or sterile field are considered contaminated ....f. Disposable anesthesia circuits, masks, and endotracheal tubes are discarded after use ....” Observations on tour of labor and delivery unit on 07/22/2024 revealed two operating rooms, OR A and OR B. Both operating rooms had surgeries in the morning, and had been cleaned. Observations of OR A revealed an opened Flexicare ProVu Single Use Video Laryngoscope Handle. Observations of OR B revealed two opened Covidien Shiley Hi-Lo Oral/Nasal Tracheal Tube Cuffed. The tracheal tubes had the label “Single use” and “Do not use if package is opened or damaged” on the packaging. Employee #5 confirmed during an interview conducted on 07/22/2024 that sterile single use items are not to be reused. Employee #5 also confirmed the opened single use items in the clean operating rooms should had been disposed.”

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the hospital failed to ensure comprehensive policies were established, documented and implemented to address recipient hospital responsibilities, “code purple” events, and failed to document ED provider to ED provider communication for potential transfers and/or transfer requests. This deficient practice has the potential risk of harm to patients if appropriate EMTALA policies are not developed and implemented as well as appropriate tracking and oversight of ED activities by administrative leadership. Cross reference A-0043, A-0057 Findings include: 1. The policy titled “Emergency Medical Treatment And Labor Act (EMTALA), last review date 2/2021, last revised date 11/2017” revealed: “...Effect an appropriate transfer for a patient who has a medical condition that exceeds the capability and capacity of the facility. This is to include appropriate medical treatment, within the capability and capacity of the facility, to minimize risk to the individual, arranging for and coordinating the patient transfer by means most appropriate for the patient ’ s clinical condition and providing pertinent medical records to the receiving facility so that appropriate care is not delayed...Patient Transfers...In the event the patient’s clinical condition exceeds both the capability and capacity of the facility, or the patient or designee requests, and appropriate transfer may be effected if the attending emergency room physician determines that the medical benefits exceed the associated risks....” The policy titled “Emergency Medical Treatment And Labor Act (EMTALA), last review date 2/2021, last revised date 11/2017” did not address “Recipient Hospital Responsibilities.” A policy that addressed “Recipient Hospital Responsibilities” was requested; however, none was provided. Employees #5, 6, and 22 confirmed that the hospital EMTALA policy only addressed transfer out of their facility and did not address potential transfers in, nor did it or other facility policies address the hospital’s recipient responsibilities. 2. The policy titled “Emergency Medical Treatment And Labor Act (EMTALA), last review date 2/2021, last revised date 11/2017” revealed: “...Central Log...The hospital will maintain a log of all patient who have presented to the hospital and requested emergent medial services....The purpose of the central log is to track the care provided to each potential patient who comes to the hospital seeking care for an emergent medical condition....” A request for documentation of the facility’s ED provider to ED provider calls was requested but not provided. Employee #22 confirmed on 07/22/2024 that the facility does not track ED provider to ED provider calls with requests to transfer a patient from other hospital ED’s to Hospital #1’s ED for emergency medical treatment. 3. The policy titled “Code Purple” requires: “...Purpose: To define and provide an alert response when the activity on a patient care area or critical change in patient condition results in a situation that exceeds the unit’s capability to provide appropriate patient care...Policy: A Code Purple alert is utilized in the event of a sudden influx of patient activity or change in patient condition that requires additional clinical staff to respond to a patient care area. The Code Purple alert indicates the need to mobilize additional staff to a patient care area to provide short term patient care and assistance to stabilize the patient care environment. This alert does not replace the Capacity Alert Plan, Disaster Plan, Rapid Response Team alert or Code Blue alert...Guidelines: 1. When a rapid change in patient activity or condition exceeds the capability for a patient care unit to safely provide patient care, the Nurse Clinical Leader (NCL) will notify the Administrative Shift coordinator (ASC) of the potential need to activate a “Code Purple”...2. The Administrative Shift Coordinator (ASC) will report immediately to the alerted area and rapidly assess the situation with the NCL. If readily available, additional staff from other resources are allocated to the unit. If it is determined that these resources are not enough to safely meet patient needs, the ASC announces “Code Purple __________(department names)” alert overhead. If the ASC cannot physically respond to the unit, the above is implemented by phone...3. In the event of a “Code Purple” alert, each nursing department will designate a Registered Nurse (RN) to respond to the alert area. The ASC will collaborate with the NCL on the unit in crisis regarding need for additional clinical support staff (ie. Physician, pharmacist, respiratory therapist, social worker, radiology technician, laboratory technician)...4. The NCL on the patient care area in crisis will direct the responders regarding patient care duties according to level of competency...5. In the event the responders are unable to utilize the crisis unit’s electronic medical records, paper progress notes are utilized to document patient care...6. The ASC will coordinate movement of patients out of the unit in crisis to other clinical areas as available. Example: move admitted patients out of the Emergency Department (ED) to allow staff to adequately care for higher acuity patients and ease overcrowded waiting room...7. In the event the “Code Purple” alert response is inadequate to stabilize the patient care environment within thirty to sixty minutes, the ASC and NCL will call staff to report from home...8. Enter “Code Purple” alert in incident reporting system...9. All “Code Purple” alerts are reviewed by Nursing Unit Directors to assess responses, appropriateness and recommend future improvement opportunities as deemed necessary....” Monthly ED staffing schedules dated April, May, June, and July 2024 revealed minimal hand-written notes documenting the following “Code Purple” events on daily schedules as follows: “...Tuesday April 9, 2024...code purple...1400 (sic) (no stop time noted)... Monday April 22, 2024...Code purple...1800-2330... Friday May 3, 2024...Code Purple...1330...end 1730... Saturday May 11, 2024...Code Purple...12-1500 (sic)... Friday May 17, 2024...Code purple...1955-0100... Monday May 20, 2024...Code purple...1800-0030... Wednesday May 22, 2024...code purple...2320-0600... Wednesday May 29, 2024...Code purple...2115-0100... Friday May 31, 2024...Code purple...1800-0100... Tuesday June 4, 2024...Code Purple...0945-1400... Saturday June 8, 2024...code purple (start and stop times/notes illegible and unable to determine)... Wednesday June 12, 2024...code purple...before 1800-about 0000 (sic)... Saturday June 15, 2024...Code purple...0325- (sic) (no stop time noted)... Monday July 1, 2024...code purple...till 0100ish (sic) (no start time noted)... Monday July 8, 2024...Code Purple...1400-1800++ (sic)... Tuesday July 9, 2024...code purple...1100-0600... Saturday July 13, 2024...code purple (no start or stop times noted) Friday July 19, 2024...CODE purple...11-1500 (sic)....” Each of the above listed code purple events documented on the ED staffing schedules did not contain documented evidence that the facility followed their “Code Purple” policy for nursing leadership notifications, determinations of additional resources and nursing staff allocated to respond to the ED to meet patient needs, movement of admitted patients out of the ED to inpatient areas if possible, any staff called in to help stabilize the patient care environment, documentation of the event in the facility incident reporting system, and documentation of oversight by leadership and an assessment of the response and appropriateness of interventions for the code purple events that occurred. Documentation of evidence that the facility followed their “Code Purple” policy for nursing leadership notifications, determinations of additional resources and nursing staff allocated to respond to the ED to meet patient needs, movement of admitted patients out of the ED to inpatient areas if possible, any staff called in to help stabilize the patient care environment, documentation of the event in the facility incident reporting system, and documentation of oversight by leadership and an assessment of the response and appropriateness of interventions for the code purple events that occurred was requested. Employees #6 and 22 confirmed 07/23/2024 on that the ED did not follow the facility policy “Code Purple” for reporting events of an increase in patient activity in the ED or changes in patient conditions that would require additional staff and/or resources to safely provide care in the ED. Employees #22 confirmed on 07/23/2024 that Patient #21 was not accepted as an ED to ED transfer due to the ED being in “Code Purple” status on 06/12/2024 and that s/he is unaware of how often this may happen as the ED does not track ED provider to ED provider calls and keep detailed documentation of “Code Purple” events as required by facility policy.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the facility failed to ensure comprehensive policies were established, documented and implemented to address recipient hospital responsibilities, “code purple” events, and failed to document ED provider to ED provider communication for potential transfers and/or transfer requests. This deficient practice has the potential risk of harm to patients if appropriate EMTALA policies are not developed and implemented as well as appropriate tracking and oversight of ED activities by administrative leadership. Findings include: 1. The policy titled “Emergency Medical Treatment And Labor Act (EMTALA), last review date 2/2021, last revised date 11/2017” revealed: “...Effect an appropriate transfer for a patient who has a medical condition that exceeds the capability and capacity of the facility. This is to include appropriate medical treatment, within the capability and capacity of the facility, to minimize risk to the individual, arranging for and coordinating the patient transfer by means most appropriate for the patient ’ s clinical condition and providing pertinent medical records to the receiving facility so that appropriate care is not delayed...Patient Transfers...In the event the patient’s clinical condition exceeds both the capability and capacity of the facility, or the patient or designee requests, and appropriate transfer may be effected if the attending emergency room physician determines that the medical benefits exceed the associated risks....” The policy titled “Emergency Medical Treatment And Labor Act (EMTALA), last review date 2/2021, last revised date 11/2017” did not address “Recipient Hospital Responsibilities.” A policy that addressed “Recipient Hospital Responsibilities” was requested; however, none was provided. Employees #5, 6, and 22 confirmed that the hospital EMTALA policy only addressed transfer out of their facility and did not address potential transfers in, nor did it or other facility policies address the hospital’s recipient responsibilities. 2. The policy titled “Emergency Medical Treatment And Labor Act (EMTALA), last review date 2/2021, last revised date 11/2017” revealed: “...Central Log...The hospital will maintain a log of all patient who have presented to the hospital and requested emergent medial services....The purpose of the central log is to track the care provided to each potential patient who comes to the hospital seeking care for an emergent medical condition....” A request for documentation of the facility’s ED provider to ED provider calls was requested but not provided. Employee #22 confirmed on 07/22/2024 that the facility does not track ED provider to ED provider calls with requests to transfer a patient from other hospital ED’s to Hospital #1’s ED for emergency medical treatment. 3. The policy titled “Code Purple” requires: “...Purpose: To define and provide an alert response when the activity on a patient care area or critical change in patient condition results in a situation that exceeds the unit’s capability to provide appropriate patient care...Policy: A Code Purple alert is utilized in the event of a sudden influx of patient activity or change in patient condition that requires additional clinical staff to respond to a patient care area. The Code Purple alert indicates the need to mobilize additional staff to a patient care area to provide short term patient care and assistance to stabilize the patient care environment. This alert does not replace the Capacity Alert Plan, Disaster Plan, Rapid Response Team alert or Code Blue alert...Guidelines: 1. When a rapid change in patient activity or condition exceeds the capability for a patient care unit to safely provide patient care, the Nurse Clinical Leader (NCL) will notify the Administrative Shift coordinator (ASC) of the potential need to activate a “Code Purple”...2. The Administrative Shift Coordinator (ASC) will report immediately to the alerted area and rapidly assess the situation with the NCL. If readily available, additional staff from other resources are allocated to the unit. If it is determined that these resources are not enough to safely meet patient needs, the ASC announces “Code Purple __________(department names)” alert overhead. If the ASC cannot physically respond to the unit, the above is implemented by phone...3. In the event of a “Code Purple” alert, each nursing department will designate a Registered Nurse (RN) to respond to the alert area. The ASC will collaborate with the NCL on the unit in crisis regarding need for additional clinical support staff (ie. Physician, pharmacist, respiratory therapist, social worker, radiology technician, laboratory technician)...4. The NCL on the patient care area in crisis will direct the responders regarding patient care duties according to level of competency...5. In the event the responders are unable to utilize the crisis unit’s electronic medical records, paper progress notes are utilized to document patient care...6. The ASC will coordinate movement of patients out of the unit in crisis to other clinical areas as available. Example: move admitted patients out of the Emergency Department (ED) to allow staff to adequately care for higher acuity patients and ease overcrowded waiting room...7. In the event the “Code Purple” alert response is inadequate to stabilize the patient care environment within thirty to sixty minutes, the ASC and NCL will call staff to report from home...8. Enter “Code Purple” alert in incident reporting system...9. All “Code Purple” alerts are reviewed by Nursing Unit Directors to assess responses, appropriateness and recommend future improvement opportunities as deemed necessary....” Monthly ED staffing schedules dated April, May, June, and July 2024 revealed minimal hand-written notes documenting the following “Code Purple” events on daily schedules as follows: “...Tuesday April 9, 2024...code purple...1400 (sic) (no stop time noted)... Monday April 22, 2024...Code purple...1800-2330... Friday May 3, 2024...Code Purple...1330...end 1730... Saturday May 11, 2024...Code Purple...12-1500 (sic)... Friday May 17, 2024...Code purple...1955-0100... Monday May 20, 2024...Code purple...1800-0030... Wednesday May 22, 2024...code purple...2320-0600... Wednesday May 29, 2024...Code purple...2115-0100... Friday May 31, 2024...Code purple...1800-0100... Tuesday June 4, 2024...Code Purple...0945-1400... Saturday June 8, 2024...code purple (start and stop times/notes illegible and unable to determine)... Wednesday June 12, 2024...code purple...before 1800-about 0000 (sic)... Saturday June 15, 2024...Code purple...0325- (sic) (no stop time noted)... Monday July 1, 2024...code purple...till 0100ish (sic) (no start time noted)... Monday July 8, 2024...Code Purple...1400-1800++ (sic)... Tuesday July 9, 2024...code purple...1100-0600... Saturday July 13, 2024...code purple (no start or stop times noted) Friday July 19, 2024...CODE purple...11-1500 (sic)....” Each of the above listed code purple events documented on the ED staffing schedules did not contain documented evidence that the facility followed their “Code Purple” policy for nursing leadership notifications, determinations of additional resources and nursing staff allocated to respond to the ED to meet patient needs, movement of admitted patients out of the ED to inpatient areas if possible, any staff called in to help stabilize the patient care environment, documentation of the event in the facility incident reporting system, and documentation of oversight by leadership and an assessment of the response and appropriateness of interventions for the code purple events that occurred. Documentation of evidence that the facility followed their “Code Purple” policy for nursing leadership notifications, determinations of additional resources and nursing staff allocated to respond to the ED to meet patient needs, movement of admitted patients out of the ED to inpatient areas if possible, any staff called in to help stabilize the patient care environment, documentation of the event in the facility incident reporting system, and documentation of oversight by leadership and an assessment of the response and appropriateness of interventions for the code purple events that occurred was requested. Employees #6 and 22 confirmed 07/23/2024 on that the ED did not follow the facility policy “Code Purple” for reporting events of an increase in patient activity in the ED or changes in patient conditions that would require additional staff and/or resources to safely provide care in the ED. Employees #22 confirmed on 07/23/2024 that Patient #21 was not accepted as an ED to ED transfer due to the ED being in “Code Purple” status on 06/12/2024 and that s/he is unaware of how often this may happen as the ED does not track ED provider to ED provider calls and keep detailed documentation of “Code Purple” events as required by facility policy.”