Solara Specialty Hospitals Harlingen

“A Life Safety Code (LSC) survey was conducted at the Harlingen facility on 6/25/2025. An entrance conference was conducted on the morning of 6/25/2025 with the CEO, COO and Director of Facilities to discuss the purpose of the LSC compliant and the survey process. An opportunity was provided for questions and discussion. The LSC survey was conducted under the authority of Chapter 2 of the State Operations Manual, Appendix A, Acute Care Hospitals, 42CFR482 to determine the Hospital’s compliance. A LSC exit conference was conducted on the afternoon of 6/25/2025, with the CEO, COO, and Director of Facilities. The preliminary findings of the survey and the next steps in the survey process were explained. An opportunity was provided for questions and discussion. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the plan of correction, correction dates, and the signature space. Any discrepancy in the original deficiency citation(s) will be reported to the Dallas Regional Office (RO) for referral to the Office of the Inspector General (OIG) for possible fraud. If information is inadvertently changed by the provider/supplier, the State Survey Agency (SA) should be notified immediately.”

“Hazardous Areas - Enclosure CFR(s): NFPA 101 Hazardous Areas - Enclosure Hazardous areas are protected by a fire barrier having 1-hour fire resistance rating (with 3/4 hour fire rated doors) or an automatic fire extinguishing system in accordance with 8.7.1 or 19.3.5.9. When the approved automatic fire extinguishing system option is used, the areas shall be separated from other spaces by smoke resisting partitions and doors in accordance with 8.4. Doors shall be self-closing or automatic-closing and permitted to have nonrated or field-applied protective plates that do not exceed 48 inches from the bottom of the door. Describe the floor and zone locations of hazardous areas that are deficient in REMARKS. 19.3.2.1, 19.3.5.9 Area Automatic Sprinkler Separation N/A a. Boiler and Fuel-Fired Heater Rooms b. Laundries (larger than 100 square feet) c. Repair, Maintenance, and Paint Shops d. Soiled Linen Rooms (exceeding 64 gallons) e. Trash Collection Rooms (exceeding 64 gallons) f. Combustible Storage Rooms/Spaces (over 50 square feet) g. Laboratories (if classified as Severe Hazard - see K322) This Standard is not met as evidenced by: 29106 Based on observation and interview during the survey walk of the facility with the Facilities Director on the morning of 6/24/2025, the Body Hold Room and Assisted Bathing were being used as Storage, the double doors at the central storage room did not close and latch properly, and the janitor room in the kitchen did not have a closer. NFPA 101, 2012: 19.3.2.1 Any hazardous areas shall be protected in accordance with Section 8.7, and the areas described in Table 19.3.2.1 shall be protected as indicated. The doors shall be a minimum ¾ hour fire rated doors set in rated frames. With that classification, the door’s hardware, including door closers device and latching hardware, must meet the requirement for storage rooms. Unrelated items for building support spaces, such as grills, tables, plywood, and miscellaneous equipment was observed being stored in the riser and electrical rooms. The clearances around the panels and riser were not maintained. 2012 NFPA 101 7.13.1.2 - Building service equipment support areas shall not contain fuel-fired equipment or be used for the storage of combustibles. 2010 NFPA 110, 7.11.1 - Protection. The room in which the EPS equipment is located shall not be used for other purposes that are not directly related to the EPS. Parts, tools, and manuals for routine maintenance and repair shall be permitted to be stored in the EPS room.”

“HVAC CFR(s): NFPA 101 HVAC Heating, ventilation, and air conditioning shall comply with 9.2 and shall be installed in accordance with the manufacturer’s specifications. 18.5.2.1, 19.5.2.1, 9.2 This Standard is not met as evidenced by: 29106 Based on observation during the survey walk of the facility on the morning of 6/24/2025 with the COO, CEO and Maintenance Director, the requirement was not met. The HVAC unit was out of service for the Administration area, and temporary units were in place. It was noted the unit is scheduled for repair. A project is required to be submitted to ARU for construction projects. HLR §505.167 (a)(1) Hospital owners/operators may not begin construction of a new building, additions to or renovations or conversions of existing buildings until the department approves final construction documents.”

“Operating Features - Other CFR(s): NFPA 101 Operating Features - Other List in the REMARKS section any LSC Section 18.7 and 19.7 Operating Features requirements that are not addressed by the provided K-tags, but are deficient. This information, along with the applicable Life Safety Code or NFPA standard citation, should be included in Form CMS-2567. This Standard is not met as evidenced by: 29106 Based on review of records during the survey of the facility on the morning of 6/24/2025 with the COO, CEO and Maintenance Director, the facility failed to provide written after-action reports of the annual community disaster drills. Ensure the facility is included in community drills and maintain reports.”

“Evacuation and Relocation Plan CFR(s): NFPA 101 Evacuation and Relocation Plan There is a written plan for the protection of all patients and for their evacuation in the event of an emergency. Employees are periodically instructed and kept informed with their duties under the plan, and a copy of the plan is readily available with telephone operator or with security. The plan addresses the basic response required of staff per 18/19.7.2.1.2 and provides for all of the fire safety plan components per 18/19.2.2. 18.7.1.1 through 18.7.1.3, 18.7.2.1.2, 18.7.2.2, 18.7.2.3, 19.7.1.1 through 19.7.1.3, 19.7.2.1.2, 19.7.2.2, 19.7.2.3 This Standard is not met as evidenced by: 29106 Based on review of the records on the morning of 6/24/2025, with the Administrator, the facility failed to provide proper paperwork for the Evacuation and Relocation Emergency Plan. The last review and update was in January 2023. The requirement is to review and update every 2 years. The files were not readily available in one place. There was no documentation located in the notebook for Emergency policies and procedures for the required food provision. Based on interview the food required for subsistence was managed by the Dietary department. This procedure was not listed in the Emergency Preparedness plan or referenced where to locate it. A log for testing the Emergency Preparedness twice yearly was not found. Consolidate location of emergency plans and indicate staff responsible for maintaining documentation.”

“Health Care Facilities Code - Other CFR(s): NFPA 101 Health Care Facilities Code - Other List in the REMARKS section any NFPA 99 requirements (excluding Chapter 7, 8, 12, and 13) that are not addressed by the provided K-Tags, but are deficient. This information, along with the applicable Health Care Facilities Code or NFPA standard citation, should be included on Form CMS-2567. This Standard is not met as evidenced by: 29106 Based on observation during the survey walk of the facility on the morning of 6/24/2025 with the COO, CEO and Maintenance Director, the facility failed to maintain the facility. The film room adjacent to the Rad room did not have flooring installed. The Isolation Exam and adjacent Toilet had flooring peeling at the seams. This does not provide a clean, safe environment. Hospital Licensing Rules Title 26 TAC (HLR) §505.162 (d)(1) (A) Physical environment. A physical environment that protects the health and safety of patients, personnel, and the public shall be provided in each hospital. The physical premises of the hospital and those areas of the hospital’s physical structure that are used by the patients (including all stairwells, corridors, and passageways) shall meet the local building and fire safety codes and Subchapters H and I of this chapter. HLR §505.162 (2)(B)(iii) Floor finishes. Flooring shall be easy to clean and have wear resistance appropriate for the location involved.”

“Gas and Vacuum Piped Systems - Modifications CFR(s): NFPA 101 Gas and Vacuum Piped Systems - Modifications Whenever modifications are made that breach the pipeline, any necessary installer and verification test specified in 5.1.2 is conducted on the downstream portion of the medical gas piping system. Permanent records of all tests required by system verification tests are maintained. 5.1.14.4.1, 5.1.14.4.6, 5.2.13, 5.3.13.4.3 (NFPA 99) This Standard is not met as evidenced by: 29106 Based on observation during the survey walk on the morning of 6/24/2025, the Director of Facilities informed the surveyor the Medical Air Compressors had been decommissioned in or around year 2017. The State was not notified, and a project was not submitted. Hospitals are required to have Medical Air. Refer to HLR §505.169(f) Table 6 STATION OUTLETS FOR OXYGEN, VACUUM, AND MEDICAL AIR SYSTEMS”

“Electrical Systems - Other CFR(s): NFPA 101 Electrical Systems - Other List in the REMARKS section any NFPA 99 Chapter 6 Electrical Systems requirements that are not addressed by the provided K-Tags, but are deficient. This information, along with the applicable Life Safety Code or NFPA standard citation, should be included on Form CMS-2567. Chapter 6 (NFPA 99) This Standard is not met as evidenced by: 29106 During the survey walk of the facility on the morning of 6/24/2025 with the COO, CEO and Maintenance Director, it was observed the Fire Alarm control panel and accessory devices were not powered from the Life Safety Branch.”

“Electrical Systems - Maintenance and Testing CFR(s): NFPA 101 Electrical Systems - Maintenance and Testing Hospital-grade receptacles at patient bed locations and where deep sedation or general anesthesia is administered, are tested after initial installation, replacement or servicing. Additional testing is performed at intervals defined by documented performance data. Receptacles not listed as hospital-grade at these locations are tested at intervals not exceeding 12 months. Line isolation monitors (LIM), if installed, are tested at intervals of less than or equal to 1 month by actuating the LIM test switch per 6.3.2.6.3.6, which activates both visual and audible alarm. For LIM circuits with automated self-testing, this manual test is performed at intervals less than or equal to 12 months. LIM circuits are tested per 6.3.3.3.2 after any repair or renovation to the electric distribution system. Records are maintained of required tests and associated repairs or modifications, containing date, room or area tested, and results. 6.3.4 (NFPA 99) This Standard is not met as evidenced by: 29106 Based on review of the records and interview with the CEO, COO and Director of Facilities on the morning of 6/25/2025, the facility failed to document testing of the hospital grade receptacles at the patient bed locations. GFCI testing log was provided. This does not meet the requirements. Document testing at the intervals required by documented performance data. Provide this information with the testing for review of conformity in the future. “Where hospital-grade receptacles are required at patient bed locations and in locations where deep sedation or general anesthesia is administered, testing shall be performed after initial installation, replacement, or servicing of the device.” - NFPA 99, 2012, 6.3.4.1.1 “Additional testing of receptacles in patient care rooms shall be performed at intervals defined by documented performance data.” - NFPA 99, 2012, 6.3.4.1.2”

“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: 29106 Based on review of the records and interview with the CEO, COO and Director of Facilities on the morning of 6/25/2025, the facility failed to periodically exercise the Main feeder and circuit breakers. Thermal imaging reports for breakers were provided for 2023 and 2025. The 2024 report was missing. Documentation indicating the dates of exercising the breakers and main feeder was not provided. Begin exercising breakers and maintain a log. “EPSS circuit breakers for Level 1 system usage, including main and feed breakers between the EPS and the transfer switch load terminals, shall be exercised annually with the EPS in the “off” position.” - NFPA 110, 2010, 8.4.7*. Note: “Circuit breakers should be tested under simulated overload conditions every 2 years.” - NFPA 110, 2010, A.8.4.7”

“CONTRACTED SERVICES CFR(s): 482.12(e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. This Standard is not met as evidenced by: 36827 Based on observation, review of records, and interview, the facility’s Governing Body failed to ensure all contracted services were provided in a safe and effective manner. Findings included: On 6-2-25 at 2:23 PM during a tour of the ICU, an ice machine was observed to have a heavy buildup of white deposits, pale green gelatinous substance and pink residue around the dispense tube. On 6-2-25 at 2:26, the ice machine for the medical unit was observed to have a light buildup of mineral deposits. On 6-3-25, review of maintenance records revealed a contracted service had cleaned both machines a week prior, on 5-28-25. Review of the work order showed a “Description” of services as follows: “Quarterly - Note: Ice machine cleanings will be scheduled with an onsite Supervisor prior to removing from floor. 1) Check operation of ice machine. 2) Clean condenser coil, as required. 3. Inspection ice trays, clean as required (for cleaning refer to manufacturer’s procedures) 4) inspect ice bin, replace rubber seal, clean as required. 5) Clean exterior and interior and for proper drainage. 6. Replace water filter(s) before back in service.” The manufacturer’s manual was provided and reviewed on 6-3-25. The manual, page 15 stated, “NOTE: A Sanitizing Procedure must be performed after all cleaning procedures have been completed.” Interview with Staff #7 on 6-3-25 confirmed the ice machine had not been effectively cleaned per the instructions in the manufacturer’s manual. The ice machine was removed from service and the contracted service provider was called out to clean and sanitize the ice machine. Contaminated water from ice machines had the potential to cause a life-threatening illness in debilitated patients such as those in the ICU. On 6-4-25 at 1:49 PM, contracted Staff #22 was observed in room #8 (a contact isolation patient’s room) without wearing any Personal Protective Equipment (PPE). Staff #22 was observed to leave the room without washing his hands in the room or in the sink outside of the room. The observation was confirmed with Staff #11. On 6-4-25, Staff #22’s personnel file was reviewed. Staff #22 went through a contractor’s orientation on 5-5-2015 with a completed General Hospital Orientation Post Test in his file. The test was observed to include information on PPE and handwashing. Review of Staff #22’s personnel file showed that he had not attended annual training required of staff since that time. Failure to wear PPE while in an infectious patient’s room and failure to wash hands at the time of exit of an infectious patient’s room could result in the spread of dangerous infections to other patients and staff. Staff #1, Staff #2, and Staff #12 were asked to provide any evidence of quality indicators or measures that had been used to evaluate contracted services in the past. No such evidence was provided. During interview with Staff #1 and Staff #2 on 6-4-25 at 9:50 AM, it was confirmed that no contract services had been routinely evaluated using measurable quality indicators to ensure services were safe and/or effective.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 32143 Based on a chart review and interviews, the facility failed to ensure that the physician documented and signed the blood consent before the patient received information about the risks and benefits of blood prior to signing a consent for blood administration in both patients reviewed, Patient #1 and #12. Findings included: A review of the facility policy and procedure, “Consent for Medical and Surgical Procedures,” stated, “Policy- Informed consent is the responsibility of the physician and must be obtained by them ... 7. Statement that the procedure was explained to the patient or guardian and name/signature of the person who explained the procedure.” A review of patient #1’s chart revealed the patient was ordered 1 unit of packed red blood cells on 5/8/25. The blood consent was signed by the patient and the nurse on 5/8/25 at 1640. The physician did not sign and date the consent until 5/8/25 at 1700. A review of patient #12’s chart revealed that the patient was ordered 1 unit of packed red blood cells on 5/12/25 at 9:50 am. Patient #12 and the nurse both signed the consent on 5/12/25 at 9:50 am. The physician did not sign the consent until 5/12/25 at 1900. There was no documentation in the physician’s notes or the history and physical that indicated the patient was informed of the risks and benefits prior to the consent. An interview was conducted with staff # 13, CNO, on 6/3/25 in the afternoon. Staff # 13 stated the physicians had training on the process and had been calling the patients if they were not in the facility before the consents were signed. Staff #13 confirmed that with patient #1 and #12 charts, the physician had not documented prior to the consent that the risks and benefits were discussed with the patient to allow the patient to make an educated decision. An interview was conducted with Staff #10 MD on 6/3/25 at 1:46 PM. Staff #10 stated that he will have some more education sent out to the physicians to ensure the documentation is charted appropriately. Staff #10 asked questions and stated that the physicians were not aware that they could document the risks and benefits to the patient before admission or after admission in the History and Physical. Staff #10 stated he would take the issue back to the PI process.”

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 32143 Based on review and interviews, the facility failed to ensure a completed nurse staffing plan was developed, approved by the governing body, and followed to ensure safe staffing was available for safe patient care in 2 of 2(Harlingen and Brownsville) campuses. Findings included: A review of the nurse staffing grid revealed the nurse staffing for both campuses. (A nurse staffing grid is a tool used to determine the optimal number and type of nursing staff needed to meet patient care needs. It helps balance patient acuity levels, workload, and available nursing resources to ensure safe and efficient patient care.) The grid was a tool that must address all units and include all staff required at a minimum to maintain patient safety. A review of the staffing grid revealed that it did not differentiate between the Intensive Care Unit and the Medical Unit. There was no way to determine what staff were required. The grid revealed that if 1 to 8 patients were on a unit, only 1 Registered Nurse (RN) and an unlicensed unit clerk were required. The RN would be left with up to 8 patients on a closed unit with no other licensed personnel, leaving the unit vulnerable. A review of the policy and procedure, “Nurse Staffing Plan,” stated, “POLICY Solara Specialty Hospital will ensure that a sufficient number and mix of licensed clinical individuals are on site at all times to support safe, quality care, treatment and services offered, there will be adequate numbers of registered Nurses (RNs) Licensed Practical (Vocational) Nurses and other personnel to provide nursing care to all patients. Cornerstone Hospital ensures the nurse executive (CNO/CCO), RNs, and other designated nursing groups have input into the development of nurse staffing plan(s). In addition, it is the policy of Cornerstone Hospital to use data and information to improve the safety and quality of care, treatment, and services. The leaders must provide the resources needed for data and information use, including staff, equipment, and information systems. Also, the hospital will use data and information in decision-making that supports the safety, quality of care, treatment, and services. Lastly, the hospital will evaluate how effectively the data and information are used throughout the hospital ...The staffing plan for each unit (Attachment A0 establishes the minimum staffing levels for that unit.” A review of Attachment A revealed at the top” Staffing Levels for Nursing /Departments (insert specific staffing plans). The plan was blank. An interview was conducted with Staff #13, CNO-Harlingen campus, on 6/3/25 in the afternoon. Staff #13 stated that the staffing grid was something that came from the corporate office, and it did not fit for her facility. Staff #13 stated that she did not use the corporate grid but had made her own. A review of staff #13’s grid revealed 2 separate grids, one for the ICU and one for medical medical-surgical floor. Staff #13 stated that both the Harlingen campus and the Brownsville campus had a joint Nurse Staffing Effectiveness Meeting each quarter, but her grid was not created in the meeting, and it was not approved by the governing body. There was no evidence in the 3/31/2025 Nurse Staffing Committee Meeting minutes that a discussion was held on adequate staffing, any PI process to develop or approve a nurse staffing grid, or how patient needs were considered, how the nurse-sensitive outcomes were measured, and used in developing a safe plan. An interview was conducted with staff #3 CNO -Brownsville, in the afternoon of 6/4/25. Staff #3 stated that the only grid she had was from the corporate office, and she did not use it. Staff #3 stated that she and the house supervisor decided on the staffing by looking at the patients and their acuities. Staff #3 was asked if she used an acuity tool when making the decisions. Staff #3 provided a blank acuity tool but confirmed she did not use it to make staffing decisions. A review of the policy and procedure, “Nurse Staffing Plan,” stated, “PATIENT CLASSIFICATION TOOL/ACUITY ASSESSMENT stated, “Due to the nature of the LT ACH industry, the average length of stay is about 25 days. Admissions are planned, and there are not the dramatic fluctuations in acuity as seen in short-term acute care hospitals. Therefore, the nurse executive or designee will review classification/acuity at a minimum of daily and PRN. This information is used during the daily assignment of patients and the annual budgeting and planning process to ensure that patient needs are always met and that patient/staff safety remains at the forefront. Due to the nature of our industry and the need to distinguish between licensed and non-licensed duties, this tool takes a unique approach to staffing. This tool specifically addresses the needs of licensed nurses (RN, LVN/LPN). RN Supervisors/Charge RN Nurse will be assigned patients when situations arise and additional licensed nursing staff is called in. The tools attached for the Patient Classification/Acuity is at the discretion of the RN Supervisor/Charge RN and direct patient care nurse to adjust the staffing based on the patient’s condition.””

“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: 32143 Based on policy reviews and interview the facility failed to ensure that policies had been approved by the governing board of the specifically named hospital and that those policies and procedures were clearly for the specific hospital in 2 of 2(Complaint and Grievance Process and Medical Records: Verbal and Telephone Orders) policies reviewed. A review of the policy and procedure, “Complaint and Grievance Process” revealed it was revised on 1/23/24. The policy stated that the “scope” was for all the LTAC hospitals by an organization that no longer owns the facility. An interview with staff # 3 on 1/27/25 stated that the facility was bought by another corporation a year ago and not all policies have been changed or approved. Staff #3 stated the facility department head was to bring the revised policy to the committee for approval, take it through medical staff, and then send it for approval by the Governing Board. A review of the policy and procedure, “Medical Records: Verbal and Telephone Orders” revealed it was reviewed on 3/2023. The policy stated that the scope was “Organization-Wide.” The facility was not listed, and the organization no longer owns the facility. A review of the policy and procedure “Policies and Procedures Guidelines” The two policy and/or procedure types that may be developed and approved for Sciara Hospital Harlingen, LP, and Brownsville Campus are defined as follows: 1 Organization-Wide Policies and/or Procedures - Policies and/or procedures developed by a department or by administration with applicability to more than two departments shall be approved by the Administration Staff and formatted and indexed in accordance with the following. There are four organization-wide policy and procedure manuals located in appropriate departments. Administration Leadership Human Resources (including Employee Health and Education) Environment of Care (including Safety, Security, Hazardous Materials, Infection Control, Emergency Preparedness, Life Safety, Medical Equipment, Utility Systems) Nursing Services (as applicable) Departmental Policies - Each department director will develop and approve internal policies governing his/her operation provided these policies have no influence or control over another department’s functioning. The Executive Staff member over the department will have final authority of policy and procedure manual alterations. Departmental policies and procedures will be developed in the standardized format and indexed according to the uniform system developed and utilized by Sciara Hospital Harlingen, LP and Brownsville Campus. 2. Policies pertinent to patient care will be submitted to the medical staff body for approval or revision/approval.” The policy failed to ensure that all policies were to be approved by the governing board. Staff #3 was unable to provide any governing body meeting minutes where the policies were approved. . Based on document review and interview the facility failed to; 1. ensure a properly executed informed consent was completed before the administration of blood and blood products in 2 (Patient #7 and Patient #9) of 2 medical records reviewed. Also, the facility failed to follow the policy titled, “Consent for Medical and Surgical Procedures”. Refer to TAG A0131 2. A. ensure that chemical restraints administered were identified as chemical restraint/ emergency behavioral medications (EBM) in 2 of 2(pt #10 and 13) charts reviewed. B. ensure psychotropic medications ordered IV or IM were not written as PRN orders for behavioral emergencies in 2 of 2 (pt #10 and 13) charts reviewed. C. ensure a process was in place for monitoring after administering a chemical restraint/emergency behavioral medication for side effects, respiratory or cardiac distress, and assessment of medication effectiveness, safety after administration, and for how long in 2 of 2 (pt #10 and 13) charts reviewed. D. follow their own policy and procedures to ensure the restraint packet was filled out appropriately and completely, a face-to-face was conducted by a trained individual, and patient/ staff debriefing was completed and appropriate in 2 of 2 (pt #10 and 13) charts reviewed. E. ensure chemical restraints were added to the restraint log and monitored through Risk and Quality. Refer to TAG A0160 3. Based on document review and interview the facility failed to: 1. ensure 3 (Physician #10, Physician #11, and Nurse Practitioner #9) of 3 provider orders included the rate or duration for the transfusion of blood/blood products in 2 (Patient #7 and #9) of 2 patient medical records reviewed. 2. ensure 3 (Physician #10, Physician #11, and Nurse Practitioner #9) of 3 providers gave orders to increase the rate of transfusion from the initial rate of the blood/blood product transfusion in 2 (Patient #7 and #9) of 2 patient medical records reviewed. 3. ensure the nursing staff followed the facility policy titled, “Blood and Blood Components-Administration” and documented the vital signs (blood pressure, pulse, respirations, temperature, and oxygen level) during and after a blood/blood product transfusion in 2 (Patient #7 and #9) of 2 medical records reviewed. 4. ensure the nursing staff had a properly executed informed consent before initiating a blood/blood product transfusion in 2 (Patient #7 and #9) of 2 patient medical records reviewed. Refer to TAG A0410”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 32143 Based on document review and interview the facility failed to 1. ensure a properly executed informed consent was completed before the administration of blood and blood products in 2 (Patient #7 and Patient #9) of 2 medical records reviewed. Also, the facility failed to follow the policy titled, “Consent for Medical and Surgical Procedures”. Refer to TAG A0131 2. A. ensure that chemical restraints administered were identified as chemical restraint/ emergency behavioral medications (EBM) in 2 of 2(pt #10 and 13) charts reviewed. B. ensure psychotropic medications ordered IV or IM were not written as PRN orders for behavioral emergencies in 2 of 2 (pt #10 and 13) charts reviewed. C. ensure a process was in place for monitoring after administering a chemical restraint/emergency behavioral medication for side effects, respiratory or cardiac distress, and assessment of medication effectiveness, safety after administration, and for how long in 2 of 2 (pt #10 and 13) charts reviewed. D. follow their own policy and procedures to ensure the restraint packet was filled out appropriately and completely, a face-to-face was conducted by a trained individual, and patient/ staff debriefing was completed and appropriate in 2 of 2 (pt #10 and 13) charts reviewed. E. ensure chemical restraints were added to the restraint log and monitored through Risk and Quality. Refer to TAG A0160”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 40989 Based on document review and interview the facility failed to: 1. ensure 3 (Physician #10, Physician #11, and Nurse Practitioner #9) of 3 provider orders included the rate or duration for the transfusion of blood/blood products in 2 (Patient #7 and #9) of 2 patient medical records reviewed. 2. ensure 3 (Physician #10, Physician #11, and Nurse Practitioner #9) of 3 providers gave orders to increase the rate of transfusion from the initial rate of the blood/blood product transfusion in 2 (Patient #7 and #9) of 2 patient medical records reviewed. 3. ensure the nursing staff followed the facility policy titled, “Blood and Blood Components-Administration” and documented the vital signs (blood pressure, pulse, respirations, temperature, and oxygen level) during and after a blood/blood product transfusion in 2 (Patient #7 and #9) of 2 medical records reviewed. 4. ensure the nursing staff had a properly executed informed consent before initiating a blood/blood product transfusion in 2 (Patient #7 and #9) of 2 patient medical records reviewed. Refer to TAG A0410”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 40989 Based on document review and interview the facility failed to ensure a properly executed informed consent was completed before the administration of blood and blood products in 2 (Patient #7 and Patient #9) of 2 medical records reviewed. Also, the facility failed to follow the policy titled, “Consent for Medical and Surgical Procedures”. Findings: Patient #7 A review of the medical record for Patient #7 was conducted on 1/28/2025 after 9:00 AM with Chief Clinical Officer (CCO)/Chief Operating Officer (COO) Staff #3 and Director of Quality Manager (DQM) Staff #6. The review revealed Patient #7 was a 92-year-old female admitted to the facility on 11/01/2024. Further review revealed Patient #7 received a transfusion of Packed Red Blood Cells (PRBC) on 11/19/2024 at 2350 (11:50 PM). Further review of the medical record revealed a document titled; “Informed Consent for Transfusion” dated 11/16/2024. The document was as follows: “ ...1. Proposed Treatment(s)/Physician(s) For:____________(Patient #7) Transfusion(s) proposed: 1 unit of PRBC ...”. The signature page revealed a telephone consent was obtained from the patient’s daughter and witnessed by two employees of the hospital on 11/16/2024 at 2240 (10:40 PM). “ ... PHYSICIAN CERTIFICATION: I hereby certify that I have discussed the treatment(s) described above with the patient (or patient’s legal representative). The discussion was held prior to treatment and included the risks/benefits, consequences/ alternatives and other pertinent information about the proposed treatment(s). __I hereby certify that the patient has received a copy of the California Department of Health Care Services information pamphlet, A Patient’s Guide to Blood Transfusion. (CA only) (Printed Name/Signature of Physician) Time: ____:____ AM/PM Date:____/____/______...” The final page of the 4-page consent was as follows: “Policy or Resource: INFORMED CONSENT/ PROCEDURE REQUIRING INFORMED CONSENT. Completion Instructions: CONSENT FOR TRANSFUSION Use this consent form for every patient requiring transfusion. It is the treating physician’s responsibility to obtain informed consent. Hospital personnel should not be involved in providing the information necessary to secure the patient’s informed consent. Personnel can answer general questions the patient has regarding the treatment. The hospital’s role in the consent process should be limited to verifying that the physician obtained informed consent. This form serves the dual purposes of assuring that the physician obtained informed consent from the patient prior to the proposed treatment and indicating that the patient is aware of the right to give informed consent or refusal to the treatment recommended by the physician. Instructions for use: The entire form should be read to the patient. ...Section 1: All blanks must be filled in prior to the patient or legal representative signing the form. *If multiple blood product types are ordered, they must each be listed on the consent form. *If different blood products are ordered during the patient’s hospitalization, a new informed consent is required. Section 2: *This form lists the risks of transfusion. The physician should document the informed consent discussion in the progress notes, noting additional risks and benefits not addressed on the form. Section 3: o If the patient/legal representative consents to the proposed treatment(s), the form should be signed. Complete the signature sections appropriately ... *The physician should always sign the consent form prior to the transfusion ...” Patient #9 A review of the medical record for Patient #9 was conducted on 1/28/2025 after 9:00 AM with Chief Clinical Officer (CCO)/Chief Operating Officer (COO) Staff #3 and Director of Quality Manager (DQM) Staff #6. The review revealed Patient #9 was a 58-year-old female who was admitted to the hospital on 12/27/2024. Further review revealed Patient #9 received 1 unit of Packed Red Blood Cells (PRBC) on 12/29/2024 at 2:45 AM, one unit of platelets on 12/30/2024 at 2:03 PM, and one unit of platelets on 1/03/2025 at 4:32 PM. A review of the document titled; “Informed Consent for Transfusion” was as follows; “1. Proposed Treatment/Physician: For: __________(Patient #9) Transfusion(s) proposed: _______Anemia______ Transfusion(s) ordered by: Physician #11 On the bottom of page 1(1 of 2 pages) Patient #9 signed and the Registered Nurse (RN) signed the page. There was no date or time by the nurse or the patient. This was not the signature page for the informed consent. On page 2 of 2, the signature page for the patient or surrogate, the witness to the patient’s signature, and the physician’s signature. The page was blank. The physician failed to sign the informed consent. An interview was conducted with Staff #6 on 1/28/2025 after 2:00 PM. DQM Staff #6 confirmed there was no way to determine when the consent was signed by Patient #9 and no proposed transfusion was documented. The nursing staff and physician failed to obtain a signed informed consent for the transfusion of PRBC’s and platelets before Patient #9 received the 3 of 3 blood/blood product transfusions. A review of the facility policy titled, “Consent for Medical and Surgical Procedures”, Policy # CL-4.0 with a revised date of 1/2023 was as follows: PURPOSE: To provide the patient with clearly defined written agreements for purpose performed medically or surgically and to morally, legally, and personally protect the rights of the patients and those rendering care to them. POLICY: Medical records must contain a properly executed and completed written informed consent form for all procedures and treatments as specified and approved by the Hospital’s Medical Staff, or State or Federal laws or regulations. Informed consent is the responsibility of the physician and must be obtained by them. A properly executed informed consent form contains at least the following: 1. Name of patient, and when appropriate, patient’s legal guardian; 2. Name of hospital; 3. Name of specific procedure(s); 4. Name of practitioner(s) performing the procedure(s) or important aspects of the procedures, as well as the name(s) and specific significant surgical tasks that will be conducted by practitioners other than the primary surgeon/practitioner. (Significant surgical tasks include: harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissues.); 5. Risks of the proposed procedure; 6. Alternative procedures, treatments or therapies; 7. Statement that procedure was explained to the patient or guardian and name/signature of person who explained the procedure. 8. Implications for recovery, post procedure. 9. Signature of patient of legal guardian; 10. Date and time consent is obtained; 11. Signature of professional person witnessing the consent. RESPONSIBILITIES: The role of nursing in the informed consent process is to obtain the signature on the consent form and witness the signature, after ascertaining that the patient has been informed ... GENERAL STAGEMENTS: (sic) A ... B. The Consent Form 1. The consent form must be signed prior to the start of the procedure and if the patient is signing their own consent, prior to administration of any pre-operative medication or mind-altering drugs. 2. The consent form must include the name of the physician performing the procedure in the appropriately designated space on the form. 3. The full terminology of the procedure(s) must be written in the designated space(s) on the consent form without the use of abbreviations. 4. All blanks must be completed. 5. The patient must underline/circle and initial whether they do or do not consent to the use of blood or blood products. 6. The date, time of signing, patient/legal guardian’s signature and witness’ signature are required and must be signed in ink. ...” The policy titled, “Consent for Medical and Surgical Procedures” Policy # CL-4.0 with a reviewed date of 1/2023 had two attachments, 4.0A and 4.0B. 4.0A was a document titled Surgical & Therapeutic Procedure Consent Form and 4.0B was a document titled Blood and Blood Product Administration Consent Form. The hospital was not using the informed consent document attached to the informed consent policy. The hospital was using a document titled Informed Consent for Transfusion with a Created Date of 7/24. An interview was conducted with CCO/COO Staff #3 and DQM Staff #6 on 1/28/2025 after 2:00 PM. Staff #3 and Staff #6 were asked if the physician had to sign the informed consent for blood transfusions. Staff #6 stated, “Yes they are required to sign the consents”. Staff #3 and Staff #6 were asked why was there information about the state of California requirements above the physician signature line on the informed consent. Staff #3 stated, “Our physicians do not acknowledge that statement. This is a corporate consent form used at all facilities, not just for Texas”. An interview was conducted with RN Staff #12 at 10:45 AM on 1/28/2025. RN Staff #12 was asked who gets the consent signed for the blood transfusions. RN Staff #12 stated, “Usually the nurse that is giving the blood gets the consent signed”. RN Staff #12 was asked how she confirmed the physician explained all the risks and benefits of a blood/blood product transfusion to the patient. RN Staff #12 stated, “The risks and benefits are on the consent form and the physician is supposed to sign the consent”. An interview was conducted on 1/28/2025 after 2:00 PM with CCO/COO Staff #3 and DQM Staff #6. DQM Staff #6 confirmed the physician failed to sign the informed consent for the transfusion of blood/blood products for 2 (Patient #7 and Patient #9) of 2 patients’ medical records reviewed. Also, it was confirmed that the staff failed to follow the facility policy by not ensuring there was a date and time of the signatures documented on the consent and not use abbreviations.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(1)(i)(B) [A restraint is-] (B) A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition. This Standard is not met as evidenced by: 32143 Based on document review and interviews the facility failed to: A. ensure that chemical restraints administered were identified as chemical restraint/ emergency behavioral medications (EBM) in 1 of 1(pt #13) charts reviewed. B. ensure psychotropic medications ordered IV or IM were not written as PRN orders for behavioral emergencies in 2 of 2 (pt #10 and 13) charts reviewed. C. ensure a process was in place for monitoring after administering a chemical restraint/emergency behavioral medication for side effects, respiratory or cardiac distress, and assessment of medication effectiveness, safety after administration, and for how long in 1 of 1 (pt #13) charts reviewed. D. follow their own policy and procedures to ensure the restraint packet was filled out appropriately and completely, a face-to-face was conducted by a trained individual, and patient/ staff debriefing was completed and appropriate in 1 of 1 (pt #13) charts reviewed. E. ensure chemical restraints were added to the restraint log and monitored through Risk and Quality. Findings: Patient #10 A review of patient # 10’s medical chart revealed patient #10 was admitted to the facility on 7/8/24. She was a 64-year-old female admitted to the facility to receive IV antibiotics due to sepsis from a post-surgical laminectomy. A review of the physician’s history and physical revealed she had a history of major depressive disorder. The physician stated under Neurological: “There were no focal deficits ... The patient has a past history of hypertension, diabetes mellitus, hypothyroidism, and underlying depression with psychosis...” Patient was documented as being alert and oriented x3. There was no documentation that patient #10 had any current mental health diagnosis or current behaviors that would describe the need for psychotropic medications to be given therapeutically. A review of the physician orders dated 7/8/24 stated Zyprexa 2.5mg = 0.5 ml IM q6hr prn for aggression, violence, paranoia. Seroquel (antipsychotic) 25mg by mouth twice a day as needed for anxiety. There was no documentation of current mental health diagnosis or inappropriate behaviors by the physician that would constitute the use of IV or IM psychoactive medications for therapeutic mental health disorders. A review of the facility’s policy and procedure Restraint Reduction Plan stated, “The use of PRN or standing-order drugs or medications is only prohibited if the drug or medication meets the definition of a drug or medication used as a restraint ... Pg 4 of 10 PRN ordering of a restraint: Orders for the use of restraint must never be written as a standing order or on an as needed basis (PRN).” There was no agitation scale or physician order found that defined agitation or aggression and the multilevel of agitation that would require a chemical restraint. A registered nurse must follow physician orders that provide an objective (not requiring the nurse to use medical judgment to interpret symptoms) scale or scoring system for PRN medications to stay within their scope of practice. Nurses had to use medical judgment to determine if a patient should be medicated based on a symptom and not objective parameters identified by the physician within the order. According to the “TEXAS BOARD OF NURSING CHAPTER 217 LICENSURE, PEER ASSISTANCE AND PRACTICE RULE §217.11 Standards of Nursing Practice The RN does not perform medical diagnosis or prescription of therapeutic or corrective measures unless licensed as an advanced practice registered nurse.” Patient #13 A review of patient # 13’s medical chart revealed he was admitted to the facility on 10/2/24 for an acute ischemic stroke. A review of patient #13’s physician orders revealed a telephone order on 10/2/24 at 1829 for Geodon (psychotropic) 10mg IM q 8 hrs. prn agitation.” A review of patient #13’s Medication Administration Record (MAR) revealed patient #13 received the Geodon IM 10mg on 10/2/24 at 2130 and 0530. A review of patient #13’s physician orders revealed a telephone order on 10/22/24 at 2140 for “Geodon 10mg IM 1 dose now.” There was no indication on the physician’s order why this medication was to be given “now”. As of 1/28/25, there was no physician signature for this order. There was no documentation in the physician progress notes for 10/23/25 on why the patient received a “now” order for an IM psychotropic medication. A review of the nurse’s note for 10/22/24 at 2138 stated, “Agitated, vulgar, biting mittens, pulling tubes/lines. MD informed new orders received. See chart.” A review of patient #13’s chart revealed the patient had hand mittens on. There was no de-escalation documented before the administration of a chemical restraint. There was no documented evidence that a PO medication was attempted to alleviate symptoms. There was no restraint packet completed in the chart. There was no face-to-face performed. There was no nursing assessment, vital signs, or documentation of the medication effect. A review of the policy and procedure Restraint Reduction Plan stated, “Patients placed in restraint for violent or self-destructive behavior should be monitored every two hours (when in physical restraints). There was no direction in the policy on when the nurse should reassess the patient after receiving a chemical restraint, how often to reassess, and for how long. An interview was conducted with Staff #3 and Staff #6 on 1/28/25. Staff #3 confirmed the chemical restraints were written PRN. Staff #3 and #6 confirmed the policy did not address the chemical restraint for nursing assessment. Staff #6 confirmed the facility had restraint care plan packets but there were no packets used for the chemical restraints. The staff were only using nonviolent packets for physical restraints. The restraint care plan packets came in two different forms. Violent /self-destructive and non-violent/ non-self-destructive. Both packets were designed for physical restraints. The facility was unable to provide a restraint log. An interview with Staff # 6 on 1/28/25 revealed that the facility did not have a restraint roster. Staff #6 confirmed that the information she kept about physical restraints was general information on quality reports; however, the facility did not monitor chemical restraints. There were no findings of restraint and seclusion reporting in the Quality meeting minutes for the last two quarters of 2024. Geodon (Ziprasidone) belongs to a class of drugs called atypical antipsychotics used to treat schizophrenia. It is also known as a second-generation antipsychotic (SGA) or atypical antipsychotic. Ziprasidone rebalances dopamine and serotonin to improve thinking, mood, and behavior. All antipsychotics have been associated with the risk of sudden cardiac death due to an arrhythmia (irregular heartbeat). To minimize this risk, antipsychotic medications should be used in the smallest effective dose when the benefits outweigh the risks. All antipsychotics can cause sedation, dizziness, or orthostatic hypotension (a drop in blood pressure when standing up from sitting or lying down). These side effects may lead to falls which could cause bone fractures or other injuries. This risk is higher for people with conditions or other medications that could worsen these effects. Summary Of FDA Black Box Warnings Increased Mortality in elderly patients with dementia-related psychosis. Both first-generation (typical) and second-generation (atypical) antipsychotics are associated with an increased risk of mortality in elderly patients when used for dementia-related psychosis. Although there were multiple causes of death in studies, most deaths appeared to be due to cardiovascular causes (e.g., sudden cardiac death) or infection (e.g., pneumonia). Antipsychotics are not indicated for the treatment of dementia-related psychosis. https://www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Types-of-Medication/Ziprasidone-(Geodon). 40989 Findings: An interview was conducted with RN Staff #12 on 1/28/2025 after 9:30 AM. RN Staff #12 was asked to explain the difference between a medical restraint and a behavioral restraint. RN Staff #12 confirmed she was unable to describe the differences between the two different types of restraints.”

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 40989 Based on document review and interview the facility failed to: 1. ensure 3 (Physician #10, Physician #11, and Nurse Practitioner #9) of 3 provider orders included the rate or duration for the transfusion of blood/blood products in 2 (Patient #7 and #9) of 2 patient medical records reviewed. 2. ensure 3 (Physician #10, Physician #11, and Nurse Practitioner #9) of 3 providers gave orders to increase the rate of transfusion from the initial rate of the blood/blood product transfusion in 2 (Patient #7 and #9) of 2 patient medical records reviewed. 3. ensure the nursing staff followed the facility policy titled, “Blood and Blood Components-Administration” and documented the vital signs (blood pressure, pulse, respirations, temperature, and oxygen level) during and after a blood/blood product transfusion in 2 (Patient #7 and #9) of 2 medical records reviewed. 4. ensure the nursing staff had a properly executed informed consent before initiating a blood/blood product transfusion in 2 (Patient #7 and #9) of 2 patient medical records reviewed. Findings: Patient #7 A review of the medical record for Patient #7 was conducted on 1/28/2025 after 9:00 AM with Chief Clinical Officer (CCO)/Chief Operating Officer (COO) Staff #3 and Director of Quality Manager (DQM) Staff #6. The review revealed the following. Patient #7 was a 92-year-old female admitted to the facility on 11/01/2024 with a diagnosis of Sepsis secondary to bilateral pneumonia, acute hypoxic respiratory failure, metabolic encephalopathy, and chronic multiple ulcers. Review of a Telephone Order Read Back (TORB) dated 11/19/2024 at 2122 (10:22 PM) from Nurse Practitioner (NP) #9 was as follows: “ ...11/19/24 2122 - Type/Crossmatch & transfuse 1-unit (Packed Red Blood Cells) PRBC ...TORB NP #9/Physician #10” ... The Registered Nurse’s (RN) signature that obtained the telephone order was illegible. There was no rate or duration ordered for the blood transfusion and no order to increase or decrease the rate after the first 15 minutes. Review of the blood transfusion flow sheet dated 11/19/24 revealed the blood transfusion was started at 2350 (11:50 PM). The first set of vital signs was taken at 12:05 AM (15 minutes after the initiation of the transfusion) and again at 1:05 AM, 2:05 AM, and 3:05 AM. The transfusion was completed at 3:05 AM and vital signs were taken again at 3:35 AM, 30 minutes after the transfusion was completed. Further review revealed there was no documentation of the rate of infusion for the entire time of the transfusion. The surveyor was unable to determine the rate of the infusion or if the rate was increased or decreased over the total time of the transfusion. An interview was conducted with DQM Staff #6 on 1/28/2025 after 9:00 AM. Staff #6 confirmed there was no rate or duration of the blood transfusion ordered by the provider. Also, Staff #6 confirmed the nursing staff failed to document the vital signs according to the facility policy. There were no vital signs documented 5 minutes after the initiation of the blood transfusion and there were no vital signs documented 1 hour after the completion of the blood transfusion as required by the facility policy. Staff #6 confirmed the informed consent had not been signed by the provider before the start of the blood transfusion. Patient #9 A review of the medical record for Patient #9 was conducted on 1/28/2025 after 9:00 AM with Chief Clinical Officer (CCO)/Chief Operating Officer (COO) Staff #3 and Director of Quality Manager (DQM) Staff #6. The review revealed the following. Patient #9 was admitted to the facility on 12/27/2024 to the care of Physician #11. A review of the order revealed a telephone order was given by Physician #11. A review of the telephone order was as follows: “The date was illegible. At 1730 (5:30 PM) Type and crossmatch for PRBC and transfuse 1-unit PRBC. TORB Physician #11/signature of staff that obtained the telephone order was illegible”. There was no rate or duration ordered for the transfusion. Review of the blood transfusion flow sheet dated 12/29/2024 revealed the blood transfusion was started at 2:45 AM. The first set of vital signs was taken at 3:00 AM (15 minutes after the initiation of the transfusion) and again at 4:00 AM, 5:00 AM, and 5:30 AM. The transfusion was complete at 5:30 AM and vital signs were taken again at 6:00 AM. There was no signature of the nurse discontinuing the blood transfusion. Further review revealed there was no documentation of the rate of infusion for the entire time of the transfusion. The surveyor was unable to determine the rate of the infusion or if the rate was increased or decreased over the total time of the transfusion. A review of the TORB taken on 12/30/2024 at 10:20 AM by the RN was as follows: “Transfuse 1 unit of single dose platelet donor. Give Tylenol 650mg oral once prior to transfusion”. There was no rate or duration ordered for the transfusion of the platelets by Physician #11. A review of the transfusion flow sheet dated 12/30/2024 revealed the platelet transfusion was started at 1403 (2:03 PM). The first set of vital signs were taken at 1418 (2:18 PM) (15 minutes after the initiation of the transfusion) and again at 1503. (3:03 PM). The transfusion was completed at 1530 (3:30 PM) and vital signs were taken at 1600 (4:00 PM). Further review revealed there was no documentation of the rate of infusion for the entire time of the transfusion. The surveyor was unable to determine the rate of the infusion or if the rate was increased or decreased over the total time of the transfusion. A review of the TORB dated 1/03/2025 was as follows: “1/03/2025 11:00 AM Transfuse 1 single dose donor platelet. Pre-medicate with PRN Tylenol. TORB Physician #11/staff receiving telephone order was illegible”. There was no rate or duration ordered by Physician #11 for the transfusion of the 1 unit of donor platelets. A review of the transfusion flow sheet dated 1/03/2025 revealed the platelet transfusion started at 1632 (4:32 PM). The first set of vital signs after the initiation were taken at 1647 (4:47 PM) 15 minutes after the initiation of the transfusion and again at 1745 (5:45 PM). The transfusion was completed at 1745 (5:45 PM). There were no other vital signs documented after the completion of the transfusion. Further review revealed there was no documentation of the rate of infusion for the entire time of the transfusion. The surveyor was unable to determine the rate of the infusion or if the rate was increased or decreased over the total time of the transfusion. A review of the document titled, “Informed Consent for Transfusion” was as follows: “ ...1. Proposed Treatments(s)/Physician: For: Patient #9 Transfusion(s) proposed: The proposed transfusion was blank Transfusion(s) ordered by: Physician #11 (last name only) ...” The patient and the RN signed the bottom of page 1 (1 of 2 pages). There was no date or time when the patient or the nurse signed the document. Page 2 was the signature page for the patient, witness, and the physician. The page was blank. An interview was conducted with DQM Staff #6 on 1/28/2025 after 9:00 AM. Staff #6 was asked if Patient #9 was consented for the transfusions she was administered on 12/29/2024, 12/30/2024, and 1/03/2025. Staff #6 confirmed there was no way to confirm that the consent that was signed was before the transfusions were administered on 12/29/2024, 12/30/2024, and 1/03/2024. Staff #6 stated, “I cannot prove to you that Patient #9 had a signed informed consent before the blood and platelet transfusions were administered. A review of the order dated 1/05/2025 was as follows: “Transfuse 1-unit PRBC today. Transfuse 1-unit single dose platelets. Premedicate with Tylenol 650mg po (oral) and Benadryl 25 mg po”. There was no rate or duration ordered by the provider for the blood or platelet transfusion. The ordering prescriber’s signature was illegible and there was no date or time when the order was written. A review of the transfusion flow sheet for the platelets dated 1/05/2025 revealed the transfusion was started at 2125 (9:25 PM). The first set of vital signs were taken at 2140 (9:40 PM) 15 minutes after the initiation of the transfusion and again at 2225 (10:25 PM). The transfusion was completed at 2240 (10:40 PM). Vital signs were taken at the completion of the transfusion at 10:40 PM and again at 11:10 PM 30 minutes after the completion of the platelet transfusion. There was no signature of the nurse discontinuing the blood transfusion. Further review revealed there was no documentation of the rate of infusion for the entire time of the transfusion. The surveyor was unable to determine the rate of the infusion or if the rate was increased or decreased over the total time of the transfusion. A review of the transfusion flow sheet dated 1/05/2025 for the transfusion of the PRBCs revealed the transfusion started at 2245 (10:45 PM). The first set of vital signs were taken at 2300 (11:00 PM) 15 minutes after the start of the transfusion and again at 2345 (11:45 PM), 0045 (12:45 AM), 1:45 AM, and at 2:20 AM. The transfusion was completed at 2:20 AM. Vital signs were taken again 30 minutes after the completion of the transfusion at 2:50 AM. There was no signature of the nurse discontinuing the blood transfusion. Further review revealed there was no documentation of the rate of infusion for the entire time of the transfusion. The surveyor was unable to determine the rate of the infusion or if the rate was increased or decreased over the total time of the transfusion. A review of the informed consent was as follows: “ ...Proposed Treatment(s)/Physician: For: Patient #9 Transfusion(s) proposed: PRBC, platelets Transfusion(s) ordered by: Physician #11 (last name only) ...” An interview was conducted with DQM Staff #6 on 1/28/2025 after 9:00 AM. Staff #6 confirmed there was no rate or duration of the blood transfusion ordered by the provider. Also, Staff #6 confirmed the nursing staff failed to document the vital signs according to the facility policy. There were no vital signs documented 5 minutes after the initiation of the blood/blood product transfusion and there were no vital signs documented 1 hour after the completion of the blood/blood product transfusion as required by the facility policy. Staff #6 confirmed there should be no abbreviations on the informed consent and that PRBC should be spelled out. A review of the facility policy titled, “Blood and Blood Components-Administration”, Policy # CL-3.2, with a last review date of 1/2023 was as follows: “PURPOSE: * To restore blood constituents depleted or destroyed by disease, injury or surgery. * To provide guidelines for the verification process with replacement of blood and blood components. * To provide·nursing services with guidelines for the safe administration of blood and blood components and proper documentation of blood and blood components. POLICY: Registered Nurses may initiate the administration of and monitor blood and blood components. Licensed Vocational nursing staff may monitor the administration of blood and blood components ... III. At the time of infusion The registered nurse who administers the blood is the last point at which positive identification occurs before the patient is transfused. Evidence of informed consent should be checked prior to the administration of the blood ... 5. Order: The blood or component should be checked against the physician’s written order ... ADMINSTRATION PROCEDURE: I. Administration of Blood/Blood Components a. Verify physician’s order. b. Identify the patient insuring the correct identification procedures (see Patient Identification policy). c. Verify blood transfusion consent ... u. Vital signs should be performed and documented per Blood and Blood Components Flow sheet ... V. Documentation a. Document all vital signs: 1. Baseline vital signs may be taken within 30 prior to start time. Vital signs should then be taken at 5 minutes and 15 minutes, then end and 1 hour posttransfusion 2. All vital signs must be documented on the Blood/Blood Components form. b. Document the starting and ending time of the transfusion on the Blood and Blood Components form ...” An interview was conducted with RN Staff #12 on 1/28/2025 at 10:45 AM. RN Staff #12 was asked who determined the rate of infusion or the duration of the blood/blood products transfusion. RN Staff stated, “I usually start it at a slow rate of about 80ml an hour and then I will increase it”. RN Staff #12 was asked what was the duration of the blood/blood product transfusion. RN Staff #12 stated, “It goes on a pump and the pump calculates it. We consider each unit of blood is about 325 ml and we start it slow then increase it so that it gets in within 4 hours”. RN Staff #12 was asked about the rate of transfusion for platelets. RN Staff #12 stated, “Platelets can go in pretty fast”. RN Staff #12 was asked if the providers ordered the rates or duration for any of the blood products. RN Staff #12 confirmed the providers did not order rates for blood/blood product transfusions. An interview was conducted with RN Staff #13 on 1/28/2025 at 11:15 AM. RN Staff #13 was asked who gets the informed consent for the blood transfusion. RN Staff #13 confirmed the nurses get the consent from the patient before they start the transfusions. RN Staff #13 was asked who discussed the risks and benefits of receiving blood/blood products with the patient. RN Staff #13 stated, “The nurses do”. RN staff #13 was asked how did she determine the rate and duration of the transfusion for the blood/blood products. RN Staff #13 stated, “It depends on the patient’s overall health. I usually start it at 75ml an hour and then I will increase it to 100ml an hour if they are not having any problems”. RN Staff #13 was asked if the physician ordered the rate or duration for the transfusions. RN Staff #13 confirmed the physicians do not put that in their transfusion orders. An interview was conducted with CCO/COO Staff #3 and DQM Staff #6 on 1/28/2025 after 11:00 Am. Staff #3 and Staff #6 were asked if the providers documented the rate or duration for the transfusion of blood/blood products in their orders. Staff #6 confirmed the providers were not documenting a rate or duration for the transfusion in their orders. Also, Staff #6 confirmed the nursing staff failed to follow the facility policy titled, “Blood and Blood Components Administration”.”

“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: 32143 Based on review and interviews the facility failed to ensure the physicians and providers had dated, timed, and authenticated all physician orders within 96 hours as required by the Texas Administrative Code133.41(j)(7) in 4 of 4 (Patients #12, #13, #7, and #9) charts reviewed. The facility failed to follow the policy and procedure on verbal orders to ensure verbal restraint orders were being signed within 24 hours in 1(pt. #13) of 4 of 4 (Patients #12, #13, #7, and #9) charts reviewed. A review of patient medical records revealed the following orders did not have a date, time, or signature from the provider for authentication as of 1/28/25. Patient # 13 1. Telephone order dated 10/2/24 at 1829 stated, “RE: pulled out NG tube, attempting OOB -ok to place bilateral hand mittens ( failed to follow policy and procedure to ensure the order was signed within 24 hours.) - Resume Geodon 10mg IM Q8hrs PRN agitation.” 2. 10/2/24 at 1830 RE: Pulled out NGT -Reinsert NGT -CXR post placement to verify placement. Patient # 12 1. Restraint Assessment Physician Order dated 11/1/24. Telephone order for bilateral mittens. 2. 11/3/24 1205 pm verbal order, “Seroquel 25 mg po BID.” 3. 11/3/24 0930 verbal order, “VA to set up Hospice services at an SNF due to life expectancy of less than 6 months.” An interview was conducted with Staff # 8 on 1/28/25. Staff #8 was shown multiple orders without a date, time, or signature from the provider for authentication. Staff #8 was asked how she monitored the charts that did not have the physician’s signature over 96 hours. Staff #8 stated that she sends the physicians text messages to remind them. Staff #8 stated she was unaware of any time frames. Staff #8 stated that she did not have a current list of expired charts but maybe the corporate office had them. Staff #8 stated there had been no physician privileges suspended. Staff #8 was unable to provide the surveyor with a delinquent list. A review of the policy and procedure Verbal and Telephone orders stated, “5. Verbal/telephone orders shall be countersigned as soon as possible by the ordering practitioner with the following exception: verbal /telephone orders for restraints, Scheduled class II drugs, and DNRs must be signed and dated by the ordering physician within 24 hours.” 40989 Findings: Patient #7 A review of Patient #7s medical record revealed unsigned telephone orders greater than 96 hours. A review of the Telephone Orders dated 11/19/2024 were as follows: “11/19/24 (no time documented) Chem 8 today to verify Hgb & Hct. TORB Physician #10/Registered Nurse (RN) signature illegible”. “11/19/24 2122 Re: Chem 8 recheck H/H 6.1/18 Type/Crossmatch & transfuse 1-unit PRBC Repeat CBC in AM TORB Nurse Practitioner #9/Physician #10/RN signature was illegible”. Patient #9 A review of Patient #9’s medical record revealed unsigned telephone orders greater than 96 hours. A review of the telephone dated 12/30/2024 at 10:20 AM was as follows: “Transfuse 1 unit of single platelet donor. Give Tylenol 650mg oral once prior to transfusion”. The physician’s signature was illegible and there was no date or time when the physician authenticated the telephone order. The physician’s signature was illegible and there was no date or time when the physician authenticated the telephone order A review of the telephone order dated 1/3/25 at 1110 AM was as follows: “Transfuse 1-unit single dose platelets. Pre-medicate with PRN Tylenol. TORB Physician #11/staff signature was illegible.” The physician’s signature was illegible and there was no date or time when the physician authenticated the telephone order. An interview was conducted with Staff #3 on 1/28/2025 after 10:00 AM. Staff #3 confirmed the physicians were not authenticating their telephone orders within 96 hours.”

“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: 40989 Based on observation and interview, the facility failed to maintain a clean and sanitary environment to ensure patient safety in 8 (Main Hallway, Patient Hallway, Emergency Treatment Room in the Radiology Department, Central Supply, Patient Room #114 in the ICU, Medication Room, Patient Nourishment Room, and Shower Room) of 8 areas observed. Findings: An observation tour was conducted with Chief Executive Officer (CEO) Staff #1 on 1/27/2025 at 11:49 AM. The following was observed: Main Hallway to Patient Care Units Stored in a cubby in the main hallway were 8 wheelchairs and 1 patient lift. There was no way to identify if the patient equipment was clean or dirty. 6 pieces of tape were left on the arm of a wheelchair making it incapable of cleaning the surface. The vinyl covering on the armrest of two of the wheelchairs was torn and exposed the cushion beneath. The cloth cushion could not be cleaned and would absorb bodily fluids that could be unseen. The patient lift was visibly soiled with dirt and dust. Staff #1 confirmed the equipment was available for patient use. Patient Hallways It was noted in 2 separate patient care hallways that portable vital sign machines were being stored and plugged into an electric outlet and ready for patient use. The compartments under the tabletop were noted with dirt, dust, debris, and hair. The base of the portable machines was soiled with heavy dirt and dust. Emergency Treatment Room in the Radiology Department The emergency treatment room in the radiology department had an emergency cart that stored emergency medications and supplies. Inside the cart the following supplies were noted: 12-10ml normal saline syringes expired 11/30/2020 3-24 gauge (g) intravenous (IV) catheters expired 5/31/2022 5-25g IV catheters expired 4/30/2024 2-21g IV catheters expired 11/30/2024 4-16g IV catheters expired 1/31/2022 1 bottle of 500ml normal saline expired 4/06/2022 Inside a gray rolling cart was a 100 ml single-dose vial of Sterile Water. The vial was open and had been used with no opened or beyond-use date noted on the bottle. 6 large sterile gowns were stored on a shelf in the room. 1 expired on 4/2019, 1 expired on 7/2020, and 4 expired on 7/2017. Central Supply The supply room was used to store patient supplies. There was no separation between clean and dirty. External shipping boxes were stored next to sterile supplies. Supplies were delivered to this room and not to a dirty area outside the central supply. Corrugated boxes with webbed edges were stored can harbor insects and contaminate all supplies in the room. Storage bins used to store supplies were heavily soiled with dirt and dust on the lids. The lids were cracked and broken. Inside the bins there was dirt, dust, and dead insects stored with patient supplies. An interview was conducted with Staff #7 on 1/28/2025 at 1:30 PM. Staff #7 was asked to show the separation of the clean and dirty area in the supply room. Staff #7 replied, “I try and keep it separated the best I can”. Staff #7 confirmed when the supplies come in they come to his department directly and there is no other storage for them. Staff #7 confirmed he was not aware that external shipping boxes could not be stored with other supplies. Staff #7 was asked if he monitored the temperature and the humidity in the supply room due to sterile supplies and sterile solutions being stored in the room. Staff #7 confirmed he was not aware that the temperature and humidity had to be controlled or documented in the supply room. Patient Room #114/Intensive Care Unit Patient Room #114 was ready to receive a new admission. Beneath the mattress on the bed frame, it was noted to be heavily soiled with dirt, dust, and a black sticky substance. An interview was conducted with CEO Staff #1 on 1/28/2025 after 1:30 PM. Staff #1 was asked if the facility had an Infection Control Nurse. Staff #1 replied, “We do not have a full-time Infection Control Nurse. We are looking to hire an Infection Control Nurse now. Staff #6 is the interim Infection Control Nurse but she also has 2 other roles that she has responsibility over”. Staff #1 confirmed the facility did not have a policy on monitoring temperature and humidity on patient sterile supplies. 32143 Findings: Medication Room- in the nurse’s station for the medical unit. The medication room had a refrigerator for medication storage. The fridge was soiled with dirt, dust, and hair. The refrigerator was freezing along the back wall creating ice. The medication preparation area was soiled with dust and hair. The plastic containers holding patient medication and supplies were soiled with dust, hair, paper particles, and dried spilled substances. The metal trash can was rusted and dirty. The mechanical pill crusher was heavily soiled with dust, medication residue, and dried spilled liquids. The stainless worktable had rusted legs. The rust was unable to be cleaned. Patient Nourishment Room The refrigerator and freezer were soiled with hair and dust. The freezer was frozen inhibiting cleaning of the freezer surface. Patient Isolation Room on the medical unit. The patient isolation room had a wooden bedside table and chair not sealed in some areas exposing wood. The wooden furniture Wood pieces had a porous surface and were not cleaned properly. The sink area was missing laminate from the bottom of the base leaving exposed wood. The bottom of the pyxis was soiled with dust and hair. IV fluids were placed in containers that were soiled within the pyxis. Shower Room A large shower room was found on the medical floor. The room had equipment stored within the bathroom area. A large reclining Geri Chair and a bedside commode were found. Staff # 3 was unable to identify if this equipment was clean or dirty.”