Palestine Regional Medical Center

“OPERATING ROOM REGISTER CFR(s): 482.51(b)(5) The operating room register must be complete and up to date. This Standard is not met as evidenced by: 40989 Based on document review and interview Surgical Services failed to maintain a complete and up to date operating room register for 40 of the 40 days reviewed. Findings: A review of the operating room registers from 7/01/2024-8/09/2024 was conducted on 8/12/2024 at 1:00 PM with the Interim QAPI Director, Staff #3. A review of the register revealed the names of each employee who cared for the patient throughout the Perioperative period. The Perioperative period includes pre-operative (before surgery), intra-operative (in the operating room), and post-operative (after surgery) time. There were no credentials or positions (i.e., circulator or scrub) documented next to any of the case staff listed on the register. An interview was conducted with RN Staff #3 and Surgical Services Director, RN Staff #5 on 8/12/2024 at 1:30 PM. RN Staff #3 and RN Staff #5 confirmed the operating room register did not identify who the scrub (Certified Surgical Technologist, Registered Nurse, or Licensed Practical Nurse assisting the surgeon during the operation) or circulator (an RN that is responsible for the patient care outside the sterile field during the surgery) was during the patient’s surgical procedure.”

“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: 28659 Based on observation, document review, and interview, the Governing Board (Board of Trustees) failed to: 1. ensure a properly executed informed consent was completed in 9 (Patient #5, #6, #12, #13, #14, #15, #16, #65, and #66) of 9 patient medical records reviewed in 3 (Emergency Room, Anesthesia, and Labor and Delivery) of 3 departments. Also, the hospital failed to follow its policies titled, “Consent and Disclosure for Medical and Surgical Procedures and Administration of Moderate Sedation by Non-Anesthesia Personnel With Appendix in the Emergency Department”. Refer to A 0131 2. implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program when: a. the facility failed to ensure the QAPI program measured, analyzed, and tracked quality indicators and used the data to monitor the effectiveness and safety of services and quality of care when there was no evidence these were being completed through the quality council. Refer to Tag A0273 3. a. the facility failed to ensure the Quality Program took actions aimed at performance improvement and, after implementing those actions, measured its success, and tracked performance to ensure that improvements were sustained when actions/resolutions and follow-ups were not documented. Refer to Tag A0283 4. a. the facility failed to ensure the hospital’s governing body ensured the QAPI program involved all hospital departments and services when dietary staff were not involved in QAPI meetings, and each department, the clinical subcommittee, and hospital committee reports were not discussed and updated each meeting. b.ensure the hospital’s governing body ensured the QAPI program involved all hospital departments and services when dietary staff were not involved in QAPI meetings, and each department, the clinical subcommittee, and hospital committee reports were not discussed and updated each meeting. Refer to A 0308 5. ensure Staff #30 (Charge Nurse), on the 3rd Floor Medical-Surgical Unit, was competent in the use of the Life Pack emergency defibrillator on 2 of 2 emergency crash carts. Also, the hospital failed to identify and remove expired supplies from the emergency crash carts. Refer to Tag A0386 6. a. ensure adequate staffing was provided for all patient care units, was unable to provide a patient acuity tool to determine the staff needed to provide safe care, or an acuity grid/matrix to determine the number of minimal staff needed for 7 out of 7 ( Inpatient Rehabilitation, Emergency Department, Mother/ Baby 606, Psych PRU 1 and PRU 2, Medical/Surgical 605, and ICU) patient care units. b. ensure the dialysis department had, at a minimum, 2 trained Registered Nurses readily available to provide direct patient care to patients receiving hemodialysis. Also, the hospital failed to have a staffing matrix and plan for the dialysis department. Refer to Tag A0392 7. ensure the physician was explaining to the patient the risk and benefits of blood while obtaining the blood consent. The facility failed to ensure that the blood administration policy and procedure gave accurate instructions on obtaining blood consent and ensure the consent had a signature line, date, and time for the physician to sign in 2 of 2 (pt #4 and 8) charts reviewed. Refer to Tag A0410 8. ensure patient medical record entries were legible, completed, dated, timed, and authenticated by staff on the Cardiopulmonary Resuscitation Report in 5 (#29, #32, #33, #43, #44) of 5 patients records reviewed. Also, the Quality Department failed to monitor these reports for opportunities for improvement as required in the hospital’s policy, “Cardiopulmonary Resuscitation/Adult or Pediatric Code Blue and Neonatal Code Blue” Refer to Tag A0450 9. maintain a clean and sanitary environment in 7 (Medical/Surgical, Materials Management, Behavioral Health PRU #1 and PRU #2, Respiratory, Labor and Delivery/Womens Services, and Emergency Room,) of 7 Departments observed to avoid sources and transmission of infection when infection control tour findings throughout the survey were observed and infection control rounds were not being performed regularly. Refer to A 0750 10. develop and implement a hospital-wide infection surveillance, prevention, and control policies and procedures that adhered to nationally recognized guidelines when there was no active surgical site infection [SSI] surveillance. Refer to A0772”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 40989 Based on observation, document review, and interview the hospital failed to ensure: A. a properly executed informed consent was completed in 9 (Patient #5, #6, #12, #13, #14, #15, #16, #65, and #66) of 9 patient medical records reviewed in 3 (Emergency Room, Anesthesia, and Labor and Delivery) of 3 departments. Also, the hospital failed to follow its policies titled, “Consent and Disclosure for Medical and Surgical Procedures and Administration of Moderate Sedation by Non-Anesthesia Personnel With Appendix in the Emergency Department”. Refer to Tag A0131 B. the Emergency Department had a working emergency call system in 2 (Exam Room # 8 and Exam Room # 7) of 14 patient exam rooms. The nursing staff failed to ensure 3 (Patient # 22, # 23, and # 24) of 3 patients had the emergency call light within reach to utilize in the event assistance was needed. Also, the hospital failed to ensure a staff member monitored and responded to the patient call lights in the Emergency Department. C. 3 (# 67, # 68, and # 69) of 3 patients undergoing hemodialysis treatment with an unknown Hepatitis B status were treated in a location that prevented the transmission of Hepatitis B to other patients and staff members. Also, the hospital staff failed to follow the facility policy, “Hemodialysis Infection Prevention”. D. dialysate samples were sent to the laboratory for testing when dialysate manufacturers were changed. Refer to Tag A0144”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 36594 Based on review of facility documents and staff interview, the facility failed to implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program when: A. the facility failed to ensure the QAPI program measured, analyzed, and tracked quality indicators and used the data to monitor the effectiveness and safety of services and quality of care when there was no evidence these were being completed through the quality council (Cross refer A0273). B. the facility failed to ensure the Quality Program took actions aimed at performance improvement and, after implementing those actions, measured its success, and tracked performance to ensure that improvements were sustained when actions/resolutions and follow-ups were not documented (Cross refer A0283). C. the facility failed to ensure the hospital’s governing body ensured the QAPI program involved all hospital departments and services when dietary staff were not involved in QAPI meetings, and each department, the clinical subcommittee, and hospital committee reports were not discussed and updated each meeting (Cross refer A0308).”

“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: 32143 Based on observation, record review, and staff interviews, the hospital failed to. 1. ensure Staff #30 (Charge Nurse), on the 3rd Floor Medical-Surgical Unit, was competent in the use of the Life Pack emergency defibrillator on 2 of 2 emergency crash carts. Also, the hospital failed to identify and remove expired supplies from the emergency crash carts. Refer to Tag A0386 2. A. ensure adequate staffing was provided for all patient care units, was unable to provide a patient acuity tool to determine the staff needed to provide safe care, or an acuity grid/matrix to determine the number of minimal staff needed for 7 out of 7 ( Inpatient Rehabilitation, Emergency Department, Mother/ Baby 606, Psych PRU 1 and PRU 2, Medical/Surgical 605, and ICU) patient care units. B. ensure the dialysis department had, at a minimum, 2 trained Registered Nurses readily available to provide direct patient care to patients receiving hemodialysis. Also, the hospital failed to have a staffing matrix and plan for the dialysis department. Refer to Tag A0392 3. ensure the physician was explaining to the patient the risk and benefits of blood while obtaining the blood consent. The facility failed to ensure that the blood administration policy and procedure gave accurate instructions on obtaining blood consent and ensure the consent had a signature line, date, and time for the physician to sign in 2 of 2 (pt #4 and 8) charts reviewed. Refer to Tag A0410 4. ensure patient medical record entries were legible, completed, dated, timed, and authenticated by staff on the Cardiopulmonary Resuscitation Report in 5 (#29, #32, #33, #43, #44) of 5 patients records reviewed. Also, the Quality Department failed to monitor these reports for opportunities for improvement as required in the hospital’s policy, “Cardiopulmonary Resuscitation/Adult or Pediatric Code Blue and Neonatal Code Blue” Refer to Tag A0450”

“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: 36594 Based on review of records, observation, and staff interviews, the facility failed to have an active hospital-wide program for the surveillance, prevention, and control of HAIs and other infectious diseases when: A. the facility failed to ensure policies and procedures were implemented and enforced (Cross Refer A0749). B. the facility failed to maintain a clean and sanitary environment and infection control rounds in 7 (Medical/Surgical, Materials Management, Behavioral Health PRU #1 and PRU #2, Respiratory, Labor and Delivery/Womens Services, and Emergency Room,) of 7 Departments observed. (Cross Refer A0750). C. the facility failed to ensure policies and procedures adhered to nationally recognized guidelines when there was no active surgical site infection surveillance (Cross Refer A0772).”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 29191 Based on observation, interview, and record review, the surgical staff failed to: A. to provide documentation that the filters were changed on the Endoscope reprocessing washers per the IFU (instructions for use) of the water filtration system and identify that the chemical strips for checking the high-level disinfectant were within use date. B. ensure the temperature and humidity in the Post Anesthesia Care Unit were within acceptable standards for patient supplies to inhibit microbial growth, reduce the risk of infection, promote patient comfort, and assure the physical safety of all patients. C. ensure that clean and sterile tourniquets are left in the original package for surgical staff to determine if the tourniquets were clean or used. D. ensure a sanitary environment for the provision of surgical services and patient care areas for 3 (surgery, pre-holding area before surgery, and Post post-anesthesia care Unit) of 3 areas. E. check for expired supplies in the Crash Cart, pre-holding supply cart, and the designated isolation room in the Post Anesthesia Care Unit (PACU) F. place a “Certificate Registration for Lasers” from the Department of State Health Services with a current employee who works for the surgical department. G. the hospital’s employee health nurse #70 failed to ensure that 1 (# 35) of 5 staff members working in a high-risk area (surgery) were vaccinated and/or had positive immunity against the Hepatitis B virus. Findings Include: A. Water filters 1 micron, .45 micron, and 0.2 micron are to be changed every 6 months. Air filters for Station A and Station B are to be changed every 3 months. Carbon filter on the back of the “Medivators DSD reprocessor” every 6 months per the manufacturer guidelines. A review of the “DSD, SSD, Filter Change Log” for March 2022 through March 2024 for Medivators reprocessor serial # 624624-041 and 624624-038 revealed the following: Serial # 624624-041 The 6-month change for Water filters 1 micron, .45 micron, and 0.2 micron were due in September of 2023. Also, the filters for Station A and Station B and the Carbon filter on were all dated 9/28/2015 (sic..). The Air filters for “Station A and Station B” were to be changed every 3 months, but were only being changed every 6 months. Missed dates for changing the Air filters for Station A and Station B were the following: 6/2023 9/2015 was documented as 9-28-15 (sic ...) 12/2023 Serial # 624624-038 The 6-month change for Water filters 1-micron, .45-micron, 0.2-micron, and Carbon filter were due in September of 2023. There was no documentation found that the filters were changed. The Air filters for “Station A and Station B” were to be changed every 3 months but were only being changed every 6 months. Missed dates for changing the Air filters for Station A and Station B were the following: 6/2023 9/2023 12/2023 During the tour of the Endoscopy lab on 03/19/2024 at 2:17 PM observed the Medivators Rapicide chemistry strips expired on 05/04/2023. A surgical staff member had labeled the top of the Rapcide Chem-strip bottle opened on 03/18/2024 and expired on 06/15/2024. The bottle of Rapcide Chem-strip is good for 90 days once the bottle is opened per the manufacturer’s guidelines. The issue was the staff was using a bottle of Rapcide Chem-strip that expired on 05/04/2023. A review of the hospital policy titled, “Cleaning of Endoscopic Instruments” “Test the liquid chemical disinfectant(Rapicide) using the designated test strips according to the manufacturer’ guidelines. Immerse the test strip into the Rapicide reservoir for 3 seconds. Lay the strip flat for 75 seconds. Read the results. If the strip fails, do not use this station until the Rapicide is changed. Check the temperature of the Rapicide. It must be at a minimum of 35 degrees Celsius to provide high-level disinfection. The Medivator flushes the endoscopes with alcohol and air automatically at the end of each cycle.” An interview with the Director of Surgery #36 (RN) on 03/19/2024 at 2:30 PM acknowledged that there were missing dates on changing the water filters 1-micron, .45-micron, 0.2-micron, and Carbon filter every 6 months and the air filters were not changed every 3 months. Also, the staff working in the endoscopy department were using expired Rapcide Chem-strips to confirm the minimum recommended concentration of the disinfectant. B. Post-Anesthesia Care Unit (PACU) Observed a large supply closet in the PACU area that stored clean and sterile patient supplies. When the surveyor opened the door, it was very warm in the room due to the computer wiring system being located in the supply closet. Also, observed numerous patient supplies were being stored in PACU Bay #2. Aspire drainage system boxes X 3 Laparoscopic sealer X 4 Implant handle cartridge kit X 4 Radiofrequency single-use probes Cotton rolls in a large cardboard box Circular stapler X 3 Isovue-300 x 8 There were cardboard boxes stacked on sterile supplies. There were plastic bins and pieces of metal shelves being stored directly on the floor. The bay was cluttered with equipment, plastic bins, and cardboard boxes mixed with the sterile supplies on open carts. There was no organization to the arrangement of supplies, plastic bins, and equipment. The curtain used to enclose the supplies and equipment had a dark red stain unknown what the stain consisted of. There was no documentation to show that the Post-Anesthesia Care Unit Temperature and humidity were monitored in this area. An interview with Staff #36 on 2/18/2024 at 11:30 AM confirmed that no temperature and humidity was being checked in the Post-Anesthesia Care Unit. Review of the AORN Perioperative Standards and Recommended Practices, “Temperature should be maintained between 68 degrees Fahrenheit (F) to 75 degrees Fahrenheit (20 degrees to 23 C) within the operating room suite. Procedure rooms should be maintained between 70 degrees F to 75 degrees F. Temperature should be maintained at a maximum of 75 degrees F in sterile storage areas. Relative humidity should be maintained between 20% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac Catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas, and should be maintained below 60% in sterile storage areas. C. During a tour of the operating rooms on 2/18/2024 at 10:30 AM observed in operating Room #5 were sterile tourniquets out of the original package and lying in a basket of the tourniquet machine. There were 8 tourniquets all different sizes. There was no way to determine if the tourniquets were clean or had been used in a procedure. Observed in the sterile supply room were large gray plastic bins of open tourniquets of various sizes out of their original packages. Tourniquets 18-inch X 8 30-inch X 6 34-inch X 5 42-inch X 11 All tourniquets stored out of the original packages. An interview with Staff #58 on 02/18/2024 at 11:30 AM confirmed the tourniquets come in sterile individual packages. An interview with staff #36 on 02/18/2024 at 11:45 AM confirmed the surgical staff have been removing the tourniquets from the original packages. There was no way to know if tourniquets were sterile or used. D. During a tour of the Surgery Department with Staff #36 on 2/18/2024 at 11:00 AM observed the following infection control issues. * Observed an open package of Yankauer suction tip connected to the suction tubing on 3 of 3 operating rooms toured. A review of the hospital policy titled, “ Infection Control in the Operating Room” dated /approved 11/2021 revealed the following: “ANESTHESIA EQUIPMENT 1. The anesthesia machine/cart may become contaminated during the course of providing anesthesia services. 2. The exposed surfaces of the anesthesia machine/cart and the monitors are cleaned and wiped down each day and a clean towel placed on top. If the machine/cart become visibly contaminated, it should be cleaned immediately. 3. Single use equipment (ETT, face masks, breathing circuits, oral/nasopharyngeal airways) is disposed of. 4. Reusable equipment (laryngoscopes, LMAs, bougies) are cleaned and sterilized and returned to use. 5. An effective new bacterial/viral circuit filter is used for every patient. 6. Head straps and blood pressure cuffs are cleaned periodically and immediately if soiled.” * In operating room #6 observed the Boive unit ( electrosurgical unit ) had silk tape X 2 areas wrapped around the holding rod that held an instruction sign for GI Bleeds. Silk tape cannot be disinfected. * In operating room #5 was a rusted intravenous pole with a worn enamel finish. Rusted metal cannot be disinfected. * The gray plastic trash can outside operating room #5 had large gouges in the plastic making it difficult to disinfect. * In the equipment storage area observed metal stirrups with blue plastic soft holders. One of the blue cushions on the stirrup was covered in white cloth silk tape which can not be disinfected after patient use. * In the designated isolation room in the PACU area was a brown lounge chair with a cushion showing the vinyl. Cushion foam cannot be disinfected. * There was a broken back green chair in the isolation room that could be a safety hazard for nursing staff that tried to use the chair. * In the cabinet of the isolation room the following expired items were found: 1. Blunt tips X 15 expired 12/31/2021 2. 3 cc syringes X 5 expired 1/31/2024 3. 5 cc syringes X 5 expired 12/31/2022 4. 10 cc syringes X 5 expired 2/28/2022 5. A bottle of opened 1% lidocaine expired September 2023 * There was a pool of white dried substance under the ice machine located in the PACU unit. There was a wire lying in the white substance that was stuck in the dry substance. * Observed personal items (2 paper gift bags) sitting on the bedside table in bay #10 of the PACU unit where patients were treated. * In Bay #10 of the PACU unit was a staff-labeled refrigerator with food and drinks sitting up on a brown wooden table with a jar of peanuts. On the shelf was a red cup with an orange and blue bag. There was a bedside table with a scrub hat, a plastic bowl, and a paper bag. On the opposite side was another bedside table with a drinking cup, lotion, portable fan, and plastic cup of candy. On the shelf in bay #10 was a coffee cup, and another drinking cup. Surveyor observed 2 personal plaques in the cubicle designated as a PACU bay for treating patients. An interview with Staff #37 on 03/18/2024 at 11:30 AM was asked by the surveyor why Bay #10 was set up with food and drinks. Staff #37 reported we didn’t have time to go to the break room, so Bay #10 area was used for our break room. A review of the AORN (Association of Perioperative Registered Nurses) 2019 Perioperative Standards and Recommended Practices, Guidelines for Sterilization, revealed the following: “ ...Recommendation IV.c. Supplies and equipment should be removed from external shipping containers and open-edged corrugated cardboard boxes before transfer to the sterile storage area or point of use. External shipping containers and open-edged cardboard boxes may collect dust, debris, and insects during shipment and may carry contaminants into the surgical suite ...” A review of ANSI/AAMI ST79:2017 revealed the following: “11.1 Sterile Storage Sterile items should be stored under environmentally controlled condition that reduces the potential for contamination ... Supplies should be removed from external and web-edged shipping container before transport to any restricted area ...” * Observed in the Bio-hazard closet were a Christmas tree, 6 “Olympus” cardboard endoscopic boxes for shipping scopes. Also, the black plastic cases that the endoscopes come to the hospital were being stored in the closet. The “Olympus” boxes and black cases are used to ship the endoscopes back to the company for repairs. All items were stored in the closet labeled with an orange sign “Bio-hazard waste”. E. Pre-Holding Area Room There was a blue cart in the room that stored patient supplies. The top of the cart was coated in dust, dirt, debris, and hair. The bins in the cart and in the room that stored sterile and non-sterile supplies were coated in dust, dirt, and debris. Observed the following expired supplies in the blue cart. 1. Tegaderm expired 10/29/2022 2. Gloves 71/2 expired 4/28/2023 Gloves 71/2 expired 3/28/2023 Gloves 71/2 expired 5/28/2020 Gloves 81/2 expired 8/28/2022 Gloves 81/2 expired 4/28/2021 3. Nasopharyngeal airway expired 12/28/2022 F. Upon entering the Surgery department observed the “Certificate Registration for Lasers” from the Department of State Health Services with the name of an employee who no longer works at the hospital. An interview with staff #36 on 02/18/2024 at 11:45 AM confirmed that the person name on the “Certificate Registration for Lasers” from the Department of State Health Services was no longer an employee of the hospital. G. This deficient practice had the likelihood to result in harm to staff members working in high-risk areas in the hospital due to failure to monitor hepatitis B immunity and vaccination status. The unknown immunity status of staff members could result in the transmission of the hepatitis B virus between patients and staff members. Staff # 35 A review of Staff # 35’s personnel file revealed Staff # 35 had a nonreactive HBV surface Antibody result on 06/29/2020. Staff # 35 received dose # 1 of the vaccine series on 07/13/2020 from the employee health nurse. Staff #35 did not receive dose # 2 or # 3 of the series. There was no evidence of a complete vaccine series or positive immunity for Staff # 35. Staff # 35 did not sign a Declination Form verifying refusal of vaccine and understanding of occupational risk and exposure to the hepatitis B virus. A review of the hospital’s policy titled, “Employee Health Program” with a revision date of 03/2023 revealed the following: “POLICY: 1.0 Purpose: To establish the criteria for obtaining physical examination information and/or any other medical examination data deemed necessary to determine an individual’s ability to perform the essential job functions of each position within the organization. As well as, set standards for reducing the potential of introducing or acquiring infectious diseases in the hospital environment and to comply with established Infection Control, Federal, or State Guidelines. Employment Requirements: 2.0 The following proof of testing or immunization will be required by Palestine Regional Medical Center and are stratified per high or low risk to establish potential exposure risk, especially to blood-borne pathogens. Each employee will have the opportunity to refuse vaccinations on the basis of allergies, conscience, religious, and/or per VIS for each vaccine describing potential contraindications and precautions: 4.0 Employees will be rated as High risk, Medium risk, and Low risk to establish necessary vaccinations for their respective position. The following table designates positions in each group and what is established immunizations for that particular group. High Risk: Respiratory Services, Laboratory, EMS, Nursing Clinical Personnel ( Includes all nurses, aides, techs, Psych techs, and social workers), and Radiology. High Risk: Hep B vaccine required Employee screen would include: medical history, Hepatitis B titer, Varicella titer, MMR titer, and TB skin test, only necessary titers will be drawn. Note: High-Risk Employees are personnel who perform tasks that may involve exposure to blood or body fluids. Employees who decline the Hepatitis B vaccine, or those that are deemed NonResponders (refers to a person who does not develop protective surface antibodies after completing two full series of the hepatitis B vaccine and for whom an acute or chronic hepatitis b infection has been ruled out), will be counseled regarding proper protective equipment per OSHA standards (gloves, gowns masks, etc.) at screening and reiterated in employee orientation.” An interview with Staff #70 (Employee Health RN) on 03/19/2024 at 11:30 AM confirmed that Staff #35 had only been given the initial dose of the hepatitis B vaccine. The surveyor asked why Hepatitis B vaccines #2 and #3 were not given. Staff #70 stated, “I guess it just got overlooked.””

“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 hospital failed to ensure a properly executed informed consent was completed in 9 (Patient #5, #6, #12, #13, #14, #15, #16, #65, and #66) of 9 patient medical records reviewed in 3 (Emergency Room, Anesthesia, and Labor and Delivery) of 3 departments. Also, the hospital failed to follow its policies titled, “Consent and Disclosure for Medical and Surgical Procedures” and “Administration of Moderate Sedation by Non-Anesthesia Personnel With Appendix in the Emergency Department”. Findings: Patient #5 Patient #5 was admitted to the Labor and Delivery Unit on 3/16/2024. A review of the document titled, “Disclosure and Consent Medical Care and Surgical Procedures” revealed Patient #5 and the Physician (signature illegible) signed, dated, and timed the informed consent on 2/22/2024 at 4:45 PM. The witness, LVN Staff #74 failed to date or time her signature on the informed consent. A review of the Disclosure and Consent for Anesthesia was signed, dated, and timed by Patient #5 on 3/16/2024 at 1:55 PM. Patient #5 consented to General anesthesia and an Epidural. There was no witness signature on the consent. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent. Patient #6 Patient #6 was admitted to the Labor and Delivery Unit on 3/07/2024. A review of the document titled, “Disclosure and Consent Medical Care and Surgical Procedures” was as follows: “ ...Cesarean section including assisted delivery with forceps and/or vacuum with bilateral salpingectomy ...” Patient #6 and the Physician signed, dated, and timed the informed consent on 2/15/2024 at 12:00 PM. The witness, LVN Staff #73 signed, dated, and timed the informed consent on 2/15/2024 at 11:30 AM. This was 30 minutes before the patient and physician signed the consent. A review of the Disclosure and Consent for Anesthesia was signed, dated, and timed by Patient #5 on 3/07/2024 at 11:45 AM. Patient #5 consented to General anesthesia, Regional Block Anesthesia, and Spinal Anesthesia. The witness’s signature was not dated or timed. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent. An interview was conducted with RN Staff #16 on 3/18/2024 at 10:45 AM. RN Staff #16 was asked if the procedure on the consent was correct. RN Staff #16 stated, “No, it is not. The part about the forceps and the vacuum should have been removed because you do not use them during a C-section. The consent was obtained in the physician’s office and the error was not caught and corrected here.” Patient #12 Patient #12 was admitted to the hospital for surgery by Physician #75 on 1/08/2024. A review of the document titled, “Disclosure and Consent Medical Care and Surgical Procedures” revealed Patient #12 and the provider (signature illegible) signed, dated, and timed the informed consent on 1/05/2024 at 9:28 AM. The witness failed to date or time her signature. A review of the Disclosure and Consent for Anesthesia had been signed, dated, and timed by Patient #12 on 1/04/2024 at 8:28 AM. Patient #12 consented to General anesthesia, Regional Block Anesthesia, and Deep Sedation Anesthesia. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent. Patient #13 Patient #13 was admitted to the hospital for surgery on 1/17/2024. A review of the document titled, “Disclosure and Consent Medical Care and Surgical Procedures” was as follows: “ ...Cold knife conization of cervix, removal of IUD ...”. IUD is an abbreviation of Intrauterine Device. Patient #13 and the Physician signed, dated, and timed the informed consent on 1/17/2024 at 7:30 AM. The witness failed to date or time her signature. A review of the Disclosure and Consent for Anesthesia had been signed, dated, and timed by Patient #13 on 1/17/2024 at 7:10 AM. Patient #13 consented to General anesthesia. The witness’s signature, RN Staff #77 was not dated or timed. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent. Patient #14 Patient #14 was admitted to the hospital for surgery on 2/15/2024. A review of the document titled, “Disclosure and Consent Medical Care and Surgical Procedures” revealed Patient #14 and the provider (signature illegible) signed, dated, and timed the informed consent on 2/9/2024 at 11:39 AM. The witness failed to date or time her signature. A review of the Disclosure and Consent for Anesthesia had been signed, dated, and timed by Patient #14 on 2/15/2024 at 9:16 AM. Patient #14 consented to General anesthesia and Deep Sedation. The witness’s signature was not dated or timed. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent. Patient #15 Patient #15 was admitted to the hospital for surgery on 1/08/2024. A review of the document titled, “Disclosure and Consent Medical Care and Surgical Procedures” revealed the Physician signed, dated, and timed the informed consent on 12/27/2023 at 10:20 AM. Patient #15 signed, dated, and timed the informed consent on 1/02/2024 at 1:30 PM. The witness failed to date or time her signature. A review of the Disclosure and Consent for Anesthesia had been signed, dated, and timed by Patient #15 on 1/08/2024 at 10:33 AM. Patient #15 consented to General anesthesia and Deep Sedation. The witness’s signature was not dated or timed. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent. Patient #16 Patient #16 was admitted to the hospital for a procedure on 3/06/2024. A review of the document titled, “Disclosure and Consent Medical Care and Surgical Procedures” revealed Patient #16 and the Physician signed, dated, and timed the informed consent on 2/21/2024 at 9:19 AM. The witness failed to date or time her signature. A review of the Disclosure and Consent for Anesthesia had been signed, dated, and timed by Patient #16 on 3/06/2024 at 10:15 AM. Patient #16 consented to General anesthesia and Deep Sedation. The witness’s signature was not dated or timed. There was no signature by the anesthesia provider that explained the risks and benefits of anesthesia to the patient on the informed consent. An interview was conducted with Certified Registered Nurse Anesthetist (CRNA), Staff #38 and CRNA Staff #71 on 3/18/2024 at 10:05 AM. Staff #38 was asked if the anesthesia providers were required to sign the informed consent for anesthesia. Staff #38 replied, “This is the only place that I have worked that we do not sign the anesthesia consent. We have to sign them everywhere else.” Staff #38 was asked if the risks and benefits of the selected anesthesia were explained to the patient. Staff #38 replied, “We talk to the patient about the risks and benefits before the procedure we just do not sign the consent”. Staff #38 was asked if there was documentation in a patient’s medical record that confirmed the risks and benefits of anesthesia had been explained by an anesthesia provider. Staff #38 stated, “No”. Staff #71 confirmed the anesthesia consent should be signed by the anesthesia provider that explained the risks and benefits of anesthesia. Patient #65 Patient #65 was a 46-year-old male admitted to the Emergency Department (ED) on 3/05/2024 with a dislocated Right Shoulder. He had a past medical history of Asthma, Chronic Depression, Gastroesophageal Reflux, High Blood Pressure, Paroxysmal tachycardia (abnormally fast heart rate), Seizure, and venous embolism (blood clot in the vein). A review of the document titled, “Disclosure and Consent Medical Care and Surgical Procedures” was as follows: “ ... I voluntarily request my physician/health care provider Physician #78, (last name only) to treat my condition which is: Dislocation of R Shoulder. I understand that the following care/procedure(s) are planned for me: Sedation & Reduction... The Use of Blood consent was left blank and not addressed by the staff or the physician ...” Patient #65 and the RN signed the informed consent but failed to document a date and time. Physician #78 signed, dated, and timed the consent on 3/05/2024 at 9:30 PM. A review of the document titled, “Sedation for Procedure Consent” revealed Patient #65 and the witness signed, dated, and timed the consent on 3/05/2024 at 9:20 PM. Physician #78 failed to sign the informed consent for sedation. The informed consent for sedation failed to document if the procedural sedation was for moderate sedation or deep sedation. A review of the medical record with RN Staff #69 was conducted on 3/19/2024 at 1:20 PM. Physician #78 ordered the medication etomidate (general anesthetic) 10 mg (milligrams) IVP (intravenous push) once at 9:16 PM. The medication was administered by RN Staff #79 at 9:35 PM. RN Staff #69 confirmed Physician #78 failed to document and/or explain the risks and benefits of the procedural sedation or the type of procedural sedation to Patient #65. It was also confirmed Physician #78 used abbreviations on the informed consent and failed to identify the site of the reduction in the planned procedure. Patient #66 Patient #66 was admitted to the ED on 3/08/2024 and 3/12/2024 with a dislocated right shoulder. He had a past medical history of Seizures. Date of Service 3/08/2024 A review of the medical records was conducted with RN Staff #69 on 3/19/2024 at 1:45 PM. A review of the document titled, “Disclosure and Consent Medical Care and Surgical Procedures” was as follows: “ ... I voluntarily request my physician/health care provider Physician #78, (last name only) to treat my condition which is: (this information was left blank). I understand that the following care/procedure(s) are planned for me: Right Shoulder Closed Reduction ...” Patient #66 signed the informed consent on 3/08/2024 at 2:15 AM. The RN witnessed the informed consent but failed to document a date and time. Physician #78 signed, dated, and timed the consent on 3/08/2024 at 4:10 AM. This was 1 hour and 55 minutes after the patient signed the informed consent. There was no other documentation provided that Physician #78 discussed the risks and benefits of the procedure before Patient #66 signed the consent. A review of the document titled, “Sedation for Procedure Consent” revealed Patient #66 and the witness signed, dated, and timed the consent on 3/08/2024 at 2:15 AM. Physician #78 failed to sign the informed consent for sedation. The informed consent for sedation failed to document if the procedural sedation was for moderate or deep sedation. RN Staff #69 confirmed there was no documentation in the medical record that Physician #78 explained the risks and benefits of the sedation to Patient #66 before getting a signed informed consent for sedation. Physician #78 ordered etomidate (general anesthetic) 10 mg (milligrams) IVP (intravenous push) once at 1:57 AM. The medication was administered by Physician #78 at 4:16 AM. In an interview on 3/19/2024 after 12:30 PM, RN Staff #69 confirmed there should be no blanks on the informed consent and the physician’s name should include the first and last name. Date of Service 3/12/2024 A review of the document titled, “Disclosure and Consent Medical Care and Surgical Procedures” was as follows: “ ... I voluntarily request my physician/health care provider Physician #78, (last name only) to treat my condition which is: Right Shoulder Dislocation. I understand that the following care/procedure(s) are planned for me: Reduction of Right Shoulder ...” Patient #66 and Physician #78 signed the informed consent on 3/12/2024 at 8:40 PM. The RN witnessed the informed consent but failed to document a date and time. In an interview on 3/19/2024 after 12:30 PM, RN Staff #69 confirmed the physician’s name on the informed consent should include the first and last name and stated, “It is apparent that the RN documented the date and time for the physician and the patient.” A review of the document titled, “Sedation for Procedure Consent” revealed Patient #66 and the RN witness (signature illegible) signed, dated, and timed the consent on 3/12/2024 at 8:39 PM. Physician #78 failed to sign the informed consent for sedation. The informed consent for sedation failed to document if the procedural sedation was for moderate sedation or deep sedation. RN Staff #69 confirmed there was no documentation in the medical record that Physician #78 explained the risks and benefits of the sedation to Patient #66 before getting a signed informed consent for sedation. Physician #78 ordered etomidate (general anesthetic) 10 mg IVP once at 8:30 PM. The medication was administered by the RN at 8:58 PM. Physician #78 ordered an additional dose of etomidate (general anesthetic) 10 mg IVP once at 9:02 PM. The medication was administered by the RN at 9:02 PM. An interview was conducted with RN Staff #69 on 3/19/2024 at 2:15 PM. RN Staff #69 was asked if the RNs were trained in moderate and deep sedation. RN Staff #69 confirmed the RN Staff were only trained in moderate sedation. RN Staff #69 was asked if the physician was in the room with the nurse and the patient until the patient returned to baseline from the anesthesia. RN Staff #69 confirmed the physician was not always in the room after the procedure was complete, but they were always available. An interview was conducted with Physician #82 on 3/19/2024 at 2:30 PM. Physician #82 was asked what medications were used for sedation in the ED. Physician #82 stated, “We use several different medications. I use Propofol (a general anesthetic) because it works faster and it’s easier on some patients”. Physician #82 was asked if deep sedation was allowed in the ED by a non-anesthesia provider. Physician #82 was asked if Etomidate and Propofol, both a general anesthetic drug, could go from moderate to deep sedation at any time during procedural sedation. Physician #82 stated, “I guess it could, but we don’t use it as a deep sedation”. He was then asked if the patients consented to moderate or deep sedation. He replied, “We talk to the patient about moderate and deep sedation but we always have respiratory therapy in the room when we do procedures in case they are needed. The patients give consent and are required to sign a sedation consent before we start the procedure”. Physician #82 was asked if the physicians signed the informed consent after explaining the risks and benefits to the patient. He replied, “No the nurses get the consent after we talk to the patient”. RN Staff #69 confirmed Physician #78 failed to document that the risks and benefits of sedation were explained to the patient in the medical record and did not sign the informed consent for sedation. A review of the Amidate (etomidate) packet insert was as follows: “ ...Etomidate Description It is intended for the induction of general anesthesia by intravenous injection ... Warnings: WARNINGS INTRAVENOUS AMIDATE SHOULD BE ADMINISTERED ONLY BY PERSONS TRAINED IN THE ADMINISTRATION OF GENERAL ANESTHETICS AND IN THE MANAGEMENT OF COMPLICATIONS ENCOUNTERED DURING THE CONDUCT OF GENERAL ANESTHESIA ...” A review of the policy titled, “Consent and Disclosure for Medical and Surgical Procedures’ with an approved date of 11/2021 was as follows: “ ...POLICY: It is the policy of (Name of Hospital) that the patient and/or family, as appropriate, has the right to be informed about and participate in decisions regarding his/her care. Prior to the performance of certain medical, diagnostic, and any surgical procedure, the medical staff (physician, oral surgeon, or podiatrist) must first inform the patient about their condition and the recommended surgical, medical, or diagnostic procedure to be used so that they may make the decision whether or not to undergo the procedure after knowing the benefits, risks, and hazards. This explanation includes the patient’s current condition, proposed procedure, and benefits; risks and undesired effects of the procedure; potential problems related to recuperation; the [probability of improvement; the possible results/prognosis of non-treatment, and significant alternative treatments ... PROCEDURE: It is the policy of PRMC that the process of obtaining consents complies with the following: A. Procedures requiring written consent 1. Prior to any surgical, medical or invasive diagnostic procedure performed, a Disclosure and Consent form must be completed. This also includes procedures done using epidural, spinal, and general anesthesia ... F. Requirements Regarding Completion and Validity of a Consent Form... ... 5. Consent forms may not contain unfilled blanks except for the alternate signer’s signature and corresponding witness blank. Deletion of unfilled blanks should be done by drawing a line. 6. Consent forms must contain the date and time of signing, ... 8. Consent forms may NOT contain abbreviations, erasures, or eradication ... Obtaining a written consent ... 2. Write the name of the physician, oral surgeon, or podiatrist performing the procedure on the form if not already present. If the physician is not a MD, write in the appropriate title (i.e. DO, DDS, PD, etc). Confirm the presence of the provider’s signature with date and time ... Responsibility 1. It is the responsibility of the Medical Staff (physician/oral surgeon/podiatrist) to inform the patient (or person authorized to sign for the patient) and document in the patient’s medical record of the following: The patient’s condition(s) and proposed procedure, benefits, risks, and undesired effects of the procedure; potential problems related to recuperation, the probability of improvement, the possible results/prognosis or nontreatment, significant alternative treatments and type of anesthesia to be given. Staff is also required to inform the patient of ethical issues, identify and professional status of caregivers, and conflicts of interest, other health care, business or educational relationships. 2. It is the responsibility of the physician, oral surgeon, or podiatrist to: a. designate the condition that makes the procedure necessary; b. designate the name of the procedure and the site-specific information. 3. It is the responsibility of the physician ordering or performing special treatments, tests, or procedures to inform the patient as applicable above. ... 5. It is the responsibility of the nurse or imaging technologist to review any consent completed in the physician’s office to insure the form is properly filled out. It is the responsibility of the licensed nurse or imaging technologist to ascertain that a properly completed consent form has been obtained prior to the administration of pre-operative medication ...” A review of the facility policy titled, “Administration of Moderate Sedation by Non-Anesthesia Personnel With Appendix in the Emergency Department” PolicyStat ID 13263990, with an approved date of 5/2023 was as follows: “ ...II. PURPOSE: To establish safe, standardized guidelines for the administration of Moderate Sedation to all patients undergoing invasive and/or non-invasive diagnostic and therapeutic procedures. ... IV. DEFINITIONS: ... “Operator” shall refer to the physician who performs a diagnostic or therapeutic procedure during which Moderate Sedation is administered. ... V. PROCEDURE: ... 7. PRE-PROCEDURE DOCUMENTATION... * Informed Consent- Prior to the commencement of any procedure utilizing Moderate Sedation, informed consent for Conscious Sedation and for the procedure, shall be properly obtained from the Patient or the patient’s legally authorized representative and shall be documented in the patient’s medical record, in accordance with federal and state law. The operator must discuss the risks, benefits, and alternatives of the procedures and the planned sedation with the patient and answer any questions. A printed informed consent form may be used..” During an interview on 3/19/2024 after 2:00 PM with RN Staff #69 and Staff #14 it was confirmed the Medical Staff and Nursing Services failed to follow the hospital policies for Informed Consent and Moderate Sedation.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the hospital failed to ensure A. the Emergency Department had a working emergency call system in 2 (Exam Room # 8 and Exam Room # 7) of 14 patient exam rooms. The nursing staff failed to ensure 3 (Patient # 22, # 23, and # 24) of 3 patients had the emergency call light within reach to utilize in the event assistance was needed. Also, the hospital failed to ensure a staff member monitored and responded to the patient call lights in the Emergency Department. B. 3 (# 67, # 68, and # 69) of 3 patients undergoing hemodialysis treatment with an unknown Hepatitis B status were treated in a location that prevented the transmission of Hepatitis B to other patients and staff members. Also, the hospital staff failed to follow the facility policy, “Hemodialysis Infection Prevention”. C. dialysate samples were sent to the laboratory for testing when dialysate manufacturers were changed. Findings: A. This deficient practice had the likelihood to cause harm to a patient by not having a process in place to identify a patient in need of assistance which could result in patient harm and a delay in care. During a tour of the hospital’s Emergency Department with Staff # 69 (Emergency Department Director) on 03/20/2024 at 10:00 AM, the surveyor entered Exam Room # 8. The exam room was designated as clean and ready for patient admission. The surveyor hit the patient emergency call button inside the room. The surveyor waited 4 minutes before asking Staff # 69 why there was no response from the nursing staff. Staff # 69 went to the nurses’ station to check on the inadequate response time. Staff # 69 reported there was no staff member at the nurses’ station to answer the call light. The surveyor then entered Exam Room # 7 at 10:40 AM where Patient # 22 was admitted. The surveyor observed the patient’s emergency call light was not plugged into the wall and was not within the patient’s reach. The surveyor tested the emergency call cord and observed no alarm and no response from the nursing staff. The surveyor entered Exam Room # 5 at 10:45 AM where Patient # 23 was admitted. The surveyor observed the patient’s emergency call light was not within the patient’s reach and inaccessible to the patient in the event of an emergency. The surveyor entered Exam Room # 4 at 10:50 AM where Patient # 24 was admitted. The surveyor observed the patient’s emergency call light was not within the patient’s reach and inaccessible to the patient in the event of an emergency. The surveyor observed the nurses’ station of the Emergency Department at 11:00 AM. There were no staff members at the nurses’ station present to monitor and respond to the emergency call lights. In an interview with Staff # 69 on 03/20/2024 at 11:20 AM, Staff # 69 acknowledged the nursing staff did not ensure patients had access to working call lights and that staff were available to answer the call lights from patients. Staff # 69 stated, “We do not have a job position for someone to sit at the nurses’ station and answer call lights”. B. This deficient practice had the likelihood to result in the transmission of Hepatitis B between patients and staff members due to the treatment location and staffing assignments which were determined before the patient’s hepatitis B status was known. A review of treatment records for Patients # 67, # 68, and # 69 revealed the facility staff were not treating unknown Hepatitis B status patients as if they were potentially positive when determining treatment location and staffing assignments. A review of treatment records for Patient # 67 revealed the following, Patient # 67 required hemodialysis treatment on 02/03/2024 in the Intensive Care Unit. Staff # 8 was the Registered Nurse caring for the patient during hemodialysis treatment. Treatment was initiated at 3:23 PM and ended at 6:03 PM. During treatment, the patient’s hepatitis B status was unknown. The patient’s hepatitis B surface antigen was reported to the hospital by Labcorp as negative on 02/05/2024 at 8:09 AM. A review of treatment records for Patient # 68 revealed the following, Patient # 68 required hemodialysis treatment on 02/03/2024 in the Intensive Care Unit. Staff # 8 was the Registered Nurse caring for the patient during hemodialysis treatment. Treatment was initiated at 11:26 AM and ended at 12:27 PM. The patient’s hepatitis B status was unknown during the entire hospital admission. A review of Staff # 8’s personnel file revealed Staff # 8 had positive hepatitis B immunity on 03/16/2017. Staff # 8 had no titers drawn since 03/16/2017. Staff # 8’s hepatitis B immunity was unknown at the time Staff # 8 provided nursing care and treatment to Patient # 67 and Patient # 68. Staff # 8 had unknown hepatitis B immunity while caring for Patients # 67 and # 68, who had unknown hepatitis B status at the time of treatment. A review of treatment records for Patient # 69 revealed the following, Patient # 69 required hemodialysis treatment on 02/03/2024 in the 3rd-floor Dialysis Suite. Staff # 9 was the Registered Nurse caring for the patient during hemodialysis treatment. Treatment was initiated at 12:03 PM and ended at 4:36 PM. The patient’s hepatitis B status was unknown during the hemodialysis treatment on 2/3/2024. A review of Staff # 9’s personnel file revealed Staff # 9 signed a Hepatitis B Vaccination Declination Form on 02/11/2002. There was no evidence that Staff # 9 had positive immunity to Hepatitis B. Staff # 9 had unknown hepatitis B immunity while caring for Patient # 69, who had unknown hepatitis B status. A review of the hospital’s policy, “Hemodialysis Infection Prevention” with a revision date of 06/2023 revealed the following, “PURPOSE: To limit the spread of infections among staff and patients. STATEMENT OF POLICY: PERSONNEL: All employees will comply with the hospital’s Employee Health Program .... Employees are to be knowledgeable of infection control practices and Universal/Standard Precautions. HBV Precautions should be followed for known or unknown HB-positive patients. Dialysis staff must be Hepatitis B immune if dialyzing a Hep B patient. Hepatitis titers will be drawn yearly to check for immunity ... MANAGEMENT OF HEPATITIS B-POSITIVE PATIENTS: Patients will be tested per CDC recommendations for Hepatitis B. Their hepatitis B status will be communicated appropriately when orders are received. Dialysis nurse has access to the most recent labs via computer. Close communication between Acute and Chronic hemodialysis units is deemed necessary to enhance infection control efforts. Hepatitis B patients are to be dialyzed without any other patients, on a separate machine and have separate equipment ...” In an interview with Staff # 10 on 03/20/2024 at 9:30 AM, Staff # 10 acknowledged there is no process in place to identify a patient’s hepatitis B status before treatment initiation to ensure there is no risk of exposure and transmission to other patients and staff members. C. During a tour of the hospital’s 3rd-floor dialysis suite on 03/18/2024 at 10:16 AM, the surveyor observed 2 different manufacturers of bicarbonate dialysate stored in the dialysis suite supply room. The surveyor observed 3 jugs of Centrisol 45X liquid bicarbonate dialysate solution and 3 jugs of Sterilyte 45X liquid bicarbonate dialysate solution stored together on the same shelf. During an interview on 3/18/2024 at 10:16 AM, the surveyor asked Staff # 10 if both manufacturers of bicarbonate solution were being used on the same hemodialysis machine. Staff # 10 reported both were being used and the staff were not aware samples were to be sent to the laboratory for testing when changing between the 2 manufacturers on the same dialysis machine.”

“DATA COLLECTION & ANALYSIS CFR(s): 482.21(a), (b)(1),(b)(2)(i), (b)(3) (a) 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 improve health outcomes ... (2) The hospital must measure, analyze, and track quality indicators ... and other aspects of performance that assess processes of care, hospital service and operations. (b)Program Data (1) The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions. (2) The hospital must use the data collected to-- (i) Monitor the effectiveness and safety of services and quality of care; and .... (3) The frequency and detail of data collection must be specified by the hospital’s governing body. This Standard is not met as evidenced by: 36594 Based on review of facility documents and staff interview, the facility failed to ensure the QAPI program measured, analyzed, and tracked quality indicators and used the data to monitor the effectiveness and safety of services and quality of care when there was no evidence these were being completed through the quality council. Findings: Review of facility-based Quality and Patient Safety Council meeting minutes for 3/21/23 through 2/20/24 revealed some data was being collected, such as readmission rates, sepsis, and fibrinolytic therapy, however, there was no indication what the goals were, if there were actions/resolutions/assignments related to the priorities, nor if there was any follow-up. The quality program was not monitoring the effectiveness and safety of services. In an interview on the afternoon of 3/19/24 with Staff #14, Director of Quality/Regulatory, stated, “Yes, this is happening, but it’s not documented.” Facility-based “Quality/Patient Safety Plan” last revised 02/2024 stated in part, “Quality Management (QM) Department: *The Quality Management Department serves as a resource to the Quality and Patient Safety Council, chartered teams, the medical staff, and all departments. The Quality Management Department will be responsible for gathering reports from throughout the organization and analyzing them for patterns and trends that require performance improvement activities, including patient safety initiatives. These reports include patient satisfaction, variance reports, database reports, committee reports, etc. The Quality and Patient Safety Council reports identified patterns and trends, which may require a performance improvement initiative to the involved departments ... Committee Structure: -The committee structure supports Performance Improvement at [Facility name]. Activities of these committees are documented in minutes or memos, which, when appropriate, document conclusions (data analysis), recommendations (improvement strategies), action (implementation of improvement activities or committee assignments), and follow-up (effectiveness of actions).””

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 36594 Based on review of facility documents and staff interview, the facility failed to ensure the Quality Program took actions aimed at performance improvement and, after implementing those actions, measured its success, and tracked performance to ensure that improvements were sustained when actions/resolutions and follow-ups were not documented. Findings: Review of facility-based Quality and Patient Safety Council meeting minutes for 3/21/23 through 2/20/24 revealed meetings were held monthly for the past year but the columns titled “Action/Resolution/Assignment” and “Follow-up” were not consistently documented. For example, the data driven priorities #1 - 3 (Falls, Primary C-Section Rates, and Patient Satisfaction, respectively) were discussed for each quarter at every meeting; however, there was no indication what the goals were, if there were actions/resolutions/assignments related to the priorities, nor if there was any follow-up. The agenda item “Departmental PI [performance improvement]” documented the following: *11/14/23: “asked that each department choose their PI initiatives for 2024 and sent to her by November 30th.” *1/30/24: “No Update at this time.” *2/20/24: “No Update at this time.” A list of the Quality Improvement Report calendars was requested but were never provided. In an interview on the morning of 3/19/24 with Staff #14, Director of Quality/Regulatory, she reported they had a non-medical person taking meeting minute notes and did not document everything that happened in the meetings. She verified the columns were not complete and this process needed to be improved as actions aimed at performance improvement, implementing actions, and tracking performance to ensure improvements were sustained were not evidenced in the Quality Meeting Minutes for the past year. Facility-based “Quality/Patient Safety Plan” last revised 02/2024 stated in part, “Quality Management (QM) Department: Sustained Improvement: In order to sustain improvements that are initiated in the design of new processes or modification of existing processes, Palestine Regional Medical Center uses all necessary resources and staff to identify, plan and test changes. Education of staff in the changes is a key aspect of this process. Performance measures are established prior to implementing changes in order to determine whether improvements are sustained.””

“QAPI GOVERNING BODY, STANDARD TAG CFR(s): 482.21 ... The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement) ... The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Standard is not met as evidenced by: 36594 Based on review of facility documents and staff interview, the facility failed to ensure the hospital’s governing body ensured the QAPI program involved all hospital departments and services when dietary staff were not involved in QAPI meetings, and each department, the clinical subcommittee, and hospital committee reports were not discussed and updated each meeting. Findings: Review of the “Quality and Patient Safety Council” meeting minutes for the past year revealed many departments and services, such as surgery, dietary, respiratory therapy, and behavioral health, were not involved in the QAPI meetings. Several managers and directors throughout the survey discussed quality data was being collected and sent to quality but have not presented their data or discussed their performance improvement. Review of facility-based Quality and Patient Safety Council meeting minutes for 3/21/23 through 2/20/24 revealed meetings were held monthly for the past year but no representative from dietary was identified as being present or absent. In an interview on the morning of 3/19/24 with Staff #25, Dietician, she reported the department does track quality measures including patient satisfaction and quarterly audits but does not attend any facility quality meetings and does not have performance improvement projects with the facility quality council. In an interview on the morning of 3/19/24, with Staff #24, Dietary Manager, he reported his department does track quality measures including patient satisfaction and temperature monitoring but does not attend any facility quality meetings. Staff #24 reported he does report to the quality director but does not have performance improvement projects with the facility quality council. In an interview on the morning of 3/19/24, with Staff #14, Director of Quality/Regulatory, she reported dietary quality was wrapped up in patient satisfaction but was unaware they were not involved in the meetings. Review of the “Quality and Patient Safety Council” meeting minutes dated 6/20/23, stated in part, “*Agenda Item: Clinical Subcommittee Reports; *Key Discussion: -Falls Committee - Met in June -Patient Experience - Meets next week. -Health Equity Committee - Scheduled to meet in June. -Workplace Violence Prevention Committee - Met in May. -Culture of Safety Committee - CoSe Survey results are back; *Action/Resolution/Assignment: Need more participation from staff members who are on these committees. If a staff member who was previously on these committees has left [facility name] - please review list and assign another staff member. *Follow-up” was left blank. For the each of meetings that followed on 7/18/23, 8/15/23, 9/19/23, 10/17/23, 11/14/23, 1/30/24, the Agenda Item of Clinical Subcommittee Reports stated, “Action/Resolution/Assignment: Need more participation from staff members who are on these committees;” and the Follow-up column was left blank. For the meeting dated 2/20/24, both the Action/Resolution/Assignment and Follow-up Columns were not completed. In an interview on the afternoon of 3/19/24, Staff #14 reported 2/20/24 meeting minutes were not yet complete as they become complete after approval at the next meeting, therefore, none of the Action/Resolution/Assignment or Follow-up Columns were completed. Staff #14 reported some committees do not have volunteers to head them and reported that some departments do not report their numbers or performance improvement regularly. Staff #14 reported she was aware some departments and committees reported “No Updates” for several months, such as EOC [Environment of Care]/Emergency Preparedness, Health Equity Committee, P&T [Pharmacy and Therapeutics]/Antibiotic Stewardship, Staffing Effectiveness, Dialysis and some were not addressed such as surgery, respiratory, and behavioral health and stated, “Some have not gotten me data and some have but we’ve been so bust and haven’t had time to check it.” Staff #14 reported several things were discussed in the meetings but verified all the requirements of Quality were not addressed or documented.”

“ORGANIZATION OF NURSING SERVICES CFR(s): 482.23(a) The hospital must have a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care. The director of the nursing service must be a licensed registered nurse. He or she is responsible for the operation of the service, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital. This Standard is not met as evidenced by: 49344 Based on observation, record review, and staff interviews, the hospital failed to ensure Staff #30 (Charge Nurse), on the 3rd Floor Medical-Surgical Unit, was competent in the use of the Life Pack emergency defibrillator on 2 of 2 emergency crash carts. Also, the hospital failed to identify and remove expired supplies from the emergency crash carts. Findings inclued: During a tour of the 3rd floor Medical-Surgical Unit on March 19, 2024, at 11:34 AM, the surveyor observed 2 emergency crash carts with Life Pack emergency defibrillators. A review of the Daily Crash Cart Logs revealed the unit charge nurses were required to check the emergency crash carts daily, which included a test run of the Life Pack emergency defibrillator to ensure working order. During an interview with Staff #30 (Charge Registered Nurse) on March 19, 2024, at 11:34 AM, Staff #30 stated, “Charge Nurses check the crash carts daily. Once completed it is recorded in the crash cart log”. The surveyor requested Staff #30 demonstrate a test run of the Life Pack defibrillator. Staff #30 was unable to successfully demonstrate the test on 2 of 2 emergency defibrillators. During the first attempt, Staff #30 stated, “I’m unsure how to test the Life Pack, I need to run over to ICU and ask.” Two minutes passed, and Staff #30 returned to the unit and attempted the test again but was still unable to perform the test. When asked whose initials were on the log showing that testing and crash cart maintenance had been done that day, RN Staff #30 stated, “Those are my initials. I check the tag on the crash carts to make sure it is secure every time I work.” In an interview on March 19, 2024 at 11:37 AM with Staff #10 (Medical Surgical Director), Staff # 10 stated, “I need to make sure all of the charge nurses are all educated and comfortable with using and testing the Life Packs.” During the inspection of the supplies in both crash carts, it was discovered that there were expired sterile supplies. These included a Multi-Lumen CVC Kit with Blue Flex Tip Catheter, expired 4/2023 in 1 of 2 crash carts, and a 16F Foley Catheter Kit, expired 5/2023 in 2 of 2 crash carts. A review of the policy “Crash Cart Maintenance”, Dated: 10/2022 revealed: “Procedure 1.Maintenance of emergency drugs/supplies (crash cart) is the responsibility of the Unit Manager. 2.Crash carts must be checked for completeness and acceptable dating and condition at least daily by unit personnel ...The cart must be opened, and contents checked at least monthly if the cart has not been used. ...5. It is the responsibility of the Unit manager to ensure that Unit personnel are knowledgeable of and skilled in the use of emergency drugs/supplies and equipment. ...7. It is the responsibility of the Chief Nursing Officer to ensure that all supervisory staff are knowledgeable of and skilled in the use of emergency drugs/supplies and equipment. 8. Defibrillators must be checked daily ...” An interview with Staff #81, RN, Unit Director, on March 19, 2024, at 11:47 AM, on the 3rd floor, Medical-Surgical Unit, confirmed that 2 of 2 crash carts have not been maintained per policy.”

“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 observation, record review, and interview the facility failed to. A. ensure adequate staffing was provided for all patient care units, was unable to provide a patient acuity tool to determine the staff needed to provide safe care, or an acuity grid/matrix to determine the number of minimal staff needed for 7 out of 7 ( Inpatient Rehabilitation, Emergency Department, Mother/ Baby 606, Psych PRU 1 and PRU 2, Medical/Surgical 605, and ICU) patient care units. B. ensure the dialysis department had, at a minimum, 2 trained Registered Nurses readily available to provide direct patient care to patients receiving hemodialysis. Also, the hospital failed to have a staffing matrix and plan for the dialysis department. Findings: A. The surveyor reviewed the staffing sheets and staffing grids/matrix on 3/18/24 - 3/20/24 for the following units Inpatient Rehabilitation, Emergency Department, Mother/ Baby 606, Psych PRU 1 and PRU 2, Medical/Surgical 605, and ICU. Staffing grids are planning tools that assign the minimum number of staff needed to care for the number of patients on the unit per the hospital’s Nurse Staffing Effectiveness Committee. An acuity tool is a tool used to determine when the staff needs to be increased based on the clinical patient characteristics, admissions, discharges, and the care involved to provide safe patient care. The facility was found out of compliance for nurse staffing on October 19th of 2023. A review of the facility nursing grid revealed that the Registered Nurse (RN) and Licensed Vocational Nurse (LVN) were listed as the same discipline and counted as the same on the grid. However, an RN and LVN cannot be counted as the same. An LVN must have supervision by an RN and cannot be scheduled as an RN. The grid did not clarify if an RN was to be scheduled or an LVN. The surveyor was unable to determine if the schedule was covered appropriately without a way to identify if an RN or LVN was to be scheduled. According to the Texas State Board of Nursing, “ The LVN scope of practice is a directed scope of practice and requires appropriate supervision of a registered nurse, advanced practice registered nurse, physician assistant, physician, dentist, or podiatrist.” A review of the Staffing Effectiveness Committee Meeting Minutes dated 3/7/2024 revealed under new business: “Discussed and reviewed the updated unit matrix to include increasing the staff number if the unit is closed. Rehab and WU will have two staff on each shift. Also discussed changes to the staffing matrix that clearly demonstrate RN from LVN column.” There was no mention of a staffing acuity plan. An interview was conducted with staff # 60 RN on 3/19/24 concerning staffing for the ICU. Staff #60 confirmed that an acuity tool was not being used to determine staffing. There was no acuity tool used. The tool should assist in determining when nurse staffing should increase or decrease. Staff #60 stated that she or the house supervisor determines when staffing needs to be increased or decreased. Staff #60 confirmed there was no written process, and the determination was person dependent. Staff #60 was asked about staffing for breaks and lunches when the staffing grid was currently at the lowest minimal level. Staff # 60 stated that when a nurse goes to lunch there would be someone to cover for them. Staff #60 was asked how that would be documented. Staff #60 stated that there was no documentation of who covered for the RN. There was no further evidence that any other staff member would be available to assist in case of an emergency. There was no process for when the nurse would be allowed breaks, or who would relieve the nurse. An interview with Staff # 15 was conducted on 3/20/24. Staff #15 stated that she had been working on a plan since the facility received citations from October of 2023. Staff # 15 stated that she was working on an acuity tool to help determine staffing needs, but the plan had not been approved by the governing body or implemented. Staff #15 stated she planned on putting it through to the governing board in a few months. Currently, there was no evidence of a clear and safe staffing grid/matrix or an acuity tool to assist with safe staffing levels. A review of the Nurse Staffing Plan stated under purpose, “The goal of this policy is to create a healthy environment for nurses and appropriate care for patients by establishing a Nurse Staffing Effectiveness Committee whereby nurses and hospital management shall participate in a joint process regarding decisions about nurse staffing ... The plan will set minimum staffing levels for patient care units, will include a contingency plan when patient care needs unexpectedly exceed direct patient care staff resources, and will include a method for adjusting the staffing plan for each patient care unit to provide staffing flexibility to meet patient needs.” 48653 B. This deficient practice had the likelihood of resulting in a delay in hemodialysis patient care and/or an incomplete dialysis treatment. Dialysis patients who do not complete or miss treatment are at an increased risk of electrolyte imbalances which can cause heart arrhythmias, cardiac arrest, and death. During a tour of the 3rd-floor dialysis suite on 03/18/2024 at 1:15 PM with Staff # 10 (Dialysis Director), the surveyor observed Staff # 11 (Dialysis RN) initiating dialysis treatment on Patient # 3. The surveyor observed Staff # 11 did not have additional support from a trained and qualified Registered Nurse to assist in the event Staff # 11 needed to leave the patient for a lunch break or personal emergency. There were no other staff in the hospital who had completed dialysis competency at the time of the observation. In an interview with Staff # 10 on 3/18/2024 at 3:00 PM, the surveyor asked if there was an additional qualified staff member available to monitor and provide direct patient care to Patient # 3. Staff # 10 stated, “I am here, and my office is right across the hall from the dialysis suite, but I have not completed the Tablo training and dialysis competencies. I only did the introduction courses.” A review of daily staffing assignments for the dialysis department was conducted with Staff # 10. Saturday, February 17th, 2024 Staff # 11 (Dialysis Registered Nurse) was on call and clocked in from 8:00 AM to 3:30 PM in the hemodialysis department. Staff # 11 provided dialysis treatment to patients in the dialysis suite. Staff # 9 (Intensive Care Unit Charge Nurse) was deemed competent to provide direct patient care to hemodialysis patients treated on the Tablo machine. Staff # 9 was clocked in and working as the Charge Nurse in the Intensive Care Unit from 6:49 AM to 11:00 AM. Staff # 9 clocked out for a lunch break from 11:00 AM to 11: 30 AM. Staff # 9 clocked out for the day at 7:08 PM. Staff # 9 was unable to leave the Intensive Care Unit (ICU) due to the role of Charge Nurse. In the event Staff # 11 needed to leave for a break or personal emergency, there were no additional Registered Nurses who had been deemed competent and available to provide direct patient care to dialysis patients in the hospital. Saturday, March 2nd, 2024 Staff # 11 (Dialysis Registered Nurse) was on call and clocked in from 7:30 AM to 10:39 PM in the hemodialysis department. Staff # 11 provided dialysis treatment to patients in the dialysis suite. Staff # 11 did not clock out for a break during the entire 14-hour shift. Staff # 8 (Intensive Care Unit Nurse) was deemed competent to provide direct patient care to hemodialysis patients treated on the Tablo machine. Staff # 8 was clocked in from 1:03 PM to 8:00 PM in the dialysis department. Staff # 11 was working alone and did not have additional support in the dialysis department for approximately 7 hours. The surveyor requested a staffing matrix and staffing plan for the dialysis department from Staff # 10 on 3/19/2024 at 9:00 AM. The hospital was unable to provide the surveyor with a staffing matrix and staffing plan for the dialysis department. In an interview with Staff # 10 on 3/19/2024 at 10:00 AM, Staff # 10 acknowledged the dialysis department requires additional trained and qualified Registered Nurses available to provide direct patient care to hemodialysis patients.”

“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: 32143 Based on review and interview the facility failed to ensure the physician was explaining to the patient the risk and benefits of blood while obtaining the blood consent. The facility failed to ensure that the blood administration policy and procedure gave accurate instructions on obtaining blood consent and ensure the consent had a signature line, date, and time for the physician to sign in 2 of 2 (pt #4 and 8) charts reviewed. A review of patient #4’s chart revealed a blood consent dated and signed by the patient and an RN on 3/16/24 at 15:19 (3:19 PM). There was no physician signature nor a place on the consent form to sign. There was no found documentation that the physician had explained to the patient or representative the risks or benefits of blood administration. The patient had received multiple units of blood. A review of patient #8’s chart revealed a blood consent obtained by the RN on 2/20/24 at 17:57 (5:57 PM). There was no physician signature or progress note found that the physician had explained the risks and benefits. The patient received multiple units of blood. A review of the policy and procedure “Blood Transfusions” revealed the facility gave instructions for the staff to obtain blood consent. “PROCEDURE: ... 3. Unless the transfusion is an emergency, obtain a disclosure and consent from the patient or the patient’s representative if patient unable to sign consent before initiating transfusion therapy and ensure that the consent form is in the patient’s medical record. Operative consents may be used as long as all items concerning blood are initialed ...” According to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1312305/#sec1_4title, “The duty to obtain a patient’s consent for treatment rests on the patient’s treating physician (6). Hospitals, nurses, surgical assistants, and referring physicians do not owe this duty to their patients (7). The treating physician’s duty to obtain a patient’s informed consent cannot be delegated (8) ... When patients are admitted to a hospital, they usually sign a general “consent to treat,” which covers many diagnostic and therapeutic interventions. Interventions with the potential for significant morbidity or mortality require the specific informed consent of the patient, however. Most hospitals develop policies, specifying which interventions require documented informed consent (eg, central line placement, most surgical procedures, and most endoscopy procedures). This list includes transfusion of blood components and transplantation of tissues and organs. Blood components, tissue, and organs are biologically complex and vulnerable to contamination with infectious agents and thus may carry significant risk.” An interview was conducted with staff # 16 RN on 3/18/24 at 2:00 PM. Staff # 16 confirmed that the blood consents were not obtained by the physician and confirmed there was no place for the physician to sign the consent. An interview was conducted with staff # 60 RN on 3/19/24 at 11:00 AM and confirmed the blood consent had no place for the physician to sign. Staff #60 stated the physician should be giving the patient the risks and benefits but was unable to find any documentation during chart reviews.”

“MEDICAL RECORD SERVICES CFR(s): 482.24(c)(1) All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures. This Standard is not met as evidenced by: 49344 Based on record review, and staff interview the hospital’s nursing staff failed to ensure patient medical record entries were legible, completed, dated, timed, and authenticated by staff on the Cardiopulmonary Resuscitation Report in 5 (#29, #32, #33, #43, #44) of 5 patients records reviewed. Also, the Quality Department failed to monitor these reports for opportunities for improvement as required in the hospital’s policy, “Cardiopulmonary Resuscitation/Adult or Pediatric Code Blue and Neonatal Code Blue” On 3/21/2024, at 11:17 AM in the Conference Room, a review of the Cardiopulmonary Resuscitation Records for patients #29, #32, #33, #43, and #44 revealed multiple, significant errors. Findings include: Patient #29 Patient #29 required emergency resuscitative measures on 2/10/2024 at 7:46 PM. A review of the document titled, “Cardiopulmonary Resuscitation Record” lacked information regarding the responders to the emergency. While the recorder, Intensive Care Unit (ICU) nurse, and physician are identified, it was unclear who was responsible for tasks such as managing the airway, administering chest compressions, Intravenous (IV) medications, or operating the defibrillator. The document failed to specify when the first assisted ventilation took place and did not provide a reason for ending the resuscitation. The ICU nurse’s signature was illegible. According to the American Heart Association (AHA), it is suggested to have a “6-Person High-Performance Team,” which includes a Compressor, CPR Monitor/Defibrillator Coach, Airway, Team Leader, IV Medication administrator, and Recorder. Patient #32 Patient #32 required emergency resuscitative measures on 2/28/2024 at 9:08 AM. A review of the document titled, “Cardiopulmonary Resuscitation Record” lacked information regarding the responders to the emergency. While the recorder, ICU nurse, and physician are identified, it was unclear who was responsible for tasks such as managing the airway, administering chest compressions, IV medications, or operating the defibrillator. The document failed to specify when the first assisted ventilation took place, what time, size, and by whom the ETT (the endotracheal tube that assists with the delivery of oxygen when in respiratory failure) was placed, or how the placement was confirmed. The report did not provide a time the resuscitation event ended with the patient’s outcome or the reason for ending the resuscitation. There was no documentation of when chest compressions were started, or if there were any interventions with the AED (an Automated External Defibrillator is a medical device designed to deliver an electric shock to restore the heart rhythm to normal). The ICU nurse and Recorder failed to date and sign the record and both signatures were illegible. Patient #33 Patient #33 required emergency resuscitative measures on 12/31/2023 at 3:56 PM. A review of the document titled, “Cardiopulmonary Resuscitation Record” lacked information regarding the responders to the emergency. While the recorder, ICU nurse, and physician are identified, it was unclear who was responsible for tasks such as managing the airway, administering chest compressions, IV medications, or operating the defibrillator. The document failed to specify when the first assisted ventilation took place. The report did not provide a time the resuscitation event ended with the patient’s outcome or the reason for ending the resuscitation. Patient #43 Patient #43 required emergency resuscitative measures on 1/15/2024 at 6:00 PM. A review of the “Cardiopulmonary Resuscitation Record” document lacked essential information about the timing of the first assisted ventilation. An ETT was placed 8 minutes after the patient was apneic (not breathing). The report did not provide a reason for ending the resuscitation. The ICU nurse’s signature was illegible. Patient #44 Patient #44 required emergency resuscitative measures on 1/14/2024 at 11:55 AM. A review of the document titled “Cardiopulmonary Resuscitation Record” lacked information regarding the responders to the emergency. While the recorder, ICU nurse, and physician are identified, it was unclear who was responsible for tasks such as managing the airway, administering chest compressions, IV medications, or operating the defibrillator. The document failed to specify when the first assisted ventilation took place. The report did not provide a time the resuscitation event ended with the patient’s outcome or the reason for ending the resuscitation. There was no documentation of when chest compressions were started, or if there were any interventions with the AED. The ICU nurse failed to sign, date, and time the record. A record review of the hospital’s policy titled, “Cardiopulmonary Resuscitation/Adult or Pediatric Code Blue and Neonatal Code Blue” Dated: 12/2023, revealed: “Purpose ...establish a standard for restoring cardiopulmonary function utilizing guidelines from American Heart Association (AHA) ... ...Documentation A.Resuscitation “Code Blue” calls will have a code documentation form completed and placed/scanned in the patient’s medical record. 1. An adult or pediatric “Code Blue” will be documented using the Adult Code Blue form ... Quality Monitoring and Evaluation A. Code Blue events should be reviewed for compliance with ACLS standards, code duration, patient outcomes, and identified issues. The Quality Department will review Code Blue Events for opportunities for improvement in the resuscitation process and data will be shared during the Quality Patient Safety Council. B. Identified individual performance issues or identified learning needs are referred to the appropriate director, education department, or Nursing Chart Review committee as appropriate.” During an interview with RN, Staff #13 on 3/21/2024 at 11:17 AM in the Board Room, it was confirmed that the Cardiopulmonary Resuscitation Record was consistently not, legible, completed, dated, timed, or authenticated by staff, and the Quality department was not regularly monitoring for opportunities for improvement as per hospital policy.”

“SECURE STORAGE CFR(s): 482.25(b)(2)(i) §482.25(b)(2)(i) - All drugs and biologicals must be kept in a secure area, and locked when appropriate. This Standard is not met as evidenced by: 46435 Based on observation, document review, and interview the hospital failed to: A. Ensure secure storage of Radioactive Contrast (Intravenous Contrast) in 1 of 5 units observed Post Anesthesia Care Unit (PACU). B. Ensure the IV Contrast was stored at temperature ranges recommended by the manufacturer in 1 of 5 units observed (Post Anesthesia Care Unit). C. Ensure storage and security of controlled drugs in accordance with Federal and the State rules and regulations in 2 of 5 units, (Post Anesthesia Care Unit) and the dialysis suite located on the 3rd floor of the hospital. Findings: A. During a tour of the post-anesthesia care unit (PACU) on 03/18/2024 at 11:20 AM with Staff #36 the following safety issues: Observations: 1. It was observed that there were 6 cases of IV Contrast bottles stored in an area behind a curtain, PACU Bay#2, on the metal cart. This area had no door and is only separated from the main treatment are by two walls and a pull curtain. 2. The IV Contrast located in the PACU was not locked or under constant monitoring by an authorized staff member 24 hours Documentation Review: 1. Policy- Storage Of Drugs (General) #9137543, Effective 03/2021, Last revision Dated 06/2012, Expiration 03/2024. a. “Procedure: Drugs shall be stored under the proper conditions of sanitation, temperature. Light, moisture, ventilation, segregation, and security”. 2. Policy- Medication Management #7914452, Effective 06/2020, Last revision Dated 08/2014, Expiration 06/2023. a. “Storage Of Medication”: 1. Medications are secure so that unauthorized personnel cannot obtain access to them. 2. All medication storage areas are periodically inspected by the pharmacy. Each nursing unit is inspected monthly by pharmacy and floor stock inspected sheet is filled out for each area. Interviews: 1. An interview with the Director of Surgery #36 on 03/18/2024 at 11:30 AM acknowledged the evening housekeeper for the surgical department has access to the IV Contrast located in the PACU area. B. During a tour of the post-anesthesia care unit (PACU) on 03/18/2024 at 11:20 AM with Staff #36 the following safety issues: Observations: 1. It was observed that there were 6 cases of IV Contrast bottles stored in an area behind a curtain, PACU Bay#2, on the metal cart. This area had no door and is only separated from the main treatment are by two walls and a pull curtain. 2. PACU has no monitoring for the environment for temperature and or humidity that is monitored. Documentation Review: 1. Policy- Storage Of Drugs (General) #9137543, Effective 03/2021, Last revision Dated 06/2012, Expiration 03/2024. a. “Procedure: Drugs shall be stored under the proper conditions of sanitation, temperature. Light, moisture, ventilation, segregation, and security”. 2. Policy- Medication Management #7914452, Effective 06/2020, Last revision Dated 08/2014, Expiration 06/2023. a. “Storage Of Medication”: 1. Medications are secure so that unauthorized personnel cannot obtain access to them. 2. All medication storage areas are periodically inspected by the pharmacy. Each nursing unit is inspected monthly by pharmacy and floor stock inspected sheet is filled out for each area. Interview: 1. An interview with the Director of Surgery #36 on 03/18/2024 at 11:30 AM acknowledged there is no current way to monitor humidity control in PACU although there is a thermostat located in the area it also is not documented or checked on a regular basis of temperature control. C. During a tour of the post-anesthesia care unit (PACU) on 03/18/2024 at 11:20 AM with Staff #36 the following safety issues: Observations: 1. The medication refrigerator located in the PACU was not locked or under constant monitoring by an authorized staff member. 2. The following medication was in the medication refrigerator included: a. Rocephin b. Humulin Regular 4 bottles c. Famotidine 20 mg/per ml 13 vials d. Promethazine suppository e. Hemabate 250 mcg f. Methagine 0.2 mg/ml Documentation Review: 1. Policy- Storage Of Drugs (General) #9137543, Effective 03/2021, Last revision Dated 06/2012, Expiration 03/2024. a. “Procedure: Drugs shall be stored under the proper conditions of sanitation, temperature. Light, moisture, ventilation, segregation, and security”. 2. Policy- Medication Management #7914452, Effective 06/2020, Last revision Dated 08/2014, Expiration 06/2023. a. “Storage Of Medication”: 1. Medications are secure so that unauthorized personnel cannot obtain access to them. 2. All medication storage areas are periodically inspected by the pharmacy. Each nursing unit is inspected monthly by pharmacy and floor stock inspected sheet is filled out for each area. Interview: 1. An interview with the Director of Surgery #36 on 03/18/2024 at 11:30 AM acknowledged the medications in the refrigerator were not secured. Staff #36 stated, “We never locked the refrigerator; I don’t even know where the key is located.” 2. An interview with the Director of Surgery #36 on 03/18/2024 at 11:30 AM acknowledged the evening housekeeper for the surgical department has access to the medication located in the PACU area. During a tour of the Dialysis Suite on the third floor of the hospital on 03/18/2024 at 1:34 PM the following issues: Observations: 1. The medication cabinet located in front of dialysis machine # 4 was not locked or under constant monitoring by an authorized staff member. The following was located in the medication cabinet: Included: a. 3 boxes of heparin (each containing 25 (1ml) vials of heparin) b. 3 boxes of xylocaine (each containing 25 (1ml) vials of Xylocaine) c. 10 (1000ml) bags of Normal Saline IV fluid Document Review: 1. Policy- Storage Of Drugs (General) #9137543, Effective 03/2021, Last revision Dated 06/2012, Expiration 03/2024. a. “Procedure: Drugs shall be stored under the proper conditions of sanitation, temperature. Light, moisture, ventilation, segregation, and security”. 2. Policy- Medication Management #7914452, Effective 06/2020, Last revision Dated 08/2014, Expiration 06/2023. a. “Storage Of Medication”: 1. Medications are secure so that unauthorized personnel cannot obtain access to them. 2. All medication storage areas are periodically inspected by the pharmacy. Each nursing unit is inspected monthly by pharmacy and floor stock inspected sheet is filled out for each area. Interview: 1. During an interview with Staff #10 on 3/18/24 at 2:30 PM, Staff #10 acknowledged the cabinet with medications in it was unlocked and accessible to unauthorized personnel.”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 36594 Based on review of records and staff interview, the facility failed to ensure the hospital infection prevention and control policies and procedures were implemented and enforced when: A. The dialysis staff failed to perform hand hygiene and ensure proper use of PPE (personal protective equipment). Also, the dialysis staff failed to follow the hospital policy, “Hemodialysis Infection Prevention”. B. The linen and laundry service was not maintained to prevent and control transmission of infections; and C. The dietary service did not maintain temperatures, humidity, or concentration of sanitizer. These deficient practices had the likelihood to result in the transmission of infectious agents between patients and hospital staff. Findings: A. During a tour of the hospital’s 3rd-floor dialysis suite on 03/18/2024 at 1:30 PM, the surveyor observed Staff #11 wearing a pair of gloves to touch the Tablo (hemodialysis machine). Staff # 11 wore the same pair of gloves when touching Patient # 9’s CVC (central venous catheter). During a tour of the hospital’s 3rd-floor dialysis suite on 03/18/2024 at 1:34 PM, the surveyor observed Staff # 11 wearing an isolation gown while caring for Patient # 9. Staff # 11 did not remove the isolation gown before going to the nurse’s station to chart. Staff # 11 had food and drinks at the nurse’s station where she was charting. A review of the hospital’s policy titled, “Hemodialysis Infection Prevention” with a revision date of 06/2023 revealed, “PURPOSE: To limit the spread of infections among the staff members and patients. STATEMENT OF POLICY: PERSONNEL: All employees will comply with the hospital’s Employee Health Program ... Employees are to be knowledgeable of infection control practices and Universal/Standard Precautions. HBV Precautions should be followed for known or unknown HB-positive patients. Dialysis staff must be Hepatitis B immune if dialyzing a Hep B patient. Hepatitis titers will be drawn yearly to check for immunity. TRAFFIC CONTROL: No visitors are allowed while the patient is receiving dialysis due to the high risk of exposure to blood or bloodborne pathogens. Appropriate Use of Personal Protective Equipment (PPE): Staff members are to wear fluid-resistant gowns, face shields/eyewear, and masks when performing procedures in which contact with blood or blood splatter may occur. Gloves should be worn when touching bloodlines, dialyzer, or dialysis delivery system during or after dialysis. Appropriate PPE will be always worn when performing the dialysis treatment, whether in the dialysis suite or an individual patient room. When caring for two patients in the dialysis suite, all PPE will be kept separate, hands must be washed or sanitized, and new PPE donned before moving from one patient machine to the next. PPE worn during the treatment will be disposed of post-treatment in the regulated waste container. PPE should be worn when it is likely that contact with blood may occur, such as but not limited to: *The initiation and completion of dialysis treatment. *When touching patients during activities with potential exposure to bloodborne pathogens and other potentially infectious material. *Any time that the dialysis system is required to be open. (re-circulating, re-cannulating, or interruption of treatment for any reason). *When performing venipunctures or other vascular access procedures ...” During an interview with Staff # 10 on 03/18/2024 at 1:45 PM, Staff # 10 acknowledged dialysis staff were not changing PPE at the appropriate intervals. B. The following was observed on the morning of 3/20/24 with Staff #44, Area VP EVS [Environmental Services], Staff #54, EVS Director, and Staff 55, Core Measures/Abstractor: *The washer room: -discolored metal, wood, and tiles throughout, indicating these areas were not cleaned appropriately -dust build-up on hoses and equipment behind the three washers, indicating these areas were not cleaned -bubbling paint on the wall *The dryer room: -four (4) bins with debris noted along the bottom where clean clothes used to remove clothes from the dryer and into the clean linen folding room. -standing fan with a build-up of white substance on the blades. Staff #44 reported this fan was not used and will be removed. -discolored metal and chipped ceiling tiles, making it impossible to clean -a clear thick plastic barrier with six (6) flaps between the dryer room and clean linen folding room with brown and black spots and a hazy build-up throughout. Staff #54 reported they were unsure how often these were cleaned but would get replaced. -Staff #59 had appropriate PPE [Personal Protective Equipment] while de-bagging and sorting soiled linen. Staff #59 removed PPE and walked through the washer room and began removing clean linens from the dryer without washing hands up to elbows. Staff #44 asked if Staff #59 washed their hands prior to removing clean linens, Staff #59 went into the clean linen room and used alcohol-based hand rub. *The clean linen folding room: -Four (4) blue metal tables had clean linens folded and had discoloration along the lips, making it impossible to clean -The wheels on the four (4) tables had visible dirt; the table closest to the dryer room had a thick build-up of dust *The hallway: -A linen cart for the East campus covered with a mesh substance with visible discoloration. Staff #44 and 54 reported these mesh coverings were used to protect the linens and verified the mesh and holes would not protect clean linens from the air during transport. *The loading dock: -Contaminated linen bins were noted with build-up on the insides and outside, indicating they were not effectively cleaned -All contaminated linens were in bags and the bins had no covers During the tour, Staff #44 reported trucks would deliver dirty linen from the East campus and the same truck would transport the clean linen back. Staff #44 reported the trucks should be cleaned each time between dropping off dirty linens and loading the clean linens but was not sure if this was being completed. The above findings were verified during the tour with Staff 44, 54, and 55. EVS contract-based policy and procedure titled “EVS Linen Operations” with a last review date of 12/2023 stated in part, “Infection Prevention Requirements: *We’re required to cover the clean linen carts with a compatible protective cover To [sic] minimize any possible airborne contamination of the clean linen. *Carts should remain covered at all times when they’re being transported and stored on units. ...Keep Carts Clean & Check their Condition Daily *Disinfect linen delivery carts daily. *Before using a cart, check to make sure it’s in good condition. There should be no tears in the cart cover, no damaged wheels, etc. Notify your manager if the cart or cover is not in good condition. Delegate Team Member Responsibilities Appropriately: To help ensure that linen stays clean, the team member responsible for the collection of contaminated linen should not be the same team member who handles clean linen. ...Covering Soiled Linen Carts: *Secure the soiled linen collection cart with a protective cover to minimize any possibility of cross-contamination. *This cart should remain covered at all times and should only be opened when you’re placing contaminated linen inside. ...Cleaning Soiled Linen Carts: Every Day! *Every day, soiled linen collection carts must be completely cleaned with an approved disinfectant ... Facility-based policy titled “Portable Fan Use” policy #14190908 stated in part, “Fans should not be used in medication rooms, clean supply or soiled utility rooms which are located in small confined spaces ... Care and Maintenance Regular inspection is required for product integrity and safety prior to placement ... Cleaning and Disinfection ...Develop a preventative maintenance schedule and assign responsibility that includes: -Visual inspection after use -Weekly cleaning and disinfection of all components -Additional cleaning and disinfection when visibly soiled.” B. Review of Dietary temperature monitoring book revealed the following: *Sandwich #1 Refrigerator dated January 2024, indicated temperature checks to be monitored two times a day with “Refridgerator [sic] temperature should be maintained at or below 41°F. -Sandwich #1 Refrigerator dated February 2024, indicated temperature checks to be monitored three times a day with the range as 34-40 °F [degrees Fahrenheit]. 23 of 87 checks were documented out of range with no corrective action noted; the morning of 2/20/24 was documented “not working;” and no temperature was recorded for the evening of 2/29/24. *Food Warmer #2 for January 2024 stated, “Warmer temperature should be maintained at or above 141°F.” -Food Warmer #2 for February 2024 stated “Take the temperature of at least 1 pan of food inside box at each time period; record below. ...Standard = 140°F or above Corrective Action if food is less than 140°F: ~Reheat to 165°F if food had been less than 140°F for less than 2 hours. ~Discard if food has been less than 140°F for more than 2 hours. ~Inform Manager/Supervisor immediately whenever corrective action is needed” -Food Warmer #2 for February 2024 had two times for each meal to check the food warmer at breakfast 6:30 AM and 8:30 am, lunch at 11:00 am and 1:00 pm, and dinner at 4:00 pm and 6:00 pm. The first breakfast column at 6:30 am had times written for the 1st-29th. The second breakfast column had initials for the 1st-29th except of the 24th and 25th which was documented as “Off.” The lunch 11:00 am and 1:00 pm had 5 of 36 documented out of range without corrective actions noted. The dinner column marked 4:00 pm was documented as times for 1st -23rd ; the column marked 6:00 pm were documented as initials for 1st - 27th; the column marked “sup/mgr initials” was documented as “off” for 3 of 29 days. *Hot Holding Box log #1 for February 2024 had two times for each meal to check the food warmer at breakfast 6:30 AM and 8:30 am, lunch at 11:00 am and 1:00 pm, and dinner at 4:00 pm and 6:00 pm. The breakfast column at 6:30 am had times written for the 1st-29th. The breakfast column for 8:30 am had initials for the 1st-29th. The lunch 11:00 am and 1:00 pm had 5 of 36 documented out of range without corrective actions noted. The dinner column marked 4:00 pm was documented as times for 1st -27th. *”Reach thru cooking” for February 2024 stated, “Maintain cold potentially hazardous food at 40F/5C or below;” 2 of 44 were out of range with no corrective action noted. *”Patient Reach In” for February 2024 indicated temperature checks to be monitored three times a day with the range as 34-40 °F. 6 of 87 checks were out of range with no corrective actions noted or not documented. *Women’s refrigerator temperature record indicated temperature range as 34-40 °F. 6 of 29 checks were out of range with no corrective actions noted. *East Dish Machine Temp Log for January 2024 stated in part, “List comments or problems under “Actions Taken”. Notify manager whenever standards are not met. If wash temp <160°F or rinse temperature <180°F: -Test surface temp with waterproof thermometer (std=160F) and notify manager ...” However, above the Breakfast, Lunch, and Dinner columns, the was temp stated “150° or > and the rinse temp stated “180°F or >.” 26 of 84 temperatures were out of range without any actions taken documented. *The 3-compartment sink temperature record for February 2024 stated in part, “Standard: Check the instructions on the test strips package - some types specify that the test solution must be at 65°F to 75°F when tested. When in use, the solution must be at a minimum of 75°F. The 1st sink temperature must be at a minimum of 110°F. The 3rd sink temperature and ppm is dependent on the sanitizer solution used. Enter the correct 3rd sink temperature and ppm [parts per million] on the form above for the solution being used.” The columns for “Sanitizer Test Temp” and “PPM” were not completed. The breakfast column “Wash Temp” was documented as initials from 2/7/24 through 2/29/24 (23 of 29 days). Lunch sanitizer test temp ranged from 200-400 and ppm ranged from 100-180. Dinner sanitizer test temp ranged from 200-400 and ppm ranged from 60-400. It was unable to be determined if the temperatures and wash temps were appropriate for 87 of 87 checks as the form was not completed as indicated and lunch and dinner were not completed for lunch and dinner of 2/27/24 and 2/29/24. *”Concentration log: Sanitizer solution from dispenser” dated February 2024 listed times instead of PPM from 2/19/24 through 2/29/24, 11 of 29 days. *Dry Storage Temperature West Log for January 2024 stated in part, “Dry Storage temperature should be maintained between 50°F to 75°F ... Call engineering whenever temperature rises above 75°F.” 2 of 62 temperature checks were out of range without corrective actions documented. Relative humidity was not monitored for January 2024. *Dry Storage Temperature & Humidity West Log for February 2024 stated in part, “Dry Storage temperature should be maintained between 50°F to 70°F [5°F below the range from January 2024] with a relative humidity of 60%. List comments or problems under ‘Corrective Action’. Notify manager whenever standards are not met ...” 40 of 58 temperature and 14 of 58 relative humidity checks were out of range without corrective actions documented. *Dry Storage Temperature East Log for January 2024 stated in part, “Dry Storage temperature should be maintained between 50°F to 75°F ... Call engineering whenever temperature rises above 75°F.” 59 of 62 temperature checks were out of range without corrective actions documented. *Victory wash solution concentration log for January 2024 indicated the concentration should be between 40-80 ppm; 26 of 31 checks were out of range without corrective actions documented. *Victory wash solution concentration log for February 2024 indicated the concentration should be between 40-80 ppm; 29 of 29 checks were out of range without corrective actions documented. During an interview on the morning of 3/19/24, Staff #24, Food Services Director, verified the logs changed from month to month and did not always indicate which range temperatures, concentrations, and humidity should be. Staff #24 reported they did not sign-off on the logs indicating they checked them and did not consistently check the logs. Facility-based policy 603147 titled “Kitchen Sanitation” stated in part, “1. Temperature Checks: A. Refrigerators and Freezers ...2. Temperature checks are made and recorded on record sheets by Supervisory personnel. ...3. Equipment A. Steam table 1. Food temperature is checked with thermometer before serving, and temperatures are recorded. a. Hot food should be held at temperatures of 135 degrees F or above. ...4. Preparation for Dishwashing ...Insure [sic] temperature gauges are at proper temperatures before washing dishes. **140 degrees F (Wash), 160 degrees F (Pre-Rinse), and 180 degrees F (Final Rinse). 5. Dish Washing A. Automatic Dishwasher 3. The wash period is at least 40 seconds with the temperature being at least 160 degrees F. 4. The sanitizing rinse period is at least 20 seconds with the temperature 180 degrees F or higher. ...B. Wash Dishes: ... Monitor temperature dials on machine to insure [sic] proper temperature. ...7. Storage Refrigerators ...C. All refrigerators have thermometers which are monitored two times a day. 1. Fruits, vegetables, dairy products: 33-40 degrees ...Storage of Frozen Fruits, Vegetables, and Bakery Goods, etc. ...Storekeeper will place items in freezer at 10 to 0 degrees F ... G. Storage of Dairy Products, eggs cheeses, salad dressing, jelly, etc. ...Storekeeper will place items in appropriate walk-in refrigerator to 40-45 degrees F ...” Facility-based policy number 11354505 titled “Refrigerator” stated in part, “Temperature should be monitored and recorded daily. -Normal patient nourishment refrigerator temperature is between 36F and 40F and patient nourishment freezer temperatures maintained between 14F and -4F ...””

“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: 36594 Based on observation, review of records, and staff interview, the facility failed to maintain a clean and sanitary environment in 7 (Medical/Surgical, Materials Management, Behavioral Health PRU #1 and PRU #2, Respiratory, Labor and Delivery/Womens Services, and Emergency Room,) of 7 Departments observed to avoid sources and transmission of infection when infection control tour findings throughout the survey were observed and infection control rounds were not being performed regularly. Findings: During a tour of the 3rd floor medical-surgical unit on the morning of 3/19/24, Staff #30 verified following expired supplies were found in the crash carts: *Central Venous Catheter kit expired 4/2023 *(3) 16 French Foley Catheter kits expired 5/2023 During a tour of Materials Management on the afternoon of 3/19/24, with Staff #58, Director of Supply Chain and Staff #14, Director Quality/Regulatory, shipping boxes were noted throughout mixed with clean open and sterile supplies. There was no separation of sterile, clean, and dirty. The nationally accepted standards set forth by the Association for the Advancement of Medical Instrumentation (AAMI) state, “External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust.” (AAMI 5T46-Section 5.2 Receiving Items). During a tour of the Behavioral Health [BH] area on the morning of 3/20/24, the following was observed and verified by Staff #53, Director of BH Services and Staff #52, BH Quality: PRU 1: *Clean linen room with an open chip along counter and trim, making it impossible to clean *Crack on the floor of the seclusion room *Nutrition room ice maker with build-up noted on filter vents *Janitor room closet with items stored on the ground and a dark build-up noted on the ceiling vent PRU 2: *Noisy Activity/Dining/Kitchen Room: -laminate on bookshelf peeling -dirt in overhead light -gap along the crack of the door leading to the courtyard allowing light to enter and possible for pests and other contaminates to enter *Seclusion room with spiderwebs in windowsill *Patient Room 462 with chip on the wall During a tour of the Respiratory Department on the afternoon of 3/20/24 the following was observed and verified with Staff #47, Respiratory Manager: *Crack in the main station countertop *Crack in the wall above the door of sleep lab #2 Review of the facility-provided “Infection Control/EOC [Environment of Care] Rounding” logs for October 2023 through March 2024 revealed these were not performed consistently nor for each department: *Radiology rounds in 11/2023 was not completed as only “General Cleanliness, Sprinkler Head Escutcheon plates, and No stained or broken ceiling tiles” were addressed; none of the items under “Infection Control” were addressed. *There were no rounds for Surgery, Sterile Supply, Dietary, Respiratory, Inpatient Rehab, Behavioral Health, Materials Management, Linen and Laundry In an interview on the afternoon of 3/20/24, Staff #14 verified the above findings. Infection Control and Prevention Nurse job description stated in part, “Conduct regular rounds in hospital departments for discussing, monitoring, and following practices of infection control with hospital staff and volunteers. ...Monitoring the execution of preventative measures and providing guidance to staff.” Facility-based policy number 12771192 titled “Sp6036 Storage of Sterile Supplies” last approved 03/2023 stated in part, “Sterile supplies shall be separated from clean supplies. *A clean nonsterile storage area is designated for this purpose. ...Do not store any item in the sterile or clean area in their original cartons. Articles are to be removed from the shipping boxes and placed on small transfer cart which can be wheeled into the area ... All personnel in Central Service, Materials Management and other areas with sterile supplies are responsible for proper storage of these supplies.” 29191 Emergency Room During a tour of the emergency room with Staff #14 on 03/20/2024 at 11:15 AM the following infection control issues were observed: * Trauma room #1 had an overhead light fixture missing. Observed a straight pole hanging down with open wiring over the patient’s bed. * In exam room #3 expired supplies were found in the drawers. Chloraprep pads expired 07/2022 Hologic swabs expired 04/30/2023 * During the tour of the emergency room observed housekeeping staff clean exam #3. Housekeeping cleaned under the foam mattress, but the underneath was left wet there was no dry time allowing the disinfectant to activate. * The emergency call cord in the bathroom that is in the back of the emergency area fell out of the alarm panel when the surveyor touched the cord. There were dead bugs in the overhead light fixture of this bathroom and observed rust spots on the A/C vent. * Observed an intravenous pole in the back closet of the emergency room that was rusted. Rusted metal can not be disinfected. * Observed several entrances to the patient exam rooms that had chipped and missing paint from the door frames. An interview with Staff #14 on 03/20/2024 at 11:15 AM acknowledged the infection control and safety issues observed on the emergency room tour. 40989 Labor and Delivery/Women Services Unit A tour of the Labor and Delivery Unit/Women Services Unit was conducted on 3/18/2024 at 10:00 AM with RN Staff #16. The following was observed: Findings: Labor Room 2 (LDR 2) In LDR 2 the cabinets under the handwashing sink were unlocked. Inside the cabinet, under the faucet, a dried brown liquid was noted that resembled a water stain. A wooden rocking chair in the room had exposed, unsealed wood on both arms and the base of the chair. The drop-down door on the wooden cabinet that stored the fetal monitor was scratched and chipped exposing the bare wood. The porous surface was not able to be cleaned and sanitized to mitigate the spread of infectious diseases. This room was identified as clean a ready to receive a new patient. Operating Room (OR) for cesarean sections. This room was clean and ready for a new surgical patient. EKG leads hanging over the IV pole had uncovered EKG pads attached and ready for patient use. The trash can next to the anesthesia machine contained trash such as dirty gloves and a dirty napkin. On a table next to the anesthesia machine were two laryngoscope handles that were not identified as clean, dirty, or disposable. Two laryngoscope blades were in an unsealed plastic bag. The surveyor was unable to determine if the laryngoscope blades were clean or dirty. Laryngoscope blades attach to a laryngoscope handle to assist in placing a breathing tube in a patient. One 20 ml (milliliter) syringe with a blunt tip needle and one 5 ml syringe with a blunt tip needle attached were left on the table under a blue towel. An endotracheal tube (a tube placed in a patient’s airway to assist or breathe for a patient) was opened and a stylet (a flexible device placed inside an endotracheal tube to aid in directing the tube in the proper place of a patient’s airway) was noted inside the tube. The CO2 line (a line connected to the patient’s breathing circuit during anesthesia that gives instant information about the patient’s ventilation and how well the patient is eliminating carbon dioxide while under anesthesia) was connected to the patient mask on one end and the opposite end was on the floor. On top of the anesthesia cart was a metal rack that held labels with drug names to be applied to a syringe once the medication was drawn up in it. Inside the metal rack was dirt, dust, and debris that was stuck to the bottom of the inside. A tube of Lubricant eye ointment was noted on the cart and the seal had been broken. There was no date of when the ointment was opened or when it expired. Hanging on the wall was a Stericycle disposal for pills, tablets, IV fluids, and patches. The top of the disposal was open for use. A lid was noted on the bracket that holds the canister in place. The opening where you dispose of the medications was covered with a brown and black colored stain/dried liquid. The metal rack holding the container was noted with white powder, dirt, and dust. Sterile Supply Closet The sterile supply closet stored clean and sterile supplies. The room was not monitored for temperature or humidity. There was no thermostat control in the room. A metal locker was noted with chipped paint exposing the metal surface beneath the paint. A camouflage jacket was observed being stored on top of the metal locker. On 3/18/2024 after 10:00 AM RN Staff #16 confirmed the locker in the sterile supply room once belonged to the anesthesia department but had been placed in the room because it was no longer in use. Dirty Utility Room Inside the dirty utility room was storage for dirty linen, mop buckets, and trash. The mop bucket handle was reinforced with tape that was unraveled and exposed the rust inside the metal mop bucket handle. The inside and outside of the mop bucket was covered with dirt, dust, and water stains. Clean mops were placed in the bucket and then taken into patient rooms and the Operating Room to clean and sanitize the floors. The concrete floors in the dirty utility room were noted to have dried white and blue paint, dirt, dust, and debris. Patient Medication Room The wooden door leading into the patient medication room was chipped and missing wood exposing the porous surface beneath. The porous surface was unable to be cleaned and sanitized to prevent the spread of infectious diseases. On top of the patient medication cart was a pill crusher used to split and crush a patient’s medication. The pill crusher had visible dust, dirt, debris, and reddish/brown colored dried liquid noted on the top and inside. On the bottom of the medication cart, directly above the wheel, a red dried liquid was observed. Patient Nutrition Room Inside the patient nutrition room was a refrigerator used to store patient nutrition. On the bottom of the refrigerator, a dried, brown-colored liquid was observed. The floor under the refrigerator was observed to have a black and brown colored sticky substance that aligned with the width of the refrigerator. In a lower cabinet, cleaning supplies were being stored. Inside this cabinet, a dried, yellow-colored liquid was on the shelf. Exam Room Inside a room designated as “EXAM ROOM” was a red examination chair that was electronic and could be laid flat to examine patients in the labor and delivery department. On the edge of the mattress, a brown-colored sticky residue was observed. An overhead light used for examinations was observed with dirt and dust. Women’s Services Unit The room used to store clean and sterile supplies did not have a way to monitor temperature and humidity. Inside the storage room was a restroom that was used by the staff. There was no separation of clean and dirty in the supply room due to the restroom being utilized by staff. RN Staff #16 confirmed there was no thermostat control in the sterile storage area. A review of the AORN (Association of periOperative Registered Nurses) Perioperative Standards and Recommended Practices, “Temperature should be maintained between 68 degrees F to 75 degrees Fahrenheit (20 degrees to 23 C) within the operating room suite ... Relative humidity should be maintained between 20% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 60% in sterile storage areas ... Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system. Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system.” A review of the ANSI/AAMI standards was as follows: “ ...ANSI/AAMI S179:2017 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities 11 Storage and transportation ’ 11.1 Sterile storage 11.1. Storage facilities Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination. Sterile storage areas should be kept clean and dry...” An interview was conducted with RN Staff #16 on 3/18/2024 after 10:00 AM. RN Staff #16 was asked how the sterile supplies were monitored to ensure the supplies stayed within the required temperature and humidity ranges to ensure the sterility of the package. RN Staff #16 confirmed the rooms used to store sterile and clean supplies were not monitored daily. Also, she confirmed the restroom in the sterile supply storage was used by staff daily. 32143 A tour was conducted in the Emergency Room on (ER) 3/19/24 at 2:50 pm with staff # 69 RN. The following items were found. Findings: The sink in the medication room did not have a splash guard. The eye wash station was attached to the sink. Medications were stored next to the sink. There was spray and splash of sink water on the tops of normal saline bottles. In the medication room soiled and full medication waste containers were found sitting next to clean and sterile patient medical supplies. The medication bio-hazard container was also pushed up against a cabinet door. The door was heavily soiled with dried liquids, dirt, dust, and hair. The paint was chipped and missing. The hinge on the door allowed the cabinet door to stay cracked. Inside the door were blood tubes and needles ready for patient use. In the medication room, a trash can was found sitting on a box next to the clean and sterile patient supplies. Clean tourniquets were found spilling over into the trash can and ready for patient use. The nurse’s desk in the ER was found to have large chunks of missing laminate exposing bare wood surfaces that cannot be cleaned properly. The ER refrigerator and freezer in the nourishment room were covered with ice and were not able to be cleaned properly. 4- ER stretchers were found to have tape on the beds and handles. The beds are unable to be cleaned properly due to the tape and tape residue.”

“IC PROFESSIONAL RESPONSIBILITIES POLICIES CFR(s): Standard: Leadership responsibilities (2) The infection preventionist(s)/infection control professional(s) is responsible for: (i) The development and implementation of hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines. This Standard is not met as evidenced by: 36594 Based on review of records and staff interviews, the facility failed to develop and implement a hospital-wide infection surveillance, prevention, and control policies and procedures that adhered to nationally recognized guidelines when there was no active surgical site infection [SSI] surveillance. Findings: In an interview on the morning of 3/19/24 with Staff #14, Director of Quality/Regulatory and Staff #55, Core Measures/Abstractor, they reported they were managing the Infection Control [IC] & Prevention program since the IC nurse position was vacant, and all information was provided they had access to. Staff #55 reported they monitor SSIs by reviewing lab reports for infections as they come through. Staff #55 verified there was no documentation of SSI monitoring and each patient who had surgery was not reviewed, only if an infection report came through. In an interview on the afternoon of 3/19/24, Staff #36, Director of Surgery, reported they do not complete SSI monitoring and were notified through facility quality/infection control if an infection from a surgical patient came across. Staff #36 reported surgeons did not necessarily report if a patient came to see them on an outpatient basis for issues nor did they contact patients to see if they had an infection or issues after surgery. There was no documented evidence provided of nosocomial or surgical site infection surveillance conducted after 30 days or implant infection surveillance conducted after 90 days. Centers for Disease Control and Prevention [CDC] procedure-associated module titled “Surgical Site Infection (SSI) Event,” dated January 2024 found at: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf stated in part, “SSI monitoring requires active, patient-based, prospective surveillance. Concurrent and postdischarge surveillance methods should be used to detect SSIs following inpatient and outpatient operative procedures. For example, these methods include: o Review of medical records or surgery clinic patient records o ...Visit the ICU and wards - talk to primary care staff o Surgeon surveys by mail or telephone o Patient surveys by mail or telephone (though patients may have a difficult time assessing their infections). Any combination of these methods (or other methods identified by the facility) with the capacity to identify all SSIs is acceptable for use ...””

“RESPIRATORY CARE SERVICES POLICIES CFR(s): 482.57(b) Services must be delivered in accordance with medical staff directives. This Standard is not met as evidenced by: 38387 Based on review of facility policies, random review of medical charts from March 2024, and confirmed in interview, the facility failed to follow its Adult Ventilator and BiPAP policy for three of three (Patient #58, 59, 60) respiratory records reviewed. Findings included: Review of the facility policy Adult Ventilator Protocol (AVP), 5/15 (PolicyStat ID 14298801, effective 10/2023), it stated: “Guidelines for Using Ventilator Protocol A. Physician’s order for initiation of Adult Ventilator Protocol (AVP) ... Ventilator Adjustments: A. Initial assessment should be performed within 15 minutes from start of ventilation. B. Identify patient. Assessment should include breath sounds, work of breathing, blood pressure, heart rate, ventilating pressures and volumes, Sp02, and respiratory rate. C. ABG should drawn within 15 to 60 minutes from start of ventilation. D. If ABG abnormalities are due to respiratory insufficiency ventilator should be adjusted. 1. If ph less than 7.30, may adjust rate first to a maximum of 20 breaths/minute if peak pressure and expiratory time will allow. If pH greater than 7.50 may adjust rate or tidal volume to achieve desired pH. 2. If unable to increase rate, may increase tidal volume up to a maximum of 10ml/Kg of ideal body weight if peak pressures will allow. 3. ABG should be repeated 30 minutes after changes. 4. Fi02 and PEEP should be adjusted to lowest level to maintain target P02 and Sp02. Fi02 should be titrated first down to 40%, then PEEP should be weaned to lowest level to maintain adequate oxygenation. 5. If unable to maintain adequate oxygenation at Fi02 of.5 and PEEP of 10 cm H20 physician should be notified. 6. If any adjustments greater or less than those allowed by the protocol are necessary to maintain adequate ventilation the physician should be notified. Special Considerations A. Physician should be notified of 1. Increase in respiratory rate > 10 breaths/minute. 2. Decrease in Sp02 > 10 or of a value less than 85%. 3. Increase in peak airway pressures > 10cm H20. 4. Absence of breath sounds. 5. Frank bloody secretions.” Patient #58 Review of patient medical record (Patient #58) revealed she was admitted to the facility on 3/11/2024 for left distal femur displaced. She had surgery on the left femur on 3/14/2024 and she required intubation during the surgery. She was transferred to ICU after surgery. Review of Patient #58’s medical record revealed no physician orders to include the respiratory settings for her vent. Further review of Patient #58’s medical record on the RT (Respiratory Therapy) Ventilator Flowesheet revealed the respiratory therapist (Staff #68) increased the vent setting from 50% to 60% on 3/14/2024 at 7:58 PM and Peep settings were decreased to 7 from 10 on 3/14/2024 at 11:00 pm. Review of Patient #58’s record revealed no physician orders to increase the vent settings or decrease the Peep per facility policy. In an interview on the morning of 3/21/24 with Staff #47, Respiratory Manager, regarding the vent order for patient #58, he could not find an order with parameters and stated, “There’s not one for this patient. It was a very rare case. [Staff #68, Respiratory Therapist] unfortunately did not chart who she got the order from. Usually, it’s from the CRNA.” When discussing RT’s decrease of PEEP from 10 to 7 at 11:00 pm, Staff #47 stated, “It should have been guided by a physician. Normally, the doctor would put in the orders.” Patient #59 Review of patient medical record (Patient #59) revealed he was intubated on 03/12/2024 at 06:25 AM due to “respiratory failure.” Review of Patient #59’s record revealed no ABG’s collected at 15 minutes to 60 minutes after intubation, per the facility policy. The next ABG was on 03/12/2024 at 8:35 AM, more than 120 minutes after intubation. An interview with the Staff # 47 on 3/21/2024 at 11:00 AM in the nursing station confirmed the above findings. Review of facility policy Non-invasive Ventilation (PolicyStat ID 13338363, effective 05/2023) it stated: “BIPAP DEVICE PROCEDURE: 1. RECEIVE PHYSICIAN ORDER, IDENTIFY PATIENT. 2. UNCONSCIOUS PATIENTS OR PATIENTS WITH ALTERED MENTAL STATUS SHOULD BE PLACED IN ROOM WHERE VENT ALARMS ARE EASILY HEARD. 3. CALL LIGHT SHOULD BE IN REACH OF PATIENT 4. EXPLAIN THERAPY TO PATIENT AND FAMILY. 5. MEASURE PATIENT’S FACE WITH DEVICE PROVIDED WITH MASKS. 6. SET VENTILATOR TO PRESCRIBED SETTINGS.” Patient #60 Review of patient medical record (Patient #60) revealed she was placed on bipap on 03/19/2024. Review of the physician orders had no prescribed settings. An interview with the respiratory therapist (Staff # 83) on 03/21/2024 at 12:30 PM in the Respiratory area confirmed that their usual process is that they would verify the settings with the provider and request the provider enter the settings discussed. Glossary: Bipap - bilevel positive airway pressure, type of ventilator device to help with breathing. Peep - Positive end-expiratory pressure is used therapeutically during mechanical ventilation”

“POSTING OF SIGNS CFR(s): 489.20(q) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area) a sign (in a form specified by the Secretary) specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital or rural primary care hospital (e.g., critical access hospital) participates in the Medicaid program under a State plan approved under Title XIX. This Standard is not met as evidenced by: 29191 Based on observation and interview, the hospital failed to post the required separate signage in English and Spanish in the Emergency restrooms (excluding the psych restroom) and the triage room for Human Trafficking. Findings Include: A tour of the Emergency Department on 03/21/2024 at 11:00 AM revealed no human trafficking signs observed in 1 of 2 bathrooms and the triage room which was located in the emergency department. An interview with Staff #69 during the rounds of the emergency room on 03/21/2024 at 11:00 AM acknowledged that the human trafficking signage was missing from the triage room and one of the emergency room bathrooms.”

“A life safety code (LSC) survey was conducted on site on 2/13/2024. An entrance conference was held with the Director of Plant Operation and Safety Officer to discuss the purpose of the LSC survey, and the survey process was explained. Instructions were provided on writing plans of correction. 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 L, Ambulatory Surgical Services, 42CFR416.2 to determine the Ambulatory Surgical Center compliance. An LSC exit conference was conducted on 2/13/2024 in the Hospital. In attendance was the Director of Plant Operation, O.R. Director and Safety Officer. 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.”

“Gas and Vacuum Piped Systems - Other CFR(s): NFPA 101 Gas and Vacuum Piped Systems - Other List in the REMARKS section any NFPA 99 Chapter 5 Gas and Vacuum 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 5 (NFPA 99) This Standard is not met as evidenced by: 40763 K902 GAS AND VACUUM PIPED SYSTEMS - OTHER List in the REMARKS section, any NFPA 99 Chapter 5 Gas and Vacuum 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 5 (NFPA 99) Two Entry/Exits NFPA 99, 2012 :5.1.3.3.2* Design and Construction. Locations for central supply systems and the storage of positive-pressure gases shall meet the following requirements: These are general requirements. (1) They shall be constructed with access to move cylinders, equipment, and so forth, in and out of the location on hand trucks complying with 11.4.3.1.1. (2) They shall be secured with lockable doors or gates or otherwise secured. (3) If outdoors, they shall be provided with an enclosure (wall or fencing) constructed of noncombustible materials with a minimum of two entry/exits. Based on observation the facility failed to provide two entry/exits in the oxygen farm Tanks area. The inspector observed, while accompanied by the Director of Plant Operation and Safety Officer during the hours of the inspection from 2:00 pm to 6:00 pm on 2/13/2024 that the facility oxygen farm tank area did not have two entry or exits per the code (3) above.”

“Gas and Vacuum Piped Systems - Categories CFR(s): NFPA 101 Gas and Vacuum Piped Systems - Categories Medical gas, medical air, surgical vacuum, WAGD, and supply air systems are designated: o Category 1 - Systems in which failure is likely to cause major injury or death. o Category 2 - Systems in which failure is likely to cause minor injury. o Category 3 - Systems in which failure is not likely to cause injury, but can cause discomfort. Deep sedation and general anesthesia are not to be administered using a Category 3 medical gas system. 5.1.1.1, 5.2.1, 5.3.1.1, 5.3.1.5 (NFPA 99) This Standard is not met as evidenced by: 40763 Based on observation the facility failed to provide a risk assessment for the medical gas system. The inspector observed, while accompanied by the Director of Plant Operation and Safety Officer during the hours of the inspection from 2:00 pm to 6:00 pm on 2/13/2024 that the facility had not done a risk assessment to determine the medical gas supply failure likelihood to cause major injury or death.”

“Gas and Vacuum Piped Systems - Maintenance Pr CFR(s): NFPA 101 Gas and Vacuum Piped Systems - Maintenance Program Medical gas, vacuum, WAGD, or support gas systems have documented maintenance programs. The program includes an inventory of all source systems, control valves, alarms, manufactured assemblies, and outlets. Inspection and maintenance schedules are established through risk assessment considering manufacturer recommendations. Inspection procedures and testing methods are established through risk assessment. Persons maintaining systems are qualified as demonstrated by training and certification or credentialing to the requirements of AASE 6030 or 6040. 5.1.14.2.1, 5.1.14.2.2, 5.1.15, 5.2.14, 5.3.13.4.2 (NFPA 99) This Standard is not met as evidenced by: 40763 Based on observation the facility failed to provide a risk assessment for the medical gas system. The inspector observed, while accompanied by the Director of Plant Operation and Safety Officer during the hours of the inspection from 2:00 pm to 6:00 pm on 2/13/2024 that the facility had not done a risk assessment to determine the procedures and schedule for testing the medical gas system.”

“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: 40763 Generator Manual Kill Switch “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” - NFPA 110, 2010, 5.6.5.6* Note: “For systems located outdoors, the manual shutdown should be located external to the weatherproof enclosure and should be appropriately identified.” A.5.6.5.6. Based on observation the facility failed to provide adequate generator safety features. The inspector observed, while accompanied by the Director of Plant Operation and Safety Officer during the hours of the inspection from 2:00 pm to 6:00 pm on 2/13/2024 that the facility had a generator kill switch installed outside the generator enclosure but in a locked location. The kill switch shall be at a location with unfettered access. Segregation of the Essential Electrical System (General) Type 1 EES The critical system shall serve functions related to patient care. - NFPA 99, 2012, 6.4.2.2.4.1 The critical branch shall be permitted to be subdivided into two or more branches. 6.4.2.2.4.2 The critical branch shall supply power for task illumination, fixed equipment, select receptacles, and select power circuits serving the following areas and functions related to patient care: (1) Critical care areas that utilize anesthetizing gases, task illumination, select receptacles, and fixed equipment (2) Isolated power systems in special environments (3) Task illumination and select receptacles in the following: (a) Patient care rooms, including infant nurseries, selected acute nursing areas, psychiatric bed areas (omit receptacles), and ward treatment rooms (b) Medication preparation areas (c) Pharmacy dispensing areas (d) Nurses’ stations (unless adequately lighted by corridor luminaires) (4) Additional specialized patient care task illumination and receptacles, where needed (5) Nurse call systems (6) Blood, bone, and tissue banks (7) Telephone equipment rooms and closets (8) Task illumination, select receptacles, and select power circuits for the following areas: (a) General care beds with at least one duplex receptacles per patient bedroom, and task illumination as required by the governing body of the health care facility (b) Angiographic labs (c) Cardiac catheterization labs (d) Coronary care units (e) Hemodialysis rooms or areas (f) Emergency room treatment areas (select) (g) Human physiology labs (h) Intensive care units (i) Postoperative recovery rooms (select) (9) Additional task illumination, receptacles, and select power circuits needed for effective facility operation, including single-phase fractional horsepower motors, which are permitted to be connected to the critical branch. Based on observation the facility failed to provide correct Essential Electrical System separation. The inspector observed, while accompanied by the Director of Plant Operation and Safety Officer during the hours of the inspection from 2:00 pm to 6:00 pm on 2/13/2024 that the lights in the following areas are powered from the normal branch instead of the critical branch: 1. The Pre-Ops restroom. 2. All the ICU patient restrooms. 3. Nourishment area light and add a critical receptacle for Ice Maker. 4. Medical Surgical suite, all the patient rooms and restrooms lights are on normal branch. It shall be on critical 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: 40763 Based on observation the facility failed to provide adequate maintenance and testing. The inspector observed, while accompanied by the Director of Plant Operation and Safety Officer during the hours of the inspection from 2:00 pm to 6:00 pm on 2/13/2024 that there were the following issues: 1. That the required annual receptacles testing was not being performed. 2. No records of where, type of repair performed and date of electrical maintenance and required tests performed in all the patient care areas.”

“Electrical Systems - Essential Electric Syste CFR(s): NFPA 101 Electrical Systems - Essential Electric System Categories *Critical care rooms (Category 1) in which electrical system failure is likely to cause major injury or death of patients, including all rooms where electric life support equipment is required, are served by a Type 1 EES. *General care rooms (Category 2) in which electrical system failure is likely to cause minor injury to patients (Category 2) are served by a Type 1 or Type 2 EES. *Basic care rooms (Category 3) in which electrical system failure is not likely to cause injury to patients and rooms other than patient care rooms are not required to be served by an EES. Type 3 EES life safety branch has an alternate source of power that will be effective for 1-1/2 hours. 3.3.138, 6.3.2.2.10, 6.6.2.2.2, 6.6.3.1.1 (NFPA 99), TIA 12-3 This Standard is not met as evidenced by: 40763 Based on observation the facility failed to provide a Type I electrical system. The inspector observed, while accompanied by the Director of Plant Operation and Safety Officer during the hours of the inspection from 2:00 pm to 6:00 pm on 2/13/2024 that the facility electrical system was not “Type I” Essential Electrical System (EES) as required for Ambulatory Surgery Centers. Provide Life Safety, Critical and Equipment Panels per the code.”

“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: 40763 Based on observation the facility failed to provide all the required documentation for the essential electrical system maintenance. The inspector observed, while accompanied by the Director of Plant Operation and Safety Officer during the hours of the inspection from 2:00 pm to 6:00 pm on 2/13/2024 that there were: 1. There was no record of 36-month load bank test being performed. 2. There was no record of the main and feeder circuit breakers being inspected annually. 3. There were no records of maintenance and testing of the EES system being catalogued.”

“Electrical Equipment - Testing and Maintenanc CFR(s): NFPA 101 Electrical Equipment - Testing and Maintenance Requirements The physical integrity, resistance, leakage current, and touch current tests for fixed and portable patient-care related electrical equipment (PCREE) is performed as required in 10.3. Testing intervals are established with policies and protocols. All PCREE used in patient care rooms is tested in accordance with 10.3.5.4 or 10.3.6 before being put into service and after any repair or modification. Any system consisting of several electrical appliances demonstrates compliance with NFPA 99 as a complete system. Service manuals, instructions, and procedures provided by the manufacturer include information as required by 10.5.3.1.1 and are considered in the development of a program for electrical equipment maintenance. Electrical equipment instructions and maintenance manuals are readily available, and safety labels and condensed operating instructions on the appliance are legible. A record of electrical equipment tests, repairs, and modifications is maintained for a period of time to demonstrate compliance in accordance with the facility’s policy. Personnel responsible for the testing, maintenance and use of electrical appliances receive continuous training. 10.3, 10.5.2.1, 10.5.2.1.2, 10.5.2.5, 10.5.3, 10.5.6, 10.5.8 This Standard is not met as evidenced by: 40763 Based on observation the facility failed to provide adequate training check of the service technicians. The inspector observed, while accompanied by the Director of Plant Operation and Safety Officer during the hours of the inspection from 2:00 pm to 6:00 pm on 2/13/2024 that the facility failed to check the training record of the technicians calibrating the center medical equipment.”

“Gas Equipment - Testing and Maintenance Requi CFR(s): NFPA 101 Gas Equipment - Testing and Maintenance Requirements Anesthesia apparatus are tested at the final path to patient after any adjustment, modification or repair. Before the apparatus is returned to service, each connection is checked to verify proper gas and an oxygen analyzer is used to verify oxygen concentration. Defective equipment is immediately removed from service. Areas designated for servicing of oxygen equipment are clean and free of oil, grease, or other flammables. Manufacturer service manuals are used to maintain equipment and a scheduled maintenance program is followed. 11.4.1.3, 11.5.1.3, 11.6.2.5, 11.6.2.6 (NFPA 99) This Standard is not met as evidenced by: 40763 Based on observation the facility failed to provide adequate medical gas equipment testing. The inspector observed, while accompanied by the Director of Plant Operation and Safety Officer during the hours of the inspection from 2:00 pm to 6:00 pm on 2/13/2024 that the facility had no scheduled maintenance program for medical gas equipment.”

“LICENSURE OF PERSONNEL CFR(s): 482.11(c) The hospital must assure that personnel are licensed or meet other applicable standards that are required by State or local laws. This Standard is not met as evidenced by: 29191 Based on record review and interviews, the facility failed to ensure that staff working in the emergency department had current EMTALA (Emergency Medical Treatment & Labor Act) training for 7 (#13, #14, #15, #16, #17, #18, and #19) of 15 staff members. A review of the training log provided by the education department revealed that 7 (#13, #14, #15, #16, #17, #18, and #19) of 15 nursing staff working in the emergency room did not have the EMTALA training within the last year. Staff # 13 last EMTALA training was 01/25/2022 Staff # 14 last EMTALA training was 03/20/2021 Staff # 15 last EMTALA training was 03/27/2021 Staff # 16 last EMTALA training was 02/09/2021 Staff # 17 last EMTALA training was 02/22/2021 Staff # 18 last EMTALA training was 03/15/2022 Staff # 19 last EMTALA training was 04/10/2021 An interview with Staff #8 on 11/06/2023 at approximately 11:00 AM confirmed that EMTALA training was required on an annual basis. A review of the facility policy titled, “Orientation, Training, & Education of Staff - Competency Plan for 2023” revealed the following: “Mandatory Annual Training for all employees: Annually, all employees will be required to complete a self-study educational program via on-line education modules. These topics include requirements from The Joint Commission, CMS, Risk Management, Infection Control, OSHA, etc. The specific topics covered by the training modules set by Corporate are: FOR NON-CLINICAL EMPLOYEES: (as appropriate to job description) 1. Active Shooter Response in Healthcare Setting 2. Acute Coronary Syndrome 3. Anti-Discrimination Training 4. Code of Conduct 5. Early Heart Attack Care (EHAC) 6. EMTALA 7. Information Security Awareness 8. MRI Safety 9. National Patient Safety Goals 10. Patient Abuse/ Assault/ Neglect 11. Preventing Patient Falls 12. Radiation Safety 13. Rapid Regulatory Compliance Non-Clinical I, including, Corporate Compliance & Ethics, HIPAA, Sexual Harassment, Patient Rights, Confidentiality, Participation in Treatment Decisions, Respect, Safety and nondiscrimination, Patient Visitation Rights, Grievances 14. Rapid Regulatory Compliance Non-Clinical 11, including, General Safety, Fire Safety, Electrical Safety, Ergonomics, Back Safety, slips, Trips, & Falls, Hazard Communication, Security & Workplace Violence, Reporting Incidents, Emergency Preparedness, Infection Control, Health¿care Associated Infection, Hand Hygiene, Antibiotic Resistance, Airborne Pathogens, Bloodborne Pathogens, Personal Responsibility 15. Safety Incident Management EMTALA Training Course and Test is required for the following employees: ED Employees ED Physicians OB Department Staff ED Registration Clerks/Phone Operators EMS Personnel Security Personnel All Administrative Officers House Supervisors” An interview with Staff #4 on 11/06/2023 at approximately 11:00 AM confirmed that EMTALA training was required on an annual basis and staff #13, #14, #15, #16, #17, #18, and #19 had not had EMTALA training within the last year.”

“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: 29191 Based on observation and interview, the facility failed to monitor and provide a sanitary environment to minimize the transmission of infectious agents within the emergency room of the hospital that were observed. These findings had the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility. During a tour of the facility on 11/06/2023 at 3:00 PM with Staff #4, #5 and #8 the following infection control issues were observed and acknowledged: Emergency Department: Triage room The chair in the triage room had a large amount of cushion missing on the arms. The yellow discolored sponge cushion was showing on both arms. There was no way that staff could clean the chair. Exam room #3 Observed broke off knobs on the cabinet drawers. The surveyor was unable to open the cabinets; the housekeeping staff took a flat edge tool to open the cabinet doors. There were numerous scratches in the paint of the cabinets and large areas of plaster missing from the wall. (This was cited on the survey from 1/18/2023.) Patient Bathroom (Located outside exam #12) The bathroom floor was dirty with black substance in the corners of the room. The top side edge of the tile around the walls of the bathroom was brown with dust particles and debris. The emergency pull cord had the tip pulled off and if the patient tried to pull the cord, the cord would just pull through the hand of the patient. Exam room #12 Observed a large piece of equipment that was used to create a negative pressure room in exam room #12. The ducting was taped with a large amount of black tape to a vent in the ceiling. (This was cited on the survey from 1/18/2023.) The was a small black portable 2-drawer cabinet in the room that had dust and dirt on the crease of the cabinet. Also, white spillage was running down the side of the cabinet. There was a large yellow rusted “H” (size of the cylinder) cylinder observed sitting in the corner of exam room #12. Mutiple dead bugs were observed in two of ceiling light fixture outside of exam room #12. Exam room #12 was cluttered and had an unclean appearance. (This was cited on the survey from 1/18/2023.) Supply Storage Area (located by exam room #8) The floor was covered in lint, trash particles, dust, and dirt around all 3 walls of the storage closet. There were 2 bedside commode chairs wrapped with plastic stacked on top of themselves, which per staff #4 meant the equipment was clean. There was a brown substance smeared down the leg of the commode chair. Also, stored in the closet was a portable “InTouch Health” video monitor. This equipment was used for telehealth services for Neurology. There was no way to determine if the monitor was clean or dirty. Patient Nourishment Room The cabinet below the sink had loose handles that were falling from the cabinet doors. Holes from missing screws and chipped paint were exposing the wooden surface. There was a coffee pot on top of the counter. The drawer directly beneath the coffeepot stored “Community Coffee” packets used to make coffee. Inside the drawer was a moderate amount of loose coffee grounds. When opening the drawer, observed a large dried brown liquid spill. Also below the drawer was a cabinet that had a dried brown liquid spill on the door surface. (This was cited on the survey from 1/18/2023.) The drawer directly beneath the refrigerator stores crackers for patients’ use. Inside the drawer was a large amount of broken cracker crumbs. Stored in the cabinet beneath the refrigerator was a plastic container of 10 Ounces of “Thick-It”. This product is used to thicken a patient’s liquids to aid in swallowing. There was no open date on the container. (This was cited on the survey from 1/18/2023.) ER Hallways Multiple, blue-painted doorframes throughout the ER Department were missing paint and exposing the bare metal surface. Metal cannot be sanitized to prevent the spread of infectious diseases. Along the hallways, attached to the walls, were wooden hand rails painted blue. The wood was chipped and missing paint exposing the wooden surface beneath. The porous surface cannot be sanitized to prevent the spread of infectious diseases. (This was cited on the survey from 1/18/2023.) An interview was conducted with Staff #4 on 11/06/2023 at 3:30 PM and confirmed the infection control issues that were observed on the tour. Staff #4 acknowledged that some of the issues observed on tour were seen on the previous survey from 01/18/2023.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 29191 Based on record review and interview, the facility’s emergency department physician #11 failed to provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services. Findings include: The patient had been in the local Emergency room 8 times since the beginning of the year 2023. The dates of service and diagnosis are as follows: 1-01-2023 -Cough 1-23-2023 -Cystitis 2-25-2023 -Fever 3-12-2023 -Nausea/vomiting 3-24-2023 -CT scan (Diagnostic imaging) 4-12-2023 -Nausea/vomiting 9-11-2023 -Nausea/vomiting 9-12-2023 -Nausea/vomiting Patient #1 was born at the local Hospital on 7-11-2022 Patient # 1 was a 14-month-old female with a Wilms tumor on the right kidney and had a resection of the kidney on 3/27/2023 at a children’s hospital in Dallas. The patient was discharged on 4/1/2023 after the surgery from the children’s hospital. The patient had to undergo 19 weeks of Chemotherapy which concluded on August 8, 2023. A review of the medical record for the date of service on 9/11/2023 at 11:50 AM revealed Patient # 1 was in the emergency room for nausea and vomiting. Vital signs: 11:57 AM Pulse 132, Respiratory rate 32, Temperature 97.3 (No blood pressure documented) Pulse Oxygen 100% 1:53 PM B/P 98/65 pulse 120, Pulse Oxygen 97% 2:00 PM B/P 103/62 pulse 106, Pulse Oxygen 98% 3:00 PM B/P 98/56 pulse 125, Pulse Oxygen 98% Temperature 99.3 4:00 PM B/P 114/75 pulse 129 Pulse Oxygen 97% 4:47 PM B/P 104/64 pulse 123, respiratory rate 20 temperature 98.3 Pulse Oxygen 97% A review of Physician #11 notes revealed the following: “2:29 PM The patient presents to the emergency department with nausea and vomiting. Onset: The symptoms/episode began/occurred acutely. Possible causes: unknown. The symptoms are aggravated by nothing. The symptoms are alleviated by nothing. Associated signs and symptoms: The patient has no apparent associated signs or symptoms. Severity of symptoms: At their worst, the symptoms were moderate this morning, in the emergency department the symptoms are unchanged. The patient has not experienced similar symptoms in the past. The patient has not recently seen a physician. The patient recently finished chemotherapy for renal carcinoma. Abdomen/GI: Inspection: abdomen appears normal, Bowel sounds: normal, in all quadrants, Palpation: abdomen is soft and non-tender, in all quadrants, mass, is not appreciated, rebound tenderness, voluntary guarding, is not appreciated, involuntary guarding, is not appreciated, no appreciated organomegaly.” A review of patient #1’s labs dated 09/11/2023 revealed the following abnormalities: “Glucose-109 BUN- 20 Create- 0.25 WBC- 13.2 Neut%- 81 Lymp%- 15 Low Ketones in the urine- 40 Protein in the urine- 30” A review of Physician #11 notes showed no documentation that the elevated WBC, BUN, or ketones in the urine were addressed. A review of the Chest x-ray performed at the 09/11/2023 revealed the following: “Right chest wall port tip overlying the SVC. Normal heart size. No pulmonary vascular congestion. No pneumothorax or pleural effusion. The lungs are clear. No fracture. Surgical clips overlying the midline abdomen. IMPRESSION: No acute cardiopulmonary abnormality.” Patient #1 had undergone major abdominal surgery for a Wilms tumor on the right kidney and had a resection of the kidney. There were no tests ordered for possible bowel obstruction, bowel ischemia, or abscess which could have addressed the reason for nausea and vomiting. Patient #1 had the likelihood of having an emergency medical condition of sepsis, which could have led to septic shock, multiorgan failure, and death. A review of the nurse’s notes revealed that the mother reported the child had only 1 wet diaper before arrival and was lethargic. There was no documentation from the registered nurse or the physician addressing hypovolemia/dehydration/sepsis. Also, there was no pediatric consult from the local pediatrician or consult for a transfer back to the Children’s Hospital where the child had previously received care. The medical chart did not indicate that the child was tolerating oral fluids before discharge. A review of the nurse’s discharge note revealed Patient #1 was discharged home at 4:47 PM. “Discharge Assessment: Patient lethargic. Patient appropriate for age. Discontinued IV intact, bleeding controlled, pressure dressing applied, No redness/swelling at site. 4:57 Patient left the ED (emergency department).” Patient #1 was discharged lethargic to the mother with instructions to return if conditions worsen. An interview with Staff #6 on 11/06/2022 at 4:00 PM acknowledged that emergency physician #11 failed to provide an appropriate medical screening examination.”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 29191 Based on record review and interview, the facility’s emergency department physician #10 failed to determine if an emergency medical condition existed and failed to stabilize Patient #1’s condition before transferring to a children’s hospital. A review of the medical record for patient #1 revealed the patient arrived at 1:42 AM on 09/12/2023 at the local emergency room with her parents with continued vomiting. This visit was approximately 9 hours after patient #1 was discharged on 9/11/2023 emergency room visit for vomiting. A review of Physician #10’s notes revealed the following: “2:18 AM This 14-month-old White Female presents to ED via walk-in with complaints of Vomiting. The patient is a 14-month-old female with a history of Wilms tumor status post resection who presents to the emergency department for nausea, vomiting, and lethargy. Mom states the child has been vomiting for a couple of days and they were seen here in the emergency department earlier today and given fluids. She states that she maxed out on her Zofran and so brought her here. She states that her daughter is pale and extremely lethargic. She states that she was going to drive her daughter to “Facility-A” in Dallas where she gets her care however she did not think that she could make it. She states that her daughter just finished 20 weeks of chemo and that was last finished on August 8th. She will have surgery again next month. Abdomen/GI: Positive for vomiting. Head/Face: Normocephalic, atraumatic. Eyes: Pupils equal round and reactive to light, extra-ocular motions intact. Lids and lashes are normal. Conjunctiva and sclera are non-icteric and not injected. Periorbital areas with no swelling, redness, or edema. ENT: Nares patent. No nasal discharge. Tympanic membranes are normal and external auditory canals are clear. Oropharynx with no redness, swelling, or masses, exudates, or evidence of obstruction, uvula midline. Mucous membranes are moist. Neck: Trachea midline and no cervical lymphadenopathy. Supple, full range of motion without nuchal rigidity, or vertebral point tenderness. No Meningismus. Chest/axilla: Normal symmetrical motion. No tenderness. No axillary masses or tenderness. Cardiovascular: Regular rate and rhythm with a normal S1 and S2. Skin: Warm and dry with excellent turgor. No rashes are appreciated. MS/ Extremity: Pulses equal, no cyanosis. Neurovascular intact. Full, normal range of motion. Neuro: Awake and alert, interacting appropriately. Moving all extremities equally. Sensory grossly intact. Constitutional: The patient appears lethargic, obviously ill, pale. Respiratory: the patient does not display signs of respiratory distress, Respirations: tachypnea, Breath sounds: are normal, and clear throughout. Abdomen/GI: Inspection: abdomen appears normal, Bowel sounds: normal, Palpation: abdomen is soft and non-tender, in all quadrants.” Further review of the Emergency room notes revealed that the only lab drawn was a BMP (basic metabolic panel). This was the only test performed on the 09/12/2023 emergency room visit. Patient #1’s primary physician was not notified. A review of the emergency on-call log for 09/12/2023 revealed there was a pediatrician on call. The pediatrician was not notified. A review of the lab report revealed the following were documented as abnormal. “Potassium- 5.7 BUN- 40 Creatine-1.02 Bun/Creatine- 43 Osmoc- 296” A review of Physician #10’s notes showed no documentation that the elevated Potassium and BUN were addressed. The medical record revealed that these were the only vital signs recorded during the visit. “Vital signs: 1:46 AM P 181 R 30 Temp 97.2 pulse OX 96% 2:42 AM B/P 69/34 P 158 100% 2liter N/C 3:05 AM B/P 70/40 P 189 100% 2liter N/C 3:16 AM B/P 68/38 P 180 100% 2liter N/C 3:46 AM B/P 73/42 P 194 100% 2liter N/C 4:06 AM B/P 80/47 P 180 100% 2liter N/C 4:25 AM B/P 87/37 P 188 100% 2liter N/C 4:30 AM B/P 88/43 P 171 100% 2liter N/C” A review of the vital sign log revealed there was no blood pressure taken on admission and the respiratory rate was only taken on admission. A review of Physician #10’s notes showed no documentation that the elevated heart rate and low blood pressure were addressed. Patient #1 showed signs and symptoms of septic shock as evidenced by the low blood pressure and elevated heart rates. The medical record revealed that Physician #10 called the children’s hospital where patient #1 had received treatment in the past and had undergone major surgery. A review of the “Telephone Encounter” that transpired on 9/12/2023 at 2:44 AM with the physician at the children’s hospital revealed the following: “... 14-month w/ hx of Wilms, currently done with chemotherapy was seen on 9/11/2023 for vomiting unable to control w/ home Zofran, got 20 ml/kg bolus, UA negative, chest x-ray negative. Reportedly has a blood culture from that time. Got vomiting under control so was d/c home. Approximately 70 min ago now (2:50) mom brought her in appearing-pale, tachycardic, and “lethargic”. Satting 90% on Room air so put on 2L NC. Initial heart rate 180’s, BP 69/34, “clamped down”. HR 150’s after 20 ml/kg bolus. Small line, unable to get further access. No viral symptoms, no sick contacts. Repeat BP 70/42. HR 194 w/ crying. Cap refill (less than <5 sec but couldn’t specify if greater than 2-3). Didn’t know if there was a port in place. Discussed: Emergently - repeat fluid bolus to improve hypotension. Pt. has shock, possibly hypovolemic but most concerning for sepsis given severe presentation. Unable to draw blood cultures at this time. As per sepsis guidelines, would receive at least 60 ml/kg rescue to help manage the shock, followed by pressors. Discussed with attending Dr. - if concerned about the need for sepsis and still unable to draw blood cultures/access port and with worsening pressures/tachycardia, please give abx (antibiotics) w/o cultures. If starting to stabilize, can consider holding off at this time. Consider 2nd access such as IO if needed to help with fluid resuscitation efforts. Most recent labs: Hg - 11.5, WBC 13.2 (similar to ours 7 days ago outside of the elevation in WBC). @3:40am - called for an update. Pt overall similar, still lethargic w/ BP 70s systolic. Receiving continued fluid rescue, unable to access port so no abx right now. For acute decompensation, need to consider pressors and abx after attempting IO or other site of access. Our FW aircraft pilots are not available, and our helicopter team cannot fly out right now. Will monitor the situation but OSH trying to arrange transport for her via flight.” A review of the medical record revealed patient #1 had a 24-gauge intravenous catheter in place receiving 20 ml/kg of normal saline. The chart noted the patient had a Port-O-Cath (central catheter) but was not used as second access. There was no documentation that the physician had followed the recommendations from the children’s hospital. There was no documentation of repeat fluid bolus to improve hypotension, and sepsis guidelines were not followed because the patient should have received at least 60 ml/kg rescue to help manage the shock, followed by pressors. Also, there was no documentation that the facility staff attempted to use Port-O-Cath to draw blood cultures, and with worsening pressures/tachycardia antibiotics should have been administered. A review of patient #1 medical record for the date of service on 09/12/2023 at 6:05 AM at Children’s Hospital revealed the following: “History obtained from Other: Due to the inability of the patient to provide an adequate and complete history, I have obtained an additional, relevant history from the mother, who is the caregiver of the patient. A 14-month-old female with a history of Wilms tumor status post-chemo presents from an outside hospital for concern for fever, vomiting, and lethargy. On arrival, the patient appears lethargic, pale, tachycardic, and hypotensive. Started resuscitation. Noted to have soft central pulses. Central line accessed. Labs sent. Given fluids and placed on ephedrine drip. EKG changes were noted, with peaked T waves, given calcium. The patient then became less responsive and had large dark brown emesis. The decision was made to call anesthesia to the bedside for intubation. Given significant hemodynamic instability, preparation for possible arrest. Placed on Zoll. Increased ephedrine drip. Faint pulses but adequately seen on Point of Care Ultrasound (POCUS). Cardiopulmonary arrest post-intubation. Started CPR/ephedrine POCUS at the bedside for cardiac activity during pulse checks Given multiple rounds of epi, bicarb, and calcium. PICU paged for possible transition to ECMO CPR. No return of spontaneous circulation after 40 minutes Time of death called at 657.” A review of the completed autopsy report revealed the following: “Based on the gross findings, the following preliminary conclusions are drawn: Autopsy examination revealed diffuse small bowel ischemia with subsequent sepsis and cardiopulmonary changes. The small bowel was diffusely dusky, congested, and hemorrhagic with a tight adhesion of loops of proximal jejunum and underlying severe congestion of the vasculature within the small bowel mesentery. The peritoneal cavity contained 100 cc of serosanguinous fluid. Autopsy blood and tissue (lung) cultures show abundant growth of Escherichia coli and Lactobacillus sp., the tissue culture possibly representing bacterial growth within blood vessels (pending histologic examination of the lungs). The chest showed more subtle changes of cardiopulmonary compromise. Bilateral pleural effusions were present as well as a small pericardium effusion. The lungs were heavy and congested. Green-brown, bilious material was found in the esophagus up to the proximal aspect as well as in the distal trachea suggestive of aspiration. The abdomen also showed changes consistent with the patient’s clinical history of Wilms tumor. Post-surgical changes included surgical absence of the right kidney and non-obstructive bowel adhesions involving the ascending colon. Enlarged mesenteric lymph nodes were noted (pending histologic examination). The radiologically identified possible metastatic nodule was identified in the right lower lung base.” An interview with Staff #6 on 11/06/2022 at 4:00 PM acknowledged that emergency physician #10 failed to determine if an emergency medical condition existed and failed to stabilize Patient #1’s condition before transferring to a children’s hospital.”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 29191 Based on record review and interviews, the facility staff failed to meet the following requirements of an appropriate transfer for 4 (#1, #8, #9, and #10) of 4 Memorandum of Transfer (MOT) who had acute emergency medical conditions and were not completed before transfer. Also, the time of the risks and benefits that were explained to the family did not closely match the date and time of the actual transfer. In addition, the reason for the transfer was not documented in the Memorandum of Transfer. The facility failed to provide medical treatment within its capability and capacity that minimized the risks to the individual’s health. Findings include: A review of the transfer log for September 2023 for children under the age of 5 revealed that 4 (#1, #8, #9, and #10) of 4 Memorandum of Transfer forms were not completed before the children were transferred to the transferring facility. Memorandum of Transfer forms were reviewed with Staff #4 and #6. Patient #1 The date of service was 9/12/2023 with a diagnosis of intractable nausea and vomiting, dehydration, and immunocompromised. The reason for the transfer was a higher level of care. There was no documentation as to who the nursing report was given to, the date and time, and the nurse’s signature were all left blank. The risk and benefits were signed by physician #10 at 3:30 AM the patient did not leave the emergency room until 4:55 AM. The last vital signs documented on the MOT were at 3:30 AM. The patient left the emergency room at 4:55 AM by helicopter. Patient #8 The date of service was 9/22/2023 with a diagnosis of dehydration, vomiting, and decreased urine output. The reason for the transfer was not documented. There were no vital signs documented on the MOT. There was no documentation as to who the nursing report was given to, the date and time, and the nurse’s signature were all left blank. The risk and benefits were signed by physician #11 at 7:20 PM the patient did not leave the emergency room until 9:02 PM. The patient left the emergency room at 9:02 PM by ground ambulance. Patient #9 The date of service was 9/28/2023 with a diagnosis of seizure and respiratory failure. The reason for the transfer was a higher level of care and specialty services not available. Vital signs for the patient were not documented on the MOT. There was no documentation as to who the nursing report was given to, the date and time, and the nurse’s signature were left blank. The risks and benefits were signed by physician #12, but there was no time documented as to when the risks and benefits were explained to the family. The patient left the emergency room at 2:13 PM by helicopter. Patient #10 The date of service was 9/26/2023 with a diagnosis of recurring seizures. The reason for the transfer was specialty services were not available. There was no documentation as to who the nursing report was given to, the date and time, and the nurse’s signature were all left blank. The risk and benefits were signed by physician #11 at 3:10 PM the patient did not leave the emergency room until 4:32 PM. The last vital signs documented on the MOT were at 3:00 PM. The patient left the emergency room at 4:32 PM by ground ambulance. An interview with Staff #4 on 11/06/2023 at 3:00 PM was conducted throughout viewing the Memorandum of Transfer (MOT) and was asked to provide copies of the incomplete MOT. Staff #4 acknowledged the missing information and provided copies of the Memorandum of Transfer (MOT) forms.”