Bakersfield Memorial Hospital

“EMERGENCY SERVICES CFR(s): 482.12(f)(1) If emergency services are provided at the hospital, the hospital must comply with the requirements of §482.55. This Standard is not met as evidenced by: 45654 Based on observation, interview, and record review, the Hospital failed to ensure: 1. Emergency supplies were stored appropriately and expired products were removed from use 2. Resuscitation [emergency medical process to restart a person’s heartbeat and breathing] supplies were fully equipped and were readily available for an imminent birth [baby being delivered within minutes] in the emergency department (ED). These failures had the potential to result in delayed care and negative health outcomes for patients. Findings: 1. During a concurrent observation and interview on 7/20/26 at 2:20 p.m. with Registered Nurse (RN) 1, in the emergency room labor and delivery emergency exam room (ER L&D). The ER L&D exam room had a “Air Flow Pediatric Resuscitator with Filter, Pop- Off, Mask & Bag Resucitator,” (specialized vital airway support children ages 1 year to 14 years) lot number 316236 dated 10/24/23 and V-Care Infant Resuscitation Corrugated Tubing Reservoir and Mask,” (specialized vital airway support for infants newborn to 1 year of age) lot number 320770 dated 12/19/[undated] was hanging on the wall above head of gurney. RN 1 stated staff should be checking the room every day for expired items. During a review of the facility’s P&P titled, “Storage of Patient Care Supplies,” dated 3/23/22, the P&P indicated, “Cupboards, bins and draws in departments will be inspected on a regular basis for items that are nearing there expiration date. “ 47444 2. During a concurrent observation and interview on 7/20/26 at 2:12 p.m. with Registered Nurse (RN) 3 inside the ED obstetrics and gynecology (OB/GYN - medical specialty that focuses on women’s health, pregnancy, and the female reproductive system) room (ED OB/GYN room), three precipitous birthing kits (PBK - supplies needed when delivering a baby) were in a cabinet. The supply list for the PBK included scissors but no scissors were located in the PBK. RN 3 stated the PBK was used for delivering babies in the ED and needed to include clamps and scissors for clamping and cutting the umbilical cord. During an interview on 7/21/26 at 11:45 a.m. with RN 4, RN 4 stated on 5/4/26 she responded to an OB alert (overhead page to alert Labor and Delivery [L&D - care area where babies are born] and Neonatal Intensive Care Unit [NICU - specialized area providing medical care for newborns who have serious health conditions] specialty area staff of an imminent delivery) called for the ED. RN 4 stated when she arrived to the ED OB/GYN room the baby had already been delivered but was not breathing. RN 4 stated there was no suction cannister, suction tubing or suction catheter set up in the ED OB/GYN room. RN 4 stated it was important to have suction set up and ready for use because the first priority for caring for a baby was to clear the airway using suction. RN 4 stated there was no PDK in the ED OB/GYN room. RN 4 stated the L&D staff responding to the OB alert call brought a PDK with them but the PDK did not include scissors to cut the umbilical cord. RN 4 stated a L&D staff member had to go back to the L&D department to get another PDK that included scissors. RN 4 stated it was important to cut the umbilical cord as soon as possible when a baby was in unstable condition so the baby could be moved to the warmer and treatment could be provided. During an interview on 7/22/26 at 7:49 a.m. with RN 5, RN 5 stated she responded to an OB alert in the ED on 5/4/26. RN 5 stated the baby was not breathing and respiratory therapy (RT) was in the process of intubating (a flexible plastic tube is placed through the mouth down into the windpipe to keep the airway open and help the patient breathe) the baby. RN 5 stated RT successfully intubated the baby but there was no T-piece (medical device used to deliver controlled, consistent pressures during ventilation [machine that pumps air into and out of the lungs, breathing for a patient]. RN 5 stated RT called out to staff in the ED hallway for the T-piece and eventually the T-piece was located and taken to the ED OB/GYN room. RN 5 stated there were no suction supplies in the ED OB/GYN room on 5/4/26 and a staff member had to leave the room to gather the suction supplies needed. RN 5 stated clamps were applied to the umbilical cord but there were no scissors to cut the cord. RN 5 stated not having the suction supplies, T-piece and scissors readily available could have negatively affected the outcome of an emergency delivery. During an interview on 7/22/26 at 8:57 a.m. with RT, RT stated he was the RT in ED when the OB alert was called for the ED on 5/4/26. RT stated when he arrived to the ED OB/GYN room the baby had been born, was blue and not breathing. RT stated he had to run to the pediatric ED area to get resuscitation equipment. RT stated he returned to the ED OB/GYN room with an Ambu bag (hand-held medical device used to manually provide rescue breaths to patients who are not breathing) and mask but the mask was not the right size for the baby and was leaking air around the sides. RT stated he had the nurse take over giving the baby rescue breaths with the ambu bag and left the room to get the correct mask size for the baby. During an interview on 7/22/26 at 9:27 a.m. with RN 6, RN 6 stated she was the nurse who called the OB alert for the ED on 5/4/26. RN 6 stated there was no suction cannister, tubing or catheter set up in the ED OB/GYN room on 5/4/26 and a staff member had to leave the room to gather the suction supplies. During a review of the Hospital’s policy and procedure (P&P) titled, “Emergency Services Nursing Standards of Practice,” dated 10/23/25, the P&P indicated, “The Standards of Practice for the Emergency Department (ED) serve as guidelines for the provision of nursing care and professional performance expectations. . . Standard 3 - Outcomes Identification. . . 3. Ensure adequate ventilation and oxygenation: . . . b. Ensure presence and functionality of oxygen resuscitation equipment is readily available.” During a review of the Hospital’s P&P titled, “Neonatal Endotracheal Intubation by Respiratory Therapy,” dated 7/25/24, the P&P indicated, “Limitation on Setting: 1. Neonatal endotracheal intubation may take place in the. . . Emergency Department. . . Procedure: Refer to the following Elsevier Clinical Skills: Endotracheal Tube Intubation (Neonatal)-CE. . . 11. Make sure that the resuscitation equipment, including the T-piece or resuscitation bag, is functioning properly: . . . 12. Prepare the suction source set at 80 to 100 mm Hg [millimeters of mercury, a standard unit used to measure negative pressure] and the appropriate-size suction catheter, as indicated. . . 1. All supplies and equipment necessary for intubation will be immediately available, checked on a regular basis, and prepared prior to initiation of procedure.””

“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: 45654 Based on interview and record review, the facility failed to ensure the facility’s Policy and Procedure (P&P) titled, “Pain Management,” was followed for 8 of 30 sampled patients (Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, and Patient 9). For Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, and Patient 9, the facility failed to reassess pain level. This failure had the potential to result in continued pain for Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, and Patient 9. Findings: During a review of Patient 2’s “Facesheet(FS),” undated, the FS indicated Patient 2 was admitted to the facility on 5/30/26. During a review of Patient 2’s “Pain Assessment (PA),”dated 5/30/26 at 10:59 p.m., the PA indicated Patient 2 reported a numeric pain score (tool used to measure to measure patient’s pain intensity, pain is rated from a zero to 10, no pain [0] mild pain [1-4], moderate pain [5-6], severe pain [7-10]) Patient 2’s pain level was “10,” with no reassessment. During a concurrent interview and record review on 7/21/26 at 10:18 a.m. with Patient Safety Program Manager (PSPM), Patient 2’s PA’s were reviewed within the electronic medical record (EMR). PSPM stated she unable to provide PA reassessment and one should have been implemented. During a review of Patient 3’s “FS,” undated, the FS indicated Patient 3 was admitted to the facility on 6/1/26. During a review of Patient 3’s “PA,” dated 6/1/26 at 10:06 p.m., the PA indicated Patient 3 reported a numeric pain at “8,” with no reassessment. During a concurrent interview and record review on 7/21/26 at 2:00 p.m. with PSPM, Patient 3’s PA’s were reviewed within the EMR. PSPM stated she was unable to provide PA and indicated no PA reassessment was completed. During a review of Patient 4’s “FS,” undated, the FS indicated Patient 4 was admitted to the facility on 6/1/26. During a review of Patient 4’s “PA,” dated 6/1/26 at 10:13 p.m., the PA indicated Patient 4 reported a numeric pain at “7,” with no reassessment. During a concurrent interview and record review on 7/21/26 at 2:30 p.m. with PSPM, Patient 4’s PA’s were reviewed within the EMR. PSPM stated she was unable to provide PA and indicated no PA reassessment was completed. During an interview on 7/21/26 at 2:25 p.m. with Registered Nurse (RN) 1, RN 1 stated staff should assess pain every 2 hours then with medication administration every 15 minutes or 1 hour following their medication protocol. During an interview on 7/21/26 at 2:26 p.m. with RN 2, RN 2, stated staff need to reassess the patients pain level. During a review of Patient 5’s “FS,” undated, the FS indicated Patient 5 was admitted to the facility on 6/1/26. During a review of Patient 5’s “PA,” dated 6/1/26 at 12:21 p.m., the PA indicated Patient 5 reported a numeric pain at “8,” with no reassessment. During a concurrent interview and record review on 7/21/26 at 2:40 p.m. with PSPM, Patient 5’s PA’s were reviewed within the EMR. PSPM stated she was unable to provide PA and indicated no PA reassessment was completed. During a review of Patient 6’s “FS,” undated, the FS indicated Patient 6 was admitted to the facility on 6/1/26. During a review of Patient 6’s “PA,” dated 6/1/26 the PA indicated Patient reported a numeric pain at “10 at 10:59 a.m. 7 at 10:14 p.m. and 4 at 1:58 p.m.,” with no reassessment. During a concurrent interview and record review on 7/21/26 at 2:40 p.m. with PSPM, Patient 6’s PA’s were reviewed within the EMR. PSPM stated she was unable to provide PA and indicated no PA reassessment was completed. During a review of Patient 7’s “PA,” dated 6/2/26 the PA indicated Patient 7’s reported numeric pain was not documented on 6/1/26 at 11:59 p.m., 8:00 p.m. and 6/2/26 12:59 a.m. During a concurrent interview and record review on 7/22/26 at 8:28 a.m. with PSPM, Patient 7’s PA’s were reviewed within the EMR. PSPM stated she was unable to provide PA and indicated no PA reassessment was located within the record. During a review of Patient 8’s “FS,” undated, the FS indicated Patient 8 was admitted to the facility on 6/2/26. During a review of Patient 8’s “PA,” dated 6/2/26 at 1:59 p.m., the PA indicated Patient 8 reported a numeric pain at “8,” with no reassessment. During a concurrent interview and record review on 7/22/26 at 8:50 a.m. with PSPM, Patient 8’s PA’s were reviewed within the EMR. PSPM stated she was unable to provide PA and indicated no PA reassessment was completed. During a review of Patient 9’s “FS,” undated, the FS indicated Patient 9 was admitted to the facility on 6/2/26. During a review of Patient 9’s “PA,” dated 6/3/26, the PA indicated Patient 9 reported a numeric pain at “10, 10, and 9,” with no reassessment. During a concurrent interview and record review on 7/22/26 at 9:45 a.m. with PSPM, Patient 9’s PA’s were reviewed within the EMR. PSPM stated she was unable to provide PA and indicated no PA reassessment was completed. During a review of the facility’s (P&P) titled “Pain Management,” dated 2/5/26, the P&P indicated, “Screen or assess pain, based on scope of practice, and document the patients pain intensity, quality, location, and pain scale used in the EHR [electronic health record] under the following circumstances. On initial evaluation/admission After any known pain producing event. With each new report of pain. Approximately every four hours with vital signs (non-critical care areas). Approximately every one hour with vital signs (critical care areas). Prior to the administration of pain-relieving medication.””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(16)(v) [there must be documentation in the patient’s medical record of the following:] The patient’s response to the intervention(s) used, including the rationale for continued use of the intervention. This Standard is not met as evidenced by: 47095 Based on observation, interview, and record review, the hospital failed to ensure ongoing physical restraint (any manual method or mechanical device, material, or equipment that restricts a patient’s ability to move their arms, legs, body, or head freely, or prevents voluntary bed exit, such as four side rails) assessments, interventions, and clinical need justification was completed every 2 hours for two of two sampled patients (Patient 1, Patient 2) according to the facility policy and procedure (P&P). This failure had the potential for injury and/or use of restraints for an extended, unnecessary length of time. Findings: 1a. During a concurrent observation and interview on 3/16/26 at 9:40 a.m. with Registered Nurse (RN) 1, Patient 1 had a right upper limb soft restraint applied. RN 1 stated Patient 1 had attempted to pull at her endotracheal tube (ET- flexible tube inserted into the airway to assist with breathing). RN 1 stated patients in restraints were assessed every two hours or more frequently for safety purposes. RN 1 stated assessments included skin checks to prevent skin injuries and assessments for the continued need or discontinuation of the restraints. During an interview on 3/16/26 at 10:11 a.m. with Hospitalist 1, Hospitalist 1 stated restraints were utilized when all other less restrictive methods for patient safety failed. Hospitalist 1 stated nursing responsibilities included to follow physician orders, perform monitoring and assessments, and notify the patient’s physician of any changes in the patient’s condition. During an interview on 3/17/26 at 10:13 a.m. with Director of Nursing (DON) 1, DON 1 stated restraints should be used infrequently, with ongoing assessments and reassessments by nurses, and required a physicians order. During a concurrent interview and record review on 3/18/26 at 10:55 a.m. with Quality Patient Safety Program Manager- Registered Nurse (QPSPM-RN) 1, Patient 1’s “Restraint Order” (RO), dated 3/18/26 time 1:05 a.m. was reviewed. The RO indicated, “Restraints- Non Violent/Non Destructive. . . Type of Restraints soft Limb Side Rails x 4 Location of Restraints Wrist, right. . . Indication for Restraints Pulling at lines, Tubes or Dressings.” QPSPM-RN 1 stated patients that are restrained have nurse assessments and interventions at specific times while they are restrained. QPSPM-RN 1 stated nurses document the restraint assessments and interventions on a flow sheet (Restraint Flow Sheet [RFS]) in the patient’s medical record. During a concurrent interview and record review on 3/18/26 at 11:01 a.m. with QPSPM-RN 1, Patient 1’s RFS, dated 3/18/26 was reviewed. The RFS indicated no entry for 6 a.m. QPSPM-RN 1 stated there was a missed assessment and intervention at 6 a.m. QPSPM-RN 1 stated restraint assessments and interventions included visual safety observations, skin, circulation, level of consciousness, toileting offered, fluid nourishment, response, and any additional assessment observations restrained patients. During an interview on 3/19/26 at 3:17 p.m. with Nurse Manager (NM) 1, NM 1 stated the nursing staff were expected to follow all facility policies and procedures (P&Ps). 1b. During a concurrent interview and record review on 3/19/26 at 3:29 p.m. with RN 2, Patient 2’s, RO, dated 11/25/25 was reviewed. The RO indicated, “Restraints-Non Violent/ Non Destructive. . . Start Date/Time: 11/25/25 10:55 [a.m.]. . . Order Details. . . Monitor q2hr [every 2 hours] intervals for 24 hr [hour], Soft Limb Side Rails x 4, Bilateral Wrists, Pulling at Lines, Tubes or dressings Climbing out of bed/chair risking safety.” RN 2 stated restraint checks were to be completed every two hours or more frequently to meet the needs of Patient 2 and to maintain a safe environment of care. During a concurrent interview and record review on 3/19/26 at 3:41 p.m. with RN 2, Patient 2’s RFS, dated 11/25/25 was reviewed. The RFS indicated Patient 2 had restraints removed and reapplied at 6 p.m. RN 2 stated on 11/25/25 no assessment, interventions, or evaluation of continued use for restraints was documented at 8 p.m. or 10 p.m. RN 2 stated on 11/26/25 no assessment, interventions, or evaluation of continued use for restraints was documented at 12 a.m., 2 a.m., 4 a.m., 6 a.m., or 8 a.m. RN 2 stated missed assessments and reassessments were missed opportunities to ensure Patient 2’s safety. RN 2 stated it was “neglectful to not check” at a minimum of every 2 hours. During a concurrent interview and record review on 3/19/26 at 3:46 p.m. with RN 2, the hospital’s P&P titled, “Use of Clinical Restraints,” dated 5/21/25 was reviewed. The P&P indicated, “POLICY: 1. Restraints may only be used to ensure the immediate physical safety of the patient, staff, or others, and must be discontinued at the earliest possible time. . . Restraint Category 1. Non-Violent or Non-Self Destructive: Methods used to promote healing and improve the patient’s well-being. . . Patient Rights 1. Patient Rights for Restraints a. When restraints are deemed necessary, such activity will be undertaken in a manner that protects the patient’s health and safety and preserves his/her dignity, rights, and well-being b. Restraints will be used for medical necessity only and not as a means of coercion, discipline, convenience, or retaliation. . . 3. Assessment and Removal a. All restraints: 1) . . .The restraints shall be removed and discontinued at the earliest possible time based on the reassessment of the patient’s condition. 2) A qualified nurse may discontinue restraints when the criteria for release are met. . . 5. Monitoring and Care. . . b. Observation will be according to the following standards: 1) Non-Violent or Non-Self-Destructive Restraints Standard: a) Patients will be observed frequently. B) Monitoring and care must be documented in the patient’s record at a minimum of every 2 hours, or more often based on the patient’s assessment. i. Document in the Visual/Safety Observation Section in the Restraint Monitoring Non-Violent in iView. . . 4) Care is provided based on the assessed needs of the patient. Care will include: a) Offering liquids and nutrition b) Circulation, Sensation, and Movement (CSM) c) Skin d) Toileting e) Temporary release that occurs for the purpose of caring for a patient’s needs f) Other interventions as indicated by assessment findings . . .Documentation a. The use of restraints must be documented in the medical record, and must include the following information. . . 3) Any alternatives or other less restrictive interventions attempted. . . 5) The patient’s response to the intervention(s) used, including the rationale for continued use of the restraints 6) Individual patient assessment and reassessments 7) The intervals for monitoring 8) Revisions to the plan of care.” RN 2 stated the P&P was not followed.”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 47095 Based on interview and record review, the hospital failed to ensure an individualized nursing plan of care was developed, implemented, and re-evaluated to address patient established goals for one of five sampled patients (Patient 3). This failure had the potential to disrupt the quality of nursing care provided. Findings: During a concurrent interview and record review on 3/18/26 at 9:12 a.m. with Quality Patient Safety Program Manager Registered Nurse (QPSPM-RN) 1, Patient 3’s medical record was reviewed. The “Document In Plan (DIP - care plan documentation section),” date range from admission on 3/16/26 to discharge on 3/17/26 was reviewed. The DIP indicated, “Description [no entry]. . . Last Evaluated. . . Target [no entry]. . . Status [no entry].” QPSPM-RN 1 stated Patient 3 had no care plans developed during his hospitalization. During a review of the hospital’s policy and procedure (P&P) titled, “Core Nursing Standards of Practice - Medical/Surgical and Telemetry,” dated 7/24/25. The P&P indicated, “. . . 4. Plan of Care - The registered nurse develops a plan that prescribes strategies to attain expected, measurable outcomes. The registered nurse: a. Partners with the patient to implement the plan in a safe, effective, efficient, timely, patient-centered, and equitable manner. . . f. Integrates critical thinking and technology solutions to implement the nursing process to collect, measure, record, retrieve, trend, and analyze data and information to enhance nursing practice and patient outcomes. . . h. Documents implementation, modifications and evaluation of goals; including changes or omissions, of the identified plan (ANA, 2021). 1) The plan of care is reviewed and updated at a minimum of every shift and PRN [as needed]. See policy: Interprofessional Plan of Care.” During a concurrent interview and record review on 3/18/26 at 3:12 p.m. with Director of Nursing (DON) 1, the hospital’s policy and procedure (P&P) titled, “Interprofessional Plan of Care,” dated 4/25/25 was reviewed. The P&P indicated, “1. Developing the interprofessional plan of care (POC) will be initiated as soon as possible after admission by the RN. B. . .the RN will consult with the patient and/or family as appropriate to identify the patient care needs during hospitalization through the discharge continuum of care. . . f. The POC must be individualized to the patient’s condition and include interventions and outcomes as appropriate to measure patient progress to meet goals of care. 2. Updating and Evaluating the POC. . . b. The POC must be reviewed and updated with new problems or achieved goals each shift, upon transfer, at discharge, and as needed. . . c. When reviewing the POC, the RN may continue, add, or discontinue a problem or intervention based on the patient’s progress toward his/her goal. This will be documented in the EHR [Electronic Health Record] as “met” or “not met”. . . d. The RN is not required to update and/or evaluate goals and interventions specific to other disciplines but must review them and may address those specific to nursing.” DON 1 stated all patients should have a nursing care plan established as part of the nursing standards of practice P&P. DON 1 stated the nursing care plan should be reviewed during their shift and as needed to address the patient’s needs. DON 1 stated Patient 3 should have had a nursing care plan for the duration of his inpatient hospitalization.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 47095 Based on observation, interview, and record review, the hospital failed to follow professional standards of nursing practice when: 1. The Policy and Procedure (P&P) titled “Adult Cooling Measures” (application of cold packs to under arms, forehead, upper thighs, and behind the neck) was not implemented for two of two sampled patients (Patient 1, Patient 2). This failure had the potential to result in Patient 1’s elevated temperature (normal body temperature 98.6 degrees [°] Fahrenheit [F] unit of measurement [37°Celsius - C] body temperature) to be untreated leading to serious complications. 2. The P&P titled, “Modified Early Warning Score (MEWS-Modified Early Warning Score- an assessment tool used to recognize and respond to adult medical-surgical patients to quickly identify if a patient is deteriorating with scoring based on heart rate, respiratory rate, temperature and consciousness; scores range from 0 to 14 with the higher scores triggering nursing protocols or rapid response team calls to provide early intervention),” was not implemented for one of two sampled patients (Patient 2). This failure resulted in a change in condition to not be recognized, vital signs (measurement of bodily function) not taken more frequently, and Patient 2’s physician to not be notified. 3. The P&P titled, “Rapid Response Team (RRT)” was not implemented for one of one sample patient (Patient 2). This failure resulted in Patient 2 not having a specialized collaborative assessment of needs provided based on his MEWS and the potential to contribute to further health status decline. Findings: 1a. During a concurrent interview and record review on 3/18/26 at 11:14 a.m. with Quality Patient Safety Program Manager - Registered Nurse (QPSPM-RN) 1, Patient 1’s “Vital Signs Summary” (VSS), dated 3/13/26 was reviewed. The VSS indicated Patient 1 had documented high temperatures: 37.8°C (100°F) rectal (core) at 4:15 p.m. 38°C (100.4°F) rectal at 4:30 p.m. 38.1°C (100.6°F) rectal at 5 p.m. 38°C (100.4°F) rectal at 5:35 p.m. QPSPM-RN 1 stated Patient 1 had high temperatures according to the documented vital signs (measurement of bodily function). QPSPM-RN 1 stated there was no documentation to indicate that Patient 1 had “cooling measures” for her high temperatures. QPSPM-RN 1 stated application of cold packs was considered a nursing intervention. During a concurrent interview and record review on 3/18/26 at 3 p.m. with QPSPM-RN 1, Patient 1’s, “Cooling Measure Order” (CO), dated 3/13/26 time 5:04 p.m. was reviewed. The CO indicated, “Constant Indicator Yes Special Instructions Keep Temp[erature] below 37.5 [C; 99.5°F] please. IMPORTANT Goal normothermia. Next Dose. . . 03/13/2026 17:04 [5:04 p.m.] Validations Nurse Review. . . on 03/13/2026 at 17:15 [5:15 p.m.].” QPSPM-RN 1 stated there was no documentation that cooling measures were provided for Patient 1’s elevated temperatures. During a concurrent interview and record review on 3/19/26 at 12 p.m. with RN 3, Patient 1’s “Medical Record” (MR), dated 3/13/26 day shift (7 a.m. to 7 p.m.) was reviewed. The MR indicated a CO with temperature parameters for normothermia dated 3/13/26 time 5:04 p.m. was reviewed. The MR indicated Patient 1 had high temperatures at 4:15 p.m., 4:30 p.m., 5 p.m. and 5:35 p.m., and there was no documentation of cooling measures being implemented. RN 3 stated cooling measures included cold packs applied to the right and left under arm areas and the upper inner thigh area. RN 3 stated, “She [Patient 1] had cold feet and hands” when he received Patient 1 to the patient care unit on 3/13/26 around “3:45 p.m.” RN 3 stated he did not implement cooling measures for Patient 1’s high temperatures nor seek clarification with the attending physician for the CO for the “Risks and Benefits.” 1b. During a concurrent interview and record review on 3/19/26 at 3:16 p.m. with RN 2, Patient 2’s VSS dated 11/25/25 was reviewed. The VSS indicated Patient 2 had the following temperatures documented: 39.1°C ( 100.6°F) - oral at 12:46 p.m. 37.9°C ( 100.2°F) - oral at 1 p.m. 37.8°C (100°F) - oral at 3 p.m. 38.1°C (100.6°F) - oral at 8 p.m. 37.6°C (99.7°F) - oral at 10:05 p.m. 38.1° C (100.6°F) - axillary at 11:33 p.m. RN 2 stated Patient 2’s temperatures were above normal range. RN 2 stated cooling measures, such as cold packs, were a nursing intervention for patients with high body temperatures. RN 2 stated there was no documentation of cooling measures being implemented and no clarification of cooling measure orders with the attending physician. During a concurrent interview and record review on 3/20/26 at 10:30 a.m. with RN 4, Patient 2’s VSS, dated 11/26/25 was reviewed. The VSS indicated Patient 2 had an oral temperature of 38 C (100.4 F) at 1:27 a.m. RN 4 stated cooling measures were no provided included application of cold packs to the under arms and upper inner thigh areas. RN 4 stated there was no documentation that cooling measures were provided or that the attending physician was notified of Patient 2’s temperature. During a concurrent interview and record review on 3/20/26 at 10:37 a.m. with RN 4, Patient 2’s “RAPID RESPONSE TEAM RN DOCUMENTATION FORM” (RRTF), dated 11/26/25 at 3:13 a.m. was reviewed. The RRTF indicated, “Vitals: Time 3:18 [a.m.] BP [blood pressure-force blood exerts as heart beats] HR[heart rate- count of beats per minute-bpm- normal range 60 bpm to 100 bpm] 164 [bpm] Res [Respirations- normal range 12 to 20 breathes per minute at rest for adult] 30 . . . O2 sat [Oxygen saturation-percentage of oxygen in blood average normal range equal to or greater than 95] Temp [Temperature] 39.4 [C; 102.9 F] Time 0337 [3:337 a.m.] BP: 157/100 HR: 146 [bpm] Res 24 O2 Sat 93 Temp 38.9 [C; 102 F] Reason for call. . . [increased] MEWS = 5 Assessment : Pt [Patient] lethargic [lack of energy sleepy state not awake and alert] [Not moving] MAE [Move all extremities] spontaneously. . . Recommended Cooling Measures called [Physician]. . . Parents with c/o [complaint of] [Patient 2] receiving poor care for past 24 hrs. . . Parents Do Not want [Patient 2] restrained.” RN 4 stated Patient 2 had a critical high temperature of 39.4 C (102.9 F) which was obtained by the RRT. RRT recommended cooling measures. Physician notified by RRT-RN. During a record review of Patient 2’s “Hemodynamics and Vitals” (HV), dated 11/26/25 at 9:45 a.m., the HV indicated “Temperature PO [oral] 39.3 deg[ree] C [102.7 F]. . . Textual Results [Nurse note]. . . Patient arrived to the unit [Critical Care 2- patient care area specialized for very sick patients that require constant monitoring for advanced medical support], cooling blanket and ice packs started.” During a record review of the hospital’s P&P titled, “Adult Cooling Measures,” dated 8/25/21, the P&P indicated, “POLICY: 1. This policy defines adult cooling measures used to reduce patient’s body temperature. 2. Cooling measures will be stopped if patient begins to shiver or temperature drops to within 2 degrees Fahrenheit of desired temperature. . . b. If using cooling measures for other means, specific physician orders must be obtained included specific reason, and temperature parameters. c. If body temperature does not start decreasing within an hour, or increases, notify the ordering physician. . . Cold Application . . . A variety of methods are used to apply cold therapy ... cold packs.” 2. During a concurrent interview and record review on 3/19/26 at 3:10 p.m. with RN 2, Patient 2’s VSS, dated 11/25/25 was reviewed. The VSS indicated at 12:46 p.m. a MEWS of 4. RN 2 stated vital signs were expected to be documented every hour three times with a MEWS of 4. RN 2 stated at 1 p.m. the only vital signs documented were a blood pressure of 166/88 and oral temperature of 37.9 C (100.2 F). RN 2 stated there was no MEWS documented at 1 p.m. RN 2 stated the next vital signs and MEWS were due at 2 p.m. but none were documented. RN 2 stated there was no documentation of physician notification. RN 2 stated the policy for MEWS was not followed. During a concurrent interview and record review on 3/20/26 at 10:52 a.m. with RN 4, Patient 2’s MEWS dated 11/25/25 to 11/26/25 were reviewed. MEWS indicated, “MEWS Score . . . 11/25/25 2001[8:01 p.m.] 3. . . MEWS Score. . . 11/26/25 03:13 [3:13 a.m.] 5.” RN 4 stated Patient 2’s MEWS score on 11/25/25 at 8:01 p.m. was a 3 with a heart rate of 108 bpm. RN 4 stated no MEWS was completed with the 11:33 p.m. vital signs heart rate of 146 bpm (greater than 130 bpm) which was a change in condition from previous heart rate of 108 bpm at 8:01 p.m. RN 4 stated the MEWS was calculated from manual nurse entry documentation based on the patient vital signs and level of consciousness assessment. RN 4 stated the MEWS assessment should be completed every 4 hours. RN 4 stated the MEWS was an assistive standardized nursing assessment that was performed to identify the need for more frequent and/or higher level of care interventions based on a patient’s condition. RN 4 stated Patient 2’s MEWS of 3 on 11/25/25 at 8:01 p.m. required increased monitoring, assessments, and attending physician notification. RN 4 stated a MEWS should have been calculated on 11/26/25 at 12:01 a.m., which was 4 hours after the 11/25/25 8:01 p.m. MEWS calculation. RN 4 stated Patient 2’s MEWS was calculated as a score of 5, seven hours later, with a RRT on 11/26/25 at 3:13 a.m. RN 4 stated early detection and utilization of the hospital’s P&P’s guided clinical judgment, is meant to prevent a decline in a patient’s condition. During a concurrent interview and record review on 3/20/26 at 11:02 a.m. with RN 4 the hospital’s P&P titled, “Modified Early Warning Score (MEWS),” dated 5/22/24 was reviewed. The P&P indicated, “POLICY: 1. The Modified Early Warning Score (MEWS) is an assessment tool used to recognize and respond to adult medical-surgical patients who have or are developing a critical illness. 2. A MEW score will be assigned to all admitted medical, surgical, and telemetry level patients aged 18 years and older and documented in the electronic health record. 3. The MEWS total score is calculated from the most current vital signs and conscious level, which will be assessed by an RN only. 4. The calculated MEW score dictates when the next MEW score is to be obtained, and any interventions that may be required. Each patient will be assessed at minimum. . .c. Every four (4) hours. . . MEWS SCORE. . . 3 Increase VS[Vital Sign] frequency to every 4 hours x 3. Calculate the MEWS each time Notify Licensed Provider [attending physician]. 4 Notify Licensed Provider and consider Rapid Response Team activation. Increase VS frequency to every 1 hour x 3; include pulse oximetry - Calculate MEWS each time. . .3. Nurses may activate Rapid Response Team for any score at their discretion.” RN 4 stated the MEWS calculation and an RRT were preventative measures to prevent adverse patient outcomes. 3. During a concurrent interview and record review on 3/20/26 at 10:37 a.m. with RN 4, Patient 2’s VSS dated 11/25/25 to 11/26/25 was reviewed. The VSS on 11/25/25 at 12:46 p.m. indicated Patient 2 had a MEWS of 4. RN 4 stated increased nursing interventions were needed with a MEWS of 4, which included notification to the attending physician, increased assessments, clinical judgement, and procedural guidance based on policy for an RRT initiation. RN 4 stated when an RRT was initiated it was to benefit the patient’s well-being and assist in the prevention of further decline in the patient’s condition. During a concurrent interview and record review on 3/20/26 at 10:39 a.m. with RN 4, the hospital’s P&P titled, “Rapid Response Team (RRT),” dated 3/28/25 was reviewed. The P&P indicated, “POLICY: The Rapid Response Team (RRT) call is initiated when a patient’s condition changes and the additional critical care and respiratory therapy support is needed in order to prevent the patient from becoming so critical as to require a Code Blue activation. 2. The goal of the team is to provide early and rapid intervention in order to promote better outcomes. . . 6. Criteria for staff to activate the RRT is as follows. . . b. Acute changes in heart rate. . . greater than 130 or 20% change from baseline heart rate. . . f. Acute changes in level of consciousness. . . l. MEWS score greater than 3; nurses may activate RRT for any score at their discretion . . . 7. An attempt to notify the managing/attending physician of patient condition should always be made in conjunction with activating the RRT. 8. If patients/families feel that there is a change in their medical condition or a medical emergency that their nurse is not addressing. . . ask any staff member to ask the operator to page “Condition Help.” This will access the Rapid Response Team and direct them to the Patient’s room/location.” RN 4 stated there was a rapid response only when Patient 2’s MEWS became a 5 on 11/26/25 at 3 a.m. RN 4 stated Patient 2 had a MEWS of 4 (greater than 3) on 11/25/25 at 12:46 p.m. with heart rate increased from 82 bpm to 146 bpm, which was a change in condition. RN 4 stated there was no documentation that the physician was notified or a rapid response being called on 11/25/25 at 12:46 p.m. when the MEWS was a 4. RN 4 stated the RRT P&P was not followed.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 47095 Based on interview and record review, the hospital failed to ensure a Physician Order (PO) for Tylenol (medication used to reduce fever) was administered for one of two sampled patients (Patient 1). This failure had the potential to result in a decline in the patient’s overall physical condition. Findings: During a concurrent interview and record review on 3/18/26 at 11:03 a.m. with Quality Patient Safety Program Manager- Registered Nurse (QPSPM-RN) 1, Patient 1’s PO section dated 3/13/26 time 4:41 p.m. was reviewed. The PO indicated Patient 1 had Tylenol ordered for administration as needed when body temperature was greater than 38°Celsius (C) (100.4°Fahrenheit [F]). During a concurrent interview and record review on 3/18/26 at 11:14 a.m. with QPSPM-RN 1, Patient 1’s “Vital Signs Summary” (VSS), dated 3/13/26 was reviewed. QPSPM-RN 1 stated Patient 1 had a high temperature according to the documented vital signs (measurement of bodily function). The VSS indicated Patient 1 had the following high temperatures: 37.8°C (100°F) rectal (core) at 4:15 p.m. 38°C (100.4°F) rectal at 4:30 p.m. 38.1°C (100.6°F) rectal at 5 p.m. 38°C (100.4° F) rectal at 5:35 p.m. During a concurrent interview and record review on 3/18/26 at 11:16 a.m. with QPSPM-RN 1, Patient 1’s “Medication Administration Record” (MAR), dated 3/13/26 was reviewed. The MAR indicated Tylenol was not given for Patient 1’s documented high temperatures. During a concurrent interview and record review on 3/19/26 at 12:06 p.m. with RN 3, Patient 1’s PO dated 3/13/26 at 4:49 p.m. was reviewed. The PO indicated, “Notify MD [Medical Doctor] if. . . temperature is greater than 37.5 and unresponsive to treatment.” RN 3 stated he did not administer the Tylenol PRN and did not follow the PO. During a concurrent interview and record review on 3/19/26 at 12:17 p.m. with RN 3, the hospital’s policy and procedure (P&P) titled, “Medication Administration,” dated 12/17/25 was reviewed. The P&P indicated, “12. Medication Administration a. Medications are to be administered as ordered.” RN 3 stated the P&P was not followed.”

“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: 28020 Based on observations, interviews, and record reviews, the hospital failed to ensure the hospital had an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving care and supportive healthcare in the hospital, as evidenced by: 1. Clean Gastrointestinal endoscopes (GI scopes - thin flexible tubes with a light and a camera used to examine the inside of the digestive tract) (number of scopes varied) were not stored in a clean environment and not compliant with the National Infection Control Standards (American National Standards Institute [ANSI]/Advancement of Medical Instrumentation [AAMI] - a non-profit organization that develops and publishes standards, guidance, and other technical documents to improve patient safety and healthcare outcomes in the medical device industry) the hospital followed. This failure had the potential for clean scopes to become contaminated by bacteria (living cells that can make one sick) and viruses (tiny infectious agent) which can result in infection to a patient. (Refer to A-0749 finding 1). 2. There was no documented evidence to demonstrate that three of three storage cabinets used to store clean flexible GI scopes were cleaned and maintained according to the manufacturer’s instructions for use (IFUs). This failure had the potential for dust and debris, or microbial contaminants (bacteria, viruses) to accumulate inside the cabinets which can transfer to the clean scopes leading to infection when used on a patient. (Refer to A-0749 finding 2). 3. One of one Central Services Technician (CST 1) did not clean and decontaminate soiled surgical instruments according to procedures and the National Standards the hospital followed (ANSI/AAMI). This failure resulted in surgical instruments to not be clean prior to entering the sterilizer, resulting in un-sterile surgical instruments and the potential to cause infection in the surgical patient. (Refer to A-0749 finding 3). 4. One of one CST (CST 1) reused single-use instrument cleaning sponges multiple times. This failure had the potential to cross-contaminate instruments and surgical trays. (Refer to A-0749 finding 4). 5. There was no documented evidence to demonstrate the hospital cleaned three of three instrument washers according to manufacturer’s IFU. This failure had the potential for improperly cleaned instrument washers and the potential for surgical patients to become infected. (Refer to A-0749 finding 5). 6. The Infection Preventionist (IP, healthcare professional who develops and implements strategies to prevent the spread of infections in healthcare settings) failed to monitor and track infections for five of six sampled patients (Patient 31, Patient 32, Patient 33, Patient 22 and Patient 23) in the Neonatal (newborn) Intensive Care Unit (NICU - specialty care unit) with infections. This failure had the potential to result in an increased risk of spreading infections to all patients receiving care in the NICU. (Refer to A-0750 finding 1) 7. The IP failed to follow the requirements of All Facilities Letter (AFL) 23-08,” to report outbreaks and unusual infectious disease occurrences to the local public health officer and their respective District Office (DO) when three of six sampled patients (Patient 31, Patient 32 and Patient 33) in the NICU had positive cultures (laboratory test for disease) for Pseudomonas aeruginosa (P. aeruginosa - bacteria commonly found in the environment that cause severe infections to those individuals who have a weakened immune system). This failure resulted in the IP not utilizing outside resources to control an unusual infection. (Refer to A-0750 finding 2) 8. The IP failed to Follow the Policy and Procedure (P&P) titled “Outbreak Investigation” when the IP did not follow the procedure outlined in the P&P to conduct an investigation of an outbreak of P. aeruginosa when three of six sampled patients (Patient 31, Patient 32 and Patient 33) in the NICU had positive cultures for P. aeruginosa (the bacteria was grown and detected in a sample). This failure resulted in the hospital to not be aware of the source of the infection, how the infection spread and had the potential to result in an increased risk of spreading P. aeruginosa. to all patients receiving care in the NICU. (Refer to A-0750 finding 3) The cumulative effects of these systemic problems resulted in the hospital’s inability to provide an effective hospital wide Infection Control Program resulting in the hospital’s inability to provide patient care in a safe and effective manner and in accordance with §482.42 Condition of Participation for Infection Control Services.”

“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: 28020 Based on observation, interview, and record review, the hospital failed to ensure a system was in place for identifying, reporting, investigating, and controlling infections and communicable diseases when: 1. Clean Gastrointestinal endoscopes (GI scopes - thin flexible tubes with a light and a camera used to examine the inside of the digestive tract) (number of scopes varied) were not stored in a clean environment and not compliant with the National Infection Control Standards (American National Standards Institute [ANSI]/Advancement of Medical Instrumentation [AAMI] - a non-profit organization that develops and publishes standards, guidance, and other technical documents to improve patient safety and healthcare outcomes in the medical device industry) the hospital followed. This failure had the potential for clean scopes to become contaminated by bacteria (living cells that can make one sick) and viruses (tiny infectious agent) which can result in infection to a patient. 2. There was no documented evidence to demonstrate that three of three storage cabinets used to store clean flexible GI scopes were cleaned and maintained according to the manufacturer’s instructions for use (IFUs). This failure had the potential for dust and debris, or microbial contaminants (bacteria, viruses) to accumulate inside the cabinets which can transfer to the clean scopes leading to infection when used on a patient. 3. One of one Central Services Technician (CST 1) did not clean and decontaminate soiled surgical instruments according to procedures and the National Standards the hospital followed (ANSI/AAMI). This failure resulted in surgical instruments to not be clean prior to entering the sterilizer, resulting in un-sterile surgical instruments and the potential to cause infection in the surgical patient. 4. One of one CST (CST 1) reused single-use instrument cleaning sponges multiple times. This failure had the potential to cross-contaminate instruments and surgical trays. 5. There was no documented evidence to demonstrate the hospital cleaned three of three instrument washers according to manufacturer’s IFU. This failure had the potential for improperly cleaned instrument washers and the potential for surgical patients to become infected. Findings: 1. During a concurrent observation and interview on 8/20/25 at 9:15 a.m., with the Infection Preventionist (IP, healthcare professional who develops and implements strategies to prevent the spread of infections in healthcare settings), the Central Sterile Department was observed. IP stated the hospital follows the national infection control standards from AAMI, among others. During a concurrent observation and interview on 8/20/25 at 11:10 a.m., with IP and Endoscopy Technician (ET) 1, the scope storage room was observed. The following concerns were identified: the scopes were located in a room used to perform high level disinfection (HLD - the strongest form of disinfection, effectively killing all microorganisms, making the scopes safe to use) of reusable GI scopes. ET 1 was in the process of performing high level disinfection of a GI scope. In a room without a door and adjacent to her workspace, were three GI scope cabinets. One of the cabinets was left open which contained clean GI scopes, exposing the clean GI scopes. The IP was asked if the room storing the clean GI scopes was considered a clean room, the IP stated no because they perform HLD of GI scopes. During a review of the National Standards the hospital followed, “ANSI/AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities” the standards indicated, “11.2.2 Storage Cabinets, cabinets used for storage of flexible endoscopes should be situated in a secure location such as in the clean workroom of the endoscopy processing room in a two-room design or in a separate clean area close to, but not within, the endoscopy procedure room (AORN, 2018e, IX.a [39]). Situating the storage cabinet in a secure location helps protect inventories of flexible endoscopes and supplies that are vulnerable to misappropriation. Locating the storage cabinet in the clean workroom or in a clean area outside of the procedure room helps prevent contamination of processed endoscopes...” 2. During a concurrent observation and interview on 8/20/25 at 11:15 a.m., with ET I, the scope storage cabinet room was observed, ET 1 stated they (ETs) wipe the cabinets every week using a hospital disinfectant wipe. ET 1 stated the clean scopes remain in the cabinets while the cabinets are wiped out. ET 1 stated ETs do not remove the scopes when they clean the cabinets or the drip trays. The hospital was unable to provide documented evidence to demonstrate the three scope cabinets were cleaned routinely. During a review of the cabinet manufacturer’s IFU provided by ET 1, the IFU indicated, “Maintenance and Cleaning...(provided detailed instructions on how to clean the cabinets) ...Removable Drip Tray, remove scopes from the cabinet. Then remove drip tray [removable tray or basin located at the bottom of the cabinet that collects any residual moisture or liquid that may drip from the endoscopes during the drying process] and clean the drip tray with a non-abrasive liquid cleaner...” 3. During a concurrent observation and interview on 8/20/25 at 2:45 p.m., in the hospital sterile processing decontamination room, with the Central Sterile Processing Supervisor (CSPS), a Central Sterile Technician (CST 1) was cleaning soiled surgical instruments in a 3-compartment sink. Sink one was labeled “Rinse Sink”, sink two was labeled “Enzymatic Soak” and Sink three was labeled “Last Rinse”. The following concerns were identified: CST 1 removed soiled instruments from the “Enzymatic Soak sink”, took them over to the “Rinse Sink”, proceeded to brush the instruments above the water and over the soiled instruments that were in the “Rinse Sink”. CST 1 did not immerse the immersible instruments beneath the water level and did not use sink number three “Last Rinse” for the final rinse of the instruments. CST 1 performed the final rinse in sink one over soiled surgical instruments that were in sink one. CSPS stated that CST 1 should have brushed the soiled instruments beneath the water level in sink two “Enzymatic Soak”, not in sink one and CST should have utilized sink 3 “Last Rinse” for the final rinse prior to taking the instruments to the washers. According to CSPS, the water used for cleaning and rinsing the instruments was critical water (reverse osmosis - treated water). During a review of the National Standards the hospital followed, “ANSI/AAMI ST79: 2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities” the Standards indicated, “7.6.4.2 Manual cleaning ... (d) clean immersible devices under water to minimize aerosolization ...” During a review of a document provided by the hospital titled, “One Source Cleaning/Decontamination manual cleaning” the document indicated, “8. Rinse the device by completely immersing it in treated water ...” 4. During a concurrent observation and interview on 8/20/25 at 3 p.m., with CSPS, a tour of the sterile processing decontamination room (a room used to clean and decontaminate reusable patient equipment) was conducted. CST 1 was observed cleaning soiled surgical trays that were used to hold patient surgical instruments. CST 1 used tubular sponges to clean the trays and when asked how often she replaced the sponges, CST 1 stated she used the tubular sponges throughout the day and then disposed of tubular sponges at the end of her day or after three or four uses “sometimes”. CST 1 stated was not sure if the sponges were single-use or if they could be used multiple times. CSPS was asked how the sponges get cleaned and if they were single-use. CSPS stated, “Currently we [the hospital] don’t have a practice in place of how many times the sponges get used and replaced.” CSPT was unsure if the sponges were single-use. During a review of a document provided by the hospital, titled “Medline [Medical Supplier] ...SPONGES: TUBULAR SPONGE DRY” the document indicated the sponges the hospital used as multiuse were SINGLE USE. 5. During a concurrent observation and interview on 8/20/25 at 3:10 p.m., with CSPS, a tour of the hospital sterile processing decontamination room, CSPS was asked how they cleaned and maintained three of three instrument washers. One washer that was not in use contained white substances on the internal chamber. CSPS stated, “We currently only change the filters daily and perform a descaling.” CSPS was asked to provide documentation to demonstrate their cleaning schedule of the washers. CSPS stated they did not have documentation. CSPS was asked to provide the manufacturer’s instructions for the washers. During a review of the washer IFU, the IFU indicated, “Chamber components: 5.1 inspect rotary spray arm assemblies for free movement and clogged holes once a week...5.2 clean debris screen in chamber once a day...5.3 remove hard water deposits from interior of chamber using decontamination cycle once a week ..5.5 clean water outlet connection in chamber once a week...” “6.6 cleaning door gasket once a month.” The IFU provided detailed instructions on the frequency and the method for cleaning the washers. The facility did not have any documentation to indicate they followed the manufacturer’s instructions for cleaning and maintaining the three washers.”

“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: 51540 Based on interview and record review, the hospital failed to ensure the Infection Preventionist (IP, healthcare professional who develops and implements strategies to prevent the spread of infections in healthcare settings): 1. Monitored and tracked infections for five of six sampled patients (Patient 31, Patient 32, Patient 33, Patient 22 and Patient 23) in the Neonatal (newborn) Intensive Care Unit (NICU - specialty care unit) with infections. This failure had the potential to result in an increased risk of spreading infections to all patients receiving care in the NICU. 2. Followed the requirements of All Facilities Letter (AFL) 23-08,” to report outbreaks and unusual infectious disease occurrences to the local public health officer and their respective District Office (DO) when three of six sampled patients (Patient 31, Patient 32 and Patient 33) in the NICU had positive cultures (laboratory test for disease) for Pseudomonas aeruginosa (P. aeruginosa - bacteria commonly found in the environment that cause severe infections to those individuals who have a weakened immune system). This failure resulted in the IP not utilizing outside resources to control an unusual infection. 3. Followed the Policy and Procedure (P&P) titled “Outbreak Investigation” when the IP did not follow the procedure outlined in the P&P to conduct an investigation of an outbreak of P. aeruginosa when three of six sampled patients (Patient 31, Patient 32 and Patient 33) in the NICU had positive cultures for P. aeruginosa (the bacteria was grown and detected in a sample). This failure resulted in the hospital to not be aware of the source of the infection, how the infection spread and had the potential to result in an increased risk of spreading P. aeruginosa. to all patients receiving care in the NICU. Findings: 1. During an interview on 8/21/25, at 8:11 a.m., with IP, IP stated her process for the surveillance of infections within the hospital was to pull up the hospital isolation list every morning. IP stated she looked at each patient with an infection for the reason the patient was on isolation precautions (method of controlling the spread of infections). IP did not explain her surveillance process for patients with infections who were not on isolation precautions. IP stated she was alerted when Patient 31 in the NICU had multi-drug resistant (MDR, does not respond to three or more antibiotic categories) Pseudomonas. IP stated she was concerned and placed both Patient 31 and Patient 32 on isolation precautions. IP stated Patient 32 had the first infection of Pseudomonas in his eye and then Patient 31 had MDR Pseudomonas pneumonia. IP stated she did not want the Pseudomonas infection to spread to other babies in the NICU. During a review of Patient 31’s “Medical Record (MR)” admission date 7/21/25, with Quality and Patient Safety Manager (QPSM), the “Microbiology [study of organisms] Results (MIR),” dated 8/9/25, at 5:30 p.m., and Order Information for Isolation, dated 8/12/25, at 7:34 a.m., were reviewed. The MIR indicated Culture Sputum (saliva and mucus from the lungs), Collection Date: 8/9/25, Preliminary Results dated 8/11/25 “Many Pseudomonas aeruginosa Susceptibility (antibiotics effective against bacteria) to follow.” Final Results dated 8/12/25 “Many Pseudomonas aeruginosa******Multi-drug resistant organism******.” The Order Information for Isolation indicated “Entered and electronically signed by SYSTEM, SYSTEM ...Start Date/Time 08/12/2025 7:34 PDT [Pacific Daylight Time] Type of Isolation Contact [key practices include using gown and gloves for all interactions, dedicated medical equipment, and placing the patient in a private room when possible] reason for Isolation MDR Pseudomonas ...Comment This isolation order was auto-generated by the System. The patient met criteria for isolation based on clinical lab findings.” During a review of Patient 32’s MR, admission date 7/21/25, with QPSM, the MIR, dated 8/5/25, at 8 p.m., the Physician Note, dated 8/12/25, at 3:54 p.m., and the Order Information for Isolation, dated 8/12/25, at 11:14 a.m., were reviewed. The MIR indicated Test: Eye Culture, Collection Date: 8/5/25, at 8 p.m., Preliminary Results dated 8/6/25 Few Pseudomonas aeruginosa. Susceptibility (antibiotics effective against bacteria) to follow. Final Results dated 8/7/25 Few Pseudomonas aeruginosa. The Order Information for Isolation indicated Registered Nurse (RN) 1 entered and electronically signed an order for contact isolation due to MDR Pseudomonas Special instructions Precaution. During a review of Patient 33’s MR, admission date 7/15/25, with QPSM, the MIR, dated 8/12/25, at 6:10 a.m., and the IP documentation was reviewed. The MIR indicated Test: Eye Culture, Collection Date: 8/10/25, at 6:20 p.m., Infection Rare (few) Pseudomonas. During a review of Patient 22’s MR, admission date 7/24/25, with QPSM, the MIR, dated 7/30/25, and the IP documentation were reviewed. The MIR indicated Test: Respiratory (lungs and airways) Culture, Collection Date: 7/30/25, Infection Escherichia coli (bacteria commonly found in the lower intestine). During a review of Patient 23’s MR, admission date 7/14/25, with QPSM, the MIR, dated 8/14/25 was reviewed. The MIR indicated Test eye culture Collection Date 8/14/25, Result date 8/16/25 Infection Staphylococcus aureus (common bacterial infection in NICU). During an interview on 8/21/25 at 1:46 p.m., with IP, IP was unable to provide documented evidence of monitoring or tracking of patients with infections in the hospital including Patient 31, Patient 32, Patient 33, Patient 22, and Patient 23. IP stated Pseudomonas was not a normal occurrence in the NICU. Occurrences of Pseudomonas was not the hospital’s baseline (starting point). IP stated, “If I did not document [referring to monitoring of infections], it did not happen.” During a review of the facility’s P&P titled “Outbreak Investigation,” dated 5/22/25 the P&P indicated “Purpose: To identify probable contributing factors in order to control an outbreak and to prevent similar outbreaks in the future. Guidelines/Policy Statement: Outbreak may be suspected when healthcare-associated infections (HAIs) occur above the background rate or when an unusual microbe is recognized ... Initiate surveillance ...” 2. During a current interview and record review on 8/21/25 at 1:46 p.m. with IP, “All Facilities Letter (AFL) 23-08,” dated 1/18/23 was reviewed. The “AFL” indicated “Requirements to Report Outbreaks and Unusual Disease Occurrences (AFL 23-08): Health facilities licensed by CDPH [California Department of Public health] Licensing and Certification (L&C) are required to report outbreaks and unusual infectious disease occurrences to the local public health officer and their respective District Office (DO)...this AFL refers to recommended pathogen-specific outbreak reporting thresholds, definitions and other resources provided by the Council for Outbreak response-Healthcare Associated Infections and Antimicrobial Resistant (CORHA), where available ...Definitions: Outbreak-The occurrence of cases of a disease or condition above the expected or baseline level, usually over a given period of time, in a geographic area or facility, or in a specific populations group...the designation of an outbreak is relative to the usual frequency of the disease or condition in the same facility or community, among the specified population, over a comparable period of time... Examples of Reportable Incidents...Single case of colonization or infection with an MDRO [multiple drug resistant organism] if it was never previously or only rarely encountered in the facility, region or LHJ [local health jurisdiction]...outbreak or increased incidence of any MDRO...or infection on a neonatal intensive care unit (NICU)...Upon receipt of a report of an outbreak or unusual occurrence, the LHD [local Health Department] recommends control actions and may conduct an epidemiologic investigation...” IP stated pseudomonas was neither the baseline nor a normal occurrence in the hospital’s NICU. IP stated she reviewed the AFL, but the AFL was unclear to her. IP stated she decided not to report because there was only one case of MDR pseudomonas. During a review of the facility’s P&P titled, “Event Reporting and Management,” dated 10/24/23, the P&P indicated “E. Reporting Requirements to Regulatory Agencies 1. Patient Safety Leader, Regulatory Leader, or other designee will report to regulatory agencies in accordance with state-specific reporting requirements or other reporting as required. Reportable Events defined by either the State Department of Public Health or other applicable regulatory agency, will be reported within the required reporting timeframes. 3a. During a review of Patient 31’s MR, dated 7/21/25, the MR indicated, Patient 31 was admitted to the NICU on 7/21/25. During a review of Patient 31’s “Physician Note (PN),” dated 8/9/25, the PN indicated, “Problems by Systems: 1. Respiratory ...Last x-ray [a picture of the bones and other parts inside of the body] on 8/8 had revealed bilateral [involving both sides] ...hazy lung fields ...” During a review of Patient 31’s MIR, dated 8/12/25, the MIR indicated, “Order: Culture Sputum [mucous from the lower airways] Collect Date/Time: 8/9/2025 17:30 [5:30 p.m.] Last update Date/Time: 8/12/2025 07:41 [7:41 a.m.] ...[result]Many Pseudomonas aeruginosa ******Multi-drug resistant organism******.” During a review of Patient 31’s “Isolation Order (IO),” dated 8/12/25, the “IO” indicated, “Requested start date/Time” 8/12/25 at 7:34 am. Type of Isolation: Contact. Reason for Isolation: MDR-Pseudomonas. Comment: This isolation order was auto-generate by the System. The patient met criteria for isolation based on clinical lab findings.” 3b. During a review of Patient 32’s MR, dated 7/21/25, the MR indicated, Patient 32 was admitted to the NICU on 7/21/25. During a review of Patient 32’s MIR, dated 8/7/25, the MIR indicated, “Order: Eye Culture. Collect Date/Time: 8/5/2025 00:20 [12:20 a.m.] Last update Date/Time: 8/7/2025 06:49 [6:49 a.m.] ...[result] Pseudomonas aeruginosa ...” During a review of Patient 32’s “IO,” dated 8/12/25, the IO indicated, “Requested start Date/Time: 8/12/25 at 11:13 am Type of Isolation: Contact Reason for isolation: MDR-Pseudomonas Special Instructions: Precaution.” During a review of Patient 32’s PN, dated 8/12/25 at 3:54 p.m., the PN indicated, “The other twin [Patient 31] was recently diagnosed with MDR pseudomonal sepsis [life threatening condition]/pneumonia [infection in the lungs]. On 8/5 developed conjunctivitis [infection in the eye]. Eye culture was positive for pseudomonas. Is on tobramycin [antibiotic] ointment ...” 3c. During a review of Patient 33’s MR, dated 7/15/25, the MR indicated, Patient 33 was admitted to the NICU on 7/15/25 for respiratory distress [difficulty breathing].” During a review of Patient 33’s PN, dated 8/10/25 at 9:06 p.m., the PN indicated, “7. Infection. On 8/10 noted to have eye discharge. Eye culture will be followed. Was placed on tobramycin eyedrops for conjunctivitis [pink eye caused by a virus or bacteria].” During a review of Patient 33’s PN, dated 8/11/25 at 10:21 p.m., the PN indicated, “7. Infection. On 8/10 noted to have eye discharge. Eye culture is positive for Pseudomonas aeruginosa. Was placed on tobramycin eyedrops for conjunctivitis ...” During a review of Patient 33’s MIR, dated 8/12/25, the MIR indicated, “Eye Culture ...[result] Pseudomonas aeruginosa ...” During an interview on 8/21/25 at 8:00 a.m. IP, IP stated Pseudomonas could be transmitted through water, environment, previous infections, or visitors/family. IP stated pseudomonas could be removed by hand hygiene (washing hands or sanitizing rub) and environmental cleaning. IP stated on 8/12/25, Patient 31 had multi-drug-resistant pseudomonas pneumonia and was placed on contact isolation. IP stated on 8/7/25, Patient 32 already had a positive pseudomonas eye culture. IP stated she did not document interventions implemented to prevent the spread of the pseudomonas. IP stated she should have documented these interventions because “if you do not document it did not happen.” IP stated her risk assessment for the pseudomonas outbreak infections were to place both patients (Patient 31 and Patient 32) on contact isolation to prevent the spread of infection in the NICU. IP stated, “I did not document the risk assessment, but I should have documented.” During an interview on 8/21/25 at 8:45 a.m. with IP, IP was unable to provide documentation of action she took to prevent the spread of the infection. IP was unable to provide documentation she reviewed Patient 31, Patient 32, or Patient 33’s MR to obtain data. IP stated she did not document her process or any surveillance of the pseudomonas infection. During an interview on 8/21/25 at 9:29 a.m. with IP, IP could not provide any documentation she investigated the cause of the pseudomonas Patient 31 and Patient 32 contracted or that she implemented measures to prevent the further spread of the infection. No documented evidence she conducted a Root Cause Analysis (RCA - a systemic, data-driven problem-solving method used to identify the underlying, fundamental causes) During an interview on 8/21/25 at 9:38 a.m. with Director of Quality and Patient Safety (DQPS) 1, DQPS 1 stated the IP reported to her. DQPS 1 stated the RCA was not done. During a review of the New England Journal of Medicine (a prestigious peer reviewed medical journal) the article titled “Endemic Pseudomonas aeruginosa Infection in a Neonatal Intensive Care Unit” dated 9/7/2000 indicated “Nosocomial infections [hospital acquired infection] due to Pseudomonas aeruginosa have been well described, but the environmental reservoir [location] of the organism [germ] varies [changes] ...All potential reservoirs should be identified, including environmental sources, equipment used in patient care, and the hands of health care workers.” During a review of “Cases Journal” (a peer reviewed medical journal), the article titled “Endogenous endophthalmitis caused by Pseudomonas aeruginosa in a preterm infant: a case report” dated 12/10/2009, indicated “Endophthalmitis is an infection of the vitreous [clear gel in the eye] or aqueous humor [a water-like fluid in the eye] of the eye. Although it rarely occurs in the neonatal period [first four weeks of a child’s life] it has been previously diagnosed in preterm infants. Endogenous endophthalmitis is when eye infection is secondary to septicemia and represent 20% of the cases of endophthalmitis. Pseudomonas aeruginosa is responsible for more than 75% of invasive neonatal eye infections. The course of pseudomonal endophthalmitis is typically fulminant [severe and sudden onset], developing over hours even in early diagnosis. For survivors, the usual result is blindness of the affected eye ... Pseudomonas aeruginosa is an aggressive gram-negative bacillus and is responsible for more than 75% of invasive neonatal eye infections. Acute bacterial endophthalmitis is a vision-threatening condition and must be managed as an emergency ... Premature infants are particularly vulnerable to Pseudomonas infections. They are immunocompromised and they often have multiple systemic problems related to prematurity. Moreover they are dependent on a range of different equipments (humidifiers, incubators, respirators and suction apparatus) that are required to keep them alive but that can also be a source of nosocomial [hospital acquired] infection (when contaminated).” During a review of the facility’s P&P titled, “Event Reporting and Management,” dated 10/24/23, the P&P indicated “C. Event Analysis: For Sentinel Events and Reportable Events, an Event Analysis must begin as soon as possible with completion of the analysis and implementation of any action plans not to exceed 45 calendar days from knowledge of the event ... An Event Analysis team will meet to: a. Identify the contributing and causal factors that led to the outcome. b. Contribute to a full understanding of the event and compare it to a prescribed or expected course under the same or similar circumstances. c. Identify system and process-based solutions ....Definitions ...Event Analysis - A structured method used to analyze patient safety or quality related events. It may be a Root Cause Analysis, Event Investigation and Analysis, Apparent Cause Analysis, Common Cause Analysis, or any other type of investigation related to an Event as defined above. An Event Analysis is led by the Patient Safety Leader or Quality Leader and includes a variety of executive and department leaders dependent upon the event in question. During a review of the facility’s P&P titled “Multi-Drug Resistant Organisms (MDRO),” dated 1/25/23 the P&P indicated “Prevention of MDRO infections is multifaceted and evidenced based. Strategies for infection prevention include ...prevention of transmission ...” During a review of the facility’s P&P titled “Outbreak Investigation,” dated 5/22/25 the P&P indicated “Purpose: To identify probable contributing factors in order to control an outbreak and to prevent similar outbreaks in the future. Guidelines/Policy Statement: Outbreak may be suspected when healthcare-associated infections (HAIs) occur above the background rate or when an unusual microbe is recognized ...Epidemiologic investigations must be conducted in a standardized way that assesses the contributing factors: source, pathogen, host and mode of transmission. Ending an outbreak involves modifying one or more of these factors. Procedure: Recognition of an Outbreak Surveillance is the basic tool necessary to identify endemic and epidemic HAIs ...Epidemic (outbreak) investigations represent an excess over the expected (endemic) level of a disease within a geographic area. However, one case of an unusual disease (e.g. botulism) may constitute an epidemic ... Reporting Healthcare-associated outbreaks should be reported to local and state health departments as soon as they are suspected. Conducting an Outbreak Investigation The importance and sequence of the various steps will vary, depending on the nature of the problem ... Prepare for the investigation. Notify administration, Infection Control Committee Chair, Microbiology Department, regulatory officials as required and other pertinent individuals of the suspected outbreak ...2. Confirm the existence of an outbreak. Develop a case definition and use it to estimate the magnitude of the problem. This may change as information is gathered. Compare the current incidence with unusual or baseline incidence ...4. Search for additional cases; collect critical data; develop a line listing; collect specimens if indicated. Encourage immediate reporting of new cases by laboratory, physicians, nursing staff and others as appropriate (e.g. radiology in cases of pneumonia). Search for other cases that may have occurred retrospectively or concurrently through laboratory reports, medical records, patient charts, physicians and nursing staff, and public health data. Use a specific data collection form ... Person - Characteristics of the case patients help in defining the most likely risk factors for infections. Factors to assess include: Patient characteristics (e.g. age, sex, underlying disease) Possible exposures (i.e. surgery, nursing and medical staff, infected patients) Therapeutic modalities (i.e. invasive procedures, medications, antibiotics) Use of all of the above to develop an accurate description of the population at risk ...6. Take immediate control measures, if indicated. Institute control measures such as increased attention to hand hygiene, additional use of barriers (i.e. gowns, gloves), or confiscating suspected product (e.g. patient care item). 11. Implement and evaluate control and preventative measure. 12. Initiate surveillance ... The efficacy [ability to produce desired result] of the intervention can be measured by further surveillance to determine if cases cease to occur or return to endemic level. Use the opportunity of an outbreak to correct other practices related to the current situation that may contribute to an outbreak in the future. 13. Communicate findings and summarize investigation for stake holders.””

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 28020 Based on interview and record review, the hospital failed to have a policy and procedure in place to track all surgical equipment to a specific surgical patient. This failure resulted in the inability of the hospital to determine precisely which surgical instruments were used on a high-risk tissue and high-risk patient surgical case. Findings: On 8/20/25, a complaint validation survey was initiated which included investigation of a case where surgical instruments were used on a possible Creutzfeldt-Jakob disease (CJD - a rare and fatal neurodegenerative disease caused by abnormal proteins called prions, which trigger normal proteins in the brain to misfold causing brain cell damage and death) patient. During an interview on 8/20/25 at 9:05 a.m., with Chief Medical Officer (CMO), CMO stated the CJD case was not confirmed and the craniotomy (a procedure that involves removing a piece of the skull to access the brain) surgical tray (a sterile collection of specialized instruments and tools used by surgeons during a craniotomy) were sequestered (isolated) and removed from use until further notice. During an interview on 8/20/25 at 9:10 a.m., with Central Sterile Processing Supervisor (CSPS). CSPS stated that the instruments were pulled, cleaned, sterilized, sequestered (isolated) and were out of service (no longer being used). During an interview on 8/20/25 at 9:15 a.m., with Infection Preventionist (IP, healthcare professional who develops and implements strategies to prevent the spread of infections in healthcare settings), IP stated the hospital followed the national infection control standards from the Association for the Advancement of Medical Instrumentation (AAMI - a non-profit organization that develops and publishes standards, guidance, and other technical documents to improve patient safety and healthcare outcomes in the medical device industry), among others. During a concurrent observation and interview on 8/20/25 at 10:20 AM, with CSPS, CSPS escorted the surveyor to the office where the possible CJD craniotomy set was sequestered. CSPS stated the hospital sequestered two craniotomy sets because on the same day the possible CJD was operated on, there was a second craniotomy case. CSPS was asked why both had to be sequestered. CSPS stated “Currently the Operating Room Department (OR) does not scan instrument sets to patients, so to play it safe, both trays were sequestered.” CSPS was asked why OR did not scan instrument sets to patients, in which CSPS responded, “I don’t know.” During a review of the National Standards the hospital followed, “ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities” the Standards indicated the following: “C.2 Processing devices contaminated with high-risk tissue ... 6) A tracking system should be in place that permits recall of devices used on high-risk tissue and high-risk patients. This tracking system should permit identification of the patient on which the devices were used, the date they were used, the procedure performed, and the surgeon’s name. Facilities that do not have a commercially available or automated tracking system should create a manual system. A simple system can be created using a steam-sterilizable two-part card, with an external CI that is affixed to the outside of instrument trays. When the tray is used, the bottom part of the card is removed and affixed to the patient’s chart to identify all items used on the patient. To ensure accurate tracking of sets and devices, all items should be given a unique number. For example, if the facility has four craniotomy trays, they should be numbered #1, #2, #3, and #4 to identify the specific tray used on the patient.” During an interview on 8/21/25 at 3 PM, with Operating Room Director (ORD) and the CMO, were asked if they had a method of tracking that would allow them to recall surgical devices used on high-risk tissue and high-risk patients. The ORD and CMO stated the hospital currently did not have a method of tracking surgical devices but moving forward the hospital will start tracking surgical devices.”

“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: 40516 The facility failed to meet the regulatory requirements for the Condition of Participation at §482.12 Governing Body as evidenced by the following: Based on interview and record review, the Governing Body failed to ensure one of one Advanced Care Provider (APP, health care professional, not a doctor, has advanced education and training) Physician Assistant (PA) 1 and one of one Attending Physician (Physician) 1 provided quality care to one of one sampled patients (Patient 3) when: 1. Neither PA 1 nor Physician 1 reviewed and took action on abnormal labs for one of one sampled patient (Patient 3). 2. PA 1 did not document a medical treatment provided to one of one sampled patient (Patient 3). These failures resulted in Patient 3 return to the Emergency Department (ED) three days later in critical condition and death. ( Refer to A-049) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality health care, in compliance with the Condition of Governing Body.”

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 40516 Based on Interview and Record review, the Governing Body failed to ensure one of one Advanced Practice Provider (APP, health care professional, not a doctor, has advanced education and training) Physician Assistant (PA, advance practice provider) 1 and one of one Attending Physician (Physician) 1 provided quality care to one of one sampled patients (Patient 3) when: 1. Neither PA 1 or Physician 1 reviewed or acted on abnormal labs for one of one sampled patient (Patient 3). 2. PA 1 did not document a medical treatment provided to one of one sampled patient (Patient 3). These failures resulted in Patient 3’s return to the Emergency Department (ED) three days later in critical condition and death the following day. Findings: 1. During a review of Patient 3’s Emergency Documentation - MD, ED Physician Notes (Physician Notes), dated 12/6/24, the Physician Notes indicated PA 1 examined Patient 3. The Physician Notes indicated Patient 3 arrived at the hospital ED by private vehicle with Family Member (FM) 1. Patient 3 had a temperature of 102 degrees Fahrenheit (F, unit of temperature), which began 28 hours prior to coming to the ED, and associated symptoms of nausea and an earache. PA 1 ordered laboratory (lab) work for Patient 3. During an interview on 1/27/25 at 12:11 p.m. with Chief Medical Officer (CMO), CMO stated Patient 3 had been brought to the ED on 12/6/24 by his mother with complaints of fever. PA 1 examined Patient 3. CMO stated PA 1 ordered a urinalysis (UA- laboratory test to analyze urine) to rule out a urinary tract infection. CMO stated the results of the UA ruled out an infection and PA 1 discharged Patient 1. CMO stated the UA was positive for bilirubin (a yellow-orange pigment produced when red blood cells are broken down. Bilirubin in the urine is considered abnormal and can indicate a problem with the liver). CMO stated the abnormal UA results were missed. CMO stated Patient 3 returned to the hospital’s ED on 12/9/24 in septic shock (life-threatening condition that occurs when an infection spreads throughout the body and causes a dangerously low blood pressure), acute liver failure (life-threatening condition where the liver suddenly stops functioning properly), kidney failure (kidneys are no longer able to adequately filter waste products and excess fluid from the blood), and Disseminated Intravascular Coagulation (DIC- condition that causes abnormal blood clotting throughout the body’s blood vessels). CMO stated Patient 3 expired (died) on 12/10/24. During a review of Patient 3’s Medical Record (MR), the UA laboratory results, dated 12/6/24 at 2:15 am, were noted to be abnormal in the following categories: Specific Gravity (measures concentration of urine)... 1.028 (H) [high, normal 1.005-1.03] Bilirubin (the presence of bilirubin is an important finding in the evaluation of liver function and a positive detection could be an indication of liver disease such as jaundice, cirrhosis or hepatitis) 2+ (A) [abnormal, (trace, normal less than 0.2)] Ictotest (test for presence of bilirubin)... Positive (A), (Normal is Negative) Blood... 2+ (A) (normal is 0, could indicate, bladder infection, kidney stones, kidney disease, or injury) Protein (normal kidney function will filter out protein)...1+ (A) (normal trace or less than 0.2, could indicate kidney damage, diabetes (inability to utilize sugar), dehydration, fever, stress) Urobilinogin (caused by breakdown of red blood cells)... 1+ (A) (normal trace, could indicate liver disease, biliary tract (aids in the digestion of fats) disorder, intestinal disorders, anemia) Red blood cells (RBC)... 156 (H) (normal less than 6) Bacteria... Trace (A) (normal is none, could indicate contamination of sample or infection) All of the normal values displayed in black type and the abnormal values displayed in red type. Patient 3’s “Physician Notes” dated 1/6/24 indicated PA 1 signed Patient 3’s medical record on 12/6/24 at 4:35 a.m. and Physician 1 co-signed patient 3’s medical record on 12/7/24 at 2:58 p.m. During an interview on 1/28/25 at 3:06 p.m. with PA 1, PA 1 stated he did not remember seeing Patient 3’s abnormal UA results. During an interview on 1/28/25 at 1:19 p.m. with Physician 1, Physician 1 stated the medical records of patients seen by advanced practice providers are sent to physicians for a co-signature. Physician 1 stated the expectation was for the physician to review the MR before co-signing, but if many medical records were sent to him at once he would co-sign without reviewing the medical record. Physician 1 stated he co-signed Patient 3’s medical record but he did not review Patient 3’s medical record for 12/6/24 ED visit. During an interview on 1/30/25 at 11:43 a.m. with CMO, CMO stated the expectation was for attending physicians to review a medical record before co-signing. During a review of Patient 3’s Discharge Summary, dated 12/10/24, the Discharge Summary indicated Patient 3 was a 4-year-old male previously healthy brought to the emergency room today (12/10/24) with jaundice (yellowing of skin and whites of the eyes, caused by high bilirubin levels, typically caused by a blockage of the bile duct, liver disease or excessive breakdown of red blood cells) for the past two days. Family reported Patient 3 started having fevers six days ago. Family brought Patient 3 to the ED here at (facility name) due to high fever of 104 degrees Fahrenheit (F) at home. On 12/6/24 PA 1 diagnosed Patient 3 with an ear infection and discharged Patient 3 home with an antibiotic. The urinalysis performed on 12/6/24, indicated 2+ bilirubin and 150 RBC. Two days ago, Family Members noticed Patient 3 was turning yellow and Patient 3 was itchy. Today (12/10/24), Patient 3’s parents took Patient 3 to their primary care physician, Patient 3 was hypoxic (low levels of oxygen in body tissues) and jaundiced. PCP instructed Patient 3’s parents to take him to the lab for blood draws and then to the ED. Patient 3’s parents followed instructions and brought Patient 3 to the ED. In the ED, Patient 3 was noted to be hypotensive (low blood pressure) with systolic (upper number) in the “40’s to 60’s” (normal blood pressure range 92-107 over 50 to 64). Patient 3 was in liver and kidney failure. Patient 3 was too unstable to transfer to a higher level of care hospital by ground and the weather conditions prevented Patient 3 being airlifted to a higher level of care hospital. Medications were ordered to support Patient 3’s low blood pressure, but the interventions were not successful. Patient 3’s hemoglobin (protein contained in red blood cells that is responsible for delivery of oxygen to the tissue) continued to drop indicating significant bleeding with the abdomen (stomach) a likely source of the bleed. Multiple blood products were administered while monitoring the coagulation (blood clotting) parameters (levels) and hemoglobin. Patient 3’s abdomen increased in size and became increasingly firmer. Patient 3’s skin began to show signs of mottling (blotchy, discolored patches indicating decreased blood flow to all but vital organs, brain, heart, lungs). Patient 3’s labs showed signs of continued decline. Patient 3 experienced periods of Pulseless Electrical Activity (PEA, potential lethal medical emergency). The facility initiated Cardiopulmonary Resuscitation (CPR, life-saving interventions) until the family members elected to stop the CPR. “[Patient 3] was declared dead at 6:50 A.M.” Significant Findings included: “Acute [sudden] renal failure; Acute liver failure, Acute hypoxic respiratory failure; Shock; Disseminated intravascular coagulation [DIC, serious condition that causes abnormal blood clotting throughout the body’s blood vessels].” Discharge Diagnosis/Plan Patient Discharge Condition Expired Discharge Disposition Morgue. During a review of peer reviewed journal “UpToDate” the article titled “Patient Education: Blood in the urine (hematuria) in children (Beyond the Basics), dated 5/5/23, the article indicated, “If the child has hematuria and protein in the urine, further testing will be done. This includes blood and urine tests to evaluate the child’s kidney function. The child’s blood pressure will also be measured because high blood pressure is a common finding in children with kidney problems. The child may be referred to a pediatric nephrologist if the tests are abnormal.” 2. During a concurrent interview and record review on 1/27/25 at 11:55 a.m. with Quality Patient Safety Program Manager (QPSPM) 1, Patient 3’s medical record was reviewed. The “General Information [nursing notes] Textual Results” (GITR), dated 12/6/24, at 4:40 a.m. indicated Licensed Vocational Nurse (LVN) 1 documented, “bleeding from right nostril noted after swab for covid [sic- Corona Virus Disease: highly contagious virus] was done; pressure applied to the nose and ice pack administered; provider then placed a nasal sponge that stopped the bleeding.” QPSPM 1 stated there was no note in the medical record from a provider regarding Patient 3’s nosebleed or any interventions done to stop the bleeding. During an interview on 1/28/25 at 3:06 p.m. with PA 1, PA 1 stated he did not remember placing a nasal sponge in Patient 3’s nostril to stop a nosebleed. During an interview on 1/29/25 at 7:50 a.m. with LVN 1, LVN 1 stated she did a COVID swab by placing the swab in each nostril and rotating the swab. LVN 1 stated the nosebleed started immediately. LVN 1 stated she tried to stop the bleeding by using a tissue to apply pressure and then applied an ice pack, but the bleeding did not stop. LVN 1 stated the provider [PA 1] was in the room and he made the decision to insert a nasal sponge to stop the bleeding. LVN 1 stated she believed the provider was [stated first name of PA 1]. During an interview on 1/29/25 at 1:27 p.m. with Emergency Department Medical Director (EDMD), EDMD stated his expectation was for ED providers to document every treatment, intervention, or phone call to patients for any care provided. During an interview on 1/29/25 at 5:36 p.m. with Family Member (FM) 1, FM 1 stated she was in the ED room with Patient 3 on 12/6/24. FM 1 stated the nurse performed a nasal swab and Patient 3’s nose began to bleed as soon as she removed the swab. FM 1 stated “the male doctor” put something in Patient 3’s nose to stop the bleeding. During an interview on 1/30/25 at 11:43 a.m. with Chief Medical Officer (CMO), CMO stated his expectation would be for a provider to make a note if a nasal sponge had to be placed in a patient to stop a nosebleed. During an interview on 1/30/25 at 12:30 p.m. with Director of Quality (DQ), DQ stated PA 1 was the only APP on duty at the time Patient 3 had a nosebleed. During a review of the hospital’s “Supervisory Responsibility and Delegation of Services Practice Agreement [for] Physician Assistant (DSPA) (undated), the DSPA indicated, “The ED PA shall enter all clinical findings into the patient’s chart through the computer hospital system.” During a review of the hospital’s “Medical Staff Rules and Regulations” (MSRR) dated 12/2023, the MSRR indicated, “9. The attending physician shall be held responsible for the preparation of a complete and legible medical record for each patient. This record shall include identification data, complaint; personal history; family history; history of present illness; physical examination; special reports such as consultations; clinical laboratory; x-ray and others; provisional diagnosis; medical or surgical treatment; operative report; pathological findings; progress notes; final diagnosis; condition on discharge; follow-up and autopsy reports when available.””

“PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). This Standard is not met as evidenced by: 46958 Based on interview and record review, the facility failed to complete the Advance Directive questionnaire form (legal document that states a person’s wishes for medical care if they are unable to communicate their wishes) for six of 17 sampled patients (Patient 1, Patient 12, Patient 2, Patient 9, Patient 10, Patient 11). This failure had the potential to violate patients’ rights to formulate an Advance Directive and for staff to be unaware of the patient’s and/or legal representative’s wishes for medical care. Findings: During a concurrent interview and record review, on 1/28/25 at 10:45 a.m. with Quality Patient Safety Program Manager (QPSPM) 2, Patient 1’s “CONDITIONS OF ADMISSION-California Two-Part Form” (COA), dated 11/28/24, was reviewed. The COA indicated, the “Compliance with Advance Directive Policies” was not completed. QPSPM 2 stated the form should not be blank and should have been completed on admission. During a concurrent interview and record review, on 1/29/25 at 10 a.m. with QPSPM 2, Patient 12’s COA, dated 1/24/25, was reviewed. The COA indicated, the “Compliance with Advance Directive Policies” was not completed. QPSPM 2 stated the form should not be blank and should have been completed on admission. During a concurrent interview and record review, on 1/29/25 at 1:10 p.m. with QPSPM 2, Patient 2’s COA, dated 1/7/25, was reviewed. The COA indicated, the “Compliance with Advance Directive Policies” was not completed. QPSPM 2 stated the form should not be blank and should have been completed on admission. During a concurrent interview and record review, on 1/29/25 at 1:25 p.m. with QPSPM 2, Patient 9’s COA, dated 12/30/24, was reviewed. The COA indicated, the “Compliance with Advance Directive Policies” was not completed. QPSPM 2 stated the form should not be blank and should have been completed on admission. During a concurrent interview and record review, on 1/29/25 at 1:30 p.m. with QPSPM 2, Patient 10’s COA, dated 1/14/25, was reviewed. The COA indicated, the “Compliance with Advance Directive Policies” was not completed. QPSPM 2 stated the form should not be blank and should have been completed on admission. During a concurrent interview and record review, on 1/30/25 at 9:15 a.m. with QPSPM 2, Patient 11’s COA, dated 12/3/24, was reviewed. The COA indicated, the “Compliance with Advance Directive Policies” was not completed. QPSPM 2 stated the form should not be blank and should have been completed on admission. During a review of the facility’s policy and procedure (P&P) titled, “Advance Health Care Directives,” dated 11/21/2024, the P&P indicated, “Verify whether patient has executed an Advance Health Care Directive and document in electronic health record. 3) Inquire if patient desires assistance in completing an Advance Health Care Directives during this hospitalization and make appropriate referral to Spiritual Care Services in EHR.””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(ii) [The use of restraint or seclusion must be--] (ii) implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law. This Standard is not met as evidenced by: 46958 Based on interview and record review, the hospital failed to follow its policy and procedure (P&P) titled, “Use of Clinical Restraints [measures to keep someone under control or within limits]” for two of three sampled patients (Patient 13 and Patient 14) when restraints were not monitored timely. This failure had the potential to compromise the safety and comfort of Patient 13 and Patient 14 while on restraints. Findings: During a concurrent interview and record review on 1/30/25 at 8:55 a.m. with Quality Patient Safety Program Manager (QPSPM) 2, Patient 13’s orders were reviewed. Patient 13’s order for Restraints-Violent/Self Destructive-Adult (RVSDA) from 1/4/25, 1/5/25, 1/6/25 were reviewed. The RVSDA indicated, “Bilateral Wrists.” Restraint monitoring (RM) dated 1/4/25, 1/5/25, 1/6/25 were reviewed and RM indicated there was documentation completed every two hours instead of every 15 minutes. QPSPM stated there was no documentation for restraint monitoring every 15 minutes and there should have been documentation. During a concurrent interview and record review on 1/30/25 at 9 a.m. with QPSPM, Patient 14’s orders were reviewed. Patient 14’s order for Restraints-Non-Violent/Non Destructive (RNVB) from 1/6/25 for 1857 (6:57 p.m.) was reviewed. The RNVB indicated, “Bilateral Wrists.” RM dated 1/6/25 was reviewed and RM indicated there was no documentation. QPSPM 2 stated there was no documentation for restraint monitoring for every 2 hours During a review of the facility’s P&P titled, “Use of Clinical Restraints,” dated 10/27/21, the P&P indicated, “Non-Violent or Non-Self-Destructive Restraints Standard: a) Patients will be observed frequently. b) Monitoring and care must be documented in the patient’s record at a minimum of every 2 hours, or more often based on the patient’s assessment. . . 2) Violent or Self-Destructive (Behavioral) Restraints Standard: a) Patients will be observed frequently. b) Monitoring and care must be documented in the patient’s record at a minimum of every 15 minutes, or more often based on the patient’s assessment.””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 46958 Based on interview and record review, the hospital staff failed to follow the facility policy and procedure (P&P) titled, “Use of Clinical Restraints,” to obtain physician’s orders (PO) for restraints for two of two sampled patients (Patient 1 and Patient 12). This failure resulted in a violation of Patient 1’s and Patient 12’s right to be free from unnecessary restraints. Findings: During a concurrent interview and record review on 1/28/25 at 10:45 a.m. with Quality Patient Safety Program Manager (QPSPM) 2, Patient 1’s PO were reviewed. Patient 1’s PO for “Restraints-Non-Violent/Non Destructive” (RNVB) dated 11/29/24 was reviewed. The RNVB indicated, “Bilateral Wrists” (restaints blace on both wrists). “Restraint” monitoring (RM) dated 11/29/24 was reviewed and the RM indicated “All four extremities”. QPSPM 2 stated there was no PO and there should have been a PO for all four extremities. During a concurrent interview and record review on 1/29/25 at 10 a.m. with QPSPM 2, Patient 12’s PO were reviewed. Patient 12’s PO for Restraints-Non-Violent/Non Destructive (RNVB) dated 1/25/25 at 7:40 p.m. to 1/27/25 at 7:46 p.m. was reviewed. The RNVB indicated, “Bilateral Wrists.” The RM dated 1/25/25-1/27/25 was reviewed and RM indicated “Side rails x 4”. QPSPM 2 stated there was no PO for siderails for 1/25/25-1/27/25 and there should be have been. During a review of the facility’s policy and procedure (P&P) titled, “Use of Clinical Restraints,” dated 10/27/21, the P&P indicated, “a qualified nurse may apply restraints in response to an unanticipated event prior to obtaining a physician order. An order must be obtained as soon as possible after the patient placement [sic] in restraints.””

“DISCHARGE PLANNING - EARLY IDENTIFICATION CFR(s): 482.43(a) The hospital’s discharge planning process must identify at an early stage of hospitalization those patients who are likely to suffer adverse health consequences upon discharge in the absence of adequate discharge planning and must provide a discharge planning evaluation for those patients so identified as well as for other patients upon the request of the patient, patient’s representative, or patient’s physician. This Standard is not met as evidenced by: 46958 Based on interview and record review facility failed to follow policy and procedure (P&P) on “Safe Discharge for High Risk Patients” when one of two sampled patient (Patient 15), who was homeless, was not provided with transportation upon discharge. This failure had the potential for Patient 15 to have unmet needs. Findings: During a concurrent interview and record review on 1/30/25 at 11:20 a.m. with Quality Patient Safety Program Manager (QPSPM), Patient 15’s Discharge Summary Note dated 1/15/25 was reviewed. Patient 15’s Discharge Summary Note indicated Reason for Admission. Patient 15 was recently hospitalized for Chronic Obstructive Pulmonary Disease (COPD, ongoing lung condition caused by damage to the lungs, such as by smoking). Patient 15 was discharged four (4) days ago but returned to the hospital today (1/14/25). Patient 15’s Discharge Summary Note indicated Intent to Admit 1/14/25 at 2:55 a.m. Cardiac telemetry (remote heart monitoring, COPD exacerbation (worsening). Patient 15’s Discharge Summary Note indicated Discharge to Shelter. Patient 15’s Admit, Discharge, Transfer Forms, dated 1/25/25, indicated DC (discharge) Information Disposition (location) Shelter. Right Click on Box to View Reference Text: No. QPSPM 2 stated there was no documentation if Patient 15 was picked up by family or if the hospital provided Patient 15 transportation to the shelter. The California Department of Public Health All Facility Letter (AFL) 19-01, dated 1/4/19, indicate” “Effective January 1, 2019, SB [senate bill] 1152 (Chapter 981, Statutes of 2018) requires GACHs [General Acute Care hospital} ...to include within their discharge policies a written homeless patient discharge planning policy and process ...SB 1152 requires hospitals to document all of the following prior to discharging a homeless patient ...Hospital offered transportation to the discharge destination ...” During a review of the California Hospital Association document titled Discharge Planning California Hospital Discharge Planning for Homeless Patients, dated 2019, the document indicated “H. Transportation The hospital must offer the homeless patient transportation to his/her post-discharge destination, if that destination is within 30 minutes or 30 miles of the hospital.” During a review of the facility’s policy and procedure (P&P) titled, “Safe Discharge for High Risk Patients,” dated 12/28/2018, the P&P indicated, “The hospital will offer the homeless patient transportation to his/her post-discharge destination as identified in the discharge plan.””

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 40516 Based on interview and record review, the hospital failed to: 1. Ensure medical records (MR) were reviewed by an attending physician prior to being co-signed for two of two sampled patients (Patient 3 and Patient 4). This failure resulted in abnormal labs not being reviewed and acted upon for Patient 3 who returned to the Emergency Department (ED) three days later in critical condition and expired. 2. Ensure an Advanced Practice Provider (APP- health care professional licensed to perform medical tasks that are usually done by a doctor, but the provider is not a doctor) documented a medical treatment provided to one of one sampled patient (Patient 3). This failure resulted in an inaccurate medical record and had the potential for medical symptoms not to be correlated with laboratory results. 3. Follow its policy and procedure (P&P) titled, “Interprofessional Plan of Care” for three of three sampled patients (Patient 5, Patient 6, and Patient 7). This failure resulted in care plans not being developed or implemented for admitted patients being held in the Emergency Department (ED) and had the potential for unmet care needs. Findings: 1. During an interview on 1/27/25 at 12:11 p.m. with Chief Medical Officer (CMO), CMO stated Patient 3 had been brought to the ED on 12/6/24 by his mother with complaints of fever. Physician Assistant (PA - advanced practice provider) 1 examined Patient 3. CMO stated PA 1 ordered a urinalysis (UA- laboratory test to analyze urine) to rule out a urinary tract infection. CMO stated the results of the UA ruled out a urinary infection and PA 1 discharged Patient 1. CMO stated the UA was positive for bilirubin (yellow-orange pigment produced when red blood cells are broken down. Bilirubin in the urine is considered abnormal and can indicate a problem with the liver). CMO stated the abnormal UA results were missed. CMO stated Patient 3 returned to the hospital’s ED on 12/9/24 in septic shock (life-threatening condition that occurs when an infection spreads throughout the body and causes a dangerously low blood pressure), acute liver failure (life-threatening condition where the liver suddenly stops functioning properly), kidney failure (kidneys are no longer able to adequately filter waste products and excess fluid from the blood), and Disseminated Intravascular Coagulation (DIC- condition that causes abnormal blood clotting throughout the body’s blood vessels). CMO stated Patient 3 expired (died) on 12/10/24. During a review of Patient 3’s MR, the UA laboratory results, dated 12/6/24 at 2:15 am, were noted to be abnormal in the following categories: Specific Gravity (measures concentration of urine) ... ...1.028 (H) [high, normal 1.005-1.03] Bilirubin (the presence of bilirubin is an important finding in the evaluation of liver function and a positive detection could be an indication of liver disease such as jaundice, cirrhosis or hepatitis) ?? ... ...2+ (A) [abnormal, (trace, normal less than 0.2)] Ictotest (test for presence of bilirubin) ?? ... ...Positive (A), (Normal is Negative) Blood ... ...2+ (A) (normal is 0, could indicate, bladder infection, kidney stones, kidney disease, or injury) Protein (normal kidney function will filter out protein) ?? ... ...1+ (A) (normal trace or less than 0.2, could indicate kidney damage, diabetes (inability to utilize sugar), dehydration, fever, stress) Urobilinogin (caused by breakdown of red blood cells) ... ...1+ (A) (normal trace, could indicate liver disease, biliary tract (aids in the digestion of fats) disorder, intestinal disorders, anemia) Red blood cells (RBC) ... ...156 (H) (normal less than 6) Bacteria ... ...Trace (A) (normal is none, could indicate contamination of sample or infection) All normal values displayed in black type and abnormal values displayed in red type. The “Emergency Documentation - MD” dated 1/6/24 indicated PA 1 signed the MR on 12/6/24 at 4:35 a.m. and Physician 1 co-signed the MR on 12/7/24 at 2:58 p.m. During an interview on 1/28/25 at 3:06 p.m. with PA 1, PA 1 stated he did not remember seeing Patient 3’s abnormal UA results. During an interview on 1/28/25 at 1:19 p.m. with Physician 1, Physician 1 stated MRs of patients seen by APPs are sent to physicians for a co-signature. Physician 1 stated the expectation was for the physician to review the MR before co-signing, but if many MRs were sent to him at once he would co-sign without reviewing the MR. Physician 1 stated he co-signed but did not review Patient 3’s medical record for 12/6/24 ED visit. Physician 1 stated he co-signed but did not review Patient 4’s medical record for 12/9/24 ED visit. During a review of Patient 4’s MR, the “Emergency Documentation - MD” dated 1/9/24 indicated Family Nurse Practitioner (FNP- advanced practice provider) 1 signed the MR on 12/10/24 at 3:24 p.m. and Physician 1 co-signed the MR on 12/10/24 at 6:11 p.m. During an interview on 1/30/25 at 11:43 a.m. with CMO, CMO stated the expectation was for attending physicians to review a medical record before co-signing. During a review of the hospital’s “Supervisory Responsibility and Delegation of Services Practice Agreement [for] Physician Assistant (DSPA) (undated), the DSPA indicated, “All charts [medical records], whether the patient was treated according to protocol. . . or under the supervising physician’s patient-specific order, and which include a drug order, shall be reviewed and co-signed by the supervising physician within 72 hours of the encounter, as specified by regulation.” During a review of the hospital’s “Medical Staff Rules and Regulations” (MSRR) dated 12/2023, the MSRR indicated, “9. The attending physician shall be held responsible for the preparation of a complete and legible medical record for each patient. This record shall include identification data, complaint; personal history; family history; history of present illness; physical examination; special reports such as consultations; clinical laboratory; x-ray and others; provisional diagnosis; medical or surgical treatment; operative report; pathological findings; progress notes; final diagnosis; condition on discharge; follow-up and autopsy reports when available.” 2. During a review of Patient 3’s “Emergency Documentation - MD” dated 12/6/24 indicated PA 1 completed the provider documentation, assessments, and orders for Patient 3. During a concurrent interview and record review on 1/27/25 at 11:55 a.m. with Quality Patient Safety Program Manager (QPSPM) 1, Patient 3’s medical record was reviewed. The “General Information [nursing notes] Textual Results” (GITR) dated 12/6/24 at 4:40 a.m. indicated Licensed Vocational Nurse (LVN) 1 documented, “bleeding from right nostril noted after swab for covid [sic- Corona Virus Disease: highly contagious virus] was done; pressure applied to the nose and ice pack administered; provider then placed a nasal sponge that stopped the bleeding.” QPSPM 1 stated there was no note in the medical record from a provider regarding Patient 3 nosebleed or any interventions done to stop the bleeding. During an interview on 1/28/25 at 3:06 p.m. with PA 1, PA 1 stated he did not remember placing a nasal sponge in Patient 3’s nostril to stop a nosebleed. During an interview on 1/29/25 at 7:50 a.m. with LVN 1, LVN 1 stated she did a COVID swab by placing the swab in each nostril and rotating the swab. LVN 1 stated the nosebleed started immediately. LVN 1 stated she tried to stop the bleeding by using a tissue to apply pressure and then applied an ice pack, but the bleeding did not stop. LVN 1 stated the provider was in the room and he made the decision to insert a nasal sponge to stop the bleeding. LVN 1 stated she believed the provider was [stated first name of PA 1]. During an interview on 1/29/25 at 1:27 p.m. with Emergency Department Medical Director (EDMD), EDMD stated his expectation was for ED providers to document every treatment, intervention, or phone call to patients for any care provided. During an interview on 1/29/25 at 5:36 p.m. with Family Member (FM) 1, FM 1 stated she was in the ED room with Patient 3 on 12/6/24. FM 1 stated the nurse performed a nasal swab and Patient 3’s nose began to bleed as soon as she removed the swab. FM 1 stated “the male doctor” put something in Patient 3’s nose to stop the bleeding. During an interview on 1/30/25 at 11:43 a.m. with Chief Medical Officer (CMO), CMO stated his expectation would be for a provider to make a note if a nasal sponge had to be placed in a patient to stop a nosebleed. During an interview on 1/30/25 at 12:30 p.m. with Director of Quality (DQ), DQ stated PA 1 was the only APP on duty at the time Patient 3 had a nosebleed. During a review of the hospital’s “Supervisory Responsibility and Delegation of Services Practice Agreement [for] Physician Assistant (DSPA) (undated), the DSPA indicated, “The ED PA shall enter all clinical findings into the patient’s chart through the computer hospital system.” 3. During an interview on 1/30/25 at 10 a.m. with Emergency Department Director of Nursing (EDDN), EDDN stated ED registered nurses (RN) are not required to complete care plans unless the patient had been admitted to the hospital and held in the ED for more than four hours. During a concurrent interview and record review on 1/30/25 at 12:39 p.m. with Quality Patient Safety Program Manager (QPSPM) 1, Patient 5’s medical record was reviewed. The History and Physical (H&P) dated 1/3/25 indicated Patient 5 was a six-week-old infant who was brought to the ED for cough, congestion, and retractions (skin around the ribs, nostrils, or under the breastbone pull inward indicating the infant was having difficulty breathing). The Physician Order (PO) dated 1/3/25 at 6:03 p.m. indicated Patient 5 was admitted to the hospital with a diagnosis of Respiratory Syncytial Virus (RSV- may mimic cold-like symptoms but can be severe). The location history indicated Patient 5 was transferred from the ED to the pediatric unit on 1/4/25 at 12:10 a.m. (6 hours later) QPSPM 1 stated there was no care plan in Patient 5’s medical record while he was in the ED. During a concurrent interview and record review on 1/30/25 at 12:52 p.m. with QPSPM 1, Patient 6’s medical record was reviewed. The H&P dated 1/1/25 at 2:29 p.m. indicated Patient 6 was brought to the ED with complaints of lower back pain and left leg pain with paresthesia (abnormal sensation of tingling, prickling, burning, or numbness in the skin). The PO dated 1/1/25 at 2:05 a.m. indicated Patient 6 was admitted to the hospital. The location history indicated Patient 6 was transferred from the ED to the Medical/Surgical unit on 1/1/25 at 9:40 a.m. (7 1/2 hours later). QPSPM 1 stated there was no care plan in Patient 6’s medical record while he was in the ED. During a concurrent interview and record review on 1/30/25 at 1 p.m. with QPSPM 1, Patient 7’s medical record was reviewed. The H&P dated 1/3/25 at 11:33 p.m. indicated Patient 7 was brought to the ED with complaints of “about 3 days of cough, 2 days of rhinorrhea [runny nose], and 1 day of progressive shortness of breath.” The PO dated 1/3/25 at 4:02 p.m. indicated Patient 7 was admitted to the hospital. The location history indicated Patient 7 was transferred from the ED to the Pediatric unit on 1/1/25 at 3:05 a.m. (11 hours later). QPSPM 1 stated there was no care plan in Patient 7’s medical record while he was in the ED. During a review of the hospital’s P&P titled, “Interprofessional Plan of Care” dated 1/26/22, the P&P indicated, “The Interprofessional Plan of Care is a guideline for the healthcare team to assess and reassess the progress of the patient. This plan of care will list the active clinically relevant patient problems, goals/outcomes and interventions individualized for the patient throughout the stay from admission to discharge and communicate and coordinate care among disciplines. Procedure: 1. Developing the Interprofessional Plan of Care (POC) a. The interprofessional plan of care (POC) will be initiated within 4 hours of admission by the RN [registered nurse].””

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 48901 Based on interview and record review, the facility failed to ensure the provision of patient rights when: 1. A second “An Important Message from Medicare about Your Rights [IM - Patient’s right to appeal discharge]” notice was not provided for two of two sampled patients (Patient 6 and Patient 7). This failure had the potential for Patient 6 and Patient 7 to not be informed of their right to appeal their discharge from the hospital. 2. A representative of one of one sampled patient (Patient 2) was not informed of changes in Patient 2’s plan of care. This failure had the potential for Patient 2 to receive unwanted treatments. Findings: 1. During a review of Patient 6’s Facesheet (FS), undated, the FS indicated Patient 6 was admitted on 8/26/24 and discharged from the hospital on 9/4/24. During a review of Patient 6’s medical record (MR), an IM signed and dated on 8/26/24, was reviewed. No other IM was found in Patient 6’s MR. During a review of Patient 7’s FS, undated, the FS indicated Patient 7 was admitted on 8/27/24 and discharged from the hospital on 9/4/24. During a review of Patient 7’s MR, an IM signed and dated on 8/28/24, was reviewed. No other IM was found in Patient 7’s MR. During an interview on 10/1/24 at 4:15 p.m. with Manager of Cardiology Program (MCP), MCP stated there was no record of a second IM notice given to Patient 6 or Patient 7. During a review of “Fast appeals” (FA - law regarding a Medicare patients’ right to appeal their hospital discharges), the FA indicated, “In a hospital: Within 2 days of your admission and prior to your discharge, you should get a notice called ‘An Important Message from Medicare about Your Rights.’ This notice is sometimes called the Important Message from Medicare or the IM. . . If the hospital gives you the IM more than 2 days before your discharge day, it must give you a copy of your original, signed IM or provide you with a new one (that you must sign) before you’re discharged.” 2. During a review of Patient 2’s “XR Swallow Function Video or Cine [SF - special real-time form of x-ray that tests ability to swallow liquids and foods]” order, dated 9/29/24 at 8:14 a.m. The SF indicated the test was ordered as routine (not urgent or emergent) and the reason for test was “dysphagia” (difficulty swallowing). During a review of Patient 2’s “Level 4 Pureed Dysphagia Diet (DD - a diet of smooth, moist foods that are easy to swallow and don’t require chewing)” dated 9/30/24 at 10:19 a.m. was ordered. During a review of Patient 2’s SF, the SF indicated the swallow function test was performed on 9/30/24 at 9:30 a.m. During a review of Patient 2’s “Advance Health Care Directive Form (AHCD-gives instructions about patient’s health care choices and/or name someone to make health decisions for that patient),” dated 4/25/23, the AHCD indicated “DESIGNATION OF AGENT: I [Patient 2] designate the following as my agent to make health care decisions for me [Patient 2]”: Family Member (FM) 1, and FM 2 as Patient 2’s first alternative agent “If I [Patient 2] revoke my agent’s authority or if my agent is not willing, able, or reasonably available to make a health care decision for me. During an interview on 10/1/24 at 9:08 a.m. with FM 1, FM 1 stated she was not aware Patient 2 received a SF test. FM 1 stated she makes medical decisions for Patient 2. FM 1 stated she did not know how the SF worked, and she would have like to have known of any risks or the benefits of the test. FM 1 stated she did not know the result of the SF test and did not know that there was a recent change in Patient 2’s diet order. FM 1 stated she would like for Patient 2 to be comfortable and did not want any unnecessary tests, procedures, and medications for Patient 2. During an interview and record review on 10/1/24 at 1:29 p.m. with Manager of Cardiology Program (MCP) Patient 2’s medical record was reviewed. MCP stated there was no documentation in Patient 2’s medical record that his representatives (FM 1 and/or FM 2) were informed of the SF test or changes to his diet. During a review of the hospital’s policy and procedure (P&P) titled, “Advance Health Care Directives” dated 7/28/21, the P&P indicated, “While the focus of advance health care planning often addresses whether to withhold or withdraw life-sustaining treatment, it also can serve as an important resource for other type of health care decisions. Advance health care planning facilities the patient’s and family’s understanding of illness and prognosis, addresses the goals of care, patients’ treatment preferences and decisions, options for pain and symptoms management, preferences regarding organ and tissue donation and provision for psychological, social and spiritual needs.””

“PATIENT RIGHTS: PRIVACY AND SAFETY CFR(s): 482.13(c) Patient Rights: Privacy and Safety This Standard is not met as evidenced by: 39356 Based on interview and record review, the Hospital failed to ensure its procedure titled, “Electrosurgery [use of high-frequency electrical current to cut and stop tissue from bleeding] Safety” (ES) was followed for one of 10 sampled patients (Patient 22) when a “Rocker Switch Pencil [Bovie pencil - electrode tip - surgical device used to cut or destroy tissue, and/or control bleeding]” was placed on Patient 22’s surgical bed instead of being placed in the holster (sterile nonconductive holder for Bovie pencil) when not in use. This failure resulted in Patient 22 sustaining a second degree burn (burn that affects both the outer and underlying layers of skin) to left inner thigh. Findings: During a review of Patient 22’s “History and Physical” (H&P) dated 9/27/24 at 3:35 p.m. the H&P indicated, “[Patient 22] is a 32yo [year old] male without any PMHx [past medical history] who was BIBA [brought in by ambulance] this afternoon after sustaining burns while working when the semi-truck he was driving caught fire.” During a review of Patient 22’s “Perioperative Record” (PR) dated 9/3/24 at 9:51 a.m. the PR indicated, “There was a bovie malfunction with spark of the bovie that caused a partial thickness burn to inner left thigh which was 4x2cm [centimeter - unit of measure]. This was excised [cut out surgically] and autograft [use of a person’s own tissue to repair another area of skin on their body] was placed and secured with dermabond [topical skin adhesive].” During a review of Patient 22’s “Physician Note” (PN) dated 9/3/24 at 12 p.m. the PN indicated, “post op [after surgery] discussed with patient the the [sic] electocaughtery [sic] incident that occurred intraoperatively [during surgery]. Described that the electrocaughtery [sic] malfunctioned, created sparks and it caused a small 2x2 deep 2nd degree burn to left inner thigh near his previous burned injury. discussed [sic] that the area was then excised and autografted, along with the rest of his previous right lower extremity injury. And that it should not cause any lasting medical problems. Patient understood what happened and was thankful everything was grafted.” During an interview on 9/30/24 at 2:20 p.m. with Surgical Tech (ST), ST stated midway thru the case with the patient (Patient 22), the bovie pencil was “acting up” and becoming sparkly. ST stated Surgeon 1 picked up the Bovie pencil which had been placed between the patients legs and the Bovie pencil continued to spark. ST stated the Bovie pencil should not have been laying next to patients legs. During an interview on 9/30/24 at 3:15 p.m. with Physician Assistant (PA), PA stated in the middle of the case, “I smelled something” and we saw smoke between Patient 22’s legs. PA stated Surgeon 1 picked up the Bovie pencil under Patient 22’s legs and the Bovie pencil was sparking and smoking without being activated. PA stated the Bovie pencil had not been placed in the holster and whoever last used the Bovie pencil should have put it back in the holster. During an interview on 10/1/24 at 9:27 a.m. with Surgeon 1, Surgeon 1 stated Patient 22 had multiple burn sites being treated and sustained a small burn to left thigh. Surgeon 1 stated the Bovie pencil malfunctioned and was sparking. Surgeon 1 stated the Bovie pencil was on the surgical bed and laying next to the Patient 22’s legs. Surgeon 1 stated Bovie pencil should not be on the surgical bed and should be holstered. Surgeon 1 stated, “I assume the tech (Surgical Tech) is responsible (for holstering the Bovie pencil).” During an interview on 10/1/24 at 9:33 a.m. with Operating Room Registered Nurse (ORRN), ORRN stated during the case we all smelled something burning. ORRN stated Surgeon 1 picked up the Bovie pencil that was on the surgical bed and the Bovie pencil was sparking without being activated. ORRN stated the Bovie pencil should not be lying on the surgical bed. During a review of the hospital’s Procedure titled, “Electrosurgery Safety” dated 10/25/23, the procedure indicated, “Electrosurgery Unit [ESU] (Perioperative - [around the time of surgery]). . .10. Follow the manufacturer’s instructions for use (IFU) for safe operation of the ESU generator and use accessories that are compatible with the specific ESU generator per the manufacturer’s IFU. . .32. The scrub person returns the active electrode [Bovie pencil] to the provided nonconductive holster when not in use.” During a review of the Manufacture’s IFU’s for “Rocker Switch Pencil”, the IFU indicated, “When not in use, place active accessories in a holster or in a clean, dry, nonconductive, and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns.””

“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: 48901 Based on observation, interview, and record review, the hospital failed to: 1. Follow their policy and procedure (P&P) titled, “Peripheral Intravenous Catheter (PIVC): Insertion, Maintenance, Removal (Adult)” for one of two sampled patient’s (Patient 3) when Patient 3’s intravenous (IV - into a vein) medications and tubing were not labeled. This failure had the potential to cause infection and to receive the wrong medication. 2. Follow their P&P titled, “Gastrointestinal (GI - passageway of the digestive system that leads from the mouth to the anus) Tubes, Gastric Lavage (medical procedure that involves cleaning out the contents of the stomach using a tube), and Enteral Feeding (process of the delivery of nutritional needs directly to the stomach or upper intestines) for Adult Patients,” for one of one sampled patient (Patient 2) when Patient 2’s formula was not labeled. This failure had the potential for Patient 2 developing GI complications. Findings: 1. During a concurrent observation and interview on 9/30/24 at 10:07 a.m. with Medical Surgical Nurse Manager (MSNM) in Patient 3’s room, Patient 3 had two IV medications being administered without any labels indicating time, date or clinical staff’s initials. MSNM stated the IV medication and tubing should had been labeled when administered or when tubing was changed. During a review of the facility’s P&P titled, “Peripheral Intravenous Catheter (PIVC): Insertion, Maintenance, Removal (Adult),” dated 3/7/23, the P&P indicated, “administration sets will be labeled with time, date and clinical staff’s initials. The date and time used may be the date of set change or the date that the tubing should be changed next, depending on facility policy. The label should clearly indicate which date/time reference is used (e.g. Tubing changed on xx versus Tubing to be changed on xx).” 2. During a concurrent observation and interview on 9/30/24 at 9:33 a.m. in Patient 2’s room, Patient 2’s enteral feeding formula and associated tubing was not labeled with date, time, or clinical staff’s initials. The Registered Nurse (RN) 1 stated she did not notice that the formula bottle was not labeled. RN 1 stated she did not know how long the formula had been hanging open. RN 1 stated nurses have to make sure that the formula bottle has the patient’s name, date formula was open and time of expiration. During an interview on 9/30/24 at 9:50 a.m. with MSNM, MSNM stated the expectation is the nurse will label the formula with the patient’s name, date, and time. MSNM stated it is important to label the formula to make sure you do not give “spoiled” formula to the patient. MSNM stated if it is not labeled then the formula should be thrown away and replaced. During a review of the facility’s P&P titled, “Gastrointestinal (GI) Tubes, Gastric Lavage, and Enteral Feeding for Adult Patients,” dated 9/26/24, the P&P indicated, “POLICY: 5. b. Follow the guidance in Elsevier Skills [Evidence-based skills and procedures]. . .Procedure: Refer to the following Elsevier Clinical Skills: Feeding Tube: Enteral Nutrition via Nasoenteric Tube. . .3. Flushing, feeding, and set-up: a. Enteral feeding bags, tubing, and syringes are changed every 24 hours. b. The formula in a closed enteral feeding system is changed every 24 hours or any time the tubing is changed.” During a review of Elsevier Clinical Skills: Feeding Tube: Enteral Nutrition via Nasoenteric Tube, the clinical skill indicated, “h. Label the bag with patient information; enteral access type; and the tube feeding formula type, strength, and amount. Include the date and time and initial it.””

“PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). This Standard is not met as evidenced by: 40516 Based on observation, interview, and record review, the hospital failed to follow its policy and procedure (P&P) titled, “Advance Health Care Directives [legal document indicating person’s preference for end-of-life treatment decisions]” for three of four sampled patients (Patient 1, Patient 2, and Patient 3). This failure resulted in the hospital to be unaware of patients end-of-life care wishes and had the potential for patients’ health care decisions to not be honored. Findings: During a concurrent observation, interview, and record review on 8/20/24 at 9:57 a.m. with Patient Access clerk (PA) 1, in the Pre-Admission Testing registration area, PA 1 registered Patient 1 for an out-patient procedure. PA 1 asked Patient 1 if she had an advance directive and Patient 1 stated she did not have one. On the “Conditions of Admission” form subsection “Compliance with Advance Directive Policies” dated 8/20/24, PA 1 checked the box indicating, “The Patient does not have a written advance directive about health care decisions and.” PA 1 did not ask Patient 1 any other questions about advance directives. PA 1 then checked the box indicating “Does not want further information now.” PA 1 stated, “I did not ask her [Patient 1]” if she wanted more information about advance directives. During a concurrent observation, interview, and record review on 8/20/24 at 10:08 a.m. with PA 2, in the Pre-Admission Testing registration area, PA 2 registered Patient 2 for an out-patient procedure. PA 2 asked Patient 2 if he had an advance directive and Patient 2 stated he did not have one. On the “Conditions of Admission” form subsection “Compliance with Advance Directive Policies” dated 8/20/24, PA 2 checked the box indicating, “The Patient does not have a written advance directive about health care decisions and.” PA 2 did not ask Patient 2 any other questions about advance directives. PA 2 then checked the box indicating “Does not want further information now.” PA 2 stated, “I did not ask this time” if Patient 2 wanted more information about advance directives. During a concurrent observation, interview, and record review on 8/20/24 at 10:35 a.m. with PA 3, in the Emergency Department (ED) registration area, PA 3 registered Patient 3 to be seen in the ED. PA 3 asked Patient 3 if he had an advance directive and Patient 3 stated he did not have one. On the “Conditions of Admission” form subsection “Compliance with Advance Directive Policies” dated 8/20/24 at 10:42 a.m. PA 3 checked the box indicating, “The Patient does not have a written advance directive about health care decisions and.” PA 3 did not ask Patient 3 any other questions about advance directives. PA 3 then checked the box indicating “Does not want further information now.” PA 3 stated she bypassed that question because it seemed liked the wife [of Patient 3] knew about advance directives. During an interview on 8/20/24 at 10:50 a.m. with Patient Access Supervisor (PAS), PAS stated Patient Access clerks should be asking all patients who do not already have an advance directive for health care, if they want more information about one. PAS stated that information (advance directive for health care) was available at all registration areas. During a review of the hospital’s P&P titled, “Patient Rights,” dated 2/28/24, the P&P indicated, “All employees of [the Hospital] are responsible for assuring that patient rights are protected. . . Patients have the right to. . . 10. Formulate advance directives. This includes designating a decision maker if you become incapable of understanding a proposed treatment or become unable to communicate your wishes regarding care. Hospital staff and practitioners who provide care in the hospital shall comply with these directives. All patients’ rights apply to the person who has legal responsibility to make decisions regarding medical care on your behalf.” During a review of the hospital’s P&P titled, “Advanced Healthcare Directives” dated 7/28/21, the P&P indicated, “Policy: [The Hospital] is committed to creating a health care environment that promotes health care decision-making as an ongoing collaborative process between patients or their surrogate decision-makers, medical and other clinical staff, and that is consistent with Patient Care Policies and the [Hospital Corporation’s values]. [The Hospital] respects the right of patients to accept or refuse any treatment options offered or to request withdrawal of any treatment that has already been initiated regarding their treatment options. . . Procedure: 1. Responsibilities of Admitting [Department] a. For Adult Inpatients, ER [ED], and Outpatient Surgery/Procedures Admissions: 1) Provide patient with brochure entitled “Your right to make Decisions about Medical Treatment”. 2) Verify whether patient has executed an Advance Health Care Directive and document in the medical record. 3) Inquire if patient desires assistance in completing an Advance Health Care Directive during this hospitalization and make appropriate referral to Spiritual Care Services in HER [electronic health record].””

“PATIENT RIGHTS:RESTRAINT/SECLUSION DEATH RPT CFR(s): 482.13(g)(1) & (3)(i) [Death Reporting Requirements: Hospitals must report deaths associated with the use of seclusion or restraint.] (1) With the exception of deaths described under paragraph (g)(2) of this section, the hospital must report the following information to CMS by telephone, facsimile, or electronically, as determined by CMS, no later than the close of business on the next business day following knowledge of the patient’s death: (i) Each death that occurs while a patient is in restraint or seclusion. (ii) Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion. (iii) Each death known to the hospital that occurs within 1 week after restraint or seclusion where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient’s death, regardless of the type(s) of restraint used on the patient during this time.”Reasonable to assume” in this context includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing or asphyxiation.... (3) The staff must document in the patient’s medical record the date and time the death was: (i) Reported to CMS for deaths described in paragraph (g)(1) of this section; or .... This Standard is not met as evidenced by: 42610 Based on interview and record review, the hospital failed to ensure two of three sampled patients’ (Patient 7 and Patient 8) deaths while in restraints were reported per hospital policy. This failure resulted in the deaths of Patient 7 and Patient 8 not being reported to the regulatory agency as required. Findings: During a concurrent interview and record review on 8/21/24 at 10:44 a.m. with Quality Patient Safety Director (QPSD), an untitled log indicating deaths associated with restraints (undated) was reviewed. The log indicated Patient 7’s date of death was 4/14/24 while restrained with “Side rails X 4 Soft Limbs [all four bed rails were up and all limbs restrained].” The log indicated Patient 8’s date of death was 4/12/24 while restrained with “Side rails X 4 Soft Limbs.” QPSD stated side four side rails up with limb restraints would be reportable deaths. During a concurrent interview and record review on 8/21/24 at 10:45 a.m. with QPSD, the hospital’s policy and procedure (P&P) titled, “Use of Clinical Restraints,” dated 10/27/21 was reviewed. The P&P indicated, “Reporting. . . Deaths associated with the use of restraints will be reported to CMS [Centers for Medicare and Medicaid Services] as required by regulation by the Quality/Risk Department.” QPSD stated the two deaths should have been reported, and, “it was a miss.””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 42610 Based on interview and record review, the facility failed to ensure two of three sampled patients’ (Patient 5 and Patient 6) care plans were updated when Patient 5 and Patient 6 were placed in clinical restraints (used to limit a patient’s movement in order to keep them safe and prevent harm to themselves or others). This failure had the potential for unmet care needs for Patient 5 and Patient 6. Findings: During a concurrent interview and record review on 8/20/24 at 10:02 a.m. with Quality Patient Safety Program Manager (QPSPM) 2, Patient 5’s “Care Plan (CP),” dated 8/17/24-8/20/24 was reviewed. The CP indicated, “Suggested Care Plan” for restraints. QPSPM 2 stated the electronic healthcare system would suggest care plans, and if a restraint care plan had been initiated the CP would indicate “activated care plan.” The “Suggested Care Plan” did not indicate “activated care plan.” QPSPM 2 stated Patient 5 had been in restraints since 8/17/24. During a concurrent interview and record review on 8/20/24 at 10:21 a.m. with QPSPM 2, Patient 6’s CP dated 8/18/24-8/20/24 was reviewed. The CP indicated, “Suggested Care Plan” for restraints. The “Suggested Care Plan” did not indicate “activated care plan.” QPSPM 2 stated Patient 6 had been in restraints since 8/18/24 and the restraint care plan should have been initiated. During an interview on 8/20/24 at 10:42 a.m. with Director of Adult Critical Care (DACC), DACC stated it was his expectation that nursing staff initiated the restraint care plan when restraints were activated. During a review of the hospital’s policy and procedure (P&P) titled, “Use of Clinical Restraints,” dated 10/27/21, the P&P indicated, “The use of restraints must be documented in the medical record, and must include the following information. . . Revisions to the plan of care.””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 40516 Based on interview and record review, the hospital failed to follow its policy and procedure (P&P) titled, “Plan for the Provision of Patient Care for the Emergency Department [ED]” dated 1/26/22, for one of three sampled patients (Patient 4). This failure resulted in Patient 4 not being adequately nourished or hydrated during his ED stay. Findings: During a review of Patient 4’s medical record (MR), the following was noted: Facesheet indicated Patient 4 arrived at the hospital’s ED on 6/23/24 at 12:42 p.m. “ED Documentation” dated 6/23/24 at 12:43 p.m. indicated Patient 4 arrived from an out-of-town skilled nursing facility (SNF) due to “G-tube [gastrostomy tube - device used to give fluid, nutrition, and medication when the patient is unable to take anything by mouth] became slightly dislodged, not out all the way, but [SNF] staff unable to use [G-tube] at this time.” “ED Documentation” dated 6/23/24 at 12:43 p.m. indicated, “Problems/(Active) . . . Difficulty swallowing. . . Dysphagia [difficulty with or inability to swallow] . . . Esophageal cancer [cancer of the tube that runs from the throat to the stomach]. “ED Documentation-MD [sub-section] History of Present Illness” dated 6/23/24 at 2:19 p.m. indicated, “Patient [4] is an 83-year-old male resident of a local nursing facility who has a history of esophageal adenocarcinoma [cancer in gland tissue]. Patient apparently was in a [out of town] skilled facility [and his] newly place G-tube became dislodged and staff [at skilled nursing facility] was unable to use it . . . [Patient 4’s] g-tube apparently did not fall out[.] I [Physician 2] was able to retrieve it on the patient’s skin.” “General Information Textual Results” dated 6/23/24 at 4:21 p.m. indicated, “[Physician 4] made aware that GT [G-tube] site is leaking moments after Medication was administered.” “General Information Textual Results” dated 6/24/24 at 12 a.m. indicated, “G-tube is leaking around site. Chux [absorbent pad] pad placed and more gauze added around site.” “General Information Textual Results” dated 6/24/24 at 7:50 a.m. indicated, “Dressing changed to [G-tube] site. [Cleansed] skin around [G-tube] site with normal saline. Skin is red and excoriated [scratched or rubbed off].” “General Information Textual Results” dated 6/24/24 at 8:22 a.m. indicated, “Notified MD that [G-tube is leaking at site.” “ED Documentation-MD” dated 6/24/24 at 10:15 a.m. indicated, “I [Physician 1] was told by nursing staff that the [Patient 4] continues to have leakage around the gastrostomy tube. I reviewed the patient’s previous note, the gastronomy tube had already been replaced and the gastronomy tube injection x-ray already performed showing appropriate placement.” There was no documentation that Physician 1 assessed Patient 4’s G-tube site. “ED Documentation-MD Reexamination/Reevaluation” dated 6/24/24 at 10:19 a.m. indicated, “I [Physician 2] was able to easily replace the G-tube unfortunately [the hospital did not have the correct sized supplies.] We are currently pending G-tube evaluation.” “General Information Textual Results” dated 6/24/24 at 2:58 p.m. indicated, “MD aware [G-tube] malfunctioning. Unable to safely give medication.” “General Information Textual Results” dated 6/24/24 at 7:57 p.m. indicated, “[Per Physician 3] began feeding with [liquid nourishment] 40 ml [milliliters-unit of measure equals about 1.35 ounces] at this time [,] [Patient 4] tolerated well[.]” “General Information Textual Results” dated 6/24/24 at 8:03 p.m. indicated, “[Patient 4] provided oral care at this time for dry mouth as reported by patient.” “ED Documentation-MD” dated 10/24/24 at 11:08 p.m. indicated, “I [Physician 3] was asked to evaluate G-tube. . . Apparently [it] is still leaking around the tube when they [nursing staff] instill fluid. I examined it and . . . it was not placed properly, and it was not pushed all the way against the abdomen. Patient [4] has some surrounding erythemia [sic] [redness of the skin] that looks to be a yeast infection [fungal infection caused when the skin is overly moist] with possible cellulitis [bacterial skin infection] . . . Patient [4] was given a trial of feeding through the G-tube and fluid was not leaking out after I fixed [the problem]. Patient stable for discharge.” “Orders” dated 6/24/24 at 10:42 p.m. indicated, “Discharge” to “home or self care.” “Admit, Discharge, Transfer Forms” dated 6/24/24 at 11:37 p.m. indicated Patient 4 was discharged from the ED and was transported to “Home” via medical transport. During a concurrent interview and record review on 8/21/24 at 9:15 a.m. with Patient Safety Program Manager (QPSPM) 1, Patient 4’s medical record was reviewed. QPSPM 1 stated there was no order for intravenous (IV-given through a vein) fluids to be given. During a concurrent interview and record review on 8/21/24 at 9:37 a.m. with Emergency Department Nurse Manager (EDNM) and QPSPM 1, QPSPM 1 stated there was no documented oral intake. EDNM stated there were no nurses’ notes indicating Patient 4 could not take anything by mouth. EDNM stated Patient 4 was in the ED for around 36 hours. QPSPM 1 stated there were no nurses’ notes requesting IV fluids for Patient 4. EDNM stated there was no intake (any fluid or liquid nourishment taken in) or output (urine, vomiting, and liquid stools) documented for 6/23/24. The “Intake and Output” dated 6/24/24 at 6 a.m. to 6/25/24 at 6 p.m. indicated Patient 4 had a total of 50 milliliters (ml-fluid unit of measurement) intake and 450 ml of urine output, resulting in a negative fluid balance of 400 ml (total intake should be nearly equal to total output every day). During an interview on 6/21/24 at 3:15 p.m. with Physician 2, Physician 2 stated he would have expected to be notified if a patient was unable to take anything by mouth, the patient’s G-tube was not working properly, and the patient was not receiving IV fluids. Physician 2 stated 50 ml of intake in a 36-hour period in not sufficient. During a review of the hospital’s P&P titled, “Plan for Provision of Patient Care for the Emergency Department” dated 1/26/22, the P&P indicated, “The hospital’s plan for the provision of patient care serves to identify patient care delivery processes which ensure that all relevant patient care needs are met during their stay in the Emergency Department . . . 3. Scope and Complexity of the Patient Care Needs: The Emergency Department staff assesse3s each individual patient’s care needs, develops a plan for provision of this care . . . 4. Methods Used to Assess and Meet Patients’ Care Needs . . . All members of the healthcare team continuously reassess the patient’s response to care and treatment and revise the plan of care accordingly.””

“MONITORING RADIATION EXPOSURE CFR(s): 482.26(b)(3) Radiation workers must be checked periodically, by the use of exposure meters or badge tests, for amount of radiation exposure. This Standard is not met as evidenced by: 42610 Based on observation, interview, and record review, the facility failed to ensure one of two sampled Computerized Tomography (CT - x-ray machine that takes detailed pictures of the inside of the body) technicians (CT 1) was wearing a dosimeter badge (badge that measures radiation exposure). This failure resulted in CT 1 being exposed to an unknown amount of radiation. Findings: During a concurrent observation and interview on 8/19/24 at 11:21 a.m. with CT 1 and Director of Imaging (DI), in the CT suite, CT 1 was not wearing a dosimeter badge. CT 1 stated she would go look for the dosimeter badge. During an interview on 8/19/24 at 11:42 a.m. with DI, DI stated it was his expectation for CT staff to wear their dosimeter badges at all times. During a review of the hospital’s policy and procedure (P&P) titled, “Radiation Safety: Personnel Radiation Monitoring,” dated 10/25/23, the P&P indicated, “The film badge [dosimeter badge] shall be worn at all times while working in an area of possible radiation exposure.””

“QUALIFIED EMERGENCY SERVICES PERSONNEL CFR(s): 482.55(b)(2) There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility. This Standard is not met as evidenced by: 48901 Based on interview and record review, the facility failed to implement their policy and procedure (P&P) titled, “Stroke Alert Activation - Emergency Department [SAAED],” for one of five sampled patients (Patient 23). This failure had the potential for Patient 23 to receive delayed care and negative health outcomes. Findings: During a review of Patient 23’s “Result Details,” dated 5/15/24 at 15:12 (3:12 p.m.), the “Result Details” indicated, “Events: G1P0 [indicates one pregnancy and no births], 38+1 wks [weeks], pt [patient] of [clinic] here w/[with] c/o [complaint of] pelvic pain and possible leaking. Also c/o blurred vision and left sided numess [sic] at 1400 [2 p.m.] and a headache since then. Pt reports +fm [positive fetal fibronectin, (protein formed during pregnancy) can signify an increased risk for premature birth], denies bleeding or uc’s [uterine contractions]. Denies complications w/ preg [pregnancy] or gen [general] health.” During an interview on 7/24/24 at 9:41 a.m. with Nurse Manager of Labor and Delivery (NMLD), the NMLD stated obstetrical (OB-relating to childbirth and the processes associated with it) patients can come to the front hospital lobby to be seen in the obstetrical emergency department (OB ED). NMLD stated if an OB patient came to OB ED for evaluation and their complaints included left-sided weakness, OB patient would be seen by the triage nurse (ED nurse establishes type of care patient needs and priority to be seen). The provider (medical professional) would be notified, and the provider would determine what to do, once the Medical Screening Exam (MSE, to determine if there is an emergency situation) was completed and the patient and baby were stabilized. Then OB staff would move the patient to the Emergency Department (ED) for further non-OB evaluations. NMLD stated OB ED was an umbrella under the ED chain. During an interview on 7/24/24 at 9:50 a.m. with Director of Nursing for Labor and Delivery (DONLD), the DONLD stated a Rapid Response Team (RRT-team to help when a patient’s condition changes) would be called for OB patients who present with stroke-like symptoms and the OB nurse would follow the patient and baby. DONLD stated RRT would start the stroke process since OB ED did not have the stroke alert packet in the department which includes the Vision, Aphasia [speech difficulties] Neglect [VAN] scale [an assessment tool for stroke]. During an interview on 7/23/24 at 12:44 p.m. with ED Nurse Manager (EDNM), EDNM stated Patient 23 should have been sent to ED to be evaluated for her blurred vision, left sided numbess, and headache. EDNM stated this patient could had been seen in the ED for non-OB complaints and OB ED could come over to evaluate her and baby in the ED. During a concurrent interview and record review on 7/24/24 at 1:20 p.m. with NMLD, Patient 23’s “OB Triage [OBT, assigns priority of care],” dated 5/15/24 at 15:12 (3:12 p.m.) was reviewed. The “OBT” indicated, “Chief Complaint: pelvic pain and maybe leaking, also blurred vision, left-sided numbness and a headache. . .OB ESI [Emergency Severity Index, patient assessment tool] Level: 4 - Non Urgent. . .Triage [assigns priority of care]. . .Neuro [relating to nerves or the nervous system] Symptoms: Headache, Visual disturbances. . .Contractions, Per Patient: No. . .Leaking Fluid, Subjective: Unsure. . .Risk Factors, Antepartum [around time of birth] Current Preg: None.” NMLD stated she would expect the nurse to call RRT for OB patients who are having difficulty speaking and have one-sided weakness on “physical assessment.” During an interview on 7/24/24 at 4:19 p.m. with Director of Quality Management and Patient Safety (DQMPS) 1, DQMPS 1 stated OB ED was part of the ED. DQMPS 1 stated OB ED staff follow the P&P titled “Stroke Alert Activation - In-Patient, not the P&P titled “Stroke Alert Activation-Emergency Department” as in ED. During an interview on 7/29/24 at 3:15 p.m. with Quality Program Specialist Program Manager (QPSPM) 1, QPSPM 1 stated OB ED nurses were not trained on the P&P stroke alert activation - ED, since they were Labor and Delivery (L&D) nurses. During an interview on 7/29/24 at 3:16 p.m. with NMLD, NMLD stated the RRT nurses would be the ones to complete the VAN and start the stroke packet. During an interview on 7/29/24 at 3:20 p.m. with OB ED Triage Nurse (OBEDTN), the OBEDTN stated if a pregnant patient came to the OB ED with pelvic pain and maybe leaking, also blurred vision, left-sided numbness and a headache, she would call RRT to rule out a stroke. OBEDTN stated she would wait for the RRT nurse to start the stroke assessments since she was not very familiar with it. During an interview on 7/29/24 at 4 p.m. with Chief Nursing Executive Officer (CNEO), CNEO stated OB nurses did follow the inpatient stroke alert activation P&P. During a review of the facility’s RN Emergency Services Job Description (RNESJD), dated 3/10/20, the “RNESJD” indicated, “Responsibilities. . .8. PERFORM OTHER RELATED JOB DUTIES. . .8.4 Care and management of stroke patients.” During a review of Patient 23’s “Physician Note [PN],” dated 5/15/24 at 15:51 (3:51 p.m.), the “PN” indicated, “History of Present Illness. . .AT 38 WEEKS PRESENTED [came] WITH HISTORY OF TRANSIENT [lasting only for a short time] HEADACHES AND LEFT ARM NUMBNESS SIMILAR TO PREVIOUS EPISODES OF MIGRAINE [a headache of varying intensity, often accompanied by nausea and sensitivity to light and sound] HEADACHES. NO PHOTOPHOBIA [light sensitivity] OF [sic] DIPLOPIA [double vision] . . .Triage Plan: TO ED FOR EVALUATION MIGRAINE. During a review of Patient 23’s “[PN],” dated 5/15/24 at 18:05 (6:05 p.m.), the “PN” indicated, The patient presents with headache. The onset was 2 [two] hours ago. The course/duration of symptoms is worsening ...” During a review of Patient 23’s “ED Triage [EDT],” dated 5/15/24 at 16:13 (4.13 p.m.), the “EDT” indicated, “Chief Complaint ED: blurred vision, headache and left-sided numbness. . .Reason for visit: NEURO.” During a review of the hospital’s website, the hospital’s website indicated the hospital was a Certified Stroke Center. The hospital’s website indicated “Stroke is the third leading cause of death in the United States and the leading cause of disability. But fast treatment can reduce or even prevent disability. Remember, with stroke, time is essential. When you or someone you love is having a stroke, every minute counts. We are a fully-accredited Stroke Center ...” During a review of policy and procedure titled, “Rapid Response Team (RRT),” dated 6/24/24, the P&P indicated, “POLICY: 6. Criteria for staff to call the RRT is as follows: i. Suspicion of Acute Stroke 1) Sudden numbness or weakness. . .5) Sudden severe headache. . .7. An attempt to notify the managing/attending physician of patient condition should always be made in conjunction with activating the RRT.” During a review of the facility’s policy and procedures (P&P), “SAAED,” dated 4//26/24, the P&P indicated, “POLICY: The purpose of this policy is to identify the process for a Stroke Alert activation in the Emergency Department (ED), as well as define the roles and responsibilities of personnel, in order to provide timely and effective care to patients presenting with stroke symptoms. . .DEFINITIONS: 6. Stroke Alert is an alert that is paged out to initiate the emergent treatment of patients who present to the hospital with stroke symptoms. a. The signs/symptoms of stroke may include, but are not limited to: 1) Weakness and/or numbness on one side of the body. . .5) Sudden visual disturbance. . .9) Sudden, severe headache. . .PROCEDURE: 1. EMERGENCY DEPARTMENT (ED) STROKE ALERT ACTIVATION. . .b. A stroke alert will be called for patients presenting to the ED with acute onset of stroke symptoms and meet one of the following criteria. . .2) Their symptoms started less than 24 hours prior to their arrival. C. A stroke alert can be initiated by. . .ED provider, Charge RN, RN Navigator, or Triage RN. d. Activation occurs by ED staff dialing “77” announcing “Bakersfield Memorial” notifying the operator and reporting the location of the Stroke Alert. . .ROLES and RESPONSIBILITIES DURING STROKE ALERT. . .a) ED Triage RN 1) Triage nurse reviews symptoms of each patient presenting at ED triage entrance 2) If stroke is suspected, performs a VAN assessment and documents on Stoke VAN form (Appendix A) 3) If a patient meets criteria for stroke alert, the triage RN notifies ED charge nurse of stroke alert for prompt physician and nurse review.””

“ANESTHESIA SERVICES CFR(s): 482.52 If the hospital furnishes anesthesia services, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy. The service is responsible for all anesthesia administered in the hospital. This Condition is not met as evidenced by: 39650 Based on observation, interview, and record review the hospital failed to ensure anesthesia (medicines to prevent pain during surgery) services were provided in accordance with Department of Surgery Rules and Regulations [DSRR], and the American Society of Anesthesiologists (ASA) guidelines when: 1. Anesthesia providers (physicians or Certified Registered Nurse Anesthetist [CRNA-advanced practice registered nurse] who administer anesthesia) did not consistently remain in operating rooms (OR) to monitor patients who were under the effects of anesthesia for one of one patients (Patient 2). This failure had the potential for anesthesia providers to be unaware of rapid changes in patient status during anesthesia and the potential for a negative outcome. (Refer to A-1001) 2. The hospital did not appoint a qualified Medical Staff member to provide oversight of all anesthesia administered throughout the hospital. This failure resulted the quality of anesthesia care not being monitored, and the potential for a negative outcome. (Refer A-1001) 2. Anesthesiologists did not follow current professional practice guidelines by the American Society of Anesthesiologists (ASA) when the pre - anesthesia (administration of gases or drugs before surgical operations to lessen awareness and/or pain) evaluation for two of three patients (Patient 11, Patient 14) did not include assessment of heart and lungs. This failure had the potential to put patients at risk for harm or death.(Refer A-1003) The cumulative effect of these systemic problems had the potential to negatively impact the safety of patients undergoing medical procedures utilizing anesthesia services.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 40516 Based on intervention and record review, the hospital failed to follow its policy and procedure (P&P) titled, “Temperature and Humidity Control in Sensitive Areas” for five out of 36 Sensitive Areas (Operating Room [OR] Sterile Storage S, Neonatal Intensive Care Unit [NICU - area of the hospital where critically ill newborns receive care] 3, NICU 4, NICU 5, and Burn Intensive Care Unit [BICU - area of the hospital where critically ill patients suffering from burns receive care] equipment. This failure had the potential to negatively impact patient outcomes. Findings: During an interview on 7/22/24 at 10:28 a.m. with Director of Facilities (DOF- director of the department which ensures proper routine maintenance and repair of facility structures, systems and support areas to minimize downtime of facility/operations), DOF stated the hospital used an automated system to monitor temperature and humidity in certain rooms in the hospital. DOF stated the system allowed for remote assessment when any of the monitored rooms were out of the acceptable parameters. During a concurrent interview and record review on 7/22/24 at 1:10 p.m. with Quality Patient Safety Program Manager (QPSPM) 3, the hospital’s “Temp [temperature]/Humidity Compliance” logs, dated 7/5/24 to 7/18/24 were reviewed. The log indicated no compliance failures in this period. Requested “Temp/Humidity Compliance” logs (THCL) with last three failed readings. During a concurrent interview and record review on 7/22/24 with DOF, “Temp/Humidity Compliance” logs dated 4/23/24, 6/6/24, and 7/11/24 were reviewed. DOF stated the monitored rooms/areas had acceptable temperature and humidity ranges. The THCL dated 4/23/24 indicated “OR Sterile Storage S” had a temperature of 66.6 degrees F. The acceptable range for that room was listed as between 68 to 73 degrees F. A handwritten note at the bottom page of the log indicated a “lock box was installed.” DOF stated lock boxes were installed to prevent staff from adjusting the temperature on the thermostats in the affected areas. The THCL dated 6/6/24 indicated “NICU 3” had a relative humidity (RH- the amount of water vapor present in air expressed as a percentage) level of 62.8 %. The acceptable RH for that area was listed 30% to 60%. The THCL dated 6/6/24 indicated “NICU 4” had a RH level of 60.7 %. The acceptable RH for that area was listed 30% to 60%. The THCL dated 6/6/24 indicated “NICU 5” had a RH level of 61.2 %. The acceptable RH for that area was listed 30% to 60%. A handwritten note at the bottom page of the log indicated “Controls adjustment on AHU [air conditioning and heating unit] #2.” The THCL dated 7/11/24 indicated “BICU Equipment” had a temperature of 76.5 degrees F. The acceptable range for that room was listed as between 0 to 75 degrees F. A handwritten note at the bottom page of the log indicated “STAT relocated to correct problem. Requested work orders generated for failures and director of affected departments notification. During an interview on 7/23/24 at 2:52 p.m. with QPSPM 3. QPSPM 3 stated DOF was unable to find any requested workorders for THCL failures or director notifications. During a review of the hospital P&P titled, “”Temperature and Humidity Control in Sensitive Areas,” dated 1/26/22, the P&P indicated, “7. The building automation system can be used to monitor daily temperature and humidity levels in areas where the system is installed. . . b. If using building automation system: Facilities will monitor daily; any out of range values and corrective action will be as per policy below. . . 10. Preventative Maintenance (PM) Work Orders will be generated and documented by Facilities. . . In the event that the HVAC (heating, ventilation, and air conditioning) system fails, or any of the requirements are out of range, the following process is to occur: 2. When a reading of the building automation is found to be out of acceptable range, The [sic] Director of the affected area and the Director of Facilities or their designee(s) will be notified of the failure immediately. The notification, who was notified and the time, and the corrective action taken will be documented on the log in Facilities. . . The Infection Control Nurse will be notified by the director of the affected area(s) and given the identification of patients currently in the affected area(s) for follow-up.””

“ORGANIZATION OF ANESTHESIA SERVICES CFR(s): 482.52(a), (c) The organization of anesthesia services must be appropriate to the scope of the services offered. Anesthesia must be administered only by: (1) A qualified anesthesiologist; (2) A doctor of medicine or osteopathy (other than an anesthesiologist); (3) A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law; (4) A certified registered nurse anesthetist (CRNA), as defined in §410.69(b) of this chapter, who, unless exempted in accordance with paragraph (c) of this section, is under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed; or (5) An anesthesiologist’s assistant, as defined in Sec. 410.69(b) of this chapter, who is under the supervision of an anesthesiologist who is immediately available if needed. State Exemption (1) A hospital may be exempted from the requirement for MD/DO supervision of CRNAs as described in paragraph (a)(4) of this section, if the State in which the hospital is located submits a letter to CMS signed by the Governor, following consultation with the State’s Boards of Medicine and Nursing, requesting exemption from MD/DO supervision of CRNAs. The letter from the Governor must attest that he or she has consulted with State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State and has concluded that it is in the best interests of the State’s citizens to opt-out of the current MD/DO supervision requirement, and that the opt-out is consistent with State law. (2) The request for exemption and recognition of State laws, and the withdrawal of the request may be submitted at any time, and are effective upon submission. This Standard is not met as evidenced by: 40516 Based on interview and record review, the hospital failed to ensure Anesthesia (medicines to prevent pain during surgery) Services followed the Department of Surgery Rules and Regulations [DSRR], and the American Society of Anesthesiologists (ASA) guidelines when: 1. Anesthesia providers (physicians or Certified Registered Nurse Anesthetist [CRNA-advanced practice registered nurse] who administer anesthesia) did not consistently remain in operating rooms (OR) to monitor patients who were under the effects of anesthesia for one of one patients (Patient 2). This failure had the potential for anesthesia providers to be unaware of rapid changes in patient status during anesthesia and the potential for a negative outcome. 2. The hospital did not appoint a qualified Medical Staff member to provide oversight of all anesthesia administered throughout the hospital. This failure resulted the quality of anesthesia care not being monitored, and the potential for a negative outcome. Findings: 1. During an interview on 7/22/24 at 9:32 a.m. with Registered Nurse (RN) 3, RN 3 stated if the anesthesia provider left the OR during a surgery, while the patient was anesthetized, the anesthesia provider would ask the RN to stand by the anesthesia machine (monitors heart rate, blood pressure, oxygen levels, and contains equipment used to provide artificial breathing). RN 3 stated the nurse did not have to stand right next to the anesthesia machine but needed to be able to hear any alarms. RN 3 stated the anesthesia providers would leave the room to get intravenous (IV-through the vein) fluids or medications. During an interview on 7/22/24 at 2:08 p.m. with RN 4, RN 4 stated if anesthesia providers “step out” of the operating room, they would ask the nurse to watch the monitor. RN 4 stated most of the time, the provider left the OR to get medication from the automated drug dispensing (ADD) machine in the core (cleanest area in operating room department, used for sterile supply storage, only staff wearing appropriate surgical attire are allowed in the core). During an interview on 7/22/24 at 2:20 p.m. with Director of Perioperative Services (DPOS), DPOS stated the anesthesia providers follow the ASA guidelines. DPOS stated the anesthesia providers “should not” be leaving anesthetized patients in the operating rooms without another anesthesia provider present. During an interview on 7/23/24 at 12:38 p.m. with Anesthesiologist (Anesth) 3, Anesth 3 stated he was the “Director of Anesthesiology.” Anesth 3 stated anesthesia providers would sometimes leave the OR with a patient under anesthesia to get medication from the ADD in the core. 39650 During a concurrent interview and record review on 7/24/24, at 9:27 a.m. with RN 1 and DPOS, Patient 2’s “Perioperative Record [PR],” dated 5/14/24 was reviewed. The “PR” indicated, Procedure right total knee replacement. Case Attendees: Certified Registered Nurse Anesthetist [CRNA] 1 time in operating room 8:45 a.m., time out of operating room 10:34 a.m. Anesthesia Type Regional Block (pain management for surgery that numbs part of body) with Sedation (medication to cause sleepiness, and relaxation). RN 1 stated anesthesia providers left the operating rooms with anesthetized patients to get fluids and reversal medications (drugs used to reverse the effects of anesthetics). RN 1 stated he did not monitor the patient for the anesthesia provider because it was not his role as a nurse. RN 1 stated he was unable to recall if CRNA 1 left the room or if CRNA 2 entered and left the room during Patient 2’s procedure. RN 1 was unable to provide documentation which indicated CRNA 1 left the OR during Patient 2’s procedure or that CRNA 1 entered and left the operating room during Patient 2’s procedure. DPOS stated the anesthesia provider had no reason to leave the operating room to prepare for the next case. DPOS stated there were two teams to assist in setting up the rooms for each case. During a concurrent interview and record review on 7/24/24 at 10 a.m. with CRNA 1, Patient 2’s “Anesthesia Record (AR)” dated 5/14/24 was reviewed. The “AR” indicated. CRNA 1 was administering Propofol (highly lethal medication used as anesthesia) intravenous (IV, in the vein) infusion (method of continuously providing medication or fluids into the blood stream, requires close monitoring) to Patient 2. CRNA 1 stated he leaves the operating room, if the patient was stable, to obtain intravenous fluids or reversal medications. The “AR” indicated CRNA 2 provided a break for CRNA 1 from 9:37 a.m. until 9:56 a.m. CRNA 1 stated on 5/14/24 during Patient 2’s surgery, he left Patient 2’s room due to a personal issue and when he returned CRNA 2 was there. CRNA 1 stated he notified Anesth 3 but left before he was relieved by another anesthesia provider which left Patient 2 unmonitored. CRNA 1 was unable to provide documentation in Patient 2’s medical record that he notified Anesth 3. CRNA 1 stated current national standards for anesthesiologists indicate anesthesia providers are not leave the operating room during a procedure unless there was an emergency situation with another patient. During an interview on 7/29/24 at 12:18 p.m. with DPOS, DPOS stated anesthesia providers should not leave their patients in the operating room. DPOS stated it was not the role of the RN to monitor patients under anesthesia. DPOS stated if the anesthesia provider or RN needed an item during a surgery case, the RN was to call the supervisor or charge nurse to retrieve the item. During a review of the hospital’s “Department of Surgery Rules and Regulations [DSRR], dated 11/19/14, the DSRR indicated, “21. The anesthesiologist is not to leave the room in any case that requires anesthesia care. If the anesthesiologist leaves the room, the incident will be reported to the Chief of Service.” During a review of the American Society of Anesthesiologists Standards, Guidelines, and Statements, the Statements and Practice Parameters indicated: “STANDARD I: Qualified anesthesia personnel shall be present in the room throughout the conduct of all general anesthetics, regional anesthetics and monitored anesthesia care. 1.1 Objective -Because of the rapid changes in patient status during anesthesia, qualified anesthesia personnel shall be continuously present to monitor the patient and provide anesthesia care. In the event there is a direct known hazard, e.g., radiation, to the anesthesia personnel which might require intermittent remote observation of the patient, some provision for monitoring the patient must be made. In the event that an emergency requires the temporary absence of the person primarily responsible for the anesthetic, the best judgment of the anesthesiologist will be exercised in comparing the emergency with the anesthetized patient’s condition and in the selection of the person left responsible for the anesthetic during the temporary absence.” “STANDARD II: During all anesthetics, the patient’s oxygenation, ventilation (exchange of air and carbon dioxide [waste product]) and circulation (blood flow) shall be continually evaluated.” 2. Based on interview and record review on 7/29/24, at 3:25 p.m. with Anesth 4 and vice president chief operation officer (COO). The hospital’s “DSRR Department of Surgery Anesthesia Section” dated 6/2018, was reviewed. The DSRR anesthesia section indicated, “Structure and Qualifications A. The anesthesia service of [hospital name] shall be directed by a specialist in anesthesiology who is a member of the active medical staff. He/She shall be chairperson the Anesthesia Section of the Department of Surgery.” COO stated the Hospital’s Department of Surgery Rules and Regulations, Department of Surgery Anesthesia Section were outdated. COO stated the Anesthesia department did not have a section chair as a requirement in the current DSRR Anesthesia Section. COO stated the contracted anesthesia group had a Medical Staff member (Anesth 4) who acted as the Medical Director of anesthesia. Anesth 4 stated he was the Medical Director of the anesthesia services but only for the private contracted group of anesthesiologists and CRNAs. Anesth 4 stated he did not attend surgery supervisory committee. Anesth 4 stated he was not the chair of the anesthesia section and was not Medical Director of any other aspects of anesthesia provision in the hospital. During a review of the hospital’s “DSRR”, dated 11/19/14, the DSSR indicated, “DEPARTMENT CHAIR . . .XII SECTION CHIEF Each section shall have a chief who shall be a member of the Active Medical Staff and a member of the section which he or she is the head. . .XIII. SELECTION Each section chief shall be selected by the section in question.””

“PRE-ANESTHESIA EVALUATION CFR(s): 482.52(b)(1) [The policies must ensure that the following are provided for each patient:] A pre-anesthesia evaluation completed and documented by an individual qualified to administer anesthesia, as specified in paragraph (a) of this section, performed within 48 hours prior to surgery or a procedure requiring anesthesia services. This Standard is not met as evidenced by: 39650 During an observation, interview, and record review the facility failed to ensure the anesthesiologists (physicians or Certified Registered Nurse Anesthetist [CRNA-advanced practice registered nurse] who administer medication to prevent pain during surgery) followed current professional practice guidelines by the American Society of Anesthesiologists (ASA) when the preanesthesia evaluation for two of three patients (Patient 11, and Patient 14) did not include assessment of heart and lungs. This failure had the potential to put patients at risk for harm or death. Findings: During an observation on 7/22/24 at 8:40 a.m. in the preoperative (before surgical procedure) holding area, Anesthesiologist (Anesth) 2, conducted Patient 14’s preanesthesia (before anesthesia) evaluation. Anesth 2 did not listen to Patient 14’s lungs or heart. During an interview on 7/22/24 at 8:49 a.m. with Anesth 2, Anesth 2 stated he did not listen to Patient 14’s heart and lung sounds. Anesth 2 stated the surgeon completed the history and physical examination prior to surgery and he reviewed the surgeon’s findings and used the information for his preanesthesia evaluation. During concurrent interview and record review on 7/22/24 at 9:08 a.m. with Quality Program Specialist Program Manager (QPSPM) 2, Patient 14’s “Anesthesia Physician Note [APN]” dated 7/22/24 was reviewed. The “APN” indicated, “Preanesthesia Evaluation NEW. . . Pre Anesthesia Evaluation. . .Respiratory: Lungs are clear to auscultation (listen/hearing) Cardiovascular: Normal rate, Regular rhythm.” QPSPM verified Anesth 2 documented that he ausculatated Patient 14’s heart and lungs on the pre anesthesia evaluation. During a review of Patient 14’s “APN” dated 7/22/24, the “APN” indicated Preanesthesia Evaluation NEW. . .Active Problems included “diabetes, end stage renal [kidney] disease on hemodialysis [treatment to filter toxins from blood]. . .Tobacco Use: Former smoker. . .Quit 7 years ago. . .Assessment and Plan. . .Anesthetic technique: General anesthesia. During an observation on 7/22/24 at 1:28 p.m. in preoperative holding area, Anesth 1, conducted Patient 11’s pre anesthesia evaluation. Anesth 1 did not listen to Patient 11’s heart or lungs. During an interview on 7/22/24 at 1:30 p.m. with Anesth 1, Anesth 1 stated he did not listen to Patient 11’s heart or lungs. Anesth 1 stated a preanesthesia evaluation was a focused examination and did not require listening to the heart and lungs on every patient. Anesth 1 stated if the patient had medical concerns such as asthma he would listen to the patient’s lungs. During an interview on 7/22/24 at 8:49 a.m. with Anesth 3, Anesth 3 stated anesthesiologists were not required to listen to heart and lungs during the pre anesthesia evaluation. Anesth 3 stated the anesthesiologists were to look at the patient’s history and physical and other medical information during their evaluation. Anesth 3 stated if the anesthesiologist did not listen to the patient’s heart and lung sounds, the anesthesiologist should not document they listened to the patient’s heart and lung sounds. During a review Patient 11’s “APN” dated 7/24/24 was reviewed. The “APN” indicated, “General: Pre Anesthesia Evaluation. . .Physical Examination. . .Heart: Regular rate and rhythm Lungs: clear to auscultation. . .Anesthesia: General.” During a review of “Practice Advisory for Preanesthesia Evaluation An Updated Report by the American Society of Anesthesiologists Task Force on Preanesthesia Evaluation [preanesthesia report],” dated 2012 the “preanesthesia report” indicated, At a minimum, a focused preanesthesia physical examination should include an assessment of the airway, lungs, and heart, with documentation of vital signs.” During a review of American Society of Anesthesiologists “Statement on Documentation of Anesthesia Care, [ASA statement],” dated 10/18/23, the “ASA statement” indicated, “Accurate and thorough documentation is an essential element of high quality and safe medical care and accordingly a basic responsibility of physician anesthesiologists.””

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 39650 Based on interview and record review, the hospital failed to ensure one of one sampled Certified Physician Assistant (PA-C) 1 followed the hospital’s approved Policy and Procedure (P&P) titled, “Documentation, Corrections, Edit Functionality in the Electronic Health Record” for documenting the condition and care of 12 of 12 sampled patients (Patient 20, Patient 10, Patient 16, Patient 17, Patient 18, Patient 19, Patient 21, Patient 22, Patient 23, Patient 24, Patient 25 and Patient 26) at the time of care. This failure had the potential to affect patients’ continuity of care, due to incomplete, and inaccurate information for subsequent emergency department (ED) visits resulting in negative patient outcomes. Findings: During a concurrent interview and record review on 5/1/24 at 2:25 p.m. with Quality Patient Safety Program Manager (QPSPM) 1, Patient 20’s electronic medical records (EMR) were reviewed. Patient 5’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 20 arrived at the ED on 4/30/24 at 8:52 a.m. and discharged on 4/30/24. Patient 20’s “Orders” dated 4/30/24 were reviewed. The “Orders” indicated PA-C 1 entered discharge orders on 4/30/24 at 11:53 a.m. Patient 20’s “ED check out” dated 4/30/24 was reviewed. The “ED check out” indicated Order start Date/Time 4/30/24 12:20 p.m. QMPS was unable to provide documentation by a health care provider for Patient 20’s 4/30/24 ED encounter. QPMS stated, the PA-C 1 was the health care provider for Patient 20’s ED visit on 4/30/24 and PA-C 1 should have documented the care provided in the EMR. Patient 10’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 10 arrived at the ED on 4/30/24 at 8:13 a.m. and discharged on 4/30/24 at 10:59 a.m. Patient 10’s “EDN” dated 4/30/24 (date of ED visit) was reviewed. The EDN indicated Patient 10’s chief complaint was cough, congestion, and fever which started “yesterday 4/30/24 8:30 a.m.” The EDN indicated PA-C 1 documented Patient 10’s patient’s condition and the care provided during the 4/30/24 ED encounter on 5/1/24 at 4:13 p.m. (29 hours 14 minutes after discharge) Patient 16’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 16 arrived at the ED on 4/30/24 at 8:06 a.m. and discharged on 4/30/24 at 10:58 a.m. Patient 16’s “EDN” dated 4/30/24 (date of ED visit) was reviewed. The EDN indicated Patient 16’s chief complaint was cough, pulling at ears, wheezing. The EDN indicated PA-C 1 documented Patient 16’s patient’s condition and the care provided during the 4/30/24 ED encounter on 5/1/24 at 4:07 p.m. (29 hours 8 minutes after discharge) Patient 17’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 17 arrived at the ED on 4/30/24 at 8:22 a.m. and discharged on 4/30/24 at 11:18 a.m. Patient 17’s “EDN” dated 4/30/24 (date of ED visit) was reviewed. The EDN indicated Patient 17’s chief complaint was shortness of breath. The EDN indicated PA-C 1 documented Patient 17’s patient’s condition and the care provided during the 4/30/24 ED encounter on 5/1/24 at 4:17 p.m. (28 hours 59 minutes after discharge) Patient 18’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 18 arrived at the ED on 4/30/24 at 8:24 a.m. and discharged on 4/30/24. Patient 18’s “Orders” dated 4/30/24 were reviewed. Patient 18’s orders indicated, “ED check out” 4/30/24 9:24 a.m. Patient 18’s “EDN” dated 4/30/24 (date of ED visit) was reviewed. The EDN indicated Patient 18’s chief complaint indicated Patient 18 came to the ED for scalp suture removal. The EDN indicated PA-C 1 documented Patient 18’s patient’s condition and the care provided during the 4/30/24 ED encounter on 5/1/24 at 4:05 p.m. (30 hours 41 minutes after discharge) During an interview with on 5/2/24 at 10:15 a.m. with PA-C 1 and Medical Director of Emergency Services (MDEDS), MDEDS, stated all patient seen in the ED should have, at the minimum, the medical screening examination (MSE - assessment to determine if the individual has an Emergency Medical Condition) documented in “real time” by the health care provider. MDEDS stated “something” should be entered into the patient’s EMR to provide information as to what happened during the visit, the care given, the plan, in the event the patient returns for care before the medical provider has documented the prior visit. MDEDS stated it is not a “best practice” to take up to 48 hours to document in the EMR. During a concurrent interview and record review on 5/2/24 at 10:30 a.m. with QPSPM 1 the following patient’s electronic medical records (EMR) were reviewed. Patient 19’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 19 arrived at the ED on 4/30/24 at 8:27 a.m. and discharged on 4/30/24 at 10:24 a.m. Patient 19’s “EDN” dated 4/30/24 (date of ED visit) was reviewed. The EDN indicated Patient 19’s chief complaint was left eye pain. The EDN indicated PA-C 1 documented Patient 19’s patient’s condition and the care provided during the 4/30/24 ED encounter on 5/1/24 at 4:05 p.m. (29 hours 41 minutes after discharge) Patient 20’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 20 arrived at the ED on 4/30/24 at 8:52 a.m. and discharged on 4/30/24 at 12:21 p.m. Patient 20’s “EDN” dated 4/30/24 (date of ED visit) was reviewed. The EDN indicated Patient 20’s chief complaint was abdominal pain. The EDN indicated PA-C 1 documented Patient 20’s patient’s condition and the care provided during the 4/30/24 ED encounter on 5/1/24 at 4:44 p.m. (28 hours 13 minutes after discharge) Patient 21’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 21 arrived to the 4/30/24 at 9:44 a.m. and discharged on 4/30/24 at 12:10 p.m. Patient 21’s “EDN” dated 4/30/24 (date of ED visit) was reviewed. The EDN indicated Patient 21’s chief complaint was cough, shortness of breath and asthma (lung condition which causes difficulty breathing). The EDN indicated PA-C 1 documented Patient 21’s patient’s condition and the care provided during the 4/30/24 ED encounter on 5/1/24 at 5:05 p.m. (28 hours 59 minutes after discharge) Patient 22’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 22 arrived at the ED on 4/30/24 at 10:21 a.m. and discharged on 4/30/24. Patient 22’s “Orders” dated 4/30/24 were reviewed. Patient 22’s orders indicated, “ED check out” 4/30/24 3:22 p.m. Patient 22’s “EDN” dated 4/30/24 (date of ED visit) was reviewed. The EDN indicated Patient 22’s chief complaint was epigastric pain. The EDN indicated PA-C 1 documented Patient 22’s patient’s condition and the care provided during the 4/30/24 ED encounter on 5/1/24 at 5:09 p.m. (25 hours 47 minutes after discharge) Patient 23’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 23 arrived at the ED on 4/30/24 at 11:33 a.m. and discharged on 4/30/24. Patient 23’s “Orders” dated 4/30/24 were reviewed. Patient 23’s orders indicated, “ED check out” 4/30/24 3:01 p.m. Patient 23’s “EDN” dated 4/30/24 (date of ED visit) was reviewed. The EDN indicated Patient 23’s chief complaint was back pain. The EDN indicated PA-C 1 documented Patient 23’s patient’s condition and the care provided during the 4/30/24 ED encounter on 5/1/24 at 5:07 p.m. (27 hours after discharge) Patient 24’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 24 arrived at the ED on 4/30/24 at 12:19 p.m. and discharged on 4/30/24. Patient 24’s “Orders” dated 4/30/24 were reviewed. Patient 24’s orders indicated, “ED check out” 4/30/24 4:24 p.m. Patient 24’s “EDN” dated 4/30/24 (date of ED visit) was reviewed. The EDN indicated Patient 24’s chief complaint was nausea and vomiting. The EDN indicated PA-C 1 documented Patient 24’s patient’s condition and the care provided during the 4/30/24 ED encounter on 5/1/24 at 5:07 p.m. (24 hours after discharge) Patient 25’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 25 arrived at the ED on 4/30/24 at 12:40 p.m. and discharged on 4/30/24. Patient 25’s “Orders” dated 4/30/24 were reviewed. Patient 25’s orders indicated, “ED check out” 4/30/24 3:28 p.m. Patient 25’s “EDN” dated 4/30/24 (date of ED visit) was reviewed. The EDN indicated Patient 25’s chief complaint was fever. The EDN indicated PA-C 1 documented Patient 25’s patient’s condition and the care provided during the 4/30/24 ED encounter on 5/1/24 at 5:03 p.m. Patient 26’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 26 arrived at the ED on 4/30/24 at 12:42 p.m. and discharged on 4/30/24. Patient 26’s “Orders” dated 4/30/24 were reviewed. Patient 26’s orders indicated, “ED check out” 4/30/24 3:36 p.m. Patient 26’s “EDN” dated 4/30/24 (date of ED visit) was reviewed. The EDN indicated Patient 26’s chief complaint was vomiting and diarrhea. The EDN indicated PA-C 1 documented Patient 26’s patient’s condition and the care provided during the 4/30/24 ED encounter on 5/1/24 at 7:28 p.m. (almost 28 hours after discharge) During a review of the facility’s “Rules and Regulations of the Medical Staff [R&R],” dated 12/2023, the R&R indicated, “The attending physician shall maintain the primary responsibility for the discharge of the patient. At the time of discharge, the attending physician shall see that the record is complete, state his final diagnosis and sign the record.” During a review of the facility’s Policy and Procedures (P&P) titled, “Documentation, Corrections, Edit Functionality in the Electronic Health Record,” dated 8/8/23, the P&P indicated, “PURPOSE The purpose of this Standard is to establish parameters. . .and to address the accuracy, timeliness and correction of documentation errors. . .STANDARD. . .The health record shall. . .facilitate the continuity of patient care. Documentation must be accurate, timely, objective, and concise.”

“PROTECTING PATIENT RECORDS CFR(s): 482.24(b)(3) The hospital must have a procedure for ensuring the confidentiality of patient records. Information from or copies of records may be released only to authorized individuals, and the hospital must ensure that unauthorized individuals cannot gain access to or alter patient records. Original medical records must be released by the hospital only in accordance with Federal or State laws, court orders, or subpoenas. This Standard is not met as evidenced by: 39650 Based on interview and record review, the hospital failed to one of one sampled Certified Physician Assistant (PA-C) 1 protected and ensured the confidentiality for 12 of 12 sampled patient’s (Patient 20, Patient 10, Patient 16, Patient 17, Patient 18, Patient 19, Patient 21, Patient 22, Patient 23, Patient 24, Patient 25 and Patient 26) protected healthcare information (PHI). This failure had to potential for loss of patients’ medical records and unauthorized access to Patients protected healthcare information (PHI). Findings: During a concurrent interview and record review on 5/1/24 at 2:25 p.m. with Quality Patient Safety Program Manager (QPSPM) 1, Patient 20’s electronic medical records (EMR) were reviewed. Patient 5’s registration document (RD) dated 4/30/24 was reviewed. The RD indicated Patient 20 arrived at the ED on 4/30/24 at 8:52 a.m. and discharged on 4/30/24. Patient 20’s “Orders” dated 4/30/24 were reviewed. The “Orders” indicated PA-C 1 entered discharge orders on 4/30/24 at 11:53 a.m. Patient 20’s “ED check out” dated 4/30/24 was reviewed. The “ED check out” indicated Order start Date/Time 4/30/24 12:20 p.m. QMPS was unable to provide documentation by a health care provider for Patient 20’s 4/30/24 ED encounter. QPMS stated, the PA-C 1 was the health care provider for Patient 20’s ED visit on 4/30/24 and PA-C 1 should have documented the care provided in the EMR. During a concurrent interview and record review on 5/1/24 at 2:50 p.m. with Quality Patient Safety and Program Manager (QPSPM) and Physician Assistant - Certified (PA-C) 1. Patient 20’s electronic medical record (EMR) was reviewed. PA-C 1 was unable to provide documentation by a medical provider in Patient 20’s emergency room (ED) EMR on 4/30/24. PA-C 1 stated she did not document any provider notes in the EMR regarding Patient 20’s ED visit on 4/30/24. PA-C 1 stated she kept handwritten notes in her pocket on all the patients she saw during her shift on 4/30/24. PA-C 1 stated she took the handwritten papers home, with PHI, from most patient’s ED encounters, and would refer to the notes when she documented in the patients’ EMR as a late entry (documentation within the health record entered after the point of care). During an interview with on 5/2/24 at 9:25 a.m. with PA-C 1 and Medical Director of Emergency services (MDEDS), PA-C 1 stated she wrote notes on each patient on a “sheet of computer paper” during her 4/30/24 ED shift. PA-C 1 stated the Patient’s name, chief complaint, care provided, physical examination and other pertinent information from the ED visit was written on the paper. PA-C 1 stated the papers with the patient PHI were placed in her backpack and taken home. PA-C 1 stated the only other person in the home is PA-C 1’s significant other. PA-C 1 stated she did not know or ask what the process was to transport and store PHI. During a review of the facility’s Policy and Procedures (P&P) titled, “Privacy Safeguards for Protected Health Information,” dated 6/1/21, the P&P indicated, “Examples of appropriate Privacy Rule safeguards for PHI [Protected Health information] include (but not limited to) the following: Access and Storage Maintain paper PHI in areas that are not accessible to unauthorized individuals. This includes securing paper PHI in locked cabinets, bins, etc., and ensuring physical access to rooms containing cabinets, bins, etc., is restricted from the general public. During a review of the facility’s “Rules and Regulations of the Medical Staff [R&R],” dated 12/2023, the R&R indicated, All records are the property of the hospital and shall not be removed from the hospital except upon a court order, subpoena, or statute. In case of readmission of a patient, all previous records shall be available for the use of the attending physician.”

“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: 40516 The facility failed to meet the regulatory requirements for the Condition of Participation: §CFR 482.23 Nursing Services as evidenced by the following: Based on interview and record review the hospital failed to ensure nursing staff followed its Policies and Procedures (P&P) titled “Emergency Standardized Procedures [legal mechanism for registered nurses [RN] to perform functions which would otherwise be considered the practice of medicine]” and “Informed Consent [process in which a medical doctor (MD) educates a patient about the risks, benefits and alternatives to a procedure]” for two of four sampled patients (Patient 1 and Patient 24) when: 1. Based on interview and record review the hospital failed to ensure eight of 12 sampled Emergency Department (ED) registered nurses (RN) (RN 1, RN 3, RN 4, RN 5, RN 6, RN 7, RN 8, and RN 9) completed Critical Test Results (CTR - abnormal laboratory [lab] values that are outside the normal range to a degree that may constitute an immediate health risk to the individual or require immediate action on the part of the ordering physician) education. (Refer to A 397) 2. Follow its “Emergency Standardized Procedures [legal mechanism for RN to perform functions which would otherwise be considered the practice of medicine]” and “Informed Consent” policy and procedure (P&P) when: a. RN 12 had conflicting triage assessment documentation for Patient 1. b. Physician 4 documented Patient 1 had oral (PO) intake and adequate output but there was no order for PO intake and no documentation of Patient 1 having intake or output. c. RN 13 gave Tylenol but did not obtain a physician’s signature for the order. d. The risks, benefits, and alternatives (RBAs) to a procedure were not documented by a physician for one of one sampled patient (Patient 24) prior to Patient 24 undergoing an invasive procedure. (Refer to A 398). The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure nursing services were provided in a safe manner, patient care needs were being met, and contributed to Patient 2’s diagnosis of bacterial meningitis with a poor prognosis for meaningful recovery and discharged to hospice (specialized care for people near the end of life) care.”

“EMERGENCY SERVICES CFR(s): 482.55 The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. This Condition is not met as evidenced by: 40516 The facility failed to meet the regulatory requirements for the Condition of Participation: §CFR 482.55 Emergency Services as evidenced by the following: Based on interview and record review, the hospital failed to ensure the safety of patients in accordance with the policy and procedures and with the regulations as evidenced by: 1. Critical Test Results (CTR- abnormal laboratory [lab] values that may cause an immediate health risk to the patient or require immediate action by a physician) for Patient 2 (7-week old male infant) were not reported to a physician within one hour. (Refer to A 1112) 2. Patient 2’s CTR was never reported to the ordering physician (Physician 1) by the hospital. (A 1112) 3. Emergency Department (ED) Registered Nurses (RN) did not document receiving CTRs from lab staff for six of ten sampled patients (Patient 2, Patient 24, Patient 25, Patient 26, Patient 27, and Patient 20). (Refer to A 1112) These failures resulted in Patient 2’s positive blood culture (test that looks for germs in the blood) for Escherichia coli (E. coli- bacteria typically found in the intestines) progressing from bacteria in the blood to meningitis (infection and swelling of the fluid and membranes surrounding the brain and spinal cord) requiring transfer to a children’s hospital in another county for a higher level of care with a poor prognosis (likely outcome or course of a disease; the chance of recovery or recurrence) for recovery and discharge under hospice (specialized care for people near the end of life) care, for CTRs to not be reported timely to a physician, and incomplete medical records for Patient 2, Patient 24, Patient 25, Patient 26, Patient 27, and Patient 20. The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure emergency services were provided in a safe manner, patient care need were being met, and for Patient 2’s discharge from a higher level of care hospital under hospice care.”

“PATIENT CARE ASSIGNMENTS CFR(s): 482.23(b)(5) A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient’s needs and the specialized qualifications and competence of the nursing staff available. This Standard is not met as evidenced by: 40516 Based on interview and record review the hospital failed to ensure eight of 12 sampled Emergency Department (ED) registered nurses (RN) (RN 1, RN 3, RN 4, RN 5, RN 6, RN 7, RN 8, and RN 9) completed Critical Test Results (CTR - abnormal laboratory [lab] values that are outside the normal range to a degree that may constitute an immediate health risk to the individual or require immediate action on the part of the ordering physician) education. This failure resulted in CTR not being communicated to a physician and for Patient 2’s positive blood culture (test that looks for germs in the blood) for Escherichia coli (E. coli- bacteria typically found in the intestines) progressing from bacteria in the blood to meningitis (infection and swelling of the fluid and membranes surrounding the brain and spinal cord), which required transfer to a children’s hospital in another county for a higher level of care, with a poor prognosis for recovery and discharged under hospice (specialized care for people near the end of life) care and had the potential for CTRs to not be communicated timely to a physician. Findings: During an interview on with Clinical Lab Scientist (CLS, performs scientific testing on samples and reports results to physicians) 1 on 3/5/24 at 11:37 a.m. CLS 1 stated she confirmed prior interview and record review findings on 1/22/24 at 10:31 a.m. when she stated the lab’s blood culture “machine” alarmed on 12/19/24 and indicated Patient 2’s blood culture had abnormal bacterial growth. CLS 1 stated when she printed Patient 2’s information from the machine, the printout indicated Patient 2 had been in the hospital’s ED but was no longer there. CLS 1 stated the hospital’s process when a patient had already been discharged home from the ED, the ED charge nurse was given the CTR. During a review of Patient 2’s “Microbiology Result Details [MRD]” dated 12/19/23 at 11:47 a.m. the MRD indicated, “Gram Negative Rods [type of bacteria] . . . Phoned to [RN 1]. During an interview on 3/4/24 at 11:39 a.m. with RN 1, RN 1 stated she received the CTR for Patient 2 on 12/19/23. RN 1 stated for blood culture CTRs she typically waits until around “5 p.m.” to make calls to physicians to report findings, unless she had time earlier. RN 1 stated she realized Patient 2 had not been in the ED and she called the lab back to let them know. RN 1 stated when she called the lab, she was told the staff who reported the CTR to her earlier in the day was already gone and to call back the next day. RN 1 stated she did not document the conversation. RN 1 stated she did work the next day but never called the lab back. RN 1 stated blood culture CTR should be communicated to a physician within “one to two hours” like all other CTRs. RN 1 stated she never reported the CTR to a physician. During a concurrent interview and record review on 3/4/24 at 12:14 p.m. with Quality Manager (QM), Patient 2’s medical record was reviewed. QM stated there was no documentation of RN 1 notifying a physician of Patient 2’s CTR. During an interview on 3/5/24 at 9:38 a.m. with Quality Director (QD), QD stated no Critical Test Results education was found for RN 1 or RN 3. During an interview on 3/5/24 at 10:51 a.m. with Emergency Department Director of Nursing (EDDN), EDDN stated CTR education was done upon hire. During a concurrent interview and record review on 3/7/24 at 12:55 p.m. with Director of Education (DE), DE reviewed education records for ED RNs. DE stated many ED RNs whose date of hire was prior to 2016 had no recorded CTR education. During an interview on 3/7/24 at 1:38 p.m. with DE, DE stated RN 4, RN 5, RN 6, RN 7, RN 8, and RN 9 had no recorded CTR education. During a review of the hospital’s P&P titled, “Critical Test Results and Test Result Reporting” dated 10/25/23. The P&P indicated, “Purpose: It is the policy of the laboratory, nursing, cardiovascular services, and imaging departments to report results of critical tests and critical test results to patient caregivers accurately and timely. This policy outlines the conditions under which critical test results are communicated. Guidelines/Policy Statement: Staff will receive orientation to this process and are responsible for following [the P&P].””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 40516 Based on interview and record review the hospital failed to ensure nursing staff followed its Policies and Procedures (P&P) titled “Emergency Standardized Procedures [legal mechanism for registered nurses [RN] to perform functions which would otherwise be considered the practice of medicine]” and “Informed Consent [process in which a medical doctor (MD) educates a patient about the risks, benefits and alternatives to a procedure]” for two of four sampled patients (Patient 1 and Patient 24) when: 1. RN 12 documented conflicting triage assessment for Patient 1. This failure resulted in an inaccurate medical (triage) record. 2. Physician 4 documented Patient 1 had oral (PO) intake and adequate output but there was no order for PO intake and no documentation of Patient 1 having intake or output. These failures had the potential to negatively impact patients’ care and outcome. 3. RN 13 gave Patient 1 Tylenol but did not obtain a physician’s signature for the order. This failure resulted in an inaccurate medical record. 4. Physician failed to document the risks, benefits and alternatives (RBAs) prior to one of one sampled patient (Patient 24) undergoing an invasive procedure. This failure resulted in Patient 24 and Family Member being unaware of risks, benefits and alternatives to the procedure and unable to make a fully informed consent. Findings: 1. During an interview on 1/22/24 at 8:46 a.m. with Family Member (FM) 1, FM 1 stated she went to Hospital 1 by ambulance with Patient 1 (10-month-old female) because Patient 1 had fever, “rash over her entire body”, and was not feeding well. FM 1 stated she felt not much was done by the ED staff. FM 1 stated Physician 4 talked to her [FM 1] “like I was stupid.” FM 1 stated Physician 4 told her, “It’s a virus. I see it all the time. Let her sleep it off.” FM 1 stated after several hours in Hospital 1’s ED, Patient 1 was discharged home. FM 1 stated she felt something was wrong with Patient 1 so she and her husband drove Patient 1 straight from Hospital 1 to Hospital 2’s ED. During a review of Patient 1’s Hospital 1 “ED [Emergency Department] Triage” (EDT), dated 12/29/23 at 9:13 a.m. the EDT indicated RN 12 documented, “Chief Complaint ED: Rash, fever. . . Vomiting X 1 [one time]. . . Arrives with generalized red rash. . . Rash of unknown origin: NO.” The EDT indicated on 12/29/23 at 9:19 a.m. RN 13 documented, “Diagnoses (Active). . . Rash. . . Skin Assessment Skin Integrity Intact (ED): Rash, Other generalized rash.” The “ED Physician Notes” (EDPN), dated 12/29/24 indicated, “[Patient 1 ] has a rash on torso [trunk of body] and face.” During a concurrent interview and record review on 3/4/24 at 9:14 a.m. with Physician 4, Patient 1’s ED Physician Notes (EDPN), dated 12/29/24 indicated, “[Patient 1 ] has a rash on torso [trunk of body] and face.” Physician 4 stated he did not remember Patient 1 and could not comment on the conflicting documentation.” 2. During an interview on 3/6/24 at 6:59 a.m. with RN 12, RN 12 stated patients in the emergency department are typically not fed. RN 12 stated if a “PO trial [feeding a patient to determine if the feeding does not cause diarrhea or vomiting]” would require a “verbal order [VO- an order stated to a nurse by a physician].” RN 12 stated “I don’t know” if a VO is placed in the computer by the nurse or ordering physician. RN 12 stated she would only document input and output (I&O - method of documenting what a patient consumes by mouth, feeding tube, or intravenously and what is eliminated through urination, bowel movement, or vomiting) if it was “pertinent” to why the patient was in the ED. RN 12 did not respond when asked if fever and vomiting were pertinent to documenting I&O. RN 12 stated, “We do not document every wet and poopy diaper.” During an interview on 3/6/24 at 9:27 a.m. with Quality Manager (QM), QM stated there was no documented I&O for Patient 1. During an interview on 3/6/24 at 10 a.m. with QM and Director of Nursing Med/Surg Tele (DNMT), QM and DNMT both stated a physician’s order would be required for a “PO trial.” QM and DNMT stated there was no order for a PO trial for Patient 1. During an interview on 3/6/24 at 10:45 a.m. with RN 13, RN 13 stated a PO trial would require a physician to place an order or give a verbal order. RN 13 stated the order would indicate what type of food or liquid and how much to give. RN 13 stated once she got a PO trial order, she would document what time the PO trial started, what and how much was given, how the patient tolerated the feeding, and report the intake to the physician. RN 13 stated she would also document the output. RN 13 stated PO trials are usually liquids, graham crackers, or applesauce.” During an interview on 3/6/24 at 11:03 a.m. with Emergency Department Director of Nursing (EDDN) and Nurse Manager Emergency Department (NMED), NMED stated intake and output documentation should be done in the ED. EDDN stated at the very least an event note should be entered to document what and how much was given to the patient and how it was tolerated. EDDN stated a physician order is needed for PO trial. During a review of Patient 1’s “Emergency Documentation - MD” (EDMD), dated 12/29/23 at 2:32 p.m. the EDMD indicated, “Upon recheck, the patient was able to eat and drink. She is making normal amounts of wet diapers so unlikely to be dehydration.” 3. During a concurrent interview and record review on 3/7/24 at 9:08 a.m. with DNMT, Patient 1’s medical record was reviewed. The “Order Information” (OI) dated 12/29/23 at 2:56 p.m. indicated Patient 1 was given Tylenol 145.95 milligrams (mg) by mouth by RN 13. The OI indicated RN 13 entered the order electronically with an order entry of “No co-signature required.” DNMT stated the order was not signed by a physician. During a review of the hospital’s policy and procedure (P&P) titled, “Emergency Standardized Procedures” dated 4/11/23, the P&P indicated, “This policy provides guidance, in alignment with the guideline set by the Board of Registered Nursing article 7; by which a Registered Nurse (RN) can implement laboratory and/or radiological studies as well as provide the patient with pain and/or fever alleviating medication. . . 2. Scope and Setting of Practice a. Competent emergency department triage RNs may perform the following functions within their training specialty area and consistent with their experience and credentialing: triage assessment, assessment of acute illness and acute on[set] chronic illness (including but not limited to ordering laboratory procedures, x-rays, and medications when indicated). . . Procedure: The utilization of Emergency Standardized Procedures is a five-step process as follows. . . 4. The order will be placed in the EHR [medical record] as “co-signature required” with the signature being required by the MD on duty.” During a review of the hospital’s P&P titled, “Documentation by Nursing Personnel,” dated 12/1/17, the P&P indicated, “6. Nursing Progress Notes/Event Notes a. Entries will accurately reflect an issue or incident with the patient or patient’s care. B. Pertinent and concise entries that reflect the problem statement, the patient’s needs, problems, capabilities, and limitations, as well as the patient’s response to nursing interventions, will be recorded.” 4. During a concurrent interview and record review on 3/7/24 with Director of Nursing Med/Surg Tele (DNMT), Patient 24’s “Progress Note” (PN), dated 1/3/24 at 7:28 p.m. the PN indicated a lumbar puncture (LP- also known as a spinal tap, a medical procedure where a needle is inserted into the spinal canal, most commonly to collect cerebrospinal fluid [CSF - protective fluid for brain and spinal cord] for diagnostic testing). DNMT stated the was no documented “risks versus benefits language” for the LP in Patient 24’s medial record. During a review of the hospital’s policy and procedure (P&P) titled, “Informed Consent” dated 4/4/22, the P&P indicated, “a. Process by Which the Physician Informs the Patient. . . it is the expectation that the physician shall give a personal explanation of the nature of the operation of procedure, the expected benefits or effects of the operation or procedure, a description of any attendant discomfort, complications, or risks to the patient that may occur, a description of any alternative methods of treatment, including the nature of such treatments, their expected benefits or effects, and their possible risks and complications, the likelihood of achieving care, treatment, and service goals with procedure verse [sic] alternative.” During a review of the American Medical Association (AMA) Code of Medical Ethics, The Code of Ethics indicated 1.1.3 Patient Rights ...Physicians can best contribute to a mutually respectful alliance with patients by serving as their patients’ advocates and by respecting patients’ rights These include the right: ...(b) To receive information from their physicians and to have the opportunity to discuss the benefits, risks and cost of appropriate treatment alternatives, including the risks, benefits and costs of foregoing treatment. ...(c) To ask questions about their health status or recommended treatment when they do not fully understand what has been described and to have their questions answered (d) to make decisions about the care the physician recommends ...(g) To obtain a second opinion ...AMA Principles of Medical Ethics: I, IV, V, VIII, IX) During a review of the hospital’s P&P titled, “Universal Protocol Procedure,” dated 1/26/22, the P&P indicated, “5. Pre-operative Unit - Procedure Verification. . . c. Documentation will be compared to confirm patient identified procedure and site matches. . . iii. LIP [Licensed Independent Practitioner - medical provider] documentation of informed consent (Risks, Benefits, and Alternatives.””

“POTENTIALLY INFECTIOUS BLOOD/BLOOD PRODUCTS CFR(s): 482.27(b) Standard: Potentially infectious blood and blood products. (1) Potentially human immunodeficiency virus (HIV) infectious blood and blood components. Potentially HIV infectious blood and blood components are prior collections from a donor - (i) Who tested negative at the time of donation but tests reactive for evidence of HIV infection on a later donation; (ii) Who tests positive on the supplemental (additional, more specific) test or other follow-up testing required by FDA; and (iii) For whom the timing of seroconversion cannot be precisely estimated. (2) Potentially hepatitis C virus (HCV) infectious blood and blood components. Potentially HCV infectious blood and blood components are the blood and blood components identified in 21 CFR 610.47. (3) Services furnished by an outside blood collecting establishment. If a hospital regularly uses the services of an outside blood collecting establishment, it must have an agreement with the blood collecting establishment that governs the procurement, transfer, and availability of blood and blood components. The agreement must require that the blood collecting establishment notify the hospital -- (i) Within 3 calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection; (ii) Within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by FDA; (iii) Within 3 calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor, whenever records are available, as set forth at 21 CFR 610.48(b)(3). (4) Quarantine of blood and blood components pending completion of testing. If the blood collecting establishment (either internal or under an agreement) notifies the hospital of the reactive HIV or HCV screening test results, the hospital must determine the disposition of the blood or blood component and quarantine all blood and blood components from previous donations in inventory. (i) If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is negative, absent other informative test results, the hospital may release the blood and blood components from quarantine. (ii) If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is positive, the hospital must - (A) Dispose of the blood and blood components; and (B) Notify the transfusion recipients as set forth in paragraph (b)(6) of this section. (iii) If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is indeterminate, the hospital must destroy or label prior collections of blood or blood components held in quarantine as set fors at 21 CFR 610.46(b)(2), 610.47(b)(2), and 610.48(c)(2). (5) Recordkeeping by the hospital. The hospital must maintain -- (i) Records of the source and disposition of all units of blood and blood components for at least 10 years from the date of disposition in a manner that permits prompt retrieval; and (ii) A fully funded plan to transfer these records to another hospital or other entity if such hospital ceases operation for any reason. (6) Patient notification. If the hospital has administered potentially HIV or HCV infectious blood or blood components (either directly through its own blood collecting establishment or under an agreement) or released such blood or blood components to another entity or appropriate individual, the hospital must take the following actions: (i) Make reasonable attempts to notify the patient, or to notify the attending physician who ordered the blood or blood component and ask the physician to notify the patient, or other individual as permitted under paragraph (b)(10) of this section, that potentially HIV or HCV infectious blood or blood components were transfused to the patient and that there may be a need for HIV or HCV testing and counseling. (ii) If the physician is unavailable or declines to make the notification, make reasonable attempts to give this notification to the patient, legal guardian or relative. (iii) Document in the patient’s medical record the notification or attempts to give the required notification. (7) Time frame for notification. For donors tested on or after February 20, 2008. For notifications resulting from donors tested on or after February 20, 2008 as set forth at 21 CFR 610.46 and 21 CFR 610.47 the notification effort begins when the blood collecting establishment notifies the hospital that it received potentially HIV or HCV infectious blood and blood components. The hospital must make reasonable attempts to give notification over a period of 12 weeks unless (i) The patient is located and notified; or (ii) The hospital is unable to locate the patient and documents in the patient’s medical record the extenuating circumstances beyond the hospital’s control that caused the notification timeframe to exceed 12 weeks. (8) Content of notification. The notification must include the following information: (i) A basic explanation of the need for HIV or HCV testing and counseling. (ii) Enough oral or written information so that an informed decision can be made about whether to obtain HIV or HCV testing and counseling. (iii) A list of programs or places where the person can obtain HIV or HCV testing and counseling, including any requirements or restrictions the program may impose. (9) Policies and procedures. The hospital must establish policies and procedures for notification and documentation that conform to Federal, State, and local laws, including requirements for the confidentiality of medical records and other patient information. (10) Notification to legal representative or relative. If the patient has been adjudged incompetent by a State court, the physician or hospital must notify a legal representative designated in accordance with State law. If the patient is competent, but State law permits a legal representative or relative to receive the information on the patient’s behalf, the physician or hospital must notify the patient or his or her legal representative or relative. For possible HIV infectious transfusion recipients that are deceased, the physician or hospital must inform the deceased patient’s legal representative or relative. If the patient is a minor, the parents or legal guardian must be notified. This Standard is not met as evidenced by: 39650 Based on interview and record review, the facility failed to develop and fund a plan to ensure the transfer and storage of all units of blood and blood component records (over the past 10 years) in the event of facility ceases to operate. This failure had the potential for newly identified infectious blood or blood component information to not be provided to blood recipients thereby putting the all patients who received blood or blood components at risk for possible transmissible blood borne illness, disease, or death. Findings: During a concurrent interview and record review on 3/7/24 at 2:20 p.m. with Director of Quality (DOQ), The facility’s “Business Continuity Plan, Continuity of Operations Plan,” dated 1/2/24 and “Affiliation Agreement [AA],” dated 12/1/1995 were reviewed. DOQ stated she would not provide the surveyor a copy of the facility’s “AA.” DOQ was unable to provide documentation of a fully funded plan for storage of all the facility’s blood and blood component records (over the past 10 years) in the event of facility ceases to operate for any reason.”

“QUALIFIED EMERGENCY SERVICES PERSONNEL CFR(s): 482.55(b)(2) There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility. This Standard is not met as evidenced by: 40516 Based on interview and record the Hospital failed to follow its policy and procedure titled, “Critical Test Results and Test Result Reporting” when: 1. Critical Test Results (CTR - abnormal laboratory [lab] values that are outside the normal range to a degree that may signify an immediate health risk to the individual or require immediate action on the part of the ordering physician) for one of 16 sampled patients (Patient 2- a 7-week-old male infant) were not reported to a physician within one hour. 2. The hospital never reported Patient 2’s CTR to the ordering physician (Physician 1). These failures resulted in Patient 2’s positive blood culture (test that looks for germs in the blood) for Escherichia coli (E. coli- bacteria typically found in the intestines) progressing from bacteria in the blood to meningitis (infection and swelling of the fluid and membranes surrounding the brain and spinal cord) requiring transfer to a children’s hospital (Hospital 4) in another county for a higher level of care, with a poor prognosis for recovery and discharged under hospice (specialized care for people near the end of life) care. 3. Emergency Department (ED) Registered Nurses (RN) did not document receiving CTRs from lab staff for six of ten sampled patients (Patient 2, Patient 24, Patient 25, Patient 26, Patient 27, and Patient 20). This failure had the potential for a delay in reporting CTR and timely follow up care and resulted in an incomplete medical record. Findings: 1. During an interview on 3/4/24 at 2:51 p.m. with Registrar 1, Registrar 1 stated she confirmed prior interview findings on 1/22/24 at 11:40 a.m. when she stated she registered Patient 2 to have outpatient blood work done in the hospital’s lab on 12/18/23 at 6:15 p.m. Registrar 1 stated Patient 2 was brought to the hospital’s main admitting area by his mother. Registrar 1 stated when she registered Patient 2 for lab work, she “inadvertently” registered Patient 2’s location as “OB [obstetrics- area of hospital where women give birth] instead of “lab.” During an interview on 3/5/24 at 9:25 a.m. with RN 2, RN 2 stated she was working in the hospital’s OB triage on 12/18/23. RN 2 stated Patient 2’s name showed up on the OB tracking board (electronic system which shows patients registered to be seen and their status). RN 2 stated when she looked up Patient 2’s information, she saw that Patient 2 was a seven-week-old baby. RN 2 stated she could move patients on the tracking board to other areas of the hospital. RN 2 stated she “assumed” Patient 2 was being seen in the ED and electronically transferred him to the ED. RN 2 stated she did not confirm with the registration department or call the ED when she changed Patient 2’s electronic location. RN 2 stated her reason for electronically transferring Patient 2 to the ED was “probably just a guess.” During a concurrent interview and record review on 3/5/24 at 11:37 a.m. with Clinical Lab Scientist (CLS) 1, CLS 1 stated she confirmed prior interview and record review findings on 1/22/24 at 10:31 a.m. when she stated the lab’s blood culture “machine” alarmed on 12/19/24 and indicated Patient 2’s blood culture had abnormal bacterial growth. CLS 1 stated when she printed Patient 2’s information from the machine, the printout indicated Patient 2 had been in the hospital’s ED but was no longer there. CLS 1 stated the hospital’s process when a patient has already been discharged home from the ED, the ED charge nurse is given the CTR. During a review of Patient 2’s “Microbiology Result Details [MRD]” dated 12/19/23 at 11:47 a.m. the MRD indicated, “Gram Negative Rods [type of bacteria] . . . Phoned to [RN 1]. During an interview on 3/4/24 at 11:39 a.m. with RN 1, RN 1 stated she received CTR for Patient 2 on 12/19/23. RN 1 stated for blood culture CTRs she typically waits until around “5 p.m.” to make calls to physicians to report findings unless she has time earlier. RN 1 stated she realized Patient 2 had not been in the ED and she called the lab back to let them know. RN 1 stated when she called the lab, she was told the staff who reported the CTR to her earlier in the day was already gone and to call back the next day. RN 1 stated she did not document the conversation. RN 1 stated she did work the next day but never called the lab back. RN 1 stated blood culture CTR should be communicated to a physician within “one to two hours” like and other CTR. RN 1 stated she never reported Patient 2’s CTR to a physician. During a review of Patient 2’s medical record, the “ED Physician Notes [EDPN]” dated 12/23/23 at 12:21 a.m. indicated Patient 2 was brought to the hospital’s ED on 12/22/23 and admitted to the hospital’s Pediatric Intensive Care Unit (PICU- hospital unit that provides sick children with the highest level of medical care) in Condition Critical [unstable state, resulting from severe illness or injury, vital signs and other symptoms indicate a significant risk of death]. The “Discharge Summary” dated 12/23/23 at 10:36 p.m. indicated Patient 2’s “Reason for Admission” was “E. coli with meningitis.” The “Admission, Transfer, Discharge Orders” indicated Patient 2 was admitted to the hospital’s PICU on 12/23/23 at 1:14 a.m. and was transferred to Hospital 4 on 12/23/23 at 8:20 p.m. The “Emergency Documentation - MD” dated 12/23/23 at 12:26 a.m. indicated, “The medical records from patient’s admission at birth were reviewed by me [Physician 2]. While reviewing these records, I [Physician 2] noticed that patient had some laboratory results posted on 12/18. . . Blood culture with gram negative rods identified on the morning of 12/19/23 with final identification of pansensitive [bacteria is sensitive to all the antibiotics usually tested for potential treatment] E. coli. Upon further questioning, parents report that patient was sent for outpatient laboratory studies on 12/18. Parents report that they were not notified of any abnormal laboratory results and were unaware that patient had a positive blood culture when they decided to bring him to the ED tonight.” During an interview with Chief Nursing Office (CNO) on 3/4/24 at 3:16 p.m. CNO stated her expectation was for nursing staff to follow CTR policy and document who the nurse spoke with, which results were reported on, and any orders received.” During an interview on 3/4/24 at 4:57 p.m. with Physician 3, Physician 3 stated if he was told of an CTR for a patient who was not in hospital, he would “one hundred thousand percent” ask for the patient to be brought back to the hospital. 2. During an interview on 3/4/24 at 2:41 p.m. with Physician 1, Physician 1 stated he sent Patient 2 to the hospital for outpatient lab work to be done. Physician 1 stated was “never” notified of Patient 2’s CTR from the hospital. Physician 1 stated he found out about Patient 2’s abnormal lab results on 12/26/23 when a doctor from the Hospital 4 called him and informed him of Patient 2’s critical condition. During a concurrent interview and record review on 3/7/24 at 9:15 a.m. with Director of Nursing for Med/Surg Tele (DNMT), Patient 2’s medical record was reviewed. DNMT stated she was unable to find documentation of RN 1 notifying a physician of Patient 2’s CTR dated 12/19/23. During a review of Patient 2’s “Discharge Summary” dated 2/15/23 at 11:42 a.m. from Hospital 4, the Discharge Summary indicated, “Hospital Course: History of Present Illness: [Patient 2] is an ex-term [born at full term pregnancy] male, now 3 months of age, who presented at 8 weeks of age on 12/24/2023 as transfer from [Hospital 1] with Ecoli [sic] meningitis. Per outside hospital records, he presented to his PCP [primary doctor] on 12/18 with 5 days of fever, was diagnosed with flu and sent home after labs (including a blood culture [Bcx]). On 12/19, he re-presented to the PCP office with increased fussiness, but was sent home again. On 12/22, he was taken to [Hospital 1] ED where he was noted to have a positive Bcx from 12/18 growing gram-negative rods. An [sic] LP [lumbar puncture- also known as a spinal tap, a medical procedure where a needle is inserted into the spinal canal, most commonly to collect cerebrospinal fluid [CSF] for diagnostic testing] was performed with retrieval of cloudy/pustular [pus filled] appearing CSF fluid [sic]. . . After admission to [Hospital 4] PICU, he was noted to have tonic neck [normal reflex would be an infant’s arm and leg opposite of the side the infant was turned to flex toward the head] deviation [abnormal response] with sudden tachycardia [heart rate increased out of normal range] and conjugate gaze [both eyes move in the same direction] suggestive of a seizure [sudden, uncontrolled body movements and changes in behavior that occur because of abnormal electrical activity in the brain]. . . a repeat head CT [imaging test to help detect injury and disease] was obtained and discussed at length with radiology [physicians who interpret imaging tests] and neurosurgery [physicians who diagnose and treat nervous system disorders]. He [Patient 2] has extensive, devastating findings and further evolution [development] of parenchymal [functional tissue of the brain] loss with little functional brain apart from brainstem [part of brain responsible for vital life functions such as breathing, consciousness, blood pressure, heart rate, and sleep]. . . [Patient 2] was accepted as concurrent care patient with [local] Hospice [specialized care for people near the end of life].” 3a. During a concurrent interview and record review on 3/7/24 at 9:15 a.m. with (DNMT), Patient 2’s medical record was reviewed. DNMT stated she was unable to find nursing documentation of RN 1 receiving CTR, dated 12/19/23 from CLS 1. b. During a concurrent interview and record review on 3/7/23 at 12:33 p.m. with Quality Manager (QM), Patient 24’s medical record was reviewed. The “Results Detail” dated 1/6/24 at 11:36 a.m. indicated Clinical Lab Scientist (CLS, performs scientific testing on samples and reports results to physicians) 2 notified RN 14 of Patient 24’s CTR for an elevated blood potassium. QM stated there was no documentation by RN 14 of receiving the CTR, dated 1/6/24 from CLS 2. c. During a concurrent interview and record review on 3/7/23 at 12:39 p.m. with QM, Patient 25’s medical record was reviewed. The “Blood Culture” dated 2/19/24 at 1:02 p.m. indicated CLS 3 notified RN 1 of Patient 25’s CTR for positive blood culture. QM stated there was no documentation by RN 1 of receiving the CTR, dated 2/19/24 from CLS 3. d. During a concurrent interview and record review on 3/7/23 at 12:44 p.m. with QM, Patient 26’s medical record was reviewed. The “Blood Culture” dated 2/12/24 at 8:06 p.m. indicated CLS 4 notified RN 15 of Patient 26’s CTR for positive blood culture. QM stated there was no documentation by RN 15 of receiving the CTR, dated 2/12/24 from CLS 4. e. During a concurrent interview and record review on 3/7/23 at 12:57 p.m. with QM, Patient 27’s medical record was reviewed. The “Results Detail” dated 2/5/24 at 8:20 a.m. indicated CLS 5 notified RN 16 of Patient 27’s CTR for positive blood culture. QM stated there was no documentation by RN 16 of receiving the CTR, dated 2/5/24 from CLS 5. 39650 f. During a review of Patient 20’s “OUTPATIENT FACESHEET [OPFC],” dated 2/4/24, the “OPFC” indicated Patient 20 was admitted to the ED on 2/4/24 at 7:55 p.m. During a review of Patient 20’s “ED Physician Notes [EDPN],” dated 2/4/24, the “EDPN” indicated, “Encounter information: 2/4/24-2/4/24. History of Present Illness Patient 20 went to [facility name]’s urgent care was told to come to ER due to elevated heart rate, increased temperature and for 2 plus SIRS criteria [Systemic Inflammatory Response Syndrome - severe inflammation throughout body that can lead to organ failure and death. To be diagnosed with SIRS criteria: two or more of the following: Body temperature over 100.4 degrees Fahrenheit (F) or under 96.8 degrees, heart rate greater than 90 beats per minute, respiratory rate greater than 20 breaths per minute or partial pressure of CO2 [carbon dioxide-waste product of breathing] less than 32 mmHg (millimeters of mercury-a unit of pressure equal to the pressure exerted) or white blood cell count greater than 12,000) per urgent care doctor’s note. Patient 20’s first vital signs included: Heart Rate 106 (beats per minute) Temperature PO [by mouth] 39.5 [Celsius-a unit to measure temperature - 103.4 Fahrenheit]”. During a concurrent interview and record review on 3/7/24 at 10:55 a.m. with Quality Safety Program Manager (QSPM) 1 Patient 20’s “Blood Culture (Bcx),” dated 2/5/24 at 11:46 a.m. was reviewed. Patient 20’s “Bcx” indicated, gram negative rods (antibiotic resistant bacteria in blood stream which can include E. coli, which can result in an inflammatory response that can lead to sepsis-a life threatening emergency) in Patient 20’s blood. The results were phoned by the lab to Emergency Department (ED) Registered Nurse (RN) 16.” Patient 20’s electronic medical record (EMR) was reviewed. QSPM 1 was unable to provide documentation by RN 16 of the date and time of she received Patient 20’s “BC” laboratory (lab) test results dated 3/5/24 or who provided the results from the lab. QSPM 1 stated RN 16 should have documented date and time of when she received Patient 20’s “BC” laboratory (lab) test results and who provided the results from the lab in the EMR. During an interview on 3/7/24 at 11:05 a.m. with Director Emergency Services (DES), DES stated the expectation was for the RN to contact the provider in the Emergency Department (ED) within 60 minutes of receipt of a critical value from the lab and the patient should be notified by the ED department as soon as provider reviewed the lab results. During a concurrent interview and record review on 3/7/24 at 11:08 a.m. with DES and QPSPM 1, Patient 20’s “Blood Culture,” dated 2/5/24 at 11:46 a.m. was reviewed. Patient 20’s “Bcx” indicated, gram negative rods in Patient 20’s blood. The results were “phoned to. . . Registered Nurse (RN) 10 at 11:46 a.m. Patient 20’s electronic medical record (EMR) was reviewed. DES stated if Patient 20 was notified of the positive lab results, Patient 20’s notification should have been documented in EMR by the staff member or provider who provided the notification. Patient 20’s “ED Follow Up-Text [EDFU]” dated 2/5/24 at 1:11 p.m. and EMR were reviewed. Patient 20’s “EDFU” indicated, “Follow up action: Blood Culture Follow-up Comments: Pt [patient] results given to Physician Assistant - Certified [PAC] 1. PAC 1 to review chart and make contact w/[with] pt. RN 1-2/5/25 at 1:11 p.m.” DES did not provide documentation PA-C 1 contacted Patient 20 with Bcx results. DES stated PA-C 1 should have contacted Patient 20 and documented the contact in the EMR right after receipt of the critical results or as soon as possible on 2/5/24. Patient 20’s “ED Results Callback [EDRC],” dated 2/10/24 at 7:54 a.m. was reviewed. The “EDRC” indicated on 2/7/24, at 11:12 a.m., RN 11 “Spoke with provider in ED. Looked at blood culture result. Positive for E-coli pt on susceptible antibiotics, return if worse. . .message left. . .no f/u [follow up] needed.” During a review of the hospital’s P&P titled, “Critical Test Results and Test Result Reporting” dated 10/25/23. The P&P indicated, “Purpose: It is the policy of the laboratory, nursing, cardiovascular services, and imaging departments to report results of critical tests and critical test results to patient caregivers accurately and timely. This policy outlines the conditions under which critical test results are communicated. . . Procedure: 1. Staff in the Laboratory, Imaging, and Cardiovascular Services departments will call critical test results to the licensed personnel and/or physician caring for the patient. For laboratory critical values, if an unconfirmed test result is a new critical level, the licensed staff member will be informed that a critical test value has been obtained and will be re-run for confirmation. 2. The licensed staff member will receive a call from the Laboratory, Imaging, or Cardiovascular Services departments within 15 minutes of the time the results are available. Staff calling the result will document date, time, first initial and last name of the person receiving the results in the medical record. Staff receiving the critical result will document date, time, first initial and last name of the person reporting and signature. This will be documented on the Critical Diagnostic Results Read-Back Documentation form or elsewhere in the patient’s medical record. The responsible physician must be notified regarding a critical test result within 60 minutes of the time received by the licensed staff member (total lapse time 1 hour and 15 minutes). The exception to this requirement is the newborn bilirubin assessment. See policy “Newborn Hyperbilirubinemia, Screening and Management” for the process. 3. If a call is placed to report a critical test value and the nurse or physician cannot be contacted, the staff member will initiate the chain of command (see also policy “Chain of Command/Escalating Patient Care Concerns”). a. Nursing Non-Response 1) Initiate a second call within 5 minutes. 2) If no response, call charge RN in the department. 3) If no response, call the Nurse Manager or Director of the Department (House Supervisor during nights and weekends). b. Physician Non-Response 4. After two (2) phone calls within 15 minutes and no response or inappropriate response, the licensed personnel or designee will immediately activate the chain of command: a. The proper documentation of all efforts to obtain medical care for patients in emergency situations is essential. Documentation must include times, dates, names of physician and administrative notification as well as actions taken. 5. The receiving licensed person or physician will be asked to read back the test result that was given to them by the Imaging, EEG Tech, Laboratory and Cardiovascular Services personnel. 6. In the case of outpatients or discharged patients, the department reporting results will phone the ordering physician, the physician on call of physician’s licensed office staff immediately. Document the first and last name of the physician or person receiving the results and date and time received on the Critical Diagnostic Result Readback Documentation Form or elsewhere in the patient’s medical record.””