Stanford Health Care

“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: 44733 Based on interview and record review, the hospital failed to comply with the Condition of Participation for Nursing Services as evidenced by: 1. Failure to provide needed assistance for Patient 8 (refer to A-0395); 2. Failure to implement a fall care plan for Patient 13 (refer to A-0396); 3. Failure to obtain weight as ordered for Patient 36 (refer to A-0398); 4. Failure to document urine volume for Patient 36 (refer to A-0398); 5. Failure to perform wound care as ordered for Patients 24, 38, and 40 (refer to A-0398). The cumulative effect of these deficient practices resulted in the hospital’s inability to ensure their provision of care was done in a safe manner to meet patients’ needs.”

“RADIOLOGIC SERVICES CFR(s): 482.26 The hospital must maintain, or have available, diagnostic radiological services. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications. This Condition is not met as evidenced by: 36623 Based on interview and record review, the hospital failed to comply with the Condition of Participation for Radiologic Services as evidenced by: 1. Failure to use an appropriate irrigation fluid when an interventional radiology (IR, use of medical imaging to diagnose, treat, or perform procedures) technologist (tech) used sterile water (solution containing no solutes or electrolytes) for Patient 10’s cholangioscopy (endoscopic procedure (using an endoscope [small flexible tube with a camera and light]) to examine bile ducts [thin tubes that carries bile from the liver to help digest fat] or remove gallstones [hardened pieces of bile]) using the SpyGlass system (connection of devices used for procedures involving the pancreas [gland helps with digestion and controlling blood sugar] or gallbladder [an organ that stores and releases bile] with multiple catheters which displays live video and allows for the delivery of accessories [tools], aspiration (using suction to draw out fluid or tissue] of fluids, and injection of irrigation fluid) and failure to include the SpyGlass procedure in the hospital’s procedure book (refer to A-0535); 2. Failure to administer an appropriate contrast agent when a neurosurgery physician (neurosurgeon, a physician who specializes in diagnosing and surgically treating disorders of the nervous system [brain, spinal cord, and nerves]) injected Patient 14 with Omnipaque 350 (a contrast medium that is used for certain imaging tests to enhance visualization) intrathecally (the injection or administration of drugs into cerebrospinal fluids [CSF, a clear liquid circulating in and around the brain and spinal cord]), though Omnipaque 350 was contraindicated for intrathecal use (refer to A-0535). The cumulative effect of this problem resulted in the hospital’s inability to ensure the provision of quality health care in a safe environment. It had the potential to result in health complications for Patient 14 and resulted in Patient 10’s death. After Patient 10’s procedure, the patient was assessed to be unresponsive with fixed and dilated pupils, had acute symptomatic hyponatremia (lower than normal sodium levels that can cause severe symptoms, like rapid brain swelling, which can result in a coma and death), causing severe brain injury with diffuse (spread out over a large area)cerebral edema (swelling in the brain) and herniation (displacement of brain tissue due to pressure), leading to brain death (permanent loss of brain function).”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 48590 Based on interview and record review, the hospital failed to comply with the Condition of Participation for Surgical Services as evidenced by failure to follow its policy and procedure when incorrect solution was used during a high-resolution anoscopy (a procedure that allows for examination and evaluation of the anal canal) with possible biopsy (removal of a piece of tissue from the body) procedure (Refer to A-951). The cumulative effect of these deficient practice resulted in the hospital’s inability to provide quality health care. Patient 34 sustained 3% (a minor-to-moderate, small area burn) total body surface area (TBSA, a tool used to assess the severity of a patient’s burn) chemical burn to anus (opening at the end of the digestive tract where stool leaves the body) and gluteus (muscles in the buttock region).”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 44733 Based on interview and record review, the hospital failed to provide needed assistance for one of 47 sampled patients (Patient 8) when Patient 8 tripped on his oxygen (a gas essential for life) tube and fell in the bathroom alone. This failure had resulted in Patient 8’s unwitnessed fall with right femoral neck fracture (broken hip bone). Findings: Review of Patient 8’s History and Physical (H&P, a foundational medical document summarizing a patient’s clinical findings) dated 11/6/25 indicated Patient 8 was admitted for HA (headache) and hypertensive (high blood pressure) urgency. Review of Patient 8’s progress notes by registered nurse (RN) A, dated 11/9/25 at 11:31 a.m., indicated, “At 1036, RNs were in the room to check his skin and removed PIV (peripheral intravenous line, a short, flexible tube inserted into a vein in the hand, arm, or foot to deliver fluids or medications) for early discharge at 11 a.m. At 1045, RN just walked out to get AVS (after visit summary) printout at station 4 and got a call from the bathroom. When RN came to the bathroom, he already sat on the floor facing the floor. This was an unwitnessed fall. Per his report, He just tripped on the oxygen tube ... At 1050, he said that he could not have weight bearing on his right leg related to sharp pain 10/10 at right hip at this time.” Review of Patient 8’s X-ray (a medical imaging test): right hip 2 views, dated 11/9/25, indicated, “Impression: Impacted fracture of the right femoral neck.” Review of Patient 8’s Immediate Post-Op Note, dated 11/10/25, indicated, “Pre-Operative diagnosis: Right femoral neck fracture. The procedure was Right femur open reduction internal fixation (surgery to repair broken bones).” Review of Patient 8’s physician’s order dated 11/6/25 indicated, Oxygen Administration: Mode via nasal cannula (NC, a oxygen tube to deliver oxygen), continuous, and the order was discontinued on 11/21/25. Review of Patient 8’s Flowsheet, dated 11/9/25, indicated, “0842: O2 (oxygen) Delivery-nasal cannula at 0900: ADL assistance- Supervision. 1055: O2 Delivery-Nasal Cannula.” Review of Patient 8’s Physical Therapy Evaluation Note, dated 11/7/25, indicated, “Discharge Recommendations: Requires assistance and/or supervision. Activity recommendations for Nursing: Level of assistance: 1 person assistance ... Ambulate with Nursing.” Review of Patient 8’s care plans indicated, “Goal: Absence of Hospital-Acquired illness or injury”. Interventions on the care plan included, “Perform regular intentional rounding to assess need for position change, pain assessment, and personal needs, including assistance with toileting. Activity supervised; ...toileting supervised.” During an interview with RN A on 3/3/26 at 3:10 p.m., she confirmed she was assigned to provide care to Patient 8 on 11/9/25. RN A stated: Patient 8 was expected to be discharged on 11/9/25. Patient 8 had oxygen via NC which was connected from wall oxygen station in the room. RN A and a floating nurse assisted Patient 8 to bathroom before discharge. RN A walked out Patient 8’s room to get AVS at station and got a call from the bathroom. Patient 8 was sitting on the bathroom floor alone in the bathroom. Patient 8 stated he tripped on the oxygen tube. RN A confirmed there was no supervision provided when he fell in the bathroom. RN A further stated Patient 8’s oxygen tube was about 10 to 15 feet (a unit of measurement) long. Review of the hospital’s undated guidance of ADL (activities of daily living) Assistance indicated, “Supervision = Someone is required to provide verbal cues or set up.” During a review of the hospital’s policy and procedure (P&P) titled “Fall Prevention and Post-Fall Maintenance” dated 2/2024, the P&P indicated, “Registered nurses (RNs) assess fall risk, develop individualized fall prevention plans, and implement fall prevention measures. All patients are considered at risk of falling. Key risk factors include ...4. Mobility, 5. Medical Equipment ...””

“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: 44733 Based on interview and record review, the hospital failed to implement a fall care plan for one of 47 sampled patients (Patient 13) when Patient 13’s bedside commode blocked in the bathroom and fell. This failure had resulted in Patient 13’s fall with mild compression fractures (a break in the spine bones) of C (cervical vertebra, the neck bone)7-T (thoracic vertebrae, the mid back bone)3 and T11-L (lumbar vertebra, the lower back bone)4. Findings: Review of Patient 13’s History and Physical (H&P, a foundational medical document summarizing a patient’s clinical findings) dated 11/22/25 indicated Patient 13 was admitted for decompensated cirrhosis (an advanced, life-threatening stage of liver disease) and transplant (the act of moving body part from one place to another) evaluation. Review of Patient 13’s Operative Report, dated 12/6/25, indicated, “Operation Performed: Piggyback/cavocavostomy (a liver transplant technique) liver transplant.” Review of Patient 13’s Physical Therapy Progress Note, dated 12/19/25, indicated, “Activity recommendations for Nursing: Level of assistance: 2 person assistance.” Review of Patient 13’s care plans indicated, “Goal: Absence of Hospital-Acquired illness or injury”. Interventions on the care plan included, “clutter-free environment maintained. safety round/check completed.” Review of Patient 13’s progress notes by registered nurse (RN) B, dated 12/21/25 at 9:41 p.m., indicated, “2105: This writer was bringing the patient to bathroom. As patient was turning the FWW (front wheel walker, an assistive mobility device with wheels on the front legs to aid walking) to position himself in front of the toilet, it got caught on the legs of the bedside commode (a portable toilet designed for individuals with limited mobility) that was already inside the bathroom facing the toilet. This RN looked down to see what was blocking the FWW from moving. As RN was looking down the patient moved forward and lost his balance falling straight back and hitting his head. RN was not able to catch patient in time. Head strike with laceration. Endorses head pain and later on lower back pain.” Review of Patient 13’s MRI (magnetic resonance imaging, a non-invasive imaging test that uses magnetic fields and radio waves to produce detailed images of the body) Thoracic and Lumbar Spine without IV contrast (a dye injected into veins to enhance MRI images), dated 12/22/25, indicated, “Impression: acute (sudden onset)/subacute mild compression fractures are present at multiple levels involving the cervicothoracic (the junction of the neck and mid-back), thoracolumbar (the junction of the mid-back and lower back), and (lower back) spine (the long column of bones that extend from neck to lower back).” Review of Patient 13’s Trauma H&P, dated 12/22/25, indicated, “He was walking with the nurse and his walker when his walker hit the wall and he lost his balance and fell back and hit his head. He complained of back pain and underwent CT (computed tomography, a non-invasive imaging test that uses X-ray techniques to create detailed images of the body) head and CT total spine and was found to have new T1/T2/T11/T12/L1/L2 superior endplate fractures (a spinal injury where the top surfaces of the vertebra collapses).” Review of Patient 13’s Neurosurgery (the medical specialty concerned with the diagnosis and treatment of patients with injury to the nervous system) Consultation Note, dated 12/22/25, indicated, “MRI T and L spine reviewed with mild compression fx (fracture) of C7-T3 and T11-L4 without ligamentous disruption (a ligament [a fibrous connective tissue in the body that connects bones to other bones] tear or rupture).” During an interview with RN B on 2/26/26 at 2:52 p.m., she confirmed she was assigned to provide care to Patient 13 on 11/9/25. RN B stated the bedside commode was stored right in front of the toilet in the bathroom when she assisted Patient 13 to the bathroom by herself. RN B heard a hitting sound on the way to the toilet and looked down to check what it was. The bedside commode was blocking the patient’s walker. Patient 13 picked his walker up to move forward, lost his balance, and fell backward. RN B further stated Patient 13 did not use the bedside commode, and she could clear the path prior to assisting Patient 13 to the bathroom. During an interview with patient care manager (PCM) C on 2/26/26 at 3:03 p.m., He stated Patient 13 did not use bedside commode, and bedside commode were stored in bathroom when not in use for all patients’ rooms before Patient 13’s fall. During a review of the hospital’s policy and procedure (P&P) titled “Fall Prevention and Post-Fall Maintenance” dated 2/2024, the P&P indicated, “Registered nurses (RNs) assess fall risk, develop individualized fall prevention plans, and implement fall prevention measures. A safe environment should have been maintained for all patients ... Room free of clutter and spills.” During a review of the hospital’s P&P titled “Standards of Practice for Acute and Critical Care Nursing” dated 6/2025, the P&P indicated, “The nurse caring for the patient implements the plan of care. Employ strategies to promote and maintain a safe environment, as well as prevent hospital acquired infections and conditions.””

“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: 48590 Based on interview and record review, the hospital failed to ensure policies and procedures were followed for four of 47 sampled patients when: 1a. Failure to obtain weight as ordered by the physician for Patient 36. 1b. Failure to document urine volume for Patient 36. 2. Failure to perform wound care as ordered by the physician for Patients 38, 40 and 24. These failures had the potential to result in delayed wound healing, risk of complications and affect the patients’ health and well-being. Findings: 1a. Review of Patient 36’s Emergency Department (ED) Provider Note, dated 12/9/21, indicated Patient 36 presented to the ED with generalized weakness (a feeling of decreased muscle strength throughout the body), decreased urinary output (less urine produced than normal), and shortness of breath (feeling of not getting enough air into the lungs) with diagnoses including hypervolemia (a condition with too much fluid in the body), acute renal failure (a sudden loss of kidney function), pulmonary edema (a condition caused by too much fluid in the lungs), hyperkalemia (high potassium in the blood), hyponatremia (a condition where the level of salt [sodium] in the blood is low). During a concurrent interview and record review with the Nursing Quality Management Coordinator (NQMC) I, on 2/25/26 at 1:13 p.m., the NQMC I confirmed the daily weight physician’s order for Patient 36, dated 12/10/21, was active and not discontinued. During a concurrent interview and record review with the NQMC I, on 2/25/26 at 2:33 p.m., the NQMC I confirmed there were no weights taken on the following dates: 12/26/21, 12/30/21, 1/5/22, 1/7/22-1/15/22, 1/17/22-1/23/22, 1/26/22-2/3/22, 2/6/22-2/10/22, and 2/12/22. The NQMC I confirmed nursing staff documented unable to weigh and bed scale malfunctioning on the following dates: 1/6/22, 1/16/22, 1/23/22, 1/24/22, 1/25/22, 2/4/22, 2/5/22, 2/11/22, 2/14/22. The NQMC I stated there were no indications that hospital staff tried to weigh Patient 36 in other means when the bed scale was not working. During a concurrent interview and record review with the Patient Care Manager (PCM) J, on 2/27/26 at 10:02 a.m., the PCM J confirmed there was a physician’s order to weigh Patient 36 every Monday, dated 2/19/22 and discontinued on 3/18/22. The PCM J confirmed that the weight was not taken on 2/28/22, 3/7/22, 3/19/22, 3/24/22, and 3/30/22. The PCM J confirmed there was no documentation why the weights were not taken. The PCM J stated the expectation would be for the nurse to collect the weight and they have to notify the physician if unable. During an interview with the PCM K, on 3/2/26 at 11:04 a.m., the PCM K stated it should have been escalated and maintenance called if bed scale was malfunctioning. The PCM K stated the expectation was for nursing staff to execute the physician order and notify the provider if it was not done. 1b. Review of the physician’s order, dated 12/14/21, indicated “strict I&O after foley discontinued”. The physician’s order was discontinued on 3/18/22. During a concurrent interview and record review with NQMC I, on 2/26/26 at 9:13 a.m., the NQMC I confirmed nursing staff documented in the intake and output flowsheet that Patient 36 was “continent (ability to hold urine), voids (the act of passing urine)”. The NQMC I confirmed urine volume were not documented on 1/6/22 at 1:51 a.m., 1/6/22 at 11:00 p.m., 1/13/22 at 12:15 a.m., 1/13/22 at 4:04 a.m., 1/13/22 at 8:00 a.m., 1/13/22 at 12:00 p.m., 1/13/22 at 4:00 p.m., 1/13/22 at 10:30 p.m., 1/14/22 at 8:27 a/m/, 1/14/22 at 12:08 p.m., 1/14/22 at 1:52 p.m., 1/17/22 at 10:00 a.m., 1/17/22 at 9:24 p.m., 1/17/22 at 11:07 p.m., 1/27/22 at 5:09 a.m., 1/27/22 at 7:31 a.m., 1/27/22 at 11:25 a.m., 1/27/22 at 2:37 p.m., 1/27/22 at 4:09 p.m., 1/27/22 at 7:51 p.m., 1/27/22 at 8:00 p.m., 1/27/22 at 8:51 p.m., 2/1/22 at 7:38 a.m., 2/1/22 at 11:50 a.m., 2/1/22 at 3:52 p.m., 2/1/22 at 8:05 p.m., 2/3/22 at 8:15 a.m., 2/3/22 at 11:31 a.m., 2/3/22 at 2:31 p.m., 2/3/22 at 7:45 p.m., 2/5/22 at 12:00 a.m., and 2/5/22 at 11:00 a.m. During an interview with the PCM K, on 3/2/26 at 11:23 a.m., the PCM K stated Patient 26 was able to urinate (pass urine) if nursing staff were documenting that Patient 36 voids and continent. The PCM K stated the urine volume (output) should have been documented. Review of the hospital’s policy and procedure (P&P), titled Standards of Practice for Acute and Critical Care Nursing, dated 11/21, indicated “Through assessment, the nurse collects data pertinent to the patient’s condition or health status ...documents relevant data in HER (Electronic Health Record) in a clear, timely manner ...documents plan in the Care Plan System within the HER and provides handoff of the plan in a clear, timely manner ...Documents implementation of the plan in the Care Plan system within the HER in a clear, timely manner ...” Review of the hospital’s P&P, titled Order Policy, dated 2/19, indicated “Orders are given to direct patient care ...” Review of the hospital’s P&P, titled Documentation, dated 7/19, indicated “Medical record documentation must record all elements required by law, regulation and policy, including pertinent facts, findings, and observations about an individual’s health history (past and present illnesses), examinations, tests, treatment, and outcomes ...All documentation must be complete ...All documentation of the planning, provision and coordination of care, treatment and services must conform to specific policies including informed consent, orders ...” 2a. Review of Patient 38’s Admission History and Physical (H&P), dated 1/15/25, indicated Patient 38 was admitted to the hospital for transplant prioritization (determine the order in which patients on a waiting list are offered a donor organ) and decompensated heart failure (the heart can no longer pump enough blood to meet the body’s needs worsened). Review of the Wound Ostomy Continence Nurse (WOCN) Note, dated 12/9/25, indicated “consult requested to assess wound on posterior head/scalp”. Review of Patient 38’s physician’s order, dated 12/9/25, indicated “Cleanse with normal saline, pat dry. Apply Cavilon (medication) swab to periwound skin, let dry. Apply Duoderm (dressing for wound management) to wound bed. Cover with Allevyn (foam dressing used for wound management). Care to be done on Monday, Wednesday, Friday starting 12/12/25.” Review of Patient 38’s physician’s order, dated 12/22/25, indicated “Clean with normal saline and dab dry. Apply Solosite (a hydrating wound gel) wound gel to open wound. Cover with Allevyn. Change daily.” Review of Patient 38’s physician’s order, dated 1/6/26, indicated “Cleanse with normal saline, pat dry. Cover with Allevyn bordered foam dressing. Change Monday, Wednesday, Friday and as needed when soiled/saturated/dislodged.” During a concurrent interview and record review with NQMC I, on 3/3/26 at 8:52 a.m., the NQMC I confirmed wound care treatment was not done on 12/19/25, 12/24/25, 12/31/25, 1/2/26, 1/7/26, 1/9/26, 1/16/26, 1/19/26, 1/21/26, 1/23/26, 1/28/26, 1/30/26, 2/6/26, 2/9/26, 2/13/26, 2/23/26 and 2/24/26. 2b. Review of Patient 40’s Cardiology H&P, dated 9/15/25, indicated Patient 40 was admitted to the hospital for heart and liver transplant workup. During an interview with the Wound Care Manager (WCM) F, on 3/3/26 at 2:16 p.m., the WCM F stated the expectation was for nursing staff to follow the order for wound treatment. The WCM F also stated the nursing staff should have follow what was recommended. Review of the WOCN note, dated 10/3/25, indicated “consult requested to assess wound on left heel.” Review of Patient 40’s WOCN note, dated 12/22/25, recommended “Cleanse with normal saline, pat dry. Apply Iodosorb gel to wound bed. Cover with Allevyn border. Change daily and PRN (as needed) when dislodged.” Review of Patient 40’s physician order, dated 1/27/26, indicated “Cleanse with normal saline, pat dry. Apply Iodosorb gel (medication to wound) wound bed. Cover with Allevyn border. Change daily and PRN when dislodged.” During a concurrent interview and record review with NQMC I, on 3/3/26 at 2:35 p.m., the NQMC I confirmed wound care treatment was not done on 12/26/25, 12/30/25, 1/2/26, 1/4/26, 1/10/26, 1/22/26, 1/28/26, and 1/29/26. During an interview with the WCM F, on 3/5/26 at 2:05 p.m., the WCM F stated the expectation was to provide the wound treatment as ordered. Review of the hospital’s P&P, titled Order Policy, dated 2/19, indicated “Orders are given to direct patient care ...” 44733 2c. Review of Patient 24’s Wound Ostomy Continence Nurse (WOCN) note, dated 12/2/25, indicated: Pressure Injury NPOA (not present on admission) coccyx/sacrum (bones at the base of the spine): clean with bath wipe. Apply Solosite wound gel, cover with Duoderm. Cover with sacral allevyn. Change q MWF (every Monday, Wednesday, and Friday) and PRN (as needed) soiled. Review of Patient 24’s physician’s order, dated 12/2/25, indicated: clean with bath wipe. Apply Solosite wound gel, cover with Duoderm. Cover with sacral allevyn. Change q MWF and PRN soilage. A new treatment for patient 24’s coccyx/sacrum wound was ordered on 12/16/25. Review of Patient 24’s Flowsheet from 12/2/25 to 12/16/25 indicated there was no documentation indicating the patient’s coccyx/sacrum wound treatment was done as ordered on 12/2/25, 12/3/25, 12/10/25, 12/12/25, 12/15/25. The wound treatment documentation indicated family refused dressing change on 12/12/25. During an interview and record review with nursing quality management coordinator (NQMC) D on 2/26/26 at 11:00 a.m., she confirmed the above record review. During an interview with wound care manager (WCM) F on 3/5/26 at 2:40 p.m., she stated licensed nurses were expected to provide the wound treatment as ordered by the physician and document when they implemented treatment. During a review of the hospital’s policy and procedure (P&P) titled “Pressure Injury Prevention Protocol” dated 3/2018, the P&P indicated, “Appropriate for the prevention and/or treatment of pressure injuries is to be initiated when the patient has been determined to be at risk for, or has a pressure injury.””

“SAFETY POLICY AND PROCEDURES CFR(s): 482.26(b) [§482.26 Condition of Participation: Radiologic Services §. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications.] §482.26(b) Standard: Safety for Patients and Personnel The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel. This Standard is not met as evidenced by: 36623 Based on interview and record review, the hospital failed to adopt and implement radiologic services policies and procedures that keep patients safe when radiologic services staff did not use the appropriate substances for a procedure for two of two patients: 1. An interventional radiology (IR, use of medical imaging to diagnose, treat, or perform procedures) technologist (tech) used sterile water (solution containing no solutes [dissolved substance, salt/sugar] or electrolytes) prepare Patient 10’s cholangioscopy (endoscopic procedure (using an endoscope [small flexible tube with a camera and light]) to examine bile ducts [thin tubes that carries bile from the liver to help digest fat] or remove gallstones [hardened pieces of bile]) using the SpyGlass system (connection of devices used for procedures involving the pancreas [gland helps with digestion and controlling blood sugar] or gallbladder [an organ that stores and releases bile] with multiple catheters which displays live video and allows for the delivery of accessorries (tools), aspiration of fluids, and injection of irrigation fluid); the SpyGlass procedure was not included in the hospital’s procedure book. 2. A neurosurgery physician (neurosurgeon, a physician who specializes in diagnosing and surgically treating disorders of the nervous system [brain, spinal cord, and nerves]) injected Patient 14 with Omnipaque 350 (a contrast medium that is used for certain imaging tests to enhance visualization) intrathecally (the injection or administration of drugs into cerebrospinal fluids [CSF, a clear liquid circulating in and around the brain and spinal cord]), though Omnipaque 350 was contraindicated for intrathecal use. These failures had the potential to result in health complications for Patient 14 and resulted in Patient 10’s death. After Patient 10’s procedure, the patient was assessed to be unresponsive with fixed and dilated pupils (larger than normal pupils which does not constrict or get small in bright light), had acute symptomatic hyponatremia (lower than normal sodium levels that can cause severe symptoms, like rapid brain swelling, which can result in a coma and death), causing severe brain injury with diffuse (spread out over a large area) cerebral edema (swelling in the brain) and herniation (displacement of brain tissue due to pressure), leading to brain death (permanent loss of brain function). Findings: 1. Review of Patient 10’s Interventional Radiology History and Physical (H&P, a foundational medical document summarizing a patient’s clinical findings), dated 11/10/25 indicated, “She presents today for right internal-external biliary drain exchange [routine procedure that replaces an old catheter that allows bile to flow from the liver to the small intestine] with cholangioscopy and possible stone extraction [removal], laser lithotripsy [procedure that breaks up stones using a laser].” Review of Patient 10’s neurological (related to the brain, spinal cord, and nerves) assessment flowsheets, dated 11/10/25 at 10:15 a.m. (prior to the procedure), indicated the patient’s neurological assessment was within defined limits (normal). Review of Patient 10’s Comprehensive Metabolic Panel (lab test that measures 14 substances in the blood, including blood sugar and electrolytes, e.g. sodium [salt] and potassium) collected 11/10/25 at 12:34 p.m., indicated the patient’s sodium level was 139 millimoles per liter (unit of measurement) (normal sodium level is between 135 to 145 mmol/L). Review of Patient 10’s Case Tracking Events indicated the procedure start time was 11/10/25 at 2:48 p.m. and the procedure end time was 11/10/25 at 10:12 p.m. Review of Patient 10’s Procedure Details, dated 11/10/25 indicated the device used was Spyglass. Review of Patient 10’s neurological assessment flowsheets, dated 11/10/25 at 11:30 p.m. (after the procedure), indicated the patient was unresponsive to verbal stimulation and unresponsive to painful stimulation. The flowsheets also indicated Patient 10’s right and left pupils were both 5 millimeters (unit of measurement) (normal pupil size is 2 to 4 mm in diameter in bright light) and nonreactive (fixed, does not constrict or get small in bright light). Review of Patient 10’s Comprehensive Metabolic Panel, collected 11/10/25 at 11:45 p.m., indicated the patient’s sodium level was 116 (normal sodium level is between 135 to 145 mmol/L). Review of Patient 10’s Code Blue/Rapid Response Team Note, dated 11/11/25 indicated, “The patient was unresponsive to sternal rub [technique used to test a patient’s level of consciousness by applying pressure to the breastbone with knuckles], had dilated pupils ... her pupils were noted to be dilated bilaterally [both sides]and unresponsive ... An iSTAT (portable blood analysis system which can provide results in less than 10 minutes) showed ... sodium of 118 ... acute hyponatremia [low sodium level in the blood] and electrolyte derangements [disturbance] causing the constellation [group of symptoms] of obtundation [decreased level of consciousness] and arrythmias [abnormal heart rhythm] ... A repeat iSTAT was performed which confirmed the acute hyponatremia of 116 from 139 12-hours prior.” Review of Patient 10’s Intensive Care Unit (ICU, area in a hospital where specialized care is provided for critically ill patients with life-threatening conditions) Consult Note, dated 11/10/25 indicated, “[Patient 10] was of usual health prior to her procedure ... Upon arriving to the PACU [Post-Anesthesia Care Unit, recovery room], she was not arousable [able to be awakened] ... She was also found to have dilated pupils ... A code blue [hospital code announcing a medical emergency] was called but pulse was never lost. She was intubated [a procedure involving inserting a tube through the mouth or nose into the airway to help with breathing] and required 2 shocks [defibrillation, using electrical shock to treat an abnormal heart rhythm] ... labs most notable for Na [chemical symbol for sodium] 116 (previously 139 earlier in the day). Given her altered mental status [change in usual mental function] ... a code stroke [a protocol followed when a patient has symptoms of a stroke (medical emergency that happens when not enough blood is flowing into the brain] was then called ... CT head [computed tomography, a detailed, 3D X-ray that takes pictures of the brain, skull, and blood vessels from different angles] showed lack of gray white differentiation [loss of the distinct boundary of the gray matter and white matter of the brain, an indication of a brain injury] and cerebral edema [brain swelling] ... After the procedure she was found to have altered mental status, ventricular tachycardia [V-tach, abnormally fast heart rhythm] requiring shocks and ultimately found to have Na 116 with cerebral edema ... most likely related to acute drop in sodium ... prior to this, had normal Na levels ... 2 doses of 23% NaCL [sodium chloride, solution given to treat low blood salt levels] should be sufficient to improve Na, but reversibility of cerebral edema will also depend on degree of injuries related to potential compromise in CPP [cerebral perfusion pressure, the amount of pressure it takes to deliver oxygen to the brain] during OR [operating room] ...” Review of Patient 10’s CT Head, dated 11/11/25 indicated, “Diffuse cerebral edema with complete effacement of the cerebral sulci and basal cisterns [flattening of the grooves of the brain and the spaces containing CSF at the base of the brain] ... Overall, findings are concerning for severe diffuse hypoxic ischemic injury [brain damage caused by reduced oxygen or blood flow] with accompanying increased intracranial pressure [growing pressure inside the skull].” Review of Patient 10’s Physician Disclosure Note after Adverse Event, dated 11/11/25 indicated, “We discussed that patient did receive IV [intravenous, into the vein] fluids containing salt during the case, but that the irrigation fluid we used was sterile water, that I did think it was saline as we typically use saline ... [when] asked why water was selected and I said that we are looking to determine why that was the case ... [when] asked about how much irrigation [fluid] was used and I estimated that potentially 6-8 liters based upon discussion with a technologist, but the exact amount retained was unknown ...” Review of Patient 10’s Death Summary, dated 11/14/25 indicated, “Patient was taken to the OR at [2:15 p.m.] on 11/10 with initial code blue activation in the PACU for Vtach requiring 2 shocks (no loss of pulses) and subsequent stroke code activation for unresponsiveness. Stroke code examination with bilateral fixed and dilated pupils, CTH [CT head] demonstrating diffuse cerebral edema with complete effacement of the sulci and cisterns. Patient was admitted to the Neuro ICU for management of cerebral edema, which despite maximum medical management subsequently advance towards examination consistent with brain death on 11/14/25 ... comorbidities and complications: hyponatremia with cerebral edema.” Review of Patient 10’s Deceased Note, dated 11/14/25 indicated, “Brain death testing completed and consistent with brain death ... The patient is brain dead. The time of death is 17:09 [5:09 p.m.] on 11/14/2025.” Review of Patient 10’s Autopsy, dated 12/26/25 indicated, “The anatomic cause of death is best characterized as catastrophic global brain injury with diffuse cerebral edema and herniation. Correlation with the immediate post-procedure documentation supports consideration that the initiating event may have been acute symptomatic hyponatremia with rapid cerebral edema (and secondary neurocardiac electrical instability) ...” During an interview on 2/27/26 at 1:50 p.m., the Interventional Radiology Technologist L (IRT L) described how he prepared the room and SyGlass device prior to Patient 10’s procedure on 11/10/25. The IRT L stated he was the tech assigned to set up the room prior to Patient 10’s procedure. The IRT L stated he prepared the SpyGlass system and set up the table with supplies. He stated he brought in three 1 liter bottles of sterile water to the room and connected the sterile water to the irrigation pump for Patient 10’s procedure. The IRT L stated that because a laser machine was requested for Patient 10’s procedure, sterile water could be used. He stated he was not told beforehand which liquid to use for Patient 10’s procedure. During an interview 2/27/26 at 2:20 p.m., the Interventional Radiology Physician M (IRP M) described the procedure involving Patient 10 on 11/10/25. He stated that the expected irrigation liquid used for Patient 10’s procedure was normal saline (NS, isotonic solution of salt and water, with a salt concentration similar to human blood). The IRP M stated the SpyGlass device was usually set up by the techs. He stated typically for cases, they use NS, so there was not a discussion which fluid to use. During an interview on 3/3/26 at 9:30 a.m., the Patient Safety Director (PSD) stated the SpyGlass procedure was not included in the IR procedure book. The PSD stated the hospital updated the procedure book after Patient 10’s procedure to include the SpyGlass procedure. She stated the procedure book was also updated to make sure it was clear that isotonic solutions should be used for the SpyGlass procedure. During an interview on 3/4/26 at 9:35 a.m., the Assistant Technologist Manager N (ATM N) stated according to vendor training and hospital education provided, the irrigation fluid for SpyGlass procedures should have been normal saline (NS). The ATM N stated all the techs have been signed off on the SpyGlass training, which included a video and acknowledgement of what supplies are needed for a SpyGlass procedure. He stated in the training video, it stated normal saline should have been used as the irrigation fluid. The ATM N stated NS was stocked in the procedure rooms. The ATM stated sterile water was stored outside of the procedure rooms because it was not typically used. He stated sterile water was only used if the provider explicitly requested it. The ATM stated if there was a question on the irrigation fluid, the team should confirm with the physician. Review of the facility’s job profile for Interventional Radiology Technologist IV (IRT L’s position), printed 3/2/26 indicated the position “demonstrates technical skills, trouble-shooting skills and expert knowledge of supplies and equipment used during complex Interventional Radiology Procedures.” Review of IRT L’s Student and Group Transcript Report, generated 3/2/26 indicated he completed, “SYPGLASS: Vendor Presentation” (Care and use of SpyGlass) on 3/14/22. Review of the facility’s Course, “SpyGlass Discover - Its Use in Biliary Intervention and Cholangioscopy,” dated 2023 indicated, “This course is designed to prepare the Radiologic Technologist and/or Registered Nurse to set up the SpyGlass Discover system for Biliary Intervention and Cholangioscopy use ...” It also indicated participants should be able to list and describe SpyGlass parts and accessories, and demonstrate exam setup. The course included a presentation, set-up video, and skills checklist. Review of the Course’s undated “Spyglass Autolith Skills Checklist,” indicated to identify and gather supplies, including normal saline (NS) bottle and irrigation pump tubing. The checklist indicated irrigation pump set up included to load the irrigation tubing into the NS bottle and through the pump. It also indicated under troubleshooting, if lithotripsy not working, “check connections, double check irrigation is NS NOT sterile water ...” Review of the Sterile Water for Irrigation label indicated, “Warnings: Hypotonic [lower concentration of solutes] and Hemolytic [can rupture or destroy red blood cells].” Review of the Package Insert for Sterile Water, dated 9/2023 indicated, “Water is hypotonic and will cause hemolysis [destruction of red blood cells] and will be readily absorbed by the tissues during surgical procedures; therefore its use under such conditions is not recommended ... Sterile Water for Irrigation USP is hypotonic and will cause hemolysis, and is not recommended for use during surgical procedures.” Review of the updated procedure, “Gallstone Removal - SpyGlass,” undated, indicated supplies included normal saline. It indicated irrigation pump set up included load the irrigation tubing into the NS bottle and through the pump. It also indicated, “Ensure irrigation is using Normal Saline NOT sterile water ...” 44733 2. Review of Patient 14’s Procedure Note dated 7/14/25 indicated, “Procedure: Intrathecal pump dye study. Indications: Lack of efficacy of intrathecal baclofen (a medication used to treat muscle spasm [a sudden painful contraction of a muscle]). Fluoroscopy (a medical imaging technique that shows organs, tissues, or other internal structures moving in real time) was used to identify the side port (a small device placed under the skin to provide access for veins). 5 cc (cubic centimeter, a unit of measurement) of Omnipaque 350 (a contrast medium that is used for certain imaging test to enhance visualization) was injected under fluoroscopic control.” Review of Patient 14’s FL (fluoro) Thoracic Spine (the middle section of the backbone) Myelogram (a diagnostic imaging test) dated 7/14/25 indicated, “Injection of intrathecal baclofen pump under fluoroscopic guidance by neurosurgery (a medical field focused on diagnosing and treating the nervous system disorders). A thoracolumbar (the junction of the mid-back and lower back) myelogram was performed afterwards.” Review of Patient 14’s H&P, dated 7/15/25 indicated, “Hx (history) of spinal cord injury after equestrian (related horseback riding, or horses) accident with loss of bowel function sine 1990’s, s/p (status post) baclofen pump replacement from T (thoracic vertebrae, the mid back bone)8-T12/L (lumbar vertebra, the lower back bone)2 in 2003 (most recent replacement 1/2025), who presents acutely with inability to walk after CT myelogram (a diagnostic imaging test combining contrast dye injection with a CT [computed tomography, a non-invasive imaging test that uses X-ray techniques to create detailed images of the body] scan to produce detailed images) yesterday.” Review of Patient 14’s Physician Disclosure Note after Adverse Event dated 7/15/25 indicated, “Due to unavailability of Omnipaque 300 at yesterday’s pump injection procedure, I chose to administer Omnipaque 350 instead. I discovered today that Omnipaque 350 is associated with an increased risk of neurological complications, including paralysis. I described that it is difficult to ascertain what role (if any) this contrast agent is playing in her increased weakness, given that she also has a severe compression from a large herniated L1-2 disk.” During an interview with radiology supervisor (RS) G on 2/19/26 at 10:55 a.m., he stated Omnipaque 350 was injected intrathecally to Patient 14 to check the function of the pump on 7/14/26. The physician requested Omnipaque 300 first, and then Omnipaque 350 when Omnipaque 300 was not available. RS G stated he did not know Omnipaque 350 was contraindicated for intrathecal use. During an interview with neurosurgery physician (NSP) H on 2/19/26 at 2:04 p.m., he stated he requested Omnipaque 300 for Patient 14 to check her pump function, but Omnipaque 300 was not available. NSP H stated he used Omnipaque 350 intrathecally and did not know Omnipaque 350 was contraindicated for intrathecal use. During a radiology department observation on 2/25/26 at 9:28 a.m., there was an Omnipaque 350 mgI/ml (milligrams of iodine per milliliter, a measure of concentration used for iodinated contrast agents in medical imaging) vial labeled “NOT FOR INTRATHECAL USE” in red which was stored in locked wall cabinet. During a review of the hospital’s policy and procedure (P&P) titled “Contrast Media Administration” dated 5/2025, the P&P indicated, “The purpose of this policy is to provide appropriate and safe administration of contrast media to patients requiring imaging services. It is policy of [the hospital name] to screen all patients receiving contrast media. These measures include but are not limited to: Screening for contraindications.” During a review of the Full Prescribing Information for Omnipaque revised 10/2024, the information indicated, “Recommended Concentrations and Volumes of OMNIPAQUE Injection for Intrathecal Procedures in Adults: Thoracic Myelography- 240 mg Iodine/ml; 300 mg Iodine/ml. Risks Associated with Intrathecal Administration of OMNIPAQUE Injection 140 mg Iodine/ml and 350 me iodine/ml: Use only the iodine concentrations and presentations recommended for intrathecal procedure.””

“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: 48590 Based on interview and record review, the facility failed to implement surgical services policies and procedure for four of 11 sampled patients (Patient 34, 31, 45, and 46) when: 1. Incorrect solution was used during a high-resolution anoscopy (a procedure that allows for examination and evaluation of the anal canal) for Patient 34. 2. The primary surgeon did not participate in the pre-procedure timeout (a pause conducted by the operating team prior to surgery to verify the correct patient identity, correct procedure to be performed, correct site/side of surgery) prior to the surgeries for Patients 31, 45, and 46. These failures resulted in Patient 34 sustained 3% chemical burn (a minor-to-moderate, small area burn) total body surface area (TBSA, a tool used to assess the severity of a patient’s burn) to anus (opening at the end of the digestive tract where stool leaves the body) and gluteus (muscles in the buttock region) had the potential to result in surgical errors. Findings: 1. Review of Patient 34’s consent to operation, procedure and administration of anesthesia form, dated 11/21/25, indicated Patient 34 was admitted to the hospital on 11/21/25 for a high-resolution anoscopy with possible biopsy (removal of a piece of tissue from the body) procedure. During an interview with the Patient Care Coordinator (PCC), on 2/23/26 at 11:06 a.m., the PCC stated her role was to set up the tray with the right supplies and acetic acid (a colorless liquid with a sour, vinegar-like odor) solution needed for the procedure. The PCC picked up a bottle of solution from the supply cabinet and poured the content in a sterile container. After pouring the content, the PCC threw out the bottle. The PCC stated she did not read the label of the bottle before pouring the content. The PCC stated she just poured the content of the bottle without looking at the label. The PCC stated Patient 34 began to complain of burning sensation during the procedure. During an interview with the Nurse Practitioner (NP) D, on 2/23/26 at 1:12 p.m., the NP stated Patient 34 was to have a high-resolution anoscopy procedure. The NP stated everything was set up when she entered the procedure room. The NP inserted the anal scope (a small, lighted tube to inspect the inside of the anus and lower rectum), inserted the Q-Tip (a small stick with soft cotton wads on one or both ends) that was soaked with the solution in the sterile container, and covered the anal canal with a gauze soaked in the solution. The Q-Tip and gauze will remain in the anal area for two minutes. The NP stated it was not a common practice to verify the solution that was in the sterile container. The NP stated the common practice during the procedure was the solution was poured in the sterile container and ready to be used. During the procedure, Patient 34 complained of severe burning sensation and asked the NP to remove the Q-Tip and gauze. The NP stated she saw a white-colored burn mark on the anal area. The NP stated the burn mark was not caused by acetic acid but by trichloroacetic acid (TCA, a strong chemical used primarily for chemical peels to treat wrinkles, sun damage, acne scars, and remove warts). The NP stated acetic acid will cause burning sensation and TCA will cause burn mark. During an interview with Executive Director Quality and Safety (EDQS), on 2/23/26 at 1:33 p.m., the EDSQ confirmed the solution used was trichloroacetic acid and not acetic acid. Review of Patient 34’s Progress Note, dated 11/21/25, indicated “Anoscope was inserted briefly to introduce a gauze-wrapped swab soaked with what was thought to be 5% acetic acid prepared in container, after which the anoscope was withdrawn and the anal mucosa along with perianus were soaked. Patient then reported intense burning sensation with supposed acetic acid soak. Patient was informed burning sensation may occur from acetic acid soak and was asked whether she wanted the swab removed. After soaking for over 1 minute, patient asked to remove it due to worsening burning sensation. At which, perianus and bilateral gluteus were noted to have whitening circumferentially on perianus, scattered blotches on right gluteus and thick whitening on left gluteus which appeared like 90% TCA chemical burn. Soaked gauze was immediately removed from anal canal and perianus. Perianus and gluteus was wiped with wet wipe but chemical burn was irreversible ...Assessment and Plan: ...procedure was aborted due to incorrect solution applied during what should’ve been acetic acid soak leading to chemical burn ...Patient immediately sent to ED for further management ...Given severity of burns, patient transferred to burn service at Santa Clara Valley Medical Center for further management ...” Review of Patient 34’s ED Provider Notes, dated 11/21/25, indicated “Supposedly patient will undergo a procedure, while doing skin preparation, patient suddenly felt burning sensation and severe pain. Rash all over buttocks and anal area ...Has superficial white blanchable burns over buttocks, includes anal verge, perineum ...” Review of Patient 34’s Dermatology Inpatient Consultation note, dated 11/21/25, indicated “Anus and perianal area and buttock and posterior thigh with well-demarcated erythematous plaques with superficial desquamation and central whitening/frosting and areas of duskiness ...” Review of Patient 34’s General Surgery Consult H&P, dated 11/21/25, indicated “Chemical burn to anus, and gluteal surface bilaterally, friable tissue non blanching white skin, possible 3rd degree full thickness ...” Review of Patient 34’s Gynecology Consult Note, dated 11/21/25, indicated “Presented for scheduled high resolution anoscopy. Instead of acetic acid, had TCA 90% applied to anal canal. Immediately sent to Stanford ED for management of chemical burn. In ED received irrigation to neutralize burn, per poison control ...Plan for transfer to Valley for complex burn care ...” Review of Patient 34’s History Summary, undated, indicated “Chemical TCA burn to anus and rectum sustained 11/21 when this was mistakenly applied to anal canal instead of acetic acid during procedure for anal bx. Had been initially admitted to VMC burn unit 11/21-26 with interval improvement in serial flexible sigmoidoscopies, however in December present in hemorrhagic shock to Peninsula Hospital and was admitted 12/11-12/13/25. Imaging and subsequent scope revealed active arterial bleed ...At risk for anorectal stenosis ...” Review of the hospital’s Standardized Procedure, titled “High Resolution Anoscopy with Possible Biopsy”, dated 2/23, indicated “Equipment/Supplies: ...Acetic acid 5%...” Review of the hospital’s P&P, titled “Surgical and Procedural Safety”, dated 12/25, indicated “The purpose of this policy is to promote the highest standards of surgical and procedural safety by providing a comprehensive framework for minimizing the risk of errors and enhancing patient outcomes. Stanford Health Care (SHC) is committed to providing safe and effective surgical and procedural care in all settings where such care occurs (e.g. ...in outpatient clinics) ...” Review of the hospital’s P&P, titled “Standards of Practice for Ambulatory Care Nursing”, dated 11/24, indicated “The purpose of this policy is to define the standard of nursing care for all patients receiving care during or associated with an outpatient/ambulatory encounter at Stanford Health Care (SHC) ...It is the policy of SHC to provide evidence-based standards of nursing care for all patients ...” 36623 2. Review of Patient 31’s Operative Report, dated 1/9/26 indicated Cardiovascular Surgeon O (CS O) was the surgeon and Thoracic Surgery Resident P (TSR P) was the assistant for Patient 31’s surgery. Review of Patient 31’s Timeout, performed on 1/7/26 at 11:34 a.m., indicated “Physicians” involved in the timeout included Thoracic Surgery Resident P (TSR P) and a physician assistant. It did not indicate CSO participated in the timeout. Review of Patient 45’s Operative Report, dated 1/9/26 indicated CS O was the surgeon and Thoracic Surgery Resident R (TSR R) was the assistant for Patient 45’s surgery. Review of Patient 45’s Timeout, performed on 1/9/26 at 8:22 a.m., indicated “Physicians” involved in the timeout included Thoracic Surgery Resident R (TSR R) and a physician assistant. It did not indicate Cardiovascular Surgeon O (CS O) participated in the timeout. Review of Patient 46’s Operative Report, dated 1/9/26 indicated CS O was the surgeon and Thoracic Surgery Resident S (TSR S) was the assistant for Patient 46’s surgery. Review of Patient 46’s Timeout, performed on 1/9/26 at 8:27 a.m., indicated “Physicians” involved in the timeout included Thoracic Surgery Resident S (TSR S) and a physician assistant. It did not indicate Cardiovascular Surgeon O (CS O) participated in the timeout. During an interview on 3/9/26 at 3:11 p.m., CS O stated the surgeon is not always in the room when the timeout is conducted. Review of the hospital’s policy, Surgical and Procedural Safety” dated 12/2025 indicated, “All members of the procedure team should actively participate in the pre-procedure timeout and stop any non-critical activities.” It indicated during the pre-procudure timeout, the team will verbally agree on the correct patient identity, correct site and/or side, and correct procedure. According to the Association of periOperative Registered Nurses (AORN) “Guidelines for Perioperative Practice: Team Communication” effective 1/1/2024 indicated, “During a timeout, all activities are stopped so that the perioperative team can focus on the factors that contribute to a wrong person, wrong site, and wrong procedure surgery and other risks to the patient ... Involve all members of the perioperative team in the time out. The participating team members must include the individual performing the procedure, the anesthesia professional, the RN cirtulator, the scrub person, and any other team members who will be participating in the procedure from the beginning.” Review of the “The Joint Commission, AORN say ‘Time Out’” dated 6/1/22, indicated, “The Universal Protocol, as it is named, calls for the patient and the licensed independent practitioner to confirm the procedure and mark the body part to be operated on; and for every member of the surgical team to participate in a time out before operating to ensure that the correct procedure is about to begin on the correct part of the correct patient.”

“OPERATIVE REPORT CFR(s): 482.51(b)(6) An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon. This Standard is not met as evidenced by: 36623 Based on interview and record review, the hospital failed to ensure that operative reports included description of the significant surgical tasks (opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissues) that were conducted by practitioners other than the primary surgeon when residents (physicians undergoing specialty training in a residency program, postgraduate training) assisted in the surgeries of four of five Patients 31, 32 45, and 46. These failures had the potential for the lack of knowledge of the health care providers delivering care to the patients. Findings: Review of Patient 31’s Operative Report, dated 1/9/26 indicated Cardiovascular Surgeon O (CS O) was the surgeon and Thoracic Surgery Resident P (TSR P) was the assistant. The report did not indicate a description of the significant surgical tasks conducted by TSR P. Review of Patient 32’s Operative Report, dated 1/9/26 indicated CS O was the surgeon and Thoracic Surgery Resident Q (TSR Q) was the assistant. The report did not indicate a description of the significant surgical tasks conducted by TSR Q. Review of Patient 45’s Operative Report, dated 1/9/26 indicated CS O was the surgeon and Thoracic Surgery Resident R (TSR R) was the assistant. The report did not indicate a description of the significant surgical tasks conducted by TSR R. Review of Patient 46’s Operative Report, dated 1/9/26 indicated CS O was the surgeon and Thoracic Surgery Resident S (TSR S) was the assistant. The report did not indicate a description of the significant surgical tasks conducted by TSR S. During an interview on 3/9/26 at 3:11 p.m., the Cardiovascular Surgeon O (CS O) stated for Patient 45’s surgery, Thoracic Surgery Resident P (TSR P) was performing the peeling away of scar tissue to get to the heart. CS O confirmed that the operative notes did not describe everything done by every single person. Review of the hospital’s Medical Staff Rules and Regulations, dated August 2025 did not indicate the operative or procedure report must include a description of the specific significant surgical tasks that were conducted by practitioners other than the primary surgeon/practitioner.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 44577 Based on interview and record review, the facility failed to comply with the Emergency Medical Treatment and Labor Act (EMTALA) as evidenced by: 1. The facility failed to have written policies and procedures in place to respond to situations in which the on-call physician failed to be available to accept an appropriate higher level of care transfers. (Refer to A/C 2404) 2. The on-call physician failed to provide documentation of consultation. (Refer to A/C 2404) 3. The facility failed to ensure the emergency medical or psychiatric condition was stabilized prior to discharge. (Refer to A/C 2407)”

“ON CALL PHYSICIANS CFR(s): 489.20(r)(2) and 489.24(j)(1-2) §489.20(r)(2) [The hospital (including both the transferring and receiving hospitals), must maintain] a list of physicians who are on call for duty after the initial examination to provide further evaluation and/or treatment necessary to stabilize an individual with an emergency medical condition. §489.24(j)(1) Each hospital must maintain an on-call list of physicians on its medical staff in a manner that best meets the needs of the hospital’s patients who are receiving services required under this section in accordance with the resources available to the hospital, including the availability of on-call physicians. §489.24(j)(2)(i) The hospital must have written policies and procedures in place to respond to situations in which a particular specialty is not available or the on-call physician cannot respond because of circumstances beyond the physician’s control. §489.24(j)(2)(ii) The hospital must have written policies and procedures in place to provide that emergency services are available to meet the needs of patients with emergency medical conditions if it elects to permit on-call physicians to schedule elective surgery during the time that they are on call or to permit on-call physicians to have simultaneous on-call duties. This Standard is not met as evidenced by: 44577 Based on interviews and record reviews, the hospital failed: 1. To have written policies and procedures in place to respond to situations in which the on-call physician failed to be available to accept an appropriate higher level of care transfer for 3 of 8 sampled patients (Patients 22, 23 and 26) to provide stabilizing treatment for those patients with emergency medical conditions. This failure had the potential to place the health of patients with a serious eye injury in jeopardy or result in serious dysfunction. 2. To provide documentation in the medical record of consultation for one of 21 sampled patients (Pt 1). This failure had the potential to cause inaccurate information documented in the patients record. Findings: 1. During an interview on 11/20/25 at 10:05 a.m. Director of Inpatient Clinical Access (DICA), the DICA stated “for EMTALA transfers, when a call comes in, information was placed in the electronic medical record (EMR), a page was placed to the administrative supervisor to look for capacity, if no beds the intake was closed. If there was capacity the call was connected to the physician of the specialty requested or the ED for a physician to physician report. Capability is confirmed. If the transfer is accepted, transport is arranged and a nurse to nurse report if obtained and patient is transferred. If the patient is refused it is because the is no capability; there is nothing to offer the patient, or we do not have the specialty needed.” DICA confirmed ophthalmology and ocular plastics is a specialty service at Stanford. During a concurrent interview and record review on 11/20/25 at 11:10 a.m. with Interim Director of Quality , ED, (IDQED) the on call schedule for Ophthalmology services were reviewed dated May 2025 through September 2025. The schedules indicated Ophthalmology on-call services available everyday reviewed. During a concurrent interview and record review on 11/20/25 at 12:44 p.m. with DICA, transfer request records of ophthalmology patients denied transfer were reviewed. Three of the eight patients reviewed were refused due to capability. Review of Patient 22’s “Transfer Center Request Information” dated 7/15/25 at 11:31 p.m., indicated Patient 22’s transferring hospital reason for transfer was “needs ophthalmology, not available at referring hospital, EMTALA -yes.” DICA stated. “ the call was connected to the charge nurse, for MD to MD report but denied for capability, they always get denied for capability, the services were not available”. Review of Patient 23’s “Transfer Center Request Information” dated 7/21/25 at 6:35 p.m., indicated Patient 23’s transferring hospital reason for transfer was “requesting oculoplastic surgery”, EMTALA -yes.” Patient 23 was denied for services not available at Stanford Health Care (SHC). Review of Patient 26’s “Transfer Center Request Information” dated 9/24/25 at 6:21 p.m., indicated Patient 26’s transferring hospital reason for transfer was “services not supported-ophthalmology, EMTALA -yes.” .” Patient 26 was denied transfer “they do not have coverage tonight”. During an interview on 11/20/25 at 2:57 p.m. with Physician (MD) A, Ocular plastics Associate professor of Ophthalmology. MD A stated, “Ocular plastics does have an on-call schedule, we will see patients as a consultant but not as primary team”. “Unsure what happened with the patients on the dates reviewed, ocular plastics partners were not aware of requested transfer patients, so not called and asked.” During a concurrent interview and record review on 11/24/25 at 2:43 p.m. with the Director of Quality Management (DQM), the on-call schedule for Ocular plastics services were reviewed for July, August and September 2025. DQM confirmed Ocular plastics services had an on-call physician scheduled July 15 & 16, 2025, July 21, 2025, and September 24, 2025. During a review of an email sent by MD A to Chief Residents dated 4/1/25 titled “ OPC (Ocular plastics) transfer policy-unofficial” indicated “We will not accept hospital or ER transfers if OCP surgery/care is the primary reason for transfer”. During a review of the facility’s policy and procedure (P&P) titled, “EMTALA: Admission and Transfer-In Acceptance” dated July 2022, the P&P indicated, “Definitions: Specialized Services: are any services (including surgery) provided by the receiving hospital that are necessary to stabilize the patient’s emergency medical condition that are a higher level of care at the time of transfer, then the level of care available at the sending hospital at the time of the transfer.” “All proposed transfers will be reviewed for medical necessity, level of acuity, resource/equipment requirements and staffing availability, and assigned a medical status.” “EMTALA: An EMTALA Patient transferred from a hospital ED...., who has an emergency medical condition that is not stabilized. Denied or deferred transfers.; EMTALA transfers. If the transfer is for an EMTALA patient., the SHC (Stanford Health care) or SCH (Stanford Children’s Hospital) MD must consult with the Transfer Center Medical Director prior to refusing transfer. In the event of a dispute with the transferring hospital as to the clinical decision or needs of the patient, the views of the transferring physician as to stabilization or mode of transportation will generally prevail.” During a review of the facility’s policy and procedure (P&P) titled, “EMTALA: On Call Schedule/Consultation” dated July 2022, the P&P indicated “The purpose of the emergency call schedule is to ensure that the emergency department is prospectively aware of the physicians, including specialists and subspecialist who are available to come to the Emergency Department ... to provide treatment necessary to stabilize individuals with emergency medical conditions.” “The medical staff bylaws or rules and regulations for both SHC and SCH define the responsibility of on call physicians to respond, examine and treat patients with emergency medical conditions.” During a review of the facility’s policy and procedure (P&P) titled, “EMTALA: Compliance with the Emergency Medical Treatment and Active Labor Act (EMTALA)” dated July 2024, the P&P indicated, “Medical screening examination means the initial and ongoing evaluation of an individual that is conducted by qualified medical personnel, completed in cooperation with other dedicated emergency Department staff, including history, physical examination, appropriate testing, completion of appropriate documentation and evaluation of the patient within the capabilities of SHC ...utilizing facilities routinely available to the dedicated emergency department, including the use of indicated on call physicians as appropriate, to determine whether a patient has an emergency medical condition as defined by law.” “Qualified medical personnel means the following: In the emergency department at SHC, a physician, physician assistant or nurse practitioner acting within the scope of their education, training, licensure, and credentialing.” “Stabilization is defined as follows: Medical condition. Stabilization is defined as with respect to an emergency medical condition. That no material deteriorates. Did. Deterioration. Of the condition is likely, within reasonable medical probability, to result from or occur during the transfer. An individual is deemed stabilized if the treating physician or qualified medical personnel has determined within reasonable. Clinical confidence, that the emergency medical condition has been resolved. Stable for discharge. An individual is considered stable for discharge if the treating physician or qualified medical personnel has determined within reasonable clinical confidence that the individual has reached the point where their continued care, including diagnostic work up. And or treatment may be reasonably performed on an outpatient basis or later. On an inpatient basis, so long as the individual is giving a plan for appropriate. Follow up. Care with the discharge instructions. Sympatric condition An individual with a psychiatric condition is considered stable when the individual is protected and prevented from injuring or harming themselves or any others.” “Transfer of individuals with an emergency medical condition: Policy: SHC will not transfer any individuals with a unstabilized emergency medical condition (includes an individual with severe pain, a psychiatric disturbance, or symptoms of substance abuse) unless the individual makes an informed request for the transfer or a physician certifies that the medical benefits reasonably expected from the provision of treatment at the receiving facility outweigh the risks to the individual from the transfer.” “Acceptance of transfers. Policy: SHC has the obligation to accept an appropriate transfer of an individual with an unstabilized emergency medical condition who requires specialized capabilities or facilities if SHC has the capacity to treat the individual.” 2. Patient (Pt)1 arrived in the Emergency Department (ED) with the complaint of right flank pain, Pt 1 was evaluated by the ED provider, had labs, CT Abdomen/pelvis, IV antibiotics, urology team consult. Pt 1 was discharged to go Hospital D to be admitted. During a record review on 11/18/25 at 9:55 a.m. of Pt 1’s EMR the Providers notes dated 9/15/25 at 11:51, indicated [discussed with] urology, recommended discharge and have patient go to [Hospital D] ED so that she can be admitted. Specifically clarified that no current emergency medical condition (no fever, normal renal function, only mild hydronephrosis, pain controlled by Tylenol and can tolerate po) so therefore no indication for admission at this time and patient was safe for discharge from the outpatient setting. During an interview on 11/18/25 at 2:29 p.m. with the Emergency Department physician (EDMD) B, EDMD B stated he spoke with the on duty resident, she speaks with the attending. It was a phone consultation, formally consulted, an order was written. If MD agrees consultant does not need to see the patient, OK with phone discussion. The documentation was a variable practice with residents. There is no documentation by the urology resident. During an interview on 11/19/25 at 11:45 a.m. with Urology Resident (MD C), MD C stated, she did not see the patient therefore did not write a note. Pt 1 was to be discharged home with specific medication - antibiotic and pain medications., follow up to urology stone clinic. The recommendation to go to Hospital B was not placed by me. Was aware Pt was uninsured, Pt was interested in getting surgery that evening, was stable enough to be seen in clinic. During a review of the Medical Staff Rules & Regulations (R&R), dated August 2025, the R&R indicated, “Consultations 1. ... Services may specify the minimum criteria as to when a consultation is required. Consultations must show evidence in the medical record of the consultants’ review of the patients record his or her pertinent findings on the examination of the patient and the consultant’s opinion and recommendations. 2. Two types of consultations may be obtained. Each involves different levels of patient care, management and overall responsibility on the part of the consultant. A. “Consultation only” is ordered when the attending physician wishes the consultant to review the patient records and pertinent findings to render an opinion and make treatment recommendations. The consultant is not directly involved in the patient’s management, does not place orders in the chart, or have overall responsibility for the patients care. B. “Consultation and management” are ordered when the requesting attending physician wishes the consultant to place orders in the chart and participate directly in the patient’s care management.” “ ... Suicidal patient: For the protection of patients, the medical and nursing staff, and SHC, the following standards are to be met in the case of a patient who is determined to be potentially suicidal: 1.Psychiatric consultation must be obtained immediately or as soon as the patient’s condition permits ... after a patient has threatened suicide or made a suicide attempt. 2. Prior to the consultation, the physician in charge of the care should evaluate the type of immediate care the patient requires and write appropriate orders ... 3. If a patient’s medical history or symptoms suggests problems with alcohol and or other drugs, the attending physician is encouraged to seek information and or consultation regarding alcohol and drug treatment services to assist with detoxification, referral to community resources, or treatment sources and other support.” “”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 44577 Based on interview and record review, the hospital failed to ensure an emergency medical or psychiatric condition was stabilized prior to discharge for three of 21 sampled patients, Patients 1, 15 and 12 when: 1.Patient (Pt)1 arrived in the Emergency Department (ED) with the complaint of right flank pain, Pt 1 was evaluated by the ED provider, had labs, CT Abdomen/pelvis, IV antibiotics, urology team consult. Pt 1 was discharged to go Hospital D to be admitted. This failure had the potential to result in worsening of Pt 1’s medical condition and delay necessary treatment. 2.Pt 15 arrived in the Emergency Department (ED) by ambulance from the city county jail with a chief complaint of “Head injury, Suicidal”, was evaluated by the ED provider, had labs, CT neck, EKG, placed on elopement precautions, and the suicidal risk assessment was completed. Pt was medically cleared, seen by psychiatry, met criteria for 5150 hold for danger to self. Pt 15 was currently in police custody was discharged back to jail. This failure had the potential to result in worsening of Pt 15’s psychiatric condition, increasing the risk of being a danger to self, leading to a poor health outcome and/or serious adverse event. 3.Pt 12 arrived in the ED by ambulance from the shelter for complaints of dizziness, headache, sore throat and fever. The triage note was updated to include Pt 12 felt suicidal “now” with a plan to hang self. Security was notified for a 1:1 observation. Pt 12 left without being seen. This failure to provide appropriate medical screening and stabilization had the potential for undetected deterioration of an emergency medical condition and the safety of Patient 12. Findings: 1.During a concurrent interview and record review on 11/18/25 at 9:15 a.m. with Interim Director of Quality , ED (IDQED) the medical record dated 9/15/25 indicated, Pt 1 presented with flank pain for days with associated burning with urination. Review of medical decision making indicated Pt 1 Vital signs unremarkable. Exam benign. POCUS [point of care ultrasound] left sided hydronephrosis, urine consistent with infection. Overall concern for stone with cystitis and possible urethritis (inflammation of the urethra, the tube that carries urine from the bladder out of the body ) .... especially important as patient as current/y uninsured and has no clear path to follow up and she required surgical intervention in the past. Providers note 9/15/25 at 11:33 p.m. CT abdomen Pelvis impression: obstructing calculus (kidney stone) in the proximal right ureter (a tube that carries urine from the kidney to the bladder with associated hydroureteronephrosis (a kidney stone (calculus) is stuck in the upper part of the right ureter, the tube connecting the kidney to the bladder. This blockage is causing urine to back up, leading to swelling of both the ureter (hydroureter) and the kidney (hydronephrosis). Providers note 9/15/25 at 11:51 , [discussed with] urology, recommended discharge and have patient go to [Hospital D] ED so that she can be admitted. Specifically clarified that no current emergency medical condition (no fever, normal renal function, only mild hydronephrosis, pain controlled by Tylenol and can tolerate po) so therefore no indication for admission at this time and patient is safe for discharge from the outpatient setting. Providers note 9/16/25 at 12:09 a.m. Discussed with [Hospital D] Emergency department attending physician to make her aware of the patient who will be arriving, as well as treatment that she received and are urology team’s recommendation. Providers note 9/16/25 at 12:18 a.m. Discussed with patient about recommendations from urology team. She is pain free at this time and is well appearing. She agrees to go directly to the [Hospital D] ED We are providing a copy of the CD with her imaging, strict return precautions, patient and friend amendable to plan. 9/15/25 at 10:37 p.m. timeline indicated Pt 1 received antibiotics. 9/15/25 at 11:19 p.m. Timeline indicated order placed to consult urology. During review of nursing note dated 9/17/25 at 5:35 p.m., the note indicated “EDMD B sent a prescription for the [antibiotic]. Review of “After visit Summary dated 9/15/25 indicated, instructions: Go to [Hospital D] for further evaluation and management. You have not been prescribed any medications. Diagnosis: Ureterolithiasis (he presence of a stone in the ureter, the tube that connects the kidney to the bladder), Hydronephrosis (the swelling or enlargement of a kidney due to the buildup of urine, which happens when urine cannot drain properly from the kidney to the bladder), Acute cystitis with hematuria (an inflammation of the bladder that starts suddenly, causing symptoms like painful urination, a frequent and urgent need to urinate, and blood in the urine (hematuria)). Recommendations: Go to [Hospital D] emergency department now to be evaluated by the ED physician and likely have urology consultation and admission ... During an interview 11/18/25 at 9:55 a.m. with IDQED, IDQED stated, the fastest way to get follow up care outpatient services would be to go to the [Hospital D] Emergency Department. During an interview on 11/18/25 at 2:29 p.m. with Emergency physician (EDMD) B, EDMDB stated Pt 1, there was no longer a emergency medical condition, Pt 1 did not meet criteria for admission. Pt 1 was uninsured, was unable to follow up at a SHC clinic. Pt 1 wanted follow up care as soon as possible. She was sent to [Hospital D] purely for coordination of outpatient care. Every clinic is different, for urology clinic according to the resident Pt 1 would be unable to follow up at the outpatient clinic because of insurance. During an interview on 11/19/25 at 11:00 a.m. with the ED case managers, if a patient need insurance they are referred to financial consultants. During an interview on 11/19/25 at 11:26 a.m. with Senior manager financial counseling (SMFC), SMFC stated, if patient is uninsured or insurance not identified, would trigger as self-pay. Once flagged as self-pay an attempt is made to make sure they are uninsured, once confirmed then work with venders for the hospital to assist to qualify. Vender makes contact within 24 hours. If does not qualify for insurance can offer self pay discount. The timeframe for a decision can be a week or up to 45-60 days. Advise patient to wait for decision to make an appointment. During an interview on 11/19/25 at 11:45 a.m. with Urology Resident (MD C), MD C stated, did not see the patient therefore did not write a note. Pt 1 was to be discharged home with specific medication - antibiotic and pain medications., follow up to urology stone clinic. The recommendation to go to Hospital B was not placed by me. Was aware Pt was uninsured, Pt was interested in getting surgery that evening, was stable enough to be seen in clinic. I am not aware of the wait time in the clinic. If she received treatment, it would only be a stent because she had a dirty urine (urinary infection) would not be able to treat stone until antibiotic was completed. A follow up from patient access on 11/19/25 at 1:24 p.m., Pt 1 had insurance, it was verified on 9/15/25 at 11:50 p.m during complete registration. During an interview on 11/19/25 at 3:12 p.m. urology clinic schedulers (UCS) the UCS stated there is a standard process for scheduling follow appointments, based on diagnosis and symptoms. For kidney stones usually have appointment 24-48 hrs, if there was a request for today, we have an available appointment on 11/21/25, should have been the same in September. During a follow up interview on 11/19/25 at 4:04 p.m. with EDMD B, he confirmed the CT reading “mild obstruction” is not an obstruction, it is mild hydronephrosis (a condition where the kidney swells slightly due to a small amount of urine backup, which can happen if there’s a minor, temporary blockage). Pt 1 did not meet criteria for admission. He had requested the insurance status be updated. On the MD EMR review it indicated no insurance. 2.During a review of the hospitals EMTALA logs, Pt 15 was randomly chosen for review based on psychiatric discharge diagnosis. During a concurrent interview and record review on 11/18/25 at 2:31 p.m. with IDQED the medical record dated 8/16/25 indicated, Pt 15 was BIBA (brought in by ambulance) from the city county jail complaining of back pain status post attempt to harm their self by jumping off an approximate 5 foot ledge to the floor in the jail cell. EMS (Emergency Medical Services) reports that she also had clothes around her neck in an attempt to hang herself but was never actually suspended by the neck. Review of Pt 15’s ED provider notes dated 8/16/25 indicated The patient has history of polysubstance use, MDD (Major Depressive Disorder, which is a serious mood disorder characterized by a persistent feeling of sadness and a loss of interest in activities), PTSD (post-traumatic stress disorder: a mental health condition that’s caused by an extremely stressful or terrifying event ) currently in custody presenting. via EMS after attempted hanging. Trauma work up including physical exam, CT C spine (scan uses X-rays and computer technology to produce detailed images of the bones, muscles, and other tissues in a specific area of the body -neck), CTA angiography (scan of blood vessels) negative for acute fracture, dislocation of the c-spine or associated vascular injury. Given tenderness to palpation in the T spine (back) on exam CT spine ordered without evidence of acute fracture, dislocation. Following repeat assessment and review of basic laboratory studies, patient medically cleared. Given demonstrated danger to self, psychiatry consultant for recommendations. Discussed with psychiatry because patient is currently in custody, we were unable to place her on a 5150 (psychiatric hold . a person to be involuntarily detained for up to 72 hours for a mental health evaluation). Giving in obvious risk for self-harm, psychiatry resident explored discharge plan with law enforcement who report that the patient will be held in restraints in solitary confinement. Under video surveillance and 1:1 monitoring until the morning in which she will be transferred to a psychiatric facility for incarcerated individuals. During a continued concurrent interview and record review on 11/18/25 at 2:31 p.m. with IDQED Pt 15’s provider notes dated 9/16/25 indicated: At 10:07 p.m. Per Psychiatry, unable to place on 5150 as patient is in custody. Per jail, placed patient in solitary [confinement] and hard restraints overnight until she is able to be transferred to 1:1 psychiatric supervision in custody. To avoid hard restraints throughout the night, will maintain [in] ED, with plan for discharge in the morning until she can go directly to acute observation facility in the morning. Pending Psych recs,, attempted hanging while incarcerated, negative. CTA. High risk per psych. Can’t have 5150 due to in custody. We’ll be discharged in AM to PD. At 11:10 p.m. Discussed again with Psych, recommends observation in ED overnight until patient can be directly admitted unit of Jail, Psych cannot admit given patient in custody. At 3:08 a.m. Phone call directly with Sergeant in Sheriff’s Office. Able to get patient into a safety cell (Padded walls., toilet and room with no ability to be injured., Ferguson suit (tear-resistant, quilted single-piece garment is designed to prevent individuals at high risk of self-harm from creating a noose or weapon from their clothing.), not restrained with video monitoring and ability to get to room within a few seconds. Would not be discharged into her prior jail cell. Confirmed would be evaluated ...in the morning... Confirmed with psychiatry, also comfortable with discharge to a safety cell and a plan evaluation. Review of Psychiatry Consult Service note dated 8/16/25 at 10:27 p.m. indicated, “Reason for consult: Attempted to hang herself in jail cell with sheet and jump off bunk bed. History of present illness.... On interview, The patient stated she has been in jail for the past week due to shoplifting charges. She has been withdrawing from substances including fentanyl due to being in jail and says that she has not been able to sleep since withdrawing from fentanyl. No longer endorses any withdrawal symptoms, .... She was placed in a solitary bedroom with no lights. She said, “I just wanted to sleep and I felt like I had to do something to hurt myself in order to sleep”. When asked if she actually meant to die, she says yes, she wanted to die. She has been having thoughts about wanting to die for many years, however most recently being in jail exacerbated these thoughts as well as being placed in a solitary room. .... She does say that she feels stupid for being alive currently. She endorses a plan to drink antifreeze or gasoline in order to kill herself after she gets out of jail, ... ... She says at some point I think I will be grateful I didn’t kill myself, but it doesn’t feel like it at the moment. ... Consultant assessment and recommendations: It appears that the patient’s mental health and chronic psychiatric illness has decompensated. Patient meets criteria for 5150 hold DTS (danger to self), however, is currently in police custody so cannot file a 5150 at this time. Period patient would benefit from inpatient psychiatric care given severity of suicide attempt and ongoing SI, Due to currently being in jail, she will need to be discharged to jail facilities psychiatric unit .... Disposition: Discharge per Ed back to jail while she will be transferred to jail psych unit. Patient does require inpatient level of psychiatric care at this time. Pt 15 discharged to Law enforcement on 8/16/25 at 3:27 a.m. After visit summary instructions dated 8/16 /25 indicated, “You were seen in the ED after an attempt to harm yourself. You do not have any injuries on your imaging. You do have a skin infection on your left buttocks. At this time there is cellulitis with possible early abscess developing based on our bedside ultrasound evaluation. Take the antibiotics as directed. Follow up with a primary care doctor or urgent care evaluation in one to two days for reexamination of the infection, you may need a procedure to drain an abscess. [Pt 15] is medically stable for discharge to the safety cell ...please make sure she can continue the antibiotics as prescribed. During an interview on 11/24/25 at 3:02 p.m. with Psychiatric Attending (MD E) about patients in custody not being placed on a 5150, MD E stated “that is a deviation in practice, patients [in custody] should be evaluated and treated as any other patient” . 3.Patient (Pt) 12 arrived in the ED by ambulance from the shelter for complaints of dizziness, headache, sore throat and fever. Pt 12 left without being seen. During a review of the hospitals EMTALA logs, Pt 12 was randomly chosen for review based on a left without being seen disposition. During a concurrent interview and record review of Pt 12 Patient electronic medical record (EMR), the patient care timeline indicated, at 12:47 p.m. Pt 12 was BIBA from the shelter for dizziness, headache and sore throat . At 12:51 Pt 12 was triaged c/o of pain in abdomen as 8 on 1-10 scale. Triage level 3. At 1:31 p.m. Suicide safety -nursing intervention initiated. Suicide Risk Screening “Are you having thoughts of killing yourself right now? Yes High suicide risk. 1:33 p.m. 1:1 sitter initiated, patient within reach and under direct observation at all times. Triage complaint updated: Suicidal patient walked up to station after triage stating he was suicidal with a plan to hang himself. Patient reports auditory hallucinations and visual hallucinations of people telling him he’s not good enough and that he should die.1:35 p.m. nursing note indicated Charge nurse and security notified of patients’ new complaint of being suicidal. 3:15 p.m. nursing note indicated, This RN notified by SHC security officer who was posted on patient that patient walked out of the ED and was banging on the glass of gift shop. Patient escorted off property. SHC security no notification for intervention given to this RN.” During an interview on 11/19/25 at 10:25 a.m. with the Director of Security Services (DSS), the DSS stated, “ Security is notified for suicidal patients and request for 1:1 standby. For this patient there is not a report of a standby, a report indicates the patient was observed off property, no forceful removal. The DSS stated the expectation was to alert and notify ED staff when on standby of patient leaving. During a review of the facility’s policy and procedure (P&P) titled, “EMTALA: Compliance with the Emergency Medical Treatment and Active Labor Act (EMTALA), the P&P indicated, Medical screening examination means the initial and ongoing evaluation of an individual that is conducted by a qualified medical personnel., completed in cooperation with other dedicated emergency department staff.... Dedicated emergency department, including the use of on call physicians, as appropriate, to determine whether a patient has a emergent medical condition as defined by law. Psychiatric condition: An individual with a psychiatric condition is considered stable when the individual is protected and prevented from injuring or harming themselves or others. During review of California Code, Welfare and Institutions Code - WIC § 5150 dated 1/1/23, the WIC 5150 code indicated, “(a) When a person, as a result of a mental health disorder, is a danger to others, or to themselves, or gravely disabled, a peace officer, professional person in charge of a facility designated by the county for evaluation and treatment, member of the attending staff, as defined by regulation, of a facility designated by the county for evaluation and treatment, designated members of a mobile crisis team, or professional person designated by the county may, upon probable cause, take, or cause to be taken, the person into custody for a period of up to 72 hours for assessment, evaluation, and crisis intervention, or placement for evaluation and treatment in a facility designated by the county for evaluation and treatment and approved by the State Department of Health Care Services.””

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 10918 Based on interview and record review and hospital failed to inform a patient regarding an error in inserting a colonoscope (long flexible tube with a camera and light used to examine the large colon bowel) and taking biopsies (tissues) on the wrong site for one of four patients who underwent colonoscopy procedures in accordance with hospital policy (Patient 2). This failure had the potential to cause patient concern (i.e. pain from an unexpected area), additional discomfort and a missed opportunity for the patient to ask questions. Findings: Review of Patient 2’s Progress Note, dated 6/27/25 at 10:47 a.m., indicated a physician had inserted the colonoscope into the patient’s vagina instead of the rectum. While the scope was incorrectly positioned, biopsies and specimens were obtained under the mistaken belief the scope was appropriately placed. Review of Patient 2’s record on 7/8/25 at 2 p.m. did not contain documentation the patient was informed of the mistake. During an interview on 7/8/25 at 2:06 p.m., the Attending Physician (AP, doctor who is responsible for the overall care of patient) recalled the surgical fellow (SF, physician in training) had trouble advancing the scope, biopsies were taken and the mistake of placing it into the wrong location was identified. The AP stated nurses should inform the patient and he in addition instructed the SF to speak to the patient about the mistake. During an interview on 7/10/25 at 11:42 a.m. Physician B (Phy B) stated when a mistake occurred the physician should have informed the patient. Review of the Unanticipated Outcomes - Disclosure policy, dated 02/2025, indicated to select a appropriate treating team or staff member to have a disclosure dialogue with the patient. Often, the physician guiding current and future care is the most appropriate. The policy further indicated to document the date of disclosure, who you communicated with, content of discussion and questions addressed.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 10918 Based on interview and record review the hospital failed to timely report an allegation of staff sexual abuse to a patient when management staff were informed by a nursing asssistant (NA) for one of one sampled patient (Patient 1). The hospital did not report to the Adult Protective Services (APS) or local law enforcement and did not timely report (within five days) to the California Department of Public Health (CDPH) in accordance with hospital policies. This failure resulted in the lack of or late investigations and to not take potential further actions by the respective departments. Findings: Review of Patient 1’s record indicated the patient was admitted on 5/32/25 and discharged from the hospital on 5/26/25. During an interview on 7/8/25 at 2:41 p.m., the NA D stated she witnessed in the morning registered nurse (RN) E stating to Patient 1 that he was the captain of the cruise ship, you do not tell the captain what to do and you had to listen. Patient 1 then stated she was just trying to figure out who was taking out a meal tray. During the same interview on 7/8/24 at 2:41 p.m., NA D stated later the same day she witnessed RN D during hygiene care cupping Patient 1’s breast, holding it and asked the patient if she had a breast implant. NA D stated she did not report the incident to a management staff the same day because the staff member was not there. During an interview on 7/8/25 at 12:16 p.m., the senior director of quality management and regulatory affairs (SDQMRA) stated Patient 1 did not complain to the organization, we heard it from a staff member. If the patient had complained the incident would have been reported to CDPH immediately. During an interview on 7/8/24 at 1:37 p.m., the director of service excellence (DSE) stated staff should immediately report abuse incidents, the incident occurred on 5/24/25 and the NA reported the incident on 5/28/25, RN D was terminated on 6/20/25 and the incident was reported to CDPH on 6/23/25. The DSE stated in hindsight the incident should have been reported to CDPH earlier. During an interview on 7/10/24 at 3:03 p.m., the Director of Security Services (DSS) stated the incident by definition was classified as sexual assault, the team had a huddle and discussed the incident and did not report it to APS or local law enforcement. Review of the Abuse and Neglect Reporting Procedures policy, dated March 2023, indicated all licensed staff who have observed, have knowledge of an incident that reasonably appeared to be abuse were mandated to provide an immediate telephone report and written report to Adult Protective Services or local law enforcement. The Reporting Adverse Patint Event To Regulatory policy, dated July 2022, indicated the hospital was required to report adverse events to CDPH no later than five days after the adverse event had been detected and it referenced to Abuse and Neglect Reporting Procedures.”

“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: 10918 Based on interview and record review the hospital failed to perform a complete time out (immediate pre-procedure pause by the entire team or the individual to confirm the correct patient, procedure and site) by not including a physician who initiated the colonoscopy (medical procedure to examine the large intestine using a thin, flexible tube) for one of four sampled patients who underwent colonoscopies (Patient 2). This failure had the risk to result in wrong site procedure. The facility also failed to ensure a registered nurse (RN) had evaluated a patient’s status as part of post colonoscopy discharge criteria for one of four sampled patients who underwent colonoscopies (Patient 2). This failure placed the patient at health risk and could not been sufficiently recovered from the procedure. Findings: 1. Review of Patient 2’s Progress Note, dated 6/27/25 at 10:47 a.m., indicated a Surgical Fellow (SF, physician in training) had inserted the colonoscope (long flexible tube with a camera and light used to examine the large colon bowel) into the patient’s vagina instead of the anus. It indicated while the scope was incorrectly positioned, biopsies and specimens were obtained under the mistaken belief the scope was appropriately placed. Review of Patient 2’s Timeout form, dated 6/27/25 at 8:40 a.m., indicated the attending physician, anesthesiologist, registered nurse, were in attendance and indicated none others were present. The SF was not included in the time out. During an interview on 7/10/25 at 12:10 p.m., registered nurse (RN) B stated everyone present for a case was to be included in time out, especially anyone touching the patient. Review of the Universal Protocol policy, dated July 2022, indicated all immediate members of the procedure team were to participate in the time out process. Participation required that all team members were attentive and all activity ceased for the duration. Components of time out included correct procedure and correct site were required to be verified. 2. Review of the Endoscopy (medical procedure to examine intestines) Post Procedure form, under Discharge Status had patient discharge parameters including presence of active bleeding, awake or easily aroused, able to ambulate (walk), discharge teaching complete, and patient had transportation home accompanied by a responsible adult. Review of Patient 2’s Discharge Status of the Post Procedure form was not completed. During an interview on 7/15/25 at 3:03 p.m., registered nurse (RN) C stated Patient 2 informed her she was ready to go home and the patient’s discharge instruction consisted of informing the patient to call if any questions arose. The RN C stated she forgot to document in Patient 2’s discharge status and acknowledged that was a part of the discharge criteria. The policy addressing post procedure discharge was requested and not provided by 7/18/25.”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 48590 Based on interview and record review, the hospital failed to comply with the Conditions of Participation for Surgical Services as evidenced by: Failure to follow its policy and procedure (P&P) titled “Universal Protocol” when: (1) medical providers performed a procedure on the wrong side for one patient, and (2) there was no time out documentation for each procedure performed. The cumulative effect of these deficient practices resulted in the hospital’s inability to ensure the provision of quality health care.”

“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: 48590 Based on interview and record review, the facility failed to implement surgical services policies for one of 30 sampled patients (Patient 16) when two medical providers performed a procedure on the wrong side and there was no time out process documentation for each of the procedures performed. These failures resulted in Patient 16 sustaining a pneumothorax (commonly known as collapsed lung, a condition where air leaks into the space between the lungs and chest wall) after a chest tube was placed on the wrong side. Findings: A review of Patient 16’s “History and Physical” (H&P), dated 1/1/25, indicated Patient 16 was transferred to the facility for a higher level of care on 1/1/25 with diagnoses including acute pulmonary embolism (a condition where a blood clot travels to the lungs and blocks one or more pulmonary arteries), acute kidney injury (a sudden decline in kidney function that occurs over a short period), and acute respiratory failure (a condition where the lungs cannot get enough oxygen into the blood). A review of Patient 16’s H&P, dated 2/4/25, the H&P indicated a computed tomography (CT, a medical imaging technique that uses x-rays, a type of radiation called electromagnetic waves, and computer technology to create detailed cross-sectional images of the body) scan on 2/2/25 displayed left intrapulmonary abscesses (a localized collection of pus within the lung tissue), and small pleural effusion (build-up of excess fluid between the layers of tissue that line the lungs and chest cavity). During a concurrent interview and record review on 3/7/25, at 2:48 p.m., with Nursing Quality Management Coordinator (NQMC) A, NQMC A stated Patient 16 was to have a left chest tube placement on 2/4/25, but ended up having the chest tube inserted in the right side causing pneumothorax. A time out was done to confirm the correct site. NQMC A stated a pigtail (a small, flexible tube with a coiled or looped end used to drain fluid or air from a body cavity or wound) was placed on the right side to correct the pneumothorax. During an interview on 3/10/25, at 8:54 a.m., with NQMC B, NQMC B stated there was no documentation of the first chest tube placement procedure including time out when the chest tube was inserted on the right side leading to pneumothorax. During an interview on 3/10/25, at 1 p.m., with the Attending Physician (AP, a fully trained and licensed medical doctor), AP stated a chest tube was to be inserted on the left side of Patient 16’s chest because of the concern of empyema (a collection of pus in the area between the lungs and the chest wall). The AP stated Patient 16 was positioned on the bed with the left side down, right side up. The AP stated the Fellow (FP, a type of doctor who has advanced training in a medical subspecialty) tried to insert the chest tube once or twice but was unable to get any fluid. The AP then tried but was only getting air back (air entering the space between the lungs and chest wall through the chest tube). The AP stated he only realized the chest tube was placed on the wrong side after the chest x-ray (uses radiation to create an image of the heart, lungs, and bones) was done. A review of Patient 16’s chest x-ray, dated 2/4/25, indicated the finding of new moderate right pneumothorax. A review of Patient 16’s “Procedure Note,” dated 2/4/25, indicated a right insertion of pleural catheter drain (a thin, flexible tube inserted into the space between the lung and chest wall to drain excess fluid) with image guidance under local anesthesia (a type of medication that temporarily blocks pain and other sensations in a specific area of the body) was performed by the AP and the FP. The indication for the procedure was pneumothorax. The Procedure Note further indicated that a time out was performed, and the site of entry was marked. The site of entry was sterilized (process of removing all forms of microorganisms), and local anesthesia was accomplished. Next a small incision (a surgical cut made in skin) was made. A needle was then used to enter the pleural space (a thin, fluid-filled cavity located between the lungs and the chest wall) while aspirating (the process of withdrawing fluid from the body). Then a catheter was advanced into the pleural space, and then connected to a pleurovac chamber (a chest drainage system used to remove fluid and air from the pleural space after surgery or trauma preventing re-entry of air or fluid into the pleural cavity). A review of Patient 16’s “Procedure Note,” dated 2/4/25, indicated that a left insertion of pleural catheter drain was performed. The indication for the procedure was pleural effusion. The Procedure Note further indicated that a time out was performed, and the site of entry was marked. The site of entry was sterilized, and local anesthesia was accomplished. At the site of entry, the needle was then advanced but pleural fluid could not be accessed. The procedure was therefore aborted (to stop before being completed). During an interview on 3/10/25, at 1:31 p.m., with the Nursing Professional Development Specialist (NPDS), the NPDS stated the AORN (Association of perioperative Registered Nursing, a professional organization dedicated to advancing perioperative nursing practice) was utilized and referenced in the facility’s policy. During an interview on 3/10/25, at 1:37 p.m., with the Director of Quality Management Regulatory Affairs (DQMRA), the DQMRA stated the team did not document each time out process for each attempt of chest tube placement. During an interview on 3/11/25, at 10:12 a.m., with the Director of Informatic Education (DOIE), the DOIE stated the expectation for staff was to document each procedure in the medical record. During a telephone interview on 3/12/25, at 4:36 p.m., with DQMRA, the DQMRA stated the FP was currently overseas and will not be back until 3/20/25. Unable to be interviewed. Review of the facility’s policy and procedure (P&P), titled “Universal Protocol,” dated 7/22, indicated “The purpose of this policy is to provide a process to reduce the risk of wrong patient, wrong procedure, and/or wrong site surgery and procedures ...The following components of the Time Out are required to verify ...correct site ...The LIP (Licensed Independent Practitioner)/APP (Advanced Practice Providers) who initiated the time out must ask the team members if everyone is in agreement before proceeding with the procedure ...For all procedures requiring consent ...the Time Out must be documented in the patient’s electronic health record.” Review of the Association of periOperative Registered Nurses (AORN) “Guidelines for Perioperative Practice Time Out,” indicated “[5.1] Perform a time out before an operative or other invasive procedure begins. The time out is a tool to prevent wrong site surgeries. The purpose of the time out is for the perioperative team to conduct a final check that the correct patient, correct site, and correct procedure are identified ...[5.2] Use a standardized time-out process as defined by the facility ...[5.2.4] During the time-out process, the team must confirm, at a minimum, the correct patient, site, and procedure to be performed ...[5.2.8] After the time out is performed, document the time out as completed in the patient’s medical record in accordance with facility policy ...[5.4] Identify when a subsequent or second time out should be performed or a safety stop initiated. The second time out provided an opportunity for members of the perioperative team to discuss concerns about patient safety and address issues ...””

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 48590 Based on interview and record review, the hospital failed to ensure the registered nurse evaluated the nursing care for four of 30 sampled patients when pain assessment and/or reassessment was not done for Patients 6, 20, 30, and 22. This failure had the potential for patients to have continued pain. 1. Patient 6 was admitted to the hospital on 10/29/24 for Hypoxic Respiratory Failure (a condition where not enough oxygen in the body). During a concurrent interview and record review, on 1/14/25 at 9:28 a.m., with Nursing Quality Management Coordinator A (NQMC A) , Patient 6’s pain was assessed on 11/26/24 at 4:00 a.m., 11/28/24 at 7:49 p.m., and 12/3/24 at 5:08 p.m. prior to administration of Oxycodone (a narcotic used to treat moderate to severe pain). NQMC A confirmed that there was no pain reassessment done within 1 hour after administration of pain medication. Patient 6’s pain was not assessed prior to administration of Oxycodone on 11/28/24 at 2:02 a.m., and no pain reassessment conducted within one hour after administration of pain medication. NQMC A confirmed there was no pain assessment and reassessment done. Patient 20 was admitted to the hospital on 11/14/24 for infection (a disease caused by microorganisms that invade tissue). During a concurrent interview and record review, on 1/15/25 at 10:42 a.m., with NQMC B, Patient 20’s pain was assessed on 11/30/24 at 5:44 a.m., with pain level of 6 of 10, and Oxycodone was administered. NQMC B confirmed there was no pain reassessment done within one hour after administration of pain medication. Patient 30 was admitted to the hospital on 11/25/24 for sepsis (the body’s response to an infection). During a concurrent interview and record review, on 1/15/25 at 1:54 p.m., with NQMC B, Oxycodone was administered to Patient 30 on 1/14/25 at 7:35 p.m. without pain assessment. NQMC B confirmed there was no pain assessment prior to administration of pain medication. 38068 2. Patient 22 was admitted to the hospital on 1/11/25. During a concurrent interview and record review, on 1/15/25 at 2:12 p.m., with NQMC B, Tylenol 650 mg was administered orally to Patient 22 on 1/11/25 at 5:55 p.m. NQMC B confirmed there was no pain reassessment done within one hour after administration of pain medication. During a review of the hospital’s policy and procedure (P&P), titled “Standards of Practice for Acute and Critical Care Nursing”, last approval date 11/24, indicated “Pain assessment (reassess within 1 hour of intervention).” During a review of the hospital’s P&P, titled “Pain Management’, last approval date 12/21, indicated “(II)(C) Guiding principles for assessment and treatment of pain ...(4) Patients should be assessed for adequacy of pain control ...(IV)(B)(2)(a) pain is assessed upon admission/arrival to the patient care area ...and includes assessment ...interventions ...””

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 46939 Based on interview and record review, the hospital failed to comply with the Condition of Participation for Surgical Services as evidenced by: 1. The hospital failed to follow its policy and procedure (P&P) titled, “Universal Protocol” when, staff began a surgical procedure on the wrong surgery site. (Refer to A951) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality health care in a safe environment.”

“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: 46939 Based on interview and record review, the facility failed to follow its Policy and Procedure (P&P) titled, “Universal Protocol” for one of 30 sampled patients (Patient 20). When surgical staff who participated in a surgical procedure were not present during the site marking, and entire duration of final timeout (an immediate pause by the medical team to confirm the correct patient, procedure, and site). This failure resulted in the start of a surgical procedure on the wrong surgical site. Findings: During a review of Patient 20’s “Operative Report” dated, 10/22/24, Report indicated, “Procedure performed: Left endoscopic [a procedure using a tool to look inside the body] medial maxillectomy [procedure to remove part of your maxilla (bone) nearest to your nose and adjoining teeth] for resection of [removal of] dentigerous cyst [fluid-filled sac that forms around the crown of an unerupted permanent tooth] Left partial ethmoidectomy [removal of infected tissue and bone in the ethmoid sinuses]”. Report indicated, “Surgeon: [Ear Nose and Throat (ENT) Surgeon A] . . . Assistant (s): [Medical Doctor (MD) B.] Report indicated, “Procedure details: The surgery began on the right with an uncinectomy. [removal of the uncinate process: a thin hook-like structure of the wall of the lateral nasal cavity] . . .The uncinate was removed. . .within one minute of initiating the procedure, it was understood that the cyst was on the contralateral [opposite] side. As a result, the remainder of the surgery was performed on the left. . . I was physically present and directly participated in all portions of the above procedure.” Signed by ENT A. During a review Patient 20’s “Consent to Operation”, dated 10/19/24, Consent indicated, “Operation or procedure: Left endoscopic maxillary antrostomy [procedure to clear sinus opening]”. During an interview on 12/18/24, at 11:54 a.m., with Senior Quality Consultant (SQC) C, SQC stated, “If a new staff member came in [to operating room] who was not present during the timeout then a new one should have been performed”. During an interview with ENT A on 12/18/24, at 4:22 p.m., ENT A stated, “I was present during the second time out for my procedure. The site marking was done by me in pre-op. I marked the left side near the jaw. The resident [MD B] performed the initial start of the procedure. [MD B] was not present during the timeout for this procedure, typically they are present during the timeout, but [MD B] was elsewhere”. ENT A stated, “I was not present during the initial start of the procedure, when I came back in, [MD B] told me she started on the right side, then realized it was the incorrect side and started on the left side”. ENT A stated, he took over the procedure when he returned to the room. During an interview with MD B on 12/18/24, at 4:34p.m., MD B stated, “I was present at the very end of the second time out”. MD B stated, “I saw they marked the left jaw”. MD B stated, “[ENT A] and I had a verbal communication, start on the left maxillary”. MD B stated, “I started on the right side, I removed the tissue of the uncinate process to visual where I needed to go, after that first step, I realized it was the wrong side, because there was no blood from the prior procedure. I let everyone know that it was the wrong side, then I started on the correct side, then [ENT A] took over the rest of the procedure”. During a review of the facility’s P&P titled, “Universal Protocol” dated 2022 , the P&P indicated, “The purpose of this policy is to provide a process to reduce the risk of wrong patient, wrong procedure, and/or wrong site surgery and procedures. Universal protocol is applicable to all invasive procedures and non-invasive procedures with more than minimal risk to the patient, and excludes procedures that do not require informed consent. . . Procedure: B. Marking the operative or procedure site 2. The site will be marked by the person who is ultimately accountable for the procedure and will be present during the procedure. . . D. Final Verification-Time out 1. The Time Out is initiated by the LIP/APP [Licensed individual practitioner/Advanced practice provider] who will make the initial incision, puncture, or perform the procedure. . .2. All immediate members of the procedure team are to participate in the time-out process”.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 36623 Based on interview and document review, the hospital failed to develop an effective, ongoing, hospital wide, data driven quality assessment and performance improvement (QAPI) program as evidenced by: 1. Failure to identify the hospital’s MRI hazard checklist was complete in accordance with American College of Radiology (ACR) in order to prevent patient safety events (Refer to A-283); 2. Failure to review and revise the hospital’s MRI Safety policy as required (Refer to A-283). These cumulative failures resulted in the hospital’s inability to provide quality health care as required by the QAPI Program Condition of Participation and provide care to their patients in a safe environment. Patient 18 had an esophageal temperature probe (a device used to measure core body temperature) and underwent a magnetic resonance imaging (MRI, a medical imaging procedure that uses strong magnetic fields to create images of the inside of the body) scan, and it resulted in Patient 18 sustaining burn injuries to the lips, mouth, and tongue.”

“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: 37686 Based on interview and record review, the hospital failed to comply with the Condition of Participation for Nursing Services as evidenced by: 1. Failure to implement hospital policy and procedure when nursing staff did not change the patient’s condom catheter (a urine collection device that fits over the penis and is held in place with adhesive) (Refer to A-398). 2. Failure to identify and communicate the presence of an esophageal temperature probe (a device used to measure core body temperature) prior to a magnetic resonance imaging (MRI, a medical imaging procedure that uses strong magnetic fields to create images of the inside of the body) (Refer to A-398). The cumulative effect of these deficient practices resulted in the facility’s inability to provide quality health care in a safe environment. Patient 2 developed a condom catheter-related pressure injury (pressure-related damage to the skin and/or underlying tissue). Patient 18 suffered burn injuries to the lips, mouth, and tongue during the MRI.”

“RADIOLOGIC SERVICES CFR(s): 482.26 The hospital must maintain, or have available, diagnostic radiological services. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications. This Condition is not met as evidenced by: 36623 Based on observation, interview, and record review, the hospital failed to comply with the Condition of Participation for Radiologic Services as evidenced by: Failure to maintain compliance with facility policy and in accordance with American College of Radiology (ACR)’s safe Magnetic Resonance Imaging (MRI, a medical imaging procedure that uses strong magnetic fields to create images of the inside of the body) practices (refer to A535). The cumulative effect of this systemic problem resulted in the hospital’s inability to ensure the provision of quality health care in a safe environment. Patient 18 had an esophageal temperature probe (a device used to measure core body temperature) and underwent an MRI and it resulted in Patient 18 sustaining burn injuries to the lips, mouth, and tongue.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 36623 Based on interview and record review, the hospital failed to ensure two of 31 patients (Patients 12 and 24) were informed of their health status when: 1. Patient 12 did not receive the results of a colonoscopy (a procedure that uses a colonoscope [flexible tube with a light and camera on one end] to examine the inside of the colon [large intestine]) from 2018 that showed lymphoma (type of blood cancer); 2. Patient 24 did not receive information on her PET/CT (a combined picture from a positron emission tomography [PET] scan and a computed tomography [CT] scan) results with recommendations for further evaluation. These failures resulted in the patients not being informed of their abnormal procedure results timely and had the potential to result in delayed treatment. Findings: 1. Review of Patient 12’s medical record indicated the patient was scheduled for a colonoscopy with biopsy (procedure that involves removing tissue or cells from the body for examination) on 12/12/18. Review of Patient 12’s Pathology Specimen Review, dated 12/12/18 indicated eight specimens were collected during the colonoscopy and examined. The Review further indicated, “ ... findings support a diagnosis of mantle cell lymphoma [cancer of white blood cells]” and was signed by the gastroenterologist (GI) physician (GIP). There was no documentation in Patient 12’s medical record that indicated the patient was informed of his colonoscopy/biopsy results and diagnosis of mantle cell lymphoma. Review of Patient 12’s Surgical General results, dated 10/2/24 indicated he had a colonoscopy with biopsy and esophagogastroduodenoscopy, (EGD, procedure that uses an endoscope [flexible tube with a light and camera on one end] to examine the upper digestive tract [esophagus, stomach, or small intestine]) with biopsy on 10/2/24. The results further indicated a diagnosis of residual/recurrent mantle cell lymphoma. Review of Patient 12’s Progress Notes, dated 10/10/24 indicated, “Called patient with Spanish interpreter to discuss recent EGD/Colonoscopy biopsy results showing mantle cell lymphoma of the colon as well as adenocarcinoma [a type of cancer that starts in the glands lining the inside of organs] (likely invasive) of the colon. I disclosed that pathology results from his colonoscopy in 2018 also showed mantle cell lymphoma. The patient reports he was never informed of the pathology results from 2018 and was surprised to hear about this result. I explained to the patient that [the hospital] is looking into what occurred in 2018 to understand why he was not informed about the biopsy results. The patient needs to be evaluated by a medical oncologist for his mantle cell lymphoma and a colorectal surgeon for his colon adenocarcinoma. I will place expedited referrals to these two specialties today.” During an interview on 11/6/24 at 3 p.m., the Executive Director of Quality & Safety (EDQS) stated there was a technology issue that affected how the results were sent to the provider. The EDQS stated the doctor was devastated that the results were missed. During an interview on 11/12/24 at 2:56 p.m., the Laboratory Quality Director (LQD) and Director of Surgical Pathology (DSP) stated the ordering provider was the GIP. The LQD and DSP stated once reports are finalized, they are available for providers and the GIP should have informed Patient 12 of his 2018 colonoscopy results. 44733 2. Review of the hospital’s grievance records indicated Patient 24 reported that she was not informed about her PET/CT) findings which was performed on 12/20/23. Review of Patient 24’s medical record indicated she had an outpatient visit to the facility’s heart failure clinic on 12/20/23 for routine follow-up. Review of Patient 24’s Study Result for PET/CT Heart Sarcoidosis (a rare autoimmune disease that causes inflammation and scarring in the heart), dated 12/20/23, indicated two impressions. The result indicated, “Intense radiotracer uptake (displays when cells in a specific area of the body absorb more of a radiotracer than the surrounding tissues) in the uterus (a hollow muscular organ located in the female pelvis) unlikely to be physiologic (normal fuctioning) given age, recommend further evaluation with pelvic ultrasound (an imaging test) and gynecologic exam (a physical exam of the reproductive organs).” Review of Patient 24’s Heart Failure Clinic Patient Follow Up, dated 12/20/23, indicated, “PET done earlier today for evaluation of cardiac sarcoid - results pending though initial images do not appear overly positive.” During an interview and record review on 11/13/24 at 10:16 a.m. with Quality Specialist (QS) D, she confirmed there was no documentation indicating Patient 24 was informed about the PET/CT finding of intense radiotracer uptake in the uterus or recommended for the further evaluation with pelvic ultrasound and gynecologic exam. During a review of the hospital’s policy and procedure (P&P) titled, “Patient Rights and Responsibilities Policy,” approved 11/2024, the P&P indicated, “Patients have the right to: ... 5. Receive information about the health status, the course of treatment, prospects for recovery, and outcomes of care (including unanticipated outcomes) in a manner that the patient can understand and in their preferred language.””

“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: 44733 Based on interview and record review, the hospital failed to obtain an order for the use of restraints (any manual method or device that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely) for one of three patients (Patient 21) when Patient 21 was placed in bilateral (both sides) wrist restraints without a physician order. This failure had the potential to result in an inappropriate and prolonged use of restraints. Findings: Review of Patient 21’s medical record indicated she was admitted to the facility on 11/05/24 for stereo intracranial EEG lead placement (a procedure where electrodes are surgically inserted into the skull to monitor brain activity). Review of Patient 21’s restraints flowsheet, dated 11/06/24 to 11/12/24, indicated the patient had soft restraints on the right wrist and left wrist, starting on 11/06/24 at 7:49 a.m. Review of Patient 21’s physician’s orders, dated 11/07/24 to 11/12/24, indicated the patient had an order for restraints for both wrists. There was no order for restraints for both wrists on 11/06/24. During an interview and record review on 11/12/24 at 10 a.m. with Nursing Quality Management Coordinator (NQMC) A, he confirmed there was no order for bilateral wrist restraints on 11/06/24. During a review of the hospital’s policy and procedure (P&P) titled “Restraint and Seclusion,” approved 2/2024, the P&P indicated, “All assessments, care provided, and orders will be documented in the patient’s EHR. In an emergency, trained RN can initiate the application of restraints and obtain an order from a LIP/APP as soon as patient has been safely restrained. LIP/APP orders for non-violent restraints must specify the following: type of restraints used; description of condition requiring restraints; criteria for release; order duration.””

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 36623 Based on interview and record review, the hospital failed to fully implement its Quality Assessment and Performance Improvement (QAPI) program when the program did not identify the hospital’s magnetic resonance imaging (MRI, a medical imaging procedure that uses strong magnetic fields to create images of the inside of the body) screening process was inadequate and did not meet standards of practice. The QAPI program also did not identify the hospital’s MRI Safety policy required to be reviewed and revised. These deficient practices resulted in burns to Patient 18’s lips, mouth, and tongue and had the potential to jeopardize the health and safety of patients. Findings: Review of Patient 18’s Vascular Surgery Progress Note, dated 4/25/24 indicated the patient was admitted to the hospital on 4/6/24 with diagnoses including ruptured abdominal aortic aneurysm (AAA, enlargement of the aorta, the main blood vessel that delivers blood to the body). The note indicated Patient 18 underwent a procedure to repair the aneurysm, was intubated (a medical procedure that involves inserting an endotracheal tube [ETT] into a person’s airway to help them breathe), sedated (in a state of calmness, relaxation, or sleepiness caused by certain drugs) and required continuous renal replacement therapy (CRRT, a type of dialysis that removes wastes, toxins, and excess fluid from the body). Review of Patient 18’s Flowsheets, from 4/6/24 to 5/28/24 indicated on 4/22/24 at 10 a.m., Patient 18 had a temperature of 38.4 degrees Celsius (measurement of temperature) and the temperature source (how the temperature was taken) was “esophageal.” Patient 18’s Flowsheets also indicated on 4/25/24 the patient temperature source was “esophageal” at 2 a.m., 3 a.m., 4 a.m., 5 a.m., and 6 a.m. Review of Patient 18’s Comprehensive Critical Care Notes, dated 4/25/24 indicated on 4/24/24 the patient had an MRI of the brain and it was recommended that Patient 18 have an MRI of the spine. Review of Patient 18’s Screening Form Questions, dated 4/25/24 indicated Patient 18 had an appointment scheduled on 4/25/24 at 3 p.m. for MR Thoracic and Lumbar Spine (middle and lower section of the backbone). The form also indicated the answer to the question, “Does your patient have a temperature sensitive Foley?” was “No.” The form did not include a question regarding an esophageal temperature probe. Review of Patient 18’s Study Result MR Thoracic and Lumbar Spine indicated the patient’s exam ended on 4/25/24 at 5:25 p.m. Review of Patient 18’s Flowsheets, dated 4/25/25 indicated the patient had wounds to the left lateral (to the side) lip and mouth, first assessed on 4/25/24 at 7:25 p.m. The Flowsheets also described the mouth wound as tongue white blistering and surrounding skin was edematous (swollen with fluid). Review of Patient 18’s Comprehensive Critical Care Note, dated 4/26/24 indicated, “... esophageal temp probe found melted in mouth with wire exposed, some burns noted along lips ...” Review of Patient 18’s Otolaryngology - Head and Neck Surgery Consult History and Physical, dated 4/26/24 indicated, “Yesterday, patient was taken to radiology to undergo an MRI T and L spine. Unfortunately, an esophageal temperature probe was kept in place for the duration of the scan (approximately 90 minutes). Once the patient was received, primary team noticed the probe fused to his upper left lip, ETT and tongue. ENT consulted for evaluation of oral and OP burns and management.” The consult also indicated the pertinent findings of a flexible fiber laryngoscopy were the following: temp probe adhered to ETT; Burns involving the left upper lip; burn with fibrinous tissue involving 40% of central tongue, 30% of soft and hard palate, right base of tongue. Review of Patient 18’s Plastic and Reconstructive Surgery History and Physical/Consult Note, dated 4/26/24 indicated, “Plastic surgery was consulted to evaluate the lip burn ... Will require surgical reconstruction pending clinical stability.” During an interview on 11/7/24 at 11:30 a.m., the MRI Manager (MRIM) stated when a patient has an order for an MRI, a screening form is generated for a nurse to complete. She stated once the form is completed, the MR technologist (tech) would review the answers and ask questions as needed. She stated when the patient was taken to the department, the MR tech does a visual check on the patient before the MRI procedure. The MR tech also waves a mental detecting wand over the patient to identify any unknown metal before the procedure. The MRIM stated Patient 18 was on a ventilator and the nursing team took the patient to get an MRI. She stated after Patient 18’s MRI, the MRIM was alerted that there was a concern with a burn. The MRIM stated a nurse did an assessment and saw that Patient 18 still had an esophageal temperature probe in place. The MRIM stated they reviewed the screening form the hospital used and identified that the form only asked if the patient had a foley catheter (a tube inserted in the urinary tract into the bladder to drain urine) temperature probe. She stated the form did not ask about other temperature probes, like an esophageal probe. The MRIM stated in an ideal world, the esophageal temp probe should have been identified by the MR tech during the visual check. She stated the MR tech did not realize there was an esophageal temp probe in place because it was white and looked like it was part of Patient 18’s ET tube/respiratory equipment. She stated the MRI generated heat because of the metal in the esophageal probe, which caused the plastic on the probe to melt, and resulted in Patient 18’s burns in his mouth. During an interview on 11/8/24 at 8:55 a.m., the MR tech (MRT) involved in Patient 18’s 4/25/24 MRI stated the responsibility of the MR tech to confirm verbally with the nurse that the patient did not have any devices that could not go in the MR scanner. The MRT stated he did a visual check on Patient 18 and did not identify the esophageal probe because of the respiratory bundle surrounding the patient’s mouth. The MRT stated that the hospital’s MRI screening form did not have a question asking whether the patient has an esophageal probe. During an interview on 11/13/24 at 1:02 p.m., the MRIM stated the hospital’s MR policy was not changed. During a telephone interview on 11/14/24 at 3:25 p.m. the Executive Director Quality & Safety (EDQS) stated the hospital uses The American College of Radiology as their reference. She stated the hospital policy was adapted from ACR, but it might not be 100 percent what is published. Review of the hospital’s policy, “Magnetic Resonance Imaging (MRI) Safety”, last approved 7/2019 indicated, “Practices outline here are aligned with the 2017 American College of Radiology (ACR) Practice Parameters for Performing and Interpreting MRI and the 2013 ACR Guidance Document on MRI Safe Practices.” The policy also indicated, “All patients entering Zone 4 [MRI scanner magnet room] will be thoroughly screened for non-MRI conditional apparatuses prior to entry ... it is the responsibility of the MRI technologist to review the screening form with the patient and visually check for any metal objects.” The policy further indicated, “This policy will be reviewed and/or revised every three years or as required by change of law or practice.” The hospital’s policy should have been updated in 2022. Review of “Appendix A; MRI Screening Procedure for Incapacitated Inpatients,” of the hospital’s “MRI Safety” policy, indicated, “The MR safety screening form is the final safety checkpoint for patients undergoing a MRI exam ... The screening for will then be filled out with the nurse who will go through the questions ...” Review of the ACR Guidance Document on MR Safe Practices: 2013 contained Appendix 2, which included a “Hazard Checklist for MRI Personnel.” The checklist indicated an area to check yes or no to the following: Endotracheal tube, Swan-Ganz catheter (a tube placed inside the heart to monitor heart function and blood flow), Extra ventricular device (a system that drains fluid from the brain), Arterial line transducer (a device used to measure blood pressures), Foley catheter with temperature sensor and/or metal clamp, Rectal probe (device inserted in the rectum to take temperature or examine the rectum), Esophageal Probe (device inserted in the esophagus to take temperature), Tracheotomy tube (tube inserted in the trachea to help with breathing), and Guidewires (a thin wire used to help place catheters in the body). According to the American College of Radiology (ACR) website, “MR Safety continues to evolve and in response, the ACR’s Committee on MR safety created the ACR Manual on MR Safety with updates and critical new information which replaces all earlier versions of the ACR Guidance Document on MR Safe Practices.” The website contained links to access documents, including the ACR Manual on MR Safety 2024 and Safety Screening Form for MR Procedures. Review of the “ACR Manual on MR Safety 2024” indicated, “This 2024 edition of the ACR Manual on MR Safety replaces all earlier versions.” Review of ACR’s Safety Screening for Magnetic Resonance (MR) Procedures indicated the Hazard Checklist for Level 2 MR Personnel included yes/no check boxes for the following: pulse oximetry device, EKG pads/leads, Endotracheal tube, Swan-Ganz catheter, Extra ventricular device, Arterial line transducer, Foley catheter with temperature sensor and/or metal clamp, Rectal probe, Esophageal Probe, Tracheotomy tube, Guidewires, Halo vest, and other. The screening procedures also indicated, “If any Level 2 MR Personnel checklist items are answered yes, this should be brought to the attention to the covering MR Physician.” Review of the hospital’s “Quality Assessment and Performace Improvement Plan 2024,” approved 2/2024 indicated, “Along with Management Guidance Team, Quality Councils, and Improvement Programs, [the hospital] seeks input from executive leadership, departments, and services from all areas involved with quality performace measurement and improvement to determine if there are gaps or opportunities for improvement.””

“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: 37686 Based on interview and record review, the hospital failed to implement its policies and procedures for two of 10 patients when: 1. Nursing staff did not change Patient 2’s condom catheter (a urine collection device that fits over the penis and is held in place with adhesive); and 2. Nursing staff failed to identify and communicate the presence of Patient 18’s esophageal temperature probe (a device used to measure core body temperature) prior to a magnetic resonance imaging (MRI, a medical imaging procedure that uses strong magnetic fields to create images of the inside of the body). These failures resulted in injuries for both patients. Patient 2 developed a condom catheter-related pressure injury (pressure-related damage to the skin and/or underlying tissue). Patient 18 suffered burn injuries to the lips, mouth, and tongue during the MRI. Findings: 1. Review of Patient 2’s History & Physical, dated 9/14/24, indicated Patient 2 was admitted with diagnoses including Huntington’s disease (a disease that causes nerve cells in the brain to decay over time) and perirectal abscess (a collection pus in the rectal area). Review of Patient 2’s skin assessment, dated 9/15/24, indicated Patient 2 did not have any wounds or other skin issues at the time of this assessment. Review of Patient 2’s External Urinary Catheter assessment indicated the hospital placed a condom catheter on Patient 2 on 9/15/24 at 7:30 p.m. The assessment further indicated the condom catheter was removed on 9/20/24 at 9:00 a.m. There was no documentation in the medical record that indicated the hospital changed Patient 2’s condom catheter from the time it was placed to the time it was removed. Review of Patient 2’s Progress Notes, dated 9/20/24, indicated Patient 2’s condom catheter was accidentally pulled off when he turned in bed. The Progress Notes further indicated a wound was found on Patient 2’s penis. Review of Patient 2’s Wound Ostomy Continence Nurse (WOCN) Note, dated 9/20/24 indicated, “Wound care consult for wound to penile area. Per primary RN [registered nurse] noted wound on removal of condom catheter. Patient denies having wound to area prior. Patient reports having catheter in place for 4 days.” The WOCN Note further indicated the wound on Patient 2’s penis was a stage 3 pressure injury (full-thickness loss of skin). Review of Patient 2’s Neurology Discharge Note, dated 9/20/24, indicated he had a pressure-related wound on the penis. The note further indicated this was a condom catheter-related wound that needed wound care twice a day. During an interview and concurrent record review with quality specialist B (QS B) on 11/6/24 at 10:04 a.m., QS B acknowledged that the hospital’s policy indicated condom catheters must be changed every two days. QS B reviewed Patient 2’s medical record and confirmed it appeared as though Patient 2 had the same condom catheter from the time it was placed to the time it was removed. QS B stated he would conduct further review of Patient 2’s medical record and try to find documentation that the condom catheter was changed. During an interview with interim assistant patient care manager C (IAPCM C) on 11/6/24 at 12:53 p.m., IAPCM C confirmed she was a wound specialist. IAPCM C explained it was important to change condom catheters every two days so the underlying skin can be assessed. IAPCM C confirmed that not changing a condom catheter could contribute to the development of a pressure injury. During a follow-up interview with QS B on 11/7/24 at 2:24 p.m., QS B confirmed there was no documentation that indicated Patient 2’s condom catheter was changed from the time it was placed to the time it was removed. The hospital’s policy and procedure titled “External Urinary Collection Devices,” dated 5/2019, was reviewed. The section related to condom catheters indicated, “Change catheter when site is soiled, and condom catheter needs to be removed for adequate cleansing, if leaking is present or every two days.” 36623 Review of Patient 18’s Vascular Surgery Progress Note, dated 4/25/24 indicated the patient was admitted to the hospital on 4/6/24 with diagnoses including ruptured abdominal aortic aneurysm (AAA, enlargement of the aorta, the main blood vessel that delivers blood to the body). The note indicated Patient 18 underwent a procedure to repair the aneurysm, was intubated (a medical procedure that involves inserting an endotracheal tube [ETT] into a person’s airway to help them breathe), sedated (in a state of calmness, relaxation, or sleepiness caused by certain drugs) and required continuous renal replacement therapy (CRRT, a type of dialysis that removes wastes, toxins, and excess fluid from the body). Review of Patient 18’s Flowsheets, from 4/6/24 to 5/28/24 indicated on 4/22/24 at 10 a.m., Patient 18 had a temperature of 38.4 degrees Celsius (measurement of temperature) and the temperature source (how the temperature was taken) was “esophageal.” Patient 18’s Flowsheets also indicated on 4/25/24 the patient temperature source was “esophageal” at 2 a.m., 3 a.m., 4 a.m., 5 a.m., and 6 a.m. It also indicated on 4/25/24 at 7 a.m. there was no temperature source documented. Review of Patient 18’s Comprehensive Critical Care Notes, dated 4/25/24 indicated on 4/24/24 the patient had an MRI of the brain and it was recommended that Patient 18 have an MRI of the spine. Review of Patient 18’s Screening Form Questions, dated 4/25/24 indicated Patient 18 had an appointment scheduled on 4/25/24 at 3 p.m. for MR Thoracic and Lumbar Spine (middle and lower section of the backbone). The Form also indicated the answer to the question, “Does your patient have a temperature sensitive Foley?” was “No.” Review of Patient 18’s Study Result MR Thoracic and Lumbar Spine indicated the patient’s exam ended on 4/25/24 at 5:25 p.m. Review of Patient 18’s Flowsheets, dated 4/25/25 indicated the patient had wounds to the left lateral (to the side) lip and mouth, first assessed on 4/25/24 at 7:25 p.m. The Flowsheets also described the mouth wound as tongue white blistering and surrounding skin was edematous (swollen with fluid). Review of Patient 18’s Comprehensive Critical Care Note, dated 4/26/24 indicated, “... esophageal temp probe found melted in mouth with wire exposed, some burns noted along lips ...” Review of Patient 18’s Otolaryngology - Head and Neck Surgery Consult History and Physical, dated 4/26/24 indicated, “Yesterday, patient was taken to radiology to undergo an MRI T and L spine. Unfortunately, an esophageal temperature probe was kept in place for the duration of the scan (approximately 90 minutes). Once the patient was received, primary team noticed the probe fused to his upper left lip, ETT and tongue. ENT consulted for evaluation of oral and OP burns and management.” The consult also indicated the pertinent findings of a flexible fiber laryngoscopy were the following: temp probe adhered to ETT; Burns involving the left upper lip; burn with fibrinous tissue involving 40% of central tongue, 30% of soft and hard palate [roof of the mouth], right base of tongue.” Review of Patient 18’s Plastic and Reconstructive Surgery History and Physical/Consult Note, dated 4/26/24 indicated, “Plastic surgery was consulted to evaluate the lip burn ... Will require surgical reconstruction pending clinical stability.” During an interview on 11/7/24 at 11:30 a.m., the MRI Manager (MRIM) stated when a patient has an order for an MRI, a screening form is generated for a nurse to complete. She stated once the form is completed, the MR technologist (tech) would review the answers and ask questions as needed. She stated when the patient is taken to the department, the MR tech does a visual check on the patient before the MRI procedure. The MR tech also waves a mental detecting wand over the patient to identify any unknown metal before the procedure. The MRIM stated Patient 18 was on a ventilator and the nursing team took the patient to get an MRI. She stated after Patient 18’s MRI, the MRIM was alerted that there was a concern with a burn. The MRIM stated a nurse did an assessment and saw that Patient 18 still had an esophageal temperature probe in place. The MRIM stated they reviewed the screening form the hospital used and identified that the form only asked if the patient had a foley catheter (a tube inserted in the urinary tract into the bladder to drain urine) temperature probe. She stated the form did not ask about other temperature probes, like an esophageal probe. The MRIM stated in an ideal world, the esophageal temp probe should have been identified by the MR tech during the visual check. She stated the MR tech did not realize there was an esophageal temp probe in place because it was white and looked like it was part of Patient 18’s ET tube/respiratory equipment. She stated the MRI generated heat because of the metal in the esophageal probe, which caused the plastic on the probe to melt, and resulted in Patient 18’s burns in his mouth. During an interview on 11/8/24 at 8:55 a.m., the MR tech (MRT) involved in Patient 18’s 4/25/24 MRI stated the responsibility of the MR tech to confirm verbally with the nurse that the patient did not have any devices that could not go in the MR scanner. The MRT stated he confirmed with Patient 18’s nurse that the patient did not have any devices that could not go in the MR scanner. During an interview on 11/8/24 at 10 a.m., Registered Nurse E (RN E) stated he was Patient 18’s primary nurse on 4/25/24. RN E stated he was not aware Patient 18 had an esophageal temperature probe. He stated he only found out about Patient 18’s esophageal probe after the MRI on 4/25/24. During an interview on 11/12/24 at 9:53 a.m., Quality Specialist B (QS B) stated RN E could not remember whether Patient 18’s esophageal temp probe was communicated to him by the previous nurse. During an interview on 11/13/24 at 10:45 a.m., the Executive Director Quality & Safety (EDQS) stated Patient 18’s flowsheet contained documentation of of an esophgeal probe and it is the nurse’s responsibility to know and check for what items the patient has. Review of an email sent on 11/14/24 at 10:41 a.m., QS B indicated that there were no care plans prior to 4/25/24 specifically addressing esophageal probes. Review of the hospital’s policy, “Magnetic Resonance Imaging (MRI) Safety,” last approved 7/2019 indicated, “Practices outline here are aligned with the 2017 American College of Radiology (ACR) Practice Parameters for Performing and Interpreting MRI and the 2013 ACR Guidance Document on MRI Safe Practices.” The policy also indicated, “All patients entering Zone 4 [MRI scanner magnet room] will be thoroughly screened for non-MRI conditional apparatuses prior to entry ... “ Review of “Appendix A; MRI Screening Procedure for Incapacitated Inpatients,” of the hospital’s “MRI Safety” policy, indicated, “The MR safety screening form is the final safety checkpoint for patients undergoing a MRI exam ... The screening for will then be filled out with the nurse who will go through the questions ...” Review of the hospital’s policy, “Standards of Practice for Acute and Critical Care Nursing,” approved 11/2021 indicated, “Through Assessment, the nurse collects data pertinent to the patient’s condition or health status ... Documents relevant data in EHR [electronic health record] in a clear, timely manner ... The nurse caring for the patient develops a plan of care that prescribes strategies and alternatives to attain desired outcomes ... establishes priorities and continuity of care within the plan, including transfer of information and handoffs at shift change ... documents plan in the Care Plan system within the EHR and provides handoff of the plan in a clear, timely manner.” Review of the “Appendix A: Critical Care Standard Work” from the policy, “Standards of Practice for Acute and Critical Care Nursing” indicated record temperature (and more frequently as needed) and document lines and tubes every four hours.”

“SAFETY POLICY AND PROCEDURES CFR(s): 482.26(b) [§482.26 Condition of Participation: Radiologic Services §. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications.] §482.26(b) Standard: Safety for Patients and Personnel The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel. This Standard is not met as evidenced by: 36623 Based on interview and record review, the hospital failed to follow their Magnetic Resonance Imaging (MRI, a medical imaging procedure that uses strong magnetic fields to create images of the inside of the body) policy when the MR tech did not identify one of four patients (Patient 18) had a device that was unsafe to be used in an MR scanner. The hospital also failed to ensure the MRI Safety policy was in accordance with American College of Radiology (ACR)’s safe MRI practices, and review and revise their policy as required. These failures resulted in Patient 18 sustaining burn injuries to the lips, mouth, and tongue when he had an esophageal temperature probe (a device used to measure core body temperature) when undergoing an MRI. Findings: Review of Patient 18’s Vascular Surgery Progress Note, dated 4/25/24 indicated the patient was admitted to the hospital on 4/6/24 with diagnoses including ruptured abdominal aortic aneurysm (AAA, enlargement of the aorta, the main blood vessel that delivers blood to the body). The note indicated Patient 18 underwent a procedure to repair the aneurysm, was intubated (a medical procedure that involves inserting an endotracheal tube [ETT] into a person’s airway to help them breathe), sedated (in a state of calmness, relaxation, or sleepiness caused by certain drugs) and required continuous renal replacement therapy (CRRT, a type of dialysis that removes wastes, toxins, and excess fluid from the body). Review of Patient 18’s Flowsheets, from 4/6/24 to 5/28/24 indicated on 4/22/24 at 10 a.m., Patient 18 had a temperature of 38.4 degrees Celsius (measurement of temperature) and the temperature source (how the temperature was taken) was “esophageal.” Patient 18’s Flowsheets also indicated on 4/25/24 the patient temperature source was “esophageal” at 2 a.m., 3 a.m., 4 a.m., 5 a.m., and 6 a.m. Review of Patient 18’s Comprehensive Critical Care Notes, dated 4/25/24 indicated on 4/24/24 the patient had an MRI of the brain and it was recommended that Patient 18 have an MRI of the spine. Review of Patient 18’s Screening Form Questions, dated 4/25/24 indicated Patient 18 had an appointment scheduled on 4/25/24 at 3 p.m. for MR Thoracic and Lumbar Spine (middle and lower section of the backbone). The Form also indicated the answer to the question, “Does your patient have a temperature sensitive Foley?” was “No.” The form did not include a question regarding an esophageal temperature probe. Review of Patient 18’s Study Result MR Thoracic and Lumbar Spine indicated the patient’s exam ended on 4/25/24 at 5:25 p.m. Review of Patient 18’s Flowsheets, dated 4/25/25 indicated the patient had wounds to the left lateral (to the side) lip and mouth, first assessed on 4/25/24 at 7:25 p.m. The Flowsheets also described the mouth wound as tongue white blistering and surrounding skin was edematous (swollen with fluid). Review of Patient 18’s Comprehensive Critical Care Note, dated 4/26/24 indicated, “... esophageal temp probe found melted in mouth with wire exposed, some burns noted along lips ...” Review of Patient 18’s Otolaryngology - Head and Neck Surgery Consult History and Physical, dated 4/26/24 indicated, “Yesterday, patient was taken to radiology to undergo an MRI T and L spine. Unfortunately, an esophageal temperature probe was kept in place for the duration of the scan (approximately 90 minutes). Once the patient was received, primary team noticed the probe fused to his upper left lip, ETT and tongue. ENT consulted for evaluation of oral and OP burns and management.” The consult also indicated the pertinent findings of a flexible fiber laryngoscopy were the following: temp probe adhered to ETT; Burns involving the left upper lip; burn with fibrinous tissue involving 40% of central tongue, 30% of soft and hard palate [roof of the mouth], right base of tongue. Review of Patient 18’s Plastic and Reconstructive Surgery History and Physical/Consult Note, dated 4/26/24 indicated, “Plastic surgery was consulted to evaluate the lip burn ... Will require surgical reconstruction pending clinical stability.” During an interview on 11/7/24 at 11:30 a.m., the MRI Manager (MRIM) stated when a patient has an order for an MRI, a screening form is generated for a nurse to complete. She stated once the form is completed, the MR technologist (tech) would review the answers and ask questions as needed. She stated when the patient is taken to the department, the MR tech does a visual check on the patient before the MRI procedure. The MR tech also waves a mental detecting wand over the patient to identify any unknown metal before the procedure. The MRIM stated Patient 18 was on a ventilator and the nursing team took the patient to get an MRI. She stated after Patient 18’s MRI, the MRIM was alerted that there was a concern with a burn. The MRIM stated a nurse did an assessment and saw that Patient 18 still had an esophageal temperature probe in place. The MRIM stated they reviewed the screening form the hospital used and identified that the form only asked if the patient had a foley catheter (a tube inserted in the urinary tract into the bladder to drain urine) temperature probe. She stated the form did not ask about other temperature probes, like an esophageal probe. The MRIM stated in an ideal world, the esophageal temp probe should have been identified by the MR tech during the visual check. She stated the MR tech did not realize there was an esophageal temp probe in place because it was white and looked like it was part of Patient 18’s ET tube/respiratory equipment. She stated the MRI generated heat because of the metal in the esophageal probe, which caused the plastic on the probe to melt, and resulted in Patient 18’s burns in his mouth. During an interview on 11/8/24 at 8:55 a.m., the MR tech (MRT) involved in Patient 18’s 4/25/24 MRI stated the responsibility of the MR tech to confirm verbally with the nurse that the patient did not have any devices that could not go in the MR scanner. The MRT stated he did a visual check on Patient 18 and did not identify the esophageal probe because of the respiratory bundle surrounding the patient’s mouth. The MRT stated that the hospital’s MRI screening form did not have a question asking whether the patient has an esophageal probe. During an interview on 11/13/24 at 1:02 p.m., the MRIM stated the hospital’s MR policy was not changed. Review of the hospital’s policy, “Magnetic Resonance Imaging (MRI) Safety”, last approved 7/2019 indicated, “Practices outline here are aligned with the 2017 American College of Radiology (ACR) Practice Parameters for Performing and Interpreting MRI and the 2013 ACR Guidance Document on MRI Safe Practices.” The policy also indicated, “All patients entering Zone 4 [MRI scanner magnet room] will be thoroughly screened for non-MRI conditional apparatuses prior to entry ... it is the responsibility of the MRI technologist to review the screening form with the patient and visually check for any metal objects.” The policy further indicated, “This policy will be reviewed and/or revised every three years or as required by change of law or practice.” The hospital’s policy should have been updated in 2022. Review of “Appendix A; MRI Screening Procedure for Incapacitated Inpatients,” of the hospital’s “MRI Safety” policy, indicated, “The MR safety screening form is the final safety checkpoint for patients undergoing a MRI exam ... The screening for will then be filled out with the nurse who will go through the questions ...” Review of the ACR Guidance Document on MR Safe Practices: 2013 contained Appendix 2, which included a “Hazard Checklist for MRI Personnel.” The checklist indicated an area to check yes or no to the following: Endotracheal tube, Swan-Ganz catheter (a tube placed inside the heart to monitor heart function and blood flow), Extra ventricular device (a system that drains fluid from the brain), Arterial line transducer (a device used to measure blood pressures), Foley catheter with temperature sensor and/or metal clamp, Rectal probe (device inserted in the rectum to take temperature or examine the rectum), Esophageal Probe (device inserted in the esophagus to take temperature), Tracheotomy tube (tube inserted in the trachea to help with breathing), and Guidewires (a thin wire used to help place catheters in the body). According to the American College of Radiology (ACR) website, “MR Safety continues to evolve and in response, the ACR’s Committee on MR safety created the ACR Manual on MR Safety with updates and critical new information which replaces all earlier versions of the ACR Guidance Document on MR Safe Practices.” The website contained links to access documents, including the ACR Manual on MR Safety 2024 and Safety Screening Form for MR Procedures. Review of the “ACR Manual on MR Safety 2024” indicated, “This 2024 edition of the ACR Manual on MR Safety replaces all earlier versions.” Review of ACR’s Safety Screening for Magnetic Resonance (MR) Procedures indicated the Hazard Checklist for Level 2 MR Personnel included yes/no check boxes for the following: pulse oximetry device, EKG pads/leads, Endotracheal tube, Swan-Ganz catheter, Extra ventricular device, Arterial line transducer, Foley catheter with temperature sensor and/or metal clamp, Rectal probe, Esophageal Probe, Tracheotomy tube, Guidewires, Halo vest, and other. The screening procedures also indicated, “If any Level 2 MR Personnel checklist items are answered yes, this should be brought to the attention to the covering MR Physician.””

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 46939 Based on interview and record review, the hospital failed to comply with the Condition of Participation for Surgical Services as evidenced by: 1. Hospital staff failed to implement their policy titled “Universal Protocol” during a nerve block (a procedure that involves injecting medication into or around a nerve to block pain) when the wrong injection site was marked, and a patient received the medication on the wrong side of the body. (Refer to A951). 2. Hospital Staff failed to implement their Policy titled “Surgical Counts” during a surgical procedure. (Refer to A951). 3. Hospital failed to have a safety practice in place to inspect, measure, or observe ureteral catheter device after used in surgical procedures, ensure the device was intact and not retained in the body. (Refer to A951). The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality health care in a safe environment.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(8) Unless superseded by State law that is more restrictive-- (i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours: (A) 4 hours for adults 18 years of age or older; (B) 2 hours for children and adolescents 9 to 17 years of age; or (C) 1-hour for children under 9 years of age; This Standard is not met as evidenced by: 48590 Based on interview and record review, the hospital failed to ensure the physician’s order for the use of restraint was renewed each calendar day for one of eight sampled patients (Patient 17) as required by the hospital’s policy and procedure (P&P). This failure resulted in the continued use of soft restraints without renewal orders from the physician. Findings: Review of Patient 17’s History and Physical (H&P) dated 6/8/24, indicated Patient 17 presented to the Emergency Department (ED) and was admitted to the hospital with a diagnosis of Pulmonary Hypertension (a type of high blood pressure that affects arteries in the lungs and in the heart). During a record review on 9/27/24 at 11:00 a.m., with Nursing Quality Coordinator (NQC) I, a Non-Violent Restraints order was placed on 6/22/24 at 6:11 p.m. with restraint criteria of pulling at lines, and removing tubes. During a concurrent interview and record review on 9/27/24 at 12:57 p.m., with NQC I, NQC I stated there was no order for the soft restraints documented applied in the Non-Violent Restraints flowsheet on 6/23/24 from 6:15 p.m. to 6/24/24 at 4:14 p.m., 6/26/24 from 6:45 p.m. to 6/27/24 at 2:29 a.m., 7/7/24 from 6:15 p.m. to 7/8/24 at 10:29 a.m., 7/11/24 from 4:15 p.m. to 7/12/24 at 12:44 a.m., 7/16/24 from 8:30 p.m. to 7/17/24 at 1:14 a.m., and 7/20/24 from 11:15 a.m. to 7/21/24 at 6:44 a.m. During an interview on 10/1/24 at 1:48 p.m., with Registered Nurse (RN) J, RN J stated “when its (restraint) applied they have to have an order”. During a review of the hospital’s policy and procedure (P&P), titled “Restraint and Seclusion”, last approved date 2/24, indicated “The continuing need for non-violent restraints must be documented by the LIP/APP and a new order written each calendar day”.”

“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: 44733 Based on interview and record review, the hospital failed to ensure a wound care plan was implemented for one out of 30 sampled patients (Patient 18) when there was no documentation indicating wound treatment was implemented as ordered. This failure had the potential for Patient 18’s needs not being met and worsening conditions of skin abnormalities. Findings: Review of Patient 18’s inpatient history and physical, dated 7/08/24, indicated the patient visited the emergency department (ED) with a chief complaint of worsening cough productive of blood-tinged sputum (a mixture of saliva and mucus coughed up from the respiratory tract), N/V (nausea/vomiting), decreased appetite, and fatigue (a feeling of extreme tiredness). Review of Patient 18’s Wound Ostomy Continence Nurse (WOCN) note, dated 7/13/24, indicated: sacrum/coccyx (bones at the base of the spine): patient with congenital dimple (a small depression in the flesh inborn), skin blanching (the skin appears whitish due to restricted blood flow) and intact (not damaged); cover clean dry skin with upside down large sacral Allevyn (foam dressing used for wound management), assess skin every shift, change dressing MWF (Monday, Wednesday, and Friday) and PRN (as needed). Review of Patient 18’s Encounter Problems included intervention to prevent skin injury was to relieve, redistribute pressure, protect bony prominences, (condition of standing out by physically projecting) and skin at risk for injury. The intervention to implement measures was based on patient-specific risk factors. Review of Patient 18’s order, dated 7/13/24, indicated: cover clean dry skin with upside down large sacral Allevyn, assess skin every shift, change dressing MWF (Monday, Wednesday and Friday) and PRN. Review of Patient 18’s WOCN note, dated 8/09/24, indicated: sacrum/coccyx: increase in wound size; agree with colleague from 7/13/24 that sacrum exhibits a congenital dimple, however area was now open. Review of Patient 18’s WOCN note, dated 8/12/24, indicated: sacrum/coccyx: multiple superficial open areas noted. Review of Patient 18’s WOCN note, dated 8/16/24, indicated: sacrum/coccyx: wound WOCN verified-pressure injury, stage 2 (partial-thickness skin loss with exposed dermis [the inner layer of the skin]). During a telephone interview on 9/27/24 at 10:48 a.m. with WOCN C, she stated there was a risk to the wound getting worsened if wound treatment was not implemented as ordered. WOCN C further stated licensed nurse should have implement the treatment as ordered by the physician and document on flowsheet when they implement treatment. During a concurrent interview and record review on 9/27/24 at 11:00 a.m. with Nursing Quality Management Coordinator (NQMC) D, Patient 18’s flowsheets dated from 7/13/24 to 8/09/24 were reviewed. The flowsheets dated from 7/15/24 to 7/20/24 indicated the licensed nurse did not implement the treatment to change Allevyn dressing on MWF and PRN as ordered for Patient 18. NQMC D confirmed there was no documentation indicating the treatment was implemented as ordered from 7/15/24 to 7/20/24 for Patient 18. During a review of the hospital’s policy and procedure (P&P) titled “Pressure Injury Prevention Protocol,” dated 9/2014, the P&P indicated, “E. Care Plan: 7. Documentation should include the type of therapy bed the patient is on, any nursing treatments and/or interventions for the prevention of pressure injuries.” During a review of the hospital’s policy and procedure (P&P) titled “Standard of Practice for Acute and Critical Care Nursing,” dated 11/2021, the P&P indicated, “E. Implementation: 1. The nurse caring for the patient implements the plan of care. F. Documents implementation of the plan in the Care Plan system within the EHR (electronic hospital record) in a clear, timely manner.””

“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: 46939 Based on interview and record review, the hospital failed to implement surgical services policies for three of 30 sampled patients (Patient 20, Patient 21, & Patient 22) and to provide acceptable standards of medical practice for surgical patient care when: 1. Hospital staff failed to implement their policy titled “Universal Protocol” during a nerve block (a procedure that involves injecting medication into or around a nerve to block pain) when the wrong injection site was marked, and a patient received the medication on the wrong side of the body. 2. Hospital staff failed to implement their policy titled “Surgical Counts” during a surgical procedure for Patient 21. 3. The hospital failed to have a safety practice in place to inspect, measure, or observe ureteral catheter devices after used in surgical procedures, ensure the device was intact and not retained in the body for Patient 22. These failures resulted in: 1. Patient 20 receiving unnecessary medication and had a “panic attack” after the incorrect administration of nerve block medication to wrong side of the body. 2. Patient 21 had multiple retained surgical items (a foreign surgical item that is not intended to remain in the patient at the end of surgery) after a surgical procedure. 3. Patient 22 had a retained surgical item after a surgical procedure. Findings: 1. During a review of Patient 20’s “Anesthesia Preprocedure Evaluation” dated 8/23/24, Evaluation indicated, “Procedure: Shoulder Total Arthroplasty [a surgical procedure that replaces a damaged joint with an artificial joint, or prosthesis](Right)”. Evaluation indicated, “Pt[patient] reports anxiety during prior nerve block at [hospital] for LT [left] shoulder sx [surgery] on 12/21/23”. During a review of Patient 20’s “Consent to Operation, Procedure and Administration of Anesthesia” dated 8/23/24, consent indicated, the procedure was “Right reverse total shoulder arthroplasty. Right”. During a review of Patient 20’s “Anesthesia Procedure Note” dated 8/29/24, the note indicated, “Peripheral Nerve Block Date/Time start: 8/29/24 5:47 AM. . .Preanesthesia Checklist Patient identified, site marked, surgical consent reviewed, pre-op evaluation reviewed, timeout performed, IV checked. . .Additional peripheral nerve block details: First interscalene [a paired structure in the neck, the space between the scalene muscles] block was placed on L [left] side using same technique after verbal confirmation by patient. Dosed with 10cc 0.25% ropivacaine [local anesthetic used for local anesthesia during surgery and for short-term management of acute pain]. Following placement, block was noted to be on incorrect side” Signed by Medical Doctor (MD) A. During an interview on 9/27/24, at 9:45 a.m., with Patient 20, Patient 20 stated, “It was a big mistake that happened, they put the nerve block on the wrong side which was the left side. I don’t know which Doctor gave the nerve block, but they never told me they were putting it on the left side. I didn’t notice they were doing it on the wrong side until they told me, they put on the wrong side. I felt like I couldn’t breath and was panicking”. Patient 20 stated, the doctors gave her something in her IV(intravenous catheter) to make her calm, so she didn’t realize what was going on. During an interview on 9/30/24 at 8 a.m., with MD A, MD A stated, he assisted with the nerve block procedure for Patient 20 on 8/29/24 along with MD B. MD A stated, himself and MD B were present during the checklist and they reviewed the patients informed consent from a computer used by another staff member. MD A stated, “The patient identifiers and surgery site do not appear on the screen at the same time due to size so we scrolled down to confirmed the surgery site”. During an interview on 9/30/24, at 1:30 p.m., with MD B, MD B stated, “generally the trainee resident preps the patient” prior to nerve block. MD B stated he prepped Patient 20 on 8/29/24. MD B stated the anesthesia team preps the patient by positioning them and marking the injection site prior to doing the anesthesia checklist. MD B stated, he could not remember if he or MD A marked the injection site on the left side, prior to marking we looked at the patient chart. MD B stated, “I think the challenge was walking from the work station and to the computer and it was easy to get distracted. We did not have a printed consent. Myself and [MD A] performed the nerve block on the left side”. MD B stated, he recognized the error after the nerve block was administered to the left side, when he went to chart in Patient 20’s medical record. MD B stated, “The most likely cause [of incorrect administration of nerve block on left side] was the cognitive overload, I am a trainee it happens where you prep the wrong side, you just proceed without taking a minute. . .you can read a form then see the opposite arm when you are busy”. During a review of the hospitals Policy and Procedure (P&P) titled, “Universal Protocol”, dated 2022, the P&P indicated, “the purpose of this policy was to provide a process to reduce the risk of wrong patient, wrong procedure, and or wrong site surgery and procedures. . . Pre-procedure verification: the process by which relevant documents, information, and equipment are available prior to the procedure and are correctly identified, labeled, and match to the patients identifiers prior to the patient receiving anesthesia”. 2. During a review of Patient 21’s “Operative Report” dated 8/2/24, report indicated, “Date of operation 8/2/24. Surgeons [MD E]. . .Procedures: 1. Bilateral neck exploration and washout 2. Control of hemorrhage 3. Right pectoralis major rotational flap [a surgical technique that uses the pectoralis major muscle to cover defects and wounds] 4. Flexible tracheoscopy [a procedure that allows a doctor to examine the inside of the trachea] and bronchoscopy [a procedure that allows a doctor to examine the inside of the lungs using a thin, flexible tube with a light and camera]. . .Findings: 2 pinpoint areas of bleeding were found at the right common carotid artery at the level of the stomal dehiscence [a complication that occurs when the skin around a stoma breaks down]. . .We applied pressure [to the bleeding artery] and called our vascular surgery colleagues for an intraoperative consultation”. Signed by MD E (Ear, Nose and Throat- ENT Physician) During a review of Patient 21’s “Operative Report” dated 8/2/24, report indicated, Date of operation 8/2/24. . . Operation performed: 1. Open exploration right common carotid artery. . . Surgeon: [MD F]. . . Findings: 1. Hemorrhage from right common carotid artery . . . At the time we joined the case a neck expiration had been performed by the head and neck team, with bleeding originating from the right common carotid artery just superior to the level of the clavicle. And approximate 2 milimeters (mm, unit of measurement) defect was visualized in the medial right common carotid artery. . . Manual pressure was held for hemostasis [stopping bleeding] and we discussed transition to endovascular [minimally invasive procedures that are done inside the blood vessels] approach for control of hemorrhage. Quick clot [type of gauze used to stop bleeding] was packed into the wound for temporary packing and secured with loban [temporary dressing]”. Signed by MD F. During a review of “Operative Report” dated 8/9/24, Report indicated, “Date of operation 8/8/24 . . . Preoperative diagnosis” Pharyngeal leak [a complication that occurs when saliva leaks from the throat through a defect in the pharyngeal mucosa], concern for retained foreign body in neck. . .Attending surgeon: MD G, assistant surgeon MD E. . .Findings: ‘Quick clot’ gauze removed from right central neck. . .specimens removed: Right foreign neck bodies. . .Procedure in detail: . . .We then examined the right central neck and removed several pieces of ‘quick clot’ gauze”. Signed by MD G. During an interview on 9/25/24, at 10 a.m., with Assistant Patient Care Manager (APCM) H, APCM H stated, regarding the reason Patient 21 had retained gauze after his procedure on 8/2/24, there were multiple factors, staff were not aware the gauze was opened and cut into pieces, the hand off from vascular team back to primary team was not well communicated regarding how much gauze was cut, the primary surgeon (MD E) knew quick clot was used prior to closing the patient up. During an interview on 9/27/24, at 9:30 a.m., with MD E, MD E stated, Patient 21 was transferred to the hospital for coughing up blood, after scanning the patient we could not identify where the bleed was coming from, so we did a neck exploration. During the exploration we consulted our on call vascular surgeon (MD F) to assist. MD F tried to repair the holes in the carotid artery and was unable to because the artery was too fragile, she decided to hold pressure while we made a plan for other equipment needed for the repair. MD F requested quick clot gauze to pack the wound. Any countable item is added to the count when they are placed onto the sterile field (a designated area in an operating room or clinical setting that is free of bacteria and particles to reduce the risk of infection), I don’t know if anyone requested the gauze be added to the countable items, we removed what we thought was all the quick clot gauze before we closed the patient up. After surgery the patient developed a fever and his tube feedings were refluxing into the neck, we had cause for a retained surgical item. We scheduled to the patient for surgery on 8/8/24. We then explored the neck again and found pieces of quick clot gauze in his neck. MD E stated, “Retained foreign objects are not a common complication from this procedure. We did not know how many pieces of the quick clot there were, if things are cut it is typically notated and communicated to the team”. MD E stated, “I don’t remember [MD F] telling us how many pieces there were in the body before closing”. During an interview on 9/27/24, at 11:30 a.m., with MD F, MD F stated, she was the vascular on call surgeon on 8/2/24, and was consulted for assistance with Patient 21 who needed a repair to his carotid artery. MD F stated, she saw a hole in the common carotid artery and the tissue of the artery was very fragile and falling apart. MD F stated, they started the process of getting the correct equipment needed for the repair, and in the meantime, she was holding pressure on the artery with her finger. MD F stated, she asked for hemostatic agents (substances used to stop or prevent bleeding during surgery). MD F stated, “they opened the quick clot it was the first available, it was a 3 foot long section. I cut it into pieces to pack into the wound then placed temporary dressing to hold the incision closed”. MD F stated, “When they opened the quick clot, I asked if there was smaller size but the team was not aware, there was a lot of chaos of people running around. I told [MD E] we need to remove the quick clot, they stated they were comfortable to remove. I left the room”. MD F stated, “I didn’t know the quick clot was supposed to be part of the count, I don’t know if the count included it. The circulator nurse [CN K] placed gauze on the sterile field. I did not count the pieces I cut”. During an interview on 9/30/24 at 10 a.m., with CN K, CN K stated, she was a circulator nurse and her role is to help set up surgical rooms, advocate for patients, and make sure consent is in order prior to surgery. CN K stated, she was assigned as an additional nurse to Patient 21 on 8/2/24. CN K stated she was asked to assist with Patient 21’s surgical team after someone in the surgery room pressed the call button for help. CN K stated they asked for quick clot gauze, she stated herself and another circulator nurse went to get the quick clot. CN K stated, she explained to the other nurse that quick clot gauze is a countable item, and we have to track its use to make sure its counted and the end of surgery. CN K stated, she could not remember who placed the gauze on the sterile field to the surgeon, but she explained it needed to be added to the count, and she saw the nurse add it to the count. CN K stated, “We gave them what they requested, generally if anything was cut, we will state it was cut into multiple pieces and stated that one count. They generally don’t cut quick clot, I didn’t know you could”. CN K stated, the count was correct because the quick clot gauze was added as one item and counted as one item. During a review of the hospital’s P&P titled, “Surgical Count”, dated 2021, the P&P Indicated, “Purpose: to ensure an environment of maximum patient safety and quality care and to protect against unintended foreign object retention within the body. . .Retained Surgical Item (RSI): A foreign surgical item that was not intended to remain in the patient at the end of surgery that remains in the patient after the patient has left the room. Also called retained foreign body (RFO). . .Count: accounting of all counted items including instruments, sponges, sharps, and miscellaneous items. . . cutting counted items: before an item that may be cut by the surgeon , the scrub person will lay it out on the back of the table drape and mark drape to indicate length or size. When the item was retrieved, scrub person will match item to table marking to determine that the item was retrieved in its entirety. Each time an item is cut, a notation must be made on the count board”. 3. During a review of Patient 22’s “Operative Report” dated 8/29/24, the report indicated, “Date of Operation 8/29/24 . . .Procedure: Cystoscopy and bilateral ureteral catheterization [a procedure that involves examining the bladder and urethra with a cystoscope, and then passing a catheter up into the kidneys]. . . Surgeon: [MD L]. . . Indication: this patient is a 60 [year old] male with recurrent diverticulitis [disease that occurs when small pouches in the large intestine become inflamed or infected] s/p [status post-after] colostomy undergoing colostomy takedown [a surgical procedure that reattaches the colon to the rectum]. Ureteral identification and catheterization was requested by the primary team”. Report indicated, bilateral ureteral catheters were placed and left for the remainder or the abdominal surgery and planned. During a review of Patient 22’s “Operative Note” dated 8/29/24, note indicated, “Date of operation: August 29, 2024. . . Surgeon: [MD M]. Operative note indicated, no indication of the removal of the bilateral ureteral catheter post abdominal surgery. During an interview on 9/27/24, at 1:30 p.m., with MD L, MD L stated he assisted with the procedure on 8/29/24 for Patient 22. MD L stated, the purpose of the procedure of ureteral catheter insertion is so the primary surgeon can find the ureter and don’t inadvertently damage them. MD L stated, his team inserted the catheters without issue and the primary surgeon is supposed to remove them after finishing their procedure. MD L stated, “2 days later the on call Physician stated they found the catheter inside cut off through the ureter and catheter. It was definitely cut off. It looks like the original surgeon [MD M] cut through the ureter, there was no other explanation”. MD L stated, It had been identified the cause of ureteral dissection (cutting through the ureter) was technical error on part of the surgeon, despite having urology perform the catheterization to minimize risks of damage to ureter, through technical error the surgeon damaged the ureter, it was not identified prior to closure. During an interview on 9/30/24, at 9:30 a.m., with MD M, MD M stated, he was the general surgeon for Patient 22 on 8/29/24. MD M stated, the reason the urology team placed ureteral catheters are to minimize risk of damage to the ureter during the abdominal surgeon we performed. MD M stated, we (general surgery) remove the catheters after closure they are taken out at the end of the surgery. MD M stated, We removed the catheters at the end of the surgery, but that is not something we normally put in the operative note. MD M stated, the cause of the ureter to be cut “was almost certainly the ligasure [a vessel sealing system that uses radiofrequency energy and mechanical compression to seal vessels and tissue bundles], it was me who cause the damage. . .It was a technical error on my part”. MD M stated normally if you inadvertently cut the ureter, you would see the catheter, but in this situation, it sealed the ureter which is why we didn’t see the stent. MD M stated, the normal procedure for removing the catheters is to just remove them, we do not measure, or inspect them, it should have been noticed during the removal that the catheters were two different lengths, at the time we did not notice a piece was left behind.”