UCSF Medical Center

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 49264 Based on interview and record review, the hospital failed to appropriately monitor five out of 30 sampled patients (Patients 16, 17, 18, 12, and 23) after administration of medication or blood products (therapeutic substances derived from human blood to treat a disease or condition) according to approved hospital policy and procedure when: 1. Patient 16 was admitted for desensitization (the process of reducing or eliminating an allergic response to a specific substance by administering gradually to safely increase tolerance) to chemotherapy (a cancer [a large group of diseases characterized by uncontrolled cell growth] treatment that uses powerful drugs to kill fast-growing cancer cells or stop them from dividing and spreading) and was not monitored per a provider’s order 2. Patient 17’s vital signs (measurements that indicate the status of a person’s basic body functions, e.g. body temperature, heart rate [how fast the heart is beating], respiratory rate [how fast a person is breathing], blood pressure [a measurement of the amount of force blood needs to get throughout the body, and SpO2 [measure of how much oxygen the blood is carrying as a percentage of the maximum it could carry up to 100%]) were not reassessed 15 minutes after blood product administration 2a. Patient 18’s vital signs were not reassessed 15 minutes after blood product administration 2b. Patient 12’s vital signs were not reassessed 15 minutes after blood product administration 2c. Patient 23’s vital signs were not reassessed 15 minutes after blood product administration These failures have the potential for patients to have adverse reactions (harmful, unintended, and undesired effect resulting from medication or treatments) that go unnoticed leading to delayed care in stopping or reversing reactions Findings: 1. A review of Patient 16’s History and Physical (H&P, a formal and complete assessment of a patient and their problems) titled “CRITICAL CARE HISTORY AND PHYSICAL NOTE”, dated 09/23/25, indicated Patient 16 had a medical history of Acute Lymphoblastic Leukemia (ALL, a fast-growing, aggressive cancer of the blood) that required treatment with Calaspargase Pegol (a type of chemotherapy). However, Patient 16 has a “history of [allergic] reaction to calapargase” and required admission to the Pediatric Intensive Care Unit (PICU, area of the hospital providing the highest level of critical care specialized for children, adolescents, and young people) for “calaspargase desensitization”. The H&P’s attending attestation (a signed statement that a supervising physician agrees with and participated in a patient’s care) also indicated Patient 16 was “at risk of anaphylaxis [a severe, rapid-onset, and potentially fatal systemic allergic reaction affecting the whole body] upon repeat administration” of Calaspargase. A review of a medication order titled “calaspargase pegol-mknL (ASPARLAS [brand name for calaspargase]) 7.5 Units in sodium chloride 0.9 % [a salt water solution that medication can be mixed into] 100 mL [milliliters, metric unit of measurement used for liquid medication dosages] infusion”, dated 09/23/25, indicated Patient 16’s calaspargase was to be administered intravenously (IV, given directly into the blood stream) over one hour. The medication order further indicated in the administration instruction, “V/S [vital signs] at baseline, 15 minutes after initiation of infusion, upon completion, and one hour post infusion. Maintain close observation for first 15 minutes of infusion.” The medication order further indicated that the medication infusion was started on 09/23/25 at 2:07 PM by Registered Nurse (RN) 1 and was completed on 09/23/25 at 3:15 PM. During a concurrent interview and record review on 03/26/26 at 11:23 AM with RN 1, Patient 16’s vital signs flow sheet (a document summarizing assessments and routine care tasks over time), dated 09/23/25, was reviewed. The vital signs flow sheet indicated a full set of vital signs (includes a blood pressure, heart rate, temperature, respiratory rate, and SpO2) were obtained at 2:28 PM. The vital signs flow sheet further indicated only a heart rate and respiratory rate were obtained at 3:00 PM and the next full set of vital signs was at 4:00 PM. RN 1 stated she is a Hematology-Oncology nurse (a nurse with special training to care for patients with cancer and blood disorders) with special training to administer chemotherapy. RN 1 stated per the hospital’s standard, two chemotherapy trained nurses were to start the infusion to ensure correct dose and rate of administration, but monitoring is done by the primary nurse; in this case, the patient was in the PICU and therefore the PICU nurse would monitor the patient. RN 1 stated she was one of the chemotherapy trained nurses that started Patient 16’s Calaspargase. RN 1 was asked if there were documented vital signs when the chemotherapy was started on 09/23/25 at 2:07 PM, RN 1 stated, “no initial [vital signs]”. RN 1 also verified there were no vitals signs obtained at the completion of chemotherapy on 09/23/25 at 3:15 PM. RN 1 was asked why it was important to monitor patients so closely while on Calaspargase, RN 1 stated, “There are a lot of side effects ...especially PEG [referring to Calaspargase Pegol] ... we want to make sure they’re [the patient] hemodynamically stable [blood circulation works properly, usually measured as a blood pressure and heart rate] ... we want to make sure the patient is tolerating the dose and the medicine.” RN 1 stated that early signs of a negative reaction to Calaspargase could include a patient having a fever or tachycardia (increased heart rate). RN 1 was also asked if vital signs in this case could provide early detection of an allergic reaction; RN 1 affirmatively answered, “correct.” A review of a second medication order titled “calaspargase pegol-mknL (ASPARLAS) 7.5 Units in sodium chloride 0.9 % 100 mL infusion”, dated 09/23/25, indicated Patient 16’s calaspargase was to be administered intravenously (IV, given directly into the blood stream) over one hour. The medication order further indicated in the administration instruction, “V/S [vital signs] at baseline, 15 minutes after initiation of infusion, upon completion, and one hour post infusion. Maintain close observation for first 15 minutes of infusion.” The medication order further indicated this was the second IV bag of medication which was started on 09/23/25 at 3:17 PM by RN 1 and was completed on 09/23/25 4:23 PM. During a concurrent interview and record review on 03/26/26 at 11:25 AM with RN 1, Patient 16’s vital signs flow sheet, dated 09/23/25 was reviewed. The vital signs flow sheet indicated a full set of vital signs was obtained at 4:00 PM followed by a documented heart rate, respiratory rate, and blood pressure obtained at 4:45 PM. RN 1 was asked if she would agree that there was no full set of vital signs obtained when initiating the medication, at 15 minutes after the initiation, and at the completion of the medication, RN 1 stated affirmatively, “correct”. During an interview on 03/26/26 at 2:08 PM with the Hematology-Oncology and Bone Marrow Transplant (BMT, a specialized unit of the hospital for patients undergoing blood and stem cell transplants) Unit Director (UD) 2, UD 2 stated that Calaspargase has strict monitoring of vital signs to find early signs of a reaction because of a high chance of anaphylaxis. During a concurrent interview and record review on 03/26/26 at 2:14 PM with UD 1, Patient 16’s vital signs flow sheet, dated 09/23/25, was reviewed. The vital signs flow sheet indicated vital signs obtained at the following times: - 2:28 PM: full set of vital signs documented - 3:00 PM: only a heart rate and a respiratory rate documented - 4:00 PM: full set of vital signs documented - 4:45 PM: only a heart rate, respiratory rate, and blood pressure were documented. UD 1 was asked if there were vital signs obtained when Patient 16’s first infusion of Calaspargase was started on 09/23/25 at 2:07 PM; UD 1 stated there is “not a full set [of vital signs]”. UD 1 was also asked to confirm if there were no vital signs obtained at the initiation, the first 15-minutes after initiation, and completion of the second infusion of Calasparagase started on 09/23/25 at 3:17 PM; UD 1 stated, “yeah.” A review of hospital Policy and Procedure (P&P) titled, “Medication Management: Administration of Medication”, dated as last approved 08/2025, indicated, “F. Responsibilities of Personnel Authorized to Administer Medication (“Personnel”) ... 4. Personnel monitor the patient’s response to medication and include documentation of any specific PRN [as needed], titration [process of gradually increasing a medication dose up or down to find the optimal amount for maximum benefit with minimal side effects to the patient], and/or hold [to not give a medication for a reason] parameters that are included in the medication order.” A review of hospital P&P titled, “Antineoplastic [drugs/therapies that stop growth of cancer cells] Chemotherapy/Immunotherapy [type of cancer treatment that boosts or changes a patient’s immune system] for Oncologic [Relating to oncology, or the branch of medicine dedicated to diagnosis, treatment, and study of cancer] Indications [reasons for giving a medication]”, dated as last reviewed/revised 09/2024, indicated, “1. Prior to administration, a chemotherapy-qualified RN must: ... Ensure patient meets the following administration parameters, as indicated: ... vital sign parameters ...” 2. A review of Patient 17’s interval H&P (an updated medical assessment that documents changes in a patient’s condition, medications, or health status since their last comprehensive visit), dated 09/30/25, indicated Patient 17 was undergoing a “Fontan procedure [an open-heart surgery for children with complex heart defects] with cardiopulmonary bypass [when a machine temporarily takes over the functions of the heart and lungs.” A review a provider order for Patient 17 titled, “Transfuse [to administer a blood product to a patient] Pheresed Platelets [when platelets, a component of blood important in stopping bleeding, is collected from a human to be used for donation] : 1 Unit”, dated 10/03/25 indicated Patient 17 needed platelets due to being on “ECMO [Extracorporeal Membrane Oxygenation, a specific machine that temporarily takes over the functions of the heart and lungs] /ECLS [Extracorporeal Life Support, another word for ECMO ...”. During a concurrent interview and record review on 03/26/26 at 12:53 PM with Pediatric Cardiac ICU Unit Director (UD) 1, Patient 17’s Single Transfusion Record (a summary of information relating to an administration of a specific blood product, includes information like vital signs, rate of infusion, and date/time of transfusion), dated 10/03/25, was reviewed. The Single Transfusion Record indicated a unit of platelets was initiated for Patient 17 on 10/03/25 at 5:53 PM. The Single Transfusion Record further indicated, in a section labeled “Required Vitals (Pre Infusion, 15 min into infusion, End of Infusion)”, that a full set of vital signs were obtained on 10/03/25 at 6:00 PM and 7:00 PM. UD 1 was asked if she was able to see documentation of vital sign reassessment 15 minutes after the start of the platelet infusion; UD 1 stated, “I do not.” UD 1 further stated that 15-minute reassessment after the initiation of a blood product transfusion is required “based on [hospital] policy”, A review of hospital P&P titled, “BLOOD PRODUCT TRANSFUSION/ADMINISTRATION”, last reviewed and revised 05/2025, indicated “2. Transfuse Blood Product(sa. Start infusion slowly ... with close observation by transfusionist [someone administering blood products] during the first 15 minutes (+/- 5 minutes) ... b. Assess vital signs 15 minutes (+/- 5 minutes) of transfusion start. If no signs of a reaction, flow rate may be increased ... SIGNS OF TRANSFUSION RELATED REACTIONS ... 2. Watch for the following signs and symptoms: ... fever ... Significant change in vital signs...” 2a. A review of Patient 18’s H&P titled, “CRITICAL CARE HISTORY AND PHYSICAL NOTE”, dated 10/13/25, indicated Patient 18 was admitted due to respiratory failure (when the lungs cannot adequately provide oxygen or remove carbon dioxide from the body) and had a medical history of coagulopathy (a condition where the blood’s ability to clot is impaired) and thrombocytopenia (a blood disorder characterized by an abnormally low number of platelets). During a concurrent interview and record review on 03/26/26 at 1:40 PM with PICU Interim Assistant Unit Director (AUD) 1, Patient 18’s Single Transfusion Record, dated 10/16/25, was reviewed. The Single Transfusion Record indicated a unit of platelets was initiated for Patient 18 on 10/16/25 at 7:32 AM. The Single Transfusion Record further indicated on 10/16/25, there was a document ted temperature, heart rate, and respiratory rate at 7:32 AM; in addition, a temperature recorded at 7:49 AM and a full set of vital signs documented at 8:00 AM. AUD 1 stated that nursing staff are expected to obtain “pre-vital signs” prior to giving blood products, “15 minutes” after the start of the transfusion, and at the “completion of the transfusion.” When AUD 1 was asked if there were vital signs documented 15-minutes after the start of the platelet infusion, AUD 1 stated, “she has a temperature [documented] at 7:49 AM ... although she [the primary nurse] did not take a full set until 0800 [8:00 AM] ...” 39792 2b. During a review of Patient 12’s H&P, dated 03/3/26, indicated Patient 12 was admitted to the facility with a diagnosis of cardiogenic shock (a life-threatening medical emergency where the heart suddenly cannot pump enough blood to meet the body’s oxygen needs). A review of provider order for Patient 12 titled, “Transfuse RBC: (Red Blood Cells, a medical procedure where donated blood or blood components are delivered into your bloodstream through an intravenous [vein], to replace blood lost either due to surgery, injury or diseases like anemia.) 1 Unit” (approximately 300 milters of fluid),” dated 03/6/26. During a review of Patient 12’s “Blood Administration Flowsheet” dated 03/6/26, indicated the blood transfusion vital signs (were defined as body temperature [measured by the body’s ability to generate/eliminate heat], pulse/heart rate [measured as the number of times the heart beats per minute], respiratory rate [measured as the number of breaths taken per minute], blood pressure [measured as the force of blood pushing against artery walls, measured in millimeters of mercury (mmHg), which includes systolic over diastolic numbers]). The Blood Administration Flowsheet dated 3/6/26, indicated vital sign measurements of temperature (Temp), heart rate (HR), respirations (Resp) and blood pressure (BP) were obtained at 6:00 AM prior to the blood transfusion starting and then at 6:13 AM when the blood transfusion was started, and at 7:00 AM; approximately 47 minutes after the blood transfusion had started and then again at 11:50 AM when the blood transfusion had been completed. During a concurrent interview and record review on 03/26/26 at 1:01 PM with Registered Nurse 2 (RN 2), Patient 12’s Blood Administration Flowsheet, dated 03/06/26, was reviewed. The Blood Administration Flowsheet indicated the unit of blood was initiated for Patient 12 on 03/06/26 at 6:13 AM. The Blood Administration Flowsheet indicated the unit of blood on 03/06/26 had a documented Temp, HR, Resp, and BP (VSS) recorded at 6:00 AM, 6:13 AM and 7:00 AM. RN 2 stated the standard for obtaining vital signs when administering blood to a patient would be before the transfusion started, at the time the transfusion started, every 15 minutes for an one hour, every 30 minutes for one hour and then every two hours or until the transfusion has been completed. RN 2 stated there should have been a set of vital signs recorded at 6:30 AM or 15 minutes after the start of the transfusion. 38066 2c. A review of Patient 23’s H&P, dated 12/20/25 indicated, Patient 23, an infant, was admitted on 12/20/25 with prenatal [before birth] diagnoses that included aortic stenosis [when the aortic valve in your heart is narrowed or blocked], and suspected coarctation of aorta (a congenital [present at birth] heart defect where a segment of the aorta-the body’s main artery-is abnormally narrowed). Patient 23 was admitted for possible Ross-Konno procedure (a surgical technique used to treat aortic valve disease [occurs when the heart’s aortic valve malfunctions, restricting blood flow or allowing leakage, causing the heart to work harder]). During a concurrent interview and record review on 03/26/26 at 12:32 PM with UD 1, Patient 23’s “Single Transfusion Record,” dated 12/25/25 was reviewed. The single transfusion record indicated, Patient 23 had RBC (red blood cells - transport oxygen from the lungs to the body) transfusion that started at 1:07 PM and ended at 3:15 PM. Initial VS was taken at the start of infusion. Per the same single transfusion record, the next set of VS recorded was at 2:00 PM. According to UD 1, VS are taken at start of infusion, then 15 minutes after start of infusion, and at the end of infusion. UD 1 confirmed that there were no VS taken 15 minutes after start of infusion. UD 1 stated, “I don’t see the 15-minute vital signs.””

“POST-OPERATIVE CARE CFR(s): 482.51(b)(4) There must be adequate provisions for immediate post-operative care. This Standard is not met as evidenced by: 38066 Based on interview and record review, the facility failed to provide adequate post-operative care for seven of 30 sampled patients (Patients 2, 18, 6, 21, 24, 5, and 4), when timely pain assessments were not performed when: 1. Pain reassessment for Patient 2 and Patient 18 was not performed after pain medication administration; 2. Pain medication was administered to Patient 6 who did not exhibit pain on assessment, and pain reassessment was not performed within 30 minutes of pain medication administration; 3. Pain medication was administered to Patient 21 without performing pain assessment, and pain reassessment was not performed after pain medication administration; 4. Pain medication was administered to Patient 24 and Patient 5 not in accordance with the physician’s order, and without performing pain assessment prior to medication administration; and 5. Pain reassessment for Patient 4 was not performed after pain medication administration. These deficient practices may result in inadequate pain management and had the potential to compromise patient care. Findings: 1.a. Review of Patient 2’s clinical record indicated Patient 2, an infant, was admitted to the facility on 6/2/25 for surgical repair of ventricular septal defect (a hole in the heart). Review of Patient 2’s “Medication Administration Record” (MAR) indicated a physician order of oxycodone (ROXICODONE) [a brand-name, immediate-release formula of the prescription opioid oxycodone, used to treat moderate-to-severe pain but poses high risks for addiction, abuse, and respiratory depression] oral solution 0.6 mg (milligram) every 6 hours PRN (as needed) for 1st line for pain. Review of Patient 2’s “Pain Assessment” (PA) flowsheet on 6/3/25 at 7:39 AM indicated, a pain score of 5 using the FLACC pain scale [a behavioral tool designed for caregivers and healthcare professionals to assess pain in nonverbal patients or those with cognitive impairments. It measures pain on a 0-10 scale based on five categories (Face, Legs, Activity, Cry, Consolability), with each category scored from 0 to 2]. Patient 2 was given oxycodone 0.6 mg at 7:31 AM. The PA flowsheet indicated pain reassessment was not performed after pain medication administration. 1.b. Review of Patient 18’s clinical record indicated Patient 18, a newborn, was admitted to the facility on 8/12/25 for prematurity (baby born too early), and double outlet right ventricle (DORV - heart condition present at birth, two major blood vessels aren’t attached to the heart in the usual positions). During a concurrent interview and record review on 1/13/26 at 2:48 PM, with Clinical Nurse Specialist (CNS) 2, Patient 18’s clinical record was reviewed. Patient 18’s MAR indicated a physician order of morphine intravenous (IV) injection (a strong pain medication administered directly into the vein for rapid relief of severe, acute, or chronic pain. Common effects include significant pain relief, deep sedation, and potential side effects like respiratory depression and low blood pressure) 2 mg/ml (milliliter) 0.6 mg every 2 hours PRN for 1st line for pain. Patient 18’s PA flowsheet on 1/12/26 at 8:00 PM indicated, a pain score of 7 using the FLACC pain scale. Patient 18 was given morphine 0.6 mg IV at 7:55 PM. CNS 2 acknowledged the PA flowsheet did not indicate pain reassessment was performed after pain medication administration and stated, “No reassessment.” CNS 2 further stated that pain reassessment is done 30 minutes after IV pain medication administration and 90 minutes after oral pain medication is given. 2. Review of Patient 6’s clinical record indicated Patient 6, an infant, was admitted to the facility on 6/30/25 with diagnoses including congenital heart disease (a defect in the heart’s structure present at birth that affects blood flow), and coarctation of the aorta (a birth defect where the aorta, the body’s main artery, has a narrowed or pinched section, obstructing blood flow). Review of Patient 6’s MAR indicated a physician order of morphine 1 mg/ml injection 0.06 mg every 2 hours PRN for 1st line for pain. Patient 6’s PA flowsheet on 7/10/25 at 8:00 PM indicated a pain score of 0 (zero) using the NIPS (Neonatal Infant Pain Scale, a behavioral assessment tool used by healthcare providers to measure acute pain in infants up to one year old. It evaluates pain based on 6 indicators: facial expression, cry, breathing patterns, arm movement, leg movement, and state of arousal), and pain interventions indicated “none”. On 7/10/25 at 8:49 PM, Patient 6 was given morphine 0.06 mg IV. There was no evidence that pain assessment was performed before medication administration. Furthermore, pain reassessment was not performed after pain medication administration. The succeeding pain reassessment was done at 11:45 PM. During an interview on 1/13/26 at 2:41 PM, CNS 2 stated, it is not necessary to give anything (pain medication) with a pain assessment of zero as there is no indication for use, no pain intervention needed. CNS 2 further stated, “There should be an assessment before giving pain medication.” 3. Review of Patient 21’s clinical record indicated Patient 21, a child, was admitted to the facility on 7/21/25 with diagnoses including acute heart failure (a rapid onset of severe, life-threatening symptoms, most commonly intense breathlessness, fatigue, and fluid congestion, requiring urgent medical attention and hospitalization). Patient 21 underwent a surgical procedure on 8/20/25. Review of Patient 21’s MAR indicated a physician order of morphine 2 mg/ml injection 1 mg every 2 hours PRN for 1st line for pain. The MAR indicated that on 8/27/25, Patient 21 was given morphine 1 mg IV at 11:00 AM, 3:38 PM, and 8:28 PM. Review of Patient 21’s PA flowsheet for 8/27/25 indicated, there was no evidence that pain assessment was performed before medication administration at 11:00 AM, 3:38 PM, and 8:28 PM. On 8/28/25, the MAR indicated morphine 1 mg IV was administered at 8:50 AM, 10:30 AM, 5:51 PM, and 7:54 PM. On Patient 21’s PA flowsheet for 8/28/25, there was no evidence that pain assessment was performed before medication administration at 8:50 AM, 10:30 AM, 5:51 PM, and 7:54 PM. Furthermore, pain reassessment was not performed after pain medication administration. 4. a. Review of Patient 24’s clinical record indicated Patient 24, an infant, was admitted to the facility on 11/7/25 for pulmonary artery plasty (a surgical procedure to repair, widen, or reconstruct narrowed, enlarged, or malformed lung arteries) with cardiopulmonary bypass (or heart-lung machine, also called the CPB pump, a machine that temporarily takes over the function of the heart and lungs during open-heart surgery by maintaining the circulation of blood and oxygen throughout the body). During a concurrent interview and record review on 1/15/26 at 2:21 PM, with the Assistant Director of Regulatory Affairs (ADRA), Patient 24’s clinical record was reviewed. Patient 24’s MAR indicated a physician order of morphine (PF) [preservative-free] 1 mg/ml injection 0.2 mg every 2 hours PRN for 1st line for pain. Patient 24 was administered morphine 0.2 mg IV on 12/1/25, at the following times: 12:52 PM, 1:24 PM, and 2:18 PM; given less than an hour apart, which was not in accordance to the physician’s order. There was no documented evidence of a physician consultation that a dose is to be given outside of the physician’s order. At 5:26 PM, Patient 24 was given another dose of morphine 0.2 mg IV. There was no evidence that pain assessment was performed before medication administration at 12:52 PM, 1:24 PM, 2:18 PM, and 5:26 PM. The ADRA acknowledged that there was no pain assessment performed prior to giving the medication and stated, “None. I don’t see it.” During an interview on 1/20/26 at 10:14 AM, with Unit Director of the Pediatric Cardiac Intensive Care Unit and Pediatric Cardiac Transitional Care Unit (UD) 1, UD 1 stated, nurses are expected to perform pain assessment, document the pain score before giving pain medication, and 30 minutes after IV pain medication administration. UD 1 further stated, documentation is done in the pain assessment flowsheet. 4.b. Review of Patient 5’s clinical record indicated Patient 5, a child, was admitted to the facility on 6/5/25 with diagnoses including aortic valve insufficiency (a condition where the valve between the heart’s main pumping chamber and the body’s main artery fails to close tightly). During a concurrent interview and record review on 1/20/26 at 10:14 AM with UD 1, Patient 5’s clinical record was reviewed. Patient 5’s MAR indicated a physician order of morphine 2 mg/ml injection 2 mg every 2 hours PRN for 1st line for pain. Patient 5 was given morphine 2 mg IV on 6/21/25, at 11:31 AM and 12:33 PM, administered an apart, which was not in accordance with the physician’s order. There was no evidence of a physician consultation that a dose is to be given outside of the physician’s order. Additionally, there was no evidence that pain assessment was performed before the 12:33 PM medication administration. UD 1 acknowledged that the medication was given an hour apart and stated, “I can see that.” UD 1 also said that there should be an assessment before giving the medication and stated, “There’s none.” Furthermore, UD 1 confirmed that there was no documented evidence of a provider (physician) consultation prior to administration of another dose outside of the physician’s order. UD 1 stated, “I don’t see a conversation with the provider that another dose is to be given. I expect a documentation from the nurse and there’s none. 39792 5. Review of Patient 4’s clinical record indicated Patient 4, a minor, was admitted to the facility on 9/26/25 for cardiac surgery. Review of Patient 4’s MAR indicated a physician order of fentanyl (a rapid -acting synthetic medication used for acute pain, requiring medical supervision due to risks of severe respiratory depression and the potential to cause low blood pressure) intravenous route (through the vein) 30 mcg (micrograms) every one hour PRN for 1st line for pain. The PA flowsheet on 10/12/25 at 8:45 PM indicated Patient 4 had pain by using the “Assume Pain is Present (APP) tool whereby the blood pressure was documented as elevated. Patient 4 was administered 30 mcg of Fentanyl IV at 8:45 PM. The PA flowsheet indicated pain reassessment was not performed after pain medication administration. During a concurrent interview and record review on 1/14/26 at 2:39 PM with CNS 2, Patient 4’s MAR dated 10/12/25 was reviewed. CNS 2 stated that they could not locate the pain reassessment after the fentanyl 30 mcg IV administration at 8:45 PM. CNS 2 stated it was the expectation for licensed staff to perform an assessment after a IV medication at least 30 minutes or later and could not explain why that assessment was not performed. A review of facility policy and procedures titled, “Pain Assessment & Management” last reviewed/revised on 10/25 indicated, “ ...Pain Assessments ...2. Assess pain prior to pharmacological or nonpharmacological interventions and reassess for efficacy and monitor for side effects within the required timeframes ...Pain Reassessments are ongoing and an integral part of routine care. They should be conducted based on clinical judgment and the anticipated time frame for the intervention’s effectiveness. A focused pain assessment following each intervention evaluates the treatment’s effectiveness and potential side effects, such as sedation, respiratory depression ...Hospital A Health recommends that nurses document pain reassessments as follows: Within 90 minutes following PO, PR, or enterally administered analgesics ...Within 30 minutes following IV, IM, and subcutaneous routes ...” A review of facility policy and procedures titled, “Medication Administration” last reviewed/revised on 10/25 indicated, “ ...Critical Points: 7. The “7 Rights” of medication administration are: Right Patient Right Medication Right Dose Right Time ...Compare medication to medication order within the MAR ...Administration of Medications ...2. High Risk Medications ...a. Hospital A Health has identified the following medications as high-risk medications ...v. In Hospital B (in addition to above): All routes of opioids/narcotics ...””

“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: 49264 Based on interview and record review, the facility failed to comply with the provisions in 42 CFR 489.20 and 489.24, when it failed to provide stabilizing treatment for an emergency medical condition (EMC) within its capabilities for two of 20 sampled patients (Refer to A-2407). This failure had the potential for patients with unstabilized EMCs to be discharged without appropriate counseling or assessment resulting in deterioration of the patients’ condition or death.”

“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: 38066 Based on interview and record review, the facility failed to provide stabilizing treatment for an emergency medical condition (EMC) within its capabilities for two of 20 sampled patients (Patient 17 and Patient 6) when: 1. Patient 17 presented to the emergency department (ED) for altered mental status (AMS) and left against medical advice (AMA) without any physician reassessment of the patient’s decision-making capacity prior to leaving. 2. Patient 6 presented to the ED with chest pain and notified a nurse practitioner (NP - an advanced practice registered nurse with a graduate degree who provides a wide range of healthcare services, including diagnosing and treating acute and chronic illnesses) that they wanted to leave AMA, but the electronic health record did not indicate the steps taken to try to secure the written, informed refusal if it was not able to be obtained. This failure had the potential for patients with unstabilized EMCs to be discharged without appropriate counseling or assessment resulting in deterioration of the patients’ condition or death. Findings: A review of a facility provided ambulance report, dated 09/18/25, indicated, the San Francisco Fire Department (SFFD) responded to a call for Patient 17. The ambulance report indicated that upon arrival by the Emergency Medical Services (EMS, pre-hospital medical care and transportation often by ambulance), “Patient [17] sitting in the driver seat of her vehicle ...opened her eyes to verbal stimulation but was unable to speak. Patient presented GCS 13 [Glasgow Coma Scale, is a system to “score” or measure how conscious you are. The total score, from 3 to 15, helps classify a person’s level of consciousness and the severity of a potential head injury: a score of 13-15 indicates a mild injury]. Patient had an empty sleeve of SOMA [brand name for carisoprodol, a prescription muscle relaxant] medication on her person. Patient extricated [removed] from vehicle and transferred to gurney. Patient was unable to speak or follow commands for EMS.” A review of Resident 17’s initial toxicology (medical specialty focused on adverse effects of chemical substances on living organisms ) consult note written by Medical Doctor (MD) 4, dated 09/18/25, indicated MD 4 assessed patient as having “dilated [widened] pupils but reactive, tongue tremors, mild facial tremors and intermittent myoclonic jerks [sudden, brief, and involuntary muscle twitches] in bilateral [both] lower extremities (BLE).” The initial toxicology consult note further indicated, “Carisoprodol is a muscle relaxant whose exact mechanism is unknown, but it inhibit [sic] interneuronal activity [process of signals to the spine and brain] in the spinal cord leading to muscle relaxation ...In toxic doses, it can cause CNS [Central Nervous System] depression [slowing down], respiratory depression [slower breathing] ... and you can see anticholinergic effects ( ...dry mouth, tachycardia [fast heart rate], urinary retention, etc).” The initial toxicology consult note by MD 4 indicated under the recommendations section, “Clinical picture is consistent with a carisoprodol overdose with CNS depression and myoclonic jerks ...Primarily supportive [sic] including IVF [intravenous fluid-fluid given directly into the vein] or hypotension [low blood pressure] and tachycardia ...cardiorespiratory monitoring for at least 24 hours and until back to baseline ...Repeat EKG q6h x 2 [every six hours, two times] to ensure no interval changes ...” During a concurrent interview and record review on 10/14/25 at starting at 3:48 PM with Registered Nurse (RN) 1, Patient 17’s Emergency Department (ED) triage (the process of evaluating and prioritizing patients based on the urgency of their medical needs) RN Note written by RN 1, dated 09/18/25, was reviewed. The ED triage RN note indicated that Patient 17 was, “BIBA [(brought in by ambulance]) CODE 3 [most commonly indicates that an ambulance is en route with lights and sirens activated, signifying a life-threatening emergency that requires the fastest possible response] for AMS.” RN 1 stated that the triage process was bypassed and patient was brought directly to the code room as patient’s condition was deemed critical. Furthermore, Patient 17’s GCS assessment dated 09/18/25 at 18:42, was reviewed. The assessment indicated a score of 10. RN 1 stated, “GCS score of 10 as patient lost points for incomprehensible speech.” Additionally, Patient 17’s C-SSRS (Columbia-Suicide Severity Rating Scale, can assist clinicians in evaluation of patients in the emergency department to predict overall suicide risk and the need for admission) Suicide Risk Modified Screening, dated 09/18/25 at 6:47 PM, was reviewed. Screening indicated it was deferred. RN 1 stated, “Patient was unable to engage in conversation,” at the time. During an interview on 10/15/25 at 6:49 AM with RN 2, RN 2 stated he cared for Patient 17 from around 7:00 PM to around 9:45 PM on 09/18/15 when Patient 17 presented with AMS. RN 2 stated Patient 17 was “Very somnolent [sleepy or drowsy] when I received her.” When RN 2 was asked if he assessed Patient 17 for suicidal risk, RN 2 stated the first screening done by RN 1 was deferred and “I [RN 2] didn’t document [a suicide screening] on my shift,” for Patient 17. .Furthermore, RN 2 was asked if he documented on Patient 17’s neurological exam or mentation to show that Patient 17 improved, RN 2 stated, “No, I did not document.” A review of ED Provider Note written by a Resident Physician (MD 2), dated 09/19/25, indicated that “Pt [Patient 17] uncooperative on exam... Neurological: Mental Status: She is confused. GCS: GCS eye subscore is 4, GCS verbal subscore is 4, GCS motor subscore is 5 [these subscores total to an assessed GCS of 13] ... Tongue fasciculations [visible, rapid, involuntary muscle twitches in the tongue] noted and facial tremor. Intermittent myoclonic spasms in LLE (left lower extremity ) ...Most concerning for withdrawal or substance use/alcohol intoxication. Will continue to monitor for anticholinergic crisis (a life-threatening condition that occurs when there is an excessive amount of anticholinergic drugs in the body).” During a concurrent phone interview and record review on 10/15/25 at 11:23 AM with MD 2, Patient 17’s ED Course Documentation written by MD 2, dated 09/19/25, was reviewed. The documentation indicated, “2036 [8:36 PM] Tox rec [toxicology recommendation] observation for 24 hours given long half-life [the half-life of a medication determines the rate at which it is eliminated from the body] (10 hours). Request electrocardiogram (EKG, a non-invasive medical test that records the electrical activity of the heart) q6h ...2239 [10:39 PM] Per medicine [team that admits patients into the hospital] patient requesting to leave. Informed patient that is unsafe for dispo [disposition] given ingestion - with concerns of anticholinergic crisis, cardiac abnormalities, etc. Pt [Patient 17] denies taking the medication and believed she was drugged ...2315 [11:15 PM] Pt frustrated and not willing to engage in teach back (a communication technique used in healthcare to ensure that patients understand the information provided by their healthcare provider) ... Patient much more alert compared to initial presentation ...Attg [Attending] [Medicine Physician, [MD 3] talked to patient who continue to endorse AMA. [MD 3] stated she would rescind medicine admission and recommended ED hold with psych consult. Pt self-discharged and self-removed IV.” MD 2 stated that an order for psychiatry consult was placed but was canceled. MD 2 deemed a psychiatry consult was inappropriate, and stated, “I think it was not needed because patient denied SI (suicidal ideation - having thoughts, fantasies, or a preoccupation with ending one’s own life).” When asked if patient was screened for SI, MD 2 stated, “I don’t see on my documentation.” When asked if she was able to document an assessment of Patient 17’s capacity to make a health care decision, MD 2 stated, “No I didn’t write that ... she [Patient 17] was not willing to engage in teach back,” about the possible consequences and risks of her choice. When queried about if anyone assessed Patient 17’s decision-making capacity, MD 2 stated, “I can’t say who decided about capacity.” In general, when patients leave AMA without documented capacity, MD 2 stated, “Patient’s safety was a concern.” During a phone interview on 10/15/25 at 8:30 AM with Attending Physician (MD 1), MD 1 stated that he was the attending physician for Patient 17. MD 1 stated poison control was called and recommended to monitor patient for 24 hours given the half-life of SOMA which was 10 hours. According to MD 1, the ED team had a conversation with the admitting hospital doctor (MD 3), who was uncomfortable discharging the patient because of the risk of suicidality. MD 1 stated, the ED was ultimately responsible for determining patient’s decision-making capacity. When asked for documentation of assessment for Patient 17’s capacity, MD 1 stated, “It is poorly documented. We failed to document that.” During a phone interview on 10/15/25 at 12:32 PM with MD 3, MD 3 stated that she planned to admit Patient 17 for observation after SOMA overdose, which seemed appropriate, but did not push through with the admission as patient was not agreeing to stay. MD 3 stated, “I talked to the ED team to discharge her AMA, which they agreed to do.” According to MD 3, Patient 17 denied SI and said she was drugged. When asked what her determination was of Patient 17’s decision-making capacity, MD 3 stated patient was very awake, mental status was at baseline and didn’t believe patient was drugged. Additionally, MD 3 stated, “I thought she had capacity based on my assessment.” When queried about documentation on Patient 17’s decision-making capacity, MD 3 stated, “I didn’t document that.” 49264 2. A review of facility policy and procedure titled, “Emergency Medical Treatment and Labor Act (EMTALA)”, last approved on 8/2025, indicated, “ ...Emergency Medical Condition (“EMC”): This is a condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances, and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in: 1. Placing the health of the individual (including the health of an unborn child) in serious jeopardy; serious impairment to bodily functions; or serious dysfunction of any bodily organ or part ...Stabilize: This means to provide medical treatment to ensure, within reasonable medical probability, that no material deterioration of an individual’s condition is likely to occur at discharge or is likely to result from or occur during transfer from one location to another ... Informed Refusal ...1. The Medical Center will obtain or attempt to obtain written informed refusal of examination, treatment or an appropriate transfer in the case of an individual who refuses to consent. 2. In the event written informed refusal cannot be obtained, documentation of the individual’s refusal will be documented in the medical record; in the event a medical record cannot be created, an incident report describing the refusal will be documented ...” A review of facility policy and procedure titled, “Elopement [a patient leaving a healthcare facility without authorization or notification]/Against Medical Advice (AMA)”, last approved on 03/2024, indicated, “ ...Leaving Against Medical Advice (“AMA”): A patient with medical decision-making capacity who expresses the wish to leave the hospital prior to completion of evaluation and treatment ... Capacity to Make Health Care Decisions: A patient’s ability to understand the nature and consequences of a decision and to communicate a decision, and includes in the case of proposed health care, the ability to understand its significant benefits, risks and alternatives. The patient’s physician should determine whether a patient has the Capacity to Make Health Care Decisions (Probate Code Section 4658) ... B. Leaving Against Medical Advice (AMA)1. Adult patients with Capacity to Make Health Care Decisions: a. When an adult patient with capacity expresses to a physician the wish to leave the hospital prior to the completion of evaluation and treatment, the physician will explain to the patient the risks of not completing the recommended evaluation or course of treatment. The physician should document the discussion with the patient. Note: Pursuant to Probate Code section 4658, the Attending MD can determine if patient has healthcare decision making capacity ...” During an interview on 10/15/25 at 6:47 AM with Registered Nurse (RN) 2, RN 2 stated he is an ED nurse. RN 2 was asked generally about the process for patients leaving AMA in the ED and stated that the provider should fill out the AMA paperwork with patient and while the patient may not sign it, it should be documented that the provider attempted to get a signature. During a concurrent interview and record review on 10/15/25 at 8:58 AM with Nurse Practitioner (NP) 1, Patient 6’s ED Provider Note written by NP 1, dated 04/28/25 was reviewed. The note indicated Patient 6 presented to the ED on 04/28/25 with chest pain since 10AM in the morning. NP 1’s note further indicated under ED Course that Patient 6’s “Heart score [an evidence-based calculation of a patient’s risk for a heart-related event after developing chest pain; scores of 0-3 indicated likely able to discharge a patient, 4-6 indicated admission to the hospital, 7-10 indicated possible need for invasive interventions] of 4 recommended patient stay overnight for stress test [clinical test to see a heart’s functioning and blood flow during stress] in the morning but patient declined, left AMA, understands risks including possible missed MI [myocardial infarct-a heart attack or loss blood flow to the heart muscle] and death.” NP 1 stated that he was the provider that took care of the patient and was working them up to rule out an emergency medical condition. NP 1 further stated that Patient 6 did notify him that he wanted to leave AMA. NP 1 stated that he usually asks patients leaving AMA to sign an AMA form, but he does not recall if he asked Patient 6 to sign one. During a concurrent interview and record review on 10/15/25 at 8:58 AM with Nurse Practitioner (NP) 1, Patient 6’s ED Disposition Note written by NP 1, dated 04/28/25 was reviewed. The Disposition note indicated Patient 6 “has made the decision to leave the current treatment against the advice of me [NP 1]”. NP 1 was asked if there is an AMA form for Patient 6 and stated “I see the discharge form but not the AMA form.””

“INFECTION CONTROL PROFESSIONAL CFR(s): 482.42(a) Infection prevention and control program organization and policies. The hospital must demonstrate that: (1) An individual (or individuals), who is qualified through education, training, experience, or certification in infection prevention and control, is appointed by the governing body as the infection preventionist(s)/infection control professional(s) responsible for the infection prevention and control program and that the appointment is based on the recommendations of medical staff leadership and nursing leadership; This Standard is not met as evidenced by: 49264 Based on interview and record review, the hospital failed to follow its infection control policy when one out of ten sampled patients (Patient 3) had their isolation precautions (steps taken to prevent the spread of germs in healthcare and residential settings) discontinued when they continued to be at risk for spreading Clostridium Difficile (C. diff, a highly contagious bacteria that causes diarrhea and other intestinal issues and is spread through contact with contaminated surfaces, hands, or equipment). This failure has the potential for the spread of C. diff to other patients or hospital staff due to the lack of appropriate precautions and protections. Findings: A review of a critical care progress note, dated 01/04/25, indicated that Patient 3 was admitted in October of 2024 and has a complex medical history including a cardiac arrest (when the heart suddenly stops working), end stage renal disease (ESRD, a permanent condition that occurs when the kidneys can no longer function and require dialysis or a kidney transplant to survive), respiratory failure (when the lungs don’t work properly), and septic shock (a life-threatening condition that occurs when an infection overwhelms the body causing dangerously low blood pressure). A review of a Patient 3’s medical record overview, screenshot provided by facility on 01/15/25, indicated a section titled “Patient Isolation Status”. The overview section indicated that Patient 3 was placed on “Enteric Contact” isolation (a set of procedures that prevent the spread of infection from a person who has a gastrointestinal illness) on 12/27/24 and was subsequently removed from isolation on 01/04/25 for an undocumented reason. A review of Patient 3’s Stool Assessment/Output Flowsheet (a form that gathers all the important data regarding a patient’s condition), dated 01/03/25, indicated that Patient 3 had 200 milliliters (mL, a metric unit of measurement used to quantify an amount of liquid) of stool at 6:00 PM that was described as “loose” and “watery”. This measurement came from a “rectal tube” (a flexible tube inserted into the rectum that can help drain stool). A review of Patient 3’s Stool Assessment/Output Flowsheet, dated 01/04/25, indicated that Patient 3 had an unmeasured amount of stool at 11:00 AM and 4:00PM that was described as “loose” and “watery”. Both episodes of stool came from a “rectal tube”. A review of Patient 3’s Stool Assessment/Output Flowsheet, dated 01/05/25, indicated that Patient 3 had an unmeasured amount of stool at 8:00 AM that was described as “loose; watery” and 80mL of stool at 5:00 PM that was described as “watery”. Both episodes of stool came from a “rectal tube”. A review of Patient 3’s Stool Assessment/Output Flowsheet, dated 01/06/25, indicated that Patient 3 had an unmeasured amount of stool at 12:00 AM that was described as “watery” and “loose”, 100mL of stool 6:30 AM that was described as “watery”, and an unmeasured amount of stool at 8:00PM that was described as “watery” and “loose”. All three episodes of stool came from a “rectal tube”. A review of Patient 3’s Stool Assessment/Output Flowsheet, dated 01/07/25, indicated that Patient 3 had 50mL of stool at 7:00 AM that was described as “watery” and an unmeasured amount of stool at 8:00 AM that was described as “watery” and “seedy” (loose stool that has a texture similar to seeds). Both episodes of stool came from a “rectal tube”. During a concurrent interview and record review on 01/14/25 at 2:21 PM with the interim-infection prevention manager (IPM), Patient 3’s Stool Assessment/Output Flowsheet, dated 01/04/24 to 01/07/25, was reviewed. The flowsheet indicated that Patient 3 had multiple episodes of “loose” and “watery” stools while their enteric isolation precaution was discontinued. The IPM stated that Patient 3 should have been continued on enteric isolation as they continued to be symptomatic. A review of Patient 3’s laboratory report titled “Clostridioides difficile Toxigenic PCR with Reflex to Toxin Immunoassay” (a laboratory test for C. diff), dated 01/07/25, indicated that Patient 3’s stool tested positive for the C. diff toxin gene (specific segment of genetic instructions for making a C. diff toxin protein) and negative for C. Diff toxin protein. The report further indicated, “Correlate with clinical information. Contact Infectious Disease for help with interpretation and management ...Enteric Contact Isolation required” During an interview on 01/15/2025 at 2:14 PM with an Infection Preventionist (IP), the IP was stated that upon additional review of Patient 3’s clinical record, there continued to not be a clinical rationale documented as to why enteric isolation was discontinued on 01/04/25. A review of facility guidelines titled, “UCSF ADULT POPULATION: CLOSTRIDIOIDES DIFFICILE (C. DIFF) PREVENTION GUIDELINES”, dated 08/22/23, indicated that “Enteric Contact Isolation can be discontinued when: 1. Diarrhea resolves with discontinuation of laxatives/stool softeners or adjustment of tube feeds and there is no suspicion for an infection. 2. C. difficile test result is negative ...and no alternative diarrheal infection is suspected. 3. C. difficile test result is gene ...positive/toxin protein negative AND diarrhea absent for >/= [greater than or equal to] 48 hours AND a new clean room is available ...” The guidelines further indicated that “If your patient’s C. difficile test is negative, continue enteric contact isolation IF you still suspect an alternative infectious source of diarrhea. C. difficile is not the only organism that can spread in the hospital. If you are concerned that another infection is responsible for your patient’s diarrhea, then continue enteric isolation and consider diagnostic testing for other infections. 2. If your patient is C. difficile toxin gene positive/protein negative and having diarrhea, then continue enteric contact isolation. Although colonized [has the bacteria but not actively infected] patients may have an alternative explanation for their diarrhea, they may still transmit spores into the environment while having diarrhea, which can subsequently infect other vulnerable patients ...””