Mercy Hospital

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 41166 The Condition of Participation is NOT met as evidenced by: Based on observation, interview, and record review, the hospital failed to ensure that safe pharmaceutical services were provided and meet the needs of each patient as evidenced by: 1. The hospital failed to have adequate processes in place for medications to be stored, dispensed, and administered in a safe manner, consistent with hospital policy and procedures (P&P) and standards of practice when: a. For Hospitals A and B, the hospitals failed to develop and implement a P&P that addressed the use of auto-verified medication orders (orders entered by providers and medications dispensed bypassing verification of a pharmacist) and did not have a system for monitoring the appropriate use of the auto-verification process to ensure that medications dispensed by the use of auto-verification process were distributed in accordance with applicable standards of practice; b. For Hospital B, droperidol (a medication used to treat mental conditions, agitation and nausea/vomiting) was administered to two of two sampled patients (Patient 12 and Patient 13) without baseline and continuous cardiac monitoring consistent with standards of practice and manufacturer’s specifications; c. For Hospitals A and B, multiple medications were stored in the pharmacy not protected from light in accordance with hospital P&P and manufacturers’ specifications; d. For Hospital B, rocuronium and succinylcholine (medications that cause temporary muscle paralysis) were stored co-mingled in a bin in the pharmacy, not separated and not labeled with high alert labels in accordance with hospital P&P; e. For Hospital B, dinoprostone (medication used to induce labor in pregnant women near their delivery) was not stored at the appropriate temperature in the pharmacy freezer in accordance with hospital P&P and manufacturer’s specifications; f. For Hospitals A and B, the patients’ own medications (medications brought to hospital by patients) for 13 of 15 sampled patients (Patient 3, Patient 4, Patient 5, Patient6, Patient 7, Patient 8, Patient 26, Patient 27, Patient 28, Patient 29, Patient 30, Patient 31, Patient 32) were observed stored in the pharmacy after the patients were discharged and were not handled in accordance with hospital P&P; and g. For Hospital A, the patients’ own medications for three of three sampled patients (Patient 33, Patient 34, and Patient 35) were not stored in the pharmacy, in accordance with hospital P&P. (Refer to A-500) 2. The hospital failed to ensure Controlled Substance (CS, drugs with high probability of addiction and are controlled by the federal government) drugs were stored according to hospital P&P for one of fifteen randomly sampled patients (Patient 1), when brivaracetam (CS drug used for seizures) was not stored in a locked cabinet in the pharmacy. (Refer to A-503) 3. The hospital failed to ensure unusable medications were not available for patient use according to hospital P&P, when a partially used and undated 3-ml (milliliter- unit of measure) insulin lispro (fast acting form of insulin used to manage blood sugar levels) multidose vial was stored and available for patient use. (Refer to A-505) 4. The hospital failed to ensure up-to-date reference material on drug therapy was readily available to direct patient care staff when the hospital did not have the most current version of BROSELOW Pediatric Reference Tape (a measuring tool that relates a child’s height as measured by the tape to their weight to provide medical instructions including medication dosages, the size of the equipment that should be used, and the level of energy when using a defibrillator (machine that provides electrical shock to the heart)) available at the Operating Room (OR) emergency pediatric (treatment of children) medication and treatment cart. (Refer to A-510) The cumulative effect of pharmaceutical services systemic problems resulted in the hospital’s inability to ensure the provision of quality health care, in compliance with the Condition of Pharmaceutical Services.”

“FOOD AND DIETETIC SERVICES CFR(s): 482.28 The hospital must have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company may be found to meet this Condition of Participation if the company has a dietitian who serves the hospital on a full-time, part-time, or consultant basis, and if the company maintains at least the minimum standards specified in this section and provides for constant liaison with the hospital medical staff for recommendations on dietetic policies affecting patient treatment. This Condition is not met as evidenced by: 27157 Based on observation, interview, and record review, the hospital did not meet the requirements for Condition of Participation, CFR (Code of Federal Regulations) 482.28 Food and Dietetic Services when the hospital failed to ensure: 1. The Food and Nutritional Services (FNS) department was unaware of interdepartmental recently approved Policy and Procedure (P&P) titled, “Latex Sensitive Patient” and of standard of practice guidance provided in the Academy of Nutrition and Dietetics (AND) (Nutrition Care Manual) in order to establish performance standards via P&P for Registered Dietitian’s (RDs) and ensure dietary staff followed procedures per “FNS Food Handling” P&P, dated 6/25/24 for one of one sampled patient (Patient 87) at Hospital B. This failure resulted in impeded communication for Patient 87’s latex allergy with food preparation staff in the kitchen which had the potential for cross contact with a food that could have similarly structured proteins that the body mistakenly recognizes as latex potentially resulting in cross-reactive food allergies for a patient. There were 61 patients with po diet orders who received their meals from the kitchen at Hospital B according to the “Active Diet Orders,” dated 11/19/25. (Refer to A-0620 #6) 2. The P&P titled, “Subject: Food and Nutrition Services (FNS): Patient Nutrition Care”, dated 6/25/24, that was approved by P&P Committee and Medical Executive Committee, provided clear guidance to the hospital’s clinical RDs in regard to the mechanism for providing their expert nutrition care advice to physician’s related to patient care aligned with California (CA) Business and Professions Code (BPC) 2586 for RDs. Hospital A had a total licensed bed capacity of 144, and Hospital B had a total licensed bed capacity of 84 at the time of the survey. This failure resulted in RDs writing diet orders and orders for oral nutrition supplements (ONS) for patient’s without any definition of use of supplements within the parameters of physician prescribed therapeutic diet orders listed in the hospital’s diet manual which placed the RDs working out of their legal scope of practice per the California (CA) Business and Professions Code (BPC) 2586 for Hospital A and Hospital B. (Refer to A-0630) 3. The director of food and nutrition services (DFNS), who had the authority and delegated responsibility to include the daily management of dietary services, was employed full-time to plan and direct the daily management of the foodservice operation at Hospital B, as the DFNS split his time between Hospital A and Hospital B. Hospital A had a total licensed bed capacity of 144, and Hospital B had a total licensed bed capacity of 84 at the time of the survey. This failure of insufficient daily oversight of the foodservice operation could have resulted in delayed identification and correction of unsafe food handling or sanitation practices for patient health and safety. (Refer to A-0620) 4. One of one cooks (CK 2) immersed a chemistry (chem) test strip in the sanitizer solution located in a red bucket for 10 seconds in accordance with manufacturer’s guidelines (MGs) to test parts per million (PPM; concentration) at Hospital B. Failure to use a chem test strip in accordance with the MGs guidelines and in accordance with the manufacturer’s EPA-registered label for the sanitizer could result in a darker color that indicates a higher concentration (false high) than what is actually present. There were 61 patients with po diet orders who received their meals from the kitchen at Hospital B according to the “Active Diet Orders,” dated 11/19/25. This failure had the potential to cause foodborne illness in the highly susceptible patients. (Refer to A-0620) 5. One of two cooks (CK 1) and one of three Nutrition Assistant’s (NA 2) washed their hands after removing soiled gloves prior to donning new gloves at Hospital A and Hospital B in the kitchen. There were 118 patients with po (by mouth) diet orders who received their meals from the kitchen at Hospital A according to the “Active Diet Orders,” dated 11/19/25. There were 61 patients with po diet orders who received their meals from the kitchen at Hospital B according to the “Active Diet Orders,” dated 11/19/25. This failure had the potential to cause foodborne illness in the highly susceptible patients. (Refer to A-0620) 6. Two of two Nutrition Assistant’s (NA 1 and NA 2) were monitoring, and documenting wash and final rinse temperatures in accordance with MGs while the dish machine was in use, at Hospital A and Hospital B to ensure patient safety. There were 118 patients with po (by mouth) diet orders who received their meals from the kitchen at Hospital A according to the “Active Diet Orders,” dated 11/19/25. There were 61 patients with po diet orders who received their meals from the kitchen at Hospital B according to the “Active Diet Orders,” dated 11/19/25. This failure had the potential to cause foodborne illness in the highly susceptible patients. (Refer to-0620) 7. Dietary staff followed refrigerated food storage chart for dating of refrigerated food for 2 of 6 meat/poultry items located in the walk-in refrigerator to ensure quality and safe food was served to patients at Hospital B. There were 61 patients with po diet orders who received their meals from the kitchen at Hospital B according to the “Active Diet Orders,” dated 11/19/25. This failure had the potential to cause foodborne illness in the highly susceptible patients. (Refer to A-0620) 8. One of one Nutrition Assistant’s (NA) 3 washed and sanitized a cutting board after use and prior to using again during food preparation (prep) to prevent potential of cross-contamination and/or cross-contact in regard to a patients’ potential food allergy. In addition, the FNS staff did not follow the hospital’s P&P titled “Food Handling”, dated 6/25/24, when Cook 1 was unaware there were current hospitalized in-patients with food allergies. The following patients had a food allergy as listed on the “Active Diet Orders [generated from the patient’s EHR],” dated 11/19/25 at 11:05 a.m., at Hospital B. (Patient 87, Patient 88, Patient 89, Patient 91). There were 61 patients with po diet orders who received their meals from the kitchen at Hospital B according to the “Active Diet Orders,” dated 11/19/25. This failure placed patients with a food allergy at an increased risk of experiencing allergic symptoms ranging from mild to life-threatening. (Refer to A-620) According to the FDA (Food and Drug Administration) Food Code 2022, “A “Highly susceptible population” means persons who are more likely than other people in the general population to experience foodborne disease because they are: (1) Immunocompromised; ... or older adults; and (2) Obtaining food at a facility that provides services such as...health care...hospital.” 9. Hospital A and Hospital B’s overall hospital structure was evaluated for follow-up (f/u) care for high risk patients when Registered Dietitian (RD) could schedule a patient f/u up to five days after the completion of an initial nutrition assessment for a high risk patient, despite the hospital’s average length of patient stay was 4.18 days. This failure had the potential to not meet patients nutritional needs during their hospitalization. Hospital A had a total licensed bed capacity of 144, and Hospital B had a total licensed bed capacity of 84 at the time of the survey. (Refer to A-0629) 10. The Hospital was effectively monitoring nutrition intervention for one of one sampled patient (Patient 90) when the quantity of oral nutrition supplement (ONS-liquid nutrition to increase calories and protein) consumed by by Patient 90 was not documented by nursing and the RD follow up date was up to 7 days after initial nutrition assessment by RD 1 which indicated Patient 90 required an oral nutrition supplement (ONS) due to increased protein needs. This failure resulted in standard of practice (ASPEN), utilized by the Manager of Food-Nutrition Services/RD, to not be met and failed to ensure a Patient 90’s nutritional needs would be met. The hospital’s average patient length of stay was 4.18 days. (Refer to A-0629) 11. Hospital A and Hospital B’s drop down diet orders available in the electronic health record (EHR) followed the hospital’s P&P titled, “FNS Patient Nutrition Care, A-1003S (PNC),” dated 6/25/24, when only one default CCHO (Consistent Carbohydrate diet to manage diabetes) diet of 60 g [grams] of CHO (carbohydrate) order was readily available to physicians responsible for care of the patients. Hospital A had a total licensed bed capacity of 144, and Hospital B had a total licensed bed capacity of 84 at the time of the survey. This failure had the potential for the physician to not have full range of therapeutic diet options readily accessible that aligned with the facility’s diet manual for routinely prescribed diets to meet patients special dietary needs for chronic disease, such as diabetes. (Refer to A-0629) 12. Hospital A and Hospital B clinical RDs completed nutrition assessments for patients with chronic diseases and comorbidities (a disease or medical condition that is simultaneously present with another) that required specialized dietary needs such as a therapeutic CCHO diet for diabetes or a therapeutic renal diet for kidney disease as indicated in the hospital’s approved NCM diet manual from AND. Hospital A had a total licensed bed capacity of 144, and Hospital B had a total licensed bed capacity of 84 at the time of the survey. This failure had the potential for patient’s with chronic diseases or conditions to not have their special dietary needs met during their hospitalization. (Refer to A-0629) 13. At Hospital A and Hospital B the CCHO default diet of 60 g (grams) CHO (carbohydrate) per meal ordered in a patient’s EHR consistently matched the actual CCHO menus provided to patients. RDs were allowed to independently change the diet order to either a 45 g or 75 g CCHO diet in a software program located in the FNS department, in which the software did not interface with the patient’s EHR. Hospital A had a total licensed bed capacity of 144, and Hospital B had a total licensed bed capacity of 84 at the time of the survey. This failure had the potential to impede accurate communication and care planning for the management of a patient’s diabetes, amongst the interdisciplinary team, including the physician responsible for the care of the patient and who was authorized to write diet orders.(Refer to A-0629) 14. Hospital A and Hospital B ONS (oral nutrition supplements) were provided to patients in accordance with orders from a practitioner responsible for the care of the patient, as required by State law for RDs per California Business and Professions Code 2586 for one of one sampled patient (Patient 90). This facility practice was a system concern as hospital leadership approved RDs to initiate ONS without a physician order and without the ONS being within the parameters of a physician prescribed diet order according to the facility’s diet manual, which was not in accordance with State law (CA BPC 2586). Hospital A had a total licensed bed capacity of 144, and Hospital B had a total licensed bed capacity of 84 at the time of the survey. The facility failed to ensure RDs performed clinical nutrition patient care within their scope of practice in CA placed patients at an increased risk of lack of oversight by the medical staff when RDs initiated ONS without established performance criteria and was outside of scope of practice for RDs practicing in California. (Refer to A-0618) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure food and nutrition services meets the needs of the patients in compliance with the Condition of Participation for Food and Dietetic Services. This had the potential to affect the hospital census of 167 highly susceptible patients.”

“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: 27157 Based on interview, and record review, the hospital failed to ensure: 1. Data was collected to evaluate and review the hospital’s established time frames for the Registered Dietitians (RD) to follow-up on high, moderate, and low risk nutrition patients and to ensure provision of dietetic services, based on the average length of stay, to meet the patient’s nutritional needs during hospitalization. (Cross Reference A-0629) 2. The hospital’s Quality Assurance and Performance Improvement (QAPI) identified that the hospital’s structure/policies and procedures (P&P) did not follow standards of practice to ensure RD’s assess and evaluate the therapeutic dietary needs of patients with ordered therapeutic diets (CCHO: consistent carbohydrate and renal: kidney diet) based on disease or clinical condition. (Cross Reference A-0629) 3. The Manager of Food and Nutrition Services (MFNS/RD) possessed the necessary authority and communication channels to fulfill job duties according to the hospital’s Quality Assurance Performance Improvement (QAPI) plan. In addition, the hospital did not ensure data collection was conducted to evaluate whether the hospital’s P&P on nutritional screening was accurately identifying those patients who may have a nutrition diagnosis and benefit from nutrition assessment and intervention by a registered dietitian (RD), in addition to identifying malnutrition via MST (malnutrition screening tool). These failures resulted in hospital P&Ps, for screening risk and provision of nutritional care, to not provide the structure and systems to ensure the hospital operated in accordance with high quality and evidence-based practice, such as (but not limited to) Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM) and American Society of Parenteral and Enteral Nutrition (ASPEN), and did not reflect the actual day to day nutrition activities being conducted by the clinical RDs for evaluation of adequate RD staffing needs for both Hospital A and Hospital B. Nutrition care P&Ps provide a framework for daily activities of staff, ensuring consistency, patient safety, and should be based on the needs of the patient population and standard of practice versus structured around limited RD staffing of which there were three clinical RDs splitting time between Hospital A and Hospital B. Hospital A had a total licensed bed capacity of 144, and Hospital B had a total licensed bed capacity of 84 at the time of the survey. Findings: 1. During a concurrent interview and record review on 11/24/25 at 8:45 a.m. with RD 2, in the presence of Manager of Food-Nutrition Services who was a RD (MFNS/RD), RD 2 stated they tried to avoid scheduling patient follow- ups on Wednesdays and Thursdays because those days only had one clinical RD available to provide clinical nutrition care for both Hospital A and Hospital B combined. RD 2 stated they had to schedule that way since there were only 3 clinical RDs employed to be shared between Hospital A and Hospital B and they also had to provide weekend coverage. (Cross Reference A-0629) RD 2 stated the hospital’s structure via their approved P&Ps for determining patient’s who would receive a nutrition assessment, other than via the MST (Malnutrition Screening Tool), and their follow up time frames were not based on evidenced based standard of practice, patient population’s nutritional needs or average length of patient hospitalization. Rather their follow up time frames were structured far enough apart to ensure their three clinical RDs could meet their timeframe’s listed in the P&Ps. During an interview on 11/24/25 at 9:00 a.m. with MFNS/RD, MFNS/RD stated the hospital’s P&P allowed RDs to follow up on high risk patients five days after the initial nutrition assessment, seven days for moderate risk and 10 days for low risk patients. MFNS/RD stated the P&P’s were set by corporate and she could not change them. During a review of the hospital’s P&P titled, “Subject: Nutrition Care Process -Screening Risk and Provision of Nutritional Care for Adults,” dated 1/15/24, the P&P indicated, “Guidelines for follow-up care are as outlined: a. High-Risk patients should have follow-up within five (5) days of last assessment/reassessment, Moderate risk patients should have follow-up within 7 days of last assessment/reassessment, Low risk patients should have follow-up within 10 days of last assessment/reassessment. . .The dietitian monitors and evaluates the patient’s response to care.” During an interview on 11/24/25 at 4:13 p.m. with MFNS/RD, MFNS/RD stated she referred to ASPEN and ANDs NCM for guidance on standard of practice in clinical nutrition. During an interview on 11/24/25 at 4:30 p.m. with MFNS/RD and Director of Food and Nutrition Services (DFNS), MFNS/RD and DFNS stated the hospital’s average length of stay was 4.18 days. MFNS/RD and DFNS stated the nutrition screening and follow up times were structured in a manner to ensure their three clinical RDs could meet their P&P’s for timeliness of nutrition care to be in compliance with their policy, between Hospital A and Hospital B. MFNS/RD stated she also tried to pitch in and complete nutrition assessments or follow up nutrition care to help the three clinical RDs when she could, as she split her time between Hospital A and Hospital B, as well. MFNS/RD stated she had not collected data to be aware as to how many patients were discharged prior to the RD f/u with the patient, and was unaware how many potential patients nutritional needs were not met during those five days between RD visits and prior to patient discharge from the hospital. During a review of ASPEN’s standards of care guidance titled “ASPEN Adult Nutrition Care Pathway (Age 18+ years)”, (ANCP), dated 9/14/22, the “ANCP” indicated once inadequate nutrient intake had been identified “Monitoring & Evaluation: Follow-up within 3 days, monitor parameters; tolerance of nutrient intake, oral intake including supplements, vitamins, minerals, anthropometric data (weight trends), functional status.” During a review of the hospital’s job description (JD) titled,”Clinical Dietitian 1,” dated 1/25, the “JD” indicated, “Works with an interdisciplinary environment to contribute toward overall patient care. Closely monitors, evaluates and rescreens patient nutrition status as appropriate. . .Monitors and evaluates patient response to interventions by meeting specific measurable goals documented in the nutrition care plan in a timely and thorough manner in the medical record.” During a review of the hospital’s P&P titled, “Subject: Patient Nutrition Care,” dated 6/25/24, the P&P indicated, “Nutritional Care Quality Improvement: 1. Performance improvement (PI) projects will be implemented to identify barriers to nutrition care and help create action plans to better the nutrition care component of the patient visit. a. Develop nutritional care PI benchmarks based on national guidelines. b. Identify champions to gather and analyze data. c. Present data at department, Quality, and other facility meetings, as requested.” 2. During an interview on 11/20/25 at 3:43 p.m. with MFNS/RD, in presence of DFNS, MFNS/RD stated within the hospital’s system RD’s were not required to perform a nutrition assessment for chronic diseases with comorbidities (a disease or medical condition that is simultaneously present with another) that required specialized dietary needs such as a therapeutic CCHO diet for diabetes or a therapeutic renal diet for kidney disease per the hospital’s policies and procedures. During a review of AND’s NCM titled, “Management in Acute and Post-Acute Care Settings,” dated 2025, the NCM indicated, “Diabetes Management in the Hospital: The goals of MNT [Medical Nutrition Therapy] in the hospital setting are to provide adequate energy [calories] to meet metabolic demands, optimize glycemic [blood sugar] control, address personal food preferences, and facilitate creation of a discharge plan. . .The RD is integral in the role of assessment, intervention, and monitoring/evaluation of hyperglycemic [high blood sugar] individuals in the hospital setting.” During a review of AND’s NCM titled, “Diet For Chronic Kidney Disease,” dated 2025, the NCM indicated, “A diet for CKD [chronic kidney disease] may be ordered upon admission. It is expected that the diet order will be individualized by the RD. . .A preliminary diet order before the RD is able to perform an assessment may comprise the following: protein: 80 g [grams] protein, Phosphorus: 1000-1200 mg, Potassium: 2000-2500 mg, Sodium: 2300 mg.” During a review of the hospital’s P&P titled, “Subject: Food and Nutrition Services (FNS): Patient Nutrition Care,” dated 6/25/24, the P&P indicated, “Guidelines: Diet Manual: The online Nutritional Care Manual (NCM) (“Diet Manual”) is the approved Diet Manual for [name affiliated with the hospital].” 3. During a concurrent interview and record review on 11/24/25 at 8:33 a.m. with RD 2, in the presence of MFNS/RD, RD 2 stated, in addition to the hospital’s MST completed by nursing for patients upon admission, RD 2 screened patients for certain pertinent diagnosis or conditions based on evidence based practice to help identify patients who could benefit from an RD nutrition assessment in which there is known diet therapy that could improve those conditions, since the hospital’s P&P for nutrition care seemed to be based on the limited RD staffing and not standard of practice. RD 2 stated she screened for the following diagnosis; DKA (Diabetic ketoacidosis (DKA) is a serious, potentially life-threatening complication of diabetes that occurs when the body breaks down fat for energy, creating a buildup of acidic ketones in the blood), new onset diabetes, any cancers, ICU (intensive care unit) patients, Hepatic (liver) encephalopathy (a brain dysfunction caused by liver failure, where toxins build up in the blood and affect the brain), ESRD (end stage kidney disease), less than 18.5 BMI (body mass index), full liquid diet greater than 5 days, patients 65 years or older and eating disorders for an RD nutrition assessment within 2 days. During a review of ASPEN’s Journal of Parenteral and Enteral Nutrition (JPEN) article titled, “Recognizing malnutrition in adults with critical illness: Guidance statements from the Global Leadership Initiative on Malnutrition,” dated March 31, 2025, the article indicated, “To identify pre-existing malnutrition, we suggest evaluation within 48 h [hours] of ICU [intensive care unit] admission when feasible (100% agreement) or within 4 days (94% agreement).” During a concurrent interview and record review on 11/24/25 at 8:40 a.m. with MFNS/RD, the facility’s P&P titled, “Addendum: Food and Nutrition Services (FNS) A-1002P-3, Subject: Nutrition Care Process - Screening Risk and Provision of Nutritional Care for Adults,” dated 1/15/24 was reviewed. MFNS/RD stated the P&P did not direct the clinical RDs to screen patients for the diseases and conditions as stated by RD 2 in order for an RD to complete a nutrition assessment, to include intervention (included diet therapy counseling) and monitoring. MFNS/RD stated she and her clinical RDs recognized there were gaps in the hospital’s P&Ps related to identifying high risk nutrition patients based on diagnosis who may benefit from nutrition assessment and intervention by a registered dietitian (RD) within two days. MFNS/RD stated even though there were only three clinical RDs who worked at the hospital, plus herself to pitch in as she was able, the RDs still wanted to identify patients with a nutrition risk the best they could. MFNS/RD stated she trained the clinical RDs to screen patients for, “Admitting Diagnosis, and to re-screen for these during the patient’s hospitalization, of bariatric (medical weight management) surgery, burns, cancer of the head, neck, throat, liver, pancreas, esophagus, stomach and/or small intestine. End Stage Liver Disease/Cirrhosis (the final stage of chronic liver disease, characterized by scarring of the liver that impairs its function), Hepatic Encephalopathy, Current Organ Transplantation, Cystic Fibrosis (an inherited genetic disease that causes thick, sticky mucus to build up in the lungs, pancreas, and other organs, leading to breathing problems, digestive issues, and infections), Diabetes (new onset, DKA, GDM (diabetes just during pregnancy), End Stage Renal Disease, Eating Disorders, malnutrition, short bowel syndrome (a condition where the small intestine can’t absorb enough nutrients from food due to its length or lack of function), other contributing factors; BMI < 18.5, vent (ventilator) dependent (a medical device that assists or takes over breathing for patients), pressure ulcer/injury. . .(a wound from constant pressure on the skin, cutting off blood flow, leading to tissue damage), and > (greater than) 70 years of age with hip fracture.” During a review of ANDs NCM titled, “Gastrointestinal Disease-Cirrhosis,” dated 2021, the NCM indicated, “All inpatients and outpatients with a diagnosis of cirrhosis (severe scar tissue that can’t perform vital functions like filtering blood or fighting infections, often leading to liver failure, high blood pressure. . .) should be rescreened at each admission or visit. Re-screen inpatients at periodic intervals during hospital stay.” During a concurrent interview and record review on 11/24/25 at 9:16 a.m. with MFNS/RD, MFNS/RD repeated the above was not incorporated into the hospital’s current P&Ps. MFNS/RD stated the hospital’s current P&Ps have been streamlined to fit the hospital’s RD staffing, consisting of three clinical RDs (RD 1, RD 2, RD 3) split between Hospital A and Hospital B. MFNS/RD stated she did not feel comfortable with the current P&P as it was not in accordance with standard of practice or professional performance expected from RDs. MFNS/RD stated the hospital’s nutrition care P&Ps were developed by corporate and she could not change them. MFNS/RD stated the structure of the hospital was to report any concerns with the system for nutrition care to a corporate “CA [California] Nutrition Council”. MFNS/RD stated she was not part of CA Nutrition Council and had not reported her concerns. MFNS/RD stated the actual daily nutrition activities completed by the clinical RDs was directed by her solely within the FNS department. MFNS/RD stated the extent of the daily nutrition activities that the clinical RDs were performing were more closely aligned with established performance standards but were not communicated hospital wide to aid in the hospital’s ability to evaluate RD staffing needs. MFNS/RD stated she had not conducted data collection related to the hospital’s P&P titled, “Addendum: Food and Nutrition Services (FNS) A-1002P-3, Subject: Nutrition Care Process - Screening Risk and Provision of Nutritional Care for Adults,” dated 1/15/24, to identify the quantity of patients that may not have had their nutrition risk identified by the hospital’s nutrition screening P&P to include other problems, in addition to malnutrition, in which a patient’s chronic disease or condition could have benefited from an RD nutrition assessment, intervention and/or dietary counseling during their hospitalization. During a review of ANDs NCM titled, “Selecting and Implementing Screening Tools,” dated 2025, NCM indicated, “Tips for Implementing Nutritional Risk Screening Programs: Because nutritional status often declines during prolonged hospitalization, protocols should be established to rescreen patients whose initial nutrition screen did not justify referral to a registered dietitian nutritionist (RDN) on admission. Each facility must determine the time frame for rescreening, based on average length of stay. Appropriate protocols should be in place to ensure consistent and accurate communication of the results of the nutrition screen to the RDN. The results of nutrition screening programs should be monitored and evaluated at regular intervals in order to determine whether the screen is accurately identifying those patients who require nutrition assessment and intervention and whether appropriate referrals are being made.” During a review of ANDs NCM titled, “Definition of Nutrition Screening,” dated 2025, NCM indicated, “Nutrition Screening Definition: The process of identifying patients, clients, or groups who may have a nutrition diagnosis and benefit from nutrition assessment and intervention by a registered dietitian (RD) or registered dietitian nutritionist (RDN). Patients. . .enter nutrition assessment, the first step of the Nutrition Care Process (NCP), through screening, surveillance systems data.” During a review of ANDs NCM titled, “Screening For Nutrition Problems Other Than Malnutrition,” dated 2025, NCM indicated, “Registered dietitian nutritionists (RDN) must also receive referrals for nutrition problems other than malnutrition, such as the following: Knowledge deficits. For example, education focused on modification of sodium and fluid intake, in order to mitigate heart failure symptoms and reduce readmission rates.” During a review of the hospital’s job description (JD) titled,”Clinical Dietitian 1,” dated 1/25, the “JD” indicated, “Job Summary/Purpose:. . .the Clinical Dietitian I assesses the nutritional status of the patient using recognized tools of assessment, and recommends & counsels patients, family, and/or caregivers on the appropriate nutrition plan to improve the patient’s disease or condition management. Works with the general population, as well as with patients in more complex levels of care under the supervision of a Clinical Dietitian II or Clinical Nutrition Director.” During a review of the hospital’s “Quality Assurance Performance Improvement Plan (QAPI)”, dated FY [fiscal year] 2026, the “QAPI” indicated, “The Quality Department has the responsibility for data collection and analysis of quality metrics as outlined by internal and external requests and requirements in order to support the achievement of [name of hospital] goals related to quality and to foster integration of all quality assessment functions, including Medical Staff, Nursing, and ancillary/support services. . .Hospital Departments/Ancillary Services: Directors/Managers/Supervisors of all departments/services (includes inpatient, outpatient, and contracted services). . have responsibility for the quality of the services provided in their area for: Developing and implementing policies and procedures that guide and support the provision of services, Recommending a sufficient number of qualified and competent persons to provide care.” During a review of the hospital’s job description (JD) titled, “Manager Food-Nutrition Services,” dated 1/25, indicated, “Job Summary/Purpose: Responsible for maintaining and administering established department operational systems, providing for the operational needs of staff, and to contribute to the development of new operational systems as an active team member of the management team. Leads designated Food and Nutrition Services (FNS) team members and ensures service excellence is provided and quality initiatives are maintained. Essential Key Job Responsibilities: Directs all patient interactive positions (i.e. dietitians (if applicable), diet clerks, etc.) and provides for the operational needs of these positions. Maintains regulatory compliance (including. . .CMS, state specific department of health, etc.). . .Maintains adequate staffing for daily needs reflecting cost efficiency. Assigns staff and workload, respecting changing priorities in daily operations. Recruits, hires and manages performance staff. Assists with managing facility diet manual, as well as patient diet and nutritional analysis compliance with the diet manual. Participates in hospital committees as indicated by the department policies and procedures (i.e. MEC, Quality, and P&T committees).” During a review of the Commission on Dietetic Registration (CDR), the credentialing agency for the Academy of Nutrition and Dietetics, published the, “Revised 2024 Scope and Standards of Practice for the Registered Dietitian Nutritionist,” dated January 2024, the publication indicated, “RDs in leadership roles: Determine appropriate quality standards in foodservices and nutrition programs, lead or participate in organization, department and interprofessional quality assurance and performance improvement activities to demonstrate commitment to safe, ethical, and quality person-/population-centered care and/or programs and services. . .RDs use various tools and resources, including the Academy’s Evidence Analysis Library, Nutrition Care Manuals (Adult, Pediatric, and Sports), practice guidelines from federal agencies such as the National Institutes of Health and other professional organizations (e.g., American Diabetes Association, National Comprehensive Cancer Network, American Society for Parenteral and Enteral Nutrition, National Kidney Foundation, and American Academy of Pediatrics) to guide MNT [Medical Nutrition Therapy] care practices.” (www.cdrnet.org/scope. Accessed 12/5/25). During a review of the hospital’s P&P titled, “Subject: Nutrition Care Process -Screening Risk and Provision of Nutritional Care for Adults,” dated 1/15/24, the P&P indicated, “Procedure: The clinical nutrition staff (Registered Dietitian, Registered Dietetic Technician or a Dietetic Intern supervised by a Registered Dietitian) will complete the nutrition care process on patients determined to be at nutritional risk. A. Step 1: Screening process to identify patients at risk for nutrition deficits 1. Nursing will complete a malnutrition risk assessment within 24 hours of admission [MST]. B. Step 2: Nutrition Assessment: Registered Dietitian (RD) or dietetic intern under the direction of RD will complete a nutritional assessment of appropriate at risk patients 1. Within two (2) days of: a. Nutrition consults/referrals/alerts for acute hospitalized inpatients, b. Patients identified at risk by initial screening with a score of >/=2 [MST by nursing], c. Patients with orders for enteral or parenteral nutrition, d. Notification of patients with stage 2 or greater pressure ulcers/injuries, e. Patients who are ventilator dependent, f. Patients with a diet order of NPO/Clear Liquids for > 3 consecutive days, g. Consult for behavioral patients, 2. Within (7) days for any hospitalized medical inpatient not previously assessed.” During an interview on 11/24/25 at 4:30 p.m. with MFNS/RD and Director of Food and Nutrition Services (DFNS), MFNS/RD stated the portion of the P&P [as listed above] that indicated, “Within (7) days for any hospitalized medical inpatient not previously addressed,” meant that if patient’s with chronic diseases and/or diagnosis in which there was evidenced based practice of known diet therapy that could help those conditions were not triggered by the hospital’s criteria per their screening P&P, then those patients would be seen on the 7th day of hospital admission. However, MFNS stated the hospital’s average length of stay was 4.18 days.”

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 41166 Based on observation, interview, and record review, the hospital failed to have adequate processes in place for medications to be stored, dispensed, and administered in a safe manner, consistent with hospital policy and procedures (P&P) and standards of practice when: 1. For Hospitals A and B, the hospitals failed to develop and implement a P&P that addressed the use of auto-verified medication orders (orders entered by providers and medications dispensed bypassing verification of a pharmacist) and did not have a system for monitoring the appropriate use of the auto-verification process to ensure that medications dispensed by the use of auto-verification process were distributed in accordance with applicable standards of practice. 2. For Hospital B, droperidol (a medication used to treat mental conditions, agitation and nausea/vomiting) was administered to two of two sampled patients (Patient 12 and Patient 13) without baseline and continuous cardiac monitoring consistent with standards of practice and manufacturer’s specifications. 3. For Hospitals A and B, multiple medications were stored in the pharmacy not protected from light in accordance with hospital P&P and manufacturers’ specifications. 4. For Hospital B, rocuronium and succinylcholine (medications that cause temporary muscle paralysis) were stored co-mingled in a bin in the pharmacy, not separated and not labeled with high alert labels in accordance with hospital P&P. 5. For Hospital B, dinoprostone (medication used to induce labor in pregnant women near their delivery) was not stored at the appropriate temperature in the pharmacy freezer in accordance with hospital P&P and manufacturer’s specifications. 6. For Hospitals A and B, the patients’ own medications (medications brought to hospital by patients) for 13 of 15 sampled patients (Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, Patient 26, Patient 27, Patient 28, Patient 29, Patient 30, Patient 31, and Patient 32) were observed stored in the pharmacy after the patients were discharged and were not handled in accordance with hospital P&P. 7. For Hospital A, the patients’ own medications for three of three sampled patients (Patient 33, Patient 34, and Patient 35) were not stored in the pharmacy, in accordance with hospital P&P. These failures had the potential to result in patient harm due to the dispensing and administration of inappropriate or ineffective medications, inadequate administrative oversight, and potential for medication error if patient’s own medications were inappropriately administered. Findings: 1. During an interview on 11/17/25 at 3:15 p.m., with Interim Pharmacist in Charge (IPIC), IPIC was asked about the medication order verification process. IPIC stated Emergency Department (ED) providers in Hospitals A and B were able to enter certain medication orders without verification by a pharmacist. IPIC stated the auto-verified orders entered by the ED providers were made available to licensed nursing staff to administer to patients from the automated dispensing machine (ADM-medication distribution system that provides computer-controlled storage, dispensing, and tracking of drugs at the point of care in patient-care units). IPIC stated Hospitals A and B did not have a P&P for auto-verification. IPIC stated having a P&P for auto-verification would have provided an extra level of security for safe administration of medications, if other healthcare providers reviewed and ensured medications that were being auto-verified would be safe for patients. IPIC stated there were a lot of parameters that went into reviewing orders, and a P&P was important to ensure the process was standardized and all staff knew how to go about their activities in a safe and effective way. When asked about how many medication orders were verified monthly, IPIC was unable to provide the information, stating, “I don’t know how many orders are auto-verified on a monthly basis.” When asked if pharmacists periodically reviewed auto-verified orders to ensure medication orders auto-verified were appropriate, IPIC stated, “No, no retrospective review on orders auto-verified.” When asked about the process for deciding which medication orders were being auto-verified, IPIC stated, “I am aware of how not having P&P for criteria for medications to be auto verified can negatively impact a patient. . .It is a safety issue, should consistently have medication experts look at medication whether they are admitted or not, there could be mismatch of medications, patient characteristics, disease state.” During an interview on 11/18/25 at 10:33 a.m., with IPIC, when asked if only one-time medication orders were auto-verified, IPIC stated, “one-time orders, prn [as needed] orders and routine orders are auto-verified...” When asked why Hospitals A and B implemented auto-verification process, IPIC stated auto-verification was implemented so that patient care would not be delayed when medications were needed urgently. IPIC stated that administering the first dose of a medication would be considered urgent to initiate therapy, “after that it’s as needed or routine, does not get review by pharmacist...” When asked if prn or routine medications once auto-verified where available in the ADM for licensed nursing staff to administer to patients, IPIC stated, medication were available to nursing to get from [ADM] unless there is a change in order or patient gets admitted. During a concurrent interview and record review on 11/18/25 at 11:33 a.m., with IPIC, Hospitals A and B’s “Auto-verified Medication Order List,” dated 10/1/25 to 11/18/25 was reviewed. Hospitals A and B’s “Auto-verified Medication Order List” indicated a total of 18,681 medication orders were auto-verified. A review of Patient 10’s ED physician orders, dated 9/15/25 at 9:40 p.m., the physician’s orders indicated, one dose of hydromorphone (a medication with high probability of addiction and are controlled by the federal government) 1 mg (milligram- unit of measure) intravenously (IV- into the vein). The physician’s order was verified by “system, system” on 9/16/25 at 9:41 p.m., and administered by licensed nursing staff on 9/16/25 at 9:58 p.m. IPIC stated orders verified by “system, system” were orders that had bypassed pharmacist verification and were readily available in the ADM for licensed nursing staff to retrieve and administer to patients. During an interview on 11/20/25 at 10:54 a.m., with Registered Pharmacist (RPH) 1, who was now acting as the interim pharmacist in charge, RPH 1 stated it was important for pharmacists to review medication orders to check for interactions, allergies, and contraindications for patient safety. RPH 1 verified pharmacists did not do any retrospective audits for auto-verified medication orders. RPH 1 stated retrospective audits were important so pharmacists could identify issues and resolutions could be implemented. RPH 1 stated having a P&P for auto-verification of medication orders was important for having the same expectation and standard across all the different departments. RPH 1 also stated that having a P&P meant that it had gone through various committees who brought in different expertise to ensure the P&P was sound and best for patient care. During a review of American Journal Health-System Pharmacy article titled, “ASHP [American Society of Health-System Pharmacists] Guidelines: Minimum Standard for Pharmacies in Hospitals,” dated 2013, the article indicated, “All medication orders shall be prospectively reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated dispensing device, except in emergent situations in which the treatment of the patient would be significantly compromised by the delay that would result from pharmacist review of the order. There shall be a procedure for retrospective review of these orders.” During a review of American Journal Health-System Pharmacy article titled, “ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System,” dated 5/15/21, the article indicated, “The formulary system should review and approve all policies related to the medication-use process; all medication-use policies, regardless of their origination, should flow through the P&T committee.” During a review of ASHP article titled, “Autoverification Toolkit,” dated 2024, the article indicated, “3. Define scope for autoverification. . .5. Draft policy changes to support autoverification within the organization. a. Medication-use policies b. Downtime policies ...6. Seek appropriate committee approval for policy changes. a. Pharmacy and Therapeutics b. Relevant clinical leadership/medical staff committees ...8. Develop process for continued assessment and optimization/new requests for autoverification. Monitoring may include but is not limited to: a. Patient safety events b. Technical event c. Retrospective analysis of auto-verified orders d. Autoverification utilization. . .9. Develop education plan for all appropriate stakeholders. a. Initial roll-out education b. Ongoing educational needs.” 2. During an interview on 11/18/25 at 12:34 p.m., with IPIC, when asked if the hospital had a P&P regarding the administration of droperidol, IPIC stated the hospital did not have a P&P for droperidol administration. The IPIC stated the hospital had a P&P for black box warning drugs (strongest warning the government requires a drug manufacturer to include in their product package labeling because it carries a significant risk of serious or even life-threatening adverse events). IPIC acknowledged droperidol had a black box warning for irregular heartbeats. During a concurrent interview and record review on 11/18/25 at 12:54 p.m., with Manager of Infection Prevention (MIPRN), Patient 12’s medical records were reviewed. Patient 12’s medical records indicated Patient 12 was a 30-year-old, admitted on 11/8/25 and discharged on 11/10/25. Patient 12’s medication orders indicated, one dose of droperidol 2.5 mg (milligram, unit of measure) intravenously (IV, into the veins) for nausea and vomiting, was ordered on 11/18/25 at 2:14 p.m. and administered on 11/8/25 at 2:59 p.m. Patient 12’s medical record indicated, on 11/8/25 at 2:40 p.m. a 12-lead ECG (electrocardio gram - a test that records electrical activity of the heart to show rhythm and rate) with a QTc (heart rate corrected QT interval [heart rhythm]) of 385 was obtained prior to administration of droperidol. MIPRN was unable to provide documentation for ongoing 12-lead ECG monitoring for 2 to 3 hours after completing treatment to monitor for irregular heartbeats. MIP stated, “I don’t have an EKG [ECG] after, I only have the one at 14:40 [2:40 p.m.].” During an interview on 11/18/25 at 2:49 p.m., with Certified Registered Nurse Anesthetist (CRNA) 1, CRNA 1 stated droperidol was mostly reserved for bariatric (treatment of overweight patients) patients who had 12-lead ECG. CRNA 1 stated there were risks for arrythmias associated with high doses and he would not have given a 5 mg dose, not in a million years.” During a concurrent interview and record review on 11/18/25 at 2:58 p.m., with MIPRN, Patient 13’s medical records were reviewed. Patient 13’s medical records indicated Patient 13 was a 73-year-old, admitted on 10/30/25 and discharged on 11/7/25. Patient 13’s medication orders indicated the first dose of droperidol 5 mg intramuscularly (IM, into the muscle) was ordered on 11/11/7/25 at 1:56 a.m. and administered on 11/7/25 at 2:04 a.m. The second dose of droperidol 5 mg IM was ordered on 11/7/25 at 2:25 a.m. and administered at 5:04 a.m. MIP stated an ECG was obtained on 10/27/25, with a QTc of 425. MIP was unable to provide documentation of 12-lead ECG monitoring prior to administration of droperidol doses or ongoing 12-lead ECG monitoring for 2 to 3 hours after completing treatment to monitor for irregular heartbeats. During an interview on 11/18/25 at 3:40 p.m. with IPIC, IPIC stated droperidol’s black box warning stated high doses of 2.5 mg and above required cardiac monitoring. IPIC acknowledged there were no warnings or safeguards for pharmacists when they verified droperidol orders verifying a 12-lead ECG had been obtained. IPIC stated having safeguards were important because droperidol affected the heart and could cause irregular heartbeats in patients. IPIC was unable to find hospital guidelines or criteria for droperidol administration. During an interview on 11/20/25 at 11:01 a.m., with RPH 1, who was now acting as the interim pharmacist in charge, RPH 1 stated droperidol was a black box drug. RPH 1 stated that a 12-lead ECG prior to administration allowed a baseline for providers to know what to compare to after administration of droperidol and make sure patients did not have signs or symptoms of irregular heartbeats. RPH 1 stated if patients had an abnormal 12-lead ECG, droperidol would not have been given, because it could cause heart block (disruption in the heart’s electrical system causing irregular heartbeat). During a review of the manufacturer’s drug information sheet for droperidol, dated 1/2009, the drug information sheet indicated the following black box warning for droperidol, “Cases of QT prolongation [heart’s lower chambers take too long to recharge between beats] and/or torsade de pointes [a life-threatening heart rhythm disturbance where the heart’s lower chamber beat faster and are out of sync with the heart’s upper chambers) have been reported in patients receiving droperidol at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal...Based on these reports, all patients should undergo a 12-lead ECG prior to administration of droperidol to determine if a prolonged QT interval [time it takes for heart’s lower chamber to contract and relax] (i.e. [example], QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, droperidol should NOT be administered. For patients in whom the potential benefit of droperidol treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2-3 hours after completing treatment to monitor for arrhythmias. . .Droperidol should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome...risk factors may include age over 65 years. . .Droperidol should be initiated at a low dose and adjusted upward, with caution. . . Adult Dosage: The maximum recommended initial dose of droperidol is 2.5 mg I.M. or slow I.V. Additional 1.25 mg doses of droperidol may be administered to achieve the desired effect. However, additional doses should be administered with caution, and only if the potential benefit outweighs the potential risk.” During a review of the hospital’s P&P titled, “Medications with Black Box Warnings,” dated 11/18/25, the P&P indicated, “Pharmacists shall be informed of selected warnings and recommended criteria for use by the P&T [pharmacy and therapeutics] committee.” 3a. During a concurrent observation and interview on 11/17/25 at 10:35 a.m., with IPIC, in Hospital B’s pharmacy, the following medications were identified and stored on the pharmacy shelf, not protected from light, and available for patient use: - 25 vials containing lidocaine (medication used to treat irregular heart rhythms) with 0.5% epinephrine (medication numbing and as an emergency drug to treat severe allergic reactions, asthma attacks, and heart attack) 50 ml (milliliter, unit of measure); and - 28 vials containing lidocaine with 1% epinephrine 50 ml. IPIC stated pharmacy staff should have placed the vials in amber (brown, light resistant) bags. IPIC stated it was important to protect the vials from light because epinephrine was broken down when not protected from light and it would not have been safe if used for patients. During a review of the manufacturer drug information sheet for lidocaine and epinephrine provided by the hospital, dated 5/2024, the manufacturer drug information sheet indicated, “Protect from light.” 3b. During an observation on 11/17/25 at 11:48 a.m. in the pharmacy at Hospital A, multiple bags of premade metronidazole (antibiotic used to treat infections) 500 mg / normal saline (NS, 0.9% sodium chloride solution, a mixture of salt and water) 100 ml IV bags were identified and were stored on a metal shelf, not protected from light, and available for patient use. The manufacturer’s label on the premade metronidazole 500 mg / NS 100 ml IV bags indicated: “Protect from light during storage.” During an interview on 11/17/25 at 11:50 a.m. with Pharmacist (RPH) 5, RPH 5 acknowledged the premade metronidazole 500 mg/ NS 100 ml IV bags were not stored protected from light and stated they should have been. During a concurrent observation and interview on 11/18/25 at 10:42 a.m. in the pharmacy at Hospital A, with the Interim Director of Pharmacy (IDOP) and RPH 4, 109 premade metronidazole 500 mg/ NS 100 ml IV bags were on the metal shelf in the pharmacy not stored protected from light. The IDOP stated the bags should have been stored in a brown bag to protect from light exposure. During an interview on 11/18/25 at 11:15 a.m. with the IDOP, the IDOP stated it was important to store the metronidazole 500 mg/ NS 100 ml IV bags protected from light to ensure stability and sterility of the medication. During an interview on 11/20/25 at 10:38 a.m., with RPH 1, (acting as the interim pharmacist in charge) RPH 1 stated the expectation was for pharmacy staff to protect light sensitive medications from light. RPH 1 stated it was important because light could affect the structure of the medication and make the medication less effective. During a review of the manufacturer drug information sheet for metronidazole 500 mg/ NS 100 ml IV bags provided by the hospital, dated 3/2021, the manufacturer drug information sheet indicated, “Protect from light during storage.” During a review of the hospital’s P&P titled, “Light Sensitive Medications,” dated 1/20/23, the P&P indicated, “Any light-sensitive medications that are removed from the original manufacturer’s container will be sent and stored in amber, light-resistant bags.” 4. During a concurrent observation and interview on 11/17/25 at 11:19 a.m., with RPH 1 and Inventory Pharmacy Technician (IPT), in Hospital B’s pharmacy, the following medications were stored co-mingled in a bin in the pharmacy main refrigerator, not segregated and not labeled as high alert: - 29 vials containing rocuronium 50 mg/5 ml - 51 vials containing succinylcholine 200 mg/10 ml. IPT stated succinylcholine and rocuronium vials should have been in segregated high alert bins because they were paralytics and high alert medications that should not be mixed up. RPH 1 stated if staff grabbed the wrong medication and administered by mistake, it could have been dangerous to the patient. During an interview on 11/20/25 at 10:40 a.m., with RPH, RPH 1 stated the expectation was for pharmacy staff to separate paralytic medication in differently colored bins and label the bin with a sticker that indicated “neuromuscular blocking agents” so they are easily identified and not mistakenly used as regular medications. During a review of the hospital’s P&P titled, “High Alert Medication Management,” dated 9/5/23, the P&P indicated, “Storage and Dispensing: Labeling. . .stickering high alert medications dispensed from the pharmacy.” 5. During a concurrent observation and interview on 11/17/25 at 11:52 a.m., with RPH 1, in Hospital B’s pharmacy, dinoprostone vaginal insert was stored in the pharmacy freezer. The range of temperature for the freezer was -20 degree Fahrenheit to -40 degree Fahrenheit. The instructions for storage on the packaging of the dinoprostone vaginal insert stored in the freezer indicated, “Store in freezer: between -4 degree Fahrenheit to 14 degree Fahrenheit.” During a review of the pharmacy freezer temperature logs dated 7/1/25 to 7/31/25, 8/1/25 to 8/31/25, 9/1/25 to 9/30/25 and 10/1/25 to 10/31/25, and 11/1/25 to 11/17/25, the temperature logs indicated the freezer storing dinoprostone was maintained between a temperature range of -7 degree Fahrenheit to -11 degree Fahrenheit. RPH 1 acknowledged dinoprostone was not appropriately stored and stated the temperature was important because if dinoprostone got too cold, it could have an impact on the potency of the medication. During an interview on 11/20/25 at 10:47 a.m., with RPH 1, RPH 1 stated pharmacy staff were expected to use manufacturer guideline to set temperature range for medications stored in the pharmacy freezer. RPH 1 stated if temperature was out of range, pharmacy will have to contact manufacturer to inquire about how temperature might affect structure of the medication. RPH 1 stated the manufacturer was unable to provide any information for the temperature range dinoprostone was to be stored in the pharmacy freezer. During a review of the manufacturer drug information sheet for dinoprostone dated 1/2020, the drug information sheet indicated, “Store in a freezer between [-20 degree centigrade and -10 degree centigrade (-4 degree Fahrenheit and 14 degree Fahrenheit].” During a review of the hospital’s P&P titled, “Medication Storage Requirements,” dated 9/17/24, the P&P indicated, “All medications requiring freezing, according to the manufacturer ’ s labeling shall be stored between a temperature range of -4 to -20 degree Fahrenheit.” 6. During a concurrent observation and interview on 11/17/25 at 11:10 a.m., with RPH 1 and IPT, in Hospital B’s pharmacy, six patients’ (Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8) own medication bags containing non-controlled drugs for each patient were stored in an open bin in the pharmacy area. IPT stated patient’s own medications that were not picked up by patients or family member after 15 days following discharge were destroyed by pharmacy staff. During a concurrent interview and record review on 11/17/25 at 11:10 a.m., with RPH 1 and IPT, clinical records for Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8 were reviewed. Patient 7 was admitted on 1/17/25 and discharged on 1/18/25, Patient 8 was admitted on 5/18/25 and discharged 5/18/25, Patient 5 was admitted on 6/1/25 and discharged on 6/2/25, Patient 6 was admitted on 6/13/25 and family contacted on 9/10/25, Patient 3 was admitted on 6/13/25 and discharged on 6/17/25, Patient 4 was admitted on 7/16/25 and discharged on 7/18/25. RPH 1 acknowledged all six patients had been discharged for over 15 days, Patient 7 had been discharged for 10 months and stated the medications should have been destroyed appropriately for medication safety. 46393 6b. During an interview on 11/17/25 at 12:05 p.m. with RPH 5, RPH 5 stated pharmacy staff had not been assigned to regularly audit or reconcile patients’ own medications stored in the pharmacy or in medication rooms on nursing units after discharge. The RPH 5 stated the hospital’s process for handling medications brought from home by patients included; - When patient’s own medications were not used by the patient during admission: the medications were stored in a tamper evident bag sealed by the nurse, stored locked inside the medication room on the nursing unit, and not reviewed by pharmacy staff. - When the patient’s own medications were used by the patient during admission: the medications were counted by the nurse with the patient, the nurse delivered the patient’s own medications to the pharmacy, the pharmacy staff logged the medications on the log sheet. Controlled drugs (drugs that are regulated by the federal government due to potential of abuse/addiction) were stored inside the narcotic vault (secured room designed to store controlled drugs to prevent unauthorized access or theft) and non-controlled drugs were stored on the shelf in the designated pharmacy area. - After the patient was discharged, pharmacy staff attempted to contact the patient if the medications were not returned to the patient when the patient was discharged. The pharmacy continued to store the medications for 30 days and then the medication(s) were destroyed if not picked up by the patient after 30 days from discharge. During a concurrent observation and interview on 11/17/25 at 12:09 p.m. with RPH 5 and the Omnicell Coordinator Pharmacy Technician (OCPT) in the pharmacy at Hospital A, two plastic bins on a shelf in the pharmacy contained discharged patients Patient 26, Patient 27, Patient 28, and Patient 32’s own medication bags containing non-controlled drugs as follows: - For Patient 26, RPH 5 and the OCPT confirmed Patient 26 was admitted on 6/25/25 and discharged on 6/26/25 (approximately 4.5 months ago); - For Patient 27, RPH 5 and the OCPT confirmed Patient 27 was admitted on 6/20/25 and discharged on 6/23/25 (approximately 4.5 months ago); - For Patient 28, RPH 5 and the OCPT confirmed Patient 28 was admitted on 6/16/25 and discharged on 6/17/25 (five months ago); and - For Patient 32, RPH 5 and the OCPT confirmed Patient 32 was admitted on 4/21/25 and discharged on 4/22/25 (approximately 7 months ago). The narcotic vault in the pharmacy contained discharged Patient 29, Patient 30, and Patient 31’s own medication bags containing controlled drugs as follows: - For Patient 29, RPH 5 and the OCPT confirmed Patient 29 was admitted on 2/5/25 and discharged on 2/12/25 (approximately 9 months ago); - For Patient 30, RPH 5 and the OCPT confirmed Patient 30 was admitted on 10/11/25 and discharged on 10/11/25 (37 days ago); and - For Patient 31, RPH 5 and the OCPT confirmed Patient 31 was admitted on 8/18/24 and discharged on 9/11/24 (approximately 14 months ago). During the same group observation and interview on 11/17/25 at 12:09 p.m., RPH 5 and the OCPT acknowledged the patient’s own medications for Patients 26, 27, 28, 29, 30, 31, and 32 were stored in the pharmacy more than 30 days after the patients were discharged and were not destroyed according to the hospital policy. During an interview on 11/17/25 at 3:10 p.m. with the IDOP, IDOP stated the expectation was for the patient’s own medications to have been stored for 15 days after the patient was discharged and should have been disposed of according to hospital policy if unable to reach the patient. During an interview on 11/20/25 at 10:35 a.m. with the IDOP and RPH 1, RPH 1 stated it was important to follow the hospital’s policy for handling patient’s own medications and when discharged, medications needed to be destroyed within the days specified by the policy. A review of the hospital’s P&P, titled “Medications Brought By Patient,” dated July 2016, the P&P indicated, “Patient medications remaining in the Pharmacy 15 days after discharge will be destroyed. All medications destroyed shall be documented. Controlled substances shall be destroyed and witnessed by two pharmacists.” 7a. During an interview on 11/17/25 at 3:10 p.m. with the IDOP, IDOP stated all medications brought to the hospital by the patient that were not taken home should have been brought to the pharmacy for storage. During a concurrent observation and interview on 11/17/25 at 3:20 p.m., with the IDOP and Registered Nurse (RN) 16 in the medication room on nursing unit 3 West at Hospital A. Two sealed tamper proof bags were identified stored inside a cabinet containing Patient 33’s own medications brought from home. There was no list or documentation that indicated the contents inside the bags. RN 16 stated nobody knows what medications are inside the bag. RN 16 stated the hospital’s process for handling patient’s own medications as follows: nurses counted the medication bottles with the patient, sealed the bag(s), stored them inside the medication room on the nursing unit, and documented in the patient’s medical record as “personal belongings.” RN 16 stated the patient’s own medications were not taken to the pharmacy for storage or review unless the medication needed to be used by the patient during admission. The IDOP stated she was unaware Patient 33’s own medications were stored on the nursing unit. The IDOP stated Patient 33’s own medications should have been brought to the pharmacy for storage. The IDOP acknowledged the hospital’s policies and procedures were not implemented for the safe and effective storage of patient’s own medications. 7b. During a concurrent group observation and interview on 11/18/25 at 8:25 a.m. with the IDOP, the Director of Medical Surgical and Telemetry (DMTRN), and RN 3 in the ICU nursing station at Hospital A, the locked medication cabinet had one sealed tamper proof bag inside the cabinet containing Patient 34’s own medications brought from home. RN 3 described the hospital’s process for handling patient’s own medications as follows: Nurse reviewed the medications with the patient, medications brought from home were sealed in a bag, and non-controlled drugs were stored in the locked cabinet in the ICU nursing station. RN 3 stated any patient’s own medications that were controlled drugs were brought to pharmacy for storage. 7c. During a concurrent observation and interview on 11/18/25 at 8:39 a.m. with the IDOP and the DMTRN in the medication room on nursing unit 2 West at Hospital A one sealed tamper proof bag was stored inside a cabinet containing Patient 35’s own medications brought from home. The DMTRN stated if the patient’s own medication was not used during admission it was kept stored in the medication room on the nursing unit and returned to the patient upon discharge. The IDOP stated the patient’s own medications should have been stored in the pharmacy and should not have been kept on nursing units. During a concurrent interview and record review on 11/18/25 at 11:15 a.m., with IDOP, the hospital’s P&P titled, “Medications Brought by Patient,” dated July 2016 was reviewed. The P&P indicated, patient’s own medications should have been stored in the pharmacy and accounted for by pharmacy staff. The IDOP stated it was important to ensure the P&P was followed to prevent diversion of medications, loss of patient property, and to ensure accurate accountability for all medication inventory in the hospital. During a interview on 11/20/25 at 10:35 a.m. with the IDOP and RPH 1, RPH 1 stated nursing staff (on 2 West, 3 West, and ICU) should have brought all patients’ own medications to the pharmacy for storage. During a review of the hospital’s P&P, titled “Medications Brought By Patient,” dated July 2016, the P&P indicated, “All medications brought from home (home meds), shall be sent home with the patient’s family, be evaluated by the pharmacy for patient use, or stored in the pharmacy until the patient is discharged...At [Hospital A] Pharmacy medications are placed in the narcotic vault or the patient own medication storage area for storage until patient discharge. At [Hospital B] Pharmacy medications will be locked in the narcotic vault lockable filing cabinet.””

“CONTROLLED DRUGS KEPT LOCKED CFR(s): 482.25(b)(2)(ii) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept locked within a secure area. This Standard is not met as evidenced by: 41166 Based on observation, interview, and record review, the hospitals failed to ensure Controlled Substance (CS, drugs with high probability of addiction and are controlled by the federal government) drugs were stored according to hospital policy and procedures (P&P) for one of fifteen sampled patients (Patient 1), when brivaracetam (CS drug used for seizures) was stored in a locked cabinet in the pharmacy. This failure had the potential for CS drug diversion (illegal use of prescription medication or use for purposes not intended by the prescriber) and unauthorized access to medications. Findings During an observation and interview on 11/17/25 at 11:10 a.m., with the Pharmacist (RPH) 1 and Inventory Pharmacy Technician (IPT), in Hospital B’s pharmacy, there were bags containing patients’ medications brought from home (patients’ own medications) stored in an open bin in the pharmacy area. IPT stated pharmacy staff would have destroyed patients’ own medications that were not picked up by patients or family members after 15 days following discharge. During a concurrent observation and interview on 11/17/25 at 11:19 a.m., with RPH 1, Patient 1’s medication brought from home contained as 57 tablets of brivaracetam 25 milligrams (mg- unit of measure) stored inside a clear bag in the open bin, unsecured. RPH 1 stated CS drugs were supposed to be stored in the locked CS cabinet if not being used by Patient 1, because diversion was a “big issue.” Patient 1 was admitted on 6/17/25 and discharged on 6/18/25, 5 months ago. During an interview on 11/20/25 at 10:42 a.m., with RPH 1 (acting as the interim pharmacist in charge), RPH 1 stated pharmacy staff was expected to lock CS drug with other CS drugs in the CS cabinet, separate from non-CS patients’ own medications to ensure only necessary personnel had access to the CS drug. During a review of the hospital’s P&P titled, “Medications Brought by Patients,” dated 7/2016, the P&P indicated, “At [Hospital B] Pharmacy medications will be locked in the narcotic vault lockable filling cabinet ...All medications will be placed in the in the patient ’ s own medication locked cabinet located in the Pharmacy CII Safe [a secure, automated, storage unit used store, track, and monitor controlled substances] vault room.””

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 41166 Based on observation, interview, and record review, the hospital failed to ensure unusable medications were not available for patient use according to hospital policy and procedure (P&P), when a partially used and undated 3-ml (milliliter- unit of measure) insulin lispro (fast acting form of insulin used to manage blood sugar levels) multidose vial was stored and available for patient use. This failure had the potential for patients to receive expired medications and expose patients to infections. Findings: During a concurrent observation and interview on 11/17/25 at 12:30 p.m., with Interim Pharmacist in Charge (IPIC), in Hospital B’s in the Emergency Department (ED) medication room a partially used 3-ml insulin multidose vial for Patient 1 was observed stored in a bin available for patient use. IPIC acknowledged the open date and expiration date label affixed to the clear bag containing Patient 1’s insulin lispro had not been filled out by nursing staff after the insulin lispro vial was opened and partially used. IPIC stated it was important for nursing staff to appropriately label the open and expiration date so the Patient 1’s insulin lispro was efficacious and to also prevent bacteria contamination. During an interview on 11/20/25 at 10:51 a.m. with Registered Pharmacist (RPH) 1 (interim pharmacist in charge), RPH 1 stated unlabeled, partially used insulin vials were unacceptable because nursing staff would be unable to determine how long the vial had been opened and when the medication expired. RPH 1 stated potency of the insulin could be lost and the potential for bacteria contamination could be a problem if the insulin was used beyond the expiration date. During a review of the manufacturer’s information drug sheet for insulin lispro, dated 10/2025, the information drug sheet indicated, “Store in-use (opened) vials and pens according to table below. Must be used within 28 days. Discard if not used within 28 days.” During a review of the hospital’s P&P titled, “Multi-dose Vial Policy;” dated 11/16/25, the P&P indicated, “The pharmacy can dispense Multi Dose vials with a 28-day expiration date (as unopened) before dispensing or loading into the Omnicell. Expired, discontinued or discharged patient specific vials must be discarded immediately.””

“STAFF ACCESS TO DRUG INFORMATION CFR(s): 482.25(b)(8) §482.25(b)(8) - Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration must be available to the professional staff. This Standard is not met as evidenced by: 41166 Based on observation and interview, the hospital failed to ensure up-to-date reference material on drug therapy was readily available to direct patient care staff when the hospital did not have the most current version of BROSELOW Pediatric Reference Tape (a measuring tool that relates a child’s height as measured by the tape to their weight to provide medical instructions including medication dosages, the size of the equipment that should be used, and the level of energy when using a defibrillator (machine that provides electrical shock to the heart)) available at the Operating Room (OR) emergency pediatric (treatment of children) medication and treatment cart. This failure had the potential for incorrect medication and treatment to be administered to pediatric patients. Findings: During a concurrent observation and interview on 11/17/25 at 12:05 p.m. with Director of Surgery (DOSRN) in the OR suite at Hospital B, a BROSELOW Pediatric Reference Tape dated 2019 was observed stored at the OR emergency pediatric medication and treatment cart. DOSRN acknowledged 2019 was not the most recent version of the BROSELOW Pediatric Reference Tape. DOSRN stated the most recent version was 2025 and it was important to have the most up to date version so direct patient care staff could take the best care of their patients. During an interview on 11/20/25 at 10:50 a.m., with Registered Pharmacist (RPH) 1 (interim pharmacist in charge), RPH 1 stated it was important for the hospital to keep the most up to date clinical guidelines that were evidenced-based so staff could provide the most efficacious care to patients.”

“ORGANIZATION CFR(s): 482.28(a) Organization This Standard is not met as evidenced by: 27157 Based on interview and record review, the hospital failed to ensure the organization of Food and Nutrition Services department (FANS) was structured in a manner to ensure CMS (Centers for Medicare & [and] Medicaid Services) Condition of Participation (CoP): Food and Dietetic Services would be implemented as required when: 1. The Food and Nutritional Services (FNS) department was unaware of interdepartmental recently approved Policy and Procedure (P&P) titled, “Latex Sensitive Patient” and of standard of practice guidance provided in the Academy of Nutrition and Dietetics (AND) (Nutrition Care Manual) in order to establish performance standards via P&P for Registered Dietitian’s (RDs) and ensure dietary staff followed procedures per “FNS Food Handling” P&P, dated 6/25/24 for one of one sampled patient (Patient 87) at Hospital B, however, this deficient practice applied to Hospital A, as well. This failure resulted in impeded communication for Patient 87’s latex allergy with food preparation staff in the kitchen which had the potential for cross contact with a food that could have similarly structured proteins that the body mistakenly recognizes as latex potentially resulting in cross-reactive food allergies for a patient. (Refer to A-0620 #6) 2. The P&P titled, “Subject: Food and Nutrition Services (FNS): Patient Nutrition Care”, dated 6/25/24, that was approved by P&P Committee and Medical Executive Committee, provided clear guidance to the hospital’s clinical RDs in regard to the mechanism for providing their expert nutrition care advice to physician’s related to patient care aligned with California (CA) Business and Professions Code (BPC) 2586 for RDs. This failure resulted in RDs writing diet orders and orders for oral nutrition supplements (ONS) for patient’s without any definition of use of supplements within the parameters of physician prescribed therapeutic diet orders listed in the hospital’s diet manual which placed the RDs working out of their legal scope of practice per the California (CA) Business and Professions Code (BPC) 2586. (Refer to A-0630) 3. The director of food and nutrition services (DFNS), who had the authority and delegated responsibility to include the daily management of dietary services, was employed full-time to plan and direct the daily management of the foodservice operation at Hospital B, as the DFNS split his time between Hospital A and Hospital B. This failure had the potential for insufficient day to day oversight over the foodservice operation to promptly identify breaks in unsafe food handling or sanitation for immediate correction for health and safety of patients. (Refer to A-0620) Findings: 1. During a concurrent interview and record review on 11/19/25 at 10:07 a.m. with a CK 2 in the kitchen at Hospital B, CK 2 was preparing food for patient’s lunch meal. CK 2 pointed to a sheet of paper posted on an overhead shelf titled, “Menu Item Pick List (MIPL),” dated 11/19/25. CK 2 stated he referred to the list to know what recipes and/or type of food he needed to prepare for patient’s lunch that day. CK 2 was asked how he would know if there was a patient with a food allergy. CK 2 stated the Nutrition Assistant Lead position verbally tells him everyday and he usually wrote it down on the “MIPL”, in which there was no patient food allergy noted. CK 2 stated currently, there were zero patients with food allergies in the hospital. During a concurrent interview and record review on 11/24/25 at 8:45 a.m. with RD 2, in the presence of Manager of Food-Nutrition Services who was a RD (MFNS/RD), Patient 87’s “Nutrition Services Assessment (NSA),” dated 11/16/25, completed by RD 1 was reviewed. The “NSA” indicated, “Food Allergies: Almond, iodine.” RD 2 stated Patient 87 was allergic to almonds and iodine. RD 2 was asked if Patient 87 had any other known allergies and RD 2 stated the patient’s electronic health record (EHR) indicated other allergies included (but not limited to) latex. RD 2 stated we only put the food related allergies on a patient’s nutrition assessment as the nurse asks the patient upon admission to the hospital. RD 2 stated the kitchen staff wore latex free gloves and that was all they needed to do for a patient with latex allergy. RD 2 stated the clinical RDs were not instructed to do anything further for patients with a latex allergy, such as educate patients with a latex allergy that certain foods contain proteins similar to latex that can cause a cross-reactive allergic reaction. (https://allergyasthmanetwork.org/allergies/latex-allergy/latex-allergy-foods/) During a concurrent interview and record review on 11/24/25 at 9:16 a.m. with MFNS/RD, MFNS/RD stated she agreed with RD 2. MFNS/RD stated the hospital’s diet manual consisted of AND’s NCM and “[name of company associated with the hospital] Diet Manual Handbook (DMH).” MFNS/RD reviewed the “DMH”, last approved on 11/6/25, and MFNS/RD stated there was no information related to latex allergy located in the DMH. During a concurrent interview and record review on 11/24/25 at 9:37 a.m. with MFNS/RD, ANDs NCM, dated 2025 was reviewed. The NCM indicated, “A nutrition consult should be ordered when a patient with latex allergy. . .is admitted to the hospital. Patients with latex allergy may need an allergen-free prescription.” MFNS/RD stated the hospital used ASPEN (American Society For Parenteral And Enteral Nutrition) and NCM as their standard of practice. MFNS/RD stated they did not develop a system for the clinical RDs to follow the standard of practice per the NCM related to patient’s latex allergy. MFNS/RD stated, “I’ll have to look at that.” During review of the hospital’s P&P titled, “FNS Patient Nutrition Care, A-1003S,” (PNC), dated 6/25/24, he P&P indicated, “Guidelines: Diet Manual: The online Nutritional Care Manual (NCM) (“Diet Manual”) is the approved Diet Manual for [name affiliated with the hospital]. The System Office Diet Manual Handbook (“Diet Handbook”) template is used to align the NCM guidelines with facility diet orders, modifiers, and menus. Diets in the Diet Handbook will align with those available for a physician to order in the Electronic Health Record (EHR).” During a review of the hospital’s P&P titled, “Subject: Latex Sensitive Patient,” dated 11/14/25, the P&P indicated, “Statement: A latex-safe environment will be provided for patients and staff with a known or suspected latex allergy. Reactions to latex by latex allergic patients can range from mild contact dermatitis to wheezing, anaphylaxis and death. Because equipment and supplies may contain latex, it is important that all health care workers are familiar with this policy before caring for a patient with latex allergy. Risk Factors for Latex Sensitivities:. . .Allergies avocado, bananas, chestnuts, kiwi, papaya, white potato, tomato. . .General Action Steps: All patients will be assessed for food, drug, and environmental allergies and reactions upon arrival and this information will be entered in the Electronic Health Record (E.H.R.). . .Latex allergic and latex sensitive patients will be educated about. . .foods that can cause cross-reactions in order to prevent future allergic reactions. . .Food precautions: 1. Inspect all food trays for latex containing products. 2. Inspect all food trays for foods associated with cross allergies to latex; avocado, bananas, chestnuts, kiwi, papaya, white potato, tomato.” During a review of Allergy & Asthma Network on-line information titled, “Latex Allergy and Foods,” (LAF), dated 2025, the LAF indicated, “If you have a latex allergy, you can sometimes have reactions to certain fruits and vegetables. These reactions occur in 30-50% of people with latex allergy. Latex reactions to certain fruits and vegetables can happen because these foods share similarly structured proteins that the body mistakenly recognizes as latex. This, in turn, causes allergic reactions in latex-sensitive people. These allergic reactions can occur not only after eating these foods but also after touching or smelling them.” (https://allergyasthmanetwork.org/allergies/latex-allergy/latex-allergy-foods.) During a review of the hospital’s P&P titled, “FNS Food Handling,” dated 6/25/24, the P&P indicated, “Clean and sanitize cutting boards and other food contact surfaces between different food preparation steps. Use different cutting boards for each type of food product. May utilize color-coded cutting boards to reduce the risk of cross contamination and cross contact. For example. . .green for produce. . .Prevention of Food Allergy Reactions: If a customer, patient, or resident has an identified food allergy, the associates preparing and serving the food must work with the manager or chef who is knowledgeable about recipes and menu content. This individual becomes the food allergy point of contact for all inquiries. Prepare food with clean, sanitized equipment and serve on clean, sanitized dishes. The food must be prepared to order to avoid any cross contact.” 2. During a concurrent interview and record review on 11/24/25 at 9:16 a.m. with MFNS/RD, the facility’s “Diet Manual Handbook (DM Paper copy),” dated 11/6/25 was reviewed. The “DM” indicated the following diets as routinely ordered diets at the hospital; Regular diet, Heart Healthy, 2 gram Low Sodium Diet, Consistent Carbohydrate, Gestational [pregnancy] Consistent Carbohydrate, Renal [for kidney disease] and Fiber Restricted [low in fiber] in which none of those diets were defined to include any ONS within the parameters of those hospital approved diets. MFNS/RD stated the Hospital’s doctor’s allow RDs to write orders for ONS as an addition to the diet order, including therapeutic diets, such as CCHO and renal without speaking with the doctor and/or obtaining a physician signature. MFNS/RD stated doctors also allowed RDs to independently write diet orders without a cosignature by physician. During a concurrent interview and record review on 11/24/25 at 9:42 a.m. with MFNS/RD, Patient 90’s “Nutrition Services Assessment (NSA),” dated 11/23/25 was reviewed. The “NSA” indicated Patient 90 had a wound on left shoulder and had a history of Type 2 diabetes mellitus (T2DM) when the body cannot use insulin correctly and sugar builds up in the blood.). The NSA indicated, “Diet Order: HHD [Heart Healthy Diet]. . .Nutritional Intervention: JUVEN [Therapeutic Nutrition Powder for Wound Healing per manufacturer, “Use under medical supervision.”] BID [two times a day] to promote wound healing during admission, Continue heart healthy diet, Consider additional dietary modifier: Consistent Carbohydrate due to hx [history] DM, Nutrition Care Plan: Dietitian’s Recommendations: Continue heart healthy diet, Consider additional dietary modifier Consistent Carbohydrate [diet for management of diabetes], JUVEN BID to promote wound healing during admission. . .Recommended Follow-Up by, From: 11/24/2025 Recommended Follow-Up by, To: 12/01/2025 [seven days later], Follow-Up Details: JUVEN BID”, signed by RD 1 on 11/23/2025 at 12:33 PST [12:33 p.m. in the Pacific Standard Time zone].” During a concurrent interview and record review on 11/24/25 at 9:53 a.m. with MFNS/RD, Patient 90’s electronic health record (EHR) dated 11/23/25 was reviewed, The EHR indicated, “[Patient 90’s name] - Order Information for: Dietary Supplements, Original order entered and electronically signed by [name of RD 1] on 11/23/25 at 12:39 PST. No Cosignature Required order by [name of physician] MD [medical doctor], Nutrition Services Department, Dietary Supplements, Order Status: Ordered, Department Status: Ordered, Details: Requested start date and time: 11/23/2025 12:35 PST, Frequency: BID, Special Instructions: JUVEN BID, Next Dose Dt [date] Tm [time]: 11/23/2025 21:00 PST, Validations: Nurse Review: Nurse reviewed by [name of nurse] RN [Registered Nurse] on 11/23/2025 at 13:42 [1:42 p.m.] PST.” MFNS/RD stated that order meant the RD placed the order for JUVEN BID that immediately was recognized as an order that could be provided to Patient 90 as no MD signature was require to be obtained at any point and time. When MFNS/RD was asked how the documentation of “order by [name of physician] MD” get placed on the order screen, MFNS/RD stated IT (information technology department) arranged it that way. MFNS/RD repeated that the RD was allowed to write dietary supplement orders because the hospital’s medical staff granted order writing privileges to the RDs without any cosignature from a doctor being needed at any point and time. MFNS/RD stated she did not no why the start time for JUVEN BID indicated 9:00 p.m. because the JUVEN was mixed with water or juice in the kitchen and was delivered to patient’s on their meal trays, usually with lunch and dinner. During a concurrent interview and record review on 11/24/25 at 9:58 a.m. with MFNS/RD, Patient 90’s EHR was dated 11/23/25 was reviewed. The EMR indicated, “[Patient 90’s name] - Order Information for: Consistent Carbohydrate Diet, Original order entered and electronically signed by [name of RD 1] on 11/23/2025 at 12:39 PST. No Cosignature Required order by [name of physician] MD [medical doctor], Nutrition Services Department, Consistent Carbohydrate Diet, Order Status: Ordered, Department Status: Ordered, Details: Start date and time: 11/23/2025 12:39 PST, Modifiers: Heart Healthy, Validations: Nurse Review: Nurse reviewed by [name of nurse] RN on 11/23/25 at 13:42 PST.” MFNS/RD stated the physician ordered Patient 90 a heart healthy diet (HHD) upon admission on 11/23/25. MFNS/RD stated the RD [RD 1] ordered the CCHO diet without a co-signature being required by a physician and kept the original diet order prescribed by the physician of HHD by adding it in the “Modifier” box, so Patient 90’s diet order immediately changed to CCHO HHD without the physician electronically ordering the diet. In addition, MFNS/RD stated for those patients the RDs ordered ONS in addition to their therapeutic diet order, they would not need to follow up with the patient up to five days later. MFNS/RD stated the hospital’s average length of stay was 4.18 days. During a concurrent interview and record review on 11/24/25 at 3:40 p.m. with MFNS/RD, the hospital’s P&P titled, “FNS Patient Nutrition Care, A-1003S,” dated 6/25/24 was reviewed. The P&P indicated, “Therapeutic diets must be prescribed by a licensed practitioner or the approved medical staff member for the patient’s care. . .Guidelines: Diet Manual: The online Nutritional Care Manual (NCM) (“Diet Manual”) is the approved Diet Manual for [name affiliated with the hospital]. The System Office Diet Manual Handbook (“Diet Handbook”) template is used to align the NCM guidelines with facility diet orders, modifiers, and menus. Diets in the Diet Handbook will align with those available for a physician to order in the Electronic Health Record (EHR). . .qualified Registered Dietitians may order therapeutic diets if consistent with state law or local facility procedure. . .Regulatory impediments may exist at the state level, preventing Registered Dietitians from implementing the privilege (see https://www.eatrightpro.org/advocacy/licensure/therapeutic-diet-orders-state-status-and-regulation for clarification on state status and regulation). . .Registered Dietitians may individualize the patient’s nutritional or dietary treatment when necessary, by modifying the distribution, type, or quantity of food and nutrients within the parameters of the diet order. . .Physician/licensed provider prescribed nutrition prescriptions/diet orders include the provision of oral nutritional supplements by the Registered Dietitian.” MFNS/RD stated the hospital’s regular nor therapeutic diet orders as defined in the hospital’s diet manual had not included any ONS within the parameters of those diet orders available for physician’s to order. MFNS/RD stated RDs were independently writing diet orders and ONS orders in addition to a patient’s ordered therapeutic diet, which were not within the parameters of a physician prescribed diet order which placed the RDs working out of scope of practice as defined in CA BPC 2586. During an interview on 11/24/25 at 3:45 p.m. with MFNS/RD, MFNS/RD stated the P&P was not clear when it contained contradictory guidance such as “therapeutic diets must be prescribed by a licensed practitioner or the approved medical staff member for the patient’s care”, but also indicated, “qualified Registered Dietitians may order therapeutic diets if consistent with state law or local facility procedure.” During an interview on 11/24/25 at 12:37 p.m. with Manager of Medical Staff (MMS), MMS stated the RDs were not granted privileges via the medical bylaws. During a concurrent interview and record review on 11/24/25 at 12:40 p.m. with DMS, DMS stated she was responsible for oversight of the hospital’s Policy and Procedure Committee. The hospital’s P&P titled, “FNS Patient Nutrition Care (PNC),” dated 6/25/24 was reviewed. DMS stated at the bottom of the PNC, dated 6/25/24, the P&P indicated, “Effective Date: June 25, 2024, Food and Nutrition (FNS): Patient Nutrition Care, Administrative Standard” meant the P&P was approved by the hospital’s P&P Committee and Medical Executive Committee (MEC). During a review of the hospital’s P&P titled, “Subject: Policy Submission Process,” dated 9/25/23, the P&P indicated, “Departments: This policy applies to all departments within [name of hospital]. Procedure: Policies are submitted via Policy Manager through project creation. . .Prior to Policy and Procedure (P&P) committee meeting, it is the responsibility of the Department Manager to include the appropriate departments/Subject Matter Experts in their review. . .P&P Committee will meet to review updates/changes to policies for approval. Meeting minutes and list of approved policies will be given to Medical Staff Manager for approval at the Medical Executive Committee (MEC) meeting at least 48 hours prior to the MEC meeting. Policies approved by the MEC will be forwarded to the Hospital Community Board of Directors (Board) for final approval as part of the MEC Report. After Board approval, the dates the policies were approved will be added to the policy, all mark-ups and tracking will be accepted and removed by Final Approver (PolicyManager Administrator).” During a review of the hospital’s P&P titled, “Subject: Verbal, Telephone and Written Physician Orders,” dated 2/16/23, the P&P indicated, “Departments: This policy is applicable to all settings that receive, accept and process verbal, telephone, and written orders. Procedure: Only those physicians or practitioners who are appropriately credentialed as a member of the medical staff with the privilege of giving orders at [name of hospital] may provide an order directing patient care.”, approved by P&P Committee and MEC on 2/16/23. 3. During a concurrent interview and record review on 11/24/25 at 3:10 p.m. with Chief Operations Officer (COO) and DFNS, the facility’s job description (JD) titled, “Director Food-Nutrition Services,” dated 1/25 was reviewed. The JD indicated, “Job Summary/Purpose: Plans, administers and directs all location activities related to food service including financial accountability, compliance with standards established by. . .regulatory agencies. Leads food and nutrition services departments. Establishes and maintains effective working relationships with other departments to provide a unified food and nutrition (dietary) service experience for patients, residents, visitors and employees. Has authority and delegated responsibility including, the daily management of the food services, implementing training programs for dietary staff and assuring that established policies and procedures are maintained.” The DFNS stated he splits his time between Hospital A and Hospital B, therefore was less than a full-time position at Hospital B. COO stated the DFNS had the delegated authority and responsibility from governing body to be responsible for the foodservice operations at both Hospital A and Hospital B, which meant he was less than full time at Hospital A, and less than full time at Hospital B since he split his time between the two hospital campuses. COO stated DFNS was a full time position to the corporation, but was not full time to be responsible for the daily management of the dietary services at Hospital A, and was not full time to be responsible for the daily management at Hospital B, as required per regulation.”

“DIRECTOR OF DIETARY SERVICES CFR(s): 482.28(a)(1) The hospital must have a full-time employee who- (i) Serves as director of the food and dietetic services; (ii) Is responsible for daily management of the dietary services; and (iii) Is qualified by experience or training. This Standard is not met as evidenced by: 27157 Based on observation, interview, and record review, the hospital failed to implement food and dietetic services (FNS: Food & Nutrition Services) policy and procedures (P&P) and/or meet federal regulation when: 1. The director of food and nutrition services (DFNS), who had the authority and delegated responsibility to include the daily management of dietary services, was not employed full-time to plan and direct the daily management of the foodservice operation at Hospital B, as the DFNS split his time between Hospital A and Hospital B. 2. One of one cooks (CK 2) immersed a chemistry (chem) test strip in the sanitizer solution located in a red bucket for 30 seconds instead of 10 seconds in accordance with manufacturer’s guidelines (MGs) to test parts per million (PPM; concentration) at Hospital B. Failure to use a chem test strip in accordance with the MGs guidelines and in accordance with the manufacturer’s EPA-registered label for the sanitizer could result in a darker color that indicates a higher concentration (false high) than what is actually present. 3. One of two cooks (CK 1) and one of three Nutrition Assistant’s (NA 2) did not wash their hands after removing soiled gloves prior to donning new gloves at Hospital A and Hospital B in the kitchen. 4. Two of two Nutrition Assistant’s (NA 1 and NA 2) were not monitoring, and documenting wash and final rinse temperatures in accordance with MGs while the dish machine was in use, at Hospital A and Hospital B to ensure patient safety. 5. Dietary staff did not follow refrigerated food storage chart for dating of refrigerated food for two meat/poultry items of six meat/poultry items to ensure quality and safe food was served to patients at Hospital B 6. One of one Nutrition Assistant’s (NA 3) did not wash and sanitize a cutting board after use, and prior to using again during food preparation (prep) to prevent potential of cross-contamination and/or cross-contact in regard to a patient’s potential food allergy. In addition, the FNS staff did not follow the hospital’s P&P titled “Food Handling”, dated 6/25/24, when Cook 1 was unaware there were current hospitalized in-patients with food allergies. The following patients had a food allergy as listed on the “Active Diet Orders [generated from the patient’s EHR],” dated 11/19/25 at 11:05 a.m., at Hospital B. (Patient 87, Patient 88, Patient 89, Patient 91) These deficient practices had the potential to cause foodborne illness in the highly susceptible patients and/or place patients with a food allergy at an increased risk of experiencing allergic symptoms ranging from mild to life-threatening. There were 118 patients with po (by mouth) diet orders who received their meals from the kitchen at Hospital A according to the “Active Diet Orders,” dated 11/19/25. There were 61 patients with po diet orders who received their meals from the kitchen at Hospital B according to the “Active Diet Orders,” dated 11/19/25. According to the FDA (Food and Drug Administration) Food Code 2022, “A “Highly susceptible population” means persons who are more likely than other people in the general population to experience foodborne disease because they are: (1) Immunocompromised; ... or older adults; and (2) Obtaining food at a facility that provides services such as...health care...hospital.” Findings: 1. During an interview on 11/18/25 at 12:10 p.m. with Director of Food and Nutrition Services (DFNS), DFNS stated he was full time and responsible for the day to day foodservice operation at Hospital B. During an interview on 11/18/25 at 4:00 p.m. with Manager of Food-Nutrition Services who was a Registered Dietitian (RD) (MFNS/RD), MFNS/RD stated she was full time and responsible for the Food and Nutrition Services Department (FNS) for Hospital A and Hospital B, and she split her time between the two campuses. During an interview on 11/20/25 at 11:45 a.m. with DFNS, DFNS repeated he was full time to Hospital B and responsible for the day to day foodservice operation at Hospital B. During a concurrent interview and record review on 11/24/25 at 3:05 p.m. with Chief Operations Officer (COO) and DFNS, the facility’s “FNS Organizational Chart” (OC), dated October 2025, was reviewed. The “OC” indicated the DFNS was over the “Food Production Manager”, located at Hospital A, and over the “Patient Services Nutrition Manager”, for Hospital B, that had the MFNS/RD listed for that position. The COO and DFNS stated the hospital’s job description (JD) for DFNS was titled, “Director Food-Nutrition Services,” dated 1/25. The COO and DFNS stated the facility’s JD for MFNS/RD was titled, “Manager Food-Nutrition Services,” dated 1/25. During a review of the hospital’s OC, dated October 2025, the OC indicated, “Food Production Manager was over MHB [Hospital A] Cooks, Nutrition Assistant Lead, Nutrition Assistant 1 & Storekeeper.” The “Patient Services Nutrition Manager was over MSH [Hospital B] Cooks, Nutrition Assistant Lead, Nutrition Assistant 1 and Clinical Dietitians.” During a review of the hospital’s JD titled, “Manager Food-Nutrition Services,” dated 1/25, the JD indicated, “Job Summary/Purpose: Responsible for maintaining and administering established department operational systems, providing for the operational needs of staff, and to contribute to the development of new operational systems as an active member of the management team. Leads designated Food and Nutrition Services (FNS) team members and ensures service excellence is provided and quality initiatives are maintained.” During a concurrent interview and record review on 11/24/25 at 3:10 p.m. with Chief Operations Officer (COO) and DFNS, the facility’s JD titled, “Director Food-Nutrition Services,” dated 1/25 was reviewed. The JD indicated, “Job Summary/Purpose: Plans, administers and directs all location activities related to food service including financial accountability, compliance with standards established by. . .regulatory agencies. Leads food and nutrition services departments. Establishes and maintains effective working relationships with other departments to provide a unified food and nutrition (dietary) service experience for patients, residents, visitors and employees. Has authority and delegated responsibility including, the daily management of the food services, implementing training programs for dietary staff and assuring that established policies and procedures are maintained.” The DFNS stated he splits his time between Hospital A and Hospital B, therefore was less than a full-time position at Hospital B. COO stated the DFNS had the delegated authority and responsibility from governing body to be responsible for the foodservice operations at both Hospital A and Hospital B, which meant he was less than full time at Hospital A, and less than full time at Hospital B since he split his time between the two hospital campuses. COO stated DFNS was a full time position to the corporation, but was not full time to be responsible for the daily management of the dietary services at Hospital A, and was not full time to be responsible for the daily management at Hospital B, as required per regulation. 2. During a concurrent observation and interview on 11/18/25 at 12:22 p.m. with a Cook (CK 2) in the kitchen at Hospital B, in the presence of DFNS, CK 2 immersed a quaternary (quat) test strip into a quat sanitizing solution located in a red bucket by CK 2 workstation. CK 2 seemed to intentionally wait a period of time, longer than 10 seconds, before removing the quat test strip to compare the color to a color coded graph located on the vial of test strips for the corresponding PPM. CK 2 stated that he needed to keep the strip immersed into the sanitizing solution for 30 seconds before removing. During a concurrent interview and record review on 11/18/25 at 12:33 p.m. with DFNS, a poster of the MGs guidelines for the sanitizer used in the red buckets (for food contact surfaces) located over the 3-compartment sink in the kitchen at Hospital B, dated 2015, was reviewed. The sanitizer MGs indicated, “Withdraw and tear off approximately 2 inches of test paper [strip] from dispenser. Dip test paper for 10 seconds in test solution.” The DFNS stated CK 2 should have dipped the test strip into the sanitizing solution in the red bucket for 10 seconds. During a review of the chem test strip MGs instructions, undated, the MGs indicated, “Dip strip in sanitizing solution for 10 seconds, then compare color with color chart.” During a review of the U.S. Food and Drug Administration (FDA) Food Code Annex,” (FDAFCA), dated 2022, the “FDAFCA” indicated, “The effectiveness of chemical sanitizers is determined primarily by the concentration. . .” 3. During an observation on 11/17/25 at 11:00 a.m. in the kitchen at Hospital A, a cook (CK 1) was plating the hot foods for the lunch meal for patients. The lunch meal included baby potatoes which CK 1 served by using gloved hands to obtain four potatoes from the serving pan to transfer to the patient plate. Alternatives to the main meal and pureed items were kept in a hot box adjacent to the cooks station. As these items were needed, the cook would grab the needed items and return to plating food without hand hygiene though her gloved hands were used to open the hot box and remove those food items. During an interview with the Dietary Manager (DM) on 11/18/25 at 9:00 a.m., DM stated CK 1 should have changed her gloves and washed her hands every time there was a change in tasks. During a review of the hospital’s P&P titled, “Food and Nutrition Services Standard Operating Procedure number FNS A-6002D,” dated August 2024, the P&P indicated, “Single-use disposable gloves are worn when preparing foods that will not be cooked again (ready-to-eat foods) or while serving food ... ii. Gloves are changed between tasks. . .When used, single-use gloves shall be used for only one task. . .and discarded when damaged or soiled, or when interruptions occur in the operation. . .Hands are to be washed with soap and water at the following times. . .Handling food. . .Putting on gloves.” During a concurrent observation and interview on 11/18/25 at 12:26 p.m. with Nutrition Assistant (NA 2), in the presence of DFNS in the dish machine room in the kitchen at Hospital B, NA 2 wore gloves to push a rack that contained dirty dishes, located on the dirty end of the dish machine, into the dish machine. NA 2 proceeded to remove her gloves and put on a new pair of gloves, without washing her hands between glove changes. NA 2 stated she knew she had to wash her hands between glove changes but thought that minimal contact with the rack that contained dirty dishes did not necessitate hand washing in that circumstance. During an interview on 11/18/25 at 4:02 p.m. with MFNS/RD, MFNS/RD stated NA 2 should have washed her hands after removing her soiled gloves and prior to putting on a new pair of gloves. During a review of the hospital’s P&P titled, “FNS Food Handling,” dated 6/25/24, the P&P indicated, “Use of gloves does not replace the need for handwashing. Hands must be washed. . .before putting on disposable gloves. Hands must be washed. . .after removing disposable gloves. . .Hands are to be washed with soap and water at the following times: After handling soiled silverware. Any other activity that may contaminate the hands.” During a review of the FDA Food Code (FDAFC), dated 2022, the “FDAFC” indicated, “When to Wash. Food employees shall clean their hands and exposed portions of their arms. . .immediately before engaging in food preparation including working with exposed food, clean equipment and utensils, and. . .After handling soiled equipment or utensils, during food preparation, as often as necessary to remove soil and contamination and to prevent cross contamination when changing tasks. . . Before donning gloves to initiate a task that involves working with food.” 4. During a concurrent observation and interview on 11/18/25 at 9 a.m. with Nutrition Assistant (NA 1) in the dish machine room in the kitchen at Hospital A, NA 1 placed dirty dishes into racks to run through the high temperature (temp) dish machine. NA 1 stated that monitoring of the sanitation was performed by running a thermal strip through the dish machine to ensure the water temp was adequate. When asked about the temp gauges on the dish machine, NA 1 stated she did not look at them. NA 1 showed the monitoring logbook for the high temp dish machine where the used thermal strips were adhered. There was no documentation of wash or rinse temperatures included in the logbook for monitoring. During a review of the high temp dish machine’s manufacturer data plate (DP) affixed to the dish machine, undated, the “DP” indicated, “Wash Water Min [minimum] Temperature 150 degrees F [Fahrenheit] Pumped Rinse Water Min. Temperature 160 degrees F, Final Rinse Water Temperature 180 to 195 degrees F.” During an interview on 11/19/25 at 9:30 a.m. with DM, DM stated she was unaware of the high temp dish machine data plate instructions. During a review of the hospital’s P&P titled, “FNS Standard Operating Procedure number FNS A-6004D”, dated August 2024, the P&P indicated, “Dish machine wash and rinse water will be maintained at temperatures not less than those established by the Food and Drug Administration (FDA) and manufacturer guidelines.” During a concurrent observation and interview on 11/18/25 at 12:32 p.m. with NA 2, in the presence of DFNS, in the dish machine room in the kitchen at Hospital B, NA 2 ran dirty dishes through the temp dish machine in which the digital temperature display attached to the dish machine indicated, “Wash 153.6 [degrees F (Fahrenheit)], Rinse 152 degrees F.” NA 2 stated she was unaware what temperatures the digital temperature gauge indicated for the wash water or final rinse water because they ran a “Dishwasher Temperature Test Strip,” (DTTS) through the dishmachine as their way of monitoring temperature. During a concurrent observation and interview on 11/18/25 at 12:34 p.m. with NA 2, in the presence of DFNS, in the dish machine room in the kitchen at Hospital B, NA 2 ran another load of dirty dishes through the high temp dish machine while being asked to observe the temperatures on the digital display attached to the front of the dish machine. NA 2 and DFNS stated the wash water temperature exceeded 150 degrees F but the final rinse temp was the same at 152 degrees F. NA 2 ran another DTTS strip through the dish machine and the color bar turned bright orange. DFNS stated the bright orange color on the temp test strip signified the dishwashing machine reached proper temperature for sanitizing. During a review of the hospital’s “Dishmachine Temp Record (High Temp Machine),” (DTR), dated November 2025, the “DTR” log indicated, “Test Strip Results Confirm 180 degrees F, Wash Temp (150-160 degrees F), Final Rinse Temp (180-194 degrees F), Checked by” for each of the meals; Breakfast, Lunch and Dinner. The DTR log was blank for all of the above criteria except a completed DTTS was taped to the DTR log. During a review of the high temp dish machine’s manufacturer data plate (DP) affixed to the dish machine, undated, the “DP” indicated, “Wash Water Min Temperature 150 degrees F [Fahrenheit], Pumped Rinse Water Min. Temperature 160 degrees F, Final Rinse Water Temperature 180 to 195 degrees F.” During an interview on 11/18/25 at 12:39 a.m. with DFNS, DFNS stated he was unaware the digital temperature display affixed to the High Temp Dish Machine indicated 152 degrees F for the final rinse temperature. DFNS stated although the temperature test strip that turned bright orange meant the dish machine was reaching sanitizing temperatures, that it should have been identified by FNS staff that there may have been a problem with the equipment itself and/or temperature gauges. DFNS stated the FNS staff were not required to document the wash and final rinse temperatures per their procedures. During a review of the FDA (Food & Drug Administration) Food Code Annex, (FDAFC), dated 2022, the FDAFC indicated, “The data plate provides the operator with the fundamental information needed to ensure that the machine is effectively washing, rinsing, and sanitizing equipment and utensils. The warewashing machine has been tested, and the information on the data plate represents the parameters that ensure effective operation and sanitization and that need to be monitored.” (FDA Food Code Annex 3, 4-204.113 Warewashing Machine, Data Plate Operating Specifications.) During a review of the FDAFC, dated 2022, the FDAFC indicated, “To ensure properly cleaned and sanitized equipment and utensils, warewashing machines must be operated properly. The manufacturer affixes a data plate to the machine providing vital, detailed instructions about the proper operation of the machine including wash, rinse, and sanitizing cycle times and temperatures which must be achieved.” (FDA Food Code Annex 3, 4-501.15 Warewashing Machines) 5. During a concurrent observation and interview on 11/18/25 at 3:14 p.m. with DFNS inside a walk-in refrigerator in the kitchen at Hospital B, on a lower rack was a large pan of thawed, raw chicken that was labeled which indicated, “Chicken Breast Frozen; Pull To Thaw; Prep 11/17/25 Use Through 11/24/25.” DFNS stated the label meant the raw chicken was obtained from the freezer on 11/17/25 and placed in the refrigerator to thaw. DFNS stated the 11/17/25 date was the first day for the thaw process to have begun and they had 7 days to keep thawed, raw chicken in the refrigerator and it must be cooked no later than 11/24/25. During a concurrent interview and record review on 11/18/25 at 3:15 p.m. with DFNS inside a walk-in refrigerator in the kitchen at Hospital B, on a rack was a pan that contained unpackaged meat covered with a clear wrap labeled as “Roast Beef Cryovac [vacuum packaging technology that extends shelf life] Sous Vide [vacuum-sealing and immersing in warm water]; Prep 11/18/25; Use Through 12/18/25.” DFNS stated the roast beef was purchased pre-cooked and just needed to be re-heated. DFNS stated the label indicated the roast beef could be stored in the refrigerator for one month prior to re-heating. DFNS stated the roast beef was dated correctly as it was received at the hospital via cryovac packaging. DFNS was asked if the roast beef was currently stored in cryovac packaging, and DFNS stated no. During a concurrent interview and record review on 11/18/25 at 3:29 p.m. with DFNS in the kitchen at Hospital B, the facility’s “Food Storage Chart,” (FSC), undated, that was posted by the walk-in refrigerator was reviewed. DFNS stated the “FSC” was not followed for the dating of the thawed, raw chicken and for the roast beef that was no longer stored in the cryovac packaging. DFNS stated the raw chicken and the roast beef should have been stored in the refrigerator no longer than 4 days before cooking and/or reheating according to the FSC. During a review of the FSC, undated, the FSC indicated, “Expiration dates printed by the manufacturer apply until the product is opened. Sealed packages within the master case follow the manufacturer’s date until that package is opened. Once opened, use these time limits unless the manufacturer’s date is earlier. Add the time in this chart to the date of opening/preparation to determine expiration. Refrigerated Storage: 4 days- Raw meat - except Cryovac packaged Top Rounds, 5 days- Allowable time period following removal of meat/poultry/seafood from freezer, 30 days -Top Rounds [roast beef] in Cryovac (from packing date).” During a review of the hospital’s policy and procedure (P&P) titled, “FNS Food Handling,” dated 6/25/2024, the P&P indicated, “Food and supplies must be stored according to food safety guidelines and regulatory standards. General food storage guidelines are followed for all stored foods including refrigerated, frozen, and dry storage foods. Follow expiration date and food storage time guidelines. Food storage guidelines are followed for food stored in refrigerators and walk-in coolers. Food stored refrigerated will be kept no longer than expiration date.” During a review of the Academy of Nutrition and Dietetics Nutrition Care Manual (NCM), dated 2025, the “NCM” indicated, “High-risk groups should be aware of how long foods will keep in the refrigerator: Raw chicken and turkey: 2 to 3 days.” During a review of “FoodSafety.Gov,” (FSG), dated 9/19/23, the “FSG” indicated, “. . .for storing food in the refrigerator. . .short time limits. . .will help keep them from spoiling or becoming dangerous to eat. . .fresh [raw] poultry: chicken whole or chicken pieces 1 to 2 days.” (https://www.foodsafety.gov/food-safety-charts/cold-food-storage-charts) During a review of the Food and Drug Administration Food Code Annex, (FDAFCA), dated 2022, the “FDAFCA” indicated, “Freezing prevents microbial growth in foods, but usually does not destroy all microorganisms. Improper thawing provides an opportunity for surviving bacteria to grow to harmful numbers and/or produce toxins.” (3-501.13) 6. During a concurrent observation and interview on 11/18/25 at 12:15 p.m. with Nutrition Assistant (NA 3), in the presence of DFNS, in the kitchen at Hospital B, NA 3 removed a green colored cutting board from a 2-compartment sink that had a brown leaf from a strawberry located in the sink with visible splash from water in the sink compartments. NA 3 placed the green cutting board on the counter to chop fresh strawberries. NA 3 stated she did not wash and sanitize the green cutting board after it was used for preparation of other fruits from a can that morning. NA 3 stated she only had one green cutting board available for her use. During a concurrent interview and record review on 11/19/25 at 10:07 a.m. with a Cook (CK 2) in the kitchen at Hospital B, CK 2 was preparing food for patients lunch meal. CK 2 pointed to a sheet of paper posted on an overhead shelf titled, “Menu Item Pick List (MIPL),” dated 11/19/2025. CK 2 stated he referred to the list to know what recipes and/or type of food he needed to prepare for patient’s lunch that day. CK 2 was asked how he would know if there was a patient with a food allergy. CK 2 stated the Nutrition Assistant Lead position verbally tells him everyday and he usually wrote it down on the “MIPL”, in which CK 2 stated there was no patient food allergy noted. CK 2 stated currently, there were zero patients with food allergies. During a concurrent interview and record review on 11/19/25 at 10:13 a.m. with a Nutrition Assistant Lead (NAL) in the diet office located in the kitchen at Hospital B, NAL was printing patient’s individualized meal tray cards. NAL stated patient’s with food allergies would have their allergy listed at the bottom of their meal tray card (MTC). NAL pointed to the bottom of Patient 88’s “MTC” that indicated, “Allergies: Banana, Nuts.” NAL showed Patient 89’s MTC that indicated, “Allergies: Tomato.” NAL stated she passed the menus to patients. NAL stated at times, a patient may report they have a food allergy and then she verbally would inform a nurse at that time. NAL stated upon return to the diet office she entered the patient’s stated food allergy into a software program that was only available in the diet office, as the software did not interface with the patient’s medical record. NAL stated she had observed multiple times that nursing staff had not entered the reported patient food allergy into the patient’s electronic health record (EHR). During an interview on 11/19/25 at 10:15 a.m. with MFNS/RD, MFNS/RD stated the “Active Diet Orders (ADO),” dated 11/19/25, was generated from patients EHR. During a review of the hospital’s “Active Diet Orders (ADO),” dated 11/19/25, the “ADO” for Patient 91 indicated, “Allergies: . . .Melons; Shrimp.” During a review of the hospital’s “ADO,” dated 11/19/25, the ADO for Patient 89 indicated, “Allergies: ibuprofen.” There lacked documentation that Patient 89 had a food allergy to tomatoes as was listed on Patient 89’s MTC. During an interview on 11/20/25 at 11:30 a.m. with CK 2, NA 4, and DFNS, CK 2 stated it was important to know whether a patient had a food allergy during the food preparation process before trayline (assembly of patient meal trays) even occurred, as he was trained to use different pots and pans, for example, to prepare food for a patient with a food allergy than he would use for the general batch of food preparation. DFNS stated kitchen staff needed to be aware of patient food allergies prior to food preparation to prepare their workstation to prevent potential for cross-contact of food allergens with a patient’s known food allergy. During a concurrent interview and record review on 11/24/25 at 8:45 a.m. with RD 2, in the presence of Manager of Food-Nutrition Services who was a RD (MFNS/RD), Patient 87’s “Nutrition Services Assessment (NSA),” dated 11/16/25, completed by RD 1 was reviewed. The “NSA” indicated, “Food Allergies: Almond, iodine.” During a review of the hospital’s P&P titled, “FNS Food Handling,” dated 6/25/24, the P&P indicated, “Clean and sanitize cutting boards and other food contact surfaces between different food preparation steps. Use different cutting boards for each type of food product. May utilize color-coded cutting boards to reduce the risk of cross contamination and cross contact. For example. . .green for produce. . .Prevention of Food Allergy Reactions: If a customer, patient, or resident has an identified food allergy, the associates preparing and serving the food must work with the manager or chef who is knowledgeable about recipes and menu content. This individual becomes the food allergy point of contact for all inquiries. Prepare food with clean, sanitized equipment and serve on clean, sanitized dishes. The food must be prepared to order to avoid any cross contact.””

“THERAPEUTIC DIETS CFR(s): 482.28(b), (b)(1) §482.28(b) Menus must meet the needs of patients. (1) Individual patient nutritional needs must be met in accordance with recognized dietary practices. This Standard is not met as evidenced by: 27157 Based on interview, and record review, the hospital failed to: 1. Evaluate their overall hospital structure for follow-up (f/u) care for high risk patients when Registered Dietitian (RD) could schedule a patient f/u up to five days after the completion of an initial nutrition assessment for a high risk patient, despite the hospital’s average length of patient stay was 4.18 days. (Refer to A-0283) 2. Effectively monitor nutrition intervention when the quantity consumed of an oral nutrition supplement (ONS) was not documented by nursing and RD follow up date was up to 7 days after one of one sampled patient (Patient 90) initial nutrition assessment was identified by RD 1 to require an ONS due to increased protein needs. This failure did not meet standard of practice (ASPEN; American Society For Parenteral And Enteral Nutrition) utilized by the Manager of Food-Nutrition Services/RD to ensure a patient’s nutritional needs would be met. The hospital’s average patient length of stay was 4.18 days. 3a. The hospital’s drop down diet orders available in the electronic health record (EHR) did not follow the hospital’s P&P titled, “FNS Patient Nutrition Care, A-1003S”, dated 6/25/24, when only one default CCHO (Consistent Carbohydrate diet to manage diabetes) diet of 60 g [grams] of CHO (carbohydrate) was readily available to physician’s responsible for care of the patients to order. 3b. Require clinical RDs to complete nutrition assessments for patients with chronic diseases with comorbidities (a disease or medical condition that is simultaneously present with another) that required specialized dietary needs such as a therapeutic CCHO diet for diabetes or a therapeutic renal diet for kidney disease as indicated in the hospital’s approved diet manual titled, “Nutrition Care Manual (NCM)” from Academy of Nutrition and Dietetics (AND). Failure to ensure patients individualized assessed nutritional needs are met could negatively impact the health status of medically fragile patients, and had the potential to increase readmission rates to the hospital. 3c. Hospital A and Hospital B’s policy and procedure (P&P) titled, “Food and Nutrition Services (FNS): Patient Nutrition Care, (FNS) A-1003S”, dated 6/25/24, was not followed when only one default CCHO (Consistent Carbohydrate diet to manage diabetes) diet of 60 g [grams] of CHO (carbohydrate) was readily available for a physician to order in the Electronic Health Record (EHR), instead of including other specific carbohydrate-controlled diet orders for physician’s to select from as indicated in the hospital’s Diet Manual Handbook and in which the P&P A-1003S indicated, “Diets are ordered through the EHR.” This failure resulted in RDs implementing either 45 g or 75 g CCHO via software in the kitchen to print menus that would not be in compliance with the default CCHO 60 g diet per the EHR. Hospital A had a total licensed bed capacity of 144, and Hospital B had a total licensed bed capacity of 84 at the time of the survey. The CCHO default diet of 60 g CHO per meal ordered in a patient’s EHR consistently matched the actual CCHO menus/CCHO diet being provided to a patient when the RDs were allowed to independently change the diet order to either a 45 g or 75 g CCHO diet and menu located in a software in the FNS (Food and Nutrition Services) department in which the software did not interface with the patient’s EHR. This failure impeded accurate communication among the interdisciplinary team, including the physician responsible for the care of the patient authorized to prescribe diet orders. Findings: 1. During a concurrent interview and record review on 11/24/25 at 8:45 a.m. with RD 2 and Manager of Food-Nutrition Services Registered Dietitian (MFNS/RD), Patient 87’s “Nutrition Services Assessment (NSA),” dated 11/16/25, completed by RD 1 was reviewed. The “NSA” indicated, “Reason seen: MST 3, Nutrition Care Rating: High, Admit Diagnosis: SBO [small bowel obstruction], Diet Order: NPO [nothing by mouth]. . .weights per recent admission to [name of hospital] (5/20/2025) at 63 kg [kilogram; unit of mass]; a 20% [percent] weight loss within 6 months considered severe according to ASPEN guidelines. Nutrition Care Plan: Dietitian’s Recommendations: NPO 1. 1 days; Advance diet to PO intakes by day 3 of admission; if unable consider Enteral nutrition upon advancement of diet; JUVEN (nutrition supplement to increase protein) BID [two times a day] to promote wound healing. . .Recommended Follow-up by, From: 11/17/25, Recommended Follow-up by, To: 11/20/25 [Up to 4 days later].” RD 2 stated 11/20/25 was a Thursday and they tried to avoid scheduling patient follow- ups on Wednesdays and Thursdays because those days only had one clinical RD available to provide clinical nutrition care for both Hospital A and Hospital B combined. RD 2 stated they had to schedule that way since there were only 3 clinical RDs employed to be shared between Hospital A and Hospital B and they also had to provide weekend coverage. RD 2 stated the hospital’s structure for determining patient’s who would receive a nutrition assessment, other than via the MST (Malnutrition Screening Tool), that could benefit from RD assessment based on evidenced based medical nutrition therapy and their follow up time frames were based on RD staffing and evidence based standard of practice and/or patient population’s nutritional needs. During a concurrent interview and record review on 11/24/25 at 8:50 a.m. with RD 2 and MFNS/RD, Patient 87’s “Nutrition Services Note (NSN),” dated 11/20/25 was reviewed. The “NSN” indicated, “SBO. Patient remains NPO x 5 days. . .Recommended Follow-up by, From: 11/21/2025, Recommended Follow-up by, To: 11/24/2025 [up to an additional 4 days later].” RD 2 stated RD 1 recommended multiple interventions to include starting a clear liquid diet, when medically feasible and if tolerated advance to Full Liquid diet, if tolerated then advance to CCHO HHD [heart healthy diet] and add ONS once diet advance (without RD 2 knowing the medical circumstances between then and up to a potential follow up of four days later). RD 2 stated the hospital only had three clinical RDs to be shared between Hospital A and Hospital B, so they tried to predict and provide nutritional options in advance as a result of limited staffing of RDs. During a review of “ASPEN Adult Nutrition Care Pathway” (ANCP), dated 9/14/22, the “ANCP” indicated, “Monitoring and Evaluation: Follow-up within 3 days, monitor parameters; Tolerance of nutrient intake. . .Enteral [nutrients delivered via a tube]/parenteral [nutrients delivered via a vein] intake, Anthropometric data (weight trends), Functional status.” During a concurrent interview and record review on 11/24/25 at 8:55 a.m. with RD 2 and MFNS/RD, Patient 87’s “Nutrition Services Note (NSN),” dated 11/21/25 was reviewed. The “NSN” indicated, “Admit dx [diagnosis] SBO. Nutrition Consult generated. Spoke with RN and stated a plan for parenteral nutrition. . .Will f/u as high risk nutrition. . .Recommended Follow-up by, From: 11/22/2025, Recommended Follow-up by, To: 11/24/2025, Follow-up Details: PN/NPO6 [follow up of up to 3 additional days later].” RD 2 stated the physician ordered an RD consult, otherwise an RD follow up might have occurred on 11/24/25. During an interview on 11/24/25 at 9:00 a.m. with MFNS/RD 2, MFNS/RD stated she used ASPEN and ANDs NCM as standard of practice to guide clinical nutrition care. MFNS/RD stated the hospital’s policy and procedure (P&P) allowed RDs to follow up on high risk patients five days after the initial nutrition assessment. MFNS/RD stated the P&P’s were set by corporate and she could not change them. During a review of the hospital’s P&P titled, “Subject: Nutrition Care Process -Screening Risk and Provision of Nutritional Care for Adults,” dated 1/15/24, the P&P indicated, “Guidelines for follow-up care are as outlined: a. High-Risk patients should have follow-up within five (5) days of last assessment/reassessment. . .The dietitian monitors and evaluates the patient’s response to care.” During an interview on 1/24/25 at 4:30 p.m. with MFNS/RD, MFNS/RD stated the hospital’s average length of stay was 4.18 days. MFNS/RD stated the nutrition screening and follow up times were structured in a manner to ensure their three clinical RDs could meet their P&P’s for timeliness of nutrition care to patients between Hospital A and Hospital B. MFNS/RD stated she also tried to pitch in and complete nutrition assessments or follow up nutrition care to help the three clinical RDs when she could, as she split her time between Hospital A and Hospital B, as well. MFNS/RD stated she had not collected data to be aware as to how many patients were discharged prior to the RD f/u with the patient, and was unaware how many potential patients nutritional needs were not met during those five days between RD visits and prior to patient discharge from the hospital. 2. During a concurrent interview and record review on 11/24/25 at 9:42 a.m. with MFNS/RD, Patient 90’s “Nutrition Services Assessment” (NSA), dated 11/23/2025 was reviewed. The “NSA” indicated “Reason seen: MST [Malnutrition Screening Tool] 3 [Score of 2 or more = patient at risk of malnutrition], Nutrition Care Rating: MOD [moderate risk]. . .Nutritional Diagnosis: Increased nutrient needs (Protein) RT [related to] wound healing AEB [as exhibited by] shoulder wound, Patient 90 had a wound on left shoulder. . .Nutritional Intervention: JUVEN BID to promote wound healing during admission. . .Recommended Follow-Up by, From: 11/24/2025 Recommended Follow-Up by, To: 12/01/2025, Follow-Up Details: JUVEN BID”, signed by RD 1 on 11/23/2025 at 12:33 PST [12:33 p.m. in the Pacific Standard Time zone].” MFNS/RD stated the hospital’s P&P allowed an RD to follow up with a patient in 7 days, even after ordering a nutrition supplement to addressed increased protein needs, and even though an RD had know way of knowing whether the patient would accept and drink the supplement during those 7 days. During a concurrent interview and record review on 11/24/25 at 9:53 a.m. with MFNS/RD, Patient 90’s electronic health record (EHR) ws reviewed. The EHR indicated, “[Patient 90’s name] - Order Information for: Dietary Supplements. . .Special Instructions: JUVEN BID. . .” MFNS/RD stated RD 1 placed the order for JUVEN BID and did not need to speak with the physician first nor needed a physician’s signature. During a concurrent interview and record review on 11/24/25 at 10:01 a.m. with MFNS/RD, Patient 90’s “Patient Meal History Report (MHR),” dated 11/23/25 to 11/24/25 obtained from a software program used in the Food and Nutrition Services department was reviewed. The “MHR” indicated, “Date: 11/23/25, Meal Period: Dinner, Menu Item: Juven Packet Orange (8 g CHO [carbohydrate]), Serv [Served] Descr [Description]: 1 Packet, Date: 11/24/25, Meal Period: Breakfast, Menu Item: Juven Packet Orange (8 g CHO).” MFNS/RD stated the kitchen prepared the Juven by placing a packet of Juven powder into either a glass of water or juice and served to Patient 90 on the breakfast and dinner meal tray. During a concurrent interview and record review on 11/24/25 at 10:01 a.m. with Quality Safety Program Manager (QSPPRN), Patient 90’s “Last 24 Hours (intake),” dated 11/23/25 was reviewed. The “intake” indicated, “17:00 [5 p.m.], Oral intake mL 120. . .Dietary Supplem...mL” was blank. QSPPRN stated the Juven nutrition supplement quantity consumed should have been documented on the “Dietary Supplem [supplement]” line, and it was not. During a review of the hospital’s P&P titled, “Subject: Core Nursing Standards of Practice,” dated 9/18/25, the P&P indicated, “Supplements are recorded according to type and volume when the patient consumes the supplement. a. Supplements consumed with meals should be recorded as a supplement, not as part of the meal.” During an interview on 11/24/25 at 10:05 a.m. with MFNS/RD, MFNS/RD stated it was important to know quantity consumed of a nutrition supplement intervention to confirm acceptance by the patient and to be able to evaluate calorie and protein intake to compare to a patient’s assessed daily calorie and protein needs to identify whether a patient’s nutritional needs are being met or if further interventions or revisions are warranted. During a review of the hospital’s job description (JD) titled,”Clinical Dietitian 1,” dated 1/25, the “JD” indicated, “Works with an interdisciplinary environment to contribute toward overall patient care. Closely monitors, evaluates and rescreens patient nutrition status as appropriate. . .Monitors and evaluates patient response to interventions by meeting specific measurable goals documented in the nutrition care plan in a timely and thorough manner in the medical record.” During a review of AND’s NCM, dated 2025, the NCM indicated, “The amount and type of food, fluid, supplement and/or enteral [providing nutrition through a tube] or parenteral [providing nutrition through a vein] intake or infusion amounts should be monitored closely to ensure that the patient is meeting their nutritional requirements. For patients receiving oral nutritional supplements, supplement acceptance and tolerance should be documented in the medical record. Frequently and carefully monitor body composition including measured weight, weight change, body mass index and the ability to meet nutrition needs orally. Without appropriate monitoring by the RDN, patients can experience delayed wound healing and/or worsening of nutritional status.” During a review of the hospital’s P&P titled, “FNS Patient Nutrition Care, A-1003S,” dated 6/25/24, the P&P indicated, “Guidelines: Diet Manual: The online Nutritional Care Manual (NCM) (“Diet Manual”) is the approved Diet Manual for [name affiliated with the hospital].” During an interview on 11/24/25 at 10:07 a.m. with MFNS/RD and Director of Food and Nutrition Services (DFNS), both MFNS/RD and DFNS stated the hospital’s system/structure via nutrition care P&P’s were based around RD staffing versus standard of care such as ASPEN or ANDs NCM to meet patients nutritional needs. During a review of the hospital’s P&P titled, “Subject: Nutrition Care Process -Screening Risk and Provision of Nutritional Care for Adults,” dated 1/15/24, the P&P indicated, “Guidelines for follow-up care are as outlined: a. Moderate Risk patients should have follow-up within seven (7) days of last assessment/reassessment. . .The dietitian monitors and evaluates the patient’s response to care.” During a review of “ASPEN Adult Nutrition Care Pathway (ANCP),” dated 9/14/22, the “ANCP” indicated, “Nutrition Care Plan And Intervention: Determine need for nutrition supplementation. . .Monitoring and Evaluation: Follow-up within 3 days, monitor parameters. . .Oral intake including supplements, vitamins, minerals. . .” The ANCP indicated the purpose of following up on a patient within three days of determing increased nutrient needs that required an intervention was to keep the patient as high risk until RD could determine if patient now had adequate intake, stable or increased weight, stability of biochemical data, improved strength and function prior to reassessing a longer follow up time of every three-five days. 3a. During an interview on 11/20/25 at 3:44 p.m. with with MFNS/RD, MFNS/RD stated the hospital’s EHR only had one drop down CCHO diet for physician’s to order which was the hospital’s default diet that provided 60 g of CHO/meal and a weekly average of 1,796 calories per day and 91 grams of protein (pro) per day per the hospital’s Diet Handbook.” During review of the hospital’s “Diet Manual Handbook” (DMH), dated 3/24, the “DMH” indicated, “Consistent Carbohydrate Definition: A consistent carbohydrate diet provides the same amount of carbohydrates at each meal (and snack), and daily. The goal is to achieve a consistent amount of carbohydrate for each meal, the standard for the Consistent Carbohydrate diet is 60 g (or 4 CHO choices) per meal. The quantity of carbohydrates recommended may vary by patient. The consistent carbohydrate diet is customizable by individual, and may be modified to provide 45 g CHO or 75 g CHO consistently per meal, per individualized diet order. Refer to the Nutrition Care Manual [NCM] Diet Manual for additional information.” During a review of the hospital’s P&P titled, “Subject: Food and Nutrition Services (FNS): Patient Nutrition Care,” dated 6/25/24, the P&P indicated, “Guidelines: Diet Manual: The online Nutritional Care Manual (NCM) (“Diet Manual”) is the approved Diet Manual for [name affiliated with the hospital]. The System Office Diet Manual Handbook (“Diet Handbook”) template is used to align the NCM guidelines with facility diet orders, modifiers, and menus. Diets in the Diet Handbook will align with those available for a physician to order in the Electronic Health Record (EHR).” 3b. During an interview on 11/20/25 at 3:30 p.m. with MFNS/RD and DFNS, MFNS/RD stated the hospital’s structure via P&Ps for nutrition care do not automatically trigger an RD to conduct a nutrition assessment for patients with diabetes to determine their daily calorie and pro needs in order to evaluate whether the prescribed CCHO diet met the patients individualized calorie and pro needs during their hospital stay. MFNS/RD stated some patient’s based on their weight (wt) and height (ht) and/or BMI [body mass index] may need more or less than the hospital’s default CCHO diet of 60 g CHO per meal that provided a weekly average of 1,796 calories per day and 91 grams of protein (pro) per day per the hospital’s Diet Handbook. During an interview on 11/20/25 at 3:40 p.m. with MFNS/RD and DFNS, MFNS/RD stated the hospital’s CCHO menu was designed to be able to decrease the CHO per meal to 45 g or to increase the CHO per meal to 75 g to adjust for a patient’s wt/ht and/or BMI. MFNS/RD was asked to provide the nutrient analysis for the 45 g CCHO non-select menu (menu served if a patient had not selected an alternative choice), and for the 75 g CHO non-select menu to reflect the total calories and pro per day those two menus would provide to a patient. MFNS/RD stated the hospital had not conducted a nutrient analysis for a non-select 45 g CHO or 75 g CHO menu and did not know how many calories and/or pro would be provided per day. MFNS/RD stated they should have had a nutrient analysis for those menus, as the RD needed to have that information to accurately evaluate whether the therapeutic diet met a patient’s individualized special dietary needs. During a review of the hospital’s P&P titled, “Subject: Food and Nutrition Services (FNS): Patient Nutrition Care,” dated 6/25/24, the P&P indicated, “The Diet Handbook reflects the Dietary Reference Intakes (DRIs) and Recommended Dietary Allowances (RDAs) for each diet. . .Menus will follow the most recent Dietary Guidelines for Americans as published by the Department of Health and Human Services and United States Department of Agriculture. . .All base EHR diets will have a menu with nutrient analysis that meets DRI/DRAs minimum targets, within upper limits, as published by the Institute of Medicine (IOM). . .Nutrition prescriptions/diet orders are based on individualized nutrition assessment and nutrition diagnosis. All diets are ordered by a Licensed Practitioner (LP) to meet patient nutritional needs.” During an interview on 11/20/25 at 3:43 p.m. with MFNS/RD and DFNS, MFNS/RD stated within the hospital’s system RD’s were not required to perform a nutrition assessment for chronic diseases with comorbidities (a disease or medical condition that is simultaneously present with another) that required specialized dietary needs such as a therapeutic CCHO diet for diabetes or a therapeutic renal diet for kidney disease per the hospital’s structure via policies and procedures. During a review of AND’s NCM titled, “Management in Acute and Post-Acute Care Settings,” dated 2025, the NCM indicated, “Diabetes Management in the Hospital: The goals of MNT [Medical Nutrition Therapy] in the hospital setting are to provide adequate energy [calories] to meet metabolic demands, optimize glycemic [blood sugar] control, address personal food preferences, and facilitate creation of a discharge plan. . .The RD is integral in the role of assessment, intervention, and monitoring/evaluation of hyperglycemic [high blood sugar] individuals in the hospital setting.” During a review of AND’s NCM titled, “Diet For Chronic Kidney Disease,” dated 2025, the NCM indicated, “A diet for CKD [chronic kidney disease] may be ordered upon admission. It is expected that the diet order will be individualized by the RD. . .A preliminary diet order before the RD is able to perform an assessment may comprise the following: protein: 80 g [grams] protein, Phosphorus: 1000-1200 mg, Potassium: 2000-2500 mg, Sodium: 2300 mg.” During a review of the “Revised 2024 Scope and Standards of Practice for the Registered Dietitian Nutritionist. Commission on Dietetic Registration Scope and Standards of Practice Task Force,” dated 2025, the scope and standards of practice for RDs indicated, “RDs. . .whose practice involves nutrition care. . .use knowledge, skills, evidence-based information and research. . .to address. . .management of acute or chronic diseases and conditions for person centered care for individuals.” 3c. During an interview on 11/20/25 at 3:44 p.m. with MFNS/RD and DFNS, MFNS/RD stated the RDs were allowed to write therapeutic diet orders at the hospital (Cross Reference A-0630). MFNS/RD stated if a patient with diabetes on a CCHO diet met one of the hospital’s criteria to have an RD perform an individualized nutrition assessment and the RD determined either a 45 g CHO or a 75 g CHO was more appropriate, the RD was able to independently change the CCHO diet order, accordingly. MFNS/RD stated that was accomplished by the RD entering the 45 g CHO or 75 g CHO in the software program in the diet office that automatically distributed the CHO evenly throughout the day. MFNS/RD stated the software in the diet office did not interface with a patient’s EHR which would continue to reflect the default CCHO diet (60 g CHO/meal), impeding accurate communication amongst the interdisciplinary team, including the physician responsible for the care of the patient. During a review of ANDs NCM titled, “,”Management in Acute and Post-Acute Care Settings,” dated 2025, the “NCM” indicated, “At all facilities that an RDN is working within, MNT (Medical Nutrition Therapy) should be integrated into overall diabetes management involving an interdisciplinary team, including the patient, their health care team, and the individuals who comprise the patient’s/client’s primary support system.” During an interview on 11/24/25 at 12:37 p.m. with Director of Medical Staff (DMS), DMS stated the RDs were not granted privileges via the medical bylaws. During a review of the hospital’s P&P titled, “Subject: Verbal, Telephone and Written Physician Orders,” dated 2/16/23, the P&P indicated, “Departments: This policy is applicable to all settings that receive, accept and process verbal, telephone, and written orders. Procedure: Only those physicians or practitioners who are appropriately credentialed as a member of the medical staff with the privilege of giving orders at [name of hospital] may provide an order directing patient care.”, approved by P&P Committee and MEC on 2/16/23.”

“DIETS CFR(s): 482.28(b)(2) All patient diets, including therapeutic diets, must be ordered by a practitioner responsible for the care of the patient, or by a qualified dietitian or qualified nutrition professional as authorized by the medical staff and in accordance with State law governing dietitians and nutrition professionals. This Standard is not met as evidenced by: 27157 Based on staff interview, and document review, the hospital failed to ensure Patient oral nutrition supplements (ONS) were provided to patients in accordance with orders from a practitioner responsible for the care of the patient, as required by State law for RDs per California Business and Professions Code 2586 for one of one sampled patient (Patient 90). This facility practice was a system concern as hospital leadership approved RDs to initiate ONS without a physician order and without the ONS being within the parameters of a physician prescribed diet order according to the facility’s diet manual, which was not in accordance with State law (CA BPC 2586). The facility failed to ensure RDs performed clinical nutrition patient care within their scope of practice in CA placed patients at an increased risk of lack of oversight by the medical staff when RDs initiated ONS without established performance criteria and was outside of scope of practice for RDs practicing in California. According to Centers for Medicare & Medicaid Services (CMS) therapeutic diets refer to a diet ordered (what a patient should eat or drink during their hospital stay or treatment) as part of the patient’s treatment for a disease or clinical condition, to eliminate, decrease, or increase certain substances in the diet. Findings: During an interview on 11/20/25 at 3:44 p.m. with Manager of Food-Nutrition Services Registered Dietitian (MFNS/RD), MFNS/RD stated the medical staff granted RDs order writing privileges in their medical bylaws. MFNS/RD stated the RDs were allowed to write diet orders and ONS orders without discussing with the physician first and without obtaining a physician’s signature. During a concurrent interview and record review on 11/24/25 at 9:16 a.m. with MFNS/RD, the hospital’s “Diet Manual Handbook (Paper copy-DM),” dated 11/6/25 was reviewed. The “DM” indicated the following diets as routinely ordered diets at the hospital; Regular diet, Heart Healthy, 2 gram Low Sodium Diet, Consistent Carbohydrate, Gestational [pregnancy] Consistent Carbohydrate, Renal [for kidney disease] and Fiber Restricted [low in fiber] in which none of those diets were defined to include any ONS within the parameters of those hospital approved diets. MFNS/RD stated the RDs were allowed to write orders for ONS without any criteria or limit in quantity as an addition to the diet order, including therapeutic diets, such as CCHO and renal. During a concurrent interview and record review on 11/24/25 at 9:42 a.m. with MFNS/RD, Patient 90’s “Nutrition Services Assessment (NSA)”, dated 11/23/2025 was reviewed. The “NSA” indicated, Patient 90 “Nutrition Care Rating; MOD [moderate risk] and had a wound on left shoulder and had a history of Type 2 diabetes mellitus (DM) (when the body cannot use insulin correctly and sugar builds up in the blood.). The NSA indicated, “Diet Order: HHD [Heart Healthy Diet]. . .Nutritional Intervention: JUVEN [Therapeutic Nutrition Powder for Wound Healing per manufacturer, “Use under medical supervision.”] BID [two times a day] to promote wound healing during admission, Continue heart healthy diet, Consider additional dietary modifier: Consistent Carbohydrate due to hx [history] DM, Nutrition Care Plan: Dietitian’s Recommendations: Continue heart healthy diet, Consider additional dietary modifier Consistent Carbohydrate [diet for management of diabetes], JUVEN BID to promote wound healing during admission. . .Recommended Follow-Up by, From: 11/24/2025 Recommended Follow-Up by, To: 12/01/2025 [seven days later], Follow-Up Details: JUVEN BID”, signed by RD 1 on 11/23/2025 at 12:33 PST [12:33 p.m. in the Pacific Standard Time zone]. During a concurrent interview and record review on 11/24/25 at 9:53 a.m. with MFNS/RD, Patient 90’s electronic health record (EHR) dated 11/23/25 was reviewed. The EHR indicated, “[Patient 90’s name] - Order Information for: Dietary Supplements, Original order entered and electronically signed by [name of RD 1] on 11/23/2025 at 12:39 PST. No Cosignature Required order by [name of physician] MD [medical doctor], Nutrition Services Department, Dietary Supplements, Order Status: Ordered, Department Status: Ordered, Details: Requested start date and time: 11/23/2025 12:35 PST, Frequency: BID, Special Instructions: JUVEN BID, Next Dose Dt [date] Tm [time]: 11/23/2025 21:00 PST, Validations: Nurse Review: Nurse reviewed by [name of nurse] RN [Registered Nurse] on 11/23/2025 at 13:42 [1:42 p.m.] PST.” MFNS/RD stated that order meant the RD placed the order for JUVEN BID that immediately was recognized as an order that could be provided to Patient 90 as no MD signature was require to be obtained at any point and time. When MFNS/RD was asked how the documentation of “order by [name of physician] MD” get placed on the order screen, MFNS/RD stated IT (information technology department) arranged it that way. MFNS/RD stated that the RD was allowed to write dietary supplement orders because the hospital’s medical staff granted order writing privileges to the RDs without any cosignature from a doctor being needed at any point and time. MFNS/RD stated she did not no why the start time for JUVEN BID indicated 9:00 p.m. because the JUVEN was mixed with water or juice in the kitchen and was delivered to patient’s on their meal trays, usually with lunch and dinner. During a concurrent interview and record review on 11/24/25 at 9:58 a.m. with MFNS/RD, Patient 90’s EHR, dated 11/23/25 was reviewed. The EHR indicated, “[Patient 90’s name] - Order Information for: Consistent Carbohydrate Diet, Original order entered and electronically signed by [name of RD 1] on 11/23/2025 at 12:39 PST. No Cosignature Required order by [name of physician] MD [medical doctor], Nutrition Services Department, Consistent Carbohydrate Diet, Order Status: Ordered, Department Status: Ordered, Details: Start date and time: 11/23/2025 12:39 PST, Modifiers: Heart Healthy, Validations: Nurse Review: Nurse reviewed by [name of nurse] RN on 11/23/2025 at 13:42 PST.” MFNS/RD stated the physician ordered Patient 90 a heart healthy diet (HHD) upon admission on 11/23/25. MFNS/RD stated the RD [RD 1] ordered the CCHO diet without a co-signature being required by a physician and kept the original diet order prescribed by the physician of HHD by adding it in the “Modifier” box, so Patient 90’s diet order immediately changed to CCHO HHD without the physician electronically ordering the diet. In addition, MFNS/RD stated for those patients the RDs ordered ONS in addition to their therapeutic diet order, they would not need to follow up with the patient up to five days later for high risk, and 7 days later for Patient 90 (moderate risk). MFNS/RD stated the hospital’s average length of stay was 4.18 days. During a concurrent interview and record review on 11/24/25 at 10:01 a.m. with MFNS/RD, Patient 90’s “Patient Meal History Report (MHR),” dated 11/23/25 to 11/24/25 obtained from a software program used in the Food and Nutrition Services department was reviewed. The “MHR” indicated, “Date: 11/23/25, Meal Period: Dinner, Diet Order: Standard, Heart Healthy, Consistent Carbohydrate, Menu Item: Juven Packet Orange (8 g CHO [carbohydrate]), Serv [Served] Descr [Description]: 1 Packet, Date: 11/24/25, Meal Period: Breakfast, Diet Order: Standard, Heart Healthy, Consistent Carbohydrate, Menu Item: Juven Packet Orange (8 g CHO).” During a concurrent interview and record review on 11/24/25 at 12:37 p.m. with Manager of Medical Staff (MMS), the facility’s “Medical Staff Bylaws (MSB),” dated September 2020 were reviewed. The “MSB” did not contain any indication that RDs were granted clinical privileges. The “MSB” indicated, “Exercise Of Privileges: A member providing direct clinical services at this Hospital, in connection with such practice. . .shall be entitled to exercise only those clinical privileges specifically granted to him or her by the Hospital Community Board. Said privileges must be within the scope of any license, certificate, or other legal credential authorizing him or her to practice in this state and consistent with any restrictions thereon.” MMS stated the RDs were not granted privileges via the medical bylaws. During a concurrent interview and record review on 11/24/25 at 3:40 p.m. with MFNS/RD, the hospital’s P&P titled, “FNS Patient Nutrition Care, A-1003S” (PNC), dated 6/25/24 was reviewed. The P&P indicated, “Therapeutic diets must be prescribed by a licensed practitioner or the approved medical staff member for the patient’s care. . .Guidelines: Diet Manual: The online Nutritional Care Manual (NCM) (“Diet Manual”) is the approved Diet Manual for [name affiliated with the hospital]. The System Office Diet Manual Handbook (“Diet Handbook”) template is used to align the NCM guidelines with facility diet orders, modifiers, and menus. Diets in the Diet Handbook will align with those available for a physician to order in the Electronic Health Record (EHR). . .qualified Registered Dietitians may order therapeutic diets if consistent with state law or local facility procedure. . .Regulatory impediments may exist at the state level, preventing Registered Dietitians from implementing the privilege (see https://www.eatrightpro.org/advocacy/licensure/therapeutic-diet-orders-state-status-and-regulation for clarification on state status and regulation). . .Registered Dietitians may individualize the patient’s nutritional or dietary treatment when necessary, by modifying the distribution, type, or quantity of food and nutrients within the parameters of the diet order. . .Physician/licensed provider prescribed nutrition prescriptions/diet orders include the provision of oral nutritional supplements by the Registered Dietitian. . .” MFNS/RD stated the hospital’s regular nor therapeutic diet orders as defined in the hospital’s diet manual had not included any ONS within the parameters of those diet orders available for physician’s to order. MFNS/RD stated RDs were independently writing diet orders and ONS orders in addition to a patient’s ordered therapeutic diet, which were not within the parameters of a physician prescribed diet order which placed the RDs working out of scope of practice as defined in CA BPC 2586. During a concurrent interview and record review on 11/24/25 at 12:40 p.m. with DMS, DMS stated she was responsible for oversight of the hospital’s Policy and Procedure (P&P) Committee. The hospital’s P&P titled, “FNS Patient Nutrition Care (PNC),” dated 6/25/24 was reviewed. DMS stated at the bottom of the PNC, dated 6/25/24, the P&P indicated, “Effective Date: June 25, 2024, Food and Nutrition (FNS): Patient Nutrition Care, Administrative Standard” meant the P&P was approved by the hospital’s P&P Committee. (Cross Reference: A-0619) During a review of U.S. Food and Drug Administration published resource titled, “Final Guidance on Frequently Asked Questions About Medical Foods” (FDAMF), dated March 2023, the “FDAMF” indicated, “Medical foods are distinguished from the broader category of foods for special dietary use by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision, and intended for the specific dietary management of a disease or condition.” During a review of the hospital’s job description (JD) titled “Clinical Dietitian 1 [one]”, dated 1/25, the “JD” indicated, “Develops an intervention plan which includes. . .nutrition prescription unique to patient’s specific needs, in accordance with physician’s orders.” During a review of CA BPC 2586, dated 1/1/2023, the CA BPC 2586 indicated, “The registered dietitian. . .may perform nutritional assessments and initiate nutritional interventions within the parameters of the prescribed diet order pursuant to a licensed health care facility’s approved nutrition screening policy and procedure.””

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 40516 Based on observation, interview, and record review, the hospital failed to ensure: 1. One of 30 (Patient 30) sampled patient’s safety when patient 30 was up to the bathroom and was left unattended. This failure resulted in Patient 30 falling and had the potential to cause an injury or death. 2. Registered nurses (RN) reported new physical assessment findings to a provider for one of 10 sampled patients (Patient 21). This failure resulted in a delayed fracture diagnosis and had the potential for delayed treatment. 3. A fractured humerus (single, large, long bone of the upper arm, running from the shoulder to the elbow), visible on an X-ray, was diagnosed timely for one of five sampled patients (Patient 21). This failure had the potential for a delay in care and pain management. 4. One of 15 sampled patient’s (Patient 3) environment was free of unattended saline flush cartridges when saline flush cartridges were left in a patient 3’s bed. This failure had the potential to cause Patient 3 harm or accidental ingestion. 5. Policy and procedure (P&P) titled, “Critical Test Results and Testing Results Reporting” was followed for one of two sampled patients (Patient 4). This failure had the potential for a delay in care and adverse health outcomes. Findings: 1. During a review of Patient 30’s “Nursing Progress Note” (NPN), dated 7/13/25 at 8:25 p.m. the NPN indicated, “Date, Time and Location of Fall: 07/13/25 [7 p.m.] [room number]. . .Patient found with family laying on floor ~Patient/family statements: patient [sic] and RN help patient to bathroom. Patient began to sway back. Patient sitting on toilet and RN left to get help. When RN came back, patient on floor”. During a concurrent interview and record review on 8/18/25 at 12:37 p.m. with Manager of Patient Safety (MPS), MPS stated on 7/13/25 at 6:50 p.m. RN 2 assisted Patient 30 to the bathroom. MPS stated Patient 30 fell in the bathroom. MPS stated Patient 30’s had a Complete Blood Count (CBC) done after the fall and the results were critically low results. MPS stated just after midnight on 7/14/25 Patient 30 was taken to the operating room (OR) and was found to have a large amount of blood and fluid in her abdomen from a bleeding ovarian cyst. Patient 30’s laboratory (lab) results, dated 7/12/25 - 7/13/25 were reviewed. The lab results indicated: 7/12/25 (date of admission) Red Blood Cells (RBC- transports oxygen from the lungs to the tissues and carry carbon dioxide from the tissues to the lungs to be exhaled) 4.18 microliter (mcL- unit of measure). Normal value in adult females is 4.0 to 5.1 mcL. Hemoglobin (Hg- oxygen and carbon dioxide transport within red blood cells) 10.8 grams per deciliter (dcL -unit of measure). Normal value in adult females is 11.5 to 15.5 g/dL. Hematocrit (Hct- percentage of RBCs in blood) 33.8 %. Normal value in adult females is 36% to 48%. 7/13/25 at 6:43 a.m. (before fall) RBC 3.17 mcL Hg 8.2 dcL Hct 25.7 % 7/13/25 at 7:52 p.m. (after fall) RBC 1.68 mcL Hg 4.6 dcL (critical value result) Hct 13.8 % (critical value result) During a review of Patient 30’s “Flowsheet (FS),” dated 7/12/25-7/13/25, the FS indicated: 7/13/25 at 11 a.m. 93/56 mmHg (B/P- normal 120/80 millimeters of Mercury [mmHg- unit of measure, low is below 90/60 mmHg] 7/13/25 at 12 p.m. 92/53 mmHg 7/13/25 at 2:29 p.m. 97/58 mmHg 7/13/25 6:50 p.m. (after fall) 72/50 mmHg During an interview on 8/18/25 at 1:33 p.m. with RN 2, RN 2 stated Patient 30 was not on on fall precautions (special measures taken to prevent at-risk patients from falling) prior to her fall on 7/13/25. RN 2 stated she and a family member assisted Patient 30 to the bathroom. RN 2 stated when Patient 30 was seated on the toilet she noticed she was “unsteady.” RN 2 stated she left Patient 2 in the bathroom and went outside of the room to call for help. RN 2 stated the bathroom did have an emergency call button, but she left Patient 30’s to go get help because she was afraid Patient 30 might “code” (code blue-medical emergency when a person’s heart and/or breathing are ineffective). During an interview on 8/18/25 at 1:40 p.m. with Nurse Director (ND) 1, ND 1 stated the hospital uses the Johns Hopkins Fall Risk Assessment Tool (JHFRAT- used in healthcare settings to identify hospitalized adult patients at high risk of falling) and Patient 30 did not qualify as a fall risk when she was admitted to the hospital. ND 1 stated nurses could also use their clinical judgement to determine if patients are at risk for falling. During an interview on 8/18/25 at 2:13 p.m. with Senior Director of Patient Care Services (SDPCS), SDPCS stated the expectation is for nurses to use their nursing knowledge to make clinical decisions and RN 2 should have stayed at Patient 30’s side and not left to call for help. During a review of the hospital’s P&P titled, “Fall Prevention and Management Policy and Procedure” dated 3/31/25, the P&P indicated, “The policy of [the hospital] is to provide a safe environment for patients and to minimize their risk of falling.” 2. During an interview on 8/18/25 at 8:25 a.m. with Family Member (FM) 1, FM 1 stated her mother (Patient 21) was admitted to the hospital on 6/7/25. FM 1 stated her mother is non-verbal due to advanced dementia and both of her arms bend inward toward her body due to contractures (permanent tightening of muscles, tendons, or other tissues that limits movement and can cause deformity). FM 1 stated Patient 21 was brought to the hospital’s emergency department (ED) for altered mental status (change in a person’s level of consciousness, awareness, and cognitive function) and decreased urine output. FM 1 stated Patient 21 had a chest X-ray (CXR) for urinary retention on 6/7/25 which showed Patient 21’s left humerus was not broken. FM 1 stated on 6/12/25 Patient 21 had a repeat CXR for wheezing which showed the left humerus was fractured (broken). FM 1 stated on 6/16/25 Patient 21 had another CXR for shortness of breath, which showed a fracture of the left humerus and at that point the family was informed of the fracture. FM 1 stated the family was told that Patient 1 was not a candidate for surgery to repair the fractured bone but referred Patient 21 to another hospital’s orthopedic surgeon after discharge. During a review of Patient 21’s History and Physical (H&P) dated 6/7/25, the H&P indicated, “Admission Information: Date of Service 06/07/25 at [10:06 p.m.] Chief Complaint: Worsening altered mental status. Source of History: Family member. History of Present Illness: Please note the patient has advanced dementia and is mainly nonverbal so most information is from daughter who is caretaker and son in-law at bedside.” During a review of Patient 21’s “Results Detail” Nurses Notes (RDNN), dated 6/14/25 at 7 p.m. the RDNN indicated a change of shift skin assessment completed by RN 7 and RN 8 found, “bruise and swelling on left arm.” During a review of Patient 21’s RDNN, dated 6/15/25 at 7 a.m. the RDNN indicated a change of shift skin assessment completed by RN 9 and RN 7 found, “swollen and bruised left arm.” During a review of Patient 21’s RDNN, dated 6/15/25 at 7 p.m. the RDNN indicated a change of shift skin assessment completed by RN 9 and RN 10 found, “swelloen [sic] and bruised left arm.” During a concurrent interview and record record review on 8/20/25 at 11:48 a.m. with Quality Patient Safety Program Manager (QPSPM) 2, Patient 21’s medical record was reviewed. QPSPM 2 stated she found no documentation that indicated Patient 21’s left arm bruising and swelling was reported to a physician by RN 7, RN 8, RN 9, or RN 10. During an interview on 8/20/25 at 1:35 p.m. with Interim Nurse Manager (INM), INM stated that nurses are expected to report any new assessment findings to a physician and their supervisor and document that the findings were reported. During a review of the hospital’s “Core Nursing Standards of Practice” (CNSP), the CNSP indicated, “STANDARD 2: DOCUMENTATION EXPECTATIONS 1. Documentation is considered a communication tool. . . As a communication tool, documentation should inform the care team succinctly of the patient’s status. a. Document in chronological order: i. Pertinent, factual, objective data ... vi. To whom information has been reported, including name and status.” 3. During a concurrent observation, interview, and record review on 8/20/25 at 1:05 p.m. with Radiologist (medical doctor specializing in medical imaging, such as X-rays, CT scans, and MRIs, to diagnose and sometimes treat diseases and injuries) and QPSPM 2, in the third-floor conference room. QPSPM 2 placed Patient 21’s CXR image, dated 6/7/25 on a big screen television. Radiologist looked at the CXR image and stated Patient 21’s left humerus was not broken. QPSPM 2 then placed Patient 21’s CXR image, dated 6/12/25 on the big screen television. Radiologist looked at the CXR image and stated Patient 21’s left humerus was fractured. QPSPM 2 then placed Patient 21’s CXR image, dated 6/16/25 on the big screen television. Radiologist looked at the image and stated Patient 21’s left humerus was “very obviously” fractured. Radiologist stated when radiologists interpret images they typically focus on the indication for the test and not look at all aspects of the image. Radiologist stated the radiologist interpreting the image should be looking at the entire image, but the process can become “cursory” which could cause the radiologist to focus only on the indication for the imaging test. During a review of Patient 21’s “Radiology Report Final Report” (RRFR), dated 6/7/25, the RRFR indicated, “Procedure: XR [X-ray] Chest 1 View Portable ... Indications: Weakness, Findings ... Bones: Mild multilevel spondylosis [age-related wear and tear affecting the spinal disks in the neck]. No fracture or visible bony lesion.” During a review of Patient 21’s RRFR dated 6/12/25, the RRFR indicated, “Procedure: XR Chest 1 View Portable Comparison : 6/12/25 ... Indications: Wheezing, Findings ... Bones: Mild multilevel thoracic [refers to the chest or rib cage area of the body] spondylosis. No fracture or visible bony lesion.” During a review of Patient 21’s RRFR dated 6/16/25, the RRFR indicated, “Procedure: XR Chest 1 View Portable ... Indications: Shortness of Breath, Findings ... Bones: Redemonstration [finding that is observed or noted again in imaging] of distracted fracture [break in a bone where fractured ends are pulled apart, often due to tension or forces that separate the bone fragments, creating a gap or widening of the bone at the fracture site] through the proximal left humeral neck [upper, narrow part of left upper arm bone that connects the shoulder joint’s head to the shaft of the humerus].” 45654 4. During a concurrent observation and interview on 8/18/25 at 10:03 a.m. with RN 3, in Patient 3’s room, six unattended saline flush cartridges (fluid used to prevent blockages in intravenous [IV] lines) lying on top of Patient 3’s foot of bed. RN 3 stated she walked out of Patient 3’s room and left the saline viles on Patient 3’s bed. During a concurrent observation and interview on 8/18/25 at 10:13 a.m. in Patient 3’s room, with RN 4, RN 4 removed the six saline flush vials from Patient 3’s bed. RN 4 stated nurses should not leave saline flushes at bedside. During an interview on 8/18/25 at 10:22 a.m. with RN 3, RN 3, stated she left Patient 3’s room and she should not have left the saline flushes on Patient 3’s bed or at bedside. During a review of the hospital’s P &P titled,” Routine Cleaning Procedures,” dated 5/16/23, the P&P indicated, “Medications and IV [intravenous - a common method to deliver medication through a vein] bags must be handled and disposed of by Nursing.” 5. During a concurrent interview and record review on 8/20/25 at 1:45 p.m. with RN 5, Patient 4’s “Critical Value Results Note” (CVRN), dated 8/8/25 was reviewed.The CVRN dated indicated Patient 4’s pCO2 (Art) [arterial measurement pressure of carbon dioxide (gas exhaled through breathing)] was 14 millimeters of mercury (mmHg- normal range is 35 mmHg to 45 mmHg) and was reported by laboratory staff to RN 11. The CVRN indicated RN 11 gave critical value results report to RN 6. RN 5 was unable to find documentation of a physician being notified of Patient 4’s 8/8/25 critical pCO2 value result. CVRN dated 8/14/25 was reviewed. The CCVRN indicated Patient 4’s pCO2 (Art) was 14 mmHg and was reported by laboratory staff to RN 12. The CVRN indicated RN 12 gave critical value results report to RN 11, who then gave report to RN 6. RN 5 was unable to find documentation of a physician being notified of Patient 4’s 8/14/25 critical pCO2 value result. RN 5 stated RN 6 should have notified the physician. RN 5 stated the nurse should initiate the call within 15 minutes of being notified by laboratory staff of a critical value result. During a review of the facility’s P&P titled, “Critical Test Results and Testing Results Reporting,” dated 1/30/23, the P&P indicated, “Staff receiving the critical results will document date, time, first initial and last name of the person reporting and signature. This will be documented in the EHR [electronic health record] on the Ad Hoc Critical Value notification form. The responsible physician must be notified regarding a critical test result within 45 minutes of the time received by the licensed staff member (total lapse time 1 hour).””

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 40516 Based on interview and record review, the hospital failed to adhere to Emergency Department (ED) registered nurse (RN) to patient ratios in the Rapid Treatment Area (RTA- designated ED space designed to quickly assess and treat patients with less severe injuries or illnesses) for nine of nine RTA patients (Patient 31, Patient 32, Patient 33, Patient 34, Patient 35, Patient 36, Patient 37, Patient 38, Patient 39). This failure had the potential for poor quality of care and undesired patient outcomes. Findings: During an interview on 8/18/25 at 11:05 a.m. with ED Nurse Director (ND) 1 and ED Nurse Shift Manager (EDNSM), EDNSM stated there were 25 patients in the ED. EDNSM stated nine patients were currently assigned to the RTA and one nurse was currently assigned to the RTA. ND 1 stated the ED used team nursing, but RN 1 was the only RN for all nine RTA patients. No other licensed nurses were assigned to RTA at that time. ND 1 stated patients in the RTA are lower acuity patients who might need an intravenous line (IV-small plastic tube inserted into a vein using a needle to give fluid, medications, and/or nutrition), oral medications, an X-ray, and are usually discharged. During an interview on 8/18/25 at 11:25 a.m. with RN 1, in the RTA room, she stated she had nine patients assigned to the RTA and she was the only licensed nurse in the RTA. RN 1 stated some RTA patients sit in chairs outside the RTA room and others wait in the waiting room lobby. RN 1 stated RTA patients usually get oral medications, IVs, or x-rays. RN 1 stated she only asked for help if she felt overwhelmed. During a review of California Code of Regulations, Title 22, §70217 - Nursing Service Staff, Title 22 indicated, “(a) Hospitals shall provide staffing by licensed nurses, within the scope of their licensure in accordance with the following nurse-to-patient ratios. Licensed nurse means a registered nurse, licensed vocational nurse and, in psychiatric units only, a psychiatric technician. Staffing for care not requiring a licensed nurse is not included within these ratios and shall be determined pursuant to the patient classification system ... Licensed nurse-to-patient ratios represent the maximum number of patients that shall be assigned to one licensed nurse at any one time. “Assigned” means the licensed nurse has responsibility for the provision of care to a particular patient within his/her scope of practice. There shall be no averaging of the number of patients and the total number of licensed nurses on the unit during any one shift nor over any period of time. Only licensed nurses providing direct patient care shall be included in the ratios ... (8) In a hospital providing basic emergency medical services or comprehensive emergency medical services, the licensed nurse-to-patient ratio in an emergency department shall be 1:4 or fewer at all times that patients are receiving treatment.””

“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: 42744 The facility failed to meet the regulatory requirements for the Condition of Participation: CFR §482.51 Surgical Services as evidenced by the following: Based on interview and record review the facility failed to implement policies governing surgical care when: 1a. One of one surgeon (Primary Surgeon [PS]) did not perform one of one sampled patient’s (Patient 1) surgery consistent with the documented informed consent (IC - process for health care provider to educate patient about the risks, benefits, and alternatives of a procedure) on 2/7/25 at 8:48 a.m. This failure resulted in Patient 1 having a wrong site surgery, an unnecessary second surgery, prolonged anesthesia (medication given before surgical operations to lessen awareness and/or pain), prolonged intubation (a tube to deliver oxygen), admission to the Intensive Care Unit (ICU), prolonged hospital stay, and social trauma to the family. (Refer to A-0951) 1b. One of one surgeon (Primary Surgeon [PS]) did not perform one of one sampled patient’s (Patient 1) surgery consistent with the documented informed consent on 2/7/25 at 7:15 p.m. This failure had the potential to result in Patient 1 and family consenting for a procedure they did not fully understand. (Refer to A-0951) 1c. Staff did not obtain informed consents for blood transfusions for one of one sampled patient’s (Patient 1) cervical laminectomy procedures. This failure resulted in the hospital staff unaware of Patient 1’s wishes regarding blood transfusions and the potential for the hospital to not have correct blood type available if needed. (Refer to A-0951) 1d. One of one surgeon (Primary Surgeon [PS]) failed to use all available methods to determine the correct level of cervical vertebrae (C- C1 through C7, neck bones of the spine) in the operating room (OR) for Patient 1’s surgery.” This failure resulted in a wrong site surgery, exposure of Patient 1 and surgical staff to excessive radiation from extensive fluoroscopy (real-time x-ray, medical imaging) equipment use, and prolonged time Patient 1 was under anesthesia. (Refer to A-0951) 1e. One of one sampled patient’s (Patient 1) preoperative X-rays were not visible to all surgical staff in the operating room. This failure had the potential for the surgical team to not be fully aware of patient’s condition. (Refer to A-0951) 1f. One of one surgeon (Primary Surgeon [PS]) failed to consider the advice of surgical staff who suggested repositioning the patient during fluoroscopy. This failure resulted in the inability to obtain good quality images during the surgery, prolonged exposure to radiation during fluoroscopy, and potentially contributed to the wrong site surgery. (Refer to A-0951) 1g. One of one surgeon (Primary Surgeon [PS]) asked the advice of an Implant Device Representative (IDR) for placement of surgical implants. This failure had the potential to result in advice from an unqualified IDR being implemented by PS. (Refer to A-0951) 1h. One of one surgeon (Primary Surgeon [PS]) did not order X-ray images after procedure on 2/7/25 7:15 p.m. This failure resulted in the inability to confirm the correct procedure was done. (Refer to A-0951) 1i. One of one sampled patient’s (Patient 1) medical record did not clearly and accurately document Patient 1’s wrong site surgery. This failure had the potential to effect Patient 1’s continuity of care due to healthcare providers being unaware of the wrong site surgery, putting Patient 1 at risk due to misinformation being relied on, and an inaccurate medical record. (Refer to A-0951) 1j. One of one surgeon (Primary Surgeon [PS]) failed to fully disclose to one of one sampled patient’s (Patient 1) family the reason Patient 1 required a second surgery. This failure had the potential to result in confusion for Patient 1’s family. (Refer to A-0951) 2. OR staff did not consistently monitor and maintain temperature and humidity in seven of seven operating rooms (OR) (OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7). This failure had the potential to result in an unsafe environment for surgical procedures.(Refer to A-0951) 3. Temperature and humidity log variances were not presented to the quality improvement committee. This failure resulted in the delay of the hospital’s ability to take corrective action. (Refer to A-0951) 4. Physician signatures were not documented on blood transfusion consents for 18 of 26 sampled patients (Patient 10, Patient 11, Patient 12, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 19, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, Patient 25, Patient 27, Patient 28, and Patient 29). This failure had the potential to result in these patients unable to make informed medical decisions regarding blood transfusions during surgical procedures and resulted in inaccurate patients’ records. (Refer to A-0955) 6. Informed consents did not have legible (easy to read) witness signature for 17 of 26 sampled patients (Patient 10, Patient 11, Patient 12, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, Patient 25, Patient 26, Patient 27, and Patient 30). This failure resulted in the inability to determine who witnessed the informed consent. (Refer to A-0955) 7. One of one surgeon (Primary Surgeon [PS]) did not immediately complete an operative report following a “lumbar laminectomy [surgical procedure to remove portion of spine/back bone] of L4, L5 [two lowest spinal bones together support the upper body and allow trunk motion] and S1 [bottom of spine provides weight support, movement, and absorbs stress]” for one of 30 sampled patients (Patient 14). This failure resulted in an incomplete medical record for Patient 14 and the potential to affect Patient 14’s continuity of care due to an unrecorded surgery. (Refer to A - 0959) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure safe quality health care, in compliance with Conditions of Participation for Surgical Services. 47734”

“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: 42744 Based on interview and record review the facility failed to implement policies governing surgical care when: 1a. Primary Surgeon (PS) did not perform one of one sampled patient’s (Patient 1) surgery consistent with the documented informed consent (IC - process for health care provider to educate patient about the risks, benefits, and alternatives of a procedure) on 2/7/25 at 8:48 a.m. This failure resulted in Patient 1 having a wrong site surgery, an unnecessary second surgery, prolonged anesthesia (medication given before surgical operations to lessen awareness and/or pain), prolonged intubation (a tube to deliver oxygen), admission to the Intensive Care Unit (ICU), prolonged hospital stay, and social trauma to the family. 1b. PS did not perform one of one sampled patient’s (Patient 1) surgery consistent with the documented informed consent on 2/7/25 at 7:15 p.m. This failure had the potential to result in Patient 1 and family consenting for a procedure they did not fully understand. 1c. Staff did not obtain informed consents for blood transfusions for one of one sampled patient’s (Patient 1) cervical laminectomy procedures. This failure resulted in the hospital staff unaware of Patient 1’s wishes regarding blood transfusions and the potential for the hospital to not have correct blood type available if needed. 1d. One of one surgeon (Primary Surgeon [PS]) failed to use all available methods to determine the correct level of cervical vertebrae (C- C1 through C7, neck bones of the spine) in the operating room (OR) for Patient 1’s surgery.” This failure resulted in a wrong site surgery, exposure of Patient 1 and surgical staff to excessive radiation from extensive fluoroscopy (real-time x-ray, medical imaging) equipment use, and prolonged time Patient 1 was under anesthesia. 1e. One of one sampled patient’s (Patient 1) preoperative X-rays were not visible to all surgical staff in the operating room. This failure had the potential for the surgical team to not be fully aware of patient’s condition. 1f. One of one surgeon (Primary Surgeon [PS]) failed to take the advice of surgical staff who suggested repositioning the patient during fluoroscopy. This failure resulted in the inability to obtain good quality images during the surgery, exposed exposure to radiation during fluoroscopy and potentially contributed to the wrong site surgery. 1g. One of one surgeon (Primary Surgeon [PS]) asked the advice of an Implant Device Representative (IDR) for placement of surgical implants. This failure had the potential to result in advice from an unqualified IDR being implemented by PS. 1h. One of one surgeon (Primary Surgeon [PS]) did not order X-ray images after procedure on 2/7/25 7:15 p.m. This failure resulted in the inability to confirm the correct procedure was done. 1i. One of one sampled patient’s (Patient 1) medical record did not clearly and accurately document Patient 1’s wrong site surgery. This failure had the potential to effect Patient 1’s continuity of care due to healthcare providers being unaware of the wrong site surgery, putting Patient 1 at risk due to misinformation being relied on, and an inaccurate medical record. 1j. PS failed to fully disclose to one of one sampled patient’s (Patient 1) family the reason Patient 1 required a second surgery. This failure had the potential to result in confusion for Patient 1’s family. 2. Operating Room (OR) staff did not monitor and maintain temperature and humidity for seven of seven operating rooms (OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7). This failure had the potential to negatively impact patient safety due to hypothermia (condition that occurs when core body temperature drops below 95 degrees Fahrenheit), increased risk of surgical site infections, increased risk of compromised sterile packaging. 3. OR staff did not report out range temperatures and humidity levels for seven of seven operating rooms (OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7) to the hospital quality committee. This failure resulted in the delay of the hospital’s ability to take corrective action. Findings: 1a. During a review of Patient 1’s “Encounter Type: Office Visit,” (OV) dated 1/23/25, the OV indicated, “[Patient 1] is a 74-year-old female . . . who complains of neck pain for over one year . . . Assessments: The patent had a magnetic resonance scan [MRI- uses strong magnets to create detailed images of the body’s internal structures] of the cervical [C- neck] spine performed on 10/14/24. The study is remarkable for severe stenosis [narrowing] at the C5-C6 [neck bones 5 and 6] level. . . Patient wishes to proceed with C5-C6 Posterior [back] Cervical Laminectomy and Lateral Mass Fusion [Surgically removing parts of cervical vertebrae (bones of the spine) at C5 and C6 to relieve pressure on the spinal cord (bundle of nerves running through spinal vertebrae), then fusing (connecting parts of) the vertebrae together to stabilize the spine using bone grafts and metal screws and rods].” During a review of Patient 1’s “CONSENTIMIENTO PARA CIRUGIA O PROCEDIMIENTO ESPECIAL [Consent to Surgery or Special Procedure],” (CSSP) dated 2/7/25 at 7:43 a.m., the CSSP indicated, “Posterior Cervical Laminectomy and Lateral Mass Fusion of Cervical Five- Cervical Six.” During a review of Patient 1’s “Perioperative Record,” (PR) dated 2/7/25 at 9:40 a.m., the PR indicated, “Procedure Description . . . DISCECTOMY [remove all or part of the cushioning structures between spinal bones] SPINE CERVICAL POSTERIOR APPROACH WITH FUSION WITH IMAGING [X-ray- medical images] GUIDANCE C5-C6 POSTERIOR LAMINECTOMY AND LATERAL MASS FUSION.” The PR indicated surgery started at 8:48 a.m. and ended at 1:50 p.m. (5 hours). During a review of Patient 1’s “Operative Report,” (OPR) dated 2/7/25 at 9:46 p.m., the OPR indicated, “The patient earlier today underwent a cervical laminectomy fusion. Postoperatively, the images revealed malposition of the instrumentation [metal implants to correct or hold bone in place] and revision [repeat surgery of same site to modify prior surgery] surgery was undertaken.” During an interview on 4/3/25 at 11:41 a.m. with Chief Medical Officer (CMO), CMO stated PS told him the metal implants were “misplaced,” meaning the surgery was not done on the right site, and Patient 1 would need to have the correct procedure done. CMO stated the impact to Patient 1 for having a wrong site surgery included having to undergo a second surgery, admission to the ICU, prolonged stay in the hospital, prolonged anesthesia and intubation, and social trauma to the family. During an interview on 4/3/25 at 12:06 p.m. with Vice Chief of Staff (VCOS), VCOS stated Patient 1 had a wrong site surgery. During a concurrent interview and record review on 4/3/25 at 12:18 p.m. with Medical Director Radiology Department (MDRD), Patient 1’s “XR [X-ray] C [cervical] Spine 1 view,” dated 2/7/25 at 3:30 p.m. was reviewed. The X-ray indicated, “INDICATIONS: S/P [status post- after] C5-C6 Posterior Cervical Laminectomy . . . BONES/DISCS: . . . Mild disc space narrowing at C5-6 and C6-7. Posterior instrumentation with bilateral pedicle screws [screws placed on both sides of the vertebrae and connected by rods to stabilize the spine] at C7 [seventh cervical vertebrae] - T1 [first thoracic (upper back) vertebrae] . . . CONCLUSION: 1. Posterior instrumentation C7- T1.” MDRD stated there was no instrumentation on C5-C6 vertebrae. During an interview on 4/3/25 at 4:35 p.m. with Post Anesthesia Care Unit Registered Nurse (PACU RN), PACU RN stated she cared for Patient 1 after her surgery. PACU RN stated PS had ordered an X-ray for Patient 1. PACU RN stated PS told her Patient 1 was going back into surgery, but did not tell her why. PACU RN stated she found out why when the House Supervisor came to the unit and asked who was taking care of the patient with the wrong site surgery. PACU RN stated the results of the X-ray taken in PACU and the informed consent for the surgery did not match. 1b. During a review of Patient 1’s CSSP, dated 2/7/25 at 6:50 p.m., the CSSP indicated, “CERVICAL 5, 6 LAMINECTOMY FUSION REVISION, POSTERIOR.” Patient 1’s husband signed the CSSP. During a review of Patient 1’s “XR C Spine 2-3 views” dated 2/12/25 at 4:01 p.m., the X-ray indicated, “INDICATIONS: post-op . . . FINDINGS: BONES/DISC: There is a posterior spinal hardware consisting of pedicle screws [screws placed on both sides of the vertebrae and connected by rods to stabilize the spine] and posterior rods which extends from C5 to C7 on the right side and C5-T1 [first thoracic (upper back) vertebrae] on the left.” During a review of Patient 1’s Operating Report (ORP) dated 2/7/25 at 9:46 p.m., the ORP indicated, “The patient [Patient 1] earlier today underwent a cervical laminectomy fusion. Postoperatively, the image revealed a malposition of the instrumentation and revision surgery was undertaken . . . Instrumentation of C5 and C6 was performed . . . new rods were placed to bridge C5, C6, C7, and T1 levels . . . Kerrison rongeurs [specialized surgical instruments used for precise bone removal, particularly in spinal and cranial procedures] were used to remove the remainer of the lamina [plates of bone that form the posterior walls of each vertebra, enclosing the spinal cord] of C5 and C6, decompressing the spinal cord.” During an interview on 4/3/25 at 11 a.m. with Director of Surgical Services (DSS), DSS stated the informed consent for the second surgery (dated 2/7/25 6:50 p.m.) did not fully describe the surgery. DSS stated the bridge should have been included in the consent. During a concurrent interview and record review on 4/3/25 at 12 p.m. with CMO, Patient 1’s CSSP, dated 2/7/25 at 6:50 p.m. was reviewed. The CSSP indicated, “CERVICAL 5, 6 LAMINECTOMY FUSION REVISION, POSTERIOR.” CMO stated he assumed PS meant he was revising the previous surgery, but he would have left off “revision.” During an interview on 4/3/25 at 3:56 p.m. with CRNA 2, CRNA 2 stated the CSSP indicated Patient 1 was having a cervical laminectomy revision. CRNA 2 stated there were discussions between nursing staff and PS about doing the consent the right way. During a concurrent interview and record review on 4/3/25 at 12:18 p.m. with MDRD, Patient 1’s “XR C Spine 1 view,” dated 2/7/25 at 3:30 p.m. was reviewed. The X-ray indicated, “INDICATIONS: S/P [status post- after] C5-C6 Posterior Cervical Laminectomy . . . BONES/DISCS: . . . Posterior instrumentation with bilateral pedicle screws at C7 [seventh cervical vertebrae] - T1 . . . CONCLUSION: 1. Posterior instrumentation C7- T1.” MDRD stated there was no instrumentation on C5-C6 vertebrae. During a review of the facility’s policy and procedure (P&P) titled, “Informed Consent,” dated 5/25/2022 the P&P indicated, “2.4. Informed Consent. . .The patient’s physician is responsible for providing the information the patient needs in order to make an informed decision. . . 7.1. Physician Responsibility. The physician is responsible for providing the patient or an incompetent patient’s surrogate decision-maker with the information that is necessary to allow an “informed decision” to be made. The topics that must be addressed, at a minimum are: 7.1.1 The nature of the operation or procedure.” 1c. During a review of Patient 1’s Medical Record (MR) on 4/1/25 at 12:34 p.m., the Medical Record did not contain any informed consents for blood transfusions for either cervical laminectomy procedures dated 2/7/25 at 8:48 a.m. and 7:15 p.m. During a review of literature from the Journal of Spine Surgery titled, “Complications following posterior cervical decompression and fusion: a review of incidence, risk factors, and prevention strategies,” dated March 2020, the literature indicated, “Abstract . . . The most common immediate complications included acute blood loss anemia . . . Overall complication rate . . . The most common complications reported across the literature included acute [sudden, rapid] blood loss anemia requiring postoperative transfusion . . . Increased number of fusion levels was also associated with increased risk of postoperative complication . . . increasing the number of fused levels lead to increased blood loss and operative times, which in turn adversely impacts patients’ postoperative risk . . . “ During an interview on 4/3/25 at 11:15 a.m. with PS, PS stated he had a case in the past involving a patient with an unanticipated anatomical anomaly who started spurting blood during spinal surgery. PS stated the case was written up in a medical journal. During an interview on 4/3/25 at 4:50 p.m. with DSS, DSS stated her expectation was informed consents for blood transfusions would be obtained on everybody having surgery. 1d. During an interview on 4/3/25 at 11:41 a.m. with CMO, CMO stated his concerns included the fact that PS implanted metal within Patient 1’s spine without knowing where it was going. CMO stated PS should have been aware of and used other options available to him in surgery, including taking plain X-rays or using an O-arm (surgical imaging system that provides real-time, two- and three-dimensional images of a patient’s anatomy, especially the spine, during surgery.) CMO stated his biggest concern was if PS was not using every available option, then what would happen with the next patient. During an interview on 4/3/25 at 12:06 p.m. with VCOS, VCOS stated PS did not look at different modalities (methods) to verify the position. VCOS stated he had concerns about PS’s decision-making processes. During an interview on 4/3/25 at 4:55 p.m. with IDR, IDR stated the images from the C-arm fluoroscopy were not good during the procedure. IDR stated a massive amount of fluoroscopy images were taken, which was not good for Patient 1 or the staff due to radiation exposure. IDR stated the hospital had different types of imaging systems available for PS to use. IDR stated it was PS’s decision to use other equipment or not. IDR stated determining the correct cervical level typically takes five to ten minutes and in this case took almost two hours. IDR stated if you are taking two hours to determine what level you are, then you need to bring in the pre-op films (X-rays), mobile Computed Tomography (CT- medical imaging scan using X-rays to create detailed cross-sectional images, of the body) scanner, or the O-arm, which would have given a 360-degree picture and provided navigation to the correct site. 1e. During an interview on 4/3/25 at 10:35 a.m. with Operating Room Charge Nurse (ORCN), ORCN stated PS usually has X-ray images on his laptop computer but does not put them up in the X-ray box in the operating room. During an interview on 4/3/25 at 11:58 a.m. with CMO, CMO stated there were no preoperative images up in the operating room, which had been discussed with the medical staff as an expectation during surgery. CMO stated everyone in the room needs to be able to see the images. During an interview on 4/3/25 at 12:06 p.m. with VCOS, VCOS stated images should be up in the operating room during surgery. VCOS stated this was the standard. During a review of the WHO [World Health Organization] Guidelines for Safe Surgery 2009: Safe Surgery Saves Lives, dated 2009, the WHO guidelines indicated “Factors such as the absence of radiographic images and wrong site labelling on the images play a causative role in faulty orthopaedic and spinal procedures...” During a review of the Agency for Healthcare Research and Quality (Division of the United Stated Department of Health and Human Services) Patient Safety Network (PSNet) article titled “Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery” dated 5/21/2013, the article indicated “In July 2004, The Joint Commission enacted a Universal Protocol that was developed through expert consensus on principles and steps for preventing wrong-site, wrong-procedure, and wrong-person surgery. The Universal Protocol applies to all accredited hospitals, ambulatory care, and office-based surgery facilities.” During a review of The Joint Commission’s Poster titled “Speak Up”, undated, the poster indicated, “Use a standardized list to verify the availability of items for the procedure. At a minimum, these include: . . . labeled diagnostic and radiology test results that are properly displayed. Examples: radiology [x-ray] images and scans...” 1f. During an interview on 4/3/25 at 10:35 a.m. with ORCN, ORCN stated she assisted with positioning Patient 1 for Patient 1’s first surgery on 2/7/25 at 8:48 a.m. ORCN stated Patient 1 was positioned posterior (back facing up) and Patient 1’s head was secured with a Mayfield (stabilizer with three pins attached to the head). ORCN stated Patient 1’s head was not positioned to expose the neck. ORCN stated she suggested to PS to reposition the Mayfield. PS refused the suggestion and stated this was Patient 1’s anatomy. During an interview on 4/3/25 at 11:15 a.m. with PS, PS stated nurses did not have the technical background to make recommendations. During an interview on 4/3/25 at 4:55 p.m., IDR stated Patient 1 had normal anatomy but the main issues with getting good images were Patient 1’s size and positioning. IDR stated if the patient was not positioned correctly, then the images would look liked there was anatomy on top of anatomy, especially in the cervical spine. IDR stated the images did not have Patient 1’s anatomy laid out properly. During a review of the WHO Guidelines for Safe Surgery 2009: Safe Surgery Saves Lives, dated 2009, the WHO guidelines indicated, “Failures in communication between team members and problems with leadership were the major contributory factors in the report of the Joint Commission for Accreditation of Health Organizations...Organizational culture, interpersonal dynamics and steep hierarchical structures [chain of command] in the operating room contribute to error by creating an environment in which persons who could prevent an error are reluctant to speak up.” 1g. During an interview on 4/1/25 at 1:13 p.m. MPOS, MPOS stated PS and IDR looked at the C-arm Fluoroscopy images and decided they (PS and IDR) were at the right level of the cervical spine, so PS proceeded with the surgery. During an interview on 4/3/25 at 10:13 a.m. with Radiology Technician (RT) 1, RT 1 stated PS was having a hard time determining the correct cervical spine level for the surgery. RT 1 stated PS and IDR were counting Patient 1’s cervical spine to determine what level they were working on. RT 1 stated she was shooting images, and PS was talking to IDR. During an interview on 4/3/25 at 11:15 a.m. with PS, PS stated the IDR was an expert on the implants used in the surgery and the IDR spent all day, every day looking at images. PS stated he would go to the level the IDR thought would be good. During an interview on 4/3/25 at 11:41 a.m. with CMO, CMO stated his concerns included the fact that PS implanted metal within Patient 1’s spine without knowing where it was going, that PS took the advice of a device representative (IDR) during the surgery for placement of the metal implants, and that PS should have been aware of and used other options available to him in surgery, including taking plain X-rays or using an O-arm. During an interview on 4/3/25 at 12:06 p.m. with VCOS, VCOS stated Patient 1 had a wrong site surgery. VCOS stated PS should have known what position he was in or should have been in. VCOS stated he had concerns about PS’s decision-making processes and where he was getting his advice. During an interview on 4/3/25 at 3:27 p.m. with CRNA 1, CRNA 1 stated Patient 1’s surgery was unusual because there were always conversations regarding the level of the cervical spine. CRNA stated multiple X-rays were taken. CRNA stated the surgeon was not sure of the exact location (cervical level). During an interview on 4/3/25 at 4:55 p.m. with IDR, IDR stated his role in spinal surgeries was to provide equipment, hardware, and implants. IDR stated he was able to advise on how to tape, position, and have proper C-arm fluoroscopy shots. IDR stated he was in surgery to be responsible for the equipment and was not there to tell the surgeon where he was at on the cervical spine. IDR stated he is not allowed to touch a patient ever. IDR stated normally he helps with positioning a patient prior to surgery but he was not in the room when Patient 1 was positioned. IDR stated PS was asking him to confirm and agree on levels. IDR stated, when asked if they were at the correct level, he said, “It maybe, but I cannot confirm we are at that level.” IDR stated PS proceeded with the surgery. During a review of The Joint Commission’s “The Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery,” (UP) dated 5/21/23, the UP indicated, “Use a standardized list to verify the availability of items for the procedure. At a minimum, these include: . . . labeled diagnostic and radiology test results that are properly displayed.” 1h. During an interview on 4/1/25 at 1:13 p.m. with MPOS, MPOS stated PS did not do another X-ray after the second procedure. During an interview on 4/3/25 at 11:03 a.m. with DSS, DSS stated she was concerned because an X-ray was not done after the second surgery. During an interview on 4/3/25 at 11:58 a.m. with CMO, CMO stated, “I would assumed if you have done a wrong site procedure, you would get x-rays to confirm you are in the right place.” During an interview on 4/3/25 at 12:06 p.m. with VCOS, VCOS stated PS failed to get X-ray images after the second surgery. 1i. During a concurrent interview and record review on 4/1/25 at 12:59 p.m. with Quality Manager (QM), Patient 1’s OPR, dated 2/7/25 at 9:46 p.m., was reviewed. The OPR indicated, “The patient earlier today underwent a cervical laminectomy. Postoperatively, the images revealed malposition of the instrumentation and revision surgery was undertaken.” QM stated the OPR indicated malposition of the instrumentation placed during Patient 1’s first surgery. During an interview on 4/3/25 at 11:41 a.m. with CMO, CMO stated PS told him the metal implants were “misplaced [implanted in the wrong position]” and Patient 1 would need to have the correct procedure done. During an interview on 4/3/25 at 12:06 p.m. with VCOS, VCOS stated the wording regarding malposition of the instrumentation was not clear. During a review of the WHO Guidelines for Safe Surgery 2009: Safe Surgery Saves Lives, dated 2009, the WHO guidelines indicated, “Objective 1 The team will operate on the correct patient at the correct site. While wrong-site or wrong-patient surgery is rare, even a single incident can result in considerable harm to the patient.” 1j. During an interview on 4/3/25 at 10:49 a.m. with DSS, DSS stated she was told PS did not disclose the wrong site surgery error to Patient 1’s family. During an interview on 4/3/25 at 11:41 a.m. with CMO, CMO stated PS told him the metal implants were “misplaced” and Patient 1 would need to have the correct procedure done. CMO stated he had met with Patient 1’s family and he was not sure they fully understood what “misplaced” meant, but they knew Patient 1 needed another surgery to get better. During an interview on 4/3/25 at 12:06 p.m. with VCOS, VCOS stated Patient 1 had a wrong site surgery. VCOS stated PS’s description to the family regarding what happened was ambiguous. During a review of the facility’s “MEDICAL STAFF BYLAWS,” (MSB) dated September 2020, the MSB indicated, “PREAMBLE . . . Whereas, it is recognized that the Medical Staff is responsible for the quality of medical, dental and podiatric care in the Hospital and accepts this responsibility to be accountable to and subject to the ultimate authority of the [Hospital] Board of Directors. . .” 47734 2a. During a concurrent interview and record review on 4/3/25 at 12:20 p.m. with Director of Surgical Services (DSS), the facility’s operating room (OR) logs, for OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7, dated March 2025 were reviewed. The OR logs indicated the normal temperature range for the OR was “68-75” degrees Fahrenheit. The OR Temperature Logs indicated Directions: 1) Read, initial, and record the temperature daily ...3) Notify manager / director of any variance 4) complete columns 1,2,3 and 4. The OR Temperature Logs indicated Variance Analysis and Action. Column 1 indicated Limit Exceeded: Column 2 indicated Noted by:________on__/__ Column 3 indicated Analysis and Actions(s) taken and Column 4 indicated Result (Outcome). The OR temperature logs indicated the following: OR 1 temperature log for March 2025 indicated: 3/15/25 - temperature was 67 degrees. 3/16/25 - temperature was 67 degrees. 3/21/25 - temperature was 59 degrees. 3/22/25 - temperature was 59 degrees. 3/23/25 - temperature was 59 degrees. OR 2 temperature log for March 2025 indicated: 3/15/25 - temperature was 67 degrees. 3/22/25 - temperature was 67 degrees. 3/23/25 - temperature was 67 degrees. OR 3 temperature log for March 2025 indicated: 3/16/25 - temperature was 67 degrees. 3/23/25 - temperature was 67 degrees. 3/31/25 - temperature was 67 degrees. OR 4 temperature log for March 2025 indicated: 3/15/25 - temperature was 67 degrees. 3/16/25 - temperature was 67 degrees. OR 5 temperature log for March 2025 indicated: 3/22/25 - temperature was 67 degrees. OR 6 temperature log for March 2025 indicated: 3/16/25 - temperature was 67 degrees. 3/23/25 - temperature was 67 degrees. OR 7 temperature log for March 2025 indicated: 3/15/25 - temperature was 67 degrees. 3/22/25 - temperature was 67 degrees. 3/23/25 - temperature was 67 degrees. None of the Temperature Logs indicated staff had completed Columns 1,2,3 and 4 when variances occurred. DSS stated there was no documentation staff notified engineering, or any action was taken to correct the OR temperature. DSS stated when the OR temperatures were out of range engineering should have been notified. During a concurrent interview and record review on 4/3/25 at 12:36 p.m. with DSS, facility’s OR temperature logs dated December 2024 were reviewed. The OR temperature logs indicated the following: OR 3 temperature log for December 2024 indicated: 12/27/24 - temperature was 60 degrees. 12/28/24 - temperature was 61 degrees. 12/29/24 - temperature was 61 degrees. OR 5 temperature log for December 2024 indicated: 12/21/24 - temperature was 67 degrees. DSS stated the ORs’ temperatures were out of range and engineering should have been notified. DSS stated there was no documentation engineering was notified of the out of range OR temperatures, or any action was taken. 2b. During a review of the hospital’s Humidity Log for OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7, dated September 2024, the Humidity Log for OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7, dated 9/13/24, 9/20/24 and 9/25/24 did not indicate the humidity in each OR and were not initialed by OR staff. During a review of the hospital’s Temperature Log for OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7, dated September 2024, the Temperature Log for OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7, dated 9/13/24, 9/20/24 and 9/25/24 did not indicate the humidity in each OR and were not initialed by OR staff. During a concurrent interview and record review on 4/3/25 at 12:52 p.m. with DSS, hospital’s “Surgery Schedule” (SS), dated 9/13/24, 9/20/24, and 9/25/24 were reviewed. The SS indicated the hospital performed surgical procedures on 9/13/24, 9/20/25, and 9/25/24. DSS stated surgical procedures were performed on 9/13/24, 9/20/25, and 9/25/24. DDS stated the staff should have recorded OR temperatures and humidities. During a review of the facility’s policy and procedure (P&P) titled, “Temperature and Humidity in Procedural Areas,” dated 8/19/24, the P&P indicated, “1. At least once per day, the humidity and temperature levels will be checked and recorded for each department. 2. Any variance will be reported to engineering and affected department(s). . .4. Document corrective actions taken on any variance.” 3. During an interview on 4/3/25 at 5:15 p.m. with DSS, DSS stated neither the temperature nor the humidity variances and the lack of action for OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7’s were discussed in quality committee meetings. During a review of the facility’s P&P titled, “Temperature and Humidity in Procedural Areas,” dated 8/19/24, the P&P indicated, “7. Quarterly, the log including variances and actions taken will be presented to the facility quality committee.””

“INFORMED CONSENT CFR(s): 482.51(b)(2) A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies. This Standard is not met as evidenced by: 42744 Based on interview and record review, the hospital failed to: 1. Ensure documented physician signatures on blood transfusion consents for 18 of 26 sampled patients (Patient 10, Patient 11, Patient 12, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 19, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, Patient 25, Patient 27, Patient 28, and Patient 29). This failure had the potential to result in these patients unable to make informed medical decisions regarding blood transfusions during surgical procedures and resulted in inaccurate patients’ records. 2. Ensure witnesses printed their names legibly (easy to read writing) on informed consents for blood transfusions for 17 of 26 sampled patients (Patient 10, Patient 11, Patient 12, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, Patient 25, Patient 26, Patient 27, and Patient 30). This failure resulted in the inability to determine who witnessed the informed consents and inaccurate patients’ record. Findings: 47734 1. During a concurrent interview and record review on 4/1/25 at 3:34 p.m. with Director of Surgical Services (DSS), Patient 10’s “CONSENT TO TRANSFUSION OF BLOOD AND/OR BLOOD PRODUCTS” (CTB), dated 3/25/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/1/25 at 3:47 p.m. with DSS, Patient 11’s “CTB”, dated 3/9/25 was reviewed. The “CTB” indicated physician signed the consent but there were no date and time documented. DSS stated a date, and time should be documented. During a concurrent interview and record review on 4/1/25 at 3:48 p.m. with DSS, Patient 11’s “CTB”, dated 3/11/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented, she stated she did not know why there were two consents for transfusion of blood. During a concurrent interview and record review on 4/1/25 at 3:57 p.m. with DSS, Patient 12’s “CTB”, dated 3/7/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/1/25 at 4:19 p.m. with DSS, Patient 14’s “CTB”, dated 2/3/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/1/25 at 4:25 p.m. with DSS, Patient 15’s “CTB”, dated 3/27/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/1/25 at 4:31 p.m. with DSS, Patient 16’s two “CTB”, dated 3/27/25 were reviewed. Both “CTB” indicated “Physician Signature” were blank with no date and time documented. DSS stated a physician’s signature should be documented, and she did not know why there were two consents for blood transfusion. During a concurrent interview and record review on 4/1/25 at 4:35 p.m. with DSS, Patient 17’s “CTB”, dated 3/25/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/1/25 at 4:40 p.m. with DSS, Patient 18’s “CTB”, dated 3/29/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/1/25 at 4:42 p.m. with DSS, Patient 19’s “CTB”, dated 2/10/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. DSS stated there needs to be date and time for both patient signature and witness and there was only one. During a concurrent interview and record review on 4/1/25 at 4:48 p.m. with DSS, Patient 20’s “CTB”, dated 3/4/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/1/25 at 4:51 p.m. with DSS, Patient 21’s “CTB”, dated 3/7/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/3/25 at 4:13 p.m. with DSS, Patient 22’s “CTB”, dated 3/12/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/3/25 at 4:33 p.m. with DSS, Patient 23’s “CTB”, dated 3/16/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/3/25 at 4:43 p.m. with DSS, Patient 24’s “CTB”, dated 3/8/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/3/25 at 4:46 p.m. with DSS, Patient 25’s “CTB”, dated 3/14/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/3/25 at 5:02 p.m. with DSS, Patient 27’s “CTB”, dated 3/7/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/3/25 at 5:05 p.m. with DSS, Patient 28’s “CTB”, dated 3/10/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. During a concurrent interview and record review on 4/3/25 at 5:08 p.m. with DSS, Patient 29’s “CTB”, dated 2/4/25 was reviewed. The “CTB” indicated “Physician Signature” was blank with no date and time documented. DSS stated a physician’s signature should be documented. 2. During a concurrent interview and record review on 4/1/25 at 3:34 p.m. with DSS, Patient 10’s “CTB” and “CONSENT TO SURGERY OR SPECIAL PROCEDURE” (CTS), dated 3/25/25 were reviewed. The “CTB” and “CTS” indicated witness name were not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/1/25 at 3:49 p.m. with DSS, Patient 11’s “CTB” and “CTS”, dated 3/9/25 were reviewed. The “CTB” and “CTS” indicated witness name were not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/1/25 at 3:57 p.m. with DSS, Patient 12’s “CTB” and “CTS”, dated 3/7/25 were reviewed. The “CTB” and “CTS” indicated witness name were not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/1/25 at 4:19 p.m. with DSS, Patient 14’s “CTB”, dated 2/3/25 was reviewed. The “CTB” indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/1/25 at 4:25 p.m. with DSS, Patient 15’s “CTB” and “CTS”, dated 3/27/25 were reviewed. The “CTB” and “CTS” indicated witness name were not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/1/25 at 4:31 p.m. with, Patient 16’s two “CTB”, dated 3/27/25 were reviewed. The two “CTB” indicated witness names were not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/1/25 at 4:35 p.m. with DSS, Patient 17’s “CTB”, dated 3/25/25 was reviewed. The “CTB” indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/1/25 at 4:40 p.m. with DSS, Patient 18’s “CTB”, dated 3/29/25 was reviewed. The “CTB” indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/1/25 at 4:48 p.m. with DSS, Patient 20’s “CTB”, dated 3/4/25 was reviewed. The “CTB” indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/1/25 at 4:49 p.m. with DSS, Patient 20’s “CTS”, dated 3/10/25 was reviewed. The “CTS” indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/1/25 at 4:51 p.m. with DSS, Patient 21’s “CTB”, dated 3/7/25 was reviewed. The “CTB” indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/1/25 at 4:52 p.m. with DSS, Patient 21’s “CTS”, dated 3/10/25 was reviewed. The “CTS” indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/3/25 at 4:13 p.m. with DSS, Patient 22’s “CTB”, dated 3/12/25 was reviewed. The “CTB” indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/3/25 at 4:33 p.m. with DSS, Patient 23’s “CTB” and “CTS”, dated 3/16/25 were reviewed. The “CTB” and “CTS” indicated witness name were not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/3/25 at 4:43 p.m. with DSS, Patient 24’s “CTB”, dated 3/8/25 was reviewed. The “CTB” indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/3/25 at 4:46 p.m. with DSS, Patient 25’s “CTB”, dated 3/14/25 was reviewed. The “CTB” indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/3/25 at 4:49 p.m. with DSS, Patient 26’s “CTB”, dated 3/7/25 was reviewed. The “CTB” indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/3/25 at 5:02 p.m. with DSS, Patient 27’s “CTB”, dated 3/7/25 was reviewed. The “CTB” indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it. During a concurrent interview and record review on 4/3/25 at 5:11 p.m. with DSS, Patient 30’s “CTB”, dated 3/20/25 was reviewed. The “CTB” indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it. During a review of the facility’s policy and procedure (P&P) titled, “Informed Consent,” dated 5/25/2022 the P&P indicated, “2.4. Informed Consent. . .The patient’s physician is responsible for providing the information the patient needs in order to make an informed decision. . . 7.1. Physician Responsibility. The physician is responsible for providing the patient or an incompetent patient’s surrogate decision-maker with the information that is necessary to allow an “informed decision” to be made. The topics that must be addressed, at a minimum are: 7.1.1 The nature of the operation or procedure . . . 8.2. Documentation. The witness should legibly print his or her name, sign the document and note the date and time the witness signed the document.””

“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: 47734 Based on interview and record review, the facility failed to follow the “General Medical Staff Rules and Regulations (RR),” when one of one sampled Primary Surgeon (PS) did not immediately complete an operative report following a “lumbar laminectomy [surgical procedure to remove portion of spine/back bone] of L4, L5 [two lowest spinal bones together support the upper body and allow trunk motion] and S1 [bottom of spine provides weight support, movement, and absorbs stress]” for one of 30 sampled patients (Patient 14). This failure resulted in an incomplete medical record for Patient 14 and the potential to affect Patient 14’s continuity of care due to an unrecorded surgery. Findings: During a review of Patient 14’s “History and Physical (H&P),” dated 1/24/25, the “H&P” indicated, “[Patient 14] with low back pain radiating to bilateral [both sides] lower extremity [legs] exacerbated [made worse] by standing and walking, relieved by sitting down. . .Patient wishes to proceed with lumbar laminectomy of L4, L5 and S1. During a review of Patient 14’s “Perioperative Record (POR - record of the time before, during, and after surgery),” dated 2/7/25, the “POR” indicated PS performed the surgery Patient 14’s surgery start time was 3:51 p.m. and surgery end time was 5:14 p.m. During a concurrent interview and record review on 4/1/25 at 4:20 p.m. with Director of Surgical Services (DSS), Patient 14’s electronic medical record (EMR) was reviewed. DDS stated an operative report was not found in Patient 14’s EMR for the lumbar laminectomy surgical procedure performed on 2/7/25 T 3:51 p.m. by PS. DDS stated PS was required to complete the operative report within 48 after hours following the end time of procedure, DSS stated she did not know why the operative report was not written. DS stated there were no other notes by PS. During a review of the facility document titled, “RR,” dated April 2024, the “RR” indicated, “G. Operative or procedure reports shall be written or dictated immediately after an operative or other high risk procedure.””

“DISCHARGE PLANNING EVALUATION CFR(s): The discharge planning evaluation must be included in the patient’s medical record for use in establishing an appropriate discharge plan and the results of the evaluation must be discussed with the patient (or the patient’s representative). This Standard is not met as evidenced by: 39650 Based on interview and record review, the facility failed to ensure their discharge policies and procedures (P&P) were followed for five of 10 sampled patients (Patient 5, Patient 6, Patient 20, Patient 23, and Patient 29). This failure had the potential to result in unmet discharge needs and resources for the homeless patient. Findings: 1. During a review of Patient 5’s “Facesheet [FS],” dated 12/8/24, the FS indicated Patient 5 was admitted to the Emergency Department (ED) on 12/8/24 at 4:16 p.m. and was homeless. During a concurrent interview and record review on 1/28/25 at 3:34 p.m. with Emergency Department Nurse Manager (EDNM), Patient 5’s electronic medical record (EMR) “ED Discharge Note [EDN],” dated 12/9/24 was reviewed. The EDN indicated mode of transportation, accompanied by, and transportation screen were blank. Patient 5’s EMR “Discharge Planning for Homeless Patients [DCP],” 12/9/24 was reviewed. EDNM stated all screens on the ED discharge note and DCP should have been completed by the Registered Nurse (RN). EDNM stated the RN documentation in the medical record is expected to be accurate and complete. During an interview on 1/29/25 at 12:58 p.m. with Director of Education (DOE), DOE stated all screens in the EMR are to be completed, not just the hard stop questions. Discharge RNs are expected to review, document, and complete each step on the discharge planning and discharge screens. During a review of Patient 5’s “FS,” dated 12/9/24, the FS indicated Patient 5 was admitted to the ED on 12/9/24 at 12:24 p.m. and was homeless. During a concurrent interview and record review on 1/29/25 at 2:30 p.m. with RN 1 and EDNM, Patient 5’s EMR “EDN,” dated 12/9/24 was reviewed. The EDN indicated mode of transportation, accompanied by, and transportation screens were blank. Patient 5’s EMR “DCP,” dated 12/9/24 was reviewed. The DCP indicated, “Patient offered” Infectious disease screening N/A Vaccination Screening N/A Meal Offered, N/A Transportation within 30 mins [minutes]/30 miles N/A, Discharge medications provided to patient screen blank,Written prescription(s) provided screen blank, Physician determined follow-up is medically necessary screen blank. Physician determined behavioral health follow up is necessary screen blank, Patient referred to screen blank, Behavioral health follow-up notification blank, Patient referred to screen blank. RN 1 stated she thought it was done so she did not review the information for completeness. RN 1 stated she overlooked the screens and they should have been completed before Patient 5 was discharged. 2. During a review of Patient 6’s “FS,” dated 12/3/24, the FS indicated Patient 6 was admitted to the ED on 12/3/24 at 11.27 a.m. During a review of Patient 6’s “ED Physician Notes [PN],” dated 12/3/24, the PN indicated, “Patient lives in a shelter.” During a concurrent interview and record review on 1/29/25 at 1:20 p.m. with Quality Patient Safety Program Manager (QPSPM). Patient 6’s EMR “DCP,” dated 12/9/24 was reviewed. The DCP indicated, “Patient Offered” Infectious disease screening N/A (non applicable-does not apply), Vaccination Screening N/A, Meal Offered N/A, Transportation within 30 mins/30 miles N/A, Patient arrived with weather appropriate clothes No. QPSPM stated there was no documentation which stated why N/A was documented on Patient 6’s DP form. 51540 3. During a review of Patient 20’s “FS,” dated 12/24/24, the FS indicated Patient 20 was admitted to the ED on 12/24/24 at 8:35 p.m. During a concurrent interview and record review on 1/29/25 at 3:52 p.m. with EDNM Patient 20’s “DCP” dated 12/24/24, was reviewed. The DCP indicated, “Patient Offered” Infectious disease screening N/A, Vaccination Screening N/A, Transportation within 30 mins/30 miles N/A. EDNM stated the nurse is responsible to verify the completion of each answer on the screening. EDNM stated the nurse should have entered a comment for each answer marked N/A or put accepted or declined. EDNM stated she was unable to provide documentation that indicated why NA was marked on Patient 20’s DCP. EDNM stated she was unable to provide documentation that indicated why NA was marked on Patient 20’s DCP 4. During a review of Patient 23’s “FS,” dated 12/26/24, the FS indicated Patient 23 was admitted to the ED on 12/26/24 at 10:16 p.m. and was homeless. During a concurrent interview and record review on 1/29/25 at 3:56 p.m. with EDNM, Patient 23’s “DCP” dated 12/30/24 was reviewed. The DCP indicated, “Patient Offered” Infectious disease screening N/A, Vaccination Screening N/A, Meal Offered N/A, Transportation within 30 mins/30 miles N/A. EDNM stated there should have been comments for any answer marked N/A. EDNM stated she was unable to provide documentation that indicated why NA was marked on Patient 23’s DCP. 5. During a review of Patient 29’s “FS,” dated 1/14/25, the FS indicated Patient 29 was admitted to the ED on 1/14/25 at 11:33 a.m. and was homeless. During a concurrent interview and record review on 1/29/25 at 3:58 p.m. with EDNM, Patient 29’s “DCP” dated 1/14/25 (updated 1/16/25) was reviewed. The DCP indicated, “Patient Offered” Infectious disease screening N/A, Vaccination Screening N/A, Meal Offered N/A, Transportation within 30 mins/30 miles N/A. EDNM stated she was unable to provide documentation that indicated why NA was marked on Patient 29’s DCP. EDNM stated there was no determination that these items were offered to the patient 29 prior to discharge. During a review of the facility’s policy and procedure (P&P) titled, “Safe Discharge for High Risk Patients,” dated 1/28/18, the P&P indicated, “Particular attention is paid to high risk and vulnerable populations by assessing, intervening, and providing basic needs of a person identified as homeless and/or in need of services or resources prior to discharge. . .The nursing staff is responsible for. . .Communicating the referral and discharge plan, including transportation arrangements, to the patient/family and other personnel involved in the patient’s plan of care. . .Each homeless patient will be offered the following services prior to discharge. Acceptance or declination of each of these will be documented. . . The homeless patient will be offered food/a meal prior to discharge. . .The homeless patient will be offered weather appropriate clothing if the patient’s clothing is inadequate. The homeless patient will be offered or referred to screening for infectious disease common to the region. . .The homeless patient will be offered vaccinations. . .The hospital will offer the homeless patient transportation to his/her post-discharge destination as identified in the discharge plan. During a review of the facility’s P&P titled, “Accurate and Proper Documentation of Medical Records,” dated 2/25/22, the P&P indicated, “The purposes of this policy are: A. To serve as an accurate and detailed record for planning patient care, ant to accurately record services ordered and/or provided by all involved providers, nurses and ancillary personnel. B. To document the patient’s medical evaluation, treatment. . .during the hospital stay. . .or emergency visit.” During a review of the facility’s P&P titled, “Written Community Plan: Discharge Planning Unsheltered Patients,” dated 1/21/25, the P&P indicated, “In compliance with California Senate Bill 1152, all three [facility names and county name] have created and implemented this written community plan when discharging unsheltered individuals. . .This written plan is in alignment with the hospital’s Safe Discharge for the High Risk Patients Policy. . .that addresses unsheltered patient discharge planning.””