Sharp Chula Vista Medical Center

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 28183 Based on interview and record review, the hospital failed to ensure nursing staff followed hospital policy for 1 of 33 sampled patients (Patient 1) related to the administration of heparin (medication; drug; anticoagulant) and TPA (Tissue Plasminogen Activator; alteplase; a clot dissolving medication). In addition, the hospital failed to ensure medications were prepared and administered in accordance with physician’s orders and accepted standards of practice when errors occurred during the medication administration observations of two of three sampled patients (Patients 70 and 72). These failures had the potential for Patients 1, 70, and 72 to experience adverse health outcomes. Findings: 1. On 7/7/26 at 8:30 A.M., an unannounced visit to the hospital was made to investigate a facility reported incident related to a medication error. Patient 1 was admitted to the Emergency Department (ED) on 4/20/26 with shortness of breath and was found to have bilateral pulmonary emboli (blood clot in both lungs), per the ED Provider note dated 4/20/26. The note also indicated Patient 1 had a Computed Tomography (CT; x-ray) scan of the head which showed no acute intracranial hemorrhage (brain bleed). Patient 1’s clinical record was reviewed. According to Interventional Radiology (IR) documentation dated 4/20/26, Patient 1 had bilateral infusion catheters placed for catheter directed thrombolysis (dissolving dangerous blood clots). On 4/20/26, the physician ordered heparin to be administered at 150 units/(per) hour (hr) (3 milliliters (ml)/hr), and alteplase to be administered at 1 milligram (mg)/hr (20 ml/hr), to be infused through each catheter. Patient 1 was transferred to the Intensive Care Unit (ICU) Stepdown unit shortly after midnight on 4/21/26, per the nursing flowsheet. On 4/21/26 at 1:30 A.M., a licensed nurse documented, “Upon line reconciliation, TPA was found to be running at heparin rate and heparin rate to be running at TPA rate.” At 2:40 A.M., a licensed nurse documented, “Hold heparin and TPA infusion, order PTT [Partial Thromboplastin Time], INR [International Normalized Ratio], and fibrinogen [PTT, INR, and fibrinogen are blood tests ordered together to evaluate the body’s ability to form clots and stop bleeding] q [every] 2hr and resume both infusions once labs improve.” According to the Medication Administration Record (MAR), the heparin and alteplase infusions were both stopped on 4/21/26 at 1:05 A.M. The alteplase and heparin were then resumed at 5:43 A.M. and 5:44 A.M. respectively. The History and Physical, dated 4/21/26, indicated, “Patient underwent IR placement of bilateral infusion catheters to the bilateral pulmonary arteries. These were infusing heparin and TPA [tissue plasminogen activator-alteplase], unfortunately the infusion rates of these medications were swapped leading to higher than desired heparin dosing and lower than desired TPA dosing.” On 4/22/26 at 1:16 P.M., the physician documented in a Progress Note, “Patient seen this morning at which time she was awake ...Subsequently she became aphasic (inability to comprehend or formulate language due to brain damage) and a stroke code (an emergency protocol to run when somebody shows signs of stroke) was called. CT head showed a left basal ganglia intracranial hemorrhage about 4 cm (centimeters) x (by) 2 cm.” A neurosurgery consult was obtained. On 4/22/26 the neurosurgeon documented, “This afternoon she (Patient 1) suddenly became aphasic and not moving her right side. CT head demonstrated intracranial hemorrhage ...family has elected not to proceed with emergent surgical intervention.” According to the Discharge Summary, dated 5/5/26, “the family elected comfort-focused care/hospice.” Patient 1 was discharged from the hospital on 5/5/26 into hospice care. The Director of Interventional Radiology (DIR) was interviewed on 7/7/26 at 9:20 A.M. According to the DIR, Patient 1 was taken to IR on 4/20/26 for placement of infusion catheters for arterial thrombolysis. The DIR stated that the ED nurse accompanied the patient to IR for the procedure. During the procedure, two catheters were placed, and one heparin and one alteplase infusion were initiated into each catheter. The process for verifying these medications required two RNs (Registered Nurse) for line tracing and IV pump verification. The two RNs usually consisted of two IR RNs, or one IR RN and one ICU RN. However, the “double check” was done with the IR RN and ED RN. During an interview on 7/7/26 at 9:30 A.M., the Supervisor of Critical Care (SCC) stated that Patient 1 was transferred to ICU Stepdown after the IR procedure. Once the patient was settled, the ICU nurse (RN 3) noticed that the medications were switched. The heparin was running at the alteplase rate and the alteplase was running at the heparin rate. On 7/8/26 at 10:58 A.M. the ED nurse (RN 2) was interviewed. RN 2 stated he was caring for Patient 1 in the ED on 4/20/26 when he assisted in transporting the patient to IR. While in IR, RN 2 stated the IR nurse (RN 1) asked him to do the medication verification. RN 1 and RN 2 then conducted IV line tracing to make sure the tubing was in the right pump channel, then checked top of channel to make sure the tubing was going to right medication (IV bag). Part of medication verification was to compare the dose and rate to the physician order to ensure they matched. According to RN 2, he was just informed of the medication error the night before this interview (7/7/26). RN 2 was unable to explain what happened, stating “I’m not too sure.” On 7/8/26 at 11:33 A.M., the ICU Stepdown nurse (RN 3) stated during an interview, that she received Patient 1 from IR and “got the patient settled. The patient was awake and talking. After about 30 minutes, RN 3 went to check the lines and medications, and discovered the “heparin and TPA were programmed incorrectly. The heparin was programmed as TPA and the TPA was programmed as heparin.” There were two bags of heparin and two bags of TPA. RN 3 stopped the infusions and notified the physician. The Manager of Critical Care (MCC) was interviewed on 7/9/26 at 3:15 P.M. The MCC acknowledged that RN 1 and RN 2 did not follow policy for medication verification when Patient 1’s heparin and TPA were switched and running at the incorrect rates. According to the hospital’s policy, Medication Administration, dated 8/2024, “The ‘6 rights’ of medication administration will be followed: ...Right Medication: Validate the medication you are planning to administer with the provider order and the Medication Administration Record (MAR) ...Right Dose: Validate the dose with the provider order and MAR.” According to the hospital’s policy, Medication Verification-Independent Double Check, dated 12/18/25, “ Independent Double Check (IDC): A process in which two qualified licensed clinicians, that are both qualified to perform the task, check (independently from each other, then compare results) critical components of prescribing, dispensing, preparation and/or monitoring prior to administration.” In addition, “Medications requiring an independent double check include: ...heparin 25,000/500 ml IV drip.” The policy further indicates, “High Risk Medication Independent Double Check Criteria (IDC) ... heparin 25,000/500 ml (50 unit/ml) ...Rate and weight on pump matches ‘unit/kg/hr’ rate and weight in MAR (see administration instructions) ...Line reconciliation.” 51705 2. During a medication administration observation on 7/8/26 at 8:43 A.M., Licensed Nurse (LN) 60 was observed preparing and administering three medications to Patient 70. One of the medications was pantoprazole (a medication used for heartburn) 40 mg (milligrams, unit of measurement) vial. After removing the cap of the vial, LN 60 was not observed wiping the rubber stopper with alcohol before preparing the dose for administration. A review of Patient 70’s medical record indicated an active order of pantoprazole 40 mg - administer 40 mg IV (intravenous, into the veins) push (using a syringe and needle over a specified timeframe) over 2 minutes, dated 7/6/26. During an interview with LN 60 on 7/8/26 at 2:19 P.M., LN 60 acknowledged she did not wipe the pantoprazole vial with alcohol after removing the cap. LN 60 stated nursing staff were to swab the vial with alcohol. A review of the facility’s policy and procedure (P&P) titled, “Adult - IV Push and Infusion Guidelines, 43150.99,” revised 7/7/26, indicated, “ ...C. Draw up medication from vial ...1. Use aseptic technique [process used in healthcare to prevent the spread of germs] and scrub the diaphragm of the vial [rubber stopper] ...using 70% alcohol. Allow time for air drying ...” 3. During a medication administration observation on 7/8/26 at 9:27 A.M., LN 61 was observed preparing and administering four medications to Patient 72. One of the medications was insulin aspart (a type of insulin, used to lower blood sugar). LN 61 was observed preparing the insulin dose and was asked if it was 8 units. LN 61 acknowledged she drew 8 units of insulin into the syringe and stated she will check to see how much food Patient 72 consumed. LN 61 was heard asking Patient 72’s family member (FM) how much food Patient 72 ate. LN 61 stated, “that’s about half.” Immediately before administering the insulin, LN 61 stated the insulin dose was 7 units and not 8 units. A review of Patient 72’s medical record indicated orders of insulin aspart, including the following: - insulin aspart 0-5 units subcutaneously (injected into the fat under the skin) 3 times daily before meals, dated 7/6/26. The administration instructions indicated the dose was based on meal consumption, “PROPORTIONAL MEAL DOSE MODERATE SCALE. Use for eating patient.” Expected to eat LESS than 25% (percent) meal = (equals) 0 units Expected to eat 26-50% meal = 3 units Expected to eat GREATER than 50% meal = 5 units - insulin aspart 0-5 units subcutaneously 3 times daily before meals, dated 7/6/26. The administration instructions indicated, “EATING MODERATE CORRECTION SCALE. Give correction dose even if patient does not eat.” BG (blood glucose or blood sugar) LESS than 151 mg/dL (milligrams per deciliter, unit of measure) = 0 units BG 151-175 = 1 unit BG 176-200 mg/dL = 2 units BG 201-225 mg/dL = 2 units BG 226-250 mg/dL= 3 units BG 251-275 mg/dL = 4 units BG 276-300 mg/dL = 5 units BG GREATER than 300 mg/dL = 5 units and notify provider now Patient 72’s Lab Test Results indicated her blood sugar was 180 mg/dL on 7/8/26 at 7:10 A.M. During a concurrent interview and record review with the Director of Pharmacy (DOP) and Pharmacist Informaticist (RXI) on 7/8/26 at 10:52 A.M., Patient 72’s medical record was reviewed. Patient 72’s Medical Administration Record (MAR, an official legal document that has a complete and accurate record of all medications administered to a resident to ensure patient safety) indicated Patient 72 was administered a total of 7 units of insulin aspart on 7/8/26 at 9:39 A.M. The MAR indicated 2 units of insulin aspart was given per the “EATING MODERATE CORRECTION SCALE.” The order instructed to administer 2 units of insulin aspart for a blood sugar of 176-225 mg/dL. In addition, the MAR indicated 5 units of insulin aspart was from the “PROPORTIONAL MEAL DOSE MODERATE SCALE” order. That order indicated 5 units of insulin aspart was to be given if the patient was expected to eat more than 50% of the meal. LN 61 documented on Patient 72’s Ins and Outs (I/Os) Flowsheet on 7/8/26 at 8:12 A.M., that Patient 72 ate 50% of her meal. The DOP and RXI acknowledged the order instructed a 3-unit dose of insulin aspart was to be given if the patient was expected to eat 50% of a meal. The RXI stated the insulin aspart orders were scheduled for specific times of the day. The RXI stated those times were 7:30 A.M., 11:30 A.M., and 4:30 P.M. The RXI acknowledged the insulin aspart doses were late and stated they were not given on time. The DOP stated breakfast was served from 7:30 A.M. to 9 A.M. A drug review of insulin aspart on Daily Med (a free drug resource site provided by the National Library of Medicine), updated 2/28/23, indicated, “Inject...subcutaneously within 5-10 minutes before a meal...” During an interview with LN 61 on 7/8/26 at 2:03 P.M., LN 61 stated she prepared 7 units of insulin. LN 61 then said she flicked out the excess insulin from the syringe and administered 7 units total of insulin aspart. LN 61 acknowledged she administered insulin after breakfast and that the order was for before meals. When asked if she needed to see and review the insulin eating scale order, which indicated to administer insulin aspart 3 units for an expected 50% meal consumption, LN 61 stated she was aware of the order. A review of the facility’s P&P titled, “Medication Administration, 30035.99,” revised 8/24, indicated, “ ...XI. PROCEDURE ...C ...using 6 Rights of medication administration ...4. Right Time ...relationship to meals ...5. Right Dose ...””

“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: 51705 Based on observation and interview, the facility failed to ensure the safe provision and storage of drugs in accordance with standards of practice when: 1. Light-sensitive drugs were not protected from light in the hospital pharmacy and 2. Two of two inspected IV (intravenous, administered into the veins) hoods (used to prepare IV drugs) in the non-hazardous (non-HD) drug IV room were observed to have visible dust particles settled on the bottom glass panel beneath the light compartment. In addition, cracks and chips were observed on the ceiling and walls of the non-HD IV room and one chip on the wall of the HD (hazardous drug) IV room (room where hazardous drugs are compounded). These failures had the potential for residents to receive deteriorated (reduced quality) medications and had the potential to contaminate (to make dirty or unsafe) IV medications, which can result in adverse patient outcomes. Findings: 1. During a tour of the hospital pharmacy with the Director of Pharmacy (DOP) and Pharmacy Supervisor (RXS) on 7/7/26 at 1:39 P.M., light-sensitive medications were observed in bins with amber lids that were partially open. The medications included the following: - triamcinolone (a medication used for its anti-inflammatory properties) 40 mg (milligrams, unit of measure) per mL (milliliters, unit of measure for volume) - ceftazidime-avibactam (an antibiotic) 2.5 g (gram, unit of measure) vial - product labeling on the vial indicated, “ ...Protect from light ...” - cefazolin (an antibiotic) 500 mg (milligram, unit of measure) vial - cefuroxime (an antibiotic) 1.5 g vial - aminophylline (a medication used to treat respiratory conditions) 250 mg per 10 mL - aminophylline 500 mg per 20mL - the bin had a green auxiliary sticker that indicated, “PROTECT FROM LIGHT.” - ceftazidime (an antibiotic) 1 g vial - product labeling on the vial read, “ ...Protect from light ...” The RXS stated the bins should have been kept closed. A review of the facility’s policy and procedure (P&P) titled, “Drug Storage / Security, 43014,” revised 6/3/26, indicated, “ ...III. POLICY ...C. Drugs stored within the pharmacy and throughout the hospital ...are stored in compliance with manufacturers’ recommendations. They must be stored under proper conditions of sanitation, temperature, light ...” 2. During an inspection of the hospital pharmacy IV rooms with the IV Specialist Technician (IVST) on 7/9/26 at 9:13 A.M., a crack was observed on the ceiling in the non-HD IV room. The IVST acknowledged the crack. Additionally, two chips on two sides of the wall in the non-HD IV room were observed. The IVST acknowledged these chips. Both IV hoods in the non-HD IV room were observed to have dust particles that settled on the bottom glass panels underneath the light compartment. The IVST acknowledged the presence of dust particles in the IV hoods. In the Hazardous Drug (HD) IV room, a small chip was observed on one wall. The IVST acknowledged the presence of the chip in the HD IV room. A review of the United States Pharmacopeia (USP, an organization that provides standards and guidance for the safe and sterile [free from germs] compounding, preparation of intravenous [administered into the vein] medications) chapter <797> (section of USP that deals with sterile IV compounding), effective 11/1/23, indicated, “ ...The surfaces of ceilings, walls...fixtures ...work surfaces ...cabinets ...must be smooth ...free from cracks and crevices, and nonshedding so they can be cleaned and disinfected and to minimize spaces in which microorganisms [bacteria, viruses or fungi] and other contaminants can accumulate ...” A review of the facility’s P&P titled, “Sterile Product Compounding in Pharmacy Services, 43165,” revised 5/7/26, indicated, “ ...III. POLICY ...B. In accordance with all appropriate State and Federal regulations and laws...Pharmacy personnel will follow ...procedures established to promote the compounding of sterile products for patients that are ...2. Free from microbial [bacterial, viral or fungal] and pyrogenic [fever inducing] contaminants 3. Free from unacceptable levels of particulate and other toxic contaminants ...””

“SECURE STORAGE CFR(s): 482.25(b)(2)(i) §482.25(b)(2)(i) - All drugs and biologicals must be kept in a secure area, and locked when appropriate. This Standard is not met as evidenced by: 51705 Based on observation and interview, the facility failed to ensure drugs were secured and locked when bins of medications were observed in an unlockable cabinet in one of three inspected Emergency Department (ED) pods. This failure had the potential for unauthorized individuals to access medications. Findings: During a tour of the ED Pod D on 7/8/26 at 1:49 P.M. with the ED Services Manager (EDSM), a cabinet storing medications was observed to be unlockable. The cabinet had six bins of medications. The medications included anesthetics (numbing agents, used to minimize pain before procedures) including the following: - lidocaine 1% (strength) with epinephrine multidose vials - lidocaine 1% multidose vials - bupivacaine 0.5% single dose vials - Hurricaine spray packets The cabinet also had bins containing the following: - sterile water 10 mL (milliliters, unit of measure for volume) vials - sodium chloride (salt water) 10 mL vials The EDSM acknowledged the cabinet containing medications could not be locked. A review of the facility’s P&P titled, “Drug Storage / Security, 43014,” revised 6/3/26, indicated, “ ...III. POLICY ...4. Drugs shall be secured and accessible only to responsible personnel designated by the hospital ...4. Access to secure medication storage sites is limited so as to prevent access by unauthorized personnel from gaining access to locked areas where drugs ...are stored ...””

“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: 51705 Based on observation and interview, the facility failed to ensure outdated drugs were not available for patient use when: 1. Expired medications were found stored with in-date medications in two of two inspected hospital pharmacy medication refrigerators and 2. Expired medications were found in one of one inspected Interventional Radiology (IR, an area where imaging, such as X-rays, is used to diagnose or treat various conditions) medication refrigerators. These failures had the potential for patients to receive deteriorated (reduced quality) and ineffective medications. Findings: 1. During a tour of the hospital pharmacy on 7/7/26 at 1:39 P.M. with the Pharmacy Supervisor (RXS), an expired insulin (medication used to lower blood sugar) vial was observed stored in a sealed “code blue [emergency hospital process that occurs when a patient’s heart stops beating] kit” in the Main Double Refrigerator. The insulin vial had a sticker affixed to it that read, “ ...EXPIRES 17 JUN 2026.” The RXS acknowledged the insulin vial was expired. In addition, the hospital pharmacy’s Double Door Refrigerator was observed to contain two expired medications: amoxicillin (an antibiotic) suspension (in liquid form) and fish oil (used to treat fats in the blood). The amoxicillin suspension had a sticker that indicated, “ ...EXPIRES 6 JUL 2026.” The RXS stated the amoxicillin suspension was expired. The fish oil had a date open sticker that read, “3/24/26.” The product labeling on the back of the bottle read, “Directions ...Refrigerate after opening, and use within 100 days.” The RXS acknowledged the fish oil was expired. 2. During a tour of IR Room 2 on 7/10/26 at 9:17 A.M. with the RXS, the medication refrigerator was inspected. Two expired prefilled syringes containing lidocaine with sodium bicarbonate (a combination drug used to cause numbness to minimize pain before procedures) were observed stored with other medications in the refrigerator. The product labeling indicated each syringe expired on 1/17/26. The RXS acknowledged both lidocaine with sodium bicarbonate syringes were expired. A review of the facility’s policy and procedure (P&P) titled, “Expiration Dating - Medications, 43110.99,” revised 11/21/23, indicated, “ ...III. POLICY ...D. Multi-dose and single dose vials shall be discarded if storage requirements have not been met ...IV. PROCEDURE ...D. Open dated MDV [multidose vials] will be discarded at the assigned ...expiration date ...” A review of the facility’s P&P titled, “Drug Storage / Security, 43014,” revised 6/3/26, indicated, “ ...5 ...Drugs shall not be kept in stock after the expiration date ...””

“PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS CFR(s): 482.13(d) Patient Rights: Confidentiality of Records This Standard is not met as evidenced by: 45909 Based on observation, interview, and record review, the facility failed to implement privacy practice for four out of six patients, when one staff (Speech Therapist [ST]) daily assignment sheet (DAS - form that included patients’ protected health information, (PHI) - refers to patient’s name, age, primary problem) was left unattended on top of a computer in the medical surgical unit (MSU) hallway. This failure had the potential to unnecessarily expose patient PHI to non-facility personnel such as visitors and/or other patients. Findings: A concurrent observation and interview was conducted with the Clinical Nurse Specialist (CNS) 22 on 2/28/25 at 9:10 A.M. in the MSU hallway. A DAS was observed on top of a computer in the MSU hallway. The DAS included patients’ PHI. CNE 22 stated that the DAS should have not been left unattended by the staff, to keep patients’ confidential information safe from the public view. An interview was conducted with the ST on 2/28/25 at 11:30 A.M. The ST stated that the DAS found in the MSU belonged to him. The ST further stated that he should have not left the DAS unattended in the hallway, to prevent non-facility personnel to gain access to patients’ PHI. An interview was conducted with the Rehabilitation Supervisor (RS) on 2/28/25 at 11:35 A.M. The RS stated that he expected all patient PHI to be protected from public view. The RS further stated that the ST’s DAS should have been kept away, nonvisible, to protect patient’s information. A review of the facility’s policy titled, Confidentiality of Information dated 4/29/24 indicated, “III.TEXT...Q. Workforce members are expected to ...3. Maintain safeguards for protection of sensitive information.””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 50175 Based on interview and record review, the facility failed to ensure care plan (document indicating a patient’s needs and goals) documentation (related to being reviewed and noted in the medical record) was completed per the facility’s policy, for two of 30 sampled patients (Patient 2 and Patient 3). This failure had the potential for the patient’s (2, 3) needs to be unmet. Findings: 1. Patient 2 was admitted to the facility on 12/6/24 with a diagnosis that included osteomyelitis (inflammation or swelling of the bone), per Patient 2’s history and physical (H&P; assessment and notes written by the physician). A concurrent interview and review of Patient 2’s medical record was conducted on 2/27/25 at 10:19 A.M. with Clinical Nurse Specialist (CNS) 2. Patient 2’s care plan indicated that the care plan was not documented (reviewed and noted in the medical record) daily. CNS 2 stated there were no documentation on Patient 2’s care plan for 12/16/24, 12/17/24, 12/19/24, 12/24/24, and 12/25/24. CNS 2 stated care plans needed to be documented every 24 hours. CNS 2 stated care plans were important because it was a documentation of the interdisciplinary (different healthcare professionals working together for a patient) plan of care. CNS 2 stated that anything could change, and goals could change, which was why care plans needed to be documented every 24 hours. A review of the facility’s Adult Nursing Guidelines of Care 2023-2026, updated 5/29/24, indicated “...Person Centered Plan of Care ...plan of care will be reviewed, communicated in the change of shift report, evaluated a minimum every 24 hours ...” 2. Patient 3 was admitted to the facility on 1/6/25 with a diagnosis that included aortic valve stenosis (a heart condition), per Patient 3’s history and physical (H&P; assessment and notes written by the physician). A concurrent interview and review of Patient 3’s medical record was conducted on 2/27/25 at 10:49 A.M. with Clinical Nurse Specialist (CNS) 2. Patient 3’s care plan indicated the care plan was not documented (reviewed and noted in the medical record) daily. CNS 2 stated there were no care plan documentation for 1/9/24, 1/11/24, 1/12/24, and 1/13/24. CNS 2 stated care plans needed to be documented every 24 hours. CNS 2 stated care plans were important because it was a documentation of the interdisciplinary (different healthcare professionals working together for a patient) plan of care. CNS 2 stated that anything could change, and goals could change, which was why care plans needed to be documented every 24 hours. A review of the facility’s Adult Nursing Guidelines of Care 2023-2026, updated 5/29/24, indicated “...Person Centered Plan of Care ...plan of care will be reviewed, communicated in the change of shift report, evaluated a minimum every 24 hours ...””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 50175 Based on interview and record review the facility failed to ensure hospital policies and procedures were implemented for two of 30 sampled patients (Patient 1, 12) when: 1. Patient 1’s STAT (immediate) computed tomography (CT, a type of X-ray imaging) ordered by the physician was not completed timely. 2. a. Patient 12’s pain assessments were not completed per policy. b. Patient 12’s physician order for pain medication was not administered per policy. c. Patient 12’s pain assessment and reassessment related to the administration of pain medication were not completed per policy. These failures had the potential to affect patients’ (1, 12) health, care, and well-being. Findings: 1. Patient 1 was admitted to the facility on 2/16/24 with a diagnosis of back pain, per the history and physical (a physician’s assessment and notes), dated 2/16/24. A review of Patient 1’s medical record was conducted from 2/25/25 through 2/28/25. The physician’s orders indicated a CT angiography (CTA, a medical imaging procedure that uses X-rays and dye to create detailed images of blood vessels) of the chest on 3/3/24 at 10:12 P.M. due to Patient 1’s complaint of new chest pain. The CTA of the chest was ordered “STAT”. A review of Patient 1’s CTA timeline indicated the CTA was started on 3/4/24 at 10:44 A.M. The STAT CTA was completed 12 hours after it was ordered. A review of the facility’s policies using the facility’s policy portal was conducted on 2/26/25 at 10:54 A.M. with Regulatory Affairs (RA) 2. There were no policies that defined “STAT”. There were no policies or procedures that defined the timeline of a STAT order. There were no policies that guided staff to determine which STAT CT orders should be completed first. An interview was conducted with CT tech (CTT) 1 on 2/26/25 at 1:46 P.M. CTT 1 stated that a STAT CTA order for an admitted patient such as Patient 1 was uncommon, so they (CT staff) knew it was supposed to be completed “right away.” CTT 1 stated there was no documentation on why there was a delay in completing Patient 1’s STAT CT. An interview was conducted with Clinical Nurse Specialist (CNS, nurse educator) 1 on 2/26/25 at 2:31 P.M. CNS 1 stated that Patient 1’s CT should had been completed sooner than 12 hours because it was ordered to be completed STAT. An interview was conducted on 2/27/25 at 7:41 A.M. with Licensed Nurse (LN) 1. LN 1 stated that Patient 1 had complained of chest pain and needed oxygen. LN 1 stated the physician ordered a STAT CTA because Patient 1 had a high heart rate and needed oxygen. LN 1 stated that “STAT” meant immediately. LN 1 stated the STAT CT was not completed by the end of the shift, 8 hours after the STAT CT was ordered. An interview was conducted on 2/28/25 at 8:20 A.M. with Medical Doctor (MD) 1. MD 1 stated the expectation was for a STAT order to be completed within one hour. MD 1 stated that when there was a STAT order, it needed to be done immediately or there was no point of ordering (to be completed) STAT. A review of the facility’s Adult Nursing Guidelines of Care, update 5/29/24, indicated “ ...ANA [American Nurses Association] Standards of Practice ...Standard 5: Implementation. The RN [Registered Nurse] implements the identified plan ...Coordination of Care. The RN coordinates care delivery ...” 43674 2. Patient 12 was admitted to the facility on 2/24/25 with diagnoses which included Deep Vein Thrombosis (DVT - clot in the vein) of the right lower extremity, per Patient 12’s undated admission record. a. A concurrent interview and record review was conducted on 2/26/25 at 2:57 P.M. with Clinical Nurse Specialist (CNS) 11. Patient 12’s pain assessments dated 2/24/25 through 2/27/25 did not include complete pain assessments and documentation that provided information on the patient’s pain location, acceptable pain level and other components of pain assessment. CNS 11 acknowledged that pain assessment and documentation should include the pain level, location, acceptable pain level, type and characteristic of pain, onset and duration, interventions provided, and response to intervention. A review of the hospital policy and procedure titled Patient Screening, Assessment and Management of Pain, last revised 5/2/24 indicated “ ...IV: Procedure ...B. Perform a Pain Assessment if pain present in screening. Pain Assessment must include. 1. Pain intensity level and function ... 2. Location 3. Acceptable pain intensity rating 4. Note: Additional assessment components may include: Onset, Duration, Quality, Radiation characteristics, Associated Factors, Associated Symptoms ... C. Perform pain assessment with any new report of pain and as determined by individual patient clinical condition/need ...” b. A review of Patient 12’s physician orders indicated “Hydromorphone PF (Dilaudid) Injection 0.5 milligrams (mg) intravenous (IV) every 4 hours PRN (pro re nata - as needed) for severe 7-10 pain” and Oxycodone (Roxicodone) immediate release tablet 5 mg oral (PO; oral route) every 4 hours PRN for severe 7-10 pain.” A concurrent interview and review of Patient 12’s medication administration records dated 2/25/25 through 2/26/25 was conducted on 2/26/25 at 2:57 P.M. with Clinical Nurse Specialist (CNS) 11. Hydromorphone IV and Oxycodone PO were administered without an indicated pain severity. CNS 11 acknowledged that pain severity and indication should have been consistently documented when the Hydromorphone IV and Oxycodone PO were administered to Patient 12. A review of the hospital’s policy and procedure titled Medication Administration last revised 8/9/24 indicated, “ ...III. Text ... B. The 6 Rights of medication administration will be followed: ...6. Right Rationale: Validate the medication is being given for the prescribed reason. ...J. For PRN medications: 1. Document reason medication was given. c. A review of Patient 12’s physician orders indicated “Hydromorphone PF (Dilaudid) Injection 0.5 milligrams (mg) intravenous (IV) every 4 hours PRN (pro re nata - as needed) for severe 7-10 pain” and Oxycodone (Roxicodone) immediate release tablet 5 mg oral (PO; oral route) every 4 hours PRN for severe 7-10 pain.” A concurrent interview and review of Patient 12’s medication administration record dated February 2025 was conducted on 2/26/25 at 2:57 P.M. with Clinical Nurse Specialist (CNS) 11. Per this record, Hydromorphone IV and Oxycodone PO were administered to Patient 12 multiple times. The record did not include consistent documentation of pain assessment and reassessment of the medication’s effectiveness. CNS 11 acknowledged that pain assessments prior to medication administration, and pain reassessments of the medication effectiveness were not consistently completed, and should have been. A review of the hospital’s policy and procedure titled Medication Administration last revised 8/9/24 indicated, “ ...III. Text ...J. For PRN medications: 1. Document reason medication was given. 2. Assess/Reassess medication effect and patient response ...” A review of hospital policy and procedure titled Patient Screening, Assessment and Management of Pain last revised 5/2/24 indicated “ ...IV: Procedure ...C. Perform pain assessment with any new report of pain and as determined by individual patient clinical condition/need ... F. Perform reassessment of pain and sedation level to evaluate the safety and effectiveness of pain management interventions... 1. NOTE: Reassessment timing is based upon analgesic, route, dose and risk factors... General guidelines... IV... within 10-30 min... PO... within 45-60 min...””

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 45909 Based on interview and record review, the facility failed to follow its policy and procedure related to medication administration when: 1. Patient 21’s Lasix (medication that helps to reduce the amount of excess fluid in the body; also used to treat high blood pressure) was given when the order was to hold (not give) Lasix if systolic blood pressure (SBP - top number of blood pressure reading) was below 110. 2. Patient 22 did not receive hydralazine (HYD- medication to lower blood pressure) for SBP more than 140. These failures had the potential to affect the patients’ (21, 22) health and well-being. Findings: 1. A review of Patient 21’s clinical record indicated Patient 21 was admitted to the facility on 2/8/25 with medical diagnoses of acute kidney failure and high blood pressure. A review of Patient 21’s physician order dated 2/9/25 indicated, ‘Give Lasix 40 milligrams (mg - unit of measurement), oral, daily. Hold for SBP less than 110.” A concurrent interview and review of Patient 21’s blood pressure flow sheet and medication administration record dated February 2025, was conducted with CNS 11 on 2/27/25 at 2 P.M. Per this record, Patient 21’s SBP was 107 on 2/25/25 at 9:05 A.M., and on 2/26/25 at 7:37 A.M. Patient 21’s SBP on 2/27/25 at 7:40 A.M. was 108. The record indicated that Patient 21 was administered Lasix on the three occasions. CNS 11 stated that Patient 21’s SBP was already low on 2/25/25 at 9:05 A.M., 2/26/25 at 7:37 A.M., and 2/27/25 at 7:40 A.M., and that Lasix should have been held per physician order. An interview was conducted with Unit Manager (UM) 21 on 2/28/25 at 10:08 A.M. UM 21 acknowledged that the Lasix should not have been administered to Patient 21 per physician order, on 2/25/25 at 9:05 A.M., 2/26/25 at 7:37 A.M. and 2/27/25 at 7:40 A.M. to prevent Patient 21’s blood pressure from dropping further. The facility’s policy titled Medication Administration, dated 8/9/24, indicated, “ ...III. Text:..B. The “6 Rights” of medication administration will be followed ...6. Right Rationale: Validate the medication is being given for the prescribed reason.” 2. A review of Patient 22’s clinical record indicated that Patient 22 was admitted to the facility on 1/30/25 with medical diagnoses of cerebral infarction (brain blockage) and high blood pressure. A review of Patient 22’s physician order dated 1/30/25 indicated, “Give Hydralazine (HYD) 10 milligrams (mg - unit of measurement) every four hours as needed for SBP above 140. A concurrent interview and record review was conducted with Clinical Nurse Specialist (CNS) 22 on 2/28/25 at 10:30 A.M. Patient 22’s blood pressure flow sheet and medication administration record dated February 2025 indicated: On 2/26/25 at 8:44 A.M., the SBP was 159. HYD was not given. On 2/27/25 at 7:55 A.M., the SBP was 149. HYD was not given. On 2/28/25 at 7:20 A.M., the SBP was 151. HYD was not given. CNS 22 stated that the licensed nurses should have given the HYD medication per physician order, to keep Patient 22’s SBP below 140. An interview was conducted with Unit Manager (UM) 21 on 2/28/25 at 11 A.M. UM 21 stated that the HYD medication should have been given to Patient 22 per physician order (as needed for SBP above 140), to prevent Patient 22’s blood pressure from further increasing. The facility’s policy titled Medication Administration dated 8/9/24, indicated, “ ...III. Text. b. The “6 Rights” of medication administration will be followed ...6. Right Rationale: Validate the medication is being given for the prescribed reason.””

“PATIENT RIGHTS:RESTRAINT/SECLUSION DEATH RPT CFR(s): 482.13(g)(1) & (3)(i) [Death Reporting Requirements: Hospitals must report deaths associated with the use of seclusion or restraint.] (1) With the exception of deaths described under paragraph (g)(2) of this section, the hospital must report the following information to CMS by telephone, facsimile, or electronically, as determined by CMS, no later than the close of business on the next business day following knowledge of the patient’s death: (i) Each death that occurs while a patient is in restraint or seclusion. (ii) Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion. (iii) Each death known to the hospital that occurs within 1 week after restraint or seclusion where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient’s death, regardless of the type(s) of restraint used on the patient during this time.”Reasonable to assume” in this context includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing or asphyxiation.... (3) The staff must document in the patient’s medical record the date and time the death was: (i) Reported to CMS for deaths described in paragraph (g)(1) of this section; or .... This Standard is not met as evidenced by: 35611 Based on interview and record review, the facility failed to timely report the death within 24 hours of restraint removal for 1 of 3 sampled patient (1) to their Center for Medicare Medicaid (CMS) regional office. As a result, there was a delay in regulatory required reporting of a death. Finding: Patient 1 was admitted to the facility on 10/9/23 with diagnoses atrial fibrillation (irregular heartbeat) per the admission History and Physical, dated 10/9/23. A review of Patient 1’s medical record titled, Restraint initiation dated, 10/10/23, was conducted. Patient 1 was placed in posey vest restraint at 12 P.M., and the restraint was removed at 4 P.M. A review of Patient 1’s nursing note, dated 10/10/23 at 8 P.M., was conducted. This nursing note indicated, “While receiving report, patient was agitated so[sic] this RN, and offgoing RN ... went into room with MD (medical doctor) (name of MD) present. Suddenly patient become unresponsive aystole [sic] on monitor, pulse was checked and when non-present compressions and code blue was called and started ...” A review of Patient 1’s Code Blue Record, dated 10/10/23, was conducted. At 7:26 P.M., Patient 1 was pulseless, and CPR (cardiopulmonary resuscitation) was started. Patient 1 was intubated (inserting a tube into mouth or nose to help breath) at 7:29 P.M., Patient 1 remained pulseless. At 7:46 P.M., Patient 1 was declared dead by the physician. An interview with the clinical nurse specialist (CNS) on 10/25/23 at 9:56 A.M., was conducted. Per CNS, Patient 1 expired on 10/10/23 and the facility did not report it to CMS until 10/16/23, which was 6 days after the event occurred. The CNS stated facility leadership staff were not aware of the reporting timeframe to CMS. CNS stated, “It’s a little late.” A review of facility policy and procedure titled, Restraint and Seclusion use, dated 7/8/22, was conducted. This policy indicated, “ ...a. All other reports other than wrist restraints will be made to CMS by telephone, facsimile, or mail no later than the close of business the next business day following knowledge of the patient’s death ...””