Good Samaritan 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: 28999 Based on record review, interview and policy review, the pharmacy failed to ensure a custom fluid order contained the correct amount of sodium, resulting in a patient’s death. This affected Patient #2. See A491”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 28999 Based on record review, interview and policy review, the facility failed to ensure pain was properly assessed. This affected two (Patients #7 and #9) patients. Findings include: 1. Review of the medical record of Patient #7 revealed the patient presented to the ED on 06/06/25 at 10:16 PM with complaints of abdominal pain. At 10:25 PM, the patient’s vital signs included a blood pressure of 135/100 mmHg, pulse of 114 beats per minute, respirations of 16 breaths per minute, temperature of 98.4 degrees Fahrenheit, and oxygen saturation of 100%. The patient reported arm pain rating it a 5 on a scale of 0-10. A triage note at 10:26 PM stated the patient complained of left sided pain and discomfort since yesterday afternoon. Although the patient reported calling the squad due to chest pain, she denied chest pain at this time. She reported arm pain. The 12 lead EKG was performed and noted to be similar to a prior EKG from 09/12/23. Numerous lab tests were also ordered and noted to be normal. The patient was medicated with Toradol 15 mg at 11:24 PM. A CT scan of the chest was ordered after a D Dimer (used to diagnosis a pulmonary embolism) was mildly elevated at 12:21 AM. The medical decision making stated the patient presented to the ED complaining of pleuritc chest pain. The patient reported recently being ill with a cough but stated as of late her symptoms were starting to improve when she developed chest pain after leaning over. The medical decision making also stated there was concern for possible pneumonia, pulmonary embolism, muscle strain. Laboratory studies in the ED with a mildly elevated D-Dimer. Chest X-ray normal, EKG unremarkable. Patient has been having chest pain for over 24 hours and troponin negative. A CT pulmonary angiogram showed no evidence of a pulmonary embolism or occult pneumonia. The ED physician believed patient’s pain was musculoskeletal and the decision was made to discharge her home. At 1:46 AM, the patient reported her pain had worsened and was now rated a six. The medical record lacked documentation the physician was notified of the patient’s worsening pain. The patient was discharged home 10 minutes later, at 1:56 AM. 2. Review of the medical record of Patient #9 revealed the patient presented to the ED on 06/06/25 at 8:22 PM with complaints of chest pain and trouble breathing. The patient was assigned a patient acuity of a 3. Numerous tests were performed and were normal. The medical record lacked documentation the patient’s pain was ever assessed. She was discharged home at 11:57 PM. During an interview on 07/08/25 at 4:00 PM, Staff M confirmed that the medical record of Patient #7 lacked documentation a provider was notified of the patient’s worsening pain. It was also confirmed that the medical record lacked documentation Patient #9’s pain was ever assessed. The facility policy titled “Pain Assessment and Management”, dated December 2010, stated at initial assessment, throughout a hospital stay or an outpatient visit, the provider will set a realistic pain goal with the patient and provide pain management education. Initial pain assessment is done at the time of the outpatient visit or admission to the hospital and may include but is not limited to the key components reported by the patient: 1. Pain score or intensity level using a pain assessment method that is appropriate to the patient’s age and ability to communicate. 2. Type of pain 3. Location of pain (each location of pain will be assessed separately) 4. Quality or descriptors in patient’s own words (e.g. dull, sharp, throbbing, stabbing, radiating) 5. Frequency or onset and duration 6. Factors which make pain worse 7. Factors that make pain worse 8. Current activity level with pain 9. Patient’s stated pain goal (0-10) 10. Patient’s stated activity goal 11. Effect of pain on patient’s quality of life 12. Current pain interventions, including pharmacologic and non-pharmacologic methods of pain management 13. If the patient cannot communicate their pain level verbally, assessment of items 1-10 will not be possible 14. Women in labor will have their coping assessed as an initial assessment of labor The policy further instructs staff that assessment of pain score is documented before administration of pain medication. Pain reassessment must be performed within two hours following an as needed analgesic or a non-pharmacologic intervention. Pain reassessment will include the pain score. During reassessment, evaluation of the need for additional pain management interventions is performed. This evaluation may include additional analgesics or non-pharmacologic interventions per current orders or notifying physician for need for additional analgesics.”

“PHARMACY ADMINISTRATION CFR(s): 482.25(a) [§482.25 Condition of Participation: Pharmaceutical Services .....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.] §482.25(a) Standard: Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles. This Standard is not met as evidenced by: 28999 Based on record review, interview and policy review, the pharmacy failed to ensure a custom fluid order contained the correct amount of sodium, resulting in a patient’s death. This affected Patient #2. Findings include: Patient #2, an infant born on 04/10/25, was admitted to the facility’s neonatal intensive care unit (NICU) on 04/10/25 at 3:17 PM from an outside hospital due to prematurity and bilateral diminished aeration, moderate to severe subcostal retractions, but symmetric breath sounds. Patient #2 was on continuous positive airway pressure (CPAP) with fraction of inspired oxygen (FiO2) at 21 percent. Review of a nursing note dated 04/10/25 at 6:55 PM stated Patient #2 had no signs of seizure activity, he was voiding and stooling appropriately, and his abdomen was soft and full. Review of a respiratory progress note dated 04/11/25 at 12:47 AM stated Patient #2 appeared comfortable with good aeration and his heart rate was stable with care. A certified nurse practitioner’s note on 04/11/25 at 1:38 PM stated a daily update was given to Patient #2’s mother via phone with the aid of an Uzbek interpreter as the parents did not speak English. She verbalized understanding of the update and stated she was in the process of being discharged and would come directly to the facility to be with the infant. On 04/12/25, the infant was receiving Total Parenteral Nutrition (TPN) and lipids via a peripherally inserted central catheter (PICC) line. Review of a respiratory progress note dated 04/12/25 stated Patient #2 continued to be comfortable with good aeration. His heart rate was stable and saturations stable and he was not having any periods of apnea or bradycardia. Review of a note by Attending Neonatologist #J on 05/18/25 at 2:13 PM stated the infant had six apnea, bradycardia, and desaturation events over the past 24 hours with one requiring positive pressure ventilation (PPV). High Flow Nasal Cannula (HFNC) therapy (a non-invasive respiratory support method that delivers heated and humidified oxygen at high flow rates) was increased to two liters. The infant was made nothing by mouth (NPO) and custom fluids were ordered. On 05/18/25 at 6:28 PM, Neonatal Nurse Practitioner #I ordered custom fluids which included Premasol 10 percent solution with an order dose of 2.5 grams per kilogram (g/kg) and administration dose of 72 milliliters (ml), Dextrose 70 percent solution with an order dose of 10 percent and administration dose of 40.32 g, sterile water solution with an order dose 264.11 ml and administration dose of 264.11 ml, Calcium Gluconate 10 percent solution with an order dose of 1.5 milliequivalents (mEq) per kilogram and administration dose 4.3199 mEq, and Sodium Chloride 4 mEq/ml solution. There was no order dose or administration dose for the Sodium Chloride. A note by a pediatrician on 05/19/25, stated an abdominal X-ray was performed which showed distended bowel loops (usually indicates an obstruction in the intestines). HFNC was increased to three liters, and Ampicillin and Gentamicin (antibiotics to treat infections) were ordered. Review of a nursing note dated 05/19/25 revealed Patient #2 had two apnea/bradycardia/desaturation events at 12:00 PM and 2:01 PM. At 6:00 PM, Patient #2 had rhythmic movements indicating seizure activity and then went into cardiac arrest. A code was initiated at 6:17 PM. Emergency medications including Epinephrine, Sodium Bicarbonate, Adenosine, Amiodarone, Magnesium Sulfate, and Naloxone were administered. Patient #2 was emergently transferred to another hospital for a higher level of care at 8:14 PM. Review of the outside medical record revealed the infant was diagnosed with iatrogenic sodium intoxication, diffuse axonal injury, respiratory failure, and profound brain injury. The decision was made to electively extubate the patient and allow a natural death. Patient #2 died on 05/27/25 at 5:35 PM. During an interview on 07/02/25 at 10:30 AM, Staff G, the Pharmacy Director, stated Sodium Chloride was selected as an ingredient of the custom fluids by the provider, however, there was no dose selected. When the pharmacist received the order in his queue to be verified before dispensing, he noted the dose field and administration volume field were blank and input an available package size of 100 mL that the Sodium Chloride could be dispensed from. According to Staff F, all other ingredients for the custom fluid order included a dose and administration volume. The pharmacist did not know that by inputting 100 mL in the dispense amount field, Sodium Chloride would be added to the custom fluids. During an interview on 07/03/25 at 4:00 PM, Staff F, the pharmacy manager and Staff G stated the pharmacist did not clarify the unclear order with Neonatal Nurse Practitioner I nor did he/she seek a second opinion from a second clinical pharmacist. The pharmacist verified the order two different times as the facility requires dual medication verification by two clinical pharmacists prior to dispensing medication. The custom fluids were compounded and administered to the infant on 05/18/25 at 7:55 PM. It was discovered that 100 mL of Sodium Chloride was administered. During an interview on 07/07/25 at 2:00 PM, Staff H, the pharmacist, stated that he worked in the pharmacy on 05/18/25 from 3:00 PM - 11:30 PM. He received the order for the custom fluids and noted there was no order dose or administration dose. The fields were completely blank. Sodium Chloride was outlined in red indicating a hard stop. A medication order can’t be verified when there is a hard stop. Staff H stated that there was a hard stop due to there being no order dose or administration dose. He also stated that it was the first time he had ever seen a hard stop with intravenous fluids. Staff H stated he did not think the order needed clarification and did not seek a second opinion from another pharmacist. During an interview on 07/07/25 at 1:00 PM, Staff J stated she placed the order for custom fluids that erroneously contained Sodium Chloride. She denied being contacted by the pharmacy to clarify the order. Staff J stated that if a pharmacist had contacted her for clarification, she would’ve advised him to delete the Sodium Chloride as it was not her intent to administer Sodium Chloride to Patient #2. The facility policy titled “Questionable Medication Orders” effective January 2014, stated medications are not dispensed from the pharmacy until the pharmacist has all information needed to make well-informed and clinically appropriate decisions. It is the pharmacist’s responsibility to clarify unclear or questionable orders (unusual dose, frequency, route, etc) prior to verifying/dispensing the medications. It is appropriate for the pharmacist to seek a second opinion from another pharmacist. If the order remains unclear or questionable, the pharmacist must clarify the medication order with the ordering provider prior to verifying/dispensing the medication. The unclear order will be clarified in the provider’s order section in the electronic medical record (EMR) by the provider or by the pharmacist as a verbal order from the provider.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 28999 Based on medical record review, facility policy review, and staff interview, the facility failed to ensure staff responded to a patient reported sexual assault. This affected one (Patient #2) out of 10 patients reviewed. Findings include: Review of the medical record of Patient #2 revealed she presented to the emergency department (ED) via squad on 01/02/25 at 9:46 PM with complaints of being suicidal. A triage note at 10:04 PM stated the patient denied both suicidal ideation and homicidal ideation, stating she was crying when she called 911 and they misunderstood her. She stated she called due to chest pain, which was gone, and she wanted to go home. A nurse’s note at 10:29 PM stated the patient reported a recent admission to a psychiatric facility after a suicide attempt. The patient reported she had been sexually assaulted at the psychiatric facility. She stated that she was feeling suicidal the day prior due to thinking about the sexual assault and the chest pain was due to anxiety. The medical record lacked documentation the patient’s report of sexual assault was investigated. The ED attending physician’s note stated the patient denied suicidal and homicidal ideation. She otherwise had no acute medical complaints and was discharged via a medical Uber at 11:37 PM. Review of the facility policy titled “Reported Sexual Assault,” effective 02/1998, stated both sexual assault and sexual abuse refer to any act of sexual contact or conduct performed upon one person by another and without the mutual consent. The procedure outlined in the policy advised staff to assess every patient, every visit in the ED. The CARES Coordinator Department/ Services, with a sexually assaulted patient should contact the on-cal CARES nurse for an evaluation and treatment. The policy revealed the the ape/sexual assault patient is viewed as a priority. The survivor is given privacy as soon as possible. The policy states to refer the patient to the Emergency Department Collection of Forensic Evidence Guideline. Interview on 04/15/25 at 5:00 PM, ED Manager, Staff C, confirmed the medical record lacked documentation the patient’s report of sexual assault at an outside hospital was reported to the CARES Coordinator Department as required by facility policy.”