Other·December 11, 2025

F726 §483.35 Nursing Services The facility must have sufficient nursing staff with the appropriate competencies and skills sets to provide nursing and related services to assure resident safety and attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, as determined by resident assessments and individual plans of care and considering the number, acuity and diagnoses of the facility's resident population in accordance with the facility assessment required at §483.71. §483.35(a)(3) The facility must ensure that licensed nurses have the specific competencies and skill sets necessary to care for residents' needs, as identified through resident assessments, and described in the plan of care. §483.35(a)(4) Providing care includes but is not limited to assessing, evaluating, planning and implementing resident care plans and responding to resident's needs. §483.35(d) Proficiency of nurse aides. The facility must ensure that nurse aides are able to demonstrate competency in skills and techniques necessary to care for residents' needs, as identified through resident assessments, and described in the plan of care. The facility failed to ensure nursing staff had the specific competencies necessary to assure Resident 1's safety, or to care for Resident 1's needs as identified by Resident 1's diagnosis of mucormycosis (severe, invasive fungal infection caused by molds from the mucormycetes group) and physician order for amphotericin B liposomal, a formulation-specific anti-fungal. This failure is evidenced by: 1. The facility's use of a nonspecific and unverifiable competency assessment framework, as demonstrated by the Nursing Comprehensive Clinical Competency Review Skills Checklist which relies on a single checkbox for "administration and monitoring of IV fluids and medications" to represent competency across all skills required for administering IV (intravenous) medications and fluids, failed to disaggregate and record specific proficiencies for each staff member including but not limited to medication reconciliation and medication reconstitution. 2. RN (Registered Nurse) 3's deficient training and skill set in the following specific competencies necessary to assure the safety of Resident 1's receipt of amphotericin B liposomal: a. Medical reconciliation, as evidenced by the lack of documented competency in this skill and failure to verify the physician's order despite recognizing the discrepancy between the dispensed medication and the ordered formulation b. Identification of formula specific medications, as evidenced by inability to distinguish amphotericin B liposomal from standard amphotericin B, despite nontrivial differences in formulation, dosing, and administration protocols c. Safe administration of a therapeutic dose of amphotericin B, as evidenced by RN 3's lack of experience and unfamiliarity with the appropriate reconstitution, safe dosing, infusion rate, and monitoring protocols, and by his administering amphotericin B to Resident 1 at a concentration higher than the recommended ratio, at two to three times the recommended rate of infusion, in an amount triple the recommended maximum for a single dose d. Safe administration of a therapeutic dose of amphotericin B liposomal, as evidenced by RN3's unfamiliarity with the appropriate reconstitution, safe dosing, infusion rate, and monitoring protocols specific to amphotericin B liposomal, and failure to recognize the clinical significance of the acknowledged disparity between the physician's order and the dispensed medication e. Reconstituting IV medications, as evidenced by absence of documentation for RN3's training or competency in this skill which was not separately assessed in the facility's competency checklist. The facility's failure to ensure that nursing staff possessed the specific competencies required for safe IV medication administration including formulation recognition, medication reconciliation, and reconstitution protocols, created conditions under which a medication error that was a substantial factor in the resident's death occurred. RN 3's inability to distinguish amphotericin B liposomal from conventional amphotericin B, combined with a lack of training in safe dosing and infusion practices, substantially and directly contributed to the death of Resident 1. Findings: a. Review of the facility's P&P (Policy and Procedure) titled Intravenous Therapy dated 2/2020 showed it is the policy of the facility to provide the administration of intravenous fluids and medications according to the physician's orders. Under the Procedures section, it showed to prepare the IV medications or IV fluids according to the pharmacy instructions. Review of the Nursing Comprehensive Clinical Competency Review Skills Checklist for RN 3 dated 8/1/24, did not show if RN 3 was trained or signed off as competent with the reconstitution of IV medications. In addition, the Nursing Comprehensive Clinical Competency Review Skills Checklist used for the RNs in the facility did not include the reconstitution of IV medications as one of the competencies the RNs must be trained and/or competent with. b. Review of the manufacture's package insert for the amphotericin B (NDC 36822-1055-5; medication delivered by the pharmacy), received from Pharmacy 1, showed to exercise caution to prevent inadvertent amphotericin B for injection overdose, which can result in potentially fatal cardiac or cardiopulmonary arrest. The package insert showed under the Dosage and Administration section: CAUTION: Under no circumstances should a total daily dose of 1.5 mg/kg (milligrams per kilograms) be exceeded. In addition, the package insert showed amphotericin B should be administered under close clinical observation by medically trained personnel. Closed medical record review for Resident 1 was initiated on 9/25/25. Resident 1 was admitted to the facility on 9/5/25, and expired at the facility on 9/7/25. Review of Resident 1's Acute Care Hospital Discharge Summary Notes dated 9/5/25, showed Resident 1 had diagnoses including mucormycosis (severe, invasive fungal infection caused by molds from the mucormycetes group) and respiratory failure. The discharge summary notes also showed the resident had a tracheostomy (surgical procedure that creates an opening in the neck and into the windpipe to allow a tube to be inserted for breathing) and was ventilator dependent (requires mechanical ventilation). Under the Infectious Disease section of the discharge summary notes showed Resident 1 was to receive AmBisome 5 mg/kg medication until 9/6/25. Review of Resident 1's Physician's Order dated 9/6/25 at 1921 hours, showed to administer amphotericin B liposomal (AmBisome - brand name) 350 mg in dextrose (sterile solution used to provide the body with extra water and carbohydrates) 5 % 250 ml (milliliters) IV at 125 ml/hr (milliliters per hour) and to be given over two hours one time for mucormycosis. Review of Pharmacy 1's Proof of Prescription Delivery (undated) showed on 9/6/25 at 2052 hours, seven vials of amphotericin B 50 mg were received by RN 3. Review of the facility's log of pharmacy deliveries for September 2025 showed on 9/6/25 at 2052 hours, the amphotericin B 50 mg Vial and dextrose 5 %-water IV solution (solution for the amphotericin medication to be mixed in) was delivered to RN 3. Review of Resident 1's IV MAR (Medication Administration Record) for September 2025 showed the amphotericin B liposomal (AmBisome) 350 mg in dextrose 5% 250 ml IV was administered to Resident 1 on 9/7/25 at 0038 hours, by RN 3. On 10/7/25 at 1450 hours, an interview and concurrent closed medical record review was conducted with RN 3. When RN 3 was shown Resident 1's physician's order for the amphotericin B liposome (AmBisome) on the IV MAR, RN 3 verified he administered the amphotericin B that was delivered by Pharmacy 1 and not the amphotericin B liposomal (AmBisome) that was ordered by the physician. RN 3 verified this was the first time he had ever given the amphotericin B medication and did not realize there was a difference between the two medications. RN 3 stated the verbiage on the packaging of the amphotericin B he received from Pharmacy 1 did not match the verbiage on the resident's physician's order written on the IV MAR. RN 3 stated the labeling on the outside of the amphotericin B packaging delivered by Pharmacy 1 showed in red font: Amphotericin B should not be given at dosages greater than 1.5mg/kg. Resident 1's weight was 69.5 kg (kilograms). RN 3 stated he did not double check and compare the dosage warnings on the amphotericin B packaging against the resident's physician's order on the IV MAR. RN 3 stated he did not research the medication prior to administering it to Resident 1 but stated he should have double checked. RN 3 also stated he had never been trained on how to administer amphotericin B products, or how to reconstitute and prepare IV medications. On 10/9/25 at 0926 hours, an interview was conducted with DON (Director of Nursing). The DON stated she expected the licensed nurses to look up a medication they have not administered before. On 10/9/25 at 1602 hours, an interview was conducted with RN 2. RN 2 stated a pharmacy consultant had observed her during her first medication administration, but the facility had not observed her or signed her off when she had to reconstitute the IV medications. On 10/9/25 at 1653 hours, an interview was conducted with the Administrator and Clinical Consultant. When the Administrator and Clinical Consultant were asked regarding RN 3 and the other RNs not trained and signed off for the reconstitution of IV medications, the Clinical Consultant verified the RN staff should have been trained and signed off for competency prior to reconstituting IV medications. The Clinical Consultant stated the facility would conduct training regarding the reconstitution of IV medications for the RNs in the facility. Cross reference F755.

F755 §483.45 Pharmacy Services The facility must provide routine and emergency drugs and biologicals to its residents... §483.45(a) Procedures. A facility must provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident. (d) Unnecessary drugs-General. Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used- (1) In excessive dose (including duplicate drug therapy); (f) Medication errors. The facility must ensure... (2) Residents are free of any significant medication errors. The facility failed to provide pharmaceutical services, including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologics to meet the needs of each resident, as evidenced by the facility's failure to implement procedures to verify that the medication dispensed matched the physician's order, resulting in the administration of amphotericin B to Resident 1 instead of the prescribed amphotericin B liposomal, at an inappropriately high concentration and rate, and amount at triple Resident 1's maximum single weight-based dose. 1. The facility failed to ensure each resident's drug regimen be free from unnecessary drugs, defined as a drug used in excessive dose, when Resident 1 received amphotericin B at triple the recommended single dose based on weight, constituting an excessive and clinically inappropriate use as evidenced by the following events: a. Pharmacy 1 dispensed 350 mg of amphotericin, instead of 350 mg of amphotericin B liposome, as ordered by Resident 1's physician. b. Pharmacy 1 dispensed a 250 ml bag of D5W (intravenous solution of 5% dextrose in water), intended for use with the amphotericin B liposomal, instead of the 3500 ml for the dispensed amphotericin B medication to be reconstituted properly to the correct concentration. c. The facility administered the amphotericin B 350 mg via IV infusion at a rate 2-3 times the recommended rate of administration. d. Resident 1 received three times the maximum single dose based on weight of amphotericin B, at a rate 2-3 times the recommended rate of administration, and at a concentration higher than the manufacturer's recommended. 2. The facility failed to ensure residents are free of significant medication errors, when Resident 1 received an anti-fungal agent not ordered by the physician, at a clinically unsafe concentration, infusion rate, and dosage. Based on the available evidence and findings, CDPH (California Department of Public Health) has determined that the facility's medication error is a substantial factor in Resident's 1 rapid and catastrophic clinical deterioration and subsequent death, as evidenced by within hours of receiving the concentrated overdose of the incorrect medication known to have substantial risk for cardiac and metabolic toxicity, Resident 1 was found pulseless during routine a vitals check and following unsuccessful resuscitation was pronounced dead. Findings: Review of the facility's P&P titled Intravenous Therapy dated 2/2020 showed it is the policy of the facility to provide intravenous fluids and medications according to the physician orders. Additionally, the P&P showed to follow the five rights of medication administration. Review of the manufacture's package insert for the amphotericin B (NDC 36822-1055-5; medication delivered by the pharmacy), received from Pharmacy 1, showed to exercise caution to prevent inadvertent amphotericin B for injection overdose, which can result in potentially fatal cardiac or cardiopulmonary arrest. The package insert showed under the Dosage and Administration section: CAUTION: Under no circumstances should a total daily dose of 1.5 mg/kg be exceeded and the intravenous infusion should be given over a period of approximately 2-6 hours. Rapid intravenous infusion has been associated with hypotension (low blood pressure), hypokalemia (low levels of potassium in the blood), arrythmias (abnormal heart rhythm, which could lead to sudden cardiac arrest) and shock (a life-threatening medical condition that occurs when the body's organs and tissues do not receive enough blood flow and oxygen) and should, therefore, be avoided. In addition, the package insert showed that the amphotericin B medication should be administered under close clinical observation by medically trained personnel. On 9/12/25, CDPH, L&C Program (California Department of Public Health, Licensing and Certification Program) received a complaint from Family Member 1 alleging Pharmacy 1 dispensed the amphotericin B medication that was different from Resident 1's discharge order from Acute Care Hospital 1. Family Member 1 alleged on 9/6/25, amphotericin B (NDC 39822-1055-05) was ordered by Resident 1's physician and at approximately 2300 hours on 9/6/25, the amphotericin B medication was delivered to the facility. The licensed nurse then administered the medication to the resident, however, shortly after the infusion began, Resident 1's condition rapidly deteriorated and passed away shortly after. Closed medical record review for Resident 1 was initiated on 9/25/25. Resident 1 was admitted to the facility on 9/5/25, and expired at the facility on 9/7/25. Review of Resident 1's Acute Care Hospital Discharge Summary Notes dated 9/5/25, showed Resident 1 had diagnoses including mucormycosis and respiratory failure. The discharge summary notes also showed the resident had a tracheostomy and was ventilator dependent (requires mechanical ventilation). Under the Infectious Disease section of the discharge summary notes showed Resident 1 was to receive the AmBisome 5 mg/kg medication until 9/6/25. Review of Resident 1's Physician's Order dated 9/6/25 at 1921 hours, showed to administer amphotericin B liposomal (AmBisome - brand name) 350 mg in dextrose (sterile solution used to provide the body with extra water an