Health inspection·March 13, 2025

§483.45 Pharmacy Services The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in §483.70(f). The facility may permit unlicensed personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse. §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. §483.45(b) Service Consultation. The facility must employ or obtain the services of a licensed pharmacist who-- §483.45(b)(1) Provides consultation on all aspects of the provision of pharmacy services in the facility; §483.45(b)(2) Establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation; and §483.45(b)(3) Determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled. 22 CCR §72523. Patient Care Policies and Procedures. (a) Written patient care policies and procedures shall be established and implemented to ensure that patient related goals and facility objectives are achieved. On 1/21/2025, the California Department of Public Health (CDPH) conducted an unannounced visit at the facility to investigate a complaint and facility-reported-incident regarding missing narcotics (a medication or substance that in moderate doses dulls the senses, affects mood or behavior, relieves pain and induces sleep). The facility failed to have a system-wide (something that extends or exists throughout a system) method of accountability for controlled medications (drugs that are regulated by the government because it may be abused or cause addiction) and ensure safeguarding of controlled medications for Resident 1 and Resident 2 by: 1. Failing to ensure licensed nurses document the administration of controlled substances in Resident 1’s electronic Medication Administration Record (eMAR- an electronic report detailing the drugs administered to a resident). 2. Failing to maintain records on the transfer of controlled medications from licensed nurses to the Director of Nursing (DON) after Resident 1 was discharged, and after the controlled medications were no longer in use and were cleared for disposition (process of returning and/or destroying unused medications). 3. Failing to ensure the DON investigate all discrepancies related to Resident 1’s and Resident 2’s controlled medication reconciliation (process of comparing a resident’s medication orders to all the medications that the resident has been taking) to determine the cause of the missing controlled medications. 4. Failing to ensure the DON reported Resident 1’s and Resident 2’s missing controlled medications to the Administrator (ADM). As a result, the facility was not able to account for 43 doses of Norco (a controlled medication used to treat moderate to severe pain) 5-325 milligrams (mg – unit of measure) belonging to Resident 1 and was not able to account for the exact amount of Oxycodone-Acetaminophen (generic name for Percocet, a controlled medication used to treat moderate to severe pain) 5-325 mg belonging to Resident 2. The failure to maintain a system to ensure accountability of controlled medications increased the risks of diversion (when a medication is taken for use by someone other than whom it is prescribed or for an indication other than what is prescribed) of medications, staff working in an impaired state (weakened or imperfect condition that results in a loss of function or ability), or accidental exposure of controlled medications to the residents possibly resulting in respiratory depression (inability to breathe) leading to hospitalization and death. a. A review of Resident 1’s Admission Record indicated the facility originally admitted Resident 1, a 57-year-old female, to the facility on 8/29/2024 and re-admitted on 10/7/2024 with diagnoses including malignant neoplasm (a cancerous tumor [mass of abnormal cells that form in the body]) of unspecified part of the left lung, asthma (a chronic lung disease that causes inflammation and narrowing of the airways, making breathing difficult), and anxiety disorder (a mental health condition that involves excessive fear and worry that interferes with daily life). A review of Resident 1’s Minimum Data Set (MDS - a resident assessment tool), dated 12/2/2024, indicated Resident 1 had intact cognition (the mental action or process of acquiring knowledge and understanding through thought, experience, and the senses). Resident 1 required maximum assistance from staff with lower body dressing and moderate assistance with toileting hygiene, shower or bathing, upper body dressing and personal hygiene. A review of Resident 1’s Physician’s Orders, dated 9/20/2024, timed at 7:22 a.m., indicated an order for Norco 5-325, give one tablet by mouth every six hours as needed for severe pain (pain rated seven to ten, using the pain scale as a tool to measure and describe the intensity of pain, using numbers from zero [no pain] to ten [worst possible pain]). A review of the document titled, “Leaving Facility Against Medical Advice,” indicated Resident 1 left the facility against medical advice (AMA – a situation where a resident leaves a healthcare facility or discontinues treatment against the advice of their physician) on 1/21/2025 at 9:30 a.m. During an interview on 1/27/2025 at 12:34 p.m. with Licensed Vocational Nurse 1 (LVN 1), LVN 1 stated a physician’s order is required for the resident to be discharged with the controlled medication. LVN 1 stated that the Controlled Medication Count Sheet (a form used to account for all controlled medications, and to transfer accountability from the out-going nurse to the on-coming nurse) will be signed by two licensed nurses and would then release the remaining controlled medication doses to the resident or resident’s responsible party. LVN 1 further stated that if a resident is to be discharged and the controlled medications are not to be released with the resident, the Controlled Medication Count Sheet will be signed by two licensed nurses and will then be handed off to the DON, who would also sign the Controlled Medication Count Sheet and will conduct a count of the remaining controlled medication confirming the medication, the dose, and the total amount removed from the medication cart given to the DON for disposal (discarding or destroying unused medications that remain after the end of medical treatment) or destruction. LVN 1 stated that the DON had informed her that “in this facility, we do not have to do that”. LVN 1 stated that “the DON just asks for it (referring to discontinued controlled medications or controlled medications for discharged residents).” LVN 1 was asked how licensed nurses can prove the controlled medications are no longer in the medication carts if there is no signature proof it was provided to the DON, LVN 1 replied, “There would be no evidence we turned in the controlled medications to the DON.” During an interview on 1/28/2025 at 1:17 p.m. with Licensed Vocational Nurse 2 (LVN 2), LVN 2 stated, “The DON would come around asking if there are controlled medications to be removed from our medication carts. I have only worked here in this facility, but the previous DON never went around asking for our discontinued or discharged controlled medications.” LVN 2 stated, “If a resident is discharged, we normally give the discharged controlled medications to the DON. We (licensed nurses) don’t sign anything. The DON has never asked us to sign a form that indicated we are handing off the discharged controlled medications to her.” LVN 2 further stated that “Controlled medications can impair the person, like being under the influence, be drowsy (sleepy) or lethargic (having little energy), affecting judgment and decision making. Controlled medications can slow or stop breathing and ultimately cause someone to pass away. It is very dangerous if handled incorrectly. That is why we have the two locked system. The DON has access to a master key. For us (licensed medication nurses), we have two separate keys to access the medication cart. One key is to open the main medication cart, the second key is to open the controlled medication drawer (part of the medication cart located on the side). The DON has access to a key that can open both medication cart and controlled medication drawer with just one key. I don’t feel safe that someone has that key in the facility.” During a phone interview on 1/28/2025 at 2:20 p.m. with Pharmacist 1 (PD 1), from the facility’s contracted pharmacy, PD 1 stated that there were 30 tablets of Norco 5-325 mg delivered to the facility for Resident 1 on 9/20/2024, 26 tablets of Norco 5-325 mg delivered to the facility for Resident 1 on 10/6/2024, 30 tablets of Norco 5-325 mg delivered to the facility for Resident 1 on 10/16/2024, and, lastly, 26 tablets of Norco 5-325 mg were delivered to the facility for Resident 1 on 11/18/2024, for a total of 112 tablets of Norco 5-325 mg delivered to the facility for Resident 1’s pain management needs as ordered. During a concurrent observation and record review on 1/28/2025 at 2:47 p.m., observed Resident 1’s bubble pack (a form of tamper-evident packaging where an individual pushes individually sealed tablets through the foil to take the medication) for Norco 5-325 mg, located in Medication Cart 1, where Resident 1’s medications were stored, and the Controlled Medication Count Sheet for Resident 1 was reviewed. The observed bubble pack for Resident 1’s Norco 5-325 mg and Controlled Medication Count Sheets indicated there were only ten tablets of Norco 5-325 mg under the name of Resident 1 that were found in the medication cart. During an observation on 1/29/2025 at 11:10 a.m., a facility-wide search for Resident 1’s missing Norco 5-325 mg tablets was initiated on all nursing medication carts (total of 6 medication carts) and nursing medication rooms (total of 2 medication rooms) at both facility’s nursing stations. Resident 1’s Norco 5-325 mg were not found. There were 43 doses of Norco 5-325 mg belonging to Resident 1 that are missing and unaccounted for. During a concurrent interview and record review on 1/29/2025 at 12:09 p.m., with the DON, Resident 1’s eMARs, from 9/20/2024 to 1/21/2025 were reviewed. The DON stated Resident 1 had an order on 9/20/2024 for Norco 5-325 to be given every six hours as needed for management of severe pain. The DON stated Resident 1 received a total of five doses of Norco 5-325 mg for 9/2024. The DON stated Resident 1 received a total of 54 tablets of Norco 5-325 mg during 10/2024, with the last dose administered to Resident 1 on 10/22/2024 at 12:17 p.m. The DON stated a total of 112 tablets were delivered by the pharmacy to the facility, with a total of 59 tablets recorded as administered to Resident 1 and ten tablets remaining in the medication cart. The DON stated a total of 43 tablets of Norco 5-325 remained missing. The DON stated the last disposal or destruction of controlled medications with Consulting Pharmacist 1 (CP 1) was on 1/8/2025. The DON stated Resident 1 was discharged from facility on 1/21/2025, and confirmed Resident 1’s controlled medications were not inside the DON’s office even with Resident 1’s discharge date happening after the controlled medication destruction date of 1/8/2025. When the DON was asked if the ADM was informed of the missing controlled medications, the DON stated the ADM was not made aware and that there was no investigation started regarding the missing controlled medications. During a concurrent interview and record review on 1/30/2025 at 7:44 a.m., with Licensed Vocational Nurse 3 (LVN 3), Resident 1’s eMARs, from 9/20/2024 to 1/21/2025 and Controlled Drug Records (Controlled Medication Count Sheet) were reviewed. LVN 3 stated, “Most residents know what medications they have, such as Norco. So, I check when the controlled medication was last administered, then I prepare the controlled medication, sign the controlled medication count sheet, then administer the medication to the resident. I then document on the eMAR that it was administered.” LVN 3 further stated that Resident 1’s eMAR and Controlled Drug Records indicated a total of 10 doses of Norco 5-325 mg that was dispensed by LVN 3, but not recorded as administered to Resident 1 on the eMAR. LVN 3 stated, “I was failing to document the administration of the controlled medication.” During an interview on 1/30/2025 at 7:52 a.m., with RN 1, RN 1 stated, “I think there is a lack of training in the facility. The LVNs (licensed vocational nurses in general) think that by signing the Controlled Medication Count Sheet, it is equal to administering the controlled medication itself. They (LVNs) don’t realize that the count sheet only counts the remaining controlled medications, but they (LVNs) would still need to sign the eMAR to prove the controlled substance was administered to the resident.” b. A review of Resident 2’s Admission Record indicated the facility originally admitted Resident 2, a 91-year-old male, to the facility on 9/13/2016 and re-admitted on 2/8/2022 with diagnoses including hypertensive urgency (a medical condition in which a person’s blood pressure is very high), osteoarthritis of hip (a degenerative disease that causes cartilage in the hip joint to wear away, causing pain and stiffness), and depression (a mental health condition that involves persistent feelings of sadness, hopelessness, and loss of interest in activities). A review of Resident 2’s Physician’s Order, dated 2/8/2022, timed at 9:12 p.m., indicated an order for Oxycodone-Acetaminophen 5-325 mg, give one tablet by mouth twice a day as needed for moderate to severe pain. A review of Resident 2’s MDS, dated 1/9/2025, indicated Resident 2 had moderate cognitive impairment. During an interview on 1/29/2025 at 3:20 p.m., with Licensed Vocational Nurse 4 (LVN 4), LVN 4 stated that on 1/2/2025, while counting the controlled medications with Licensed Vocational Nurse 5 (LVN 5), the controlled medications (Oxycodone-Acetaminophen 5-325 mg) of Resident 2 were missing. LVN 4 stated she (LVN 4) was informed by LVN 5 that in the morning (7 a.m. to 3 p.m.) shift, the DON had asked for the keys to the medication cart from LVN 5. LVN 4 stated in the afternoon of that same day (1/2/2025) that she (LVN 4) was in a meeting when the DON had called her (LVN 4) to step out and was handed Resident 2’s missing Oxycodone-Acetaminophen 5-325 mg. LVN 4 stated that Resident 2’s bubble packet for Oxycodone-Acetaminophen 5-325 mg only contained 16 tablets when LVN 4 recalled there were over 20 tablets of Resident 2’s Oxycodone-Acetaminophen 5-325 mg just the day before (1/1/2025). LVN 4 stated she (LVN 4) witnessed the DON returned the Controlled Medication Count Sheet and noticed it was in handwritten form with the DON’s handwriting. LVN 4 stated she took pictures of the incident. LVN 4 stated, “No, there is no form that she (DON) has us sign when we give her the discharged residents’ controlled medications, so there is no proof that the staff (LVNs) even gave the controlled medications to the DON.” LVN 4 stated she (LVN 4) called the facility’s pharmacy on 1/2/2025 at around 3:30 p.m. and confirmed the DON ordered more Oxycodone-Acetaminophen 5-325 mg for Resident 2. LVN 4 stated having days off in between, then she (LVN 4) returned to work on 1/5/2025, only to notice Resident 2’s delivered Oxycodone-Acetaminophen 5-325 mg controlled medications were now missing (total amount of missing tablets unknown). During an interview on 1/30/2025 at 11:24 a.m., with LVN 5, LVN 5 stated on 1/2/2025 in the morning shift (7 a.m. to 3 p.m.), the DON had borrowed the keys to the Medication Cart 5 (containing Resident 2’s medications). LVN 5 stated during the change of shift with the 3 p.m. to 11 p.m. shift nurse (LVN 4), LVN 5 was asked by LVN 4 on where Resident 2’s Oxycodone-Acetaminophen 5-325 mg medications were. LVN 5 stated feeling panicked, but that was when another LVN (Licensed Vocational Nurse 6 [LVN 6]) wor