Health inspection·October 11, 2024

F755 §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. 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. (c) Each facility shall establish and implement policies and procedures, including but not limited to: (5) Pharmaceutical services policies and procedures. 22 CCR 72353. Pharmaceutical Service - General. (b) Dispensing, labeling, storage and administration of drugs and biologicals shall be in conformance with state and federal laws. On 8/28/2024, the California Department of Public Health (CDPH) made an unannounced visit to the facility to conduct a facility reported incident investigation regarding pharmaceutical services and quality of care. The facility failed to have a system in place to ensure safeguarding of all prescribed medications (a drug that can be obtained only by means of a physician ' s order) including controlled medications (medications with a high potential for abuse) for Resident 1, Resident 2, and Resident 3, by failing to: 1. Implement its policy and procedure titled, "Medication Dispensing Controlled Substances," that indicated "an inventory count of all Controlled Dangerous Substances (CDS, a drug or chemical whose manufacture, possession, or use is regulated by a government because it may be abused or cause addiction) medications stored in each nursing unit shall be performed at each change of shift. Both the incoming and outgoing nurse on each unit that is responsible for handling the controlled substances will sign the inventory count." 2. Ensure two licensed nurses counted the CDS before and after the nursing shift and signed in the untitled sign-in sheet (form signed by both incoming and outgoing nurse indicating the CDS count was completed) for CDS. The four medication carts' CDS sign in sheets, dated 8/2024, had missing signatures for the following: a. Station 1 Medication Cart (Cart 1) CDS sign in sheet indicated 12 missing signatures. b. Station 1 Middle Medication Cart (Cart 2) CDS sign in sheet indicated 18 missing signatures. c. Station 2 Medication Cart (Cart 3) CDS sign in sheet indicated three missing signatures. d. Station 2 Middle Medication Cart (Cart 4) CDS sign in sheet indicated 18 missing signatures. 3. Account for three CDS on 8/18/2024 at 7:30 a.m. for Residents 1, 2, and 3: a. Resident 1 was missing ten tablets of hydrocodone-acetaminophen (an opioid [a class of drug used to reduce moderate to severe pain] medication used to manage pain) 5-325 milligrams (mg- unit of measurement). b. Resident 2 was missing six tablets of hydrocodone-acetaminophen 5-325 mg. c. Resident 3 was missing four tablets of oxycodone-acetaminophen (a drug used to treat moderate to severe pain) 5-325 mg. 4. Ensure medication carts and cabinets that contained controlled medications and other medications, were maintained locked, when not in use to prevent unauthorized access to medications that included non-controlled medications for Cart 4. The facility failed to provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biological) for Resident 1, Resident 9 and Resident 10, by failing to: 5. Ensure Resident 1 was medicated with hydrocodone-acetaminophen (medication used to treat pain) on 7/21/2024 at 6:30 a.m. and 7/28/2024 at 9:00 p.m. when LVN 1 and LVN 2 took hydrocodone-acetaminophen from Resident 1 ' s Controlled Drug Inventory (a document used to document and track the administration of controlled substances). 6. Ensure Resident 9 was medicated with hydrocodone-acetaminophen on 8/21/2024 at 2:00 a.m. and 8/22/2024 at 9:30 a.m., when LVN 2 and LVN 5 took hydrocodone-acetaminophen from Resident 9 ' s Controlled Drug Inventory. 7. Ensure Resident 10 was medicated for pain with hydrocodone-acetaminophen on 8/17/2024 at 10:00 a.m., when LVN 16 took hydrocodone-acetaminophen from Resident 10 ' s Controlled Drug Inventory. As a result, the facility had a wide system failure to secure, accurately account for and reconcile controlled medications for Residents 1, 2, and 3 and placed Residents 1, 2, and 3 at risk for medication errors, to receive more or less medication than prescribed, adverse reactions (harmful or unpleasant reaction, resulting from an intervention related to the use of a medication) such as falls, hospitalizations, harm, and inability to readily identify the loss or drug diversion (illegal distribution of abuse of prescription drugs or their use for unintended purposes) of controlled medications. Resident 1, Resident 9, and Resident 10 were placed at risk for uncontrolled pain management. A review of Resident 1 ' s Admission Record indicated the facility admitted Resident 1, a 63-year-old male, on 6/28/2024 with diagnoses that included multiple fractures (broken bone) of ribs on the right side, liver cell carcinoma (a disease in which malignant (cancer) cells form in the tissues of the liver), and pressure ulcer (injuries to skin and underlying tissue resulting from prolonged pressure on the skin) of the right elbow and sacral region (a triangular-shaped bone at the bottom of the spine). A review of Resident 1 ' s Minimum Data Set (MDS - a standardized assessment and care screening tool), dated 7/4/2024, indicated Resident 1's cognitive (mental action or process of acquiring knowledge and understanding) skills for daily decisions were intact. The MDS indicated Resident 1 had received scheduled and as needed pain medications. The MDS indicated Resident 1 received non-medication intervention for pain. A review of Resident 1 ' s Physician Orders, dated 6/28/2024, the Physician Orders indicated to assess for pain every shift and chart intensity of pain using one to ten numeric pain scale (a pain scale from zero [0] to 10, where 10 is the worst possible pain). A review of Resident 1 ' s Physician Orders, dated 7/17/2024, indicated to administer hydrocodone-acetaminophen 5-325 mg tablet, give one tablet by mouth every six hours as needed for severe pain (pain rated at eight to 10, on a pain scale). A review of Resident 2 ' s Admission Record indicated the facility admitted Resident 2, a 68-year-old male, on 8/23/2021 with diagnoses that included end stage renal disease (the kidneys cease functioning on a permanent basis), type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar [glucose]), and chronic obstructive pulmonary disease (COPD - a lung disease characterized by long term poor airflow). A review of Resident 2 ' s Physician Orders, dated 9/1/2023, indicated to administer hydrocodone-acetaminophen 5-325 mg tablet every six hours as needed for severe pain. A review of Resident 2 ' s MDS, dated 7/29/2024 indicated the resident ' s cognitive skills for daily decisions were intact. The MDS indicated Resident 2 received non-medication intervention for pain. A review of Resident 3 ' s Admission Record indicated the facility admitted Resident 3, an 82-year-old female, on 2/7/2024 with diagnoses that included type 2 diabetes mellitus, essential hypertension (an abnormally high blood pressure that was not a result of a medical condition), and gastro-esophageal reflux disease (a condition in which stomach acid repeatedly flows back up into the tube connecting the mouth and stomach [esophagus]). A review of Resident 3 ' s Physician Orders, dated 12/15/2023, the Physician indicated to administer oxycodone-acetaminophen 5-325 mg tablet every four hours as needed for severe pain. A review of Resident 3 ' s MDS, dated 7/29/2024 indicated the resident ' s cognitive skills for daily decisions were moderately impaired. The MDS indicated Resident 3 received scheduled pain medication regimen. A record review of the facility-provided Investigation Letter, dated 8/21/2024, indicated that on 8/18/2024 at 7:30 a.m., Resident 1, Resident 2, and Resident 3 had missing medications as follows: a. Resident 1 was missing ten tablets of hydrocodone-acetaminophen 5-325 mg. b. Resident 2 was missing six tablets of hydrocodone-acetaminophen 5-325 mg. c. Resident 3 was missing four tablets of oxycodone-acetaminophen 5-325 mg. During a concurrent observation and interview on 8/28/2024 at 9:51 a.m., Cart 4 was observed locked, however, the third left drawer remained unlocked. The third medication drawer had residents' (multiple residents) prescribed medications in it. Licensed Vocational Nurse 3 (LVN 3) stated she noticed the medication cart ' s third drawer was not locking since 8/26/2024. LVN 3 stated she did not report the medication cart drawer that was not locking to the Director of Nursing (DON) because she (LVN 3) thought the other licensed nurses had reported it. LVN 3 stated unlocked medication carts were a hazard and had the potential for other residents, facility staff, and visitors to take the medications and overdose (taking more than the recommended amount of medication). During a concurrent interview and record review on 8/28/2024 at 10:11 a.m., with LVN 5, the Station 1 CDS sign in sheet dated 8/2024 was reviewed. The Station 1 CDS sign in sheet indicated there were no signatures on 8/17/2024 (3:00 p.m. to 11:00 p.m.) outgoing shift and 8/18/2024 (7:00 a.m. to 3:00 p.m.) incoming shift. LVN 5 stated signatures of the licensed nurses on the CDS sign in sheet indicated the licensed nurse worked that day and counted the CDS with another licensed nurse. LVN 5 stated CDS sign in sheet that were not signed had a potential for CDS medications to be lost and not accounted for. During a concurrent interview and record review on 8/28/2024 at 11:20 a.m., with the DON, the Controlled Drug Inventory (a physical count of all quantities of each federal controlled substance) for Resident 1, Resident 2, and Resident 3 were reviewed. The DON stated Resident 1 had ten tablets of hydrocodone-acetaminophen 5-325 mg that were missing. The DON stated Resident 2 had six tablets of hydrocodone-acetaminophen 5-325 mg that were missing. The DON stated Resident 3 had four tablets of oxycodone 5-325 mg that were missing. The DON stated the licensed medication nurse was the only person that had the medication cart and the CDS drawer keys. The DON stated the medication cart and CDS drawer keys were given to the next licensed medication nurse after the CDS count. During a phone interview on 8/29/2024 at 10:54 a.m. with LVN 2, LVN 2 stated that she (LVN 2) came to work late for the 11:00 p.m. to 7:00 a.m. shift on 8/17/2024. LVN 2 stated LVN 1 and Registered Nurse 1 (RN 1) informed her that Cart 1 CDS count was done. LVN 2 stated she (LVN 2) did not count the CDS during her shift on 8/17/2024. LVN 2 stated RN 1 had possession of the Cart 1 and CDS drawer keys when RN 1 assisted with resident (unnamed) care. LVN 2 stated she (LVN 2) counted the CDS with LVN 15, the 7:00 a.m. to 3:00 p.m. medication nurse for 8/18/2024, at the end of LVN 2 ' s shift. LVN 2 stated during the CDS count, LVN 1 and LVN 2 identified a total of three residents (Residents 1, 2, and 3) with missing CDS medications. LVN 2 stated each resident (Residents 1, 2, and 3) had one bubble pack of CDS missing. During a phone interview on 8/29/2024 at 11:18 a.m. with LVN 1, LVN 1 stated she (LVN 1) worked the 3:00 p.m. to 11:00 p.m. shift on 8/17/2024 and was assigned at station 1. LVN 1 stated LVN 2 arrived late (time not indicated) in the facility. LVN 1 stated RN 1 refused to count the CDS with her and informed her to wait for LVN 2. LVN 1 stated she counted the Cart 1 CDS without another licensed nurse as witness. LVN 1 stated RN 1 was near the Cart 1 but was not actively involved on the CDS count. LVN 1 stated she (LVN 1) should have counted the CDS with another licensed nurse. LVN 1 stated RN 1 gave LVN 1 permission to sign out for her shift and leave the facility after LVN 1 informed RN 1 that the CDS count was complete. During a concurrent interview and record review on 8/29/2024 at 1:03 p.m. with the DON, the policy titled, "Medication Dispensing Controlled Substances," last reviewed on 4/4/2024, was reviewed. The DON stated that she (DON) did not complete a controlled substance loss form per facility policy. During a phone interview on 8/29/2024 at 1:10 p.m. with RN 1, RN 1 stated that on 8/17/2024, he (RN 1) saw LVN 1 flipping the pages of the CDS logbook, but RN 1 did not see LVN 1 count the Cart 1 CDS. RN 1 stated he saw LVN 2 at the station 1 hallway and thought LVN 1 and LVN 2 counted the station 1 CDS. RN 1 stated LVN 1 and LVN 2 did not ask him (RN 1) for assistance on counting the CDS. RN 1 stated he did not have possession of the Cart 1 and CDS drawer keys on 8/17/2024 and 8/18/2024. RN 1 stated on 8/18/2024 at 7:30 a.m., he was informed that one CDS bubble pack was missing. RN 1 stated he witnessed LVN 2 and LVN 15 count the CDS and identified a total of three missing bubble packs of CDS. RN 1 stated he instructed the facility staff to perform a search for the missing CDS inside resident rooms, facility bins, and trash cans. RN 1 stated on 8/18/2024 at 7:45 a.m., RN 1 reported the missing CDS to the DON via text message. RN 1 stated the missing CDS were not found. RN 1 stated as an RN supervisor, he (RN 1) was responsible for checking and making sure two licensed nurses completed and signed the CDS count. During a follow up interview on 8/29/2024 at 4:32 p.m. with the DON, the DON stated Resident 1, Resident 2, and Resident 3 were not assessed and monitored for pain after identifying the missing CDS. A record review of the four medication carts' (Cart 1, Cart 2, Cart 3, Cart 4) CDS sign in sheets, dated 8/2024, indicated Cart 1 CDS sign in sheet had 12 missing signatures. The Cart 2 CDS sign in sheet indicated 18 missing signatures. The Cart 3 CDS sign in sheet indicated three missing signatures. The Cart 4 CDS sign in sheet indicated 18 missing signatures. During a follow up interview on 8/30/2024 at 1:49 p.m. with the DON, the DON stated that LVN 1 and LVN 2 should have counted the CDS with another licensed nurse or with RN 1, who was present and working in the facility on 8/17/2024 and 8/18/2024. The DON stated that missing CDS would be considered a drug diversion. The DON defined drug diversion as medications that can be used for other than what they were intended for. The DON stated that licensed nurses were informed that CDS sign in sheet should be signed before and after the CDS count. The DON stated that the CDS sign in sheet with missing signatures should not be filled with signatures on a later date. The DON stated the facility failed to follow the policy and procedure on accounting for all the CDS every change of shift. A review of the facility's policy and procedure (P&P) titled, "Medication Dispensing Controlled Substances," last reviewed in 4/4/2024, indicated the controlled Dangerous Substances are handled by the facility in a manner that promotes proper storage, security, and compliance with applicable State and Federal regulations. The P&P indicated the DON is designated by the facility to be responsible for the control of such drugs. The P&P indicated an inventory count of all CDS medications stored on each nursing unit shall be performed at each change of shift. Both the incoming and outgoing nurse on each unit that is responsible for handling the controlled substances will sign the inventory count. The Loss of a Controlled Dangerous Substance section of the policy indicated the facility will complete a report of theft or loss of controlled substances form. A review of Resident 1's Controlled Drug Inventory for hydrocodone-acetaminophen dated 7/2024 indicated