Other·March 13, 2024

F761 Code of Federal Regulations, Title 42, Section §483.45(g) Labeling of Drugs and Biologicals Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable. California Code of Regulation Tittle 22 Section 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. California Code of Regulation Tittle 22 Section 72355. Pharmaceutical Service - Requirements. (a)Pharmaceutical service shall include, but is not limited to, the following: (2) Dispensing of drugs and biologicals. (3) Monitoring the drug distribution system which includes ordering, dispensing and administering of medication. (4) Provision of consultative and other services furnished by pharmacists which assist in the development, coordination, supervision, and review of the pharmaceutical services within the facility. Code of Federal Regulations, Title 22, Section 72371 Required Services. (c) Patient's drugs supplied by prescription which have been discontinued and those which remain in the facility after discharge of the patient shall be destroyed by the facility in the following manner: California Code of Regulation, Title 22, Section 72357 Pharmaceutical Services – Labeling and Storage of Drugs. (b) All drugs obtained by prescription shall be labeled in compliance with state and federal laws governing prescription dispensing. No person other than the dispenser of the drug shall alter any prescription label. (n)Discontinued drug containers shall be marked, or otherwise identified, to indicate that the drug has been discontinued, or shall be stored in a separate location which shall be identified solely for this purpose. Discontinued drugs shall be disposed of within 90 days of the date the drug order was discontinued, unless the drug is reordered within that time. On 1/22/2024 at 10:48 am. the California Department of Public Health (CDPH, the Department) conducted an unannounced recertification survey. The Department determined the facility failed to: 1a. Maintain accurate acquiring, receiving, dispensing, and administering all routine medications for Resident 26. 1b. Properly label Resident 26's insulin glargine pen (long-acting insulin [hormone that regulates blood sugar] that keeps blood sugar levels stable during periods of fasting) in Medication Cart (Med Cart) 3. 2. Dispose an expired Epi-Pen (life-saving medication to treat a severe allergic reactions) in Med Cart 1. 3. Properly label and store the discontinued medications or medications of discharged residents in a designated locked area. As a result of these failures, Resident 26’s did not receive the 9 am medication on 1/24/2024 timely. These failures also had the potential for Resident 26s well-being to decline due to missed medications and possible drug diversion (transfer of a resident's prescribed medication to another individual) related to unaccounted medications, medication administration errors and/or drug diversions due to improper medication labeling and storage. 1a. A review of Resident 26's Admission Record (AR), indicated the facility admitted an 81-year-old female, on 3/13/2021 with multiple diagnoses including stroke (brain damage due to blocked blood flow to the brain) with hemiplegia (paralysis of one side of the body) and muscle atrophy (reduced muscle mass due to lack of muscle use), type 2 diabetes mellitus (chronic condition wherein body does not produce enough or resists insulin [hormone that regulates blood sugar]) with long-term use of insulin, and colon cancer (growth of malignant cells in the lower end of the digestive tract). A review of Resident 26's Minimum Data Set (MDS, a standardized resident assessment and care-planning tool), dated 10/31/2023, indicated Resident 26 had severely impaired cognitive skills (ability to acquire and understand information) for daily decision-making. The MDS indicated Resident 26 had impairment in both sides of her upper and lower extremities. The MDS indicated Resident 26 was dependent on staff with eating, oral hygiene, toileting hygiene, showering, dressing, putting on/taking off footwear, and personal hygiene. The MDS indicated Resident 26 had an abdominal feeding tube (gastrostomy tube, tube inserted through the abdomen to bring nutrition directly to the stomach). A review of Resident 26's physician (MD) orders for 1/2024, the MD orders indicated the following: a. Order Date: 12/29/2023 - Insulin glargine solution (long-acting insulin that keeps blood sugar levels stable during periods of fasting) 100 units/milliliters - Inject 30 units subcutaneously (under the skin) two times a day for DM type 2 - Hold for blood sugar (BG) < 60 and call MD, Call for BG > 300. b. Order Date: 12/29/2023 - Insulin aspart (rapid-acting insulin taken before meals that works quickly to prevent blood sugar from going too high after carbohydrates intake) - Inject as per sliding scale (151-200 = 1 unit; 201-250 = 2 units; 251-300 = 3 units; 301-350 = 4 units; 351-400 = 5 units subcutaneously two times a day for diabetes; 400 and above = Give 6 units and call MD. If BS < 60, give 1-gram intramuscular (IM) Glucagon (medication to treat low blood sugar). c. Order Date: 12/29/2023 - Hydroxyzine hydrochloride (HCl) (antiallergy medication to alleviate itching) 50 milligrams 1 tablet via GT three times a day for itching. d. Order Date: 1/12/2024 - Zinc Sulfate (mineral that promotes skin health) oral tablet 220 milligrams via GT one time a day for wound healing for 21 days. 1b. During a concurrent observation and interview on 1/24/2024 at 9:15 a.m. with Licensed Vocational Nurse 1 (LVN 1), LVN 1 stated the insulin aspart, Hydroxyzine, and Zinc Sulfate were missing from the medication cart and were not available to be administered for the scheduled 9 a.m. administration. The insulin glargine pen had a label with the pharmacy dispense date 11/21/2023, manufacturer's expiration date 11/30/2025, and a handwritten Date Opened (with a marker) 11/3/2024. LVN 1 stated she would discard the insulin glargine in the medication cart because the Date Opened was inaccurate. LVN 1 stated she would obtain a new insulin glargine pen from the Medication Room refrigerator. During a concurrent observation and interview on 1/24/2024 at 10:18 a.m. with LVN 1, LVN 1 prepared Resident 26's 9 a.m. scheduled medications via GT. LVN 1 stated she would hold the insulin glargine at this time since the insulin glargine pens available in the Medication Room refrigerator were not individually labeled with Resident 26's name. LVN 1 stated the pharmacy regularly delivers the medications, but the licensed nurse could call the pharmacy if determined that there were a few doses left. During a concurrent observation and interview on 1/24/2024 at 10:53 a.m. with LVN 1, LVN 1 administered Resident 26's 9 a.m. scheduled medications via GT, except for the insulin glargine, insulin aspart, Zinc sulfate, and Hydroxyzine. LVN 1 stated the medications must be administered within least 1 hour before or 1 hour after of the scheduled administration time (that is, for 9 a.m. scheduled medications - must be administered between 8 a.m. - 10 a.m.) During an interview on 1/25/2024 at 6:27 p.m., the Director of Nursing (DON) stated, after multiple requests to obtain the Pharmacy Records for Resident 26's medications, she did not have the Pharmacy Receipts for the insulin glargine, insulin aspart, Zinc Sulfate, and Hydroxyzine. The DON stated the delivery receipts were important for the accounting of all the medications delivered to and received by the facility to ensure Resident 26 had all the medications available for administration as ordered. The DON stated the medications must be reordered by the licensed nurse about 3 days before it runs out, so the treatment of the resident (in general) was not interrupted. During a review of the facility's policy and procedures, titled "Pharmacy Hours and Delivery Schedule (undated)," the P&P indicated the administrator, director of nursing, and dispensing pharmacy must establish a daily delivery and pick-up schedule for medication orders. In addition, during a review of the facility's policy and procedures, titled "Prescriber Medication Orders (undated)," the P&P indicated the following: a. The prescriber must be contacted for direction when the medication would not be available. b. To ensure complete documentation and receipt of medications, any orders must be clarified as necessary; entered on a medication order form; and medication order/s must be called, faxed, or electronically transferred to the provider pharmacy. 2. During a concurrent observation and interview on 1/25/2024 at 3:47 p.m. with the Director of Nursing (DON), a box of Epi-Pens was observed inside the 2nd drawer of Medication Cart 1 with an expiration date of 11/2022. The DON stated the box of Epi-Pens were "house supply," and should be discarded in the Medication Room due to decreased [medication] effectiveness and to avoid the use of expired medication during an emergency. 3. During a concurrent observation and interview on 1/25/2024 at 3:54 p.m. with the DON, a box of non-controlled medications in blister packs were observed on the floor in the DON's office. The DON stated the blister packs were discontinued medications or medications of discharged residents, but the medications were not labeled "discontinued." The DON stated the DON did not have a log to indicate all discontinued medications "given to her [the DON]," but the DON placed them [non-controlled medications in blister packs] in the DON's office for destruction. During a review of the facility's P&P, titled "Procedures for All Medications (undated)," the P&P indicated medications must be administered in a safe and effective manner. The P&P indicated when opening a multi-dose container, the date must be placed on the container and the expiration date must be checked. The P&P indicated medication label must be read before administering the medication. During a review of the facility's P&P, titled "Storage of Medications (undated)," the P&P indicated the following: Medications must be stored safely, securely, and properly. 2.Outdated, contaminated, or deteriorated medications and those in containers that are cracked, soiled, or without secure closures must be immediately removed from stock, disposed of according to procedures for medication disposal, and reordered from the pharmacy if a current order exists. During a review of the facility's P&P, titled "Discontinued Medications (undated)," the P&P indicated the following: a. When medications are expired, discontinued by a prescriber due to a resident's transfer, discharge, or resident's death, the medication container/s must be marked as "discontinued" with the date it was discontinued and stored in a separate location designated solely for this purpose and later destroyed. b. Medications awaiting disposal or return must be stored in a locked secure area designated for that purpose until destroyed. c. Medications must be removed from the medication cart or storage area prior to expiration and immediately upon receipt of an order to discontinue. During a review of the facility's P&P, titled "Medication Destruction (undated)," the P&P indicated the following: a. All discontinued medications and medications left in the facility after a resident's discharge must be destroyed. b. All medications must be placed in the proper waste container per facility policy. The facility must maintain a contract with a waste disposal company specifying pick-up and disposal procedures. c. Non-controlled medication destruction must occur in the presence of two licensed nurses. d. The medication disposition form must be kept on file in the facility for 3 years. As a result of the investigation, the Department determined the facility failed to ensure, The Department determined the facility failed to: 1a. Maintain an accurate acquiring, receiving, dispensing, and administering all routine medication for Resident 26. 1b. Properly label Resident 26's insulin glargine pen in Med Cart 3. 2. Dispose an expired Epi-Pen in Med Cart 1. 3. Properly label and store the discontinued medications or medications of discharged residents in a designated locked area. As a result of these failures, Resident 26 did not receive the 9 am medication on 1/24/2024 timely. These failures also had the potential for Resident 26’s well-being to decline due to missed medications and possible drug diversion related to unaccounted medications, medication administration errors and/or drug diversions due to improper medication labeling and storage. The above violation, jointly, separately, or in any combination, had a direct or immediate relationship to the health, safety, or security of Resident 26 and other residents in the facility.