Health inspection·December 2, 2021

F761 §483.45 §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. §483.45(h) Storage of Drugs and Biologicals §483.45(h)(1) In accordance with State and Federal laws, the facility must store all drugs and biologicals in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys. §483.45(h)(2) The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected. § 72369. Pharmaceutical Service -Controlled Drugs. (a) Drugs listed in Schedules II, III and IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 shall not be accessible to other than licensed nursing, pharmacy and medical personnel designated by the licensee. Drugs listed in Schedule II of the above Act shall be stored in a locked cabinet or a locked drawer separate from noncontrolled drugs unless they are supplied on a scheduled basis as part of a unit dose medication system. (b) Separate records of use shall be maintained on all Schedule II drugs. Such records shall be maintained accurately and shall include the name of the patient, the prescription number, the drug name, strength and dose administered, the date and time of administration and the signature of the person administering the drug. Such records shall be reconciled at least daily and shall be retained at least one year. If such drugs are supplied on a scheduled basis as part of a unit dose medication system, such records need not be maintained separately. (c) Drug records shall be maintained for drugs listed in Schedules III and IV of the above Act in such a way that the receipt and disposition of each dose of any such drug may be readily traced. Such records need not be separate from other medication records. §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 10/22/2021, an unannounced visit was made to the facility to investigate a Facility-Reported Incident (FRI) about quality of care and treatment. The facility failed to safeguard controlled medications (scheduled II medications that cause physical and mental dependence), as indicated in the facility's Controlled Medications policy and procedure, for Residents 1 and 2, by: 1. Allowing Registered Dietitian (RD), an unauthorized staff, access to the drawer where the controlled medications for Residents 1 and 2 were kept. 2. Licensed Vocational Nurse 1 (LVN 1) not having control of the keys to the Medication Cart (Med Cart #2) where controlled medications for Residents 1 and 2 were kept. As a result, on 10/21/2021 at 11:17 am, after LVN 1 left the Med Cart # 2 keys unsupervised, RD took the keys, opened the controlled medication drawer, and took nine tablets of oxycodone-acetaminophen (a Schedule II narcotic used to treat moderate to severe pain) 5/325 (combination of 5 milligrams [mg] of oxycodone and 325 mg of acetaminophen) prescribed to Resident 1 and three tablets of hydrocodone-acetaminophen (Schedule II narcotic medication used to treat moderate to severe pain) 5/325 mg (5 mg of hydrocodone and 325 mg of acetaminophen) prescribed to Resident 2. A review of Resident 1's Admission Record indicated the resident was admitted to the facility on 9/25/2021 with diagnoses including above the knee amputation (surgical removal of part of the body, such as an arm or leg). A review of Resident 1's Physician’s Order dated 9/25/2021, indicated to administer the resident oxycodone-acetaminophen tablet 5-325 mg, one tablet by mouth every four hours as needed for moderate generalized pain. A review of Resident 1's Medication Count Sheet for oxycodone-acetaminophen 5-325 mg dated on 9/25/2021, indicated there were 25 tablets remaining. A review of Resident 2's Admission Record indicated the resident was admitted to the facility on 10/12/2021with diagnoses including peripheral neuropathy (weakness, numbness, and pain from nerve damage, usually in the hands and feet). A review of Resident 2's Physician’s Order dated 10/12/2021, indicated to give the resident hydrocodone-acetaminophen 5-325 mg, one tablet by mouth every four hours as needed for severe generalized body pain. A review of Resident 2's Medication Count Sheet for hydrocodone-acetaminophen 5-325 mg dated 10/12/2021, indicated there were 12 tablets remaining. A review of the Medication Disposition Log dated 10/21/2021, indicated Resident 1 had nine missing tablets of oxycodone-acetaminophen 5-325 mg, and Resident 2 had three missing tablets of hydrocodone-acetaminophen 5-325 mg. During an interview on 10/22/2021 at 12:08 pm, LVN 1 stated she was assigned to Med Cart #2 on 10/21/2021. LVN 1 stated she counted the narcotic medication and received the keys to the cart and the narcotic drawer at the beginning of her shift at 7AM. At around 2 pm, she discovered the keys were missing. LVN 1 did not know how long she did not have the keys in her possession. LVN 1 stated the last time she used the keys was around 11 am. LVN 1 found the keys on top of Med Cart #2 on at 2:10 pm. LVN 1 asked LVN 3 to recount with her the narcotic medications and nine tablets of oxycodone-acetaminophen 5/325 prescribed to Resident 1 were missing along with three tablets of hydrocodone-acetaminophen 5/325 mg prescribed to Resident 2. During an interview on 10/22/2021 at 12:53 pm, Registered Nurse Supervisor (RN Sup) stated only the assigned medication nurses had access to their assigned medication carts and narcotic keys until endorsement to the next shift. RN Sup stated the narcotic keys should stay with the licensed nurse throughout the shift for safety to maintain the integrity of the narcotic count and prevent unauthorized access to the medication cart. During an interview on 10/22/2021 at 2:43 pm, the administrator (ADM) stated a review of the surveillance video footage showed RD accessing Med Cart #2. ADM stated he retrieved from RD the missing tablets for Residents 1 and 2. ADM stated RD admitted taking the missing medications. On 10/22/2021 at 5:17 pm and 5:25 pm, the Surveyor tried to contact RD by but the calls were not answered. A review of the facility's policy and procedures titled, "Controlled Medications" dated 7/2020, indicated separately locked, permanently affixed compartments for storage of controlled drugs and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored was minimal and a missing dose could be readily detected. Only authorized licensed nursing and pharmacy personnel had access to controlled medications. Access key to controlled medications was not the same key giving access to other medications. The licensed nurses maintained possession of the key to controlled medication storage areas. The facility failed to safeguard controlled medications, as indicated in the facility's Controlled Medications policy and procedures, for Residents 1 and 2, by: 1. Allowing RD, an unauthorized staff, access to the drawer where the controlled medications for Residents 1 and 2 were kept. 2. LVN 1 not having control of the keys to Med Cart #2 where controlled medications for Residents 1 and 2 were kept. As a result, on 10/21/2021 at 11:17 am, after LVN 1 left the Med Cart # 2 keys unsupervised, RD took the keys, opened the controlled medication drawer, and took nine tablets of oxycodone-acetaminophen 5/325 prescribed to Resident 1 and three tablets of hydrocodone-acetaminophen 5/325 mg prescribed to Resident 2. These violations jointly, separately, or in any combination, had a direct or immediate relationship to the health, safety, or security of Residents 1 and 2.