Other·September 1, 2021

T22 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. F755 -K §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(g). 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 The facility failed to provide pharmacy services, have safeguards and systems in place for the control, accountability, and reconciliation of controlled medications by failing to: 1. Reconcile and account for the use of Methadone (a Schedule II controlled substance [medications with a high potential for abuse]) among licensed nurses prior to the start/end of their working shift to conduct the narcotic counts (a physical inventory of all controlled medications, including the emergency supply, is conducted by two licensed nurses) and document on the facility's controlled medication accountability record for Residents 25 on controlled drugs to prevent diversion [stealing prescription medicines or controlled substances such as opioids for their own use] or accidental misuse and exposure of the controlled drug medication in accordance with the facility's policy. 2. Create a "Controlled Drugs Count" sheet (medication accountability record or an inventory log for controlled substances [CS] -medications which had a potential for abuse that may also lead to physical or psychological dependence) when receiving the CS Methadone liquid bottles (medication packaging system that contains individual doses of medication per bottle) dispensed by the Methadone Clinic Dispensing Pharmacy every Fridays since November 2020, for Resident 25 in one of two inspected Medication Carts. 3. Ensure the dosage in Resident 25's Methadone liquid's pharmacy label was checked for the correct dosage as indicated in the physician's order and the Medication Administration Record (MAR) prior to administration, for Resident 25 to prevent underdosing or overdosing of the medication. 4. Accurately document the medication administration of Resident 25's Methadone liquid in the facility and at the Methadone Clinic for Resident 25 who receives medication dispensed outside the facility's own pharmacy to ensure proper dosage of medication is being given to the resident in accordance with the physician's order. These failures had the potential to impact Resident 25 who was receiving Methadone, a controlled drug medication with the increased risk for drug diversion, misuse, and had the potential for the resident to not receive the dosage amount of controlled drug as ordered by the physician. 1. A review of Resident 25's Admission Record indicated the resident was a 63 year-old male, admitted to the facility on 8/17/20 with diagnoses that included other symptoms and signs involving the musculoskeletal system (a general term which relates to the muscles and the skeleton of the body), anxiety (a mental condition characterized by excessive apprehensiveness and worries ), Hepatitis C (a viral infection contracted only through direct contact with the blood of a person infected with the Hepatitis C virus), and long-term use of opiate analgesic (highly addictive narcotic medication used to relieve pain from a variety of conditions). A review of Resident 25's Minimum Data Set (MDS; a care area screening tool and assessment) dated 2/12/21, indicated the resident's cognition (the process of thinking) was intact, and required supervision (oversight, encouragement or cueing) during activities of daily living (walking, dressing, bed mobility, dressing, eating). A review of Resident 25's History and Physical dated 7/12/21, indicated the resident had the capacity to understand and make decisions. A review of Resident 25's Physician Orders recapped (summarized) for the months of December 2020, January 2021, February 2021, March 2021, April 2021, May 2021, June 2021, and July 2021 indicated an order dated 11/25/2020 for the resident to receive Methadone 120 mg, 1 bottle liquid by mouth every day for opioid (synthetic narcotics that provides pain relief and can be highly addictive) abuse. A review of Resident 25's Medication Administration Record for the months of November 2020 (from 11/25/20 to 11/30/20), December 2020, January 2021, February 2021, March 2021, April 2021, May 2021, June 2021, and July 2021 indicated signature initials for the Methadone 120 mg, from the facility's licensed nurses every day, including Fridays except for 6/4/21 (Friday). The Nurses Medication Notes found at the back of the June 2021 MAR indicated that on 6/4/21 timed at 6 AM, the Methadone liquid was not available, and Resident 25 would be picking up the medications. A review of Resident 25's Care Plan Description dated 11/25/20, indicated the resident had a history of substance abuse and had been taking Methadone since admission (8/17/20). The care plan goal indicated the resident would exhibit acceptable behavior as evidenced by not having alcohol/drugs hidden in the room. The interventions included for nursing to administer medications as ordered and monitor for side effects of Methadone 120 mg daily for opioid use (drugs to treat moderate to severe pain but can cause long lasting side effects and addiction). The interventions also indicated Resident 25 would go to the Methadone Clinic for counselling (no dates indicated) and that the Methadone Clinic would be providing the medication that will be kept in a lock box and to be kept by the facility in the narcotic drawer. The care plan did not indicate that the facility's licensed nurses would only administer the Methadone liquid at the facility from Saturday to Thursday and the Methadone Clinic would administer the last dose every Friday. On 7/14/21 at 11:05 AM, during an inspection of Station 1's Medication Cart A's narcotic drawer with Licensed Vocational Nurse (LVN) 1, an unlabeled cloth handbag with an attached lock and key was found inside the narcotic drawer. Inside the handbag were six 3.5-inch, opaque plastic bottles. One out of the six plastic bottles contained a quarter-full of pink liquid medication and the remaining five bottles were observed empty. The label on the six bottles indicated Resident 25's name and the medication name and dose of, "110 milligrams (mg), Methadone" (physician's order is for 120mg). During a concurrent interview, LVN 1 stated Resident 25 brings the liquid Methadone into the facility from an outside dispensing clinic and the licensed nurses in the facility administers the medication to the resident. On 7/14/21 at 11:30 AM, during an interview, LVN 1 stated the facility did not keep a controlled medication accountability record of Resident 25's Methadone liquid since 11/2020. LVN 1 stated Resident 25 goes to the Methadone Clinic every Friday and picks up six bottles of Methadone for the facility staff to administer to the resident. LVN 1 stated the facility did not keep a controlled medication accountability record of Resident 25's Methadone liquid because the medications were not dispensed from the facility's own pharmacy. LVN 1 stated the licensed nurses signs out the Methadone liquid administration in Resident 25's MAR as administered. LVN 1 stated without a controlled medication accountability record, the licensed nurses would not be able reconcile the controlled drug in the narcotic counts that is typically conducted every shift change. LVN 1 further stated that without a controlled medication accountability record, the facility would not be able to account for any controlled medications that may be missing. During the same interview, on 7/14/21 at 11:30 AM, LVN 1 stated the licensed nurses administers the Methadone liquid to Resident 25 every day during the nightshift at 6 AM except Fridays. LVN 1 stated the facility receives only six bottles of Methadone liquid because Resident 25 would receive the 7th dose at the Methadone Clinic on Fridays. On 7/14/21 at 1:57 PM, during an interview, the DON stated since 11/20, the Methadone Clinic dispensed Resident 25's Methadone liquid, while the facility staff administered the medication. The DON stated the licensed nurses had been administering the Methadone liquid to Resident 25, "the same way" (From Saturday to Thursday) since 11/2020. The DON stated that Resident 25's Methadone liquid should be accounted for in the facility's-controlled medication accountability record. A concurrent review and interview with the DON and Resident 25's medical record and controlled accountability records binder indicated no documented evidence the resident's Methadone liquid had been accounted for and reconciled since 11/2020 up to July 14, 2021. The DON stated that Resident 25's Methadone medication should have been counted as part of the narcotics-controlled medication count per facility policy because Methadone is a controlled substance. On 7/14/21 at 3 PM, during an interview, LVN 3 stated Methadone was not included as part of the controlled drugs count. LVN 3 stated she only counted and checked the narcotics that was indicated in the facility's Narcotic binder, where the facility put all controlled drugs count sheets. LVN 3 stated the licensed nurses had to go through each narcotic medication located inside the narcotic drawer and compare it with the count sheets with another nurse at the beginning and end of work shift to account for all the resident’s narcotics. On 7/14/21 at 3:47 PM, during an interview, Resident 25 stated, "I'm always in pain." Resident 25 stated he receives two pain medications in the facility (Dilaudid [narcotic medication] and Methadone). Resident 25 stated he goes to the Methadone clinic every Fridays unaccompanied by facility staff. Resident 25 stated a driver from a transport van takes him to the Methadone Clinic. On 7/14/21 at 3:55 PM, during an interview, the Director of Staff Development (DSD) stated the Methadone clinic used to provide the facility with the dispensing logs and the nurse would sign the logs each day to account for the use of Resident 25's Methadone liquid. DSD stated he could not recall when the Methadone Clinic had stopped providing the dispensing logs. The DSD stated the facility could not find documented evidence of the dispensing logs from the Methadone clinic that was provided to the facility several months ago because the facility did not keep copies of the dispensing logs. On 7/14/21 at 4 PM, during a concurrent observation and interview, the DON opened the Methadone bottle containing the quarter-full pink colored liquid medication. The DON verified the Methadone bottles were not sealed and there were no level markings on all 6 of the Methadone bottles for accountability during physical inventory (narcotics count) as required for every shift. The DON stated that Resident 25's Methadone was administered in the facility by the night shift licensed nurses from Saturday through Thursday at 6 AM. The DON stated Resident 25 received the 7th dose in the Methadone clinic every Friday. On 7/14/21 at 4:05 PM during a concurrent interview and review of Resident 25's MAR, the DON stated Resident 25's July MAR indicated the order for Methadone 120 mg and Methadone bottle label indicated 110 mg. The DON stated and confirmed the facility's licensed nurses' signature initials on Resident 25's MAR for the administration of Methadone every day (Saturday through Friday). The MAR indicated the facility's licensed nurses was also signing the MAR as administered on Fridays (7/2/21 and 7/9/21). The DON stated the licensed nurses should not be signing the MAR for the Methadone administration on Fridays because it was not administered by the facility's licensed nurses in the facility. The DON was unable to give an explanation as to why the licensed nurses were signing off as administering the medication on Fridays when it should have been administered at the Methadone clinic. On 7/14/21 at 4:12 PM, during a telephone interview, the facility's Pharmacy Consultant (PC) 1 stated she was not aware that Resident 25 was bringing Methadone into the facility that was being dispensed from a Methadone Clinic. PC 1 stated, "The facility should have a recorded controlled count sheet like any other controlled medication. The facility should be keeping a record even if Resident 25 was getting his medication dispensed at the Methadone clinic, either by requesting one from the clinic or by creating their own." On 7/15/21 at 7:07 AM, during a concurrent interview and review of Resident 25's July 2021 MAR, LVN 4 stated she signed the resident's MAR for Methadone administration on Fridays from 7/2/21 and 7/9/21, even if she did not administer the Methadone. LVN 4 was unable to explain as to why she signed off administering the medication to the resident when she did not administer it. LVN 4 stated she was used to signing for the Methadone administration every day, even Fridays. LVN 4 stated there were no instruction or clear directions on how to handle and account for Resident 25's Methadone medication. On 7/16/21 at 10:31 AM, during an interview, the administrator stated the facility did not know when the Methadone medication order was changed from 120 mg to 110 mg by the Methadone Clinic physician (Physician 2). The administrator stated the Methadone 120 mg dose was ordered by Resident 25's attending physician (Physician 1) based on the dispensing logs that the facility used to receive from the Methadone Clinic. The administrator stated the Methadone Clinic did not notify the facility that the dose of the Methadone was changed from 120 mg to 110 mg. The administrator stated the Methadone Clinic stopped providing the facility the medication dispensing logs, since the start of November 2020 where it indicated the number of Methadone liquid bottles and corresponding doses dispensed to Resident 25. The administrator could not provide documented evidence that the facility had followed up and coordinated with the Methadone clinic when it stopped providing the Methadone dispensing logs to the facility. On 7/16/21 at 11:05 AM, during an interview, LVN 1 stated that before a licensed nurse administers a medication, the licensed n