Other·May 2, 2024

State Title 22, § 72369. Pharmaceutical Service -Controlled Drugs. (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. § 72371. Pharmaceutical Service -Disposition of Drugs. (c) Patient's drugs supplied by prescription which have been discontinued and those which remain in the facility. F755 §483.45 Pharmacy Services §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. An unannounced visit was conducted by California Department of Public Health (CDPH) on 3/19/2024 to investigate a complaint regarding allegation of the pharmaceutical issues. The facility failed to ensure that Licensed Vocational Nurse (LVN) 1 and Registered Nurse (RN) 1 implement the facility ' s policy and procedures titled "Receiving Controlled Substances (controlled medications)," by failing to: 1. Reconcile controlled drug records with valid orders and administration record to detect irregular controlled medications activities and identify inventory discrepancy that occurred after a patient had been discharged from the facility. 2. Accepting a delivery of Norco for Patient 1 after Patient 1 had been discharged from the facility. The facility did not have a record of the physician order that matched the aforementioned delivery. As a result, there was a loss of 38 tablets of Norco (hydromorphone-acetaminophen, a narcotic or controlled medications, a potent opioid to treat pain) 10-325 milligrams (mg, an unit to measure mass) for Patient 1. These deficient practices may have led to the loss or diversion of Patient 1 ' s controlled drug, Norco. On 3/19/2024 at 9:50 AM, during an interview, the director of nursing (DON) stated on 3/4/2024 around 11 AM, LVN 4 inquired whether the licensed nurse of the previous shift had turned in the controlled medications (Norco) of Patient 1 who had been discharged from the facility. The DON stated during that time, no licensed staff had turned in Patient 1's-controlled medication for disposition. A review of Patient 1’s admission record indicated patient, a 65 years old male Admission Record who was admitted to the facility on 2/29/2024. A review of the facility clinical census indicated Patient 1 who’s alert and orientated was admitted and discharged from the facility on 2/29/2024, with diagnosis of but not limit to respiratory failure (a serious condition that makes it difficult to breathe on your own.), diabetes II (a condition that happens because of a problem in the way the body regulates and uses sugar as a fuel.) As of the date of onsite visit, Patient 1 had not returned or readmitted to the facility. A review of Patient 1 ' s physician order dated 2/29/2024 timed at 7:42 AM, indicated to give Norco oral tablet 10/325 mg, 1 tablet by mouth "one time only" for severe pain (8 to 10). A review of Patient 1 ' s Progress Notes (dated 2/29/2024 timed at 2:40 PM) indicated a change in condition had occurred. This note indicated while Patient 1 ' s attending physician (MD) was at the facility, Patient 1 was experiencing shortness of breath and was transferred to the general acute care hospital (GACH) on 2/29/24. On 3/19/2024 at 10 AM, during an interview with the DON, and a concurrent review of Patient 1 ' s "Individual Narcotic Record," for the hydrocodone-acetaminophen 10-325 mg (also known as Norco) indicated five tablets had been taken out of the inventory for administration from 2/29/2024 through 3/1/2029. The DON stated Patient 1 was discharged to the GACH on 2/29/2024 at around 2 PM. The Individual Narcotic Record indicated the following information: · 1 tablet removed on 2/29/2024 at 4 PM · 1 tablet removed on 2/29/2024 at 10 PM · 1 tablet removed on 3/1/2024 at 8 AM · 1 tablet removed on 3/1/2024 at 3:45 PM · 1 tablet removed on 3/1/2024 at 9 PM During the same interview and record review of Patient 1 ' s Individual Narcotic Record, on 3/19/2024 at 10 AM, the record also indicated there were 38 tablets of Norco to start. Thus, there should be 33 (38 tablets minus 5 tablets) tablets remained in inventory. The DON stated the remaining 33 tablets of Norco were missing. On 3/19/2024 at 10:33 AM, during an interview and concurrent review, the DON presented a copy of the pharmacy delivery receipt for Patient 1's Norco. The delivery receipt indicated the facility ' s pharmacy delivered 38 tablets of Norco, and Registered Nurse (RN) 1 signed the receipt on 2/29/2024 (not timed). The delivery receipt was printed on 2/29/2024 at 7:48 PM. The DON stated the delivery happened after Patient 1 had already been transferred to the GACH and was no longer residing in the facility on 2/29/2024. On 3/19/2024 at 10:51 AM, during an interview, the DON stated she collected all the signatures/initials of the licensed nursing staff to compare with the writings in the Narcotic Records. During a concurrent review of Patient 1 ' s Individual Narcotic Record of Norco, the DON stated the record indicated 5 doses were given at 5 different times. During the review of the licensed staff signatures log, the DON pointed at the writing of those 5 entries and the signatures of the first two entries looked the same, however, the other 3 signatures were somewhat different and did not match any staff ' s signatures on record. The DON stated she compared and interviewed the signatures of the licensed nurses. The DON stated that all licensed nurses with the exception of one licensed vocational nurse (LVN 1), had denied administering and/or signing the narcotic record for Patient 1. The DON stated the signatures on the first two doses (2/29/24 at 4 PM and 2/29/24 at 10 PM) of Patient 1 ' s Norco Individual Narcotic Record was LVN 1's signature. The DON stated she was not able to interview LVN 1 because LVN 1 did not respond to the facility ' s requests for interviews. The DON stated LVN 1 had "abandoned" the position at the facility and LVN 1 had not come back to work at the facility since the incident. A review of LVN 1's payroll record indicated LVN 1 last worked at the facility on 3/2/2024 from 5:12 PM to 11:21 PM. On 3/19/2024 at 12:30 PM, during a review and concurrent interview with the medical record and the DON, the medical record staff stated Patient 1 had one controlled medication (narcotic) order, which was Norco 10/325 mg to be given one tablet one time only, dated on 2/29/2024 at 7:42 AM. During the same interview and review of Patient 1 ' s electronic medication administration record (eMAR) on 3/19/2024 at 12:30 PM, the medical records staff stated that the eMAR indicated LVN 5 administered a single dose of Patient 1 ' s Norco at 8:17 AM on 2/29/2024. The medical record staff confirmed that there was no other order of Norco for Patient 1. During the same interview, the DON stated the physician order of Norco did not indicate why the facility ' s pharmacy would deliver #38 tablets of Norco to the facility. A review of the facility ' s interview statement with LVN 5, dated 3/6/2024 timed at 9 AM, indicated LVN 5 ' s statement that Patient 1 ' s Norco dose given on 2/29/2024 around 9 AM was the only dose she administered for Patient 1. LVN 5 stated the Norco she administered to Patient 1 was taken from the facility ' s emergency drug supplies (EKit) kit. On 3/19/2024 at 1:04 PM, the DON presented a screen shot of a document from the facility ' s pharmacy and stated the facility ' s pharmacist received Patient 1 ' s physician approval on 2/29/2024 at 8:01 AM, to modify Patient 1 ' s Norco from the one-time dose to give one tablet every 4 hours as needed. The DON stated that was the reason why the facility ' s pharmacy delivered 38 tablets of Norco for Patient 1 on 2/29/2024. The DON stated, the facility ' s pharmacy did not notify the facility of the modification of the Norco order. The DON stated the Norco delivery happened after Patient 1 had been transferred out of the facility on 2/29/2024. The DON stated the pharmacy did not inform the facility of Norco ' s order modification. On 3/19/2024 at 1:51 PM during an interview, the DON stated RN 1 received Patient 1's Norco from the pharmacy on 2/29/2024, passed the Norco bubble packs to LVN 1, and witnessed LVN 1 logged Patient 1 ' s Norco inventory in Patient 1 ' s "Individual Narcotic Record." During a concurrent interview, the DON stated the nurse who accepted the controlled medications delivery should check with patients ' physician orders. The DON stated the licensed nurses should not accept the Norco since Patient 1 had already been transferred out of the facility. On 3/19/2024 at 2:06 PM, during a telephone interview, in the presence of the DON, RN 1 stated he did not check Patient 1's order when he received the pharmacy delivery because the GACH had called the facility earlier to discuss Patient 1 ' s possible return to the facility later that evening. The DON stated Patient 1 did not return to the facility. On 3/19/2024 at 2:58 PM, during an interview, LVN 4 stated during a medication pass (administration) preparation on 3/4/2024, for another patient, she flipped through the facility ' s-controlled medications record book and noticed the written note "Pt was in hospital" (dated 3/2/2024) on Patient 1 ' s Norco. LVN 4 stated she checked the controlled medication drawer (the secured compartment of the medication cart) and did not find Patient 1 ' s Norco. LVN 4 stated that was the reason she asked the DON if someone turned in Patient 1's Norco for disposition. LVN 4 also stated during shift count the incoming and out-going nurses would count what were in the controlled medications drawer. LVN 4 could not remember if Patient 1's Norco was part of the shift count. On 3/19/2024 at 4:27 PM, during an interview, the DON stated the pharmacy delivered Patient 1 ' s Norco without notifying the facility of a modified order. The DON stated RN 1 should have declined Patient 1 ' s Norco delivery because Patient 1 had been discharged and the facility did not have an active order for Patient 1. On 3/19/2024 at 4:36 PM, during an interview, DON confirmed the nursing staff did not notice Patient 1 ' s narcotic record for Norco had activities after the patient had been transferred out of the facility. Both Administrator (ADM) and DON acknowledged the facility failed to reconcile Patient 1 ' s Norco with valid order and administration record daily which led to the 38 tablets of Norco not accounted for. A review of the facility policy and procedures, Receiving Controlled Substances (dated February 2020), indicated "Medications included ... classification as controlled substances ... are subject to special ordering, receipt, and recordkeeping requirements by the facility in accordance with federal and state laws and regulations ... Procedures for receiving controlled substances include: ... A nurse reconciles controlled substance orders and refill requests against what has been received from the pharmacy; a nurse notifies the pharmacist if controlled substance orders or doses are missing or incorrect ... Two nurses witness placement of the controlled substances in the secured compartment of the medication cart ..." The facility failed to ensure that Licensed Vocational Nurse (LVN) 1 and Registered Nurse (RN) 1 implement the facility ' s policy and procedures titled "Receiving Controlled Substances (controlled medications)," by failing to: 1. Reconcile controlled drug records with valid orders and administration record to detect irregular controlled medications activities and identify inventory discrepancy that occurred after a patient had been discharged from the facility. 2. Accepting a delivery of Norco for Patient 1 after Patient 1 had been discharged from the facility. The facility did not have a record of the physician order that matched the aforementioned delivery. As a result, there was a loss of 38 tablets of Norco (hydromorphone-acetaminophen, a narcotic or controlled medications, a potent opioid to treat pain) 10-325 milligrams (mg, an unit to measure mass) for Patient 1. These deficient practices may have led to the loss or diversion of Patient 1 ' s controlled drug, Norco. These violations, jointly, separately, or in any combination, had a direct or immediate relationship to the health, safety, or security of patients or residents.