Other·June 12, 2024

F755 Code of Federal Regulations, Title 42, Section §483.45 Pharmacy Services The facility must provide routine and emergency drugs and biologicals to its patients, 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 patient. §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. California Code of Regulations, Title 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 Regulations, Title 22, Section 72355. Pharmaceutical Service - Requirements. (a) Pharmaceutical service shall include, but is not limited to, the following: (1) Obtaining necessary drugs including the availability of 24-hour prescription service on a prompt and timely basis as follows: (D) Refill of prescription drugs shall be available when needed. (2) Dispensing of drugs and biologicals. (3) Monitoring the drug distribution system which includes ordering, dispensing, and administering of medication On 5/3/2024, the California Department of Public Health (CDPH) conducted an unannounced visit at the facility to investigate a facility reported incident regarding pharmacy services and misappropriation of patient’s/resident’s property. As a result of the investigation, the facility failed to follow its policy and procedures (P&P) on controlled medication storage for one Medication Storage (MS) Rooms (MS Room 1) when: 1. Two licensed nurses were not present when checking the Controlled Substance Two (II) Emergency Kit in MS Room 1 when five tablets of 10/325 milligrams of Percocet and two tablets of 5/325 mg of Percocet were reported missing from the CS II E-kit on 5/1/2024. 2. A discrepancy on Cart 1 Controlled Drug Reconciliation form was not reported to the Director of Nursing (DON) on 4/21/2024. These violations resulted in two tablets of 5/325 mg of Percocet and five tablets of 10/325 mg of Percocet were missing CS II E-kit and had the potential for drug diversion of patients'/residents’-controlled medications. A review of the facility's Manifest: CRVN [facility's name] CAR 01, dated 4/18/2024 timed at 12:15 AM indicated CS II E-kit was replaced, delivered, and received by LVN 5 on 4/18/2024 at 12:12 AM. A review of the facility's Nursing Sign in Sheet (NSIS), dated 4/20/2024, indicated Registry LVN 6 worked at the facility from 11:00 PM to 7:30 AM. The NSIS indicated on 4/30/2024: LVN 2 worked at the facility from 7 AM to 7 PM, LVN 4 worked from 3 PM to 7:30 AM, and LVN 5 worked from 11 PM to 7:30 AM. During an interview on 5/3/2024 at 9:44 AM with the Administrator (Admin), the Admin stated the Admin was made aware by the Registered Nurse Supervisor (RN Sup) 1 of five tablets of 10/325 mg and two tablets of 5/325 mg of Percocet were missing from the CS II E-kit on 5/1/2024. The Admin stated the CS II E-kit's two red tags were cut behind the tag and placed back into the plastic bag to make it look like the CS II E-kit was intact. During an interview on 5/3/2024 at 9:59 AM with RN Sup 1, RN Sup 1 stated RN Sup 1 was made aware of the incident from Licensed Vocational Nurse 5 (LVN 5) the morning of 5/1/2024. RN Sup 1 stated LVN 5 stated the plastic covering for CS II E-kit looked as if someone ripped the bottom very carefully. RN Sup 1 stated at every change of shift, licensed nurses were required to count the controlled medications in the medication carts, check if CS II E-kits were opened, and document the information in the CDR form. RN Sup 1 stated the process needed to be completed by two licensed nurses. RN Sup 1 stated licensed nurses were to physically check if the CS II E-kit was sealed and stated it should not be one nurse to check the CS II E-kit. During a concurrent observation and interview on 5/3/2024 at 10:15 AM with RN Sup 1 in MS Room 1, the original red tags and plastic of the CS II E-kit were observed to be cut. RN Sup 1 stated the plastic was cleanly ripped on the perforated edges. RN Sup 1 stated the red tags were cut carefully and cleanly behind the tag so it would not be visible to staff. RN Sup 1 stated LVN 5 found the plastic flap near the perforated line to be slightly up and opened. During an interview on 5/3/2024 at 10:52 AM with LVN 2, LVN 2 stated LVN 2 worked on 4/30/2024 from 7 AM to 7:30 PM in Station 1. LVN 2 stated LVN 2 did a visual check of the CS II E-kits at the beginning of the shift alone in MS Room 1. LVN 2 stated LVN 2 did not see any discrepancies on the plastic or tags. LVN 2 stated the CS II E-kit was not opened recently and stated if the CS II E-kit was opened there should be a yellow tag. LVN 2 stated LVN 2 did medication reconciliation for the medication cart in Station 1 and gave report to LVN 4 at 7:30 PM. LVN 2 stated LVN 2 did not check the CS II E-kit with LVN 4 on 4/30/2024, and stated it was a usual practice of the facility for only one licensed nurse checking E-kits in MS Room 1. During an interview on 5/3/2024 at 11:45 AM with LVN 4, LVN 4 stated LVN 4 worked on 4/30/2024 in Station 1 from 7 PM to 11 PM, and in Station 3 from 11 PM to 7 AM. LVN 4 stated LVN 4 did medication reconciliation of the medication cart in Station 1 with LVN 2 on 4/30/2024 at 7 PM. LVN 4 stated LVN 4 did a visual check on the E-kits alone in MS Room 1. LVN 4 stated LVN 5 came to relieve LVN 4 at 11 PM and completed the medication reconciliation of the medication cart in Station 1 with LVN 5. LVN 4 stated at around 11:30 PM, LVN 5 asked LVN 4 if LVN 4 opened the CS II E-kit. LVN 4 stated LVN 4 saw the plastic bag covering the CS II E-kit was opened at the perforation line, and two red tags were on the CS II E-kit to look like they were intact. LVN 4 stated LVN 4 and LVN 5 proceeded to count each narcotic medication individually and stated two tablets of 5/325 mg of Percocet and 10/325 mg of Percocet were missing. LVN 4 stated LVN 4 called the pharmacy to ask when the last time the CS II E-kit was replaced and stated the E-kit was replaced on 4/18/2024 and was received by LVN 5. LVN 4 stated, the incident was reported to RN Sup 1 the morning on 5/1/2024. LVN 4 stated it was usually one nurse to check E-kits in MS Room 1. During an interview on 5/3/2024 at 12:25 PM with LVN 5, LVN 5 stated LVN 5 worked on 4/30/2024 from 11 PM to 7 PM. LVN 5 stated LVN 5 counted narcotic medications in the medication cart with LVN 4 in Station 1 at 11 PM. LVN 5 stated at around 11:30 PM, LVN 5 checked E-kits alone in MS Room 1 and saw the plastic of CS II E-kit was opened. LVN 5 stated LVN 5 saw the plastic was ripped from the perforation line and the two red tags were cut from behind. LVN 5 stated LVN 5 called LVN 4 to witness the CS II E-kit and asked LVN 4 if LVN 4 opened the CS II E-Kit. LVN 5 stated LVN 5 and LVN 4 counted the medications in CS II E-kit and stated an entire box ( five tablets) of Percocet 10/325 mg, and two tablets of 5/325 mg were missing. LVN 5 stated LVN 5 placed the CS II E-kit back into the locked cabinet and notified RN Sup 1 the morning of 5/1/2024. LVN 5 stated from 4/18/2024 to 4/30/2024 the CS II E-kit was not opened. LVN 5 stated licensed staff were to document if the emergency kits were checked on the CDR form for Cart 1. LVN 5 stated licensed nurses checked the red tags on an E-kit because the unbroken red tags indicated an E-kit had not been opened. LVN 5 stated if the CDR form was not filled out, this was considered a discrepancy. LVN 5 stated one nurse checked E-kits in MS Room 1, and it was usually the incoming nurse. LVN 5 stated not filling out the CDR form indicated staff did not check the E-kit and there was a risk for medications to be taken from the E-kit. During an interview on 5/3/2024 at 1:11 PM with the facility's Pharmacy Consultant (PC), the PC stated the purpose of monitoring CS medications, in particular, Percocet, was due to the medication being an easily addictive medication. The PC stated Percocet was monitored because there was a high risk of misuse which could result in an overdose, decreased respiration, or death. During a concurrent interview and record review on 5/3/2024 at 2:05 PM with RN Sup 1, Cart 1 CDR form dated 4/21/2024 was reviewed. The Cart 1 CDR form indicated a signature for an incoming and outgoing nurse but did not indicate if the emergency box was intact or expired. RN Sup 1 stated Cart 1 CDR form was not filled out and was considered a discrepancy. RN Sup 1 stated if there was a discrepancy on the form, the incoming nurse needed to check the completeness of the form before signing the form. RN Sup 1 stated staff needed to report the discrepancy to the DON and Admin immediately and stated the risk of not filling out the CDR form was that staff would not know if the E-kit was opened or missing medication. During a concurrent interview and record review on 5/3/2024 at 3:06 PM with the DON, the facility's P&P titled, "Controlled Medication Storage" dated 8/2014 was reviewed. The P&P indicated at each shift change a physical inventory of all controlled medications, including the emergency supply, is conducted by two licensed nurses, and is documented on the controlled medication accountability record. The P&P indicated any discrepancy in controlled substances medication counts is reported to the DON immediately. The DON stated staff are not following the P&P if one nurse was checking the CS II E-kit. The DON stated the risk of having one nurse check the CS II E-kit was that there can be a discrepancy or medications can be taken by staff. The DON stated both the outgoing and incoming nurses needed to sign the CDR form at the same time. The DON stated if the form was not filled out, it indicated staff did not monitor the E-kit, During an interview on 5/3/2024 at 3:53 PM with LVN 6, LVN 6 stated LVN 6 worked at the facility on 4/20/2024 from 11 PM to 7 AM. LVN 6 stated LVN 6 did not have any patients with orders for Percocet. LVN 6 stated LVN 6 did not know where the E-kits were placed. LVN 6 stated LVN 6 purposefully left the section of checking the E-kit blank because LVN 6 did not visually see the E-kits. LVN 6 stated LVN 6 did not check the E-kits with both the outgoing and incoming nurses. A review of the facility's P&P titled, "Drug Diversion", dated 8/2023 indicated the designated staff members will be responsible for maintaining the controlled substance inventory, storage, and disposal. The P&P indicated all records of controlled substances, including receipts, administration, waste, disposal, loss, or possible diversion must be accurate and maintained. The facility failed to follow its P&P on controlled medication storage for one MS Room 1 when: 1. Two licensed nurses were not present when checking the Controlled Substance Two (II) Emergency Kit in MS Room 1 when five tablets of 10/325 milligrams of Percocet and two tablets of 5/325 mg of Percocet were reported missing from the CS II E-kit on 5/1/2024. 2. A discrepancy on Cart 1 Controlled Drug Reconciliation form was not reported to the DON on 4/21/2024. These violations resulted in two tablets of 5/325 mg of Percocet and five tablets of 10/325 mg of Percocet were missing from the CS II E-kit and had the potential for drug diversion of patients'/residents’-controlled medications. These violations, jointly, separately, or in any combination, had a direct or immediate relationship to the health, safety, or security of patients in the facility.