§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.
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Observations:
Based on a review of clinical records and controlled drug medication sheets, and staff interview, it was determined that the facility failed to implement procedures to promote accurate accounting of controlled medications for three of four residents sampled (Resident 64, 54, and 52).
Findings include:
A review of Resident 64's clinical record revealed that the resident was admitted to the facility on January 18, 2024, with diagnoses which included lower back pain and abdominal pain.
A review of the resident's clinical record revealed that Resident 64 had a physician order initially dated March 27, 2024, and revised on April 4, 2024, for Oxycodone HCL (a narcotic opioid pain medication) 5 mg tablet every 6 hours as needed for pain level 8 to 10.
A review of the resident's controlled substance records accounting for the above controlled medication revealed on April 8, 2024, at 12:00 AM, April 18, 2024, at 12:00 AM, and May 10, 2024, at 11:00 PM revealed that nursing staff signed out a dose of the resident's supply of Oxycodone 5 mg. However, the administration of the controlled drug to the resident was not recorded on the resident's Medication Administration Record on those dates and times.
A review of Resident 52's clinical record revealed the resident was admitted to the facility on July 12, 2022, with diagnoses which included Parkinson's disease, left knee pain, and intervertebral disc degeneration.
A review of the resident's clinical record revealed that Resident 52 had a physician order initially dated February 15, 2024, for Oxycodone HCL 5 mg tablet every 8 hours as needed for pain level 8 to 10.
A review of the resident's controlled substance records accounting for the above controlled medication revealed on April 3, 2024, at 9:00 PM, April 4, 2024, at 9:00 PM, April 7, 2024, at 8:00 PM, April 15, 2024, at 9:00 PM, April 18, 2024, at 9:00 PM, April 20, 2024, at 9:00 PM, April 23, 2024, at 9:00 PM, April 24, 2024 at 9:00 PM, April 28, 2024, at 11:00 PM, April 29, 2024, at 10:33 AM, and May 1, 2024, at 9:00 PM revealed that nursing staff signed out a dose of the resident's supply of Oxycodone 5 mg.
However, the administration of the controlled drug to the resident was not recorded on the resident's Medication Administration Record on those dates and times.
A review of the clinical record revealed Resident 54 was admitted to the facility on March 10, 2023, with diagnoses to include post traumatic stress disorder ([PTSD] a mental health condition that develops following a traumatic event causing distress and anxiety) and anxiety (fear characterized by behavioral disturbances).
A physician order dated January 7, 2024, at 9:43 AM was noted for the resident to receive Lorazepam (Ativan) 0.5 milligram (mg) by mouth give one tablet every 12 hours related to anxiety disorder (standing order dose).
A physician order dated May 10, 2024, at 6:37 PM was noted for Lorazepam (Ativan) 0.5 milligram (mg) by mouth give one tablet every 24 hours, as needed, for anxiety related to anxiety disorder, not to be given within two hours of standing order dose (as needed dose).
A review of medication administration record (MAR) for the month of May 2024 revealed staff administered the prn (as needed) Ativan to the resident on the following dates:
May 11th at 3:27 PM May 12th at 4:27 PM May 13th at 4:47 PM May 14th at 4:47 PM
A review of "Controlled Substance Record" for Resident 54 revealed that controlled drug record was maintained for Ativan 0.5 mg take one tablet by mouth every 12 hours (straight order) and did not include the physician prn Ativan order to account for the doses removed. The controlled substance record revealed that both orders for Ativan were being recorded on the straight order "Controlled Substance Record."
Employee 5 Licensed Practical Nurse (LPN) and the Nursing Home Administrator (NHA) confirmed the observation that both orders, prn and straight, for the Ativan were being recorded on the same controlled substance record and staff used the same blister pack failing to have an accurate record of both orders for this medication.
An interview on May 17, 2024, at approximately 1:15 PM the Nursing Home Administrator confirmed the inconsistencies in the accounting and administration of the opioid pain medications for Resident 64 and Resident 52, and the lack of a controlled drug record for Resident 54's prn Ativan supply.
Refer F761
28 Pa Code 211.12 (d)(3)(5) Nursing services
28 Pa Code 211. (c)(k) Pharmacy services
28 Pa Code 211.5(f) Medical records
| | Plan of Correction - To be completed: 07/02/2024
1. Facility cannot retroactively correct past medication administration. Resident 54's narcotic cards, sheets, and MAR was updated to reflect two separate physician orders. 2. Facility completed baseline audit on residents with pain medication to ensure PRN and straight orders of same medication have separate MAR orders, sheets, and cards. 3. DON educated licensed staff on ensuring narc book and MAR have to be signed each time, and when a narcotic is ordered both straight and PRN orders, cards, and sheets have to be separate. These new orders will be monitored in clinical meeting. 4. DON/designee will randomly audit narc sheets weekly for 4 weeks and monthly for 2 months to ensure the narc sheet matches the MAR. DON/designee will audit new pain medicine orders that are same medicine PRN and straight weekly for 4 weeks and monthly for 2 months to ensure there are separate orders, cards, and sheets. 5. Audits will be submitted to QAPI for review.
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