§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 review of controlled drug records and select facility policy and staff interview, it was determined that the facility failed to implement pharmacy procedures for reconciling controlled drugs and records accounting for their administration for two of five residents sampled (Resident 3 and 4) .
Finding include:
A review of the clinical record revealed that Resident 3 had a physician order dated January 13, 2023, for Oxycodone (a narcotic opioid pain medication) 5 mg Tablet, 2 tablets every 4 hours, as needed for severe pain, pain scale 7-10 (a pain scale, 1-10, 1 least pain, 10 most pain).
A review of the controlled substance record accounting for the above narcotic medication revealed that on December 20, 2023, at 8:30 P.M, December 21, 2023, at 4 P.M, December 21, 2023, at 8 P.M., December 22, 2023, at 5 P.M., December 23, 2023, at 5 P.M., 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 (MAR) on those dates and times.
A review of a November 2023 MAR revealed that nursing signed out a dose of Resident 3's supply of Oxycodone 5 mg according to the MAR on the following dates:
-November 18, 2023 at 11:50 A.M., November 19, 2023 at 07:56 A.M., November 25, 2023 at 08:03 A.M. and November 26, 2023 at 08:31 A.M. --October 1, 2023 at 8 A.M., October 1, 2023 at 12:20 P.M., October 3, 2023 at 8:08 A.M., October 3, 2023 at 1:30 P.M., October 4, 2023 at 5:50 P.M., October 5, 2023 at 4 P.M., October 5, 2023 at 9:30 P.M., October 10, 2023 at 8 A.M and October 10, 2023 at 1 P.M. --September 16, 2023 at 8 A.M., September 16, 2023 at 12:15 P.M., September 17, 2023 at 07:59 A.M., September 17, 2023 at 12:27 P.M., September 19, 2023 at 8:30 A.M., September 19, 2023 at 1:30 P.M., September 25, 2023 at 8:17 A.M. --August 5, 2023 at 08:01 A.M., August 5, 2023 at 12:25 P.M., August 6, 2023 at 07:39 A.M., August 6, 2023 at 1:05 P.M., August 8, 2023 at 07:36 A.M., August 8, 2023 at 1:01 P.M., August 10, 2023 at 4:43 P.M., August 15, 2023 at 08:31 A.M., August 16, 2023 at 08:08 A.M., August 16, 2023 at 1:31 P.M., August 17, 2023 at 5 P.M., August 17, 2023 at 9:01 P.M., August 22, 2023 at 1 P.M., August 24, 2023 at 08:11 A.M., August 24, 2023 at 1 P.M., August 29, 2023 at 07:51 A.M., August 29, 2023 at 1:04 P.M., August 30, 2023 at 3:20 P.M.
There were no narcotic sign out records available at the time of the survey ending January 29, 2024, for the months of August 2023, September 2023, October 2023 and November 2023 to reconcile the accounting of the resident's supply of the controlled drug.
According to the Medication Administration Records, Employee 1, LPN administered all the doses of Resident 3's prn Oxycodone 5 mg during August 2023, September 2023, October 2023 and November 2023 MARS
During an interview, January 17, 2024, at approximately 2 PM the Director of Nursing confirmed the inconsistencies in the accounting and administration of the opioid pain medications for the above resident and confirmed the narcotic drug records were missing for the above months and not available to reconcile with the quantity dispensed for the resident and to verify administration to the resident on those date and times.
A review of a facility investigation report dated January 9, 2024, at 3 P.M. revealed that on this date and time during shift to shift narcotic count, the day shift RN and the evening shift RN had noticed that one pill from Resident 4's supply of the medication Lacosamide ( a controlled substance, for seizure treatment) 200 mg pills was missing from the from the card and the nursing staff made the Director of Nursing (DON) aware.
The DON visualized the controlled substance utilization record as well as the physical card of Lacosamide 200 mg. On the bubble pack in slot 25 there was no pill visible. Bubble packets 26, 27 and 28 were visibly removed and accounted for on the controlled substance utilization record. The remaining pockets were visualized and all pills accounted for. The DON contacted the pharmacy and spoke to the pharmacist to notify them of the incident. The missing pill was identified as a Pharmacy fill error.
A review of a pharmacy order invoice revealed that Lacosamide 200 mg by mouth, give one tablet twice daily for seizures. The form indicated that 27 pills were dispensed and delivered to the facility.
During an interview January 17, 2024, at 2:15 P.M., the DON confirmed the Pharmacy error and that the licensed nursing staff receiving the controlled medications did not ensure the correct count of the controlled meds upon receipt of the meds at the facility. He also confirmed that licensed nurses completing the shift to shift count of the meds did not ensure all the medications were in the card.
28 Pa Code 211.12 (d)(3)(5) Nursing services.
28 Pa Code 211.9(a)(1)(2)(k) Pharmacy services.
| | Plan of Correction - To be completed: 02/06/2024
1. Unable to documentation for PRN narcotic documentation on MAR. Unable to locate narcotic utilization records for identified months for resident #3 Unable to correct narcotic utilization record for resident #4 2. To identify other residents that have the potential to be affected, the DON/designee reviewed 72 hours of MAR to narcotic utilization record to identify any omissions on the MAR To prevent this from reoccurring, the DON/designee will audit current residents who received a narcotic from pharmacy in last month to ensure utilization record if completed, the record is available to review To identify other residents that have the potential to be affected, the DON/designee reviewed last week of narcotic medications received from pharmacy to ensure they received the same amount as pharmacy invoice dispensed and all pills are accounted for 3. To prevent this from reoccurring, the DON/designee educated licensed nurses to ensure all narcotic medications signed on utilization record are signed off in MAR To prevent this from reoccurring, the DON/designee educated licensed nursing staff on ensuring the completed narcotic utilization record is given to the DON and is then uploaded to the documents portion of the medical record To prevent this from reoccurring, the DON/designee educated licensed nursing staff on ensuring when they receive narcotics from the pharmacy, they are removed from the bag immediately, compare the amount of pills in the package to the invoice sheet, then document amount of the narcotic utilization record, sign and date 4. To monitor and maintain ongoing compliance, the DON/designee will audit 5 random residents weekly x 4 then monthly x 2 to ensure any narcotic medications signed off on utilization record are documented in MAR To monitor and maintain ongoing compliance, the DON/designee will review completed narcotic utilization records weekly x 4 then monthly x 2 to make sure any completed records are uploaded to the medical record To monitor and maintain ongoing compliance, the DON/designee reviewed narcotic delivery invoices weekly x 4 then monthly x 2 to ensure narcotic utilization record matches invoice and amount of pills in blister pack 5. The results of the audits will be forwarded to the facility QAPI committee for further review and recommendations
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