§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 facility documents, observations, and interviews with staff, it was determined that the facility did not establish a system of records of receipt and disposition of controlled drugs in sufficient detail to enable an accurate reconciliation for one resident and failed to provide necessary pharmaceutical services for one of five residents reviewed. (Resident R86 and Resident R4).
Findings include:
Review of facility policy on controlled substances revealed that under section "Policy Statement", the facility shall comply with all laws and regulations and other requirements related to storage, disposal and documentation of scheduled II and another controlled substances. Under section "Policy Interpretation and Implementation", #3. Controlled substances must be, counted upon delivery. The nurse receiving the medication, along with the person delivering the medication, must count the controlled substances together. Both individuals must sign the designated controlled substance record. #4. If the count is correct, an individual resident controls substance record must be made for each resident who will be receiving a controlled substance. Do not enter more than one prescription per page. This record must contain: a. Name of the resident, b. Name and strength of the medication, c. Quantity received, d. Number on hand, e. Name of Physician, f. Prescription number, g. Name of Issuing Pharmacy, h. Date and time received, i. Time of administration, j. Method of administration, k. Signature of person receiving medication and l. Signature of nurse administering medication. #5. Controlled substances must be stored in the medication room in a locked container, separate from containers for any non-controlled medications. This container must remain locked at all times, except when it is accessed to obtain medications for residents. #9. Nursing staff must count controlled medications at the end of each shift. The nurse coming on duty and the nurse going off duty must make the count together. They must document and report any discrepancies through their Director of Nursing services.
Review of second floor narcotic book revealed that there were two narcotic accountability sheets for liquid morphine sulphate for Resident R4.
Review of the first narcotic accountability for a Morphine Sulphate for Resident R4 conducted with Employee E13 revealed that the page was numbered 70. Further, the following were written on the accountability sheet. Resident's name: Resident R4, Drug dosage: 0.25 milliliters (ml) (morphine sulphate), Direction: 0.25 ml every 3 hours for pain or SOB (shortness of breath) . Further review revealed that on July 10 (no year was indicated), 30 ml was the amount left.
Review of the second narcotic accountability for a Morphine Sulphate for Resident R4 conducted with Employee E13 revealed that the page was numbered 72. Further, the following were written on the accountability sheet: Resident's name: Resident R4, Drug dosage: 0.25ml (morphine sulphate), Direction: 0.25 ml every 3 hours for pain or SOB. Further review revealed that on July 14 (no year was indicated), at 9am, 30 was the amount left.
Observation of the medication refrigerator in the second-floor medication room with Employee E13 conducted on December 13, 2023, at 12:03 pm revealed a box containing two bottles of liquid Morphine Sulfate.
Observation of bottle #1 conducted with Employee E13 revealed that bottle #1 of Morphine Sulfate was labelled with Resident R4's name. Further, it was labelled "Morphine Sulphate Solution 100 ml/5ml solution, quantity 30, light blue, solution raspberry.
Further observation revealed that there was 30 ml of liquid inside bottle #1
Observation of bottle #2 conducted with Employee E13 revealed that the second bottle of Morphine Sulfate was labelled with Resident R4's name. Further, it was labelled "Morphine Sulphate 20 mg/ml concentrate Generic for Roxanol, 0.25 ml, quantity 15 and with date July 13, 2023
Further observation revealed that there was 15 ml of liquid inside bottle #2.
The above observation revealed that there was a discrepancy between the 15 ml. of Morphine Sulphate in bottle #2 and the documentation on the morphine sulphate accountability sheet.
Interview with Licensed nurse. Employee E13 conducted at the time of the observation confirmed that that bottle #1 labelled "Morphine Sulphate Solution 100 ml/5ml (20 mg/ml) for Resident R4 had 30 ml of liquid inside bottle #1 and that bottle #2 was labelled "Morphine Sulphate 20 mg/ml concentrate Generic for Roxanol had 15 ml of liquid inside bottle #2.
Further interview with Licensed nurse, Employee E13 also confirmed that there was a discrepancy between the 15 ml. of Morphine Sulphate in bottle #2 and the documentation on the morphine sulphate accountability sheet.
This discrepancy was not identified during the shift-to-shift count from July 14, 2023, to December 13, 2023.
Review of physician orders for Resident R86 dated November 18, 2023, revealed medication orders for Cephalexin (Antibiotic medication) 500 mg one tablet four times a day for cellulitis.
Review of medication administration record (MAR) for Resident R86 for the month of November 2023 revealed that the resident did not receive Cephalexin on November 18, 2023, at 1:00 p.m., November 19, 2023, at 1:00 p.m. and 5:00 p.m. and November 28, 2023, at 9:00 p.m. The MAR documentation revealed that the medication was not available to be administered.
Interview with the Assistant Director of Nursing, Employee E3, on December 15, 2023, at 11:10 a.m. confirmed that the medication was not administered as ordered and the medication was not available from the pharmacy.
28 Pa. Code 201.18(b)(2) Management
28 Pa. Code 211.9(a)(1)(k) Pharmacy services
28 Pa. Code 211.12(d)(1)(3)(5) Nursing services
| | Plan of Correction - To be completed: 01/30/2024
Resident R 4's narcotic inventory was corrected at the time of the discovery. Resident R86's physician was made aware that the antibiotic medication was not available to be administered.
The narcotic inventory and the narcotic accountability sheets were audited to ensure that were no discrepancies. Current residents who received antibiotic medication from 12/1/23 will be audited to ensure that medication was available and administered as ordered.
The Director of Staff Development or designee will re-inservice the RN and LPN staff regarding the Controlled Substances Policy with a focus on ensuring that the narcotic inventory matches the narcotic accountability sheets. The Director of Staff Development or designee will re-inservice the RN and LPN staff regarding the need to ensure that antibiotic medication is available from the pharmacy and administered as ordered.
The Director of Nursing or designee will audit the narcotic inventory and the narcotic accountability sheets to ensure there are no discrepancies weekly x 4 and then monthly thereafter for 90 days. The results of the audits will be forwarded to the QAPI Committee for additional review and recommendations and to determine the need for further audits and/or action plans.
The Director of Nursing or designee will perform random audits for those residents on antibiotic medication to ensure that the medication is available and administered as ordered weekly x 4 and then monthly thereafter for 90 days. The results of the audits will be forwarded to the QAPI Committee for additional review and recommendations and to determine the need for further audits and/or action plans.
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