|§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.
Based on review of facility policy and clinical records and staff interview, it was determined that the facility failed to provide pharmaceutical services to assure accurate dispensing and receiving of medications for one of seven residents (Resident R1).
The facility policy entitled "Medication and Treatment Orders" dated 9/27/18, indicated that the QAPI Committee will conduct a root cause analysis of medication administration errors to determine the source of errors, implement process improvement steps and compare results over time to determine that system improvements are effective in reducing errors.
Review of the Minimum Data Set dated 1/30/19, indicated that Resident R1 had diagnoses that included multiple sclerosis (degenerative neuromuscular disease), depression and hemiplegia (weakness on one side of the body).
Review of a physicians order dated 12/5/18, indicated that Resident R1 was ordered Tecfidera (medication for multiple sclerosis) 240 mg. capsule by mouth to be given at 9:00 a.m. and 9:00 p.m. In addition, the physician order indicated that the Tecfidera was to be reordered from the specialty pharmacy every 25 days to ensure the medication was received.
Review of Resident R1's Medication Administration Record (MAR) for the month of January 2019, indicated that the Tecfidera had been reordered from the specialty pharmacy on 1/25/19.
Review of the MAR for the month of February 2019, indicated that Resident R1 was not administered the Tecfidera on 2/3/19, at 9:00 p.m., 2/4/19, at 9:00 a.m. and 2/4/19, at 9:00 p.m. because the medication was not available from the pharmacy.
During an interview on 3/18/19, at 1:55 p.m., the Director of Nursing confirmed that the Tecfidera was not administered to Resident R1 as ordered on 2/3/19, and 2/4/19, as listed above because the specialty pharmacy failed to supply the medication.
During an interview on 3/27/19, at 11:20 a.m., Pharmacy Technician Employee E1 confirmed that the specialty pharmacy failed to supply the Tecfidera for Resident R1 after receiving the reorder on 1/26/19.
28 Pa. Code: 201.14(a) Responsibility of licensee.
Previously cited 12/21/18.
28 Pa. Code 211.9(f)(k) Pharmacy services.
28 Pa. Code 211.12(d)(1)(5) Nursing services.
Previously cited 12/21/18.
| ||Plan of Correction - To be completed: 05/01/2019|
Disclaimer: Preparation, Submission and Implementation of this POC does not constitute an admission of, or agreement with, the facts and conclusions set forth on the complaint survey report. Our POC is prepared and executed as a means to continuously improve the quality of care and to comply with applicable state and federal regulatory requirements.
Plan of Correction for Requirement of 42 CFR Part 483, Subpart B, Requirements for Long Term Facilities and the 28 PA Code: The facility does employ and obtain the services of a licensed pharmacist, Susan Allen, through who will be consulted immediately on emergency situations like this in the future.
Plan of Correction: Corrective action for the resident found to be affected will be : Orders have/had been put in place for re-ordering the medication seven days early; the local pharmacy cannot refill due to insurance restrictions.
We will identify other residents having the potential to be affected by the same deficient practice by doing audits on all non-facility pharmacies upon admission.
As a measure to put into place to ensure the deficient practice does not re-occur, we will audit the whole house for outside pharmacy usage weekly x 4, then twice a month for 2 months, then monthly. The DON, ADON or delegated nurse will then audit for any outside pharmacy usage with monthly cart checks. The pharmacy was also educated on the situation.