|§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 clinical record review and staff interview, it was determined that the facility failed to implement procedures to promote accurate narcotic medication records for one resident (Resident 79) and failed to ensure physician-ordered medications were available in a timely manner for one resident out of 18 sampled. (Resident CR1).
A review of the clinical record revealed that Resident 79 was admitted to the facility on July 2, 2021, with diagnoses of pain and dementia. The resident expired in the facility on August 29, 2021.
The resident had physicians orders dated August 27, 2021, for Morphine Sulfate Solution (a pain medication) 5 milligrams (mg) sublingually four times a day for dyspnea/pain and for Ativan (an anti-anxiety medication) 0.5 mg sublingually every 4 hours for end stage agitation.
Review of the Medication Administration Record (MAR) for August 2021 indicated that Morphine Sulfate Solution and the Ativan were administered August 27, 2021, August 28, 2021, and August 29, 2021. At the time of the survey ending November 5, 2021, there was no documented evidence of a Controlled Drug Records for the resident's Morphine Sulfate Solution and Ativan and no evidence of the quantity remaining at the time of the resident's discharge and its disposal.
Interview with the Director of Nursing on November 5, 2021, at 12:30 p.m. confirmed that there was no documented evidence of the quantity and disposition of any remaining Morphine Sulfate Solution and Ativan upon the resident's discharge.
Resident CR1 was admitted to the facility on October 27, 2021, with numerous diagnoses including end stage kidney disease with dependence on dialysis, hypertension, heart failure, and benign neoplasm of cerebral meninges (a tumor that grows from the protective membranes that cover the brain and spinal cord).
Among the resident's physician ordered medications upon admission, were Apixaban 2.5 mg give one tablet daily for atrial fibrillation, Calcium-Vitamin D3 tablet 250-125 mg give one tablet two times a day (day and time dependent on dialysis days), Famotidine 10mg give one tablet by mouth two times a day for GERD (gastroesophageal reflux disease), Lactobacillus Acid-Pectin Capsule give one capsule two times a day for supplement, Levetiracetam 500 mg one tablet two times a day for meningioma of brain with seizures (day and time dependent on dialysis days), Levothyroxine Sodium 100 mcg one tablet at bedtime for hypothyroidism, Prednisone 10mg give 5 tablets in the afternoon until 10/28/21, Prednisone 20mg one tablet in the afternoon for hypopituitarism, Prednisone 10mg give 4 tablets in the afternoon until 10/29/21 for hypopituitarism, Prednisone 10mg give 3 tablets in the afternoon until 10/30/21 for hypopituitarism, Renvela 800 mg two tablets with meals chronic kidney disease with hemodialysis (day and time dependent on dialysis days), and Testosterone Gel 10 mg/act (2%) apply 4 pumps transdermally one time a day for panhypopituitarism.
A review of the resident's medication administration records for October 2021, revealed that Prednisone 10 mg five tablets, Testosterone gel, Apixaban, Calcium-Vit D3, Famotidine, Lactobacillus, Levetiracetam, and Renvela were not administered as ordered in the morning of October 28, 2021. The October 2021 medication administration record revealed that Famotidine, Lactobacillus evening doses and Renvela afternoon dose were not administered on October 28, 2021.
Further review of the resident's clinical record revealed that Employee 5, licensed practical nurse (LPN), documented on October 28, 2021, that the resident's medications had not been received from pharmacy.
When interviewed on November 4, 2021, at 11:05 a.m., the Nursing Home Administrator and Director of Nursing were unaware that the facility was having any issues with obtaining m
medications from the pharmacy timely.
28 Pa Code 211.12 (a)(c)(d)(1)(3)(5) Nursing services.
28 Pa Code 211.9(a)(1)(k) Pharmacy services.
| ||Plan of Correction - To be completed: 01/04/2022|
1. Resident CR1's controlled record was unable to be located.
2. RN Staff Development Nurse/Designee will educate nursing personnel on Controlled substances Policy.
3. Pharmacy delivery occurs twice a day with cut-off order times. Facility has access to an Omnicell (emergency back-up dispense machine) on premise, as well as the ability to utilize a back-up pharmacy to obtain medications. Licensed Nursing personnel will be re-educated on use of Omnicell, pharmacy ordering and delivery protocols, and if medication can not be obtained the physician will be notified.
4. Current resident with a physician order for a controlled drug will be audited for an accurate controlled drug record to include disposition and quantity of remaining controlled drug.
5. Current resident records will be audited for discontinuation of controlled drugs with accuracy for disposition and quantity.
6. New resident admissions EMAR shall be reviewed to ensure medications have been received by Pharmacy and administered as per physician's order. Results of audit will be presented to QA for comment and review.
7. Corrective Action Date January 4, 2022