|§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 policies, clinical records, and an inventory record for the facility's emergency drug box, as well as staff interviews, it was determined that the facility failed to obtain needed medications from the pharmacy in a timely manner for one of 12 residents reviewed (Resident 6).
The facility's policy regarding obtaining of medications that were not available, dated February 26, 2019, indicated that if medications were not available on the medication cart, staff were to search the medication cart for the medications, and if unable to locate them, staff were to search the facility's emergency medication box and use the available medications. If the medications were not available in the emergency medication box, staff were to call the pharmacy to determine how soon the medication could be delivered. If the pharmacy was not available to deliver the medication in time for the ordered administration, and the medication was not available in the emergency medication box, then the registered nurse supervisor was to be notified. Follow-up action was to be taken to ensure the medication was delivered, administered as ordered, and stored in the medication storage drawer.
A nursing note for Resident 6, dated April 24, 2019, at 6:50 p.m. revealed that the resident was admitted to the facility with diagnoses that included infection following a procedure (knee replacement surgery), disruption of a wound (an infection in the wound), diabetes mellitus (disease that interferes with the body's ability to control blood sugar levels), hyperlipidemia (high levels of fat in the blood), post traumatic stress disorder (a mental health condition that may be triggered by a terrifying event), and bipolar disorder (mental health disorder that causes unusual shifts in mood, energy and activity levels).
Physician's admission orders dated April 24, 2019, at 6:54 p.m. included orders for the resident to receive 20 milligrams (mg) of atorvastatin (treats hyperlipidemia) at bedtime, 80 mg of Latuda (treats bipolar disorder) at bedtime, 100 mg of sitagliptin (controls blood sugar levels) daily, 4 mg of ropinirole (treats restless leg syndrome) at bedtime, 150 mg of Lyrica (treats nerve pain) every 8 hours, 4 mg of tizanidine every 8 hours for muscle spasms, and 240 mg of verapamil (treats high blood pressure) daily.
Resident 6's Medication Administration Record (MAR) for April 2019 revealed that the resident did not receive atorvastatin on April 24 at 8:00 p.m., Latuda on April 24 at 8:00 p.m. and April 25 at 8:00 a.m., sitagliptin on April 25 at 8:00 a.m., ropinirole on April 25 at 8:00 p.m., Lyrica on April 24 at 8:00 p.m. and April 25 at 6:00 a.m. and 2:00 p.m., tizanidine on April 24 at 8:00 p.m. and April 25 at 6:00 a.m. and 2:00 p.m., and verapamil on April 25 at 8:00 a.m.
A current undated inventory sheet for the facility's emergency medication kit, provided by the facility on April 25, 2019, revealed that atorvastatin was available in the dosage required by Resident 6.
There was no documented evidence of any attempts to obtain Resident 6's medications in a timely manner from the pharmacy, from a back-up pharmacy (local pharmacy to be contacted if medications are not delivered timely from the main pharmacy), or from the facility's emergency medication supply, and no documented evidence that the physician was notified that the medications were not administered as ordered.
Interviews with the Director of Nursing on April 25, 2019, at 5:25 p.m. and 5:45 p.m. confirmed that nursing staff should have obtained the medication that was available in the facility's emergency medication supply for Resident 6. She also confirmed that there was no documented evidence that the pharmacy was contacted to request an immediate delivery of the remaining medications or that the physician was notified about the missed doses.
42 CFR 483.45(a)(b)(1)-(3) Pharmacy Services/Procedures/Pharmacist/Records.
Previously cited 10/17/18, 9/6/18.
28 Pa. Code 211.9(a)(1) Pharmacy services.
Previously cited 9/6/18.
28 Pa. Code 211.12(d)(3)(5) Nursing services.
Previously cited 3/4/19, 10/17/18, 9/6/18.
| ||Plan of Correction - To be completed: 05/15/2019|
Resident R6 physician was notified of missed doses of medications, and physician gave no new orders. Resident R6 was not affected by the missed medication. Root cause analysis identified the nurse did not check electronic medication list to see if meds available. Medication lists have since been placed at each nursing unit, instead of only in the central location electronic dispense room.
House surveillance of new medication orders to ensure medications were available and if not, then staff are to follow the facility policy on obtaining medications.
Re-education to licensed staff on facility policy for administering medications, specifically retrieving medications from the electronic dispense unit or making notification to the pharmacy to delivery the medication if it is not readily available in the facility.
Audits of new medication orders and administrations will be conducted twice weekly x2 weeks, and then monthly x3 to ensure medications are obtained and given as ordered.
The audits will be taken to the facility monthly Quality Assurance Performance Improvement meeting for further review and recommendations.