|§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 the review of clinical records, review of facility documentation and review of facility policy, it was determined that the facility failed to ensure the timely availability of medication for administration as ordered by the physician, and failed to ensure that a controlled substance was documented as being reconciled for three out of 18 residents reviewed (Resident R11, R19, R61).
Review of the facility's policy entitled, "Controlled Substances Documentation," with a revision date of "12/29/14," stated that, it is the policy of the facility and its affiliates, to ensure accuracy in documenting-controlled substances in accordance with standard nursing practices and state and federal guidelines.
Review of the February, 2020 physician's orders for Resident R19 revealed a physician's order with a start date of July 9, 2019, and monthly thereafter, for a Fentanyl Patch 72 hour 12 micrograms, apply 12 micrograms transdermally every 72 hours for pain. The order stated, "please remove patch and document removal of patch."
Review of Resident R19's September, 2019 Medication Administration Record (MAR) revealed that there was no documentation of the removal of the Fentanyl Patch by nursing staff for September 3, 2019, September 6, 2019, September 9, 2019, September 12, 2019 and September 15, 2019.
During a discussion and a review of the MAR with licensed nursing staff, Employee E3, on February 28, 2020 at approximately 2:45 p.m., revealed that the patch should be witnessed by two nurses, and that the nurses should document that it was removed. During this time Employee E3 confirmed that no documentation could be produced to show the removal of the Fentanyl Patch, per the physician's order.
The facility failed to ensure that a controlled substance was documented as being reconciled for one resident.
Review of Resident R61's Annual Minimum Data Set (an MDS is a periodic assessment of needs) dated, November 16, 2019 revealed that, the resident had diagnoses that included, Alzheimer Disease, Seizures and Anxiety, had severe cognitive impairment, was incontinent of bowel and bladder, needed extensive assistance for toileting and ambulated with a wheelchair and a walker with the assistance of one person.
Review of Resident R61's January 2020 physician orders revealed an order for Quetiapine Fumarate Tablet, give 12.5 mg by mouth in the afternoon related to Resident R61's Dementia.
Further review of the orders revealed on January 17, 2020, that the resident R 61 did not receive her afternoon medication and the Registered Nurse (RN), Employee E5, stated in the nursing progress note, "Awaiting from Pharmacy."
Review of the medication's availability to nursing, in the facility's emergency medication supply, indicated that, Quetiapine was available.
During an interview on February 28, 2020 at 9:38 a.m. with the RN Employee E5 she stated that she was not aware of the facility's emergency stock of medications, as she said, "I am not sure, I don't use of often". Furthermore, she did not contact the physician when the medication-dose was missed.
The facility failed to ensure that medications including controlled substances were documented as being reconciled or administered as ordered.
Review of the interdisciplinary notes for Resident R11 revealed diagnoses that included, but not limited to atrial fibrillation (a disease of the heart characterized by irregular and often faster heartbeat); hypertension (high blood pressure); hyperlipidemia (high level of fats in the blood), and diabetes (disorder in which the body has high sugar levels for prolonged periods of time).
Review of the physician's orders for Resident R11, dated February, 2020 revealed an order for Spironolactone Tablet 25 milligrams, give 1 tablet by mouth one time a day related to hypertension starting August 10, 2019 and monthly thereafter; an order for Nesina Tablet 25 milligrams, give 1 tablet by mouth one time a day for diabetes mellitus starting September 4, 2019 and monthly thereafter; an order for Oxybutynin Chloride tablet give 2.5 milligrams by mouth two times a day for overactive bladder; Ezetimibe Tablet 10 milligrams, give 1 tablet by mouth in the morning related to hyperlipidemia, in addition to Vitamin D3 Tablet give 1 tablet by mouth in the morning for supplement.
Review of the nursing note dated October 3, 2019 indicated that the resident was not administered Nesina. The nursing note stated, "awaiting delivery from pharmacy."
Review of the nursing note dated October 6, 2019 indicated that the resident was not administered the Vitamin D3 Tablet. The nursing note stated, "med not available. Pharmacy contacted."
Review of the nursing note dated October 11, 2019 indicated that the resident was not administered Nesina. The nursing note stated the medication was, "not available."
Review of the nursing note dated October 11, 2019 indicated that the resident was not administered Sprionolactone Tablet. The nursing note stated that the medication was "not available."
Review of the nursing note dated December 20, 2019 stated that the resident was not administered the Ezetimibe Tablet and that the medication was "not available."
Review of the interdisciplinary notes for Resident R19 revealed diagnoses that included, but not limited to, anxiety (a feeling of worry, nervousness, or unease); hypertension (high blood pressure), and arthritis. Review of the interdisciplinary notes also revealed that the resident had dry eyes.
Review of the physician orders for February 2020 revealed an order for Clonazepam 1 milligram tablet, give 1 tablet by mouth at bed time for anxiety with a start date of July 23, 2019 and monthly thereafter; an order for Ocuvite Lutein 1 capsule, give 1 capsule by mouth one time a day for supplement eye support with a start date of July 23, 2019 and monthly thereafter and an order for Artificial tears 1.4% drops, instill 1 drop in both eyes six times a day for dry eyes.
Review of the nursing notes dated September 3, 2019 indicated that medication Clonazepam was not administered. The nursing note stated, "med not available, awaiting med from pharmacy."
Review of the nursing notes dated October 6, 2019 indicated that the resident's 8:00 a.m. treatment for artificial tears was not administered. The nursing note stated, "med not available. Pharmacy contacted."
Review of the nursing note dated November 7, 2019 indicated that the resident's 8:00 am treatment for artificial tears was not administered. The nursing note stated, "med is not avail pharmacy contacted."
Review of the nursing note dated November 11, 2019 indicated that the resident's Ocuvite Lutein was not administered. The nursing note stated, "not available. reordered."
During a discussion with the Director of Nursing (DON) on February 27, 2020 at approximately 11: 00 a.m., the DON reported that it was the nurse's responsibility to reorder the resident's medication on time. The DON also reported that if a resident's medication was missed, the physician needed to be notified.
During a interview with licensed nursing staff, Employee E3, on February 28, 2020 at approximately 12:45 p.m., the missed dosages of mediations for Residents R11 and Resident R19 were discussed. Employee E3 confirmed that the above referenced medications were not available from the pharmacy for nursing to administer to the residents, as ordered. Employee E3 also stated that the nurses can order the medications from pharmacy on the electronic system or via fax.
28 Pa Code 201.18(b)(1) Management
28 Pa. Code 211.9(a)(1) Pharmacy services
28 Pa Code 211.12 (c) Nursing services
28 Pa Code 211.12(d)(1) Nursing services
28 Pa Code 211.12 (d)(2) Nursing services
28 Pa Code 211.12(d)(3) Nursing services
28 Pa Code 211.12(d)(5) Nursing services
| ||Plan of Correction - To be completed: 04/28/2020|
1.R19 Fentanyl order has been corrected and witnessed by 2 nurses removal of patch has been added to the Fentanyl order. R61 physician has been notified on missed quetiapine dose on 1/7/2020/ R11 physician made aware of meds not given. R19 physician made aware med not given. Resident R19 physician was made aware that clonazepam, artificial tears, ocuvite lutein were not given as ordered. Physician was notified, no adverse effects no new orders. R11, physician made aware spirolactone, nesina, Vitamin D, Ezetimibe, were not given. Physician was notified. No new orders and no adverse effect.
2. Residents MAR documentation was audited, other concerns for missing entries were resolved.
3. Licensed nursing staff will be re-educated to re-order meds timely, reconciling removal of controlled substances, and in-service on emergency medication supply. Staff will also be educated to notify MD if medication is not given as prescribed.
4. DON/Designee will audit med administration daily x2 weeks, weekly x2 weeks, then monthly x3 months. Audits will be reported to QAPI x3 months or until substantial compliance