§483.45(c) Drug Regimen Review. §483.45(c)(1) The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist.
§483.45(c)(2) This review must include a review of the resident's medical chart.
§483.45(c)(4) The pharmacist must report any irregularities to the attending physician and the facility's medical director and director of nursing, and these reports must be acted upon. (i) Irregularities include, but are not limited to, any drug that meets the criteria set forth in paragraph (d) of this section for an unnecessary drug. (ii) Any irregularities noted by the pharmacist during this review must be documented on a separate, written report that is sent to the attending physician and the facility's medical director and director of nursing and lists, at a minimum, the resident's name, the relevant drug, and the irregularity the pharmacist identified. (iii) The attending physician must document in the resident's medical record that the identified irregularity has been reviewed and what, if any, action has been taken to address it. If there is to be no change in the medication, the attending physician should document his or her rationale in the resident's medical record.
§483.45(c)(5) The facility must develop and maintain policies and procedures for the monthly drug regimen review that include, but are not limited to, time frames for the different steps in the process and steps the pharmacist must take when he or she identifies an irregularity that requires urgent action to protect the resident.
|
Observations:
Based on review of facility contract and policy, and clinical record review, and staff interviews, it was determined that the facility failed to ensure that monthly pharmacy drug regimen reviews were completed for five of five residents reviewed (Residents R11, R13, R17, R30, and R52).
Findings include:
A facility contract entitled "Care Apothecary Consultant Pharmacy Retainer Agreement" dated 6/07/24, indicated that: monthly reviews of the drug regimen of each resident at Ball Pavilion will be conducted; recommendations, plans for implementation, and continuing assessment regarding medication policies and use through dated, and signed reports will be provided to administrator; and the pharmacy agrees to be responsible for providing continuous Consultant Pharmacist Services to the facility through the term of the agreement.
A facility policy entitled "Pharmacy Consultant Report at Ball Pavilion" dated 9/09/24, indicated that the Pharmacy Consultant will e-mail Director of Nursing, Administrator, RNAC (Registered Nurse Assessment Coordinator), and Rehab Director with monthly pharmacy summary.
Resident R11's clinical record revealed an admission date of 4/26/24, with diagnoses including Parkinson's Disease (disease of involuntary muscle movements) atrial fibrillation (irregular heart beat) and orthostatic hypotension (low blood pressure when in a standing position).
Resident R13's clinical record revealed an admission date of 2/22/22, with diagnoses including dementia, Type 2 diabetes (happens when the body cannot use insulin correctly and sugar builds up in the blood), irregular heartbeat, and anxiety.
Resident R17's clinical record revealed an admission date of 6/25/24, with diagnoses including dementia with mood disturbance, anoxic brain damage (occurs when the brain is deprived of oxygen, leading to brain cell death and potentially permanent brain damage or even death), heart disease and convulsions.
Resident R30's clinical record revealed an admission date of 12/12/23 with a diagnoses of Alzheimer's disease (a disease characterized by forgetfulness and confusion) Type 2 diabetes (condition of poor blood sugar control) and hypertension (high blood pressure).
Resident R52's clinical record revealed an admission date of 6/20/18, with diagnoses including stroke with left-sided weakness, Type 2 diabetes, dementia, and high blood pressure.
Residents R11, R13, R17, R30, and R52's clinical records lacked evidence that a Pharmacy Consultant review was conducted for October 2024, November 2024, and December 2024.
During an interview on 3/20/25, at 2:20 p.m. the Registered Nurse Assessment Coordinator confirmed that the pharmacy did not provide a Pharmacy Consultant to conduct the monthly reviews of the drug regimen of each resident during October 2024, November 2024, and December 2024.
28 Pa. Code 201.14(a) Responsibility of licensee
28 Pa. Code 201.18(b)(1)(3) Management
28 Pa. Code 211.5(f)(x) Medical records
28 Pa. Code 211.9(f)(3) Pharmacy Services
28 Pa. Code 211.12(d)(1)(3)(5) Nursing services
| | Plan of Correction - To be completed: 05/20/2025
To correct the deficiency as it relates to the individuals affected by the deficient practice, a medication regimen review was conducted by the pharmacy consultant between 3/1/2025 and 3/17/2025 and all recommendations reported to Registered Nurse Assessment Coordinator, Administrator, Director of Nursing and Medical Director and followed up at that time.
To protect residents having the potential to be affected by the same deficient practice, the pharmacy consultant will conduct a thorough review of all resident medications and document findings monthly. Nurses will be educated on the importance of drug regimen review and the immediate process to report and act on any identified irregularities.
To ensure that the deficient practice does not recur, the pharmacy consultant will conduct monthly drug regimen reviews for all residents and will report irregularities to the Registered Nurse Assessment Coordinator, Administrator and Director of Nursing. A report will be sent via email. If a report is not received by the last week of the month, Administrator will contact pharmacy consultant and request this review.
To monitor corrective action and ensure that the deficient practice will not recur, the Director of Nursing and Administrator will conduct monthly audits to ensure drug regimen review have been completed. The Director of Nursing will monitor the completion and documentation of all drug regimen reviews and will ensure that any identified irregularities are addressed. This audit be reviewed at the monthly QAPI meeting for the next three months.
|
|