|§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.
Based on clinical record review and staff interview, it was determined that the facility failed to ensure that the resident's physican reviewed the licensed pharmacist's report for a medication irregularity for one of 10 residents reviewed. (Resident R2)
Review of the facility policy titled, "Medication Regimen Review," dated July 1, 2017, revealed that the findings and recommendations are reported to the Director of Nursing and the attending physican and to the appropriate Medical Director and/or Adminsitrator.
Review of Resident R2's clinical record revealed diagnoses including but not limited to: congenital hypothyroidism without goiter (condition due to deficiency in the thyroid hormone resulting in decreased body metabolism without an enlarged thyroid gland), unspecified atrial fibrillation (irregular and rapid heart beat), unspecified heart failure (heart muscle does not pump properly)
Review of a monthly drug regimen review completed by the consultant pharmacist on October 25, 2018, revealed a recommendation of "Resident's TSH (thyroid stimulating hormone) level on 10/16/18 was 9.19. Consider increasing her Levothyroxine Dose to 75 mcg daily and recheck her level in 8 to 12 weeks." Further review of Resident R2's clinical record failed to reveal documented evidence that the resident's physician was aware of or responded to this pharmacy recommendation.
Review of a monthly drug regimen review completed by the consultant pharmacist on November 21, 2018, revealed a recommendation of "Resident's TSH level on 10/16/18 was 9.19. Resident's level on 10/30/18 was 7.22. Consider increasing her Levothyroxine Dose to 75 mcg daily and recheck her level in 8 to 12 weeks." Further review of Resident R2's clinical record failed to reveal documented evidence that the resident's physician was aware of or responded to this pharmacy recommendation.
An interview with the Assistant Director of Nursing on January 24, 2018, at 11:00 a.m. confirmed that the physician did not respond to or act upon the above pharmacy recommendations. The interview also revealed the expectation that the physician should have responded to the pharmacy recommendations.
28 Pa. Code 211.5(f) Clinical records
Previously cited 08/10/18
28 Pa. Code 211.5(h) Clinical records
28 Pa. Code 211.9(a)(1) Pharmacy services
28 Pa. Code 211.12(c)(d)(1)(5) Nursing services.
Previously cited 08/10/18, 07/17/17
28 Pa. Code 211.12(d)(3) Nursing services
| ||Plan of Correction - To be completed: 02/15/2019|
1. The physician has addressed the pharmacy recommendation for resident R2.
2. The facility will review the pharmacy recommendations from the December reviews to ensure that recommendations have been responded to by the physician and have been documented.
3. The facility will communicate with the medical staff via email or through a communication folder on the neighborhood, depending on physician preference. The physician will then complete the review in the electronic medical record. Re-eduction will be provided to the medical providers. DON will review the next month's recommendation to ensure follow up was completed.
4. The facility will audit the pharmacy recommendations monthly, starting with the January reviews, for three months to ensure that a medical practitioner has addressed the concerns in a timely manner. Follow up with the medical practitioners will occur if warranted. The findings of the audit will be forwarded to the quality assurance committee for review and further recommendations.