§483.45(d) Unnecessary Drugs-General. Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used-
§483.45(d)(1) In excessive dose (including duplicate drug therapy); or
§483.45(d)(2) For excessive duration; or
§483.45(d)(3) Without adequate monitoring; or
§483.45(d)(4) Without adequate indications for its use; or
§483.45(d)(5) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or
§483.45(d)(6) Any combinations of the reasons stated in paragraphs (d)(1) through (5) of this section.
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Observations:
Based on clinical record review and staff interviews, the facility failed to ensure documented evidence of clinical necessity for the administration of antibiotic medications in accordance with established guidelines for two of five sampled residents for unnecessary medication prescribing practices (Resident 14 and 34).
Findings included:
A review of Resident 14's clinical record revealed the resident was admitted to the facility on September 16, 2024, with diagnoses including psychotic disorder with delusions (type of serious mental illness called a psychotic disorder and people who have it can't tell what's real from what is imagined) and history of UTI (urinary tract infection - an infection in any part of the urinary system).
A review of nursing progress notes for Resident 14's completed by Employee 1, a Licensed Practical Nurse (LPN), dated November 14, 2024, at 10:59 AM, revealed the resident had increased confusion and complaints of burning upon urination with NON (new orders noted) for a (urinalysis) and C & S (culture and sensitivity - a urine culture is considered positive if it shows the presence of more than 100,000 colony-forming units (CFUs) of bacteria per milliliter of urine and indicates the presence of an infection. The sensitivity test helps select the best medicine to treat the infection).
C&S results dated November 18, 2024, at 7:07 AM identified Citrobacter murliniae (a species of bacteria) 70,000-90,000 CFU/mL and Proteus mirabilis (gram-negative rod-shaped bacteria) 20,000-30,000 CFU/mL and was susceptible (responsive to treatment) to nitrofurantoin, gentamicin, and trimethoprim/sulfamethoxazole (antibiotics).
A review of a facility provided form entitled "Revised McGeer's Criteria for Infection Surveillance Checklist" (an algorithm that uses criteria to make an empiric diagnosis of UTI in nursing home residents. For resident's that do not have an indwelling urinary catheter and with at least three of the following signs and symptoms must be present prior to a practitioner prescribing antibiotic therapy include a fever (temperature of at least 100.4new or increased frequency, urgency, or burning on urination, new flank or suprapubic pain or tenderness, change in character of urine, and worsening of mental or functional status) determined that UTI criteria was not met for an ATB to be prescribed.
Despite results not meeting McGeer's criteria for a UTI diagnosis, the physician prescribed Macrobid 100 mg twice daily for 7 days on November 18, 2024, at 12:54 PM.
A review of a facility provided form entitled "72-Hour Antibiotic Time-Out" form indicated antibiotic appropriateness as "no" and confirmed that the resident did not meet McGeer's criteria for antibiotic treatment.
The resident received 13 of 14 prescribed doses of Macrobid without documented justification for the antibiotic's use.
During an interview on January 16, 2025, at 10:15 AM the Infection Preventionist (IP) confirmed the prescribing physician was aware the criteria were not met, and the facility failed to prevent unnecessary antibiotic use.
A review of Resident 34's clinical record revealed the resident was admitted to the facility on September 16, 2024, with diagnoses including dementia (a term used to describe a group of symptoms affecting memory, thinking and social abilities and the symptoms may interfere with individual's daily lives) and a history of UTI.
A review of Resident 34's clinical record of nurses' progress notes completed by Employee 2, a LPN, dated December 3, 2024, at 10:18 AM and 1:09 PM, revealed that the resident had increased lethargy and weakness, leading to physician orders for urinalysis and C&S testing. Macrobid 100 mg (an antibiotic that fights bacteria in the body) oral capsule 100 mg (milligrams), twice daily was prescribed the same day.
A review of a facility form entitled "Newly Diagnosed Infection Report" dated December 3, 2024, completed by the Director of Nursing (DON) indicated a diagnosis of UTI; the resident was transferred to the ER (emergency room) and returned on Macrobid 100 mg orally twice daily for 7-days.
However, the "Revised McGeer's Criteria for Infection Surveillance Checklist" form was incomplete and did not provide evidence supporting the UTI diagnosis.
Further review of physician's orders dated December 4, 2024, at 5:51 PM, revealed an order for Rocephin (ceftriaxone sodium an antibiotic administered via injection and used to treat many kinds of bacterial infections) Sodium Injection Solution Reconstituted, inject 1 gm (gram) intramuscularly two times a day related to UTI until December 9, 2024, at 1:00 PM.
Additionally, physician's orders were obtained on December 4, 2024, at 9:27 PM, to discontinue IM Rocephin and change to IV (intravenous therapy is a medical technique that administers fluids, medications, and nutrients directly into a person's vein) Rocephin Solution Reconstituted 1 gm (gram) intravenously every 12 hours for infection related to UTI.
A review of culture results dated December 6, 2024, at 7:59 AM, revealed Resident 34's final urinalysis and C & S results that were 80,000-90,000 CFU/mL of E. coli (is bacteria from the intestines is present in fecal matter and trace amounts of fecal matter make their way into the urinary tract through the urethra opening and begin to multiply).Despite this, the "72-Hour Antibiotic Time-Out" form indicated the resident did not meet McGeer's criteria for antibiotic treatment.
The resident received two doses of Macrobid, one dose of intramuscular (IM) Rocephin, and four doses of intravenous (IV) Rocephin without documented evidence of clinical necessity.
During interviews on January 16, 2025, at 10:30 AM, the IP and the Nursing Home Administrator (NHA) confirmed the prescribing physician and staff failed to ensure adherence to prescribing guidelines, and nursing staff inconsistently completed the surveillance checklist.
During an interview on January 16th, 2025 at 11:05 AM, the nursing home administrator (NHA) confirmed the facility failed to ensure adherence to antibiotic prescribing criteria for Residents 14 and 34. This failure resulted in the administration of unnecessary medications, inconsistent completion of infection surveillance documentation and non compliance with the established guidelines for the prevention of unnecessary medication use.
28 Pa. Code 211.2 (3) Medical Director
28 Pa. Code 211.9 (k) Pharmacy Services
28 Pa. Code 211.12 (d)(1)(3) Nursing Services
28 Pa. Code 211.5 (f)(ix) Medical records
| | Plan of Correction - To be completed: 03/05/2025
1. The facility cannot retroactively correct administration of unnecessary medications given to resident 14 and resident 34. 2. Current antibiotic therapies reviewed for proper documentation. 3. Nursing staff will be in serviced by Infection Preventionist on the "Revised McGeer's Criteria for Infection Surveillance Checklist" regarding completion of infection surveillance and documentation. Physicians will be educated by Infection Preventionist on the established guidelines for the prevention of unnecessary medication use. McGeer's will be reviewed during AM report to assure documentation appropriate. 4. A QAPI study will be completed by Infection Preventionist/designee to identify completion criteria met and appropriate antibiotic prescribing practices x 8 weeks.
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