§ 483.25 Quality of care
Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents. Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the residents' choices.
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Observations:
Based on staff interviews, clinical record review, and select guidelines, it was determined that the facility failed to discontinue/alter medication dosage and/or to ensure the risks were known with refusal of monitoring to prevent hyperkalemia (elevated potassium level) for one of three residents reviewed (Resident 1).
Findings include:
A review of Food and Drug Administration guideline, last approved October 27, 2025, for use of Potassium Chloride ER (extended release) tablets stated, "the use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment."
Based on National Institutes of Health guidelines, dated October 5, 2024, severe hypokalemia (<3mEq/L): For oral administration initiate at 40 mEq (milliequivalents- a unit of measure for concentration of electrolytes in body) 3 to 4 times daily or 20 mEq every 2 to 3 hours. The dose should be adjusted based on serum potassium levels, which should be rechecked every 2 to 4 hours. For patients with renal impairment: Starting at the lower end of the dosing range is recommended for patients with reduced renal function.
Review of Resident 1's clinical record revealed diagnoses that include chronic kidney disease (progressive loss of kidney function), diabetes (a long-term condition in which the body has trouble controlling blood sugar and using it for energy), and hypertension (the force of blood against the artery walls is too high). Further review revealed Resident 1 was admitted to the facility on December 15, 2025, post-surgery for a right hip fracture.
Review of Resident 1's Admission MDS (Minimum Data Set, periodic assessment of care needs) dated December 21, 2025, Section C0500 a Brief Interview for Mental Status test (BIMS -brief interview of mental status) indicated a score of 13, indicating the Resident was cognitively intact.
On December 17, 2025, laboratory results revealed Resident 1 had hypokalemia (low potassium level) of 2.8 (normal 3.5-5.3).
Other lab results included:
BUN (blood urea nitrogen [Normal level 7-20. High levels often indicate kidney dysfunction, dehydration, or heart failure]) -28
Creatinine (waste product from muscle metabolism and protein digestion, filtered from the blood by the kidneys [Normal level for women is 0.59 to 1.04]) -1.29.
eGFR (estimated Glomerular Filtration Rate - a blood test calculating how well kidneys filter waste, primarily used to diagnose and monitor chronic kidney disease [Normal level is 90 or higher, with levels below 60 for 3 months indicating chronic kidney disease]) -40.9
On December 18, 2025, Potassium Chloride ER (extended release) orders were written for 20 mEq tablets and to administer 40 mEq (2 tablets) three times a day without an end date.
On December 19, 2025, a repeat laboratory result revealed a normal potassium level of 4.5 (normal level).
Other Lab results included:
BUN -36 (high)
Creatinine -1.33 (high)
eGFR -39.5 (low)
There were no laboratory tests ordered for December 20 or 21, 2025. A laboratory test was ordered for December 22, 2025, and the Resident refused two attempts to obtain a specimen for the potassium level. There was no documentation that the facility ensured Resident 1 was made aware of the risk of declining the laboratory test. When the physician was notified that Resident 1 refused the laboratory test, the physician reordered the test to be completed on December 24, 2025.
The facility continued to administer Potassium Chloride ER 40 mEq three times a day on December 20, 21, 22, and 23, 2025, without laboratory testing of the potassium level.
On December 23, 2025, at 6:30 PM, Resident 1 was sent to the hospital emergency department (ED) due to altered mental status (confusion).
Admission labs in the emergency room revealed hyperkalemia (elevated potassium level) of 7.1. Other labs in the ED revealed creatinine 2.29, eGFR 20.6, and BUN 65. The hyperkalemia was resolved with treatment in the ED. The Resident was admitted to the hospital for continued monitoring for cause of altered mental status and an elevated white blood cell count indicating possible infection.
A written statement was received via email from the Medical Director on February 23, 2026, at 4:51 PM, which stated, "After the chart review patient potassium was replaced and corrected but due to ongoing GI losses (with h/o [history of] Crohn's disease and ongoing diarrhea receiving IV fluid also for the same ) continued on Potassium supplement with the plan to recheck but unfortunately patient refused . Patient had K checked on 12/17 Wednesday, 12/19 Friday and was ordered to be checked on Monday 12/22 (which she refused). If patient had blood work done as scheduled on 12/22, we would be able to have plan of action in place but unfortunately, she refused and due to her ongoing diarrhea rationale seems like to continue meds as this point and attempt recheck next day."
During an interview with the Nursing Home Administrator (NHA) on February 24, 2026, the NHA said staff followed the physician's orders.
28 Pa, Code 211.2(d)(3)(9) Medical Director
28 Pa. Code 211.10(c) Resident Care Policies
28 Pa. Code 211.12(c) Nursing Services
| | Plan of Correction - To be completed: 03/20/2026
1. Resident was offered to have labs drawn x2 on 12/22, MD notified and orders were received to draw labs on 12/24, resident displayed a change in condition, not related to refusal of labs and sent to ED for eval. on 12/23.
2. The facility will complete a 1 month house sweep back for all residents who had labs to ensure no adverse effects were observed from the refusal.
3. To ensure the deficient practice does not reoccur, licensed staff and provider education will be completed on educating residents who refuse laboratory collection on risk vs. benefits and direct follow up plan of care.
4. The DON/designee will audit 10 patient lab orders weekly x1 month to ensure resident lab refusals are being educated on risk vs. benefit and physician direct follow up plan of care being completed. Results will be reviewed with QAPI.
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