Fmc Elizabethton

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 27405 Based on policy review, medical record review and interview, the facility failed to ensure a physician order was followed to hold a medication for 1 patient (Patient #4) of 5 sampled patients. The findings include: Review of the facility policy, “Physician Order...,” dated 7/3/2023, revealed “...Nurse practice act require nurses to carry out treatment care...based on physician orders...an order is needed whenever a new medication...or when a dose of a medication is changed...” Record review revealed Patient #4 was admitted to the center for hemodialysis on 11/1/2022, with diagnoses including End Stage Renal Disease and Type 2 Diabetes Mellitus. Record review of a hospital encounter note pertaining to a brain mass dated 7/23/2024, revealed “...fell about 5 weeks ago and imaging showed a pituitary tumor...” Record review of a physician order dated 12/21/2024, revealed “...No Mircera [an erythropoietin stimulating agent (ESA) used to treat anemia] until further direction D/T [due to] Pituitary Adenoma...” Record review of a dialysis treatment sheet dated 3/28/2025, revealed Mircera 30.000 mcg (micrograms) administered by the facility Registered Nurse. Record review of a dialysis treatment sheet dated 4/11/2025, revealed Mircera 30.000 mcg administered by the facility Registered Nurse. Record review of a physician order dated 4/24/2025, revealed “...Mircera 60 mcg...every 2 weeks...” Record review of Patient #4’s Comprehensive Interdisciplinary Assessment and Plan of Care revealed no documentation of the Pituitary Adenoma or special instructions related to administration of Mircera. During an interview on 5/29/2025 at 8:55 AM, the Clinic Manager confirmed the physician order dated 12/21/2024, was not followed when the Mircera was administered on 3/28/2025 and 4/11/2025. Interview confirmed the patient’s comprehensive plan of care did not include the presence of the Pituitary Adenoma and the reason the physician withheld the ESA for an interval. During an interview on 5/29/2025 at 10:15 AM, the Physician confirmed the medication should not have been administered on 3/28/2025 and 4/11/2025. Continued interview revealed the Physician determined to restart the medication on 4/24/2025 after Patient #4 experienced no more changes with risk versus benefit for the patient.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 27405 Based on policy review, facility documentation review and interview, the facility failed to fully assess for a Pituitary Tumor and identify a medical error for 1 patient (Patient #4) of 5 sampled patients. The findings include: Review of the facility policy “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 7/3/2023, revealed “...the patient’s Plan of Care will be guided and developed based on the findings identified in the Comprehensive Interdisciplinary Assessment...Patient stability must be reviewed monthly. The interdisciplinary team will offer input to the attending physician who will determine whether the patient is stable or unstable...” Record review revealed Patient #4 was admitted to the center for hemodialysis on 11/1/2022, with diagnoses including End Stage Renal Disease and Type 2 Diabetes Mellitus. Record review of a hospital encounter note pertaining to a brain mass dated 7/23/2024, revealed “...fell about 5 weeks ago and imaging showed a pituitary tumor...” Record review of a physician order dated 12/21/2024 revealed “...No Mircera [ESA used to treat anemia] until further direction D/T [due to] Pituitary Adenoma...” During an interview on 5/29/2025 at 8:55 AM, the Clinic Manager confirmed Patient #4’s medication error had not been identified prior to surveyor review.”