Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 852539	(X3) Date Survey Completed 06/10/2021
Name of Provider or Supplier Eatonton Kidney Center	Street Address, City, State 103 N Washington Avenue, Eatonton, GA
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.

(X4) ID Prefix Tag

Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)

V0547

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:
Based on a review of patients' medical records, facility's anemia protocol, and staff interviews, it was determined that the interdisciplinary team (IDT) failed to conduct an evaluation of the patients' anemia management needs in order to attain and maintain appropriate blood levels of Hemoglobin (Hgb - protein in red blood cells that carries oxygen) of four of five patients (P#1, P#2, P#3, and P#5) sampled, whose Hgb levels were consistently below 10 g/dL (grams/deciLiter) until May, 2021. The accepted clinical practice standard for Hgb levels for dialysis patients is 10-12 g/dL. This deficient practice had the potential to negatively affect the health and safety of all four patients with Hgb levels of less than 10.0 g/dL at this facility. The facility census was 10. Findings include: P#1's Hgb counts: 2/3/21 - 6.7 2/8/21 - 6.7- received 2 units of Packed Red Blood Cells (PRBC) at a hospital as ordered by the Medical Director (MD). 2/10/21 - 9.0 3/3/21 - 9.0 4/9/21 - 8.3 5/5/21 - 8.1 P#1 received Mircera injection (medication used for the treatment of Anemia in patients with Kidney Failure) 60 mcg on 2/24/21, 3/12/21 and 4/19/21. P#1 also received Venofer 50 mg (for iron deficiency anemia) weekly in the month of February, 2021 then changed to Ferrlecit (also for iron deficiency anemia). The Administrative Assistant stated on 6/9/21 at 11:00 a.m. that P#1 was at the hospital for most of the month of May and had yet to return to the facility. P#2's Hgb counts: 1/2/21 - 8.8 2/3/21 - 9.6 2/10/21 - 9.2 3/3/21 - 7.9 4/7/21 - 9.4 5/7/21 - 9.2 P#2 received Mircera 30 mcg on 2/24/21, Mircera 60 mcg on 3/12/21, Mircera 30 mcg on 4/16/21, Mircera 60 mcg on 5/19/21 and 5/24/21. P#3's Hgb counts: 3/3/21 - 10.7 4/7/21 - 9.1 5/5/21 - 7.4 P#3 had 2 units of PRBC on 1/11/21, 2/15/21 and 5/10/21. P#3 received Mircera 60 mcg on 1/25/21, Mircera 30 mcg on 3/1/21, and Mircera 30 mcg on 4/16/21. P#5 Hbg counts: 1/6/21 - 8.8 2/3/21 - 7.5 2/11/21 - 7.9 3/3/21 - 7.8 4/7/21 - 8.5 5/5/21 - 8.3 P#5 had no doctor's orders for ESA (Erythropoiesis-stimulating agents) such as Mircera, in the treatment of anemia since 1/11/21 - 5/10/21 records reviewed. All four patients (P#1, P#2, P#3 and P#5) received iron sucrose injections for the treatment of iron deficiency anemia. A review of the facility's anemia management protocol, specifically, titled, "Methoxy polyethylene glycol-epoetin beta (Mircera) Protocol", with no creation, effective nor revision dates, stated: - Hemoglobin Target Goal - 10.0 - 12.0 g/dL Methoxy polyethylene glycol-epoetin beta dosing: - Step 1 - 30 mcg every four weeks - Step 2 - 50 mcg every four weeks if no reticulocyte response - Step 3 - 30 mcg every four weeks - Step 4 - 50 mcg every 4 weeks ... Maximum dose (at Step 7 ) - 100 mcg every four weeks... If Hgb is below 10 g/dL then start Mircera at 30 mcg/kg/4 weeks and round up to closest step per table. The Administrative Assistant stated on 6/8/21 at 2:00 p.m., that the MD kept the Mircera in his refrigerator, and only gave the Mircera to the nurse to give to patients when he came to the facility. The Director of Nursing also confirmed on 6/8/21 at 2:00 p.m., that the MD managed the patients' anemia.