Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 852539	(X3) Date Survey Completed 07/13/2022
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 medical records, facility's anemia protocol, and staff interviews, it was determined that the interdisciplinary team (IDT) failed to develop and implement a plan of care to meet 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 three of four (P#2, P#3, P#4) sampled patients, whose Hgb levels were consistently below 10 g/dL (grams/deciliter). 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 four patients with Hgb levels of less than 10.0 g/dL at this facility. The facility census was seven. Findings include: P#2: Hgb last 6 months 1/12 - 8.2 2/9 - 7.6 2/23 - 8.1 3/9 - 7.5 3/23 - 8.0 4/4 - on Mircera 90 mcg. 4/6 - 8.5 5/4 - decreased dose from 90 mcg to 60 mcg based on last Hgb of 8.5 g/dL. 5/11 - 9.5 6/8 - 8.9 6/27 - dose decreased from 60 mcg to 30 mcg when Hgb dropped from 9.5 to 8.9 g/dL. There was no repeat Hgb since 6/8/22. Mircera orders were: 2/25/22 - 60 mcg; 4/4/22 - 90 mcg; 5/4/22 - 60 mcg; and 6/27/22 - 30 mcg. All doses were ordered for every 4 weeks. P#3: Hgb last 6 months 1/12 - 9.3 2/9 - 7.1 2/23 - 7.8 3/9 - 8.4 3/23 - 8.8 4/6 - 9.3 5/4 - on 60 mcg of Mircera. 5/11 - 9.0 6/8 - 8.7 6/27 - dose remained at 60 mcg even after the dropped of Hgb from 9.0 to 8.7 g/dL with no repeat Hgb level since 6/8/22. Mircera orders were: 2/25/22 - 90 mcg; 4/4/22 - 90 mcg; 5/4/22 - 60 mcg; and 6/27/22 - 60 mcg. All doses were ordered for every 4 weeks. P#4: Hgb last 6 months 1/12 - 9.0 2/9 - 10.2 2/23 - 9.8 3/9 - 9.8 4/6 - 9.2 5/4 - Mircera was increased to 60 mcg. 5/11 - 7.5 5/18 - 7.5 6/8 - 7.2 6/27 - Mircera was decreased from 60 mcg to 30 mcg when the Hgb had been trending down from 9.2 to 7.2 g/dL. Mircera orders were: 2/25/22 - 30 mcg, 4/4/22 - 30 mcg; 5/4/22 - 60 mcg; and 6/27/22 - 30 mcg. All doses were ordered for every 4 weeks. P#2, P#3 and P#4 received iron sucrose injections for the treatment of iron deficiency anemia. A review of the facility's Anemia Management Protocol titled, "Methoxy polyethylene glycol-epoetin beta (Mircera) Protocol" with no date 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. During a discussion with the Charge Nurse on 7/11/22 at approximately 12:30 p.m., she stated that the Medical Director did the Mircera adjustments, kept the Mircera in his office refrigerator, and only gave the Mircera to staff to give to patients when he came to the facility. During an interview on 7/12/22 at approximately 1:00 p.m., the Medical Director confirmed that he manages the Mircera adjustments and brings Mircera to the facility for nurses to administer. He added that the dosages can also be based on patient's symptoms if any, and their response to the medication.