| 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) |
| E0000 | A Recertification Survey was conducted at Eatonton Kidney Center from July 11, 2022 through July 13, 2022. The survey revealed that the facility was in compliance with 42 CFR Part 494.62, Conditions for Coverage for Emergency Preparedness Plan for End Stage Renal Disease facilities. No deficiencies were cited. |
| V0000 | A Recertification survey was conducted at Eatonton Kidney Center from July 11, 2022 through July 13, 2022. The survey revealed that the facility was not in compliance with 42 CFR Part 494. 90 - Patient Plan of Care and 42 CFR Part 494.150 - Responsibilities of the Medical Director, for End Stage Renal Disease Facilities. The following standard level deficiencies were also cited which resulted from the facility's noncompliance related to the survey: |
| V0402 | PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This STANDARD is not met as evidenced by: Based on observation and staff interview, it was determined that the facility failed to ensure that there was a safe environment for all staff and 7 patients who were dialyzing at this facility, as evidenced by uneven floor surfaces and exposed concrete. These environmental concerns were observed in one of one patient treatment room and one of one water treatment room. Findings include: During a tour of the facility on July 11, 2022 between 10:30 a.m. and 11:30 a.m., the following was observed: In the Water Treatment Room: - The floor throughout the room had uneven areas with exposed concrete creating a wavelike uneven surface. Thus had the potential for staff to trip or fall. In the Patient Treatment Room: - The vinyl strip tile in the nurses station area was lifted up from the subflooring causing an uneven surface. Thus had the potential for staff or patients to trip or fall. During an interview on 7/11/22, at approximately 2:00 p.m., the Administrative Assitant stated that the floor tiles and floor in water treatment room needed to be repaired. |
| V0403 | PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations. This STANDARD is not met as evidenced by: Based on observation and staff interview, it was determined that the facility failed to have a system in place to ensure that seven of seven hemodialysis machines (machines #1- #7) were maintained and free of unsanitary substances. Findings were: During a tour of the facility on July 11, 2022 between 10:30 a.m. - 11:30 a.m., the following was observed: - Machines #1 - #7 had peeling paint and rust colored stains covering the lower surfaces of the machines. During an interview with the Biomed on 7/12/22 at approximately 12:30 p.m., he stated that the machines needed to be painted. |
| V0540 | CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This CONDITION 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 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: Cross Reference V 547 - Failure of the facility to effectively manage the patients' anemia outcomes. |
| 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. |
| V0557 | POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This STANDARD is not met as evidenced by: Based on a review of medical records and facility policy, and staff interview, it was determined that the facility failed to ensure that a plan of care (POC) was developed and implemented within 30 days of admission for one of one new patient sampled (P#6), who was admitted in 2022. This failure had the potential to negatively affect the health and safety of all newly admitted patients. The facility census was seven. Findings were: A review of medical records revealed the following: - P#7 was admitted on 5/16/22. There was no documented initial POC within 30 days of admission. During an interview with the Administrative Assistant on 7/13/22 at approximately 2:30 p.m., the stated that the initial plan of care should have been completed for P#7 within 30 days of admission, or after 13 dialysis treatments. |
| V0632 | QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This STANDARD is not met as evidenced by: Based on a review of facility records and staff interviews, it was determined that the facility failed to develop and implement plans of action to improve the effectiveness of the facility's management of patients with Hemoglobin (Hgb - Protein in red blood cells that carries oxygen throughout the body) less than (<) 10 g/dL, for six of six months of Quality Assessment and Performance Improvement (QAPI) meeting minutes reviewed (December 2021 - June 2022 ). This deficient practice had the potential to negatively affect the health and safety of seven patients who were under the care of this facility. Findings include: A review of the Dialysis Facility Report (DFR - A report prepared by the Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients) revealed that the average Hgb <10 g/dL should not exceed 22.3 % for hemodialysis patients. The facility's average Hgb <10 g/dL for fiscal year 2021, was 32 %. A review of the facility's QAPI meeting minutes from December 2021 - May 2022, revealed the following percentage of patients with Hemoglobin <10 g/dL: December 2021 - 82% January 2022 - 62% February 2022 - 62% March 2022 - 71% April 2022 - 56% May 2022- 71% There was documentation of the same root causes and action plans every month, however, there was no documentation that the effectiveness of the action plans were evaluated to ensure improvement in the patients' anemia status. The action plans were not revised and implemented to maximize the number of patients who achieve the goals for anemia. During a discussion with the Charge Nurse on 7/11/22 at approximately 12:30 p.m., she stated that the Medical Director does the Mircera adjustments and keeps the Mircera in his office refrigerator, and only gives the Mircera to staff, to give to patients when he comes to the facility. During a discussion with the Administrative Assistant on 7/13/22 at approximately 12:00 p.m., the Administrative Assistant stated that the Medical Director did the adjustments for Mircera (medication given for low Hgb) which he kept himself and brought them to the facility when it's time to give patients their injections. |
| V0710 | CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This CONDITION is not met as evidenced by: Based on observation, a review of facility records and staff interviews, it was determined that the Medical Director failed to demonstrate responsibility for the operations of the facility, and ensured the delivery of quality patient care and clinical outcomes. This failure had the potential to negatively impact the health and safety of seven in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross References: V 547- Failure of the facility to provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. V 632 - Failure of the facility to develop and implement plans of action to improve the effectiveness of the facility's anemia management program. |