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)
E0000	A recertification survey was conducted at Eatonton Kidney Center from June 7, 2021 through June 10, 2021. 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 (CORE) and COVID-19 Focused Infection Control Survey was conducted at Eatonton Kidney Center from June 8, 2021 through June 10, 2021. The survey revealed that the facility was not in compliance with 42 CFR Part 494. 90 - Patient Plan of Care, 42 CFR Part 494.110 - Quality Assessment and Performance Improvement (QAPI), and 42 CFR Part 494.180 - Governance 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:
V0180	BACT CONVENT DIALYSATE-MAX & ACTION LEVELS CFR(s): 494.40(a) 4.3.2.1 Bacteriology of conventional dialysate: max & action limits Conventional dialysate should contain a total viable microbial count lower than 200 CFU/mL and an endotoxin concentration of lower than 2 EU/mL. The action level for the total viable microbial count in conventional dialysate should be 50 CFU/mL and the action level for the endotoxin concentration should be 1 EU/mL. If levels exceeding the action levels are observed in the dialysate, corrective measures, such as disinfection and retesting, should promptly be taken to reduce the levels. This STANDARD is not met as evidenced by: Based on a review of facility records, the Association for the Advancement of Medical Instrumentation (AAMI) standards, and staff interviews, it was determined that the facility failed to promptly take actions for dialysate microbial (bacterial) levels that exceeded the AAMI standards, to ensure that the water used to prepare dialysate was safe for all 10 in-center hemodialysis patients who were dialyzing at this facility. This failure had the potential to negatively affect the health and safety of all 10 patients who were under the care of this facility. Findings include: A review of AAMI recommendations revealed that because 48 hours can elapse between sampling water to determine microbial contamination and receiving results, and because bacterial proliferation can be rapid, corrective actions must be initiated promptly, before levels exceed the recommended maximum levels of 200 CFU/ml of total viable microbial count and 2 EU/mL of endotoxin concentration. It was also recommended that the water and distribution system be disinfected promptly any time the levels of bacteria or endotoxin exceeds the action levels. "Promptly" would be met if action is taken within 48 hours of receiving the results of testing. Action includes disinfecting the system, repeating cultures and notifying the Medical Director of the results. A review of chemical and microbiological monitoring logs which included 12 months (6/2020 - 5/2021) of chemical analysis, microbiological testing of water and dialysate, and monitoring of the water distribution system revealed the following: 1. Microbiology report for Hemodialysis machine #2 on 6/8/20 dialysate LAL test (Limulus Amebocyte Lysate, is a test for the determination of bacterial endotoxins) result was 1.40 EU/mL (Endotoxin Units per milliLiter). There was no documentation that the equipment was removed out of service or that it was promptly disinfected. There was no documentation of a re-draw of the dialysate culture of machine #2 until 6/29/20. There was no documentary evidence that the Medical Director (MD) was notified of this action level culture results within 24 hours of review and no documentation in the Quality Assessment and Performance Improvement (QAPI) that the abnormal results were discussed with plans of correction in order to avoid recurrence. During a discussion with the Biomed Technician (BMT) on 6/8/21 at approximately 2:30 p.m., he stated that a plan of correction (POC) for the out of range culture results was not discussed during their QAPI meeting and the Administrative Assistant confirmed that there was no documentation of the out of range results with a POC in the QAPI meeting minutes. A review of the facility's policy and procedure (P&P) titled, "Dialysate Water Microbiology and Endotoxin Sampling" with no date of creation, effectivity nor revision, stated: LAL Endotoxin: Action Level >/= 1.000 EU/mL 2. If the microbiology count/endotoxin concentration exceeds the action threshold, take corrective action. - If this 1st result to exceed the action threshold, retake sample as soon as possible (2 days or 1 week the latest) - If this is the 2nd result to exceed the action threshold, contact person responsible for dialysis water quality assurance (e.g. biomed, renal tech, nursing unit), if not already notified. - If this is the 3rd (or more) results to exceed the action threshold, it is likely that biofilm is present in the water treatment and must be removed. Contact the water treatment system vendor for guidance. Retest the system or DI tanks. The facility's P & P regarding the action level for culture results that were out of range did not satisfy the recommendations of AAMI.
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 observations and staff interviews, it was determined that the facility failed to ensure that there was a safe environment for all 10 in-center hemodialysis patients as evidenced by: standing water on the floor around the booster pump in one of one Dialysate Preparation room, which could promote microbial growth; two ceiling tiles in one of one isolation room that had yellowish-brown water stains approximately 7 - 12 inches in circumference; and four of four oxygen tanks along the wall toward the supply room were free standing and unsecured. This failure to maintain a safe environment could negatively affect the health and safety of all six staff and all 10 patients who were under the care of this facility. Findings include: During a tour of the facility with the Administrative Assistant on 6/8/21 at 10:00 a.m., the following was observed: Isolation Room: There were two ceiling tiles in the isolation room (one tile above the entrance door and one above the left side of the room) that had yellowish-brown water stains approximately 7 - 12 inches in circumference. Hallway to the Supply Room: There were four oxygen tanks along the wall toward the supply room that were unsecured and free standing. According to Occupational Safety and Health Administration (OSHA) 1910.253(b)(2)(ii)... ... Oxygen cylinders ... assigned storage spaces shall be located where cylinders will not be knocked over or damaged by passing or falling objects or subject to tampering by unauthorized persons... Additionally, oxygen tanks should be stored in a stand or cart to prevent tipping and falling... Do not allow tank to stand or lean in an upright position while unsecured... Dialysate Preparation Room: There was a pool of standing water, approximately three to four feet in circumference, on the floor around the booster pump. According to the Biomed Technician (BMT) on 6/8/21 at 12:00 p.m., he stated that the pipe under the booster pump was leaking and needed to be repaired. On 6/10/21 at 3:00 p.m., this surveyor observed that the standing water remained on the floor of the Dialysate Preparation Room and the leaking pipe was still not repaired. The Administrative Assistant and Human Resource personnel acknowledged this observation on 6/10/21 at 3:00 p.m.
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 a review of facility records and staff interviews, it was determined that the facility failed to follow the manufacturer's guidelines for the maintenance of the Neo2 Meter (a precision test instrument that measures the conductivity, temperature, pH (test for acidity) of liquids, such as dialysate solution used with hemodialysis delivery systems and may also be used to test the pH and conductivity of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications). This failure had the potential to negatively affect the health and safety of all 10 in-center hemodialysis patients that dialyze at the facility. Findings include: A review of facility records revealed that the last date of the annual calibration of the Neo2 Meter was not available. The only record found was a request for calibration dated 7/26/17. The manufacturer's recommendation was for the Meter to be returned for maintenance annually to keep the Meter in good repair. According to the biomed technician (BMT) on 6/8/21 at approximately 3:00 p.m., he stated that the Neo2 Meter was calibrated in 2019 but was not sure of the date and he could not provide a documented evidence of the certificate of calibration. The Administrative Assistant could not find the documentation, except a request form for calibration dated 7/26/17. The Administrative Assistant, on 6/9/21 at approximately 3:00 p.m., gave this surveyor a copy of the facility's request to Mesa Labs (Manufacturer) for calibration of Neo2 Meter dated 7/26/17 and stated that, that was all the documentation she could find.
V0519	PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- (1) At least annually for stable patients; This STANDARD is not met as evidenced by: Based on a review of patients' medical records and staff interview, it was determined that the facility failed to ensure that four of five sampled patients (P#1, P#3, P#4, and P#5) received an annual comprehensive reassessment from each member of the interdisciplinary team (IDT), prior to the development of the patients' plan of care. This failure had the potential to negatively affect the health and safety of all 10 patients who were under the care of this facility. Findings include: - P#1 was admitted to this facility on 3/18/20. There was no documented evidence that the patient had an initial comprehensive interdisciplinary (IDT) assessment, 90-day IDT reassessment, and an annual IDT reassessment and Plan of Care (POC). The Administrative Assistant stated on 6/9/21 at approximately 11:30 a.m., that P#1 was very non-compliant and had frequent absences such as "no shows" and hospitalizations although the IDT had repeatedly encouraged P#1 to come for his dialysis treatments. There was no documented evidence that the IDT evaluated and developed an unstable comprehensive assessment/reassessment and POC. - P#3 was admitted to this facility on 6/11/18. The last annual comprehensive IDT reassessment and POC was dated 2/21/20. - P#4 was admitted to this facility on 8/9/19. The last annual comprehensive IDT reassessment and POC was dated 2/21/20. - P#5 was admitted to this facility on 5/2/18. The only available IDT assessment and POC was from a previous facility where P#5 transferred from, dated 3/29/18. The Kidney Disease Quality of Life (KDQOL) was completed by the Social Worker on 7/27/20. There was no documentary evidence of an annual comprehensive reassessment and POC that was done by the IDT. The Assistant Administrator was notified of the above findings on 6/10/21 at 4:30 p.m. and did not provide evidence of comprehensive reassessments that were used for the revision of the above listed patients' plans of care. The Director of Nursing was not available for interview.
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 and staff interviews, it was determined that the facility failed to conduct an evaluation of the patients' anemia management needs in order to attain and sustain 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. The accepted clinical practice standard for Hgb levels for dialysis patients is 10-12 gm/dL. This deficient practice had the potential to negatively impact the health and safety of four of five patients whose Hgb was below (<) 10 gm/dL. The facility census was 10. 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 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.
V0625	CFC-QAPI CFR(s): 494.110 This CONDITION is not met as evidenced by: Based on a review of quality assessment and performance improvement (QAPI) meeting minutes, and staff interviews, it was determined that the interdisciplinary team (IDT) failed to develop an effective QAPI program that monitored indicators related to the patient outcomes and safety. This failure had the potential to negatively impact the health and safety of all 10 patients who were under the care of this facility. Findings include: Cross Reference V 632 - Failure of the facility to effectively manage anemia (low red blood cell counts) outcomes; and to evaluate the effectiveness of the facility's anemia protocol during QAPI meetings.
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 consistently 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 the facility's Quality Assessment and Performance Improvement (QAPI) meeting minutes reviewed (November 2020 - April 2021). This deficient practice had the potential to negatively affect the health and safety of all 10 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 hemoglobin less than 10 g/dL should not exceed 22.3 % for hemodialysis patients. The facility's average DFR report for fiscal year (FY) 2021 was 32 %. The six months of QAPI monthly report of Hgb <10 g/dL percentages that was audited far exceeded the US average hemoglobin. A review of the facility's QAPI meeting minutes from November 2020 - April 2021, revealed the following percentage of patients with Hemoglobin <10 g/dL: November 2020 - 57% December 2020 - 57% January 2021 - 57% February 2021 - 75% March 2021 - 56% April 2021 - 56% 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. During a discussion with the Administrative Assistant and the Director of Nursing on 6/8/21 at 2:00 p.m., the Administrative Assistant stated and confirmed by the Director of Nursing, that the Medical Director decided when to give Mircera Injections (medication to treat Anemia of patients with Kidney Failure), which he kept himself and brought them to the facility when it's time to give patients their injections.
V0750	CFC-GOVERNANCE CFR(s): 494.180 This CONDITION is not met as evidenced by: Based on facility record review and staff interviews, it was determined that the Governing Body (GB) failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to cause harm to all 10 patients who were receiving dialysis treatments at this facility. Findings include: Cross references: V 180 - Failure of the facility to promptly take actions for dialysate microbial (bacterial) levels that exceeded the AAMI standards, to ensure that the water used to prepare dialysate was safe. V 402 - Failure of the facility to ensure that there was a safe environment for all 10 in-center hemodialysis patients. V 403 - Failure of the facility to follow the manufacturer's guidelines for the maintenance of the Neo2 Meter. V 519 - Failure of the interdisciplinary team (IDT) to ensure that four of five sampled patients (P#1, P#3, P#4, and P#5) received an annual comprehensive reassessment from each member of the interdisciplinary team (IDT), and the development of the patients' plan of care. V 632 - Failure of the facility to effectively manage anemia (low red blood cell counts) outcomes.