Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 852569	(X3) Date Survey Completed 06/23/2023
Name of Provider or Supplier Dialysis Center Of Athens	Street Address, City, State 210 Hawthorne Park, Athens, 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 Dialysis Center of Athens from June 21, 2023 through June 23, 2023. 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 Dialysis Center of Athens from June 21, 2023 through June 23, 2023. The survey revealed that the facility was not in compliance with 42 CFR 494.30 - Infection Control, 42 CFR 494.40 - Water and Dialysate Quality, 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:
V0110	CFC-INFECTION CONTROL CFR(s): 494.30 This CONDITION is not met as evidenced by: Based on observation, staff interviews, a review of Centers for Disease Control and Prevention (CDC) guidelines, and a review of facility policy and procedures (P&P), it was determined that the facility failed to ensure that the staff practiced infection control techniques to prevent transmission of dangerous pathogens in the hemodialysis unit. This deficient practice had the potential to negatively affect the health and safety of all 13 in-center hemodialysis patients who were receiving dialysis at this facility. Findings include: Cross reference: V 117 - Failure of the facility to ensure Direct Patient Care Staff (Registered Nurse and Patient Care Technicians) did not store or keep blood specimens for labs in the Medication Refrigerator.
V0117	IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This STANDARD is not met as evidenced by: Based on observation, a review of the CDC recommendations, staff interviews, and a review of the facility P & P, it was determined that the Infection Control Committee failed to ensure that three of three Direct Patient Care (DPC) Staff (Registered Nurse - RN AA, and Patient Care Technicians (PCTs AA and BB), who were present during this observation, utilized appropriate infection control techniques to prevent cross contamination. This breach in infection control techniques could negatively affect the health and safety of four of four in-center hemodialysis Patients (P), (P#2, P#3, P#4, and P#5), who were undergoing hemodialysis at the time of this observation and the other nine patients (P#1, P#6, P#7, P#8, P#9, P#10, P#11, P#12, and P#13), who were also under the care of this facility. Findings include: During a tour of the Patient Treatment Room on 6/21/23 at 11:30 a.m., the following was revealed: -There was a ziplock bag full of blood samples in vacutainer blood collection tubes (approximately 10 tubes) in the Medication Refrigerator stored with patients' medications. - PCT AA stated on 6/21/23 at 11:40 a.m. that the new nurse probably didn't know where to put the lab tubes yet. - RN AA (new to the clinic nurse) stated on 6/23/23 at 2:05 p.m. that she did not put the lab tubes in the medication refrigerator. She added that she was shocked to see them there. -According to the CDC, cross contaminating, storing dirty (blood sample tubes) in a clean area such as (Medication Refrigerator that had pre-filled medication syringes and vials), could cause the spread of bacteria/infections.
V0175	CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This CONDITION is not met as evidenced by: Based on observation, staff interviews, a review of the manufacturer's directions for use (DFU), and a review of the facility's Policy and Procedures (P&P), it was determined the facility failed to ensure the water used for dialysis was accurately monitored to provide safe treatment for all patients. This failure had the potential to cause harm to the health and safety of four of four patients (P) (P#2, P#3, P#4, and P#5), who were receiving Hemodialysis treatment at the time of this observation. Findings include: Cross Reference: V196 - Failure of the facility to ensure that staff accurately performed the Total Chlorine Test of water used for dialysis to ensure the water was safe for dialysis.
V0196	CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This STANDARD is not met as evidenced by: Based on observations, a review of the manufacturer's directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis) using Serim Guardian Hi-Sense Ultra 0.1 Total Chlorine Test Strips, a review of the facility's Policy and Procedures (P&P), a review of the Total Chlorine logs, and staff interviews, it was determined that the facility failed to ensure that two of two Patient Care Technicians (PCTs AA and BB) observed, who were assigned the task of testing the water quality, properly performed the Total Chlorine Test according to the manufacturer's DFU. This deficient practice had the potential to cause harm to the four patients (P) (P#2, P3, P#4 and P#5), who were undergoing hemodialysis at the time of this observation. The facility in-center hemodialysis (ICHD) census was 13. Findings include: During observation of Patient Care Technicians (PCTs AA's and BB's), performance of the Total Chlorine test using Serim Guardian Hi-Sense Ultra 0.1 test strip on 6/21/23 between 12:00 p.m. and 12:30 p.m., the following was observed: - PCT BB obtain the water sample without flushing the sample site for a minimum of 30 seconds. - PCT BB stated before initiating the procedure on 6/21/23 at 12:05 p.m., that he was going to swish the test strip back and forth for 60 seconds, then proceeded to swish the test strip without looking at the clock. According to this surveyor's time, PCT BB swished the strip for 25 seconds. PCT BB stated on 6/21/23 at 12:08 p.m. that he counted the time in his head. This surveyor also pointed out to PCT BB on 6/21/23 at 12:10 p.m., that he did not flush the sample site for 30 seconds according to the facility's procedure, before obtaining the sample. PCT BB acknowledged this observation on 6/21/23 at 12:11 p.m., but stated that he did flush the sample site first thing when he opened this morning and during the second testing at 8:30 a.m. today. This surveyor allowed PCT BB to re-do the total chlorine testing. PCT BB again stated that he was going to swish the test strip for 60 seconds, and proceeded to count out loud, without looking at the clock on the wall. He counted fast 1,2,3,4... instead of 1-one thousand, 2-one thousand... This surveyor timed it and the total swishing time was 35 seconds. - PCT AA was observed performing the Total Chlorine Test on 6/21/23 at 12:15 p.m. PCT AA stated that she was going to swish the test strip (after flushing the sample site for 30 seconds before obtaining the sample), for 45 seconds, using her watch timer. When shown the Manufacturer's DFU, she stated on 6/21/23 at 12:25 p.m. that she thought it was for 45 seconds. - A review of the Manufacturer's Directions for Use (DFU) of Serim Guardian Hi-Sense Ultra 0.1 Total Chlorine Test Strips, as well as the facility' Policy (no number), titled, "SEMI-QUANTITATIVE PROCEDURE FOR FREE CHLORINE AND/OR CHLORAMINES IN FEED OR RINSE WATER Serim Guardian HiSense Ultra 0.1", no date(s), stated: 3- Flush sample site for a minimum of 30 seconds prior to collecting the sample. 4- Collect the sample just prior to performing the test as Chlorine tends to dissipate (decrease) out of the sample quickly. 5- Fill the sample cup with the water to be tested. Discard the contents and refill with 20 ml of water. 6- Start the timer and immerse the indicator pad into the water sample. Vigorously swish the test strip back and forth for a full 30 seconds. 7- Remove the strip and shake once, briskly, to remove excess water. 8- Immediately compare the color of the indicator pad to the color chart on the bottle label. 9- Record the results, then discard the test strip according to federal, state and local regulations. Note: All four patients were being taken care of by PCT CC and Registered Nurse (RN AA) and were discharged at end of their treatment, while PCTs AA and BB were performing the Total Chlorine Test. - During a review of the Total Chlorine logs on 6/21/23 at approximately 1:00 p.m., it was revealed that there was a record of the Total Chlorine Test prior to the start of each patient treatments on 6/21/23, which were consistently <0.01 parts per million (PPM). The Facility Administrator was notified of this observation on 6/21/23 at approximately 1:05 p.m. The water was re-tested and was found to be at <0.01 PPM.
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 interviews, it was determined that the facility failed to maintain the integrity of the building to ensure the safety of the 13 patients who dialyzed at this facility. This failure could hinder effective cleaning and disinfection of the surfaces, thus had the potential for microbial growth. This deficient practice was observed in one of one Dialysate Preparation Room and front lobby. Findings include: During observation in the Dialysate Preparation Room on 6/21/23 at 12:40 p.m., with Patient Care Technician (PCT AA), the following was revealed: - The cement floor around the drain area between the Primary Carbon Tank and Water Softener Tank, were chipped exposing a porous surface that was conducive to microbial growth. - The Fluorescent ceiling light at the entrance of the Dialysate Preparation Room was not working. - There were two ceiling tiles that were covered with water stains at the lobby's ceiling. - The Biomedical Technician (BMT) was notified and acknowledged the above observations on 6/22/23 at 1:50 p.m.
V0638	QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This STANDARD is not met as evidenced by: Based on a review of the Quarterly Update of the Fiscal Year 2023 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), a review of facility records, and staff interview, it was determined that the Quality Assessment and Performance Improvement (QAPI) Committee failed to track, trend, analyze, and develop plans of action to improve and sustain the facility's Dialysis Adequacy, Mineral Metabolism, Influenza Vaccination, and Transplant status for five of five months (available records at the time of this review - December 2022 to April 2023) of QAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the health and safety of 13 in-center hemodialysis (ICHD) patients, who were under the care of this facility. Findings include: A review of the Quarterly Update of the Fiscal Year 2023 DFR revealed the following facility report (specifically Quarter (Q)1, Q2 and Q3 of 2022): 1. Dialysis Adequacy - 0.0 but 100% missing or out of range 2. Mineral Metabolism (Phosphorus and Uncorrected Calcium) - 0.0 but 100% missing or out of range. 3. Influenza Vaccination - left blank -- US Threshold was 78.9% 3. Transplantation - 9.1% -- US Threshold was 17.7% The QDFR 2023 stated: "Missing values ('.') indicate there were too few patients to yield reliable results. A blank value indicates the measure was not calculated and therefore not reported for any facility". In comparison, a review of the facility's last five months available (that were available) of QAPI meeting minutes from December 2022 to April 2023, revealed the following outcomes that were greater than (>) the US threshold. ICHD patients: 1. Kt/V (a number used to quantify hemodialysis treatment adequacy) less than (<) 1.2 for ICHD ranged from 15% - 38%. Whereas, US threshold was 1.5%. 2. Mineral Metabolism: Phosphorus (PO4) greater than > 7.0 - ranged from 33.3% - 42.9%. Whereas, US threshold was 16%. Uncorrected Calcium greater than >10.2 - ranged from 5% - 26.4%. Whereas, US threshold was 1.2%. 3. Influenza Vaccination - 3 patients out of 13 were vaccinated (23%). Whereas, US threshold was 78.9% 4. Transplant - 7.69% (1 patient) on active waitlist. There were no new changes since December, 2022. The Registered Dietitian stated on 6/22/23 at approximately 1:30 p.m., that patients were educated about their PO4 and were prescribed Calcium Acetate, but most are noncompliant. During a discussion with the Facility Administrator on 6/23/23 at 3:30 p.m., she stated that the reported data in Crowne Web may have been entered incorrectly, but acknowledged the need to improve adequacy, mineral metabolism, influenza vaccination and transplantation as reflected in their monthly QAPI meeting minutes/report.
V0750	CFC-GOVERNANCE CFR(s): 494.180 This CONDITION is not met as evidenced by: Based on observations, staff interviews, a review of the manufacturer's directions for use (DFU) and facility policy and procedures (P & P), it was determined that the Governing Body who is responsible for the governance and operation of the facility, failed to ensure that policies, procedures and regulations relative to the health care and safety of patients, and to the general operation of the facility were adhered to. This failure had the potential to negatively affect the health and safety of all 13 patients who were under the care of this facility. Findings include: Cross Reference V 117 - Failure of the Governing Body to ensure Direct Patient Care Staff (Registered Nurse and Patient Care Technicians) did not store or keep blood specimens for labs in the Medication Refrigerator. Cross Reference V 196 - Failure of the Governing Body to ensure the Direct Patient Care Staff (Registered Nurses and Patient Care Technicians) follow the manufacturer's DFU to accurately determine the level of Total Chlorine in the water used for dialysis. Cross Reference V 638 - Failure of the Governing Body to monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time.