Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391
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)
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.