| Statement of Deficiencies | (X1) Provider/Supplier/CLIA Identification Number 852552 | (X3) Date Survey Completed 09/14/2023 |
| Name of Provider or Supplier Fresenius Kidney Care Mcdonough | Street Address, City, State 50 Kelly Road, Ste 100, Mcdonough, 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) |
| V0000 | An unannounced onsite survey was conducted on September 14, 2023 to investigate complaint #GA00238561. One of four allegations was substantiated. The investigation revealed that the facility was not in compliance with 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 deficiency was also cited which resulted from the facility's noncompliance related to the survey: |
| V0175 | CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This CONDITION is not met as evidenced by: Based on a review of records and facility's Policy and Procedures (P&P) and staff interviews, it was determined that the facility failed to ensure that the water used for dialysis was monitored for total chlorine in a timely manner, to provide safe treatments for all patients. Residual levels of total chlorine in the water used for dialysis may result in the destruction of patient's red blood cells (hemolysis) and had the potential to cause harm to 48 in-center hemodialysis patients who were dialyzing at this facility. Findings were: Cross Reference: V196 - Failure of the facility to measure total chlorine in the water used for dialysis in a timely manner. |
| 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 a review of records and facility's Policy and Procedures (P&P) and staff interviews, it was determined that the facility failed to ensure that the water used for dialysis was monitored for total chlorine in a timely manner, to provide safe treatments for all patients. These deficient practice occured during six of 13 dialysis days in July 2023 and one in August 2023. Residual levels of total chlorine in the water used for dialysis may result in the destruction of patient's red blood cells (hemolysis) and had the potential to cause harm to 48 in-center hemodialysis patients who were dialyzing at this facility. Findings were: A review of the daily water logs and Biomed monthly water audits from July 2023 - September 2023 revealed six late entries for total chlorine checks. All checks were completed but showed late entries of 12 minutes on 7/3/23, four minutes on 7/10/23, 15 minutes on 7/14/23, 17 minutes on 7/17/23, 18 minutes on 7/19/23, and 13 minutes late on 7/31/23. Furthermore, a review of the facility incident reports from March 2023 - September 2023 revealed one incidence of missed chlorine check on 8/28/23 with greater than four hours between checks. A review of the facility policy titled, "Carbon Filtration Monitoring Incenter Central Water System" dated 11/2022 stated Chlorine and Chloramines checks should be performed prior to the initiation of the first patient treatment of the day and at a minimum every four hours. During an interview on 9/14/23 at approximately 12:30 p.m., the Biomed Technician stated he reported the late chlorine checks to the Facility Administrator and their investigation found that the clock that alerts the staff of the time for chlorine checks was broken, and was not showing time properly. The Facility Administrator stated on 9/14/23 at approximately 1:00 p.m., that she was informed of the late entries for chlorine checks and due to the number of late entries, she investigated and found that the clock used to alert staff of the time to check the chlorine was broken and did not show the time properly. She also stated a new clock has been ordered and the invoice showed that the clock had been shipped to the facility and the charge nurse was monitoring the time for chlorine check. |
| V0750 | CFC-GOVERNANCE CFR(s): 494.180 This CONDITION is not met as evidenced by: Based on a review of records and facility's Policy and Procedures (P&P) and staff interviews, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 48 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross Reference: V196 - Failure of the facility to measure total chlorine in the water used for dialysis in a timely manner. |