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 012515 (X3) Date Survey Completed 04/20/2023
Name of Provider or Supplier Fresenius Medical Care Opelika Street Address, City, State 2609 Village Professional Drive, Suite 2, Opelika, AL
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 review of the facility policy, facility Log Readings Report for Total Chlorine (TCL) documentation, and interview, it was determined staff failed to follow the facility policy to perform and document total chlorine testing at least every 4 hours while patients dialyzed. This had the potential to negatively affect all patients who are dialyzed at the facility. Findings include: Facility Policy: Carbon Filtration Monitoring for Incenter Central Water Systems Policy Reference Number: 46310 Version: 9 Published: 11/07/2022 Purpose of this policy is to provide instructions to...staff on carbon filtration monitoring of central water systems in Incenter facilities. Test Rationale...Total chlorine testing will be the only testing methodology used to ensure the carbon filters are reducing total chlorine levels below...0.10 ppm (parts per million)...testing for both free chlorine and chloramines. What to Test... Worker Carbon Filter... When to Test... Prior to the initiation of the first patient treatment of the day and at a minimum of every four hours... Routine Total Chlorine Testing will be documented in the approved electronic documentation system... 1. Review of the facility Log Readings Report for TCL documentation dated 4/3/23 revealed the Patient Care Technician tested the chlorine at 7:55 AM and not again until 12:16 PM which was 4 hours 21 minutes and not every 4 hours per policy. In an interview conducted on 4/20/23 at 9:48 AM, Employee Identifier # 11, Biomedical Technician, confirmed staff failed to perform chlorine tests at least every 4 hours.