Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 852551	(X3) Date Survey Completed 01/15/2025
Name of Provider or Supplier Duluth Dialysis	Street Address, City, State 3170 Peachtree Ind Blvd, Ste 100, Duluth, 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)

V0250

DIALYS PROPORT-MONITOR PH/CONDUCTIVITY
CFR(s): 494.40(a)

5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer's instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient.

This STANDARD is not met as evidenced by:
Based on observation, staff interviews, and a review of the manufacturer's Directions for Use (DFU), and Policies and Procedures (P&P), it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of three of three Patient Care Technicians (PCTs) (PCT AA, PCT BB and PCT CC) observed, to correctly verify the hemodialysis (HD) machine's dialysate pH (acidity), according to the manufacturer's DFU and facility P&P. This failure had the potential to negatively affect the health and safety of 10 of 10 patients seated at Station (S) 1, S2, S3, S6, S7, S8, S9, S11, S12, and S15, who were undergoing hemodialysis treatment at the time of this observation. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. The facility in-center hemodialysis census was 32. Findings include: During observation in the Patient Treatment Room on 1/13/25 between 10:55 a.m. and 12:16 p.m., the following was revealed: - At 11:33 a.m., PCT BB was observed testing the dialysate pH using RPC Test Strip at S6. PCT BB dipped the RPC test strip into the dialysate sample for 30 seconds while looking at a clock without a second hand and immediately compared the strip to color scale. During an interview on 1/13/25 at 11:35 a.m., PCT BB stated she had always checked the pH of the hemodialysis machines that way. - The Charge Nurse asked PCT CC to check the machine's conductivity (ability of the dialysate to conduct electricity) at S6. PCT CC checked the dialysate for conductivity and performed the procedure correctly. However, at 11:39 a.m., PCT CC was observed testing the dialysate pH using RPC Test Strip. PCT CC swished the test strip in the dialysate sample for one minute and 50 seconds without looking at the clock, then immediately compared the test strip to color scale. On 1/13/25 at 11:50 a.m., PCT CC stated that she was supposed to swish the pH test strip into the dialysate sample for 20 to 25 seconds before comparing to color chart. - It was observed at 11:04 a.m. that PCT AA did not test the dialysate pH of the hemodialysis machine at S3 before initiating P#7's hemodialysis treatment. - At 12:00 p.m., PCT AA was observed during testing of the dialysate pH at S14. PCT AA dipped the RPC test strip into the dialysate sample for 20 seconds without looking at the clock and immediately compared to color scale. During an interview on 1/13/25 at 12:03 p.m., PCT AA stated that she forgot to check the pH at S3 before initiating the patient treatment. PCT AA also stated that she counted in her head before comparing pH test strip to color chart. On 1/13/25 at 12:45 p.m., the Biomedical Technician (BMT) stated that the conductivity and pH must be checked before initiation of each patient treatment. A review of "RPC K100-0117CT E-Z Chek 6.8-8.5 Test Strips Directions for Use" showed the following: 1) Dip or wet pad and briskly shake off excess liquid. 2) Compare test results to color scale on bottle between 20 and 25 seconds. 3) Determine pH value for the closest color match. During a telephonic interview with RPC Director of Technical Support on 1/28/25 at 1:56 p.m., it was revealed that if the strip was left in the sample for longer than one second, it will cause overexposure which can lead to inaccurate results due to chemical reactions. Stated that the manufacturer's DFU was specific and was determined and validated by their laboratory. The RPC Director of Technical Support also stated that it is critical to dip or wet the strip with the sample for one second and to compare test result to color scale on bottle between 20 and 25 seconds. A review of "Fresenius Medical Care 2008T BlueStar Hemodialysis Machine Operator's Troubleshooting Guide" showed the following: Page 9 - Miscellaneous - On the Test and Options screen, Independent Conductivity does not show pH (the pH is not available). - Warning! Always verify the conductivity and approximate pH of the dialysate solution through independent means (e.g. using a conductivity meter or pH paper or meter, as applicable) before initiating each dialysis treatment. Verify that the conductivity is reasonably close to the theoretical conductivity value (TCD) and the pH is between 6.9 and 7.6. If they are not, do not initiate dialysis. - A review of the facility's Policy: 1-03-02 titled, "Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate" with latest revision date of April 2020 stated: 6. Independent pH is required to be performed prior to each treatment. A review of facility Procedure: 1-21-09 titled, "Testing pH for Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8 - 8.5 Test Strips" with latest revision date of February 2024 showed the following: 2. Obtain dialysate sample using a disposable collection cup, then dip the strip into the solution for one (1) second... 3. Remove the strip from the fluid and shake off excess dialysate. 4. Within 20 to 25 seconds, compare the color reaction on strip to the color chart. The Facility Administrator was notified of the above findings on 1/13/25 at 1:15 p.m. and acknowledged the findings.