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 852553 (X3) Date Survey Completed 06/13/2019
Name of Provider or Supplier Flint River Dialysis Street Address, City, State 700 Gordon Avenue, Bainbridge, 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 facility policy and procedure (P & P), it was determined that the facility failed to ensure that the dialysate (fluid used on the other side of the membrane to remove impurities) used for dialysis was safe prior to the start of dialysis treatment. On 6/12/19, a determination was made that a situation in which the facility's noncompliance resulted in an Immediate Jeopardy with potential harm to the health and safety of one of 15 patients (P) (P#1), who were receiving dialysis treatment at the time of observation. The Facility Administrator (FA) and Clinical Service Specialist (CSS), were informed of the immediate jeopardy finding on 6/12/19 at 10:55 a..m. The noncompliance related to the immediate jeopardy was identified to have existed on 6/12/19 at 10:55 a.m. The immediate jeopardy was removed on 6/12/19 at 3:15 p.m., when the facilty implemented a Credible Allegation of Compliance related to the immediate jeopardy. The immediate jeopardy is outlined as follows: During observation in the treatment room on 6/12/19 between 9:30 a.m. and 10:55 a.m., the following was observed: The hemodialysis (HD) machine #12 at Station (S) 8 showed "test complete" on the screen. LPN AA then connected the hansen couplings (a connector device) to the dialyzer and recirculated the system. At 10:55 a.m., LPN AA initiated dialysis treatment on P #1 at S8 using HD machine #12. The pH (acidity) and conductivity (ability of the dialysate to conduct electricity) of the dialysate were not measured with an independent method prior to the start of P#1's dialysis treatment, to ensure patient safety. During an interview with LPN AA on 6/12/19 at 10:58 a.m., she stated she could not find the Phoenix Meter (a device used to measure the pH and conductivity). During an interview on 6/12/19 at 11:10 a.m., Biomedical Technician AA stated that the Phoenix Meter is used to verify the reading level of the HD machine and to check the accuracy of the dialysate solution distributed by the HD machine. A review of P & P #1-03-02 titled "Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate" stated: 1. Trained teammates will test pH and conductivity of final dialysate utilizing appropriate test strips and/or meters prior to each patient treatment. 5. The final dialysate conductivity should be checked with an approved independent meter ... 6. Independent conductivity and pH is required to be performed prior to each treatment. On 6/12/19 at 1:45 p.m., the FA stated that staff should always test dialysate's pH and conductivity with an independent meter prior to each dialysis treatment. The immediate jeopardy was removed on 6/12/19 at 3:15 p.m., when the facilty implemented a Credible Allegation of Compliance related to the immediate jeopardy. The FA checked P#1 and was found asymptomatic. LPN AA discontinued P#1's dialysis treatment and tested HD machine #12 per facility's P & P and was found to be safe to use for dialysis. P#1's dialysis treatment was then resumed on 6/12/19 at 1:41 p.m. The Governing Body met on 6/12/19 at 3:00 p.m. and all clinical employees were in-serviced on P & P #1-03-02 titled "Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate" on 6/12/19 at 3:15 p.m.