Fresenius Kidney Care Orangeburg

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 28883 Based on observation, interview, and review of the manufacturer’s package insert, the dialysis clinic nursing staff failed to ensure an opened vial of Tuberculin Purified Protein Derivative had been disposed of after reaching the beyond use date. The findings include: Observation on 6/3/24 at 12:27 PM in the treatment room medication refrigerator revealed one opened multi-dose vial of Tuberculin PPD (Purified Protein Derivative). Handwritten information on the vial revealed it had been opened on 4/29/24 and was “expired on 5/29/24” (past the beyond use date). During an interview on 6/3/24 at 12:28 PM, Registered Nurse (RN) #1 verified the finding. Review on 6/5/24 at 12:30 PM of the package insert for the Tuberculin PPD revealed that “A vial of Tubersol that has been entered and in use for 30 days should be discarded”.”

“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: 22313 Based on observations, interview, and review of the pH testing procedure, the dialysis facility failed to ensure that 1 of 3 staff observed performing the pH test correctly on the dialysate for 2 out of 2 observations prior to patient use(Patient Care Technician (PCT #1) and nursing staff failed to document the number result of the independent pH check of dialysate for 2 of 7 patients reviewed, Patients #4 and #5. The findings include: During observations on the clinic floor on 6/04/24 at 11:15 AM, Patient Care Technician (PCT)#1 did not perform the required pH test correctly on the dialysate prior to patient use by not timing the pH test per directions. “The test strip is to be dipped for 1-2 seconds into solution to about 1/2 inch of the strip, then read immediately against a color chart”. PCT#1 swished the strip for over 30 seconds, inserted the strip over the 1/2 inch mark, then waited 10 seconds longer before reading the strip against the color chart. PCT#1 did not use a timing device while performing the test, did not dip the strip to the specified length and waited too long to read the strip against the color chart for pH determination. PCT#1 was asked to repeat the test and was assisted by Registered Nurse (RN)#1. PCT#1 again did not perform the test properly by not dipping the strip to the 1/2 inch mark, did not use a timing device, and did not read the strip immediately. PCT#1 confirmed afterwards that she was unfamiliar with the procedure. Record review of training records show that PCT#1 was trained on the pH test strips on 6/03/24 and was checked off as competent. During an interview on 6/04/24 at 2:37 PM, the Clinic Manager confirmed that PCT#1 was trained, but failed to complete the pH test correctly per procedure. 28883 Review of treatment sheets for Patient #4 on 6/4/24 at 1:33 PM revealed the independent check of the dialysate pH (number result) had not been documented for dialysis treatments on 5/24/24, 5/27/24, and 5/29/24. Review of treatment sheets for Patient #5 on 6/4/24 at 1:52 PM revealed the independent check of the pH of dialysate (number result) had not been documented for a dialysis treatment on 5/24/24. During an interview on 6/5/24 at 12:58 PM, Registered Nurse (RN) #2 verified the above findings and stated that the staff documented that the test had been completed and had “passed”, but did not document the pH number.”