Dialyze Direct Louisville, KY

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 44000 Review of the facility’s “Infection Prevention and Control Practices” policy, revised 10/04/2024, revealed non-sterile gloves shall be required whenever caring for a patient of touching a patient’s equipment. Observation on 08/05/2025 at 10:35 AM revealed Patient Care Technician (PCT)1 took Patient (P)2’s blood pressure without wearing gloves. She then typed into the computer which was on a stand next to the patient. During interview with PCT1 after the observation, she stated she did not think she needed to wear gloves when taking a blood pressure. Observation on 08/05/2025 at 10:40 AM revealed Registered Nurse (RN)1 took the blood pressure of P1 without wearing gloves. During interview with RN1 on 08/05/2025 at 11:23 AM she stated she did not know what the policy said about when to wear gloves when with patients. Observation and interview on 08/05/2025 at 11:50 AM revealed PCT1 put the dialysis tubing into the red trash container while wearing gloves. She then opened the cabinet wearing the same gloves and took out a tape holder and laid it on the counter. She then removed her gloves and washed her hands. PCT1 then taped a box and put the tape holder back in the cabinet with bare hands. She did not wash her hands after putting the tape holder in the cabinet. During interview with PCT1 she stated the tape holder was clean and walked away. During interview with the Area Manager on 08/05/2025 at 2:35 PM, she stated she expected staff to wear gowns and gloves when they are working with the patients. She expected staff to follow the facility policy on hand hygiene. During interview with the Medical Director on 08/06/2025 at 10:44 AM he stated staff were to follow the policies on infection control. He further stated he was involved in the audits of infection control which was discussed in the monthly QAPI meetings. .”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 44000 Based on observations, interviews and review of facility policy, the facility failed to ensure staff followed infection control requirements when cleaning one of seven dialysis stations. A blood pressure cuff which is used for different patients who use the dialysis station was not disinfected. The findings include: Review of the facility’s “Infection Prevention and Control Policy and Practices”` revised 06/01/2023, indicated the End Stage Renal Clinic shall provide and monitor a sanitary environment to minimize the transmission of infectious agents. Any item taken to a patient’s dialysis station, including those placed on top of the dialysis machines, shall either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being returned to a common clean area or used for other patients. Observation on 08/22/2024 at 8:25 AM revealed a Patient Care Technician (PCT) 1 and Registered Nurse (RN) 1 cleaned a dialysis station. All items around and the dialysis chair were cleaned except the blood pressure cuff laying on the table behind the dialysis chair. During interview with PCT1 on 08/22/2024 at 8:35 AM she stated that she thought the RN cleaned the blood pressure cuff. She stated she always cleaned every item on and around the dialysis station. According to PCT1, the blood pressure cuff was used by multiple patients who received treatment at that station During an interview with the Area Manager on 08/22/2024 at 11:48 AM, she stated the PCT1 and the RN1 usually each take half of the unit and each clean the stations on their half. According to the Area Manager, the blood pressure cuff should be cleaned after each patient treatment. The Area Manager stated she conducts infection control audits to assure the staff maintain infection control practices.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 44000 Based on observation, interview, record review and policy review, the facility failed to ensure staff correctly documented the Dialysis Flow Rate (DFR) on the hemodialysis treatment record and failed to document patient blood pressures’ and safety/machine checks every 30 minutes for four of four sampled patients (P) P1, P2, P3 and P4. Additionally, hemodialysis treatment times were documented as less than the ordered treatment time for P1 and P3. The findings include: Review of the facility’s “Initiation/Monitoring/Termination of HD Treatment Using the Nxstage system One Cycle Procedure” policy revised 01/04/2020 indicated during treatment to check and document patient’s vital signs, level of consciousness, access pressures, machine settings, dialysate and Ultration Flow (UF) volumes, cautions/alarms, medications given, comments/concerns/complications and action taken and that all are within expected parameters, every 30 minutes or more frequently as indicated. Observation on 08/22/2024 at 10:20 AM revealed the Patient Care Technician (PCT) 1 entered the Dialysis Flow Rate (DFR) into the computer which was not attached to the dialysis machine for P1. 1. Review of Patient (P) 1’s treatment orders dated 07/05/2024 indicated the DFR to be 300 and the time for dialysis treatment to be 3 hours 30 minutes. Review of P1’s “Hemodialysis Treatment Summary” dated 08/09/2024 revealed the patient’s treatment started at 5:55 AM and ended at 9:22 AM. The DFR was not documented. Per the facility policy “Initiation/Monitoring/Termination of HD Treatment Using the Nxstage system One Cycle Procedure”, the DFR should be documented every 30 minutes during treatment. Review of P1’s “Hemodialysis Treatment Summary” dated 08/13/2024 revealed the DFR was documented at 6:11 AM as 148; at 6:12 AM as 219; at 7:00 AM as 148; at 7:30 AM as 148; at 8:00 AM as 148; at 8:30 AM as 148; and at 9:08 AM as 200 which was less than the ordered rate of 300. Review of P1’s hemodialysis treatment time on 08/13/2024 revealed the time was two hours 57 minutes which was 33 minutes less time than the treatment time ordered. There was no documentation why treatment ended early. Review of P1’s “Hemodialysis Treatment Summary” dated 07/31/3024 revealed P1’s treatment time was two hours 57 minutes which was 33 minutes less time than ordered. Review of comments revealed there was no documentation indicating the reason the full treatment time was not completed. Review of P1’s “Hemodialysis Treatment Summary” dated 08/12/2024 revealed P1’s treatment time was three hours 6 minutes which was 24 minutes less that the ordered hemodialysis treatment time. Review of comments revealed there was no documentation indicating the reason the full treatment time was not completed. Review of P1’s “Hemodialysis Treatment Summary” dated 08/08/2024 revealed P1’s treatment time was two hours 56 minutes which was 34 minutes less than the ordered hemodialysis treatment time. Review of comments revealed there was no documentation indicating the reason the full treatment time was not completed. Review of P1’s “Hemodialysis Treatment Summary” dated 08/20/2024 revealed P1’s treatment time was one hour 25 minutes which was two hours and five minutes less than ordered. Review of comments revealed there was no documentation indicating the reason the full treatment time was not completed. 2. Review of P3’s treatment orders dated 08/01/2024 indicated the DFR to be 178 and the time for dialysis to be two hours 48 minutes. Review of P3’s “Hemodialysis Treatment Summary” dated 08/01/2024 revealed the DFR was documented at 6:37 AM as 167; at 6:38 AM as 167; at 7:00 AM as 167; at 7:30 AM as 167; at 8:00 AM as 167; at 8:30 AM as 167; and at 9:00 AM as 167 which was less than than the ordered rate of 178. Review of P3’s “Hemodialysis Treatment Summary” dated 08/08/2024 revealed the DFR was document at 6:13 AM as 148; at 06:30 AM as 148; at 7:00 AM as 148; at 8:00 AM as 148; at 8:30 AM as 148; at 9:00 AM as 148; and at 9:10 as 148 which was less than than the ordered rate of 178. Review of P3’s “Hemodialysis Treatment Summary” dated 08/15/2024 revealed the DFR was document at 6:38 AM as 167; at 6:30 AM as 167; at 7:00 AM as 167; at 7:30 AM as 167; at 8:00 AM as 167; at 8:30 AM as 167; at 9:00 as 167; and at 9:30 AM as 167 which was less than than the ordered rate of 178. Review of P3’s “Hemodialysis Treatment Summary” dated 08/20/2024 revealed the time of dialysis was one hour 46 minutes which was one hour two minutes less than the ordered hemodialysis treatment time. Continued revealed there was no documentation of the reason for ending the treatment early. Review of P3’s “Hemodialysis Treatment Summary”and machine data dated 08/06/2024 revealed the patient’s hemodialysis treatment started at 6:32 AM and ended at 9:29 AM; however, the patient’s blood pressure was not checked between 7:00 AM and 8:00 AM. Per the facility policy “Initiation/Monitoring/Termination of HD Treatment Using the Nxstage system One Cycle Procedure”, during treatment staff are directed to check and document the patient’s vital signs every 30 minutes or more frequently as indicated. Review of P3’s “Hemodialysis Treatment Summary” and machine data dated 08/16/2024 revealed the patient’s treatment started at 6:40 AM and ended at 9:40 AM; however, the patient’s blood pressure was not checked between 7:00 AM and 8:00 AM. Machine Review of P3’s “Hemodialysis Treatment Summary” and machine data dated 08/20/2024 revealed the patient’s treatment started at 6:45 AM; however, the blood pressure was not checked between 7:00 AM and 8:00 AM. 3. Review of P4’s treatment orders dated 07/05/2024 indicated the Dialysis Flow Rate (DFR) to be 119 and the time for dialysis to be two hours 48 minutes. Review of P4’s “Hemodialysis Treatment Summary” dated 08/13/2024 revealed the DFR was documented at 10:18 AM as 148; at 10:19 AM as 148; at 10:30 AM at 148; at 11:00 AM at 148; at 11:30 AM at 148; at 12:00 PM at 148; at 12:30 PM at 148; and at 12:45 PM at 148 which was higher than the ordered 119 rate. Review of P4’s “Hemodialysis Treatment Summary” dated 08/14/2024 revealed the time of the dialysis treatment was three hours and 38 minutes which was 50 minutes longer than the ordered treatment time. Review of P4’s “Hemodialysis Treatment Summary” dated 08/15/2024 revealed the DFR was document at 6:22 AM as 148; at 6:23 Am as 148; at 7:00 AM at 148; at 7:30 AM at 148; at 8:00 AM at 148; 8:30 AM at 148; and at 9:20 AM at 148 which was higher than the ordered 119 rate. During interview with the PCT on 08/22/2024 at 10:25 AM she stated she must have been busy working with another patient and missed the blood pressure check for P3. She stated her eyes are constantly on all the patients during the treatment. Per the PCT, she looks for eyes closed, lethargic, any change in a patient. During interview with the RN on 08/22/2024 at 11:48 AM, she stated the DFR documented entries were errors, the computer entry is not the DFR that is running on the dialysis machine. She sets the machine at the beginning of the treatment then goes to the computer and documents the DFR and the time treatment ended. Per the RN, the incorrect DFR was documented into the computer. She stated P1 always ends treatment early and she should have documented the reason in the computer. The RN stated P1’s provider had been notified. During interview with the Area Manager on 08/22/2024 at 11:50 AM, she stated the reason P1 was taken off the dialysis machine early should have been documented. She stated she was aware that P1 did not like to complete the full treatment. She also stated the provider has been notified. Per the Area Manager, the documentation in the computer is not the DFR set on the machine as the computer and dialysis machine are not connected to each other. She stated the patient blood pressures should have been checked every 30 minutes and documented. She further stated the run times should have been completed as ordered. 4. Review of Hemodialysis Treatment Summaries from 07/31/2024 to 08/21/2024 for Patient #2 (P2) revealed documentation missing related to the patient’s 30 minute safety and machine checks. On 06/06/2024, Patient 2’s Treatment Summary had no documentation of safety and machine checks between 07:00 AM and 08:00 AM. On 08/08/2024 there was no documentation of safety and machine checks between 07:00 AM and 07:59 AM. On 08/16/2024, there was no documentation of safety and machine checks between 07:00 AM and 08:00 AM. During interview with the RN on 08/22/2024 at 11:48 AM, she stated the safety and machine checks should be completed and documented every 30 minutes. During interview with the Area Manager on 08/22/2024 at 11:50 AM, she stated the safety and machine checks should be completed and documented every 30 minutes.”