Grand Prairie Dialysis Center Inc.

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 30377 Based on facility log review and staff interviews, the facility failed to ensure that the Bicarbonate Concentrate System with Loop Log demonstrated complete documentation of required information to ensure and verify daily monitoring and weekly disinfection. Findings included: Review of Bicarbonate Concentrate System with Loop Log on 09/23/25 in the facility conference room for July 2025, August 2025 and September 2025 revealed the following: Review of July 2025 Bicarbonate Concentrate System with Loop Log revealed under the heading of Disinfectant Used, Presence Test, and Residual Test the area was BLANK for the following dates: 07/17/25 and 07/31/25 Review of July 2025 Bicarbonate Concentrate System with Loop Log revealed under the heading of RINSE the area was BLANK for the following dates: 07/09/25 and 07/31/25. Review of July 2025 Bicarbonate Concentrate System with Loop Log revealed under the heading of Decalcification / Initials the area was BLANK for the following dates: 07/09/25, 07/17/25, 07/18/25, and 07/31/25 Review of August 2025 Bicarbonate Concentrate System with Loop Log revealed under the heading of RINSE the area was BLANK for the following dates: 08/13/25, 08/15/25, 08/20/25, and 08/27/25 Review of August 2025 Bicarbonate Concentrate System with Loop Log revealed under the heading of Decalcification / Initials the area was BLANK for the following dates: 08/06/25, 08/13/25, 08/20/25, 08/22/25, and 08/27/25 Review of September 2025 Bicarbonate Concentrate System with Loop Log revealed under the heading of RINSE the area was BLANK for the following dates: 09/18/25 Review of September 2025 Bicarbonate Concentrate System with Loop Log revealed under the heading of Decalcification / Initials the area was BLANK for the following dates: 09/02/25 In an interview with Staff # 1 and # 3 on 09/23/2025 at 12:45 PM, after their own review confirmed the above findings. Staff # 1 stated she does not typically review the Bicarbonate Concentrate System Logs.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 30377 Based on observation and interview, the facility staff failed to ensure the dialysis facility was maintained in a safe, functional, and comfortable treatment environment. This deficient practice has the likelihood of increasing the risk of injury and increasing the risk of infections to dialysis patients receiving treatment at the facility. During a tour of the facility on 09/17/25 with (Staff #3) the following was noted: Treatment Area: Behind the lab refrigerator the wall was missing drywall causing the electrical outlet to dangle from the wall. The lab refrigerator was plugged into the dangling outlet. Mini Blinds covering the windows observed with dust built up and with damaged and missing blinds. Multiple cabinet walls behind the dialysis machine observed with significant paint peeling and damage. Multiple staff chairs with missing or worn away fabric Multiple dialysis machines in use had significant dust built up on the back panels of the machine, diasate filter housing, and on top of the diasafe filter cases. Multiple dialysis machines in use observed with significant paint peeling and cracking especially at the base of the machine. Multiple observations of blood pressure cuffs attached to the dialysis machine with excessive lent built up on the Velcro. Multiple observations of dialysis chair recliners with cracked and worn away fabric. Multiple observations of dried brown drips on the side of the dialysis chairs. Multiple observations of rust and grim built up on the metal aspect of the dialysis chairs. Biomed Office / Work area: Very disorganized with paperwork scattered throughout the area. Desk Chair with excessive amount of fabric worn away. Storage Area: Disorganized / Dusty with clean supplies not separated from used supplies such as Christmas supplies and discarded equipment. The corners and area around the back door were observed with excessive amounts of grim built up Water Room and adjacent area: The area was dusty, and the excessive amount of spilled acid build up remained under crates that held the acid tanks and boxed supplies. The acid build up was several inches thick. The Top of the Bicarb Tank observed with excessive amount of dust built up The pipes to the acid tanks observed with excessive amounts of acid build up. Several Ceiling tiles observed with large brown stains. The (Staff #3) accompanied the surveyor on the tour of the facility and all findings were acknowledged and confirmed. Interview with Staff # 2 on 09/23/25 at 10:30AM stated he was aware of the above findings but did not have any documented evidence that the facility was addressing any of the above issues.”