Fresenius Kidney Care Val Verde

“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: 39425 Based on observation, record review and interview, dialysis facility failed to be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This deficient practice has the likelihood of causing harm to dialysis patients receiving treatment at the facility due possible exposure to infectious material. Findings Include: Treatment Area Observations 8/27/25 from 12:04PM until 12:34PM Patient tape strips stuck to Nurses station counter. Interview with Assistant Facility Administrator on 8/27/25 at 12:10 PM stated “This is a clean area.” Facility treatment area tile chipped and cracked throughout facility. Facility treatment area counters chipped and cracked throughout facility. Facility treatment area baseboard with 1 inch gap at Phoenix meter station. March 7th 2025 Governing Body reads in part, “Physical plant issues = Treatment floor with cracked areas around the drains and is in need of repair, this to be completed by 4/30/2025. “ Interview with Director of Operations on 8/27/25 at 3:20PM confirming physical plant findings stated “Yes, I agree. It’s also in the Governing Body.” Facility Policy and Procedure Checking Conductivity and pH of Final Dialysate with the pHoenix XL Meter Procedure Published 5/11/22 Reference #25914 version 7 reads in part, “Verify standard solution expiration dates before using. Replace all expired solutions as necessary.” Conductivity Standard Solution 100mS/cm labled with date opened 6/22/25 and discard date 7/22/25. Signage posted on wall next to conductivity solutions station reads in part, “Solutions-Open bottle expiration. 14.0 and 100ms solutions- 30 days. Unopened bottles are good until the expiration date printed on them.” Interview with Biomedical Technician on 8/27/25 at 12:35PM surveyors asked if he knew that the conductivity solution was expired and Biomedical Technician stated, “I didn’t know.” Biomedical work station observations 8/27/25 at 12:17 PM Facility Policy and Procedure General Cleanliness and Infection Control Guidelines. Published 5/5/25 Reference #47685 Version 8. Policy reads in part, “Eating, drinking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure. Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present.” Open bag of Fritos and a 20 ounce Big Red botle on Biomedical technician desk.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 34839 Based on staff file review and staff interview, the facility’s governing body failed to ensure that Staff #5 had a facility orientation completed as well as the Medical Director certification of competency on the Water Skills Validation. Specifically the facility’s governing body failed to ensure that Staff #5 had a facility orientation completed and a completed Water Skills Validation: specific to the facility. This deficiency posed a likelihood of harm to dialysis patients, as staff were unaware of the facility layout, emergency preparedness and water room orientation. Findings included: Registered Nurse Staff#5 On 08/27/2025, Registered Nurse Staff #5 was observed on the treatment floor of the facility providing care and services to patients in the facility. Review of Registered Nurse Staff#5 (S#5) personnel and training file on 8/27/2025 revealed Registered Nurse S#5 is a float nurse, no evidence that an orientation was completed prior to working on 8/25/2025. The Specific facility orientation checklist had no preceptor initials and was not signed by the Clinical Manager as required. Review of the form labeled “DPC Water Skills Validation” did not specify what clinic he was trained at, nor did the Medical Director for facility #8819 sign off on the line that states “As Medical Director I certify this employee has demonstrated competency for the skills validated above, and delegate these tasks” that he was competent in the facility #8819. Interview with S#5 on 8/27/2025 at 12:56PM stated, “The clinical Manager walked me through the facility on Monday, its the same water system as the other Del Rio clinic.” Interview with the Clinical Manager on 8/27/2025 at 1:07 PM, surveyor asked, what time did you arrive at the clinic on Monday 8/25/2025? Clinical manager stated “ 7:25 AM. “ Surveyor asked, so this was after patients had started treatments? Clinical Manager stated “Yes, the first patient starts treatment at around 6:00 AM.” Interview with the Biomedical Technician on 8/27/2025 at 1:07 PM in the facility conference room stated “ I have not walked him through the water treatment room, and no its not the same water treatment system as the other Del Rio facility.” Interview with the facility Clinical Manager and Director of Operations on 8/27/25 at 1:08PM stated “Yes, it should have been completed prior to him working.””

“PQ-H20 TREATMENT SYSTEM TECHS TRAINING CFR(s): 494.140(f) Technicians who perform monitoring and testing of the water treatment system must complete a training program that has been approved by the medical director and the governing body. This Standard is not met as evidenced by: 34839 Based on review of personnel files and interview it was determined that the facility failed to ensure that the Biomedical Technician’s training and competency checklist had been completed, reviewed, and approved by the Medical Director and governing body. The lack of verified competency by leadership for the technician responsible for dialysis water treatment placed all patients at risk of exposure to waterborne contaminants, which can cause serious harm or death. Findings included: Review of Biomedical ( Biomed) #3 personell file on 8/27/2025 revealed incomplete trainig records. Validation Skills Checlist Segmant4 T machine checklist was incomplete, Biomed signature line is blank, and the colum named “Validators Name & Date of Validation” was blank. The Area Technical Operations Manager ( ATOM ) signed 5/17/23 Validation Skills Checlist Segmant4 Life Saftey PM Checklist was incomplete, Biomed signature line is blank, Validators signature line was blank and the colum named “ Validators Name & Date of Validation” was blank. The Area Technical Operations Manager (ATOM ) signed 5/17/23 Validation Skills Checlist Segmant4 NxStage Checklist was incomplete, Biomed signature line is blank, Validators signature line was blank and the colum named “ Validators Name & Date of Validation” was blank. The Area Technical Operations Manager (ATOM ) signed 5/17/23 Validation Skills Checlist Segmant4 Micro Remediation Checklist PM Checklist was incomplete, Biomed signature line is blank, Validators signature line was blank and the colum named “ Validators Name & Date of Validation” was blank. The Area Technical Operations Manager (ATOM ) signed 5/17/23 Interview with Clinical Manager on 8/27/25 at 1:29PM regarding missing signatures on Biomed training record stated “I have not gone through his chart.” Interview with Director of Operations on 8/27/25 at 3:19PM confirming that signatures were blank on the staff file record stated “Yes.””