Fresenius Medical Care Tri City

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 39425 Based on observation, interview, and record review, the facility failed to provide and maintain a sanitary environment to minimize the transmission of infectious agents. This failure created an increased risk of cross-contamination, healthcare-associated infections, and exposure to bloodborne pathogens for all patients receiving dialysis treatments. The facility’s failure impacted multiple patient care areas, supplies, equipment, and infection control practices. Findings include: During a tour of the facility on 05/28/2025 at 10:44 AM until 11:41 AM with the Facility Administrator (FA)/Staff #1 present, the surveyor observed the following infection control issues: Date on RO (reverse osmosis) water bottle was not legible. Interview with the Facility Administrator on 5/28/25 at 10:46 AM stated, “That looks like a 3, maybe they thought it was March.” Facility Policy Titled: Checking Conductivity and pH of Final Dialysate with the phoenix XL Meter Procedure; Published 05/11/22 Reference #25914. Policy indicated in part: RO water and 1% bleach solutions are replaced daily. Label solutions with date, time and initials. Rust on the patient Hoyer lift leg rails. Hair and debris stuck in 3 out of the 4 Hoyer lift wheels. Interview with the Facility Administrator on 5/28/25 at 10:56 AM surveyor asked what is that on the rails and wheels of the Hoyer lift? Facility administrator responded, “Rust on the rails and hair on the wheels.” At 10:45 AM, surveyor observed 4 containers labeled “dry towels”, with an observed liquid and disposable towels. Surveyor asked Staff (S) #1 what the liquid was. S#1 responded, “bleach, but they did not label them.” At 11:00 AM, surveyor observed a bloody heparin syringe, tape, and blood splatter/streaks on the patients’ side table. Surveyor asked why there was a bloody heparin syringe on the patients’ side table. S#3 stated “I’ll throw it out now”. Surveyor asked S#3 about the blood streaks on the table, and she responded, “I’ll wipe it off now.” At 11:28 AM, surveyor observed patient weighed at the weigh scale and placed patient belonging bag on table next to weigh scale and cane on the weigh scale handle. No disinfection observed by staff after patient left. At 11:36 AM, surveyor observed 9 out of 24 sharps containers were full beyond safe limits. Drilled holes and exposed wood on the counters behind the dialysis machines throughout the facility, not allowing for thorough disinfection. Interview at 12:59 PM with S#9 stated, “The sharps containers are not to be more than ¾ full.” Interview with S#5 on 5/29/25 at approximately 11:30 AM stated, “The holes are there from the old TVs, we need to get this fixed”. Review of the facility Governing Body Minutes dated 2/26/25 stated “ Repairs/Updates: Cabinets/countertops still pending final approval from upper management.” There were clear bags full of medical trash attached to patient’s chairs with tape at 15 out 15 patient chairs dialyzing with clean supplies approximately 1 inch away. Interview with S#1 on 5/28/25 at 11:43 AM stated “It’s the blood line bags that they’re saving.” S#1 further stated, “That looks like a practice, that’s on every chair here. I can write a policy for that.” Interview with S#9 at approximately 12:30 PM stated, “ I told the staff that can not be done because of the potential for cross contamination”. Review of Facility Policy titled: General Cleanliness and Infection Control Guidelines; Published 5/5/25 Reference #47685 Policy indicated in part: -All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms, offices and restrooms. -All containers for storage or disposal of needles/sharps shall be replaced on a regularly scheduled basis or when no more than 2/3 to 3/4 full. -Regulated medical waste shall be placed in a container that is in accordance with OSHA bloodborne standard 1910.1030 and is closeable, leak proof and labeled and/or color-coded”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 34839 Based on observation, interview, and policy review, the facility’s direct patient care (DPC) failed to ensure continuous visual observation of patient vascular access sites during hemodialysis treatment for 5 of 15 patients observed actively dialyzing. Ensuring proper visualization of the hemodialysis access is important for the early recognition and prevention of bleeding from the patient’s vascular access site, accidental needle dislodgement or a line disconnection to go undetected. This dislodgement or disconnection could result in exsanguination and possible immediate death. Findings included: During a tour of the facility’s in-center treatment area with the FA/Staff #1 present on 05/28/2025 at 11:30 AM surveyors observed 5 patient vascular accesses were covered with blankets at stations 1, 5, 12, 23 and 24. During the tour of the facility, with the FA present revealed there were no interventions or corrective action taken by the Facility Administrator to ensure the vascular accesses were uncovered and visible. Interview with S#1 at the time of observations stated, “Yes, they [the access] should not be covered, the other surveyor already told me about that.” Review of Policy titled, Patient Assessment and Monitoring Published 05/01/2023 Reference Number: 45284 indicated in part: Access: Observe connections are secure and visible. Ensure access remains uncovered throughout the treatment.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 34839 Based on record review, interviews, and review of the facility policy, the facility’s Interdisciplinary Team (IDT) failed to ensure the patient signed their individualized plan of care (POC) as an acknowledgment and/or failed to document the reason why patient refused to sign for 5 of the 7 POC’s reviewed (Patient’s #1, #2, #3, #4, and #5). The failure contests the integrity of the care planning process and reflects a systemic failure in the facility’s management of the care planning process. Findings include: Patient (P) #1 - IDT meeting date was 9/25/24. The physician signed the plan of care 10/28/24 ( greater than 30 days). Plan of care was printed on 3/19/25 for the patient to sign. Patient signed plan of care 3/21/25 (approximately 6 months after the meeting). P#2 - IDT meeting was held 5/4/22. Patient signature page was printed 5/4/22, and the designated area that reads “ Patient Chooses not to sign plan of care and reason” was dated 4/22/22 (prior to the meeting) and failed to document the reason the patient refused to sign. P#2- IDT meeting was held 4/24/24. Patient plan of care was printed 6/14/24 and patient signed 6/21/24 (approximately 2 months after the meeting). P#3 IDT meeting was held 10/14/24. Patient plan of care was printed 3/19/25 and patient signed 3/21/25 (5 months after the meeting). P#4 IDT meeting date was 9/25/24. The physician signed the plan of care 10/28/24 ( greater than 30 days). Plan of care was printed on 3/19/25 for the patient to sign. Patient signed plan of care 3/21/25 (approximately 6 months after the meeting). P#4 IDT meeting date was 1/30/25. The physician signed 2/5/25, registered nurse and dietician signed 1/30/25. Plan of care was printed 3/19/25 and patient signed 3/21/25 (approximately 6 weeks later). This POC dated 1/30/25 was signed at the same time as the previous plan of care dated 9/25/24. P#5 IDT meeting date 6/24/24. POC printed for signature on 6/27/24 and the designated area that reads “ Patient Chooses not to sign plan of care and reason” was blank. No documentation of reason the patient refused to sign. Policy and Procedure: Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC), Published: 7/3/23 Reference Number: 45283 Policy reads in part: Responsibility Interdisciplinary Care Team (IDT) (RN, Attending Physician, and physician extenders as applicable, Social Worker, Registered Dietitian) If unable to sign at the time of the meeting or if attending remotely, the care plan must be signed by the IDT member within 30 days of the interdisciplinary team meeting. The Attending Physician reviews CIA and indicates with his/her signature on the POC their oversight of the patient’s Plan of Care within 30 days. The patient’s level of participation is determined by the patient. The patient must sign the plan of care meant to acknowledge the information in the plan. If the patient chooses not to sign their plan of care, the reason for refusal must be documented in the patient’s medical record. Interview with Social Worker IDT member, S#14 on 6/2/25 from 1:34PM until 1:41PM was asked why there was a time delay between completion of plan of care and obtaining patient signatures, S#14 responded, “I can’t answer for you, I’m not part of this process.” Interview with Clinical Manager, S#2 on 6/2/25 from 2:41PM until 2:54PM was asked why there is a time delay between completion of plan of care and obtaining patient signatures, S#2 responded, “I’m going to try to figure that out. I have to figure out why there’s a delay. I need to print them out and have them sign that day.””

“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: 39425 Based on review of personnel files and interview it was determined that the facility failed to ensure that the Biomedical Technician’s annual water treatment 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: Surveyor requested the staff file for the Biomedical Technician on 5/28/25 at 1:52 PM and was not produced to the surveyors until 5/29/25 at 11:30 AM. Review of the Biomedical Technician’s/Staff #8 personnel file revealed no job description, no evidence of a completed training program approved by the medical director and the governing body, no evidence for competency training and/or skills checklist. Further review revealed that S#8 signed as the technical validator and completed the annual “DPC Water Skills Validation” form for three facility staff members on 1/10/25 for S#11, 1/16/25 for S#7 and 3/13/25 for S#10. Interview with S#9 on 5/29/25 at 10:38 AM surveyor asked have you seen his skills checklists. S#9 stated “His skills checklist is not signed by the medical director.” Surveyor asked are you aware he has trained three staff members on water skills and we can’t verify his competency? S#9 stated, “I was not aware he has been training other staff members.” Interview with S#1 on 5/29/25 at 11:30 AM, surveyor asked “ Did you have a staff file for him? “ S#1 stated “ I ’ m sorry, I probably forgot. I don’t know.” Surveyor asked when was the biomedical staff hired, S#1 stated “ Fall of last year, he transferred from another region.” Surveyor asked where did you find the file? S#1 stated “ It was in the back, the ATOM (Area Technical Operations Manager) had the paperwork.”. Surveyor asked when was the last time she reviewed his staff file? S#1 stated “ I hadn’t “. Surveyor asked S#1 have you ever reviewed his staff file? S#1 responded “ I never have. We didn’t have a current skills checklist for him, he did that yesterday, nor a signed job description. I can print that(Biomedical technician job description). He’s from Florida.” Interview with S#8 on 5/29/25 at 11:57 AM, surveyor asked where was your employee file. S#8 stated, “I have no idea, I don’t know why it didn’t follow me here, it was in Florida.” Surveyor asked where is your competency training. S#8 stated, “I did it but its not there, they are waiting for me to complete it.” S#9 went on to state “ I checked with S#13 and the training is not in the system.””