Fresenius Medical Care Rockport

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 43999 Based on review of documentation and interview, it was determined the facility staff did not follow compliance with applicable State Texas ESRD Rules and Regulations. Findings : During observation of the facility treatment room and review of patient/staff assignments on 6/30/25 it was idenitifed staff # 5 & #6 , two RN’s on the schedule provide direct patient care. The RN’s duties include care to assigned patients that have a CVC (Central Venous catheter), medication administration, patient assessments, supervision of patient care technician and other charge nurse duties . Staff # 2, another RN is available to assist with nursing care if avaialble if not scheduled alread. In an interview on 7/1/25 with staff # 5 it was shared there is only one RN scheduled on Saturdays and more often than not there are more than 7 patients on each shift, many with CVC that required only only nursing care duties. Review of the facilities May and June 2025 staff schedule revealed one RN ,two techs are scheduled with up to eight patients scheduled per shift. The one RN scheduled is also the charge nurse (CN). In an interview 7/1/25 with staff #1 & #2 they confirmed the scheduled assigned CN is assigned direct patient care and on Saturdays there is only one RN scheduled for up to eight patients per shift.”

“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: 43999 Based on observation, record review, and staff interview, the facility’s staff failed to provide and monitor a sanitary environment to minimize the transmission of infectious agents in patient treatment area of the dialysis facility. Findings: Facility policy entitled “ Hand Hygiene “ stated its purpose was to, “ Promote hand hygiene practices and prevent transmission of pathogenic microorganisms to patients and staff through cross contamination. “ On 6/30/25 and 7/1 25, 6 out of 6 patients observed did not wash their hands or access site as they entered the patient treatment area. On 6/30/25, 3 out of 4 patients were observed after treatment and did not was their hands after holding access sites when leaving the facility. Staff observed assisting patients did not prompt patients to wash their hands or access sites. In an interview with Staff # 2 and #5 on 7/1/25, the above findings were acknowledged. Facility policy titled, “Infection Control Overview” ,published 05/02/2022 stated in part, All dialysis programs will incorporate the FKC infection control program, which is comprehensive in nature...All infection control policies for patient care are consistent with recommendation of the Centers for Disease Control (CDC). All infection control policies will adhere to CMS and OSHA rules and regulations.” On 6/30/25, staff # 4 did not provide family member a gown prior to entering treatment area during patient treatments. In an interview 6/30/25, Staff # 2 confirmed the above findings that the staff did not follow general infection control measures.”

“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: 43999 Based on observation, interview and record review, the facility’s direct care staff failed to wear gloves and perform hand hygiene when between each patient or station. Findings: Facility policy titled, “Infection Control Overview”, published 05/02/2022 stated in part, All dialysis programs will incorporate the FKC infection control program, which is comprehensive in nature...All infection control policies for patient care are consistent with recommendation of the Centers for Disease Control (CDC). All infection control policies will adhere to CMS and OSHA rules and regulations.” On 6/30/25, staff # 4 did not wash or sanitize hands after degloving and before regloving when providing direct patient care. Staff #4, #6 & #7 used the thermometer from shelf located at the medication area to take a temperature of a patient at the weigh station and returned it to the shelf without disinfecting it, then used the thermometer on a different patient without disinfecting it after use. The staff did not use gloves when handling the thermometer and did not sanitize hands before or after use. In an interview 7/1/25, Staff # 2 confirmed the above findings that the staff did not follow general infection control measures.”

“QA-GENERAL/RECORDS/TREND ANALYSIS CFR(s): 494.50(b)(1) 14 Quality assurance: general/records/trend analysis The criteria chosen as the internal standards of a facility shall be documented in its policy and/or procedure manual. Process review should be part of the activity of the individual carrying out the process, and oversight of that review by another qualified member of the staff or a group of staff members should affirm, modify, or repeat these observations to confirm or improve the process. Clinical outcomes serve as the most important indicator of quality of all dialysis treatment practices including reuse. Final oversight is the responsibility of the medical director. See Table 2 for a summary of the audit schedule. 14.1 Records A record of review, comments, trend analysis, and conclusions arising from QA practices serve as a foundation for future review and as documentation to external evaluation. This Standard is not met as evidenced by: 31690 Based on interview and review of documentation, the facility failed to document review, comments, trend analysis, and conclusions arising from QA practices . Findings: Review on 6/30/25 of the facility QAPI (Quality Assurance and Performance Improvement) meeting notes for March, April and May 2025 did not provide documentation that reflect facility actions plans, monitoring or follow up to improve patient outcomes. During an interview on the afternoon of 6/30/25, Staff #2 acknowledged that the existing QAPI program did not provide documentation of actions plans, reevaluation and revisions.”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 31690 Based on interview and review of documentation, the facility failed to ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist, or physician’s assistant providing ESRD care at least monthly. Findings: Review of the facility policy #61742 “Use of Telehealth for Patient Visits and Other Patient Interactions”, published 5/1/2023, reflected the following: “ ... Physicians and extenders (Providers) might use telehealth to conduct patient visits, follow up with patients following hospitalization or to otherwise communicate regarding their dialysis care between clinic visits, subject to the conditions for Coverage (CforC), any additional state law requirements, and if seeking reimbursement, subject to Medicare or other payor requirements ... ... CMS similarly extended through December 31, 2024, the ability for the Medicare ESRD CforC requirement of monthly provider in-person visits with in-center patients to be satisfied via telehealth, if the patients are considered stable. Even so, the FKC Medical Office strongly recommends providers conduct an in-person monthly visit with in-center patients (preferably the comprehensive visit). Reminder: per CMS, all incenter patients, at least quarterly, must continue to have an in-person (non-telehealth) provider visit at the dialysis clinic while the patient is receiving in-facility dialysis treatment ...” Review of the Physician Documentation Summary reflected the following visits documented by the physician (Staff #12) or NP (Staff #13): Patient #8 4/12/2025, 5/29/25 Face to Face-MD 4/22/25, 5/20/25, 5/27/25, 6/10/25, 6/17/25 Telehealth-NP Patient #9 4/5/25, 4/26/25, 5/13/25 Face to Face-MD 4/17//25, 4/24/25, 5/22/25, 5/27/25, 6/12/25, 6/19/25 Telehealth-NP Patient #10 5/17/25, 5/29/25, 6/7/25 Face to Face-MD 4/22/25, 5/20/25, 5/27/25, 6/10/25, 6/17/25 Telehealth-NP Review of Nurses notes for Patient #8 4/12/25 and 5/29/25, Patient #9 4/26/25, and 5/13/25 and Patient #10 5/17/25, 5/29/25, and 6/17/25 reflected “Dr. rounded via telehealth ...” During an interview, on the morning of 7/1/25, Patient #10 when asked how often he sees his nephrologist during treatment, he stated, “I have not seen her during my treatments here, but she has talked to me via phone during my treatment, she calls the nurses, and they bring the phone to me and we discuss my care. I saw her at the hospital on Corpus when I was there to get the catheter.” During an interview, on the afternoon of 7/1/25, Patient #9 when asked how often the nephrologist comes to the facility during treatment, she stated, “I don’t see her here, I only talk with her on the phone sometimes during treatment. I see her when I’m in the hospital in Corpus.” During a telephone interview, on the morning of 7/1/25, Physician Staff #12 reported that “I have not been able to see my patients in the facility. I asked the facility to put all my patients on one shift so I can see them in one visit. The facility will not work with me. I cannot go to the facility for multiple shifts to see my patients. I go to many different facilities. When asked about her documentation related to telehealth vs Face to Face visits, she reported that all the different facilities have different systems, and she is unsure if she is documenting correctly. Review of an e-mail sent to Staff #12, dated 4/29/24, from Staff #14, Area Team Lead, reflected “I was recently reviewing physician rounding for my 3 clinics ...for the month of April the following patients were not seen in the dialysis facility on treatment every 2 weeks as per DSHS regulations ... Rockport: Patient #11 (seen via telehealth 4/5 it was noted this patient missed treatment 4/12) Patient #9 (seen via telehealth 4/5 and 4/26) Patient #12 (seen via telehealth 4/4 and 4/26) Patient #13 (seen via telehealth 4/5 and 4/26) Patient #8 (seen via telehealth 4/12. It is noted that he has missed 5 treatments in April) Patient #14 (seen via telehealth 4/4. It was noted patient was hospitalized 4/16-4/19) **It was also noted that your method of interaction was documented incorrectly for each of these patient visits. You documented face to face interaction, when rounding was done via telehealth.” During an interview, on the afternoon of 7/1/25, Staff #5 (RN) reported that as far as she knows Staff #14 (Physician) has not made in person rounds all year. During an interview, on the afternoon of 7/1/25, Staff #1 reported that she has tried to get the physician to see her patients. The physician requested that all her patients be moved to one shift. When I asked patients to change shifts they were not interested and declined the change. It is not fair to the patients to move them to accommodate the physicians needs despite the patient’s preferences.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 31690 Based on interview and review of documentation, the Medical Director failed to ensure that the physician rounded in person in the facility at least monthly. Findings Review of the facility policy #61742 “Use of Telehealth for Patient Visits and Other Patient Interactions”, published 5/1/2023, reflected the following: “ ... Physicians and extenders (Providers) might use telehealth to conduct patient visits, follow up with patients following hospitalization or to otherwise communicate regarding their dialysis care between clinic visits, subject to the conditions for Coverage (CforC), any additional state law requirements, and if seeking reimbursement, subject to Medicare or other payor requirements ... ... CMS similarly extended through December 31, 2024, the ability for the Medicare ESRD CforC requirement of monthly provider in-person visits with in-center patients to be satisfied via telehealth, if the patients are considered stable. Even so, the FKC Medical Office strongly recommends providers conduct an in-person monthly visit with in-center patients (preferably the comprehensive visit). Reminder: per CMS, all incenter patients, at least quarterly, must continue to have an in-person (non-telehealth) provider visit at the dialysis clinic while the patient is receiving in-facility dialysis treatment ...” Review of the Physician Documentation Summary reflected the following visits documented by the physician (Staff #12) or NP (Staff #13): Patient #8 4/12/2025, 5/29/25 Face to Face-MD 4/22/25, 5/20/25, 5/27/25, 6/10/25, 6/17/25 Telehealth-NP Patient #9 4/5/25, 4/26/25, 5/13/25 Face to Face-MD 4/17//25, 4/24/25, 5/22/25, 5/27/25, 6/12/25, 6/19/25 Telehealth-NP Patient #10 5/17/25, 5/29/25, 6/7/25 Face to Face-MD 4/22/25, 5/20/25, 5/27/25, 6/10/25, 6/17/25 Telehealth-NP Review of Nurses notes for Patient #8 4/12/25 and 5/29/25, Patient #9 4/26/25, and 5/13/25 and Patient #10 5/17/25, 5/29/25, and 6/17/25 reflected “Dr. rounded via telehealth ...” During an interview, on the morning of 7/1/25, Patient #10 when asked how often he sees his nephrologist during treatment, he stated, “I have not seen her during my treatments here, but she has talked to me via phone during my treatment, she calls the nurses, and they bring the phone to me and we discuss my care. I saw her at the hospital on Corpus when I was there to get the catheter.” During an interview, on the afternoon of 7/1/25, Patient #9 when asked how often the nephrologist comes to the facility during treatment, she stated, “I don’t see her here, I only talk with her on the phone sometimes during treatment. I see her when I’m in the hospital in Corpus.” During a telephone interview, on the morning of 7/1/25, Physician Staff #12 reported that “I have not been able to see my patients in the facility. I asked the facility to put all my patients on one shift so I can see them in one visit. The facility will not work with me. I cannot go to the facility for multiple shifts to see my patients. I go to many different facilities. When asked about her documentation related to telehealth vs Face to Face visits, she reported that all the different facilities have different systems, and she is unsure if she is documenting correctly. Review of an e-mail sent to Staff #12, dated 4/29/24, from Staff #14, Area Team Lead, reflected “I was recently reviewing physician rounding for my 3 clinics ...for the month of April the following patients were not seen in the dialysis facility on treatment every 2 weeks as per DSHS regulations ... Rockport: Patient #11 (seen via telehealth 4/5 it was noted this patient missed treatment 4/12) Patient #9 (seen via telehealth 4/5 and 4/26) Patient #12 (seen via telehealth 4/4 and 4/26) Patient #13 (seen via telehealth 4/5 and 4/26) Patient #8 (seen via telehealth 4/12. It is noted that he has missed 5 treatments in April) Patient #14 (seen via telehealth 4/4. It was noted patient was hospitalized 4/16-4/19) **It was also noted that your method of interaction was documented incorrectly for each of these patient visits. You documented face to face interaction, when rounding was done via telehealth.” During an interview, on the morning of 7/1/25, Staff #11 (Medical Director) reported that this issue had been brought up and that FMC Administration was addressing it. During an interview, on the afternoon of 7/1/25, Staff #5 (RN) reported that as far as she knows Staff #14 (Physician) has not made in person rounds all year. During an interview, on the afternoon of 7/1/25, Staff #1 reported that she has tried to get the physician to see her patients. The physician requested that all her patients be moved to one shift. When I asked patients to change shifts they were not interested and declined the change. It is not fair to the patients to move them to accommodate the physicians needs despite the patient’s preferences.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 31690 Based on interview and review of documentation, the facility failed to maintain complete, accurate, and accessible records on all patients. Findings: Review of the facility policy #61742 “Use of Telehealth for Patient Visits and Other Patient Interactions”, published 5/1/2023, reflected the following: “ ... Physicians and extenders (Providers) might use telehealth to conduct patient visits, follow up with patients following hospitalization or to otherwise communicate regarding their dialysis care between clinic visits, subject to the conditions for Coverage (CforC), any additional state law requirements, and if seeking reimbursement, subject to Medicare or other payor requirements ... ... CMS similarly extended through December 31, 2024, the ability for the Medicare ESRD CforC requirement of monthly provider in-person visits with in-center patients to be satisfied via telehealth, if the patients are considered stable. Even so, the FKC Medical Office strongly recommends providers conduct an in-person monthly visit with in-center patients (preferably the comprehensive visit). Reminder: per CMS, all incenter patients, at least quarterly, must continue to have an in-person (non-telehealth) provider visit at the dialysis clinic while the patient is receiving in-facility dialysis treatment ...” Review of the Physician Documentation Summary reflected the following visits documented by the physician (Staff #12) or NP (Staff #13): Patient #8 4/12/2025, 5/29/25 Face to Face-MD 4/22/25, 5/20/25, 5/27/25, 6/10/25, 6/17/25 Telehealth-NP Patient #9 4/5/25, 4/26/25, 5/13/25 Face to Face-MD 4/17//25, 4/24/25, 5/22/25, 5/27/25, 6/12/25, 6/19/25 Telehealth-NP Patient #10 5/17/25, 5/29/25, 6/7/25 Face to Face-MD 4/22/25, 5/20/25, 5/27/25, 6/10/25, 6/17/25 Telehealth-NP Review of Nurses notes for Patient #8 4/12/25 and 5/29/25, Patient #9 4/26/25, and 5/13/25 and Patient #10 5/17/25, 5/29/25, and 6/17/25 reflected “Dr. rounded via telehealth ...” During an interview, on the morning of 7/1/25, Patient #10 when asked how often he sees his nephrologist during treatment, he stated, “I have not seen her during my treatments here, but she has talked to me via phone during my treatment, she calls the nurses, and they bring the phone to me and we discuss my care. I saw her at the hospital on Corpus when I was there to get the catheter.” During an interview, on the afternoon of 7/1/25, Patient #9 when asked how often the nephrologist comes to the facility during treatment, she stated, “I don’t see her here, I only talk with her on the phone sometimes during treatment. I see her when I’m in the hospital in Corpus.” During a telephone interview, on the morning of 7/1/25, Physician Staff #12 reported that “I have not been able to see my patients in the facility. I asked the facility to put all my patients on one shift so I can see them in one visit. The facility will not work with me. I cannot go to the facility for multiple shifts to see my patients. I go to many different facilities. When asked about her documentation related to telehealth vs Face to Face visits, she reported that all the different facilities have different systems, and she is unsure if she is documenting correctly. Review of an e-mail sent to Staff #12, dated 4/29/24, from Staff #14, Area Team Lead, reflected “I was recently reviewing physician rounding for my 3 clinics ...for the month of April the following patients were not seen in the dialysis facility on treatment every 2 weeks as per DSHS regulations ... Rockport: Patient #11 (seen via telehealth 4/5 it was noted this patient missed treatment 4/12) Patient #9 (seen via telehealth 4/5 and 4/26) Patient #12 (seen via telehealth 4/4 and 4/26) Patient #13 (seen via telehealth 4/5 and 4/26) Patient #8 (seen via telehealth 4/12. It is noted that he has missed 5 treatments in April) Patient #14 (seen via telehealth 4/4. It was noted patient was hospitalized 4/16-4/19) **It was also noted that your method of interaction was documented incorrectly for each of these patient visits. You documented face to face interaction, when rounding was done via telehealth.” During an interview, on the afternoon of 7/1/25, Staff #5 (RN) reported that as far as she knows Staff #14 (Physician) has not made in person rounds all year. During an interview, on the afternoon of 7/1/25, Staff #1 reported that she has tried to get the physician to see her patients. The physician requested that all her patients be moved to one shift. When I asked patients to change shifts they were not interested and declined the change. It is not fair to the patients to move them to accommodate the physicians needs despite the patient’s preferences.”