Fmc South County Dialysis Center

“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: 44223 Based on observation and staff interview, the facility failed to ensure a sanitary environment to minimize the transmission of infectious agents within the treatment area. Findings Include: The Centers for Disease Control and Prevention (CDC) defines a “sanitary environment” as an environment that meets “Standard Precautions” for an in-patient hospital setting plus the more stringent precautions which are recommended for hemodialysis units because of the increased potential for contamination with blood and pathogenic microorganisms. A. On 3/4/25 at 8:10 A.M. during the flash tour of the dialysis treatment area, the surveyor observed the backsplash behind the patient hemodialysis chair and hemodialysis machine was pulled away from the wall, exposing the wood underneath at stations 11 and 18. Further observation indicated the laminate on the windowsills behind the hemodialysis chair and hemodialysis machine was lifting up away from the counter/sill, exposing the wood underneath at stations 5, 6, 7, 8, and 9. This would make attempts to disinfect ineffective and create the risk of spreading infection. Further observation of the treatment area during the flash tour indicated that there was an open crevice all around the parameter of the floor scale, allowing the potential for debris or body fluids to fall underneath the scale, causing concern for cross contamination and would make attempts to disinfect ineffective and create the risk of spreading infection. During an interview on 3/5/25 at 11:30 A.M., the Clinic Manager said that these concerns would make it more difficult to disinfect and clean. B. On 3/4/25 at 9:25 A.M. during an observation of the treatment floor, the surveyor observed Certified Clinical Hemodialysis Technician (CCHT) #2 remove the contaminated tubing from station 17 and proceed to walk with the tubing through the treatment floor and by treatment stations to the biohazard closet (located in the far corner of the treatment floor) to dispose of the tubing, causing concern for risk of cross contamination. On 3/4/25 at 9:52 A.M., during an observation of the treatment floor, the surveyor observed Registered Nurse (RN) # 1 remove contaminated dialysis tubing from station 13 and proceed to walk with the tubing through the treatment floor and by treatment stations to the biohazard closet (located in the far corner of the treatment floor) to dispose of the tubing, causing concern for risk of cross contamination. On 3/4/25 at 10:30 A.M., during an observation of the treatment floor, the surveyor observed RN #1 remove the contaminated dialysis tubing from station 9 and proceed to walk with the tubing through the treatment floor and by treatment stations to the biohazard closet (located in the far corner of the treatment floor) to dispose of the tubing, causing concern for risk of cross contamination. On 3/5/25 at 9:45 A.M., during an observation of the treatment floor, the surveyor observed CCHT #5 remove the contaminated dialysis tubing from station 13 and proceed to walk with the tubing through the treatment floor and by treatment stations to the biohazard closet (located in the far corner of the treatment floor) to dispose of the tubing, causing concern for risk of cross contamination. On 3/5/25 at 11:03 A.M., during an observation of the treatment floor, the surveyor observed RN #6 remove the contaminated dialysis tubing from station 15 and proceed to walk with the tubing through the treatment floor and by treatment stations to the biohazard closet (located in the far corner of the treatment floor) to dispose of the tubing, causing concern for risk of cross contamination During an interview on 3/5/25 at 11:30 A.M. the Clinic Manager said that she was not aware that the staff were doing this and she was not sure why they don’t have the biohazard containers on the floor, but would have to look into this. She said she had just started covering this facility and has not had an opportunity to observe the treatment floor.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 44223 Based on observation and staff interview, the facility failed to ensure that there was separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to ensure patients personal belongings did not come in contact with clean items. Findings include: During an observation on the dialysis treatment floor on 3/5/25 at 9:55 A.M., the surveyor observed a patient’s personal wheelchair pushed up against and touching the hemodialysis machine and tubing at station 13, causing concern for potential cross contamination. During an interview on 3/5/25 at 10:00 A.M., Certified Clinical Hemodialysis Technician (CCHT) #6 said the wheelchair should not have been pushed up against and touching the hemodialysis machine and tubing.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 31240 Based on observation and staff interview, the facility failed to ensure 9 of 19 blood pressure (BP) cuffs observed were free from lint and debris to allow for proper disinfection. Findings Include: Review of the facility’s policy entitled, Cleaning and Disinfection of the Dialysis Station, revised 11/2/20, indicated the following: *The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. *Equipment in the dialysis station may include (but is not limited to) the following: BP cuff. *After use, all non-disposable equipment and supplies must be disinfected with 1:100 bleach or manufacturer’s recommendations, or discarded. During an observation of the treatment floor on 3/4/25 at 9:30 A.M., the surveyor observed 3 of 19 BP cuffs, including those at stations 11, 12, and 13, laden with lint and debris embedded in the Velcro of the BP cuff, making it difficult to adequately disinfect between patients. During a second observation of the treatment floor on 3/5/24 at 10:45 A.M., the surveyor observed an additional 6 BP cuffs including those at stations 3, 9, 19, 16, 17 and 18, laden with lint and debris embedded in the Velcro of the BP cuff. During an interview on 3/5/25 at 11:50 A.M., the Clinic Manager said a BP cuff that has lint build-up should be removed from the treatment floor because it can not be adequately disinfected. She said the facility had plenty of new BP cuffs to replace those with lint buildup.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 27189 Based on observation, policy review and staff interview, the facility failed to ensure that 2 of 3 staff observed (Registered Nurse [RN] #1 and Certified Clinical Hemodialysis Technician [CCHT] #6) maintained appropriate infection control practices to minimize and prevent intravascular catheter-related infections while 1.) performing exit site care for 1 patient (#9), and 2.) obtaining a lab sample from an arterial port of a Central Venous Catheter (CVC) for 1 patient (#8), of 4 applicable patients with a CVC, out of a total sample of 9 patients. Findings include: 1. For Patient #9, RN #1 failed to ensure the povidone (antiseptic cleanser) was allowed to dry for 3 minutes prior to applying the dressing to the CVC site. Review of the facility policy titled Changing the Catheter Dressing Procedure (dated 11/2019) indicated the following: *Cleaning the site: If using povidone pad: Using gentle friction disinfect the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry 3 minutes. During an observation of catheter exit site care on 3/4/25 at 10:31 A.M., RN # 1 cleansed the CVC exit site with povidone for 39 seconds and waited 2 minutes and 9 seconds (dry time) before she applied the dressing to the CVC exit site. During an interview on 3/4/25 at 2:55 P.M., RN #1 said that the dry time for povidone is 3 minutes and she said that she thought she had waited 3 minutes before applying the dressing to the CVC exit site. 2. For Patient #8, CCHT # 6 failed to disinfect the arterial port of the CVC before obtaining a blood sample for the Post Dialysis-Blood Urea Nitrogen (BUN) Laboratory test. Review of the facility’s policy titled, Post Dialysis- Blood Urea Nitrogen (BUN) Laboratory Testing , dated 11/2020, indicated the following: *Clean the arterial sampling port (closest to the arterial needle/catheter limb) with an alcohol prep pad and insert the vacutainer (a single use Tube Holder that securely holds the blood collection tubes during the blood drawing process) with needle into the port. During an observation on 3/5/25 at 9:25 A.M., CCHT # 6 inserted the vacutainer into the arterial port and obtained the Post Dialysis-BUN blood sample, without cleaning and disinfecting the port before the sample was taken. During an interview on 3/5/25 at 11:45 A.M., CCHT # 6 said that he should have disinfected the arterial port before obtaining the blood sample for the Post Dialysis-BUN lab test.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 27189 Based on clinical record review, policy review and staff interview, the facility’s interdisciplinary team (IDT) failed to complete an initial comprehensive assessment (CIA) and an initial Plan of Care (POC) for 1 of 7 applicable patients (#6), out of a total sample of 9 patients, within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis treatment. Findings include: Review of the facility’s policy titled, Comprehensive Interdisciplinary Assessment and Plan of Care, dated 7/2023, indicated the following: * An initial comprehensive interdisciplinary assessment (CIA) and plan of care (POC) must be conducted on all patients new to dialysis within the latter of 30 calendar days or 13 outpatient hemodialysis treatments. * The timeline for both the completion of the CIA and the beginning of implementation of the initial POC, is the later of 30 days from the date of admission to the facility. * CIA will be completed and reviewed by all disciplines and used to develop the patient’s POC. Patient #6 was admitted to the facility in January 2025 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis. Review of the clinical record indicated Patient #6’s first outpatient hemodialysis treatment was on 1/6/25. Further review of the clinical record included the following staff completed initial CIAs that were not completed within the latter of 30 calendar days of admission or 13 hemodialysis treatments: *Nutrition History and Assessment was completed on 2/17/25. *ESRD Comprehensive Social Worker (SW) Assessment was completed on 2/18/25. *ESRD Comprehensive Medical Doctor (MD) Assessment was completed on 2/26/25. Review of the Initial POC indicated it had been reviewed/completed on 2/26/25. The completion date was not within the latter of 30 days of admission or 13 hemodialysis treatments. During an interview on 3/5/25 at 2:40 P.M., the Director of Operations and the Clinic Manager said that the CIA and the POC should have been completed 30 days from the date of admission, but were not.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 31240 Based on record review, staff interview, and policy review, the facility failed to ensure an unstable comprehensive re-assessment and revision of the plan of care was conducted after an extended hospitalization stay greater than 15 days, for 2 of 7 applicable patients (#7 and #2), out of a total sample of 9 patients. Findings Include: Review of the facility policy entitled, Comprehensive Interdisciplinary Assessment and Plan of Care, dated 7/3/23, indicated the following: *Unstable patients must be reassessed by the Interdisciplinary Team (IDT) monthly. *Monthly reassessments and any Plan of Care (POC) updates related to the reason the patient was considered unstable must be documented until the issues have been resolved or the IDT (including the patient if possible) determines that the condition is chronic. *The following are unstable criteria: -Hospitalization of more than 15 days with discharge occurring within the last 30 days. -More than 3 admissions in the last 30 days. 1. Patient #7 was admitted to the facility in July 2024 with a diagnosis of End Stage Renal Disease, requiring hemodialysis 3 times a week. Review of the clinical record indicated Patient #7 had a 90 day comprehensive assessment completed in November 2024, with a POC developed based on that assessment. Further review of the clinical record indicated that Patient #7 had been hospitalized 12/23/24 through 1/24/25, for a total of 33 days, for bacteremia (blood stream infection) and hardware infection. Patient #7 returned to the facility 1/25/25 to resume dialysis treatments. The clinical record had no documented evidence of a comprehensive reassessment and POC update after the readmission to the facility. Review of the facility’s list of unstable patients indicated Patient #7 was not documented as unstable. During an interview on 3/5/25 at 11:45 A.M., the Clinic Manager said the patient was considered unstable, but had not had a comprehensive reassessment or POC update yet. During an interview on 3/5/25 at 12:00 P.M., the Director of Operations said the comprehensive reassessment had not been scheduled within a month of Patient #7’s readmission to the facility. She said POC reviews are scheduled around the physicians and their attendance at monthly quality meetings, so this may have been why the assessments had not been completed yet. 44223 2. Patient #2 was admitted to the facility in December 2018 with a diagnosis of End Stage Renal Disease, requiring hemodialysis 3 times a week. Review of the clinical record indicated an annual comprehensive assessment was completed in March 2024, with a plan of care developed based on that assessment. Further review of the clinical record indicated Patient #2 had been hospitalized from 12/16/24-1/9/25 for pneumonia and chronic respiratory failure with hypoxia (totaling 24 days). Further review indicated the Interdisciplinary Team (IDT) failed to identify Patient #2 as an unstable patient, per their facility policy. Review of the facility’s list of unstable patients indicated Patient #2 was not documented as unstable. During an interview on 3/6/25 at 9:00 A.M., the Clinic Manager and Director of Operations said Patient #2 should have been made unstable upon return from the 24 day hospital stay.”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 31240 Based on record review, policy review, and staff interview, the facility failed to complete necessary psychosocial status monitoring by failing to complete a standardized mental and physical assessment tool (KDQOL-36) chosen by the Social Worker (SW) within four months of initiating treatment (or first reassessment) and at least annually, at regular intervals for 1 of 7 applicable patients (#7), out of a total sample of 9 patients. Findings include: Review of the facility’s policy entitled, Measuring Patient Physical and Mental Function, revised 1/20/25, indicated the following: *Achieving and sustaining appropriate psychosocial and physical status will by measured by a standardized mental and physical assessment tool: KDQOL-36 for adults. *The KDQOL-36 is administered to patients new to dialysis between the third and fourth month starting dialysis as part of the patient’s 90-day reassessment and plan of care. *Any exception to completing the KDQOL-36 must be documented in the medical record. *When the KDQOL-36 survey is not completed, the reason for this must be documented in the patient’s medical record in the form of a progress note or exclusion report printed from the KDQOL-36 application. This note should include the date the survey was presented to the patient and/or parent/guardian, and the reason it was not completed. For Patient #7, the facility failed to ensure the KDQOL-36 had been completed within the third to fourth month of starting dialysis. Patient #7 was admitted to the facility in July 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis 3 times a week. Review of the 90 day comprehensive assessments indicated that the Social Worker (SW) had completed a comprehensive psychosocial status assessment on 11/15/24, which indicated that the KDQOL-36 was not administered. The assessment indicated the KDQOL-36 survey was not completed and the patient was not available for completion. Review of the clinical record indicated that there was no documented evidence that Patient #7 had been re-approached and administered the KDQOL-36 survey, or if he/she had refused to complete it. During an interview on 3/5/24 at 11:45 A.M., the Clinic Manager said there was not a KDQOL-36 survey completed for Patient #7. She said the facility’s SW was on a leave, and there was a covering SW who may have not completed it. During an interview on 3/5/24 at 12:00 A.M., the Director of Operations said she reviewed the clinical record and spoke with the covering SW. She said the SW had called Patient #7 to complete the survey, but was not able to speak with him/her. The Director of Operations said there was no additional documentation of the re-attempts to administer the survey, or the reason why the survey was not completed.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 44223 Based on review of the facility Quality Assessment Performance Improvement (QAPI) Committee meeting minutes, staff interview, and policy review, the facility failed to ensure that an increase in the monthly incidents of blood stream infection (BSI) rates were analyzed, and a plan was developed based on the results of these reports to reduce future infections. Findings Include: Review of the facility policy, titled Quality Assessment and Performance Improvement, published 11/4/24, indicated the following: *The QAPI program is a collaboration among the interdisciplinary team that must develop, implement, maintain, and evaluate an effective, data-driven quality assessment and performance improvement program. QAPI requires the use of aggregate patient data to evaluate the facility patient outcomes. *QAPI is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes. *A developed appropriate action plan will include: -Implementing the action plan with a specific goal. -Identifying staff member(s) responsible for action plan. -Monitoring progress and effectiveness of the action plan. -Review and document monthly updates in eQuip until a resolution is achieved. -Reassessment of the plan if portions are unsuccessful. -Sustaining the plan if successful. Review of the monthly QAPI meetings from September 2024 through February 2025 indicated there was an increase in the overall increase of blood stream infections. The QAPI meetings indicated the following: September 2024- 0.21 October 2024- 0.25 November 2024- 0.26 December 2024- 0.26 January 2025- 0.39 Further review of the QAPI meeting minutes did not indicate any documented evidence that an action plan was implemented for the increase in blood stream infection rate. The surveyor and the Clinic Manager reviewed the facility’s eQuip program (computer dashboard) that indicates quality indicators that are monitored each month. The percentages for blood stream infections indicated they were not at goal as evidenced by being in the color red (red indicates a flagged area). The corresponding graph showed an increase between the months of September 2024 through January 2025. During an interview on 3/6/25 at 10:20 A.M. the Clinic Manager said that based on the information on the dashboard it would indicate that there is an increase in blood stream infections. She said that an investigation and action plan should have been put in place when the data showed an increase in blood stream infections.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 44223 Based on review of the Quality Assessment Performance Meeting (QAPI) minutes, staff interview, and policy review, the facility failed to continuously monitor performance, take actions that resulted in performance improvements, and track performance to ensure that improvements are sustained over time. Findings Include: Review of the facility policy, titled Quality Assessment and Performance Improvement, published 11/4/24, indicated the following: *The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven QAPI program with participation by the professional members of the interdisciplinary team (IDT). The program must reflect the complexity of the organization and services and must focus on indictors related to improved health outcomes and the prevention and reduction of medical errors. *The QAPI program is a collaboration among the interdisciplinary team that must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program. QAPI requires the use of aggregate patient data to evaluate the facility patient outcomes. *QAPI is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes. *The QAPI Committee will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement, evaluate, and revise plans that result in sustainable improvements in patient care. *A developed appropriate action plan will include: -Implementing the action plan with a specific goal. -Identifying staff member(s) responsible for action plan. -Monitoring progress and effectiveness of the action plan. -Review and document monthly updates in eQuip until a resolution is achieved. -Reassessment of the plan if portions are unsuccessful. -Sustaining the plan if successful. Review of the QAPI meeting minutes from August 2024-February 2025 indicated the facility identified that missed treatments were increasing. In August 2024 an action plan was put in place by the Social Worker (SW). The action plan indicated the nurse would speak to the patient using the rescheduling script. The SW would utilize the MOST report (patient detail report) as a report card to generate discussion with the IDT. The action plan would be delegated to the nurse and the SW. The plan would be re-evaluated in one month. If no measurable improvement was made the plan would be reassessed. Review of the QAPI meeting minutes for September 2024-December 2024 did not indicate any improvement in the percentage of missed treatments. The action plan remained in place with no new interventions or changes made to the action plan. Review of the QAPI meeting minutes for January 2025 indicated there was temporary coverage in place for the facility SW who was on leave until April 2025. There was no documented evidence that the action plan for missed treatments was reviewed or reassessed for changes. During an interview on 3/6/25 at 10:20 A.M. the covering SW said that the facility SW went on leave in November and that there is 3 covering SW’s for the facility at this time. She said the action plan has not been re-evaluated since the facility SW went out on leave.”