Maple Avenue Kidney Center

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 52591 Based on document review, and interview, the hospital failed to ensure compliance with 42 CFR 492.110, Quality Assessment Performance Improvement. Findings include: 1. The facility failed to ensure that aggregate data for incenter hemodialysis and peritoneal dialysis patients were reviewed and evaluated separately by the QAPI (Quality Assurance and Performance Improvement) team. See V-628 A. 2. The facility failed to ensure that the water system (reverse osmosis/purification process and chlorine/chloramine testing/presence of disinfectant) was reviewed and evaluated by the QAPI team. See V-628 B. 3. The facility failed to ensure that physical environment audits and incidences of patient mortality were collected, reviewed, and evaluated by the QAPI team. See V-628 C.”

“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: 36774 Based on observation, document review, and interview, for 1 of 4 PCTs (Patient Care Technician/E #8) observed initiating dialysis treatment, the facility failed to ensure staff performed hand hygiene and changed gloves. 1. On 9/17/2025 between approximately 9:35 AM through 11:30 AM, an observational tour of the dialysis treatment area was conducted: - At approximately 10:10 AM, E #8 was wearing gloves while initiating dialysis for Pt. #7 in Station #12. Without removing E #8’s gloves and performing hand hygiene, E #8 went to the counter and obtained a 4 x 4 gauze, then went back to Station #12 and continue initiating the dialysis for Pt. #7. - At approximately 11:24 AM, E #8 was wearing gloves while initiating dialysis for Pt. #8 in Station #13. Without removing E #8’s gloves and performing hand hygiene, E #8 went to the counter, obtained a 4 x 4 gauze, then went back to Station #13 and continue initiating the dialysis for Pt. #8. 2., On 9/17/2025, the facility’s policy titled, “Hand Hygiene Policy” (5/24/24) was reviewed and indicated, “Purpose... to prevent the transmission of infection among patients and staff... Hand Washing... Before and after patient contact...” 3. On 9/17/2025, the facility’s policy titled, “Infection Control Guidelines” (undated) was reviewed and indicated, “... General Guidelines for Infection Control... 4. Examples of when fresh pair of gloves must be put on...b. When going from a dirty area or task to a clean area or task...” 4. On 9/17/2025 at approximately 3:30 PM, findings were discussed with E #1 (Facility Administrator). E #1 stated that the staff should have performed hand hygiene and changed gloves.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 36774 Based on observation, document review and interview, it was determined that for 1 of 2 clean sinks (Sink by station #7) observed used by staff for handwashing, the facility failed to ensure designated sink was labeled, as required by policy. Findings include: 1. On 9/17/2025 between approximately 9:35 AM through 11:30 AM, an observational tour of the dialysis treatment area was conducted. During the tour, the sink used for handwashing was not labeled. 2. On 9/17/2025, the facility’s policy titled, “Infection Control Guidelines” (undated) was reviewed and indicated, “... General Guidelines for Infection Control... 30. Sinks in the clinical area must be designated as clean or dirty... Staff must be aware of the separation of clean and dirty areas to prevent cross contamination...” 3. On 9/17/2025 at approximately 11:30 AM, findings were discussed with E #1 (Facility Administrator). E #1 stated that the sinks should be labeled as clean or dirty to prevent cross contamination.”

“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: 52591 Based on document review, observation, and interview, for 2 of 6 infusion pumps (Baxter Sigma Spectrum serial #2144091 and serial # 2151765) available for patient use, the facility failed to ensure that the cleaning and disinfection of medical devices were followed, to prevent transmission of bloodborne pathogens. 1. On 9/16/2025 the facility’s policy titled “Infection Control Guidelines” (undated), was reviewed. The policy required, “ ...For visible blood, the intermediate-level disinfection protocol must be followed, which requires the area to be immediately cleaned with a cloth soaked with tuberculocidal disinfectant or 1:100 dilution of bleach ...” 2. On 9/16/2025 between 10:45 AM and 12:30 PM, an observational tour of the dialysis treatment area was conducted. During the tour, 2 of 6 Baxter Sigma Spectrum infusion pumps were found to have blood spatter on them. 3. On 9/16/2025 at approximately 12:25 PM E#1 (Facility Administrator) was interviewed and shown the two infusion pumps. E#1 stated that the red spatter on the pumps was blood. E #1 stated that the pumps should not have blood spatter and not be available for patient use.”

“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: 52591 Based on document review, observation, and interview, for 2 of 3 PCTs (Patient Care Technician) (E #4 and E #5) observed regarding disinfection of Central Venous Catheter (CVC) ports (catheter access), the facility failed to ensure that CVC ports were properly disinfected, in order to prevent catheter related infections. Findings include: 1. On 9/16/2025, the facility’s policy titled “Initiation and Discontinuation of Hemodialysis Treatment” (Reviewed by the facility on 05/24/24) was reviewed. The policy required, “ ...Perform 30 second alcohol scrub on each port after removing caps.” 2. On 9/16/2025 between 10:45 AM and 12:30 PM, an observational tour of the dialysis treatment area was conducted: - At approximately 10:58 AM, E#4 (Patient Care Technician/PCT) was observed disinfecting the red and blue ports of the CVC with alcohol swabs during initiation of dialysis for Pt. #5. E#4 disinfected the red port for 11 seconds and disinfected the blue port for 15 seconds. - At approximately 11:55 PM, E#4 (PCT) was observed disinfecting the red and blue ports of the CVC with alcohol swabs during discontinuation of dialysis for Pt. #4. E#4 disinfected the red port for 8 seconds and disinfected the blue port for 7 seconds. - At approximately 12:12 PM, E#5 (PCT) was observed disinfecting the red and blue ports of the CVC with alcohol swabs during initiation of dialysis for Pt. #6. E#5 disinfected the red port for 12 seconds and disinfected the blue port for 15 seconds. 3. On 9/16/2025 at approximately 11:05 AM, E#4 was interviewed regarding the appropriate process of disinfecting the ports of a patient’s CVC. E#4 stated, “I think it is 20 to 30 seconds with an alcohol swab.” 4. On 9/16/2025 at approximately 12:10 pm, E#5 was interviewed regarding the appropriate process of disinfecting the ports of a patient’s CVC. E#5 stated, “I believe it is 30 seconds with the alcohol.””

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 36774 A. Based on document review and interview, for 3 of 3 Myron L D-6 Meters (measure pH/acid and base level and conductivity/monitors electrolyte balance) (Myron Meters #1, #2, and #3) observed being used to measure dialysate pH and conductivity before initiation of hemodialysis, the facility failed to ensure that calibration of the meters was documented, as required. Findings include: 1. On 9/16/2025, the Myron L D-6 Meter calibration log for September 2025 was reviewed. The log lacked documentation that the Myron Meters #1, #2, and #3 were calibrated on 9/1/2025, 9/5/2024, 9/8/2025, 9/12/2025, and 9/15/2025). 2. On 9/16/2025, the facility’s policy titled, “Policy for Using Myron L D-6 Meter” (5/24/24) was reviewed and indicated, “Purpose... calibration of the Myron L D-6 meter to ensure measurement of conductivity and pH in water and dialysate solutions used in hemodialysis treatment... Calibration Procedure: Frequency... at the beginning of each day before use and whenever accuracy is in question... Documentation: Record calibration results, including date, time, standard solutions used, and staff members performing the calibration in a logbook...” 3. On 9/17/2025 at approximately 3:30 PM, findings were discussed with E #1 (Facility Administrator). E #1 stated that the logbook lacked documentation that the Myron Meters were calibrated. E #1 stated that meters should be calibrated daily at the beginning of each day. B. Based on observation, document review, and interview, for 1 of 4 cabinets under the sinks (Cabinet Sink by Station 10) observed regarding proper maintenance, the facility failed to ensure that the cabinet was maintained and safe for use. Findings include: 1. On 9/17/2025 between approximately 9:35 AM through 11:30 AM, an observational tour of the dialysis treatment area was conducted. During the tour, the door of the cabinet under the sink by Station #10 had a broken door. The door was not attached to the door hinge and was leaning on cabinet door frame. Staff members were observed using the sink and standing in facing the broken door. 2. On 9/17/2025, the facility’s policy titled, “Supply and Storage” (5/24/24) was reviewed and indicated, “... to ensure the organized, safe and efficient storage... within our incenter dialysis facility...” 3. On 9/17/2025 at approximately 11:30 AM, findings were discussed with E #1 (Facility Administrator). E #1 stated that the cabinet door should be fixed to ensure safety for staff and patients walking or standing by the sink.”

“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: 36774 Based on observation, document review, and interview, for 2 of 12 patients (Pt. #9 and Pt. #10) observed receiving hemodialysis treatments, the facility failed to ensure that the dialysis access was visible. Findings include: 1. On 9/17/2025 between approximately 9:35 AM through 11:30 AM, an observational tour of the dialysis treatment area was conducted. From 9:35 AM through 10:10 AM (35 minutes), Pt. #9 and Pt. #10’s dialysis access sites were covered with blanket and not visible. During the time frame, no one was checking to ensure that Pt. #9 and Pt. #10’s access site was visible. 2. On 9/17/2025, the facility’s policy titled, “Patient Assessment and Monitoring Before, During, and Post Treatment” (5/24/24) was reviewed and indicated, “... Policy... 2. during treatment: a. Ongoing monitoring of the patient’s... access... is done and documented a minimum of every 30 minutes... “ 3. On 9/17/2025 at approximately 3:30 PM, findings were discussed with E #1 (Facility Administrator). E #1 stated that patient’s dialysis access site should be visible at all times.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 36774 A. Based on document review and interview, the facility failed to ensure that aggregate data for incenter hemodialysis and peritoneal dialysis patients were reviewed and evaluated separately by the QAPI (Quality Assurance and Performance Improvement) team. This has the potential to affect all 57 patients on the census. Findings include: 1. On 9/18/2025 at approximately 9:15 AM, the facility’s QAPI committee data/meeting minutes from January 2025 through July 2025, were reviewed. The meeting minutes did not indicate that aggregate data for incenter hemodialysis and peritoneal dialysis were reviewed and evaluated separately. 2. On 9/18/2025, the facility’s policy titled, “Quality Assessment and Performance Improvement (QAPI) Program” (5/24/24) was reviewed and indicated, “Purpose: To maintain a systematic process to monitor and evaluate the quality and appropriateness of patient care rendered, pursues opportunities to improve healthcare outcomes... Data Sources... Recommendation from regulatory agencies...” 3. On 9/18/2025 at approximately 9:20 AM, findings were discussed with E #1 (Facility Administrator) and E #2 (Registered Nurse). E #1 and E #2 stated that the aggregated data regarding dialysis metrics for albumin, adequacy, bone and mineral, and others that the QAPI committee discussed were for both the incenter hemodialysis and peritoneal dialysis patients. E #1 and E #2 stated that the QAPI committee do not separate aggregated data for its incenter hemodialysis and peritoneal dialysis patients. B. Based on document review and interview, the facility failed to ensure that the water system (reverse osmosis/purification process and chlorine/chloramine testing/presence of disinfectant) was reviewed and evaluated by the QAPI team. This has the potential to affect all 47 incenter hemodialysis patients on the census. Findings include: 1. On 9/18/2025 at approximately 9:15 AM, the facility’s QAPI committee data/meeting minutes from January 2025 through July 2025, were reviewed. The meeting minutes did not indicate that that facility’s logs for its water system (reverse osmosis and chlorine and chloramine testing), were reviewed. 2. On 9/18/2025, the facility’s policy titled, “Quality Assessment and Performance Improvement (QAPI) Program” (5/24/24) was reviewed and indicated, “Purpose: To maintain a systematic process to monitor and evaluate the quality and appropriateness of patient care rendered, pursues opportunities to improve healthcare outcomes... Data Sources... Log books... Meetings: Regularly scheduled meetings will be held with the Medical Director with an agenda that contain unit activities including... quality reports... The meeting agenda... to include... Water Quality Results...” 3. On 9/18/2025 at approximately 10:00 AM, findings were discussed with E #1 (Facility Administrator). E #1 stated that the QAPI team minutes do not indicate that the water quality logs for reverse osmosis and chlorine and chloramine testing were reviewed by the QAPI team. C. Based on document review and interview, the facility failed to ensure that physical environment audits and incidences of patient mortality were collected, reviewed, and evaluated by the QAPI team. This has the potential to affect all 57 patients on the census. 1. On 9/18/2025 at approximately 9:15 AM, the facility’s QAPI committee data/meeting minutes from January 2025 through July 2025, were reviewed. The meeting minutes did not indicate that that QAPI team collected, reviewed, and evaluated audits for its physical environment and incidences of mortality. 2. On 9/18/2025, the facility’s policy titled, “Quality Assessment and Performance Improvement (QAPI) Program” (5/24/24) was reviewed and indicated, “Purpose: To maintain a systematic process to monitor and evaluate the quality and appropriateness of patient care rendered, pursues opportunities to improve healthcare outcomes... Data Sources... Logbooks. Recommendation from regulatory agencies... Meetings: Regularly scheduled meetings will be held with the Medical Director with an agenda that contain unit activities including patient morbidity...” 3. On 9/18/2025 at approximately 9:20 AM, findings were discussed with E #1 (Facility Administrator). E #1 stated that the QAPI team do not collect, review, or evaluate audits regarding its physical environment. E #1 validated that the QAPI meeting minutes do not indicate that patient’s mortality was collected and evaluated.”

“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: 52591 Based on observation, document review and interview, for 1 of 1 Registered Nurse (RN) (E#2) observed regarding the handling of medications, the facility failed to ensure that the medications were kept secure, as required by policy. Findings include: 1. On 9/16/2025, an observational tour of the dialysis treatment area was conducted between 10:45 AM and 12:30 PM. During the tour, a multidose vial of Heparin (blood thinner) and multiple bottles of Cinaclcet tablets 30mg (milligrams), 60mg and 90mg (for treatment of parathyroid disease) and Calcitriol 0.5mg (a form of vitamin D) were seen unattended on the counter space below the medication cabinet. The vial of heparin, Cinaclcet tablets and Calcitriol were accessible to anyone who enters and exits the dialysis treatment area, while Registered Nurse (RN/E #2) was away from the counter space. 2. On 9/16/2025, the facility policy entitled “Medications: Handling, Storage and Disposal” (05/24/24) was reviewed. The policy stated ...”All medications will be in a locked area.” 3. On 9/16/2025 at approximately 11:06 AM, E#2 was interviewed regarding the handling and storage of medications. E#2 stated, “My practice is to get the medications I need for my shift from the locked cabinet when I arrive. I keep them on top of the counter until the end of the shift.””

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 32741 Based on document review, observation, and interview, it was determined that the Facility failed to comply with the Condition for Coverage 42 CFR 494.30, Infection Control. Findings include: 1. The Facility failed to ensure dialysis machines were free from dialyzers being stored on top of the dialysis machines. (V111) 2. The Facility failed to ensure that staff washed their hands in between patient contact. (V113) 3. The Facility failed to ensure that staff wore a gown or face shield while performing CVC site care. (V115) 4. The Facility failed to enusre that oxygen tanks were stored in a clean area. (V119) 5. The Facility failed to ensure that patients susceptible to Hepatitis B infection were monitored monthly for potential infection. (V124) 6. The Facility failed to ensure dialysis stations were cleaned and disinfected. (V122) 7. The Facility failed to disinfect AV insertion sites in a circular motion. (V132) 8. The Facility failed to disinfect CVC hubs for 30 seconds. (V147)”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 32741 Based on document review and interview, it was determined that the Facility failed to comply with the Condition for Coverage 42 CFR 494.110, Quality Assessment and Performance Improvement. Findings include: 1. The Facility failed to analyze or track indicators for hospitalizations, water & dialysate quality, infection control audits and health outcomes-physical and mental functioning (HRQOL) results. (See V-628). 2. The Facility failed to analyze or track patient safety events. (See V-634). 3. The Facility failed to analyze or track patient satisfaction and grievances. (See V-636).”

“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: 32741 Based on document review, observation and interview, it was determined that for 10 of 17 dialysis stations (station #1, station #2, station #3, station #4, station #5, station #6, station #7, station #8, station #10 and station #11), the Facility failed to ensure the dialysis machines were free from dialysis equipment stored on top the dialysis machine. This had the potential to affect all 58 in-center hemodialysis patients on census. Findings include: 1. On 5/13/2024, the Facility’s policy titled, “Supply and Storage Policy” (undated) was reviewed and indicated, “The purpose of this policy is to ensure the organized, safe, and efficient storage of supplies within our incenter dialysis facility, thereby facilitating easy access to essential items while maintaining cleanliness and infection control standards...Designated storage areas will be established for different categories of supplies, including medical equipment, consumables, medications, and cleaning supplies...” 2. On 5/13/2024 between 8:45 AM and 11:55 AM, an observational tour was conducted in the dialysis treatment area. The following was observed: -Each dialysis station (station #1 thru station #8 and station #10 & station #11) had a dialyzer (a container that a has a semipermeable membrane that separates a patient’s blood from dialysate, a washing fluid) on top of the dialysis machine. The dialyzers were observed on top of the dialysis machines of patients who had a treatment in progress. - On 5/15/2024 at 8:30 AM, there were dialyzers on top of dialysis machines at station #1, station #5, station #7 and station #8. The dialyzers were observed on top on the dialysis machines of patients who had a treatment in progress. 3. On 5/14/2024 at 2:00 PM, an interview was conducted with the Clinic Manager (E #1). E #1 stated that dialyzers should not be kept on top of the dialysis machines. E #1 stated that the dialyzers are only used when the staff set up a machine and should not be stored on top of the dialysis machines.”

“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: 32741 Based on document review, observation and interview, it was determined that for 2 of 3 Patient Care Technicians (E #3 and E #4), the Facility failed to ensure that staff washed their hands between each patient contact. This had the potential to affect all 58 in-center hemodialysis patients on census. Findings include: 1. On 5/13/2024, the Facility’s policy titled, “Hand Hygiene Policy” was reviewed and indicated, “This policy is established to ensure the highest standards of hand hygiene are maintained within our incenter dialysis facility to prevent the transmission of infections among patients and staff...All staff must wash hands thoroughly with soap and water: Before and after patient contact...After touching any potentially contaminated surfaces...Alcohol-based hand sanitizers may be used as an alternative when hand washing facilities are not readily available, but hand washing with soap and water is preferred whenever possible...” 2. On 5/13/2024 between 8:45 AM and 11:55 AM, an observational tour was conducted in the dialysis treatment area. The following was observed: -At 9:30 AM, E #3 was observed touching dialysis machine at Station #3 with gloves on, then E #3 removed the dirty glove and placed the dirty glove on top of the dialysis machine. E #3 then put another pair of gloves on and went to care for another patient at Station #4. E #3 then came back to Station #3 and took the dirty glove from on top on the machine, wrapped the glove around E #3’s finger and adjusted the dialysis machine at Station #3. E #3 did not wash his hands or use sanitizer in between each patient contact. -At 9:40 AM, E #4 was observed caring for a patient at Station #5. E #4 then went to Station #12 and adjusted the machine without changing gloves or washing hands. 3. On 5/13/2024 at 11:30 AM, an interview was conducted with E #3. E #3 stated that E #3 wraps the glove that E #3 leaves on top of the dialysis machine around E #3’s thumb and then adjusts dialysis machines. E #3 stated that E #3 keeps the glove on top of the dialysis machine for repeated use. E#3 stated that handwashing should be done in between each patient contact.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 32741 Based on document review, observation and interview, it was determined that for 1 of 2 Patient Care Technicians (E #4) observed for CVC (central venous catheter) site care, the Facility failed to ensure E #4 wore a gown or facial shield on while performing CVC site care. This had the potential to affect all CVC hemodialysis patients on census. Findings include: 1. On 5/13/2024, the Facility’s policy titled, “Personal Protective Equipment (PPE) Policy” (undated) was reviewed and indicated, “Use of PPE - Gowns should be worn to protect clothing from contamination during procedures that may generate splashes or sprays of blood or body fluids. Masks and eye protection (such as goggles or face shields) should be worn when performing procedures that may generate aerosols or splashes...” 2. On 5/13/2024 at approximately 8:30 AM, E #4 was observed performing CVC site care at Station #8 without wearing a gown and without wearing a face shield. 3. On 5/13/2024 at approximately 11:00 AM, an interview was conducted with E #4. E #4 stated that a face shield and a gown should be worn while performing CVC site care.”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 32741 Based on observation, document review and interview, it was determined that for 30 of 30 oxygen tanks observed, the Facility failed to ensure that oxygen tanks were stored in a clean area. This had the potential to affects patients who use oxygen. Findings include: 1. On 5/13/2024, the Facility’s policy titled, “Equipment Storage Policy” (undated) was reviewed and indicated, “Storage Conditions - equipment will be stored in clean, dry and well ventilated areas to prevent damage from moisture, dust, or other environmental factors...” 2. On 5/13/2024 between 8:45 AM and 11:55 AM, an observational tour was conducted in the dialysis treatment area, the following was observed: -30 oxygen tanks with white residue on each tank were noted in the corner of the dialysis treatment area next to (within a foot of) Station #18. 3. On 5/13/2024 at 3:00 PM, an interview was conducted with the Clinic Manager (E #1). E #1 stated that the oxygen tanks have always been kept in the corner of the dialysis treatment area. E #1 stated that the white residue on each tank is probably bicarbonate.”

“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: 32741 A. Based on document review, observation and interview, it was determined that for 3 of 3 Patient Care Technicians (E #3, E #4 and E #5) observed cleaning and disinfecting dialysis stations, the Facility failed to follow infection control precautions by not cleaning/disinfecting equipment, as required. This had the potential to affect all 58 in-center hemodialysis patients on census. Findings Include: 1. On 5/13/2024, the Facility’s policy titled, “Cleaning and Disinfection: Exterior Surfaces of the Delivery System, Dialysis Chair and Other Related Equipment” (undated) was reviewed and indicated, “To prevent transmission of infectious agents in the dialysis units through contact with equipment surfaces...Chairs will be reclined and all areas inspected and disinfected where blood could accumulate...” 2. On 5/13/2024 between 8:35 AM and 11:55 AM, an observational tour was conducted in the dialysis treatment area. The following was observed: - At approximately 9:50 AM, the Patient Care Technician (E # 3) did not wipe the sides of the dialysis chair and did not open the dialysis chair to disinfect the sides of the dialysis chair at Station #5. - At approximately 10:35 AM, E #4 put bleach wipes in top of the dialysis machine while the patient was still in the dialysis chair at Station #8. When the patient vacated the chair, E #4 used the bleach wipes to disinfect the dialysis machine. E #4 did not open the sides of the dialysis chair while disinfecting/cleaning the dialysis chair to disinfect all areas of the dialysis chair at Station #8. - At approximately 11:30 AM, the Patient Care Technician (E #5) was disinfecting the dialysis chair at Station #13. E #5 did not open the sides of the dialysis chair and did not recline the dialysis chair during cleaning/disinfecting the dialysis station at Station #13. 3. On 5/13/2024 at approximately 12:05 PM, an interview was conducted with the E#3. E #3 stated that all areas of the dialysis station should be cleaned including the sides of the dialysis chair. B. Based on document review, observation and interview, it was determined that for 1 of 1 Patient Care Technician (E #3), the Facility failed to ensure that a blood spill was cleaned thoroughly with a clean absorbent material, as required. Findings include: 1. On 5/13/2024, the Facility’s titled, “Infection Control Guidelines” (undated) was reviewed and required, “Blood spills must be cleaned up thoroughly and immediately, if the spill contains large amounts of blood or body fluids (e.g. > 10 ml), clean the visible matter with disposable absorbent material and discard in appropriate containers for biohazard waste...” 2. On 5/13/2024, between 8:45 AM and 11:55 AM, an observation was conducted in the dialysis treatment area. The Patient Care Technician (E #3) was observed at 9:40 AM cleaning a blood spill. E #3 poured a bleach solution on the blood spill and then wiped the area with a dirty mop. E #3 then placed the dirty mop with the blood spill in another area and did not clean the dirty mop or discard the dirty mop in a biohazard waste container. 3. On 5/13/2024 at 12:10 PM, an interview was conducted with E #3. E #3 stated that the Facility used to have blood spill kits. E #3 stated that there are no blood spill kits in the Facility. E #3 stated that E #3 will clean the mop later in the day.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 8 of 22 patients (Pts. #9-#16) susceptible to Hepatitis B (liver infection), the Facility failed to ensure that patients were routinely tested every month to determine the presence or absence of infection. Findings include: 1. The Facility’s policy titled, “Hepatitis Testing and Vaccination for Patients” (undated), was reviewed and required, “...Patients who are considered susceptible should have HBsAg [antigen] drawn every month...” 2. The clinical record of Pt. #9 was reviewed, Pt. #9 was admitted on 4/29/2019, with a diagnosis of ESRD. Pt. #9’s lab results, dated 1/8/2024, indicated that Pt. #9 was susceptible to Hepatitis B infection; however, the record lacked subsequent monthly antigen test results. 3. The clinical record of Pt. #10 was reviewed, Pt. #10 was admitted on 3/6/2023, with a diagnosis of end-stage renal disease (ESRD). Pt. #10’s lab results, dated 1/8/2024, indicated that Pt. #10 was susceptible to Hepatitis B infection and did not have an active infection at the time of the test. However, the record lacked subsequent monthly antigen results to determine the presence or absence of infection. 4. The clinical record of Pt. #11 was reviewed, Pt. #11 was admitted on 12/27/2022, with a diagnosis of ESRD. Pt. #11’s lab results, dated 1/8/2024, indicated that Pt. #11 was susceptible to Hepatitis B infection and did not have an active infection at the time of the test. However, the record lacked subsequent monthly antigen results to determine the presence or absence of infection. 5. The clinical record of Pt. #12 was reviewed, Pt. #12 was admitted on 5/1/2017, with a diagnosis of ESRD. Pt. #12’s lab results, dated 1/11/2024, indicated that Pt. #12 was susceptible to Hepatitis B infection; however, the record lacked monthly antigen test results for the months of February and April 2024. 6. The clinical record of Pt. #13 was reviewed, Pt. #13 was admitted on 10/23/2010, with a diagnosis of ESRD. Pt. #13’s lab results, dated 1/8/2024, indicated that Pt. #13 was susceptible to Hepatitis B infection; however, the record lacked monthly antigen test results for the months of February and April 2024. 7. The clinical record of Pt. #14 was reviewed, Pt. #14 was admitted on 10/21/2019, with a diagnosis of ESRD. Pt. #14’s lab results, dated 1/15/2024, indicated that Pt. #14 was not immune to Hepatitis B infection (results were indeterminate); however, the record lacked monthly antigen test results for the months from February to April 2024. 8. The clinical record of Pt. #15 was reviewed, Pt. #15 was admitted on 4/16/2020, with a diagnosis of ESRD. Pt. #15’s lab results, dated 1/8/2024, indicated that Pt. #15 was susceptible to Hepatitis B infection; however, the record lacked subsequent monthly antigen test results. 9. The clinical record of Pt. #16 was reviewed, Pt. #16 was admitted on 7/18/2023, with a diagnosis of ESRD. Pt. #16’s lab results, dated 1/8/2024, indicated that Pt. #16 was susceptible to Hepatitis B infection; however, the record lacked subsequent monthly antigen test results. 10. An interview was conducted with the Clinic Manager (E#1) on 5/16/2024, at approximately 9:30 AM. E#1 stated that for patients with negative or indeterminate results for antibodies, they will be considered susceptible to Hepatitis B infection. E#1 stated that monthly antigens should be drawn for these patients to ensure that do not have an active infection and would require isolation (not capable at this Facility, would transfer out). E#1 stated that the nurse is responsible for keeping track of which labs are do on a spreadsheet.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 32741 Based on document review, observation, and interview, it was determined that for 3 of 3 Patient Care Technicians - PCT (E #3, E #4 and E #5) observed for disinfecting AVF (arteriovenous fistula) cannulation sites, the Facility failed to ensure that staff followed infection control practices to disinfect and prevent contamination of AVF sites, as required. This had the potential to affect AVF patients. Findings include: 1. On 5/13/2024, the Facility’s policy titled, “Initiation and Discontinuation of Hemodialysis Treatment” (undated) was reviewed and indicated, “Initiating Hemodialysis AVG/AVF - Wipe patient’s access arm using Betadine/Alcohol in a circular motion...” 2. An observational tour of the dialysis treatment area was conducted on 5/13/2024, between approximately 8:45AM and 11:55 AM. The following was observed: - At approximately 9:20 AM, a PCT (E #3) was at station #3, preparing to initiate dialysis for a patient with an AVF. E#3 wiped each access site with alcohol using back and forth motions, not circular motion, as required. -At approximately 10:20 AM, a PCT (E#5) was at station #16, preparing to initiate dialysis for a patient with an AVF. E #5 wiped each access site with alcohol using back and forth motions, not circular motion, as required. -At approximately 11:35 AM, a PCT (E #4) was at Station #8, preparing to initiate dialysis for patient with an AVF. E #4. E #4 wiped each access site with alcohol using back and forth motions, not circular motion, as required. 3. On 5/13/2024 at 11:55 AM, E #3 stated that the AV insertion sites should be disinfected with alcohol or betadine using circular motions.”

“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: 32741 Based on document review, observation and interview, it was determined that for 2 of 4 Patient Care Technicians - PCT ( E #3 & E #4), the Facility failed to ensure that staff demonstrated knowledge of the Facility’s infection control practices for the disinfection of CVC (central venous catheter - used for dialysis access) insertion site for initiation of the dialysis treatment, as required. This had the potential to affect CVC patients. Findings include: 1. On 5/13/2024, the Facility’s policy titled “Initiation and Discontinuation of Hemodialysis Treatment” (undated) was reviewed and indicated, “Initiating Hemodialysis - Dual Lumen Subclavian - Perform 30 second betadine scrub on caps prior to removing...” 2. On 5/13/2024 between 8:45 AM to 11:55 AM, an observational tour of the dialysis treatment area was conducted. - At approximately 10:00 AM, a Patient Care Technician (E #3) was observed disinfecting the CVC hubs prior to connection at station #6. E #2 disinfected the CVC hub with alcohol wipe for 5 seconds instead of 30 seconds with betadine, as required. - At approximately 10:35 AM, a Patient Care Technician (E #4) was observed disinfecting the CVC hubs prior to connection at station #11. E #4 disinfected the CVC hubs for 5 seconds with alcohol wipe instead of 30 seconds with betadine, as required. 3. On 5/13/2024 at 12:05 PM, an interview was conducted with the Patient Care Technician (E #3). E #3 stated that the CVC hubs should be disinfected for 30 seconds with alcohol.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 32741 Based on document review, observation, and interview, it was determined that for 1 of 3 Patient Care Technicians (E #3) the Facility failed to ensure the dialysate pH/conductivity were measured prior to starting dialysis treatment. This had the potential to affect all 58 in-center hemodialysis patients on census. Findings include: 1. On 5/14/2024, the Facility’s policy titled, “Daily Dialysis Machine Conductivity & pH Validation” (undated) was reviewed and indicated, “The conductivity and pH of proportioned acid and bicarbonate will be checked daily prior to the start of each treatment day, and prior to each treatment.” 2. On 5/13/2024 between 8:40 AM and 11:55 AM, an observational tour was conducted in the dialysis treatment area. The Patient Care Technician (E #3) did not check the dialysate pH prior to initiating the dialysis treatment at Station #4 at 10:00 AM. 3. On 5/13/2024 at 10:15 AM, an interview was conducted with E #3. E #3 stated that the dialysate pH should be checked before each patient starts dialysis. E #3 stated that E #3 did not check pH and conductivity this morning before initiating dialysis for the patient at Station #4.”

“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: 32741 Based on document review, observation and interview, it was determined that for 2 of 10 Patients’ (Pt #8 & Pt. #9) vascular access sites observed, the Facility failed to ensure the patient’s safety during dialysis treatment by not having vascular access site was in view at all times. Findings include: 1. On 5/13/2024, the Facility’s policy titled, “Initiation and Discontinuation of Hemodialysis Treatment” (undated) was reviewed and indicated, “Initiating Hemodialysis: AVG (arteriovenous graft)/AVF (arteriovenous fistula) - Make sure fistula needle are securely taped to patient and easily visible for monitoring as part of safety check during treatment...” 2. On 5/13/2024 between 8:40 AM and 11:45 AM, an observational tour of the hemodialysis treatment area was conducted. The following was observed: - Between 8:40 AM and 10:15 AM, Pt #8’s AV (arteriovenous) access site was not in view. Pt #8 had a blanket covering the access site during that time. -Between 8:40 AM and 10:15 AM, Pt. #9’s AV (arteriovenous) access site was not in view. Pt. #9 had a blanket covering the access site during that time. 3. On 5/13/2024 at approximately 11:30 AM, an interview was conducted with the Patient Care Technician (E#4). E #4 stated that the patient’s access site should be in view at all times to monitor the access site to see if there is any disconnection.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 39802 A. Based on document review and interview, it was determined that for 1 of 5 in-center hemodialysis clinical records (Pt. #2) reviewed, the Facility failed to ensure that the fluid volume removed did not exceed the maximum ordered by the physician. Findings include: 1. The Facility’s policy titled “The Facility’s policy titled, “Patient Assessment and Monitoring before, during and Post Treatment” (undated), was reviewed and required, “...Pre-Assessment: a. Patient should be weighed before dialysis to establish safe UFR [ultrafiltration rate]... Ongoing monitoring of the patient, his/her access and the dialysis delivery system is done and documented... iii. UFR iv. volume removed...” 2. The clinical record of Pt. #2 was reviewed on 05/15/2024. Pt. #2 was admitted on 2/17/2024, with a diagnosis of end-stage renal disease (ESRD). Dialysis treatment orders, dated 4/17/2024 and 04/24/2024, included 3 dialysis treatments per week; 3.5 hours each treatment; with a UFR 10 mL (milliliters) / kg (kilogram) / hr (hour) only if blood pressure and heart are stable. Six consecutive treatment records from 04/22/2024-5/3/2024 were reviewed and included the following actual UFRs: - 4/22/2024 UFR = 15.1 mL/kg/hr (5.1 mL/kg/hr more than ordered) - 4/24/2024 UFR = 18 mL/kg/hr (8 mL/kg/hr more than ordered) - 4/26/2024 UFR = 17.8 mL/kg/hr (7.8 mL/kg/hr more than ordered) - 4/29/2024 UFR = 19.4 mL/kg/hr (9.4 mL/kg/hr more than ordered) - 5/1/2024 UFR = 19.2 mL/kg/hr (9.2 mL/kg/hr more than ordered) - 5/3/2024 UFR = 17.8 mL/kg/hr (7.8 mL/kg/hr more than ordered) - The record did not include any orders or notes from the physician to increase the maximum UFR. - The record lacked documentation to address why the maximum UFR ordered was exceeded and whether the physician was notified. 3. An interview was conducted with the Clinical Nurse Manager (E#1) on 5/15/2024, at approximately 11:40 AM. E#1 stated that the policy does not state the maximum UFR, but it is posted on the treatment floor. E#1 stated that the UFR should not exceed 13 ml/kg/hr, unless the physician orders it (never happened yet per E#1). E#1 stated that in the case of Pt. #2, the UFR should not exceed 10 ml/kg/hr. E#1 stated that if the patient’s blood pressure and heart rate are unstable, no fluid should be removed and the physician should be contacted prior to starting treatment. 50411 B. Based on document review and interview, it was determined that for 2 of 3 patients’ (Pt. #4 and Pt. #5) clinical records reviewed for in-center hemodialysis patients, the Facility failed to provide necessary care and services to manage the patients’ volume status by not addressing the patient’s target weight or Estimated Dry Weight (EDW - normal weight without any extra fluid in your body) as required. Findings include: 1. On 5/15/2024, the clinical record for Pt. # 4, was reviewed. Pt. # 4 was admitted on 3/4/2024 with a diagnosis of ESRD. Dialysis order dated 4/17/2024 included - EDW 80.0 - 80.5 kg. The dialysis treatment flowsheets dated 5/1/2024 documented today’s Wt: 80 kg...Post Wt. 78.9 kg; 5/3/2024 - Today’s Wt: - 81.2 kg...Post Wt. 79.7 kg; 5/6/2024 - Today’s Wt: 78.8 kg...Post Wt. 78.0 kg; 5/8/2024 - Today’s Wt: 79.4 kg...Post Wt. 77.5 kg; 5/10/2024 - Today’s Wt: 79.7 kg...Post Wt. 77.8 kg; and 5/13/2024 - Today’s Wt: 78.9 Kg...Post Wt. 78.4 kg. No documentation from either the Registered Nurse(RN) or physician addressing Pt. #4 target weight or dry weight. The facility did not have any policy related to EDW. 2. On 5/15/2024, the clinical record for Pt. # 5, was reviewed. Pt. # 5 was admitted on 3/25/2024 with a diagnosis of ESRD. Dialysis order dated 4/25/2024 included - EDW 74 kg. The dialysis treatment flowsheets dated 5/1/2024 documented today’s wt: 79.5 kg...Post Wt. 77.2; 5/3/2024 - today’s wt: 80.9...Post Wt. 79.0; 5/6/2024 - Today’s Wt: 84.1 kg...Post Wt. 81.6; 5/8/2024 - Today’s Wt: 84.5 kg...Post Wt. 81.6; 5/10/2024 - Today’s Wt: 80.3 kg...Post Wt. 78.2; and 5/13/2024 - Today’s Wt: 83.1 kg...Post Wt. 80.9. No documentation from either the RN or Physician addressing Pt. #5 target weight or dry weight. 3. An interview was condcuted with the Clinical Manager (E#1) on 5/15/2024, at approximately 1:00 PM. E#1 stated that if a patient is not meeting their target weight, the technician should notifiy the nurse and the nurse shoud notify the physician. E#1 stated that if the patient is having excessive fluid gains in between treatments, they will offer extra treatments or extended treatments and will educate the patient on reducing fluid gains. E#1 stated that the facility does not have any policy related to EDW.”

“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: 50411 Based on document review and interview, it was determined that for 3 of 5 in-center patients (Pt. #1, Pt. #2, and Pt. #5), the Facility failed to ensure that physician progress notes addressed the status and plan for that patient’s renal and active comorbid problems. Findings include: 1. On 5/15/2024, the facility’s policy titled “Patient Assessments: Initial and Ongoing” was reviewed and required that “3. Documentation of ongoing assessment of patient’s status by each discipline of the healthcare team is done in patient’s chart or EMR. Documentation of ongoing assessment will be documented in but not limited to the following documents/records: a. Discipline specific progress notes...d. Patient’s treatment record/hemodialysis flow sheets that includes pre and post assessments”. 2. The clinical record for Pt. #1 was reviewed on 5/15/2024. Pt. #1 was admitted on 9/16/2022 with a diagnosis of ESRD. Nursing and Social Worker progress notes from February to May 2024 indicated that Pt. #1 was deemed unstable due to frequent hospitalizations; however, the record lacked monthly physician (MD#1) progress notes to address the frequent hospitalizations. 3. The clinical record for Pt. #2 was reviewed on 5/15/2024. Pt. #2 was admitted on 2/17/2024 with a diagnosis of ESRD. Nursing and Social Worker progress notes from February to May 2024 indicated that Pt. #2 was deemed unstable due to frequent hospitalizations; however, the record lacked monthly physician (MD#1) progress notes to address the frequent hospitalizations. 4. The clinical record for Pt. #5 was reviewed on 5/15/2024. Pt. #5 was admitted on 3/25/2024 with a diagnosis of ESRD. Progress notes and treatment flowsheets between March to May 2024 indicated that Pt. #5 was not achieving target weights; however, all physician (MD#1) progress notes included only, “Seen on HD [hemodialysis], doing ok.” The notes did not address the status of the patient or the patient’s active problems. 5. An interview was conducted with the Medical Director (MD#1), on 5/15/2024 at approximately 2:30 PM. MD#1 stated that MD#1 sees the patients every day and will write a note weekly. In regards to progress notes, MD#1 stated, “We should probably document more.” MD#1 stated that if there’s a problem, “I dont want to write something bad about the patient as it may upset them.””

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 32741 Based on document review and interview, it was determined that the Facility failed to analyze and track water & dialysate quality, infection control audits, reasons for hospitalizations, and the results of the Health outcomes-physical and mental functioning (HRQOL) assessments. This had the potential to affect all 67 patients on census. Findings include: 1. On 5/15/2024, the Facility’s policy titled, “Quality Assessment Performance Improvement Program” (undated) was reviewed and indicated, “Purpose -to maintain a systematic process to monitor and evaluate the quality and appropriateness of patient care rendered, pursue opportunities to improve healthcard outcomes and services delivered, resolve problems identified, and reduction of medical errors...All patient outcomes goals set by The Renal Network, Inc. are monitored ongoing and corrective action plans developed for deviations from set goals. Those indicators reviewed monthl includin but limited to: Water Quality... Infection Control, Hospital Readmissions...” The policy did not include review of Health outcomes-physical and mental functioning (HRQOL) results. 2. On 5/15/2024, the Facility’s Quality Meeting Minutes for 2024 were reviewed. The Quality Meeting Minutes lacked documentation of review of water & dialysate quality, infection control audits, hospitalization admitting diagnoses, and the results of HRQOL assessments. 3. On 5/15/2024 at 1:05 PM, an interview was conducted with the Clinic Manager (E #1). E #1 stated that they do not review water & dialysate results, infection contol audits, reasons for hospitilizations, or the results of HRQOLs in the monthly quality meetings. E#1 stated that these are things they should be tracking and reviewing in order to identify any trends or problem areas.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that the Facility’s Quality Program failed to include review of adverse occurrences and failed to track incidents such as vascular access events; intradialytic symptoms; medical emergencies; patient transfers to hospital from dialysis; patient abuse/disrepect; deaths during dialysis, blood/body fluid exposures; and non-adherence to procedures. This had the potential to affect all 67 patients on census. Findings include: 1. The Facility’s policy titled, “Quality Assessment Performance Improvement Program” (undated), was reviewed and required, “To maintain a systemic process to monitor and evaluate the quality and appropriateness of patient care rendered, pursue opportunities to improve healthcare outcomes and services delivered, resolve problems identified, and reduction of medical errors... All patient outcome goals set by The Renal Network, Inc. are monitored ongoing and corrective action plans developed for deviations from se goals. Those indicators reviewed monthly including but not limited to: ...Medical Errors...” 2. The Facility’s policy titled, “Incident Reporting” (3/4/2024), was reviewed and required, “...Reports can be used for tracking and/or trending incidents for quality assurance indicators... Incident reports to be reviewed, investigated, and reported to the CQI/QAPI committee as part of the CQI/QAPI activities...” 3. The Facility’s Incident Report Form was reviewed and the list of reportable occurences lacked inclusion of vascular access events (i.e. infiltration, clotting, excess bleeding, infection); intradialytic symptoms (i.e hypotension with loss of consciousness, chest pain, severe cramping, nausea/vomiting); blood loss greater than 100 mL (milliliters); patient transfers to hospital from dialysis; cardiac arrest at facility; deaths during dialysis; patient abuse/disrespect; blood/body fluid exposures; and non-adherence to procedures. 4. The Facility’s Adverse Event Binder for 2023-2024 was reviewed and did not include any adverse events reported. 5. During a meeting with the Clinic Manager (E#1) and Compliance Officer (E#7) on 5/15/2025, at approximately 1:20 PM, E#1 and E#7 stated that even though they haven’t had any adverse events reported in the last year, they have not included review of adverse occurences in their past quality meetings. E#1 stated that events such as vascular access issues, symptoms during treatment, medical emergencies, deaths, transfers, patient abuse, exposures, and non-adherence should be reported and tracked, so they can identify if there is a problem that needs to be fixed.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that the Facility failed to analyze and track complaints/grievances and results of patient satisfaction surveys. This had the potential to affect all 67 patients on census. Findings include: 1. On 5/15/2024, the Facility’s policy titled, “Quality Assessment Performance Improvement Program” (undated) was reviewed and indicated, “Purpose -to maintain a systematic process to monitor and evaluate the quality and appropriateness of patient care rendered, pursue opportunities to improve healthcard outcomes and services delivered, resolve problems identified, and reduction of medical errors...All patient outcomes goals set by The Renal Network, Inc. are monitored ongoing and corrective action plans developed for deviations from set goals. Those indicators reviewed monthl includin but limited to: ...Patient Satisfaction...” 2. The Facility’s Complaint and Grievance Log for 2023 to 2024 was reviewed and included one patient grievance on 2/24/2024. 3. On 5/15/2024, the Facility’s Quality Meeting Minutes (dated 2024) was reviewed. The Quality Meeting Minutes lacked documentation of review of complaints/grievances and results of patient satisfaction surveys. 4. On 5/15/2024 at 1:05 PM, an interview was conducted with the Clinic Manager (E #1). E #1 stated that they do not review complaints/grievances as part of their monthly quality meetings. E#1 stated that they get results from patient satisfication surveys twice a year but don’t include review of these results in quality. E#1 stated that they should be tracking and reviewing those in order to identify any trends or problem areas.”

“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: 32741 A. Based on document review, observation and interview, it was determined that for 1 of 1 Registered Nurse (E#2) observed for medication supervision, the Facility failed to ensure that all medications were stored in an area to prevent patient access. This had the potential to affect all 67 patients on census. Findings include: 1. On 5/13/2024, the Facility’s policy titled, “Medications: Handling, Storage and Disposal” (dated August 2022) was reviewed and indicated, “To ensure that the Facility acquires, stores, and disposes of medications safely...” 2. On 5/13/2024 between 8:40 AM and 12:10 PM an observational tour was conducted in the dialysis treatment area. The following was observed: -There was 1 syringe (not labeled) filled with a medication on top on dialyis machine at Station #1 at 8:40 AM. -There were 6 pills on top of an unused dialysis machine near Station #17 at 12:00 PM. -There were 2 vials Heparin (anticoagulant medication), 5 vials of Benadryl (antihistamine), 1 narcan (medication used to reverse the effects of opiods) and 2 boxes of epinephrine (emergency medicine for severe allergic reactions) that were in the unlocked emergency cart. 3. On 5/13/2024 at approximately 11:55 AM, an interview was conducted with Registered Nurse (E #2). E #2 stated that E #2 prepares the Heparin syringes but does not label the syringes. E #2 stated that medications should always be supervised by the RN. B. Based on document review, observation and interview it was determined that for 1 of 1 Registered Nurse (E #2), the Facility failed to ensure that an open multi-dose vial of Tuberculin solution (used for Tuberculin testing) was discarded within 28 days, as required. This had the potential to affect all 67 patients on census. Findings include: 1. On 5/13/2024, the Facility’s policy titled, “Medications: Handling, Storage and Disposal” (dated August 2022) was reviewed and indicated, “Policy - to ensure that the Facility acquires, stores and disposes of medications safely and in a manner that meets regulatory requirements...Proper disposal of the expired medications will be followed in accordance with state regulations.” 2. On 5/13/2024 at 8:40 AM, an observational tour of the medication refrigerator was conducted and the following was noted: -An open multi-dose Tuberculin Purified Protein Derivative vial with an open date of 4/11/2024. 3. On 5/13/2024 at 9:10 AM, an interview was conducted with a Registered Nurse (E #2). E #2 stated that the open vial of Tuberculin solution expired on 5/9/2024. E #2 stated that the expired vial of Tuberculin solution should have been thrown out. E #2 threw out the expired Tuberculin solution.”