Davita Southwest Atlanta Home Training

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 49321 Based on observation, a review of the 2024 NFPA (National Fire Protection Association) 101 19.7.8* Portable Space-Heating Devices, a review of MovinCool Climate Pro D12 Product Information, a review of facility records, and interviews, it was determined that the facility failed to activate its Emergency Response Plan pertaining to extreme cold due to extended HVAC (heating, ventilation, and air conditioning) system outage. The facility’s HVAC system had been out of order for 55 days. The facility used three large MovinCool Climate Pro D12 heat pump temporary heaters (in the back hall, nurses’ station, and lobby) and six small Heat Wagon, Model P1500 (1500 watts) portable electric heaters (one in every Patient Training Room). These portable space-heating devices did not comply with the NFPA in accordance with UL 1278 and were prohibited in all health care occupancies. The use of these heaters created an unsafe environment with the potential to ignite combustible materials commonly found in treatment areas and had the likelihood to place all patients who were undergoing dialysis training and support at this facility, at risk for a fire hazard. The facility census was 37. Findings include: Cross Reference: V401 - Failure of the facility to ensure that its environment is safe (free from fire hazards), as evidenced by the use of portable space heaters in patient treatment areas which did not comply with the NFPA in accordance with UL 1278 and were prohibited in all health care occupancies, and failure of the facility to provide a comfortable environment, as evidenced by complaints from patients and staff that the facility was extremely cold.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observation, a review of the 2024 NFPA (National Fire Protection Association) 101 19.7.8* Portable Space-Heating Devices, a review of MovinCool Climate Pro D12 Product Information, a review of facility records, and patient and staff interviews and a review of the 2024 NFPA 101 19.7.8 Portable Space - Heating Devises, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of all 37 dialysis patients who were under the care of this facility. Findings include: Cross Reference: V401 - Failure of the facility to ensure that its environment is safe (free from fire hazards), as evidenced by the use of portable space heaters in patient treatment areas which did not comply with the NFPA in accordance with UL 1278 and were prohibited in all health care occupancies, and failure of the facility to provide a comfortable environment, as evidenced by complaints from patients and staff that the facility was extremely cold”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 49321 Based on observation, a review of the 2024 NFPA (National Fire Protection Association) 101 19.7.8* Portable Space-Heating Devices, a review of MovinCool Climate Pro D12 Product Information, a review of facility records, and patient and staff interviews, it was determined that the facility failed to provide a safe and comfortable environment by failing to activate its Emergency Response Plan pertaining to extreme cold due to extended HVAC (heating, ventilation, and air conditioning) system outage. The facility’s HVAC system had been out of order for 55 days. The facility used three large MovinCool Climate Pro D12 heat pump temporary heaters (in the back hall, nurses’ station, and lobby) and six small Heat Wagon, Model P1500 (1500 watts) portable electric heaters (one in every Patient Training Room). These portable space-heating devices did not comply with the NFPA in accordance with UL 1278 and were prohibited in all health care occupancies. The use of these heaters created an unsafe environment with the potential to ignite combustible materials commonly found in treatment areas and had the likelihood to place all patients who were undergoing dialysis training and support at this facility, at risk for a fire hazard. Additionally, patients and staff complained about the extremely cold temperatures in the facility. The facility census was 37. Findings include: During a tour of the facility with the Facility Administrator on 12/17/25 at 9:00 a.m., the following was revealed: In Patient Training Room #1: - A portable electric space heater was on the floor under a chair. - An empty cardboard box containing plastic materials was stored on the chair directly above the electric heater. - There were also 36 cardboard boxes that were stored on three-level shelves within 1-2 ft. from the electric space heater. In Patient Training Room #2: - A portable electric space heater was observed under the sink next to a plastic trash can. In Patient Training Room #3: - A portable electric heater was observed under a wooden counter. - The heater was 1-2 ft. from a plastic biohazard container. In Patient Training Room #4: - A portable electric heater on the floor touched the plastic sharps container and a plastic trash can. In Patient Training Room #5: - A portable electric heater was observed on the floor next to the wall and 2 ft. from a plastic biohazard container. In Patient Training Room #6: - A portable electric heater was on the floor under the wood counter and 2 ft. from a plastic biohazard container. At the Nurses’ Station: - A large MovinCool Climate Pro D 12 air conditioning/heating unit was blowing out hot air. The thermostat was set at 80 degrees. - There were three oxygen tanks that were stored less than 1 ft. from the heating unit. In the Back Hall: - At the back of the facility (by the exit door), was a large MovinCool Climate Pro D 12 air conditioning/heating unit. A review of “2024 NFPA 101 19.7.8* Portable Space-Heating Devices” stated the following: Portable space-heating devices shall be prohibited in all health care occupancies, unless both of the following criteria are met: o (1) Such devices are used only in nonsleeping staff and employee areas. o (2) Such devices are listed and labeled for use as a freestanding, movable heater in accordance with UL 1278, Movable and Wall- or Ceiling-Hung Electric Room Heaters. Portable space heaters complying with 19.7.8 should be permitted to be located in office areas, nurses’ stations, and other similar nonpatient spaces within the same smoke compartment ... A review of the “MovinCool Climate ProD12 Product Information” showed the following: This is an air conditioning unit/heating unit that is used under the following UL Codes: UL 60335-1 and UL 60335-2-40. Minimal electricity. Runs on 115V with 15-amp circuit... Inspection of the Heat Wagon, Model P1500 electric heater and MovinCool Climate ProD12 revealed that these heaters were not marked with UL Code 1278 therefore, did not comply with the 2024 NFPA 101 19.7.8. During a consultation with the Building Inspections, Plan Review and CMS Program Manager, Office of Commissioner of Insurance and Safety Fire on 12/18/25 at approximately 10:00 a.m., it was revealed that MovinCool Climate ProD12 needs a 15-amp electrical breaker which is found in the common one and two-family dwellings. Commercial requirements for an electrical circuit are 20 amp. Furthermore, these heaters were not marked with the UL listing of UL 1278. Therefore, the heaters did not meet the code and should be removed from the facility. It was also revealed that the International Fire Code 4102.1.5: Group 1-2 occupancies and ambulatory care facilities stated, “Where used in Group 1-2 and ambulatory care facilities, portable, electric space heaters shall be limited... and such only be used in nonsleeping staff and employee areas.” A review of Policy 4 -07- 01 titled, Facility Emergency Plan (ICHD, HOME) revised 10/2025, showed the following: Page 5 5. The FA, or designee is responsible for a. Implementation, adherence, and training of facility specific EMP (emergency preparedness) and applicable policy and procedures. b. Maintaining a clear understanding and ongoing awareness of the hazards that may affect the patients, teammates, and the local operating ability. This includes, but not limited to local weather conditions, natural, and man-made hazards, as identified on the Facility Hazard Vulnerability Assessment. Emergency Response Plan Activation 1. The Facility EMP is considered activated when: a. Emergency conditions exist b. Facility operations are affected c. Immediate action is required i. Safe and protect lives ii. Provide essential services iii. Prevent damage to the environment, systems, and property. Page 12 COLD, EXTREME (LOSS OF HEAT) If extended HVAC system outage Reschedule patient’s treatments Consider transfer to nearest facility A review of facility records revealed the following: - On 10/23/25: It was discovered that the HVAC system was not working. Governing Body Meeting was held. Discussion notes: Heating system down. Repair and action plan discussed and approved. - On 10/27/25: A work order was created via internet. - On10/28/25: Emails showed that the facility’s heating system was down for a week and Teammates and Patients were complaining of the facility being “very uncomfortable”. On 11/4/25: Six “Heat Wagon” portable electric heaters (1500 watts) were delivered and placed in each treatment room. - On 11/5/25: Heating technicians were dispatched to the facility and found the facility had two gas units not working and two quotes were needed. - On 11/20/25: The Administrative Assistance (AA) called to get an update and was “advised” they were waiting on quote approval. - On 12/1/25: Monday documented weather forecast: Mix of clouds and sun, high around 40 degrees Fahrenheit (F), with light snow possible snow later at night and a low near 26 degrees F. AA called again to get an update. (wanted to know when the repairs would be done). Advised again that, “waiting on quote approval”. Email was sent to Davita Account Management to find out what the hold-up was. Reply stated, “This is a client-side work order... Please reach out to them.” On 12/2/25: Weather Forecast for Tuesday: Potential winter storm with morning snow mixing with rain in the afternoon, temperature steady in the mid-30s, clearing up Tuesday night with lows around 25 degrees F. On 12/16/25 AA called again for update. “Waiting on a quote approval”. On 12/16/25: Three large temporary commercial heaters were installed (patient lobby, nurses station, and the rear door). Portable space heaters were placed in treatment rooms. On 12/17/25: Governing Body Meeting Minutes Heating system down - Action Plan: Install portable heat system in each training room and teammate offices. Install three commercial temporary heaters in the lobby, nurses station and the rear door. Patients were informed to bring extra blankets for comfort. For active PD (peritoneal dialysis) training, heat was disconnected during connection. Additionally, utilizing backup agreement with South Fulton Home Training to train/treat patients if conditions get worse. A review of the facility’s patient schedule revealed that from 10/23/25 through 12/17/25, all scheduled patients were seen at this facility. No patients were transferred to the backup facility during this time period. There was no documented evidence that the Emergency Plan for extreme cold (loss of heat) was implemented. During an interview conducted on 12/17/25 at 9:53 a.m., Registered Nurse (RN) AA stated that both staff and patients had been complaining that the facility was cold. RN AA reported that on 12/1/25, the facility was provided with only three space heaters. On 12/16/25, three large heaters were installed. RN AA further stated that patients were already experiencing cold conditions with ESRD (End Stage Renal Disease) diagnosis, and the broken heating system worsened the situation. During an interview conducted on 12/17/25 at 10:00 a.m., AA stated that the facility was very cold. AA reported that the small space heaters located in the treatment rooms were received in November. AA stated they (staff) would arrive early, around 7:30 a.m., to turn on the space heaters. AA further stated that the large heaters were installed on 12/16/25. AA reported contacting the maintenance department approximately every other day to inquire about the status of the repairs. AA stated that the building remained very cold despite the use of the space heaters. During an interview with Patient (P) #1 on 12/17/25 at 10:20 a.m., P#1 stated they had been coming to this facility for training for one month and reported that the facility had been very cold. P#1 stated that space heaters were placed in the treatment rooms; however, the environment remained cold. P#1 further stated that the waiting room, bathrooms, and hallways were “freezing “.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 33921 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis), and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that the water used for dialysis was accurately tested for Total Chlorine, to provide safe treatments for all patients. On 12/11/24 at 1:20 p.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40, Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) with the potential to cause harm to four of four hemodialysis patients (P#4, P#5, P#8 and P#9), who were undergoing hemodialysis treatment at the time of this observation, when one of one Patient Care Technician (PCT AA) and one of one Registered Nurse (RN AA) observed, who were assigned the task of testing the water quality, did not perform the Total Chlorine Test according to the manufacturer’s DFU and facility P & P. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis). The Regional Operations Manager and the Manager of Clinical Services were informed of the IJ finding on 12/11/24 at 1:20 p.m. The noncompliance related to the IJ was identified to have existed on 12/11/24 at 1:20 p.m. The IJ situation was abated on 12/12/24 at 6:45 p.m., when the facility implemented a Credible Allegation of Compliance related to the IJ that included staff training, return demonstration, and successful completion of skills competency checklists. The facility census, (including patients at the Skilled Nursing Facilities (SNF #1, SNF #2 and SNF #3), was 53. Findings were: Cross References: V 196 - Failure of PCT AA and RN AA, to correctly test the dialysis water for Total Chlorine according to the manufacturer’s DFU and facility P & P. V 250 - Failure of PCT AA to independently test the dialysate’s pH prior to each patient’s hemodialysis treatment. V 681 - Failure of the facility to ensure that PCT AA had periodic audits of skills necessary for accurate performance of duties assigned to him and failure of the facility to ensure that RN AA had current competency skills checklist and periodic audits to accurately perform the duties assigned to her.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 33921 Based on observations, facility record review, staff interviews, a review of the manufacturer’s Directions for Use (DFU) and a review of facility Policies and Procedures (P & P), it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 34 hemodialysis patients who were under the care of this facility, (including patients at the Skilled Nursing Facilities, (SNF #1, SNF #2 and SNF #3). Findings were: V 196 - Failure of PCT AA and RN AA, to correctly test the dialysis water for Total Chlorine according to the manufacturer’s DFU and facility P & P. V 250 - Failure of PCT AA to independently test the dialysate’s pH prior to each patient’s hemodialysis treatment. V 681 - Failure of the facility to ensure that PCT AA had periodic audits of skills necessary for accurate performance of duties assigned to him and failure of the facility to ensure that RN AA had current competency skills checklist and periodic audits to accurately perform the duties assigned to her.”

“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: 49321 Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) recommendations, and a review of Policy and Procedures (P&P), it was determined that the infection control committee failed to ensure that one of one Registered Nurse (RN AA) and one of one Patient Care Technician (PCT AA) who provided hemodialysis (HD) treatment in one of two sampled Hemodialysis (HD) Treatment Dens [rooms dedicated for hemodialysis treatment, storage of dialysis supplies and equipment in a Skilled Nursing Facility (SNF #1)], wore gloves, changed gloves, and performed hand hygiene (wash hands with soap and water or used hand sanitizer) between stations and between patients per facility P&P. This breach in infection control increased the risk to expose the patients who were dialyzing at Stations (S) 3, S4, S5, and S6 to bloodborne pathogens in the dialysis environment. This home program facility provided HD services to eight residents at this SNF #1. Findings include: During observation in the HD Treatment Den on 12/11/24 at 11:44 a.m. to 1:00 p.m., the following was revealed: - RN AA held a glove against the dialysis machine at S6 to silence an alarm. With that same glove, RN AA silenced the dialysis machine at S4. RN AA did not wear gloves when she touched dialysis machines and did not perform hand hygiene after each task and between stations. - PCT AA held one glove against the dialysis machine (dirty task) at S4, discarded the glove in the trash, and documented on the keyboard (clean task) on the rolling computer. - PCT AA then went to S3, held a glove against the dialysis machine, and began documenting on the keyboard on the rolling computer. - PCT AA did not wear gloves when he touched the dialysis machines and did not perform hand hygiene between tasks. PCT AA was asked at 11:48 a.m. on 12/11/24, if he realized he was not putting his gloves on when touching the dialysis machine. PCT AA stated that that was how they obtained information from the machine (blood pressure, pulse, and machine pressures). When asked about hand hygiene, he said he did not realize he was not using a hand sanitizer. PCT AA stated that they wash their hands throughout the day. During an interview with RN AA on 12/11/24 at 11:55 a.m., RN AA stated she was moving fast and forgot to pick up a new glove. RN AA was then asked about hand hygiene between patients. RN AA acknowledged that she did not wash her hands or use hand sanitizer between stations. RN AA stated she would try to do better. According to the CDC RR-5 “Recommended Infection Control Practices for Hemodialysis Units at a Glance”, staff must 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. A review of Policy: 1-12-17 titled, “DSD Infection Control for Dialysis Facilities” last revised April 2024 showed the following: Hand Hygiene: 1. All teammates, Physicians, and Non-Physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment den/bedside area b. prior to gloving and immediately after removal of gloves c. after contamination with blood or other infectious material d. after patient and dialysis delivery system contact f. between patients even if the contact is casual g. before touching clean areas such as supplies, supply cart, and computer keyboard/mouse”

“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: 49321 Based on observation, staff interview, and a review of facility policy and procedures (P&P), it was determined that the facility failed to ensure that three of three clean sinks for handwashing, in one of two sampled HD Treatment Dens [room dedicated for hemodialysis treatment, storage of dialysis supplies and equipment in a Skilled Nursing Facility (SNF #1)], had warm water, to encourage patients and staff to wash their hands. This deficient practice could discourage four of four patients (P#4, P#5, P#6, P#7) who were undergoing HD treatment at SNF #1 at the time of this observation and two of two direct patient care staff (RN AA and PCT AA), to wash their hands. Failure to wash hands increased the risk of infection transmission. The facility provided HD services to eight residents at SNF #1. Findings include: During observation in the Patient Treatment Den on 12/11/24, between 1:00 p.m. and 2:00 p.m., the following was revealed: Three of three handwashing sinks which were designated as “clean sinks”, with motion detections to initiate the water flow at the following locations, did not have warm running water, after running for two minutes: 1. The clean sink in front of Station (S) 5. 2. The clean sink in the Biomed/breakroom. 3. The clean sink in front of S2. The Facility Administrator and the Manager of Clinical Services were notified on 12/11/24 at 1:45 p.m. and 2:00 p.m. Both stated the Long-Term Care Facility was responsible for the temperature of the water. A review of Policy: 1-12-17 titled, “DSD Infection Control for Dialysis Facilities” last revised April 2024 showed the following: Facility Hygiene 19. a. Sinks must be plumbed with both hot and cold water.”

“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: 32734 Based on observation, staff interview, a review of the facility Policy and Procedures (P&P), and review of the Centers for Disease Control and Prevention (CDC) RR-5 “Recommended Infection Control Practices for Hemodialysis Units at a Glance”, it was determined that the governing body failed to ensure that the infection control committee implemented P&P when one of one Registered Nurse (RN BB) and one of one Patient Care Technician (PCT BB) who provided hemodialysis (HD) treatment in one of two sampled HD Treatment Dens [a room dedicated for hemodialysis treatment, storage of dialysis supplies and equipment in a Skilled Nursing Facility (SNF #2)], stored their drinks and food containers in the HD Treatment Den against facility P&P. This deficient practice increased the staff on-the-job exposure risks for cross contamination and transmission of bloodborne viruses and pathogenic bacteria from recognize and unrecognized sources of infection. Findings include: During observation in the HD Treatment Den at SNF #2 on 12/11/24 between 10:00 a.m. and 12:00 p.m., there was a small black refrigerator located at the nurse’s station (within the immediate patient treatment area). Observation of the contents in the refrigerator revealed drinks and containers filled with food. During an interview at 11:15 a.m., when asked about the food in the refrigerator, RN AA stated “we don’t usually leave the unit for breaks, and we don’t have a breakroom, so we eat at the nurse’s station”. A review of Policy: 1-05-01 titled, “Infection Control for Dialysis Facilities” with the latest revision date of April 2023 showed the following: Facility Hygiene: 17. Food and drinks in the treatment area will be limited to patients. Sharing and storage in the treatment area is not allowed. According to CDC RR-5 “Recommended Infection Control Practices for Hemodialysis Units at a Glance”, staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 33921 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis), and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that the water used for dialysis was accurately tested for Total Chlorine, to provide safe treatments for all patients. On 12/11/24 at 1:20 p.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40, Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) with the potential to cause harm to four of four hemodialysis patients, (P#4, P#5, P#8 and P#9), who were undergoing hemodialysis treatment at the time of this observation, when one of one Patient Care Technician (PCT AA) and one of one Registered Nurse (RN AA) observed, who were assigned the task of testing the water quality, did not perform the Total Chlorine Test according to the manufacturer’s DFU and facility P & P. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis). The Regional Operations Manager and the Manager of Clinical Services were informed of the IJ finding on 12/11/24 at 1:20 p.m. The noncompliance related to the IJ was identified to have existed on 12/11/24 at 1:20 p.m. The IJ situation was abated on 12/12/24 at 6:45 p.m., when the facility implemented a Credible Allegation of Compliance related to the IJ that included staff training, return demonstration, and successful completion of skills competency checklists. The facility census, (including patients at the Skilled Nursing Facilities (SNF #1, SNF #2 and SNF #3), was 53. Findings were: - PCT AA was observed during the performance of Total Chlorine Testing, at SNF #1, on 12/11/24 at 11:45 a.m., using RPC Ultra-Low Total Chlorine Test Strip K100 - 0118. PCT AA swished the strip in the sample dialysis water for 60 seconds then immediately compared the test strip to the color chart without waiting for 20 seconds for the color to develop, according to the manufacturer’s DFU. When asked regarding the facility’s Procedure, PCT AA stated, “wait 10 seconds?”. Then PCT AA went to a backroom, and brought a bottle of EZ- Total Chlorine Test strips and PCT AA stated, “to wait for 30 seconds”. This surveyor reminded PCT AA that he was using a RPC Test strip, not EZ-Test Strip which was totally different. When this surveyor asked PCT AA who trained him how to test the Total Chlorine, he stated via “online”. - RN AA was also observed performing the Total Chlorine Test using the RPC test strips mentioned above on 12/11/24 at 12:00 p.m. RN AA swished the strip for 20 seconds then immediately compared the strip to the color chart without waiting 20 seconds for the color to develop. When this surveyor asked RN AA on 12/11/24 at 12:10 p.m. if she was sure this was the correct procedure to test the Total Chlorine using the RPC test strip, she stated that she wasn’t sure and will find out. A review of the manufacturer’s DFU and the facility’s Procedure: 1-18-05, titled, “Total Chlorine Test Using RPC Ultra Low Total Chlorine Test Strip”, with latest revision date of October, 2023, stated: ... Remove the test strip from the foil package and dip it in the water sample for 60 seconds... ... Wait 20 seconds for the test strip color to develop... After the 20 second wait period, immediately compare the strip color to the K 100-0118 color chart to determine the Total Chlorine level in the sample. The dialysis water was retested by PCT AA on 12/11/24 at 12:25 p.m., according to the facility’s procedure, using RPC Ultra-Low Total Chlorine Test Strip K100 - 0118 and the result was <0.1. The Total Chlorine level in the water was confirmed to be safe. - The Regional Operations Manager and the Manager of Clinical Services were informed of this observation on 12/11/24 at 1:20 p.m. The IJ situation was lifted on 12/12/24 at 6:45 p.m. upon completion of the following: - The Manager of Clinical Services on 12/11/24, immediately began conducting re-education/staff in-service with PCT AA and RN AA, with return demonstration, and skills competency checklists. - PCT AA demonstrated the proper way to test Total Chlorine using RPC Ultra-Low Total Chlorine Test Strip K100 - 0118 according to the manufacturer’s DFU, specifically, waiting 20 seconds for the color to develop before comparing the test strip to the color chart. - RN AA demonstrated the proper way to test Total Chlorine using RPC Ultra-Low Total Chlorine Test Strip K100 - 0118 according to the manufacturer’s DFU, specifically, swishing the test strip in the water sample for 60 seconds and waiting 20 seconds for the color to develop before comparing the test strip to the color chart. - Based on the above corrective actions, the IJ was removed; however, the Condition remained out of compliance.”

“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: 33921 Based on observation, staff interviews, a review of facility Policy and Procedures (P & P) and a review of the manufacturer’s directions for use (DFU), it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of one of one Patient Care Technician (PCT AA) observed and interviewed, to independently verify the hemodialysis (HD) machine’s dialysate pH (acidity), according to the manufacturer’s DFU and according to the facility’s procedures before each patient treatment. This deficient practice had the potential to negatively affect the health and safety of four of four patients (P#4, P#5, P#8 and P#9), who were undergoing hemodialysis treatment at the time of this observation. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. The facility census, (including patients at the Skilled Nursing Facilities (SNF #1, SNF #2 and SNF #3), was 53. Findings were: During observation in the Patient Treatment Room at SNF #1 on 12/11/24 between 10:50 a.m. and 12:55 p.m., the following was revealed: - PCT AA did not perform pH testing of the machine’s dialysate at Station (S5). When asked if he independently tested the machine’s dialysate pH on 12/11/24 at approximately 12:30 p.m., PCT AA stated that he knew to verify the conductivity (ability of the dialysate to conduct electricity) using test strips, but he didn’t know about testing the pH with the test strips. PCT AA then went to the Biomedical Technician’s (BMT’s) room and dug up the contents inside a large plastic bin to look for the pH strips. This surveyor stated to PCT AA that it seemed like he had not tested the pH for a while, not knowing where the bottle of strips were. This surveyor also asked PCT AA when was the last time he tested the machine’s dialysate pH, and he stated, “I think last Monday?”, (two days prior). The facility schedule was Monday-Wednesday-Friday. - The National Manager of Clinical Services for SNF and the Regional Operations Manager were informed of this observation on 12/11/24 at approximately 1:30 p.m. - During a discussion with the BMT on 12/11/24 at approximately 2:30 p.m., he stated that the facility’s hemodialysis machines (Fresenius 2008T BlueStar Premium), only self-tested for conductivity, but not pH, therefore the pH must be independently tested/verified before initiating patient’s treatments. A Bibag (Bicarbonate Bag) system of pre-filled, dry bicarbonate concentrate bag (an alternative to liquid bicarbonate jugs), was also attached to each machine. - A review of facility Procedure: 1-03-06V, titled, “ Machine Start Up and Priming a Single Use Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Nipro or Combiset Blood Lines fr First Shift of the Day”. with latest revision date of October 2022, stated: ...If using Fresenius 2008T or T BlueStar model, no manual conductivity is required. Reasoning: Fresenius 2008T or T BlueStar machine performs independent conductivity at the end of pressure holding and alarms test. A pass or fail will show on the screen. The pre-treatment conductivity reading will be displayed in the dialysate screen - A review of the facility’s Policy: 1-03-02 titled, “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate” with latest revision date of April 2020 stated: 6. Independent pH is required to be performed prior to each treatment. 9. If using a non-central acid delivery system, follow manufacturer’s guidance to verify dialysate conductivity and pH when changing or replacing the acid container during the course of a treatment. During a telephonic conference with the National Manager of Clinical Services for SNF and the Biomed Operations Manager (BOM)on 12/18/24 at 12:09 p.m., both confirmed that an independent pH was required prior to each patient treatment.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 33921 Based on a review of personnel records and staff interviews, it was determined that the facility failed to ensure that one of one Registered Nurse/Charge Nurse (RN AA) sampled, had current competency skills checklist and periodic audits to evaluate her ability to perform the duties that was assigned to her; and failure of the facility to ensure that one of one Patient Care Technician (PCT AA) sampled, had periodic audits to evaluate his abilities to perform the duties assigned to him. Failure of RN AA and PCT AA to demonstrate competency had the potential to cause harm to four of four hemodialysis patients, (P#4, P#5, P#8 and P#9), who were undergoing hemodialysis at Skilled Nursing Facility (SNF #1), at the time of this review. The facility census, (including patients at SNF #1, SNF #2 and SNF #3), was 53. Findings were: - For additional details, cross reference V 196 - (Failure of PCTAA and RN AA to correctly perform the Total Chlorine test: and V 250 - (Failure of PCT AA to independently test the dialysate machine’s pH - acidity). A review of personnel records revealed the following: PCT AA’s personnel record titled, “Skilled Nursing Facility (SNF) Dialysis HD Annual Procedural Skills verification checklist”, dated 11/29/24, stated: - “Properly demonstrates the manual conductivity and pH testing based on manufacturer”. - PCT AA’s personnel record titled, “Procedural Skills Verification Checklist for Teammates Who Perform Water Monitoring and Testing”, dated 11/29/24, stated: ... “Properly performs and documents Total Chlorine testing using the primary testing device... - There was no mention of the specific testing device used during the skills verification checklist. - When this surveyor asked PCT AA on 12/11/24 at approximately 11:55 a.m., who trained him how to test the Total Chlorine, he stated via “online”. - There was no documented evidence that periodic audits were conducted to ensure consistent compliance with proper procedure according to facility P & P and manufacturer’s Directions for Use (DFU). A review of RN AA’s personnel records showed the following: - “Experienced HD Teammate Expedited Skills Checklist”- DSD (Davita Skilled Nursing Facility Dialysis)... “This checklist should only be temporarily used to care for patients in a DSD during emergency situation”. This document was dated 11/15/23, which included Infection Control. - A document titled, “Acute Basic Components and Monitoring of Dialysis Quality Water Treatment System Procedural Skills Verification checklist for Teammates Who Perform Water Monitoring and Testing”, which included Total Chlorine Testing, was dated 11/15/23. - There was no mention of the specific testing device used during the skills verification checklist. There was no current competency skills check since 11/15/23 and there was no documented evidence that periodic audits were conducted to ensure consistent compliance with proper procedure according to facility P & P and manufacturer’s Directions for Use (DFU). - RN AA had an online training, “Annual DSD Nurse Competency Exam (Previously Post-Acute)”, dated 9/25/24. The National Manager of Clinical Services stated on 12/11/24 at approximately 4:00 p.m., that there was no other documented evidence of RN AA’s skills competency checklists and periodic audits.”