Davita Centennial Atlanta Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 52051 Based on observation, staff interviews, a review of facility Policy and Procedures (P & P), a review of the manufacturer’s Directions for Use (DFU) and a review of the Association for the Advancement of Medical Instrumentation’s (AAMI’s) “American National Standard for Dialysate for Hemodialysis,” 2004 (RD52: 2004), it was determined that the facility failed to ensure that there was a safe environment for all in-center hemodialysis (ICHD) patients as evidenced by failure of one of one Registered Nurse (RN AA), observed on the first day of the survey, and one of one Patient Care Technician (PCT AA), observed on the third day of the survey, to verify the hemodialysis machines’ final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU per ANSI/AAMI RD52: 2004 guidelines. This deficient practice had the potential to negatively affect the health and safety of 11 of 11 patients, at the time of the observation on both days of the survey. 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. And if conductivity is out of range, the effectiveness of the treatment could be reduced, and patient electrolyte balance could be altered. The facility census was 64. Findings include: Cross Reference: V196 - Failure of the facility to ensure that total chlorine testing (used to detect the presence of chlorine and chloramine in the water used for dialysis), was performed and documented every four hours as required by facility Policy and Procedure and AAMI. V 250 - Failure of the facility to accurately perform independent testing of the machine’s dialysate (a solution of pure water, electrolytes and salts such as bicarbonate and sodium) pH (acidity) and conductivity (ability of the dialysate to conduct electricity) according to the Manufacturer’s DFU prior to the initiation of each patient treatment.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 52051 Based on observation, staff interviews, and a review of records, 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 60 in-center hemodialysis patients who were receiving dialysis services at this facility. Findings include: Cross References: V757 - Failure of the Governing Body to ensure that the facility had an adequate number of qualified Patient Care Givers to meet the needs of all patients, to provide safe patient care, and to be in compliance with the minimum state required staff-to-patient ratio of one dialysis caregiver to four patients.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 49321 Based observation, a review of facility records, staff interviews, facility Policies and Procedures, and the National Fire Protection Association (NFPA) standards, it was determined that the facility failed to provide documentation demonstrating that fire extinguishers were inspected monthly by a designated trained staff member and annually by a certified technician. In addition, there was no documented evidence that the facility ‘s emergency exit lighting had been inspected monthly or tested annually, as required. This deficient practice had the potential to negatively affect all 60 in-center hemodialysis patients who were under the care of this facility. Findings include: During an observation of the facility on 6/24/25 at 10:00 a.m., a total of nine fire extinguishers were noted throughout the building. Their locations included: one in the lobby, one in the office area, two in the south hallway near the back exit, two in the north hallway near the staff break room, and three in the treatment area. All fire extinguishers were last documented as inspected by a designated staff member in March 2025. A review of facility documents revealed that the most recent inspection of the fire extinguishers and emergency exit lighting by a certified technician was conducted on 11/01/2021. During an interview conducted on 6/25/25 at 7:00 a.m., the Clinical Coordinator stated that she was unaware of when the facility’s fire extinguishers and emergency exit lights were last inspected. She confirmed that this responsibility typically falls under the Biomedical Technician’s role. She further stated that, to her knowledge, no recent inspections had been documented or communicated to the clinical staff. During an interview conducted on 6/25/25 at 9:00 a.m., the Facility Administrator stated that he assumed oversight of the facility in May 2025. He reported that he had not yet reviewed the inspection records for fire extinguishers or emergency exit lighting. He also acknowledged that, based on available documentation, the last certified inspection for both appeared to have occurred in 2021, and no monthly staff inspections had been tracked in recent months. A review of Policy 4-07-04, titled, “Fire Safety Prepardness” last revised April 2019, stated: 1. Fire safety maintenance, inspection, and testing must be conducted by a certified vendor, as required by state or local regulations. Maintain documentaation of inspection for three (3) years plus the present year. 2. Emergency exit lights, auxiliary lights, and smoke detectors shall be checked and documented on form: Monthly OSHA and Safety Checklist. 3. Fire alarm and extinguishers systems b. Fire extingushers shall be checked monthly to verify it is : i Fully charged ii Safety seals are not broken or missing iii There is no evedence of physical damage, corrosion, leakage, or clogged nozzle iv Kept in its designated place at all times except during use v. There are no obstruction to access or visability vi Documented on the inspection tag or appropriate log. In accordance with the National Fire Protection Association (NFPA) standards, the facility is required to conduct regular inspections and testing of its fire safety systems. Emergency exit lighting must be functionally tested monthly for a minimum of 30 seconds and undergo a full-duration test of 90 minutes annually to ensure proper operation during power outages. These inspections are to be performed by the facility owner or trained staff, with documentation maintained for review. Fire extinguishers must undergo a monthly visual inspection by a designated trained staff member to check for accessibility, pressure, and physical condition. Additionally, they must receive comprehensive annual maintenance by a certified technician, including servicing and any necessary testing in compliance with NFPA 10. All inspection and service activities must be documented and retained as part of the facility’s fire safety records”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 49321 Based on a review of facility records and staff interviews, it was determined that the facility failed to ensure that three of three dialysis Patients (P) (P#20, P#21, and P#22) sampled, received Emergency Preparedness training. Additionally, there was no documented evidence that all patients had participated in a quarterly fire and evacuation training or drills as required. This failure had the potential to adversely impact the health and safety of all patients in the event of an emergency, as untrained individuals may not know how to respond appropriately during a critical situation. The facility census was 60. Findings include: During a review of the facility’s Emergency Preparedness Program Orientation and Training Manual for patients, it was revealed that in October 2024, all current patients were reported to have received education on how to quickly disconnect from the dialysis machine in the event of an emergency. However, there were no documented records confirming that patients P#20, P#21, and P#22 received this training. Additionally, there was no documented evidence that quarterly fire drills had been conducted with either staff or patients, as required. During an interview with the Clinical Coordinator on 6/25/25 at 7:00 a.m., she acknowledged that the clinic had recently experienced several staffing and operational changes. She confirmed that P#20, P#21, and P#22 were inadvertently omitted from the Emergency Preparedness training and that no follow-up had been conducted to ensure they received the required education. When asked about the facility’s fire drills, the Clinical Coordinator stated that she had been out on leave and was unsure whether any had been conducted during that time. During an interview conducted with the Facility Administrator on June 25, 2025, at 9:00 a.m., he stated that he was assigned to the facility in May 2025 and was not fully aware of the activities that had or had not been completed prior to his assignment A review of Policy: 4-07-04, titled, “Fire Safety Preparedness”, last revised April 2019, stated: 1. Patient training : upon admission , annually, and any changes or update to the facility’s plan. 2. Fire and evacuation training and drills: required on a Quarterly basis with each shift of patients, this includes emergency take off and evacuation of patients.”

“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: 52051 Based on observation, a review of the Centers for Disease Control and Prevention (CDC) guidelines and recommendations, a review of facility Policy and Procedures (P & P) and staff interview, it was determined that the Infection Control Committee failed to ensure that one of one Registered Nurse (RN BB) observed, wore gloves and consistently performed hand hygiene (washed hands or used an alcohol-based hand sanitizer), after touching potentially contaminated areas or tasks and when performing direct patient care to Patient (P)#23 at Station (S)9. Failure to wear gloves when touching contaminated surfaces and failure to perform hand hygiene increased the risk for cross contamination with the potential to expose all patients and staff to bloodborne pathogens in the dialysis environment. This deficient practice had the potential to negatively affect the health and safety of all 60 in-center hemodialysis patients who were dialyzing at this facility and all the Direct Patient Care (DPC) Staff (RNs, Licensed Practical Nurse - LPN, and Patient Care Technicians - PCTs). Findings include: During an observation in the Patient Treatment Room on 6/24/25, at 12:44 p.m., RN BB was observed checking the dialysis machine’s screen while using her ungloved hands on the machine’s keypads (dirty) at S9. RN BB then moved to the terminal computer located right beside the dialysis machine without performing hand hygiene and began charting using the keyboard (clean). Subsequently, RN BB spoke to P#23 while her right hand, still ungloved, touched the dialysis armchair (dirty). She then resumed using the keypads (dirty) on the dialysis machine. Throughout this observation, RN BB did not don and doff gloves and did not sanitize her hands. During an interview with RN BB on 6/24/25, at 3:35 p.m., she acknowledged that she sometimes did not wear gloves, as she considered the dialysis machines clean, particularly after they had just been wiped down. She also recognized the importance of adhering to facility policies and procedures. CDC recommends healthcare workers to wash their hands immediately before touching a patient, after glove removal, after touching a patient’s equipment or surface, and after contact with body, bodily fluids, or contaminated surfaces. Additionally, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal. A review of facility Policy: 1-05-01, titled, “Infection Control for Dialysis Facilities”, with latest revision date of April 2023, stated: HAND HYGIENE: 1. All Teammates, Physicians, Non-Physician (NPP) will perform hand hygiene: g. before touching clean areas such as supplies, supply cart, and chairside keyboard/mouse PPE 7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station.”

“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: 52051 Based on observation, staff interviews, a review of Centers for Disease Control and Prevention (CDC) guidelines, and a review of the facility’s policies and procedures (P & P), it was determined that the facility failed to ensure that four of four Direct Patient Care Staff (Registered Nurses- RN AA and RN BB, and Patient Care Technicians - PCT AA, and PCT GG), who were present during this observation, immediately and thoroughly cleaned and disinfected blood-contaminated surfaces on the cover of three of three sharps containers, between patient use. This failure could lead to the transmission of dangerous pathogens through cross contamination. This deficient practice had the potential to negatively affect the health and safety of all 60 in-center hemodialysis patients who were under the care of this facility. Findings include: On 6/24/25, at 9:50 a.m., dried drops of blood were observed on three of three sharps containers, located between Stations (S)2 and S3, S3 and S4, and S5 and S6. -Each container had between one to four dried blood drops. These sharps containers had not been cleaned or disinfected between patient uses. -This observation was made during the transition from the first shift to the second shift, when dialysis chairs were vacated, and new setups for dialysis treatment were established for second shift patients at S3, S4, and S6. The Charge Nurse (RN AA), was notified of this observation and was shown the dried drops of blood on the sharps containers mentioned above, on 6/24/25 at 11:30 a.m. According to CDC guidelines, failure in environmental cleaning and disinfection have led to transmission of bloodborne pathogens (e.g., Hepatitis B virus) and other infections from one patient to another in hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including floors, patient chair or bed surfaces, dialysis equipment surfaces, adjacent tables and work surfaces, etc., especially with blood splatters) must be performed between patient uses to prevent transmission of dangerous pathogens. A review of facility Policy: 1-05-01, titled, “Infection Control for Dialysis Facilities”, with latest revision date of April 2023, stated: DISINFECTION: 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials ...”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 52051 Based on a review of facility records, staff interview, a review of facility policy and procedures (P & P), and a review of the Centers for Disease Control and Prevention (CDC) recommendations, it was determined that the Governing Body failed to ensure that the Infection Control Committee implemented facility P&P for the prevention and control of infections as evidenced by failure to ensure that nine of nine Patients (P) (P#12, P#15, P#16, P#17, P#18, P#19, P#20, P#21, and P#22), who were susceptible to the Hepatitis B virus (HBV), were offered Hepatitis B vaccination against Hepatitis B infection (a highly infectious disease of the liver caused by the HBV, and transmitted from person to person through blood and other body fluids). Additionally, the facility failed to provide a record of baseline testing for Tuberculosis (TB- a contagious bacterial infection that mainly affects the lungs, [though it can spread to other parts of the body such as the kidneys, brain and spine], that is spread through the air), upon hire, and subsequent annual TB Risk Assessment Questionnaire (TB - RAQ), for nine of 16 personnel (Registered Nurses - RN BB and RN CC), Patient Care Technicians (PCT BB, PCT EE and PCT FF), Registered Dietitian (RD), Social Worker (SW), Biomedical Technician (BMT), Administrative Assistant (AA), sampled; and failure to provide verification of immunity to Hepatitis B Virus (HBV- a highly contagious virus that infects the liver and is spread through exposure to blood and body fluids of an infected person), for 13 of 16 personnel (RN BB and RN CC, Licensed Practical Nurse - LPN AA, PCT AA, PCT BB, PCT CC, PCT EE and PCT FF, RD, SW, BMT, the AA, Medical Director), sampled. This deficient practice had the potential to place both staff and patients at risk due to the unknown health status of personnel who may transmit (if infected) or contract (if susceptible), to these communicable diseases. This failure had the potential risk to negatively affect the health and safety of all 60 in-center hemodialysis patients who were vulnerable and many of them may already be immunocompromised. Findings include: A positive Hepatitis B surface Antibody (HBsAb or anti-HBs) test result (10 or greater) indicates that a person has developed immunity to the HBV, either through successful recovery from past infection or through vaccination. HBsAb less than 10 means the person is susceptible. A review of the facility’s “Vaccination and Surveillance Report”, revealed the following: - P#12 was tested for HBsAb on 6/12/25, with 5 mIU/mL (milli-international units per milliliter) result. - P#15 was tested for HBsAb on 5/22/25 with a 3 mIU/mL result. - P#16 was tested for HBsAb on 6/12/25 with a 5 mIU/mL result. - P#17 was tested for HBsAb on 6/11/25 with a 5 mIU/mL result. - P#18 was tested for HBsAb on 6/11/25 with a 4 mIU/mL result. - P#19 was tested for HBsAb on 6/11/25 with a 3mIU/mL result. - P#20 was tested for HBsAb on 6/11/25 with a 5 mIU/mL result. - P#21 was tested for HBsAb on 6/11/25 with a 3 mIU/mL result. - P#22 was tested for HBsAb on 6/12/25 with a 6 mIU/mL result. There was no documentary evidence that P#12, P#15, P#16, P#17, P#18, P#19, P#20, P#21, and P#22 were offered nor received the Hepatitis B vaccine and there was no documentary evidence that all nine patients declined the Hepatitis B vaccination. During an interview with the Facility Administrator on 6/26/25, at 9:50 a.m., he rechecked the records and confirmed that those nine patients mentioned above were neither offered nor received the Hepatitis B Vaccine, and there was no documented evidence to show that all nine HBV susceptible patients refused the Hepatitis B vaccination. A review of Policy: 1-05-02, titled, “Hepatitis B SURVEILLANCE, VACCINATION, INFECTION CONTROL MEASURES AND ISOLATION GUIDANCE”, last revised April 2024, stated: 13. Test all vaccinated patients for HBsAb one (1) to two (2) months after the last dose of full vaccine series (adequate response is defined as greater than or equal (>) 10 mIU/mL. a. If hepatitis B surface antibody (HBsAb) is less than (<) 10 mIU/mL, consider the patient susceptible, revaccinate with additional full series, and retest for HBsAb one (1) to two (2) months after the last dose of the second series. - A review of the CDC recommendations stated that Hepatitis B vaccination is crucial for protecting hemodialysis patients, who have a higher risk of infection due to their underlying kidney disease and frequent exposure to blood and body fluids in the dialysis setting. During a review of personnel records, the following was revealed: The Facility Administrator was unable to provide documentation verifying that the following had a baseline Tuberculin Skin Test (TST) and subsequent annual TB RAQ for: RD, SW, BMT, the AA, RN BB, RN CC, PCT BB, PCT EE, and PCT FF. Additionally, the Facility Administrator could not provide a documentary evidence of Hepatitis B testing of the following personnel: RN BB and RN CC, LPN AA, PCT AA, PCT BB, PCT CC, PCT EE and PCT FF, RD, SW, BMT, the AA, and Medical Director. During an interview with the Facility Administrator on 6/26/25 at 12:00 p.m., he stated that he took over this facility in May 2025. A review of Policy 4-06-03, titled “TEAMMATE HEPATITIS B MONITORING AND FOLLOW-UP GUIDANCE”, last revised April 2024, stated: 1. New teammates who are not able to provide documentation of hepatitis surface antibodies of 10 mIU/ml or greater from anytime in the past, regardless of documentation indicating completion of the hepatitis B vaccine series, will be screened for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) within 10 days and offered the vaccination as indicated by their results. According to CDC recommendations, all staff working in dialysis facilities should undergo baseline screening for both TB and Hepatitis B upon hire. For TB, this includes a symptom evaluation, a TB Risk Assessment Questionnaire (RAQ), and testing using either a TST or an Interferon-Gamma Release Assay (IGRA), unless there is documented proof of prior testing or treatment. Due to the higher-risk nature of dialysis settings, annual symptom screening and risk assessment are recommended, and repeat TB testing may be required in the event of exposure, an outbreak, or increased transmission within the facility. Documentation of all TB screenings and assessments must be maintained in the employee’s health file. For Hepatitis B, staff with potential exposure to blood or body fluids must undergo baseline testing for anti-HBs to assess immunity. Those who are not immune should complete the full Hepatitis B vaccine series, followed by anti-HBs testing 1-2 months after the final dose to confirm an adequate immune response (defined as 10 mIU/mL or greater). Non-responders may be given a second series and retested; if they still do not respond, they must be managed as non-responders and use appropriate precautions. Facilities are required to maintain written documentation of Hepatitis B vaccination and immunity status for all relevant staff.”

“IC-HBV-ISOLATION (EXISTING FACILITY) CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, designate a separate room for their treatment. For existing units in which a separate room is not possible, HBsAg positive patients should be separated from HBsAg susceptible patients in an area removed from the mainstream of activity. This Standard is not met as evidenced by: 49321 Based on observation, a review of facility records and staff interview, it was determined that the facility failed to properly maintain one of one Isolation Room, to be readily available for use, for patients who were infected with the Hepatitis B Virus (a highly contagious liver infection caused by the Hepatitis B Virus (HBV) that can be transmitted through the blood of an infected person and other body fluids), as evidenced by using this Isolation Room as a storage room. Improper use of the Isolation Room compromised its availability for immediate use, which had the potential to delay or prevent the safe isolation and treatment of a patient requiring HBV - specific dialysis precautions. The facility census was 60. Findings include: During a tour of the facility on June 24, 2025, at 10:00 a.m., it was observed that the Isolation Room, with one Station (S) 18, was being used as a storage room. The items stored in the Isolation Room included: One large box with miscellaneous items Four treatment chairs One office rolling chair Two moderate-sized plastic biohazard bins One oxygen tank One large privacy screen One intravenous (IV) pole One 12x12 picture - A review of Form CMS-3427, titled, “End Stage Renal Disease (ESRD) Application/Notification and Survey/Certification Report”, (a document used by facilities providing ESRD services to apply for End Stage Renal Disease Application and Survey and Certification Report Form and Supporting Regulations), submitted by this facility to CMS (Centers for Medicare and Medicaid Services) in 2023, showed that this facility had one designated room used as an Isolation Room with one station. During an interview conducted on June 25, 2025, at 4:00 p.m., the Facility Administrator stated that he was assigned to this facility in May, 2025. He also added that the facility did not have any patients currently testing positive for Hepatitis B.”

“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: 49321 Based on a review of facility records, staff interview, a review of the facility’s Policies and Procedures (P&P), and a review of AAMI (Association for the Advancement of Medical Instrumentation), it was determined that the facility failed to ensure that total chlorine testing (used to detect the presence of chlorine and chloramine in the water used for dialysis), was performed and documented every four hours as required. This was evidenced by test results being recorded between 4 and 18 minutes past the required testing intervals. Failure to perform timely testing for chlorine and chloramine can result in harmful exposure to patients, potentially leading to serious adverse outcomes such as hemolysis (destruction of red blood cells), cardiac arrhythmias, and hypotension. The facility census was 60. Findings include: A review of facility records revealed that the total chlorine testing was not consistently performed within the required four-hour intervals. Specifically: On 4/14/25, the third total chlorine test was completed at 8:11 a.m., and the fourth test was completed at 12:29 p.m., 18 minutes late. On 4/15/25, the third total chlorine test was completed at 8:35 a.m., and the fourth test at 12:40 p.m., 5 minutes late. On 5/19/25, the third total chlorine test was completed at 8:06 a.m., and the fourth test at 12:10 p.m., 4 minutes late. On 5/5/25, the third total chlorine test was completed at 8:15 a.m., and the fourth test at 12:30 p.m., 15 minutes late. During an interview conducted on June 25, 2025, at 4:00 p.m., the Facility Administrator stated that he was assigned to the clinic in May, 2025. - A review of the facility’s Policy: 2-05-02, titled, “Daily Water System Total Chlorine Monitoring”, with latest revision date of October 2023, stated: 3. Total Chlorine testing is done on a daily basis prior to the first patient treatment and within every four (4) hours until all activities that require use of dialysis quality water are completed. All samples are to be drawn only after the water system has been operating for at least 15 minutes. Document results on Routine Total Chlorine Testing Log... - A review of AAMI, in collaboration with ISO (International Organization for Standardization), requires rigorous and timely monitoring of dialysis water-specifically for contaminants like chlorine and chloramine-to ensure patient safety. According to AAMI standards (e.g., RD 52, TIR 58), water used in dialysis must undergo total chlorine testing before each treatment shift and approximately every four hours during treatments. Why this matters: Timely testing is essential because chlorine or chloramine in the dialysate water can cause immediate and life-threatening harm to patients. Even small delays in testing increase the risk that contaminated water might be used in treatments, potentially resulting in: Hemolysis - Destruction of red blood cells due to chlorine exposure. Cardiac arrhythmias - Abnormal heart rhythms triggered by metabolic disturbances. Hypotension - Sudden drops in blood pressure, which can rapidly destabilize patients. Facilities that fail to monitor water on the required schedule are in direct violation of AAMI’s protocols and are placing patients at serious risk.”

“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: 52051 Based on observation, staff interviews, a review of facility Policy and Procedures (P & P), a review of the manufacturer’s Directions for Use (DFU) and a review of the Association for the Advancement of Medical Instrumentation’s (AAMI’s) “American National Standard for Dialysate for Hemodialysis,” 2004 (RD52: 2004), it was determined that the facility failed to ensure that there was a safe environment for all in-center hemodialysis (ICHD) patients as evidenced by failure of one of one Registered Nurse (RN AA), observed on the first day of the survey, and one of one Patient Care Technician (PCT AA), observed on the third day of the survey, to verify the hemodialysis machines’ final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU per ANSI/AAMI RD52: 2004 guidelines. This deficient practice had the potential to negatively affect the health and safety of 11 of 11 patients, who were undergoing hemodialysis at the time of the observation on both days of the survey. 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. And if conductivity is out of range, the effectiveness of the treatment could be reduced, and patient electrolyte balance could be altered. The facility census was 60. Findings include: 1. During observation in the Patient Treatment Room on 6/24/25 between 9:45 a.m. and 10:45 a.m., the following was revealed: - At 10:11 a.m., RN AA was observed taking the Myron L D-1 meter (used to measure and monitor water quality parameters like conductivity) to Station (S)10. RN AA collected a dialysate sample from the Hansen sample port (the blue port) of the dialysis machine using a 20 ml (milliLiter) plastic cup. After pouring the dialysate into the Myron-L D-1 Meter cell cup, RN AA agitated the sample with a plunger by moving it up and down once. She then pressed the black button and documented the conductivity result. Following this, RN AA proceeded with a dressing change for P#8’s Central Venous Catheter (CVC; a soft plastic tube inserted into a large vein in the neck or groin, used for providing hemodialysis to patients). -At 10:20 a.m., this surveyor asked RN AA if she had checked the final dialysate pH of the hemodialysis machine before starting the treatment for P#10 at S10. RN AA stated that she had not yet done so. -At 10:21 a.m., RN AA was observed obtaining a dialysate sample again from the Hansen sample port (the blue port) of the dialysis machine, using a plastic cup. She dipped a pH test strip (RPC K100 - 0117 CT E-Z pH test strip) into the dialysate sample and immediately compared the test strip color to the color chart on the test strip bottle. -During an interview with RN AA on 6/24/25, at 10:35 a.m., she stated that she was aware of how to perform the pH testing and added that after dipping the test strip into the dialysate sample, she needed to check the result within five seconds. This surveyor prompted RN AA to review the facility’s P & P. -On 6/24/25, at 10:44 a.m., RN AA acknowledged that she had performed the procedure incorrectly after reading and reviewing the facility’s P & P for testing pH. - On 6/24/25, at 10:55 a.m., this surveyor notified the Facility Administrator of the above observation and he acknowledged that performing pH Testing and conductivity of proportioned dialysate incorrectly was a serious issue. -During an interview with RN AA on 6/24/25, at 4:15 p.m., she confirmed that she conducted the dialysate conductivity testing incorrectly and acknowledged the importance of following the facility’s P & P, despite being busy. A review of Policy: 1-03-02, titled, “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate” revised October 2024, stated: - Manual pH testing must be performed prior to each patient’s treatment. A review of Procedure: 1-21-09, titled, “Testing pH of Citric Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8 - 8.5 Test Strips”, with latest revision date of February 2024, stated: NOTES: *Manual pH testing must be performed prior to each patient treatment. *Requirement for independent conductivity testing is determined by manufacturer’s guidelines. Refer to specific hemodialysis machine priming policies and procedures to determine the requirement of performing independent conductivity testing in the facility. 2. Obtain dialysate sample..., then dip the strip in the solution for one (1) second... 3. Remove the strip from the fluid and shake off excess dialysate. 4. Within 20-25 seconds, compare the color reaction on the strip to the color chart on bottle to determine the closest match... Rationale: Following manufacturer’s directions for use. Retest if the results are not read within 25 seconds. A review of the RPC K100-0117CT E-Z Chek 6.8- 8.5 pH Test Strips’ manufacturer’s DFU showed the following: Instructions for use: 3. Dip or wet the strip pad for one second with fresh solution to be tested. 4. Briskly shake off excess solution. Compare test results to the color scale on the bottle within 20 and 25 seconds. Retest if the results are not read within the 25-second time frame. A review of Procedure: 1-21-02, titled, “Operation of Portable Myron L Conductivity Meter (D-1)”, with latest revision date of April 2020, stated: 2. Obtain proportioned dialysate sample... 3. Fill meter cell cup with sample so upper electrode is immersed. Insert plunger. 4. Agitate sample with plunger by moving up and down 3 or 4 times and then discard sample. 5. Repeat steps #3 and #4 - at least 3 times. Rationale: Verifies that any prior sample solution has been rinsed free from the cell. 6. Obtain another proportioned dialysate sample and fill the meter, drop plunger in the solution and press the black button. When the pointer stops, immediately read and release the button. 7. Repeat step #6 twice and press. Read/Check button and record conductivity reading. Rationale: Helps assure accurate reading. A review of the Myron L D-1 meter manufacturer’s DFU showed the following: 1. Fill the cell cup to just above the top electrode with a sample of the dialysate you want to test. The dipper end of the cell plunger will deliver just the right amount. Be sure hands are clean and dry to avoid contamination of the sample. 2. Drop the plunger into the cell cup. Lift it about half way out of the cell and drop it back in three or four times. Discard the sample. NOTE: This procedure must be conscientiously performed for samples at working (body) temperature to avoid artificially low readings. 3. Repeat steps 1 and 2 at least three times. 4. Take another sample, drop in the plunger and press the black button. When the pointer stops, IMMEDIATELY read and release the button. 5. Repeat step 4 twice and record the last reading. 2. During observation in the Patient Treatment Room on 6/26/25 between 7:00 a.m. and 9:00 a.m., the following was revealed: - At 8:37 a.m., PCT AA was observed testing Machine #15 at S6. At 8:42 a.m., the machine test was completed and PCT AA proceeded to attach dialysate connectors to dialyzer (without verifying the conductivity and approximate pH of the dialysate solution through independent means) and closed the shunt door. At 8:43 a.m., PCT AA began cannulating P#9. At 8:49 a.m., the Clinical Coordinator, (RN CC), arrived at the chairside to administer a Heparin (anticoagulant injection) push. During this time, this surveyor observed PCT AA separating the bloodlines, specifically the venous (blue end) and arterial (red end) line, and about to connect them to P#11’s arm access site to initiate treatment. - At 8:50 a.m., PCT AA was asked by this surveyor if she had checked the pH and conductivity of the dialysate before initiating P#11’s treatment. PCT AA stated, “No, I did not”. This surveyor then asked PCT AA what must be checked before treatment initiation. PCT AA stated, “Well, I guess the pH and conductivity”. This surveyor then looked for Clinical Coordinator (RN CC) to be notified of the observation. -At 8:52 a.m., RN CC was observed approaching S6 and spoke with PCT AA. During this time, PCT BB arrived at P#9’s chairside and assisted in checking the pH and conductivity of the dialysate from Machine #15. During an interview with the Clinical Coordinator (RN CC) on 6/26/25, at 8:55 a.m., she stated that all staff members were aware of their responsibilities before initiating dialysis treatment, but they were not carrying them out. RN CC also mentioned that she had led a morning huddle with the team earlier this day, specifically discussing the proper testing of pH and conductivity prior to treatment. During an interview with PCT BB on 6/26/25, at 8:57 a.m., she stated, “I stepped in to assist with checking the pH and conductivity. I make sure to check the pH and conductivity before treatment. We technicians know it. I don’t understand why she (PCT AA) did not do it.” On 6/26/25, at 9:40 a.m., this surveyor notified the Facility Administrator (Staff AA) of the observation. He expressed his disbelief that one of the staff members still failed to check the pH and conductivity of the dialysate prior treatment, despite the in-service training session he had conducted for the team on June 24, 2025. - A review of the 2008K2 Dialysis Machine’s manufacturer’s DFU showed the following: Recirculation 2. Check the pH and conductivity of the dialysate ... Warning: Always verify the conductivity and approximate pH of the dialysate solution through independent means (e.g., using a conductivity meter or pH paper or meter, as applicable) before initiating each dialysis treatment ...) 3.Attach dialysate connectors to dialyzer (using counter-current flow, red to red, and blue to blue) and close shunt door. According to ANSI/AAMI RD52: 2004, Section 5.6, “Dialysate Proportioning”, 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.”

“MICROB MONITOR-MO DIALYS SAMPLE/COLLECT/FREQ CFR(s): 494.40(a) 7.2 Microbial monitoring methods: 7.2.1 General: Dialysate: monthly dialysate sample/collection/freq Culture ...dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year. If testing of any dialysis machine reveals a level of contamination above the action level, an investigation should be conducted that includes retesting the offending machine, reviewing compliance with disinfection and sampling procedures, and evaluating microbiological data for the previous 3 months to look for trends. The medical director also should be notified. An example of a decision tree for this process is given in Figure 1. 7.2.2 Sample collection Dialysate samples should be collected from a dialysate port of the dialyzer ... [or] dialysate sampling ports that can be accessed using a syringe. At least 25 mL of fluid, or the volume specified by the laboratory performing the test, should be collected in sterile endotoxin-free specimen containers. This Standard is not met as evidenced by: 49321 Based on a review of records, staff interviews, a review of facility Policy and Procedures (P & P), and a review of the Association for the Advancement of Medical Instrumentation’s (AAMI’s) “American National Standard for Dialysate for Hemodialysis,” 2004 (RD52: 2004), it was determined that the facility failed to ensure that one of one Biomedical Technician (BMT), responsible for microbial monitoring of each hemodialysis (HD) machines’ dialysate for (bacteria and endotoxin), collected samples for dialysate cultures from two of 20 HD machines (HD machine #12 and #13), at least once per year. Dialysis machines can be a source of infection. If not properly maintained and monitored for bacterial growth and contamination, dialysis machines and their internal fluid pathways can harbor bacteria and endotoxins, posing a risk of bloodstream infections in all in-center hemodialysis patients. The facility had 60 in-center hemodialysis patients. Findings include: HD machine #12 (2KOS179045) was last tested for microbial sampling, including endotoxin and colony count, on June 3, 2024 (386 days). HD machine #13 (2KOS-179061) was last tested for microbial sampling, including endotoxin and colony count, on May 29, 2024 (392 days). During an interview with the current Biomedical Technician (BMT) on 6/25/25, at 3:00 p.m., he stated that the previous BMT had been terminated and he (current BMT) had been assigned to this facility since May, 2025. He stated that he was in the process of gathering information and working to bring the clinic into order. During an interview with the Facility Administrator on 6/25/25 at 4:00 p.m., he stated that he was assigned to this clinic in May, 2025. A review of policy # 1-19-04, titled, “DIALYSATE ENDOTOXIN TESTING POLICY”, last revised April 2025, stated: Page 1 5. Monthly sample sites include: 10% of all dialysis machines per month, always round up. Machine selection is rotated so that all machines are tested for endotoxin levels at least annually. According to ANSI/AAMI RD52: 2004, Section 7.2.1, “Dialysate: Sample/ Collection/Frequency”, dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 52051 Based on observation and staff interviews, it was determined that the facility failed to ensure that the building in which dialysis services were provided was sanitary and maintained to ensure the safety of the patients and staff. Failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus providing a potential for microbial growth. These environmental concerns were observed in one of one Dialysate Preparation Room and one of one Supply Room. The facility had 60 in-center hemodialysis (ICHD) patients. Findings include: During a tour of the facility on 6/24/25, between 11:10 to 11:35 a.m., with the Facility Administrator and Staff BB (Facility Administrator from another clinic, who was filling in for the Clinical Coordinator), the following was observed: In the Dialysate Preparation Room: - The discharge port on the Backflow Preventer (diverts the treated water to drain ensuring the integrity of the potable water feed), was entirely obscured by a thick layer of rust-colored substance. Additionally, the vinyl covering on the large white piping, positioned perpendicular to the shut-off valve located directly above the discharge port, had become detached in places and showed signs of peeling. This area of piping was also partially coated with the same rust-colored substance. - The floor right behind the Central Water Plant (CWP - a system to purify water for dialysis) was wet, with significant visible amount of water. The wet area measured about 8 Feet in length and 3 Feet in width. - There was a noticeable leaking coming from the white fill tube connected to the control valve head of the Softener Tank, causing the fluid to drip right on top of the lid of the Brine Tank. - The floor in front of two big Bicarbonate Tanks was covered with a moderate amount of flaky white substance. In the Supply Room: - The metal strip at the bottom of the exit door frame leading to the outside was detached from the doorframe and was sticking out, which posed a potential for a tripping hazard or cut. The damaged section measured at least 4 inches in length and 1.5 inches in width. - On the floor in front of this exit door was a loose rug that was littered with wood chips, dirt and dust. -The exit door leading to the Personnel’s Parking Lot outside, had a hole/opening right under the grab bar, that measured approximately 1 inch long and half an inch wide, allowing light to pass through. This gap could potentially permit insects and rodents to enter the building. During an interview with the Biomedical Technician (BMT) on 6/24/25, at 11:20 a.m., he stated that he was new to the facility. He mentioned that the company responsible for the facility’s Backflow Preventer would definitely address the issue during their upcoming visit, although he did not specify the exact date. He also added that he was already working on the observed leak coming from one of the tubing connections of the water softener tank. The BMT acknowledged all of the other observations mentioned above. - The Facility Administrator acknowledged all of the above observations on 6/24/25, at 11:40 a.m.”

“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: 49321 1. Based on a review of facility records, staff interviews, a review of the Fresenius 2008K2 Hemodialysis Machine Operator’s Manual, a review of the facility’s Policies and Procedures (P & P), and a review of the Myron L Meter D -1 Manual, it was determined that the facility failed to ensure an annual hemodialysis machine preventive maintenance (PM) was completed on one of five dialysis machines (machine #20 with serial number 2KOS179096) sampled, and failure of the facility to ensure daily calibration of Myron L D-1 (a handheld meter used to measure the hemodialysis machine’s dialysate conductivity [ability of the dialysate to conduct electricity]), was performed prior to daily use and as needed. Missed dialysis machine’s scheduled preventive maintenance had the potential for machine malfunctions, inaccurate performance and complete breakdowns. Failure to perform daily calibration of Myron L D-1 prior to daily use and as needed, had the potential for inaccurate measurements leading to incorrect conductivity readings and unreliable data. These deficient practices had the potential to negatively affect the health and safety of all 60 patients who were under the care of this facility. Findings include: A review of facility records revealed the following: - The last annual preventive maintenance for Hemodialysis Machine #20 with serial number 2KOS179096 was June 7, 2024. - During an interview with the Biomedical Technician (BMT) on 6/24/25, at 4:00 p.m., he stated that he had only recently assumed responsibility for this facility in May, 2025, and was unable to provide the needed documentation. - During an interview with the Facility Administrator on 6/25/25, at 4:00 p.m., he stated that he just assumed responsibility for this facility in May, 2025. - A review of the Fresenius 2008K2 Hemodialysis Machine Operating Manual, stated: The machines require regular preventive maintenance (PM) to ensure patient safety, treatment accuracy, and machine reliability. According to Fresenius manufacturer guidelines and standard clinical practice, the recommended PM interval is every six months (biannually). However, some facilities with higher machine usage may opt for quarterly PMs (every three months) to enhance safety and performance. All preventive maintenance must be performed by certified biomedical technicians or engineers who are specifically trained on the 2008K2 model. - A review of the Myron L D-1 Daily Calibration Log showed no documented evidence that a daily calibration of Myron L D-1 was performed and completed by the nurses and/or PCTs. The BMT, Patient Care Technician (PCT DD), Registered Nurse (RN AA) and the Area Technical Manager were requested for a documentary evidence of the Daily Calibration of the Myron L D-1 before use between 6/24/25 through 6/26/25, but they were not able to provide any documentary evidence of the said Daily Calibration Log. - A review of facility Procedure: 2-08-01A, titled, “Calibration Check and Calibration of Portable Myron L Conductivity Meter (D-1)”, with last revision date of October 2022, stated: NOTES: This procedure is to be performed prior to daily use or whenever inaccurate readings are suspected. - A review of the Myron L Meter D -1 Manual, stated: Using the Myron L Meter, it should be carefully checked to ensure accurate and reliable readings. Start with a visual inspection of the device, looking for any physical damage, corrosion, or dirt in the cell cup or on the electrodes. Make sure the battery is in place and the needle moves freely when the button is pressed. Rinse the cell cup at least three times with reverse osmosis or deionized water to remove any contaminants, and use the plunger several times to condition the electrodes. If required, verify calibration using a standard conductivity solution and adjust using the calibration screw if the reading does not match the known value. Ensure the green “safe zone” band is set correctly based on your facility’s prescribed dialysate range. Lastly, confirm that the needle stabilizes quickly during use-fluctuating or erratic readings may indicate a need for cleaning or servicing. 2. Based on observation, a review of facility records and staff interviews, it was determined that the facility failed to ensure a comfortable environment was provided for all patients and staff, as evidenced by a partially nonfunctional air conditioning (AC) system, specifically, AC units #5 and #6, that were used to cool key areas of the facility, including the Patients’ Lobby, Staff Training Room/Conference Room, and the left side of the Patient Treatment Room. Failure to keep all the AC units functional subjected patients and staff to an uncomfortable environment which could negatively affect the safety and wellbeing of all 60 patients who were undergoing hemodialysis treatment at this facility and all Direct Patient Care Staff (nurses and Patient Care Technicians- PCTs). Findings include: - During entrance into the facility on June 24, 2025, at 9:30 a.m., this surveyor observed that the Patients’ Lobby and the Staff’s Training Room/Conference Room, (where the survey team was stationed from June 24 to June 26, 2025), were noticeably warm. The thermostat in the Staff Training Room/Conference Room consistently reached 80 degrees Fahrenheit each day during the survey period. - A review of the facility’s grievance log revealed that patient (P) #20, submitted a complaint on April, 2025, regarding the Patient Treatment Room being uncomfortably warm. There was no documentary evidence that the grievance was resolved. - During an interview with Registered Nurse (RN AA) on 6/24/25 at approximately 5:00 p.m., RN AA confirmed that the AC system had been partially functional only since April, 2025 and the other AC units (#5 and #6), were inoperable. RN AA also added that patients had voiced their complaints about the warm temperatures and that the facility’s administration was aware of the issue. During an interview with the Facility Administrator on June 24, 2025, at 5:30 p.m., he stated that a work order had been submitted for the repairs. On June 26, 2025, at 9:00 a.m., the Facility Administrator provided documentation indicating that the work order was submitted on June 12, 2025. - A review of the Work Order #WEB-6J1207, dated 6/12/25, stated: Work Order Description: Treatment Floor is too hot on MWF (Mondays-Wednesdays-Fridays schedule) and TTS (Tuesdays-Thursdays-Saturdays schedule) days. Unit five and six are down. Repaired unit six on Friday, 6/13. (sic) - On 6/17/25, it was stated on the work order, that: Today the unit six is down again due to smoke detector alarm. I reached out to the service provider and they scheduled for a technician to come and repair smoke detector. Unit five is currently being rapaired but needs a part. We pick up parts this afternoon and return tomorrow morning to finish repair. (sic) There was no additional documentation regarding updates about the repair and AC units #5 and #6 were still out of order, even during the exit conference on 6/26/25.”

“PE-PT CARE ENVIRONMENT-SUFFICIENT SPACE CFR(s): 494.60(c)(1) The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff. This Standard is not met as evidenced by: 52051 Based on observation and staff interview, it was determined that the facility failed to ensure that the passageway to the Staff Training Room/Conference Room, Machine Training Room 2, Exit door and HVAC (Heating, Ventilation, Air Conditioning) door, were free from obstacles to ensure safety and easy passage for all personnel. This deficient practice had the potential to negatively affect the safety of all staff who might need access to or exit from these obstructed areas. Findings include: During a tour of the facility on 6/24/25, between 11:10 to 11:35 a.m., with the Facility Administrator and Staff BB (Facility Administrator from another clinic, who was filling in for the Clinical Coordinator), the following was observed: - A large stack of delivered boxes from a medical company on a long, large wooden pallet that measured approximately 10 feet long and 4 feet wide was partially blocking the hallway between the Staff Training Room/Conference Room, Machine Training Room 2 (which had several old boxes, photocopy machine and a table), HVAC door and Exit door, leaving only approximately 12-14 inches wide to pass through. As a result, movement, access to or exit from these areas were significantly restrictive, with potential risk for safety in case of an emergency. - During an interview with the Facility Administrator on 6/24/25 at approximately 11:15 a.m., he acknowledged this obstructed passageway and added that the boxes had been there for at least seven days, but he will have it taken care of.”

“PE-COMFORTABLE TEMPERATURE CFR(s): 494.60(c)(2) The dialysis facility must: (i) Maintain a comfortable temperature within the facility; and (ii) Make reasonable accommodations for the patients who are not comfortable at this temperature. This Standard is not met as evidenced by: 49321 Based on observations, facility records, and interviews, it was determined that the facility failed to ensure a comfortable indoor temperature for patients and staff, as required. At the time of the review, air conditioning units 5 and 6 were not operational. These units were responsible for cooling key areas of the facility, including the patient lobby, staff training room, and the left side of the treatment area. This failure compromised the overall comfort of the environment and may have posed a risk to the health and safety of individuals within the facility. At the time of the observation, the facility census was 60 patients. During entrance into the facility on June 24, 2025, at 9:30 a.m., the surveyor noted that the patient lobby and the staff conference room-where the survey team was stationed from June 24 to June 26, 2025-were noticeably warm upon entry. The thermostat in the conference room consistently reached 80 degrees Fahrenheit each day during the survey period. A review of the facility’s grievance log revealed that Patient #20 submitted a complaint on April , 2025, regarding the treatment area being uncomfortably warm. During an interview with RN AA, it was confirmed that the air conditioning system had been partially nonfunctional since April, specifically noting that only certain units were inoperable. RN AA also confirmed that patients had voiced complaints and that the facility ’ s administration was aware of the issue. During an interview with the Covering Facility Administrator on June 24, 2025, at 5:30 p.m., he stated that a work order had been submitted for the repairs. On June 26, 2025, at 9:00 a.m., he provided documentation indicating that the work order was submitted on June 12, 2025. The work order confirmed that AC units 5 and 6 were out of service, and that unit 6 had shut down due to a triggered smoke detector alarm. The documentation further noted that a technician would need to be scheduled to repair the smoke detector before the air conditioning contractor could return to complete the AC repairs. As of the time of the review, there was no additional documentation showing that the smoke detector had been repaired or that AC units 5 and 6 had been restored to working condition.”

“POC-PT/FAMILY EDUCATION & TRAINING CFR(s): 494.90(d) The patient care plan must include, as applicable, education and training for patients and family members or caregivers or both, in aspects of the dialysis experience, dialysis management, infection prevention and personal care, home dialysis and self-care, quality of life, rehabilitation, transplantation, and the benefits and risks of various vascular access types. This Standard is not met as evidenced by: 52051 Based on facility records review, staff interview, and a review of the Centers for Disease Control and Prevention (CDC) guidelines, it was determined that the facility failed to provide infection control education or training (e.g. vascular access care, personal hygiene, infection prevention, and benefits and risks of various vascular access types) to two of seven patient (P) samples (P#2, who was sampled for high phosphorus levels, and P#7, who was sampled for new admission less than 90 days). Infection control education is crucial for dialysis patients to prevent bloodstream infections (BSIs). This failure had the potential to negatively impact the health and safety of 60 in-center hemodialysis (ICHD) patients receiving care at this facility. Findings include: A review of the facility records on 6/26/25 revealed the following: - P#2 was admitted to the facility on 5/15/25, there was no documentary evidence that P#2 received Infection Control training education in the facility. - P#7 was admitted to the facility on 4/7/25, there was no documentary evidence that he was provided education, like access site care, handwashing, etc. On 6/26/25, at 10:10 a.m., the Facility Administrator (Staff AA) was notified of these findings. He stated that he also could not find any proof that P#2 and P#7 had been educated on Infection Control. According to CDC guidelines, infection control education is essential for dialysis patients to prevent bloodstream infections (BSIs). Key components of this education include proper hand hygiene, catheter care, and recognizing potential signs of infection. Patients are encouraged to take an active role in their care by understanding prevention measures and reporting any signs of infection they may experience.”

“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: 52051 1. Based on a review of facility records, staff interview, and a review of the facility’s Policies and Procedures (P&P), it was determined that the Medical Director failed to ensure that all Direct Patient Care (DPC) Staff (Registered Nurses - RNs, Licensed Practical Nurse - LPN, and Patient Care Technicians - PCTs), adhered to prescribed hemodialysis orders relative to ultrafiltration rate (UFR - the speed at which excess fluid is removed from the body during hemodialysis treatment which is at or below 13 mL/kg/hr [milliLiter per kilogram per hour] - the maximum safe rate for fluid removal during treatment), of four of seven patients (Ps) (P#1, P#2, P#5 and P#6), sampled. Excessive ultrafiltration (UF) during hemodialysis can lead to serious complications due to rapid fluid removal which can result in intradialytic hypotension (low blood pressure during dialysis), muscle cramping, dizziness, and potentially contribute to long-term cardiovascular complications and even mortality. This deficient practice had the potential to negatively affect the health and safety of P#1, P#2, P#5 and P#6. The facility census was 60 in-center hemodialysis (ICHD) patients. Findings include: A review of P#1’s, P#2’s, P#5’s, and P#6’s records showed elevated UFRs exceeding 13 mL/kg/hr, and were not supported with any notes or documentation from the DPC Staff. The prescribed UFR for all patients was not to exceed 13 mL/kg/hr, or maximum of 13 mL/kg/hr. P#1: -On 6/13/25 Target Weight: 54 kg (kilograms) Pre-treatment weight: 57.1 kg Post-treatment weight: 53.6 kg Actual UFR: 18.6 miliLiter mL/kg/hr - On 6/16/25 Target Weight: 53.5 kg Pre-treatment weight: 59.4 kg Post-treatment weight: 55.2 kg Actual UFR: 21.8 mL/kg/hr -On 6/18/25 Target Weight: 53.5 kg Pre-treatment weight: 59.0 kg Post-treatment weight: 54.5 kg Actual UFR: 23.9 mL/kg/hr - On 6/20/25 Target Weight: 53.5 kg Pre-treatment weight: 57.9 kg Post-treatment weight: 53.7 kg Actual UFR: 22.2 mL/kg/hr P#2: - On 6/21/25 Target Weight: 80.5 kg Pre-treatment weight: 87.8 kg Post-treatment weight: 84.8 kg Actual UFR: 14.9 mL/kg/hr - On 6/24/25 Target Weight: 80.5 kg Pre-treatment weight: 85.6 kg Post-treatment weight: 81.6kg Actual UFR: 15.4 mL/kg/hr P#5: - On 6/17/25 Target Weight: 57.0 kg Pre-treatment weight: 59.8 kg Post-treatment weight: 56.8 kg Actual UFR: 15.2 mL/kg/hr P#6: - On 6/21/25 Target Weight: 53.5 kg Pre-treatment weight: 59.4 kg Post-treatment weight: 55.2 kg Actual UFR: 21.8 mL/kg/hr On 6/26/25, at 10:10 a.m., the Facility Administrator was notified of the findings from the record review. He stated that all staff were taught of the formula - 13 mL/kg/hr UFR in dialysis during their training and teammates knew how to calculate the maximum UFR. He also acknowledged the risks associated with excessive ultrafiltration during dialysis. A review of Policy: 1-03-08, titled, “Pre - Intra - Post Treatment Data Collection, Monitoring and Nursing Assessment”, last revised April 2024, stated: 1. Patient identity, prescription and machine settings are verified by teammate prior initiation of treatment ... The prescription components are confirmed by a licensed nurse within one hour of treatment initiation ... b. Treatment time c. Target weight d. UFR and Max UFR 2. Based on observation, staff interviews, and a review of the facility’s Policy and Procedures (P&P), it was determined that the Medical Director failed to ensure that one of one Registered Nurse (RN AA), who prepared Heparin injections (anticoagulant used in hemodialysis to prevent clotting in the bloodlines and dialyzer/artificial kidney) for second shift patients, labeled 15 of 15 Heparin syringes, with date and time prepared, and initialed. This deficient practice increased the risk for medication errors. The facility had 60 in-center hemodialysis (ICHD) patients. Findings include: During observation in the Patient Treatment Room on 6/24/25 between 9:45 a.m. and 10:45 a.m., the following was observed: In the Medication Preparation Area: - There were seven 10 mL (milliLiters) syringes containing Heparin injections for hourly infusion, and six 5 mL syringes of Heparin injections for bolus infusion, that were prepared and labeled with the patients’ names, but they lacked the initials of the nurses who prepared them, as well as the date and time of medication preparation. During an interview with RN AA on 6/24/25, at 10:11 a.m., she confirmed that she prepared all the Heparin Injections. She added that those Heparin syringes were prepared around 8:00 a.m., on this date (6/24/25), and it was her duty, as the Charge Nurse, to draw up all medications. RN AA also stated that other nurses, for example, RN BB for this day, could administer them for the patients. RN AA acknowledged that it was necessary to label prepared medications with her initials, time, and date. On 6/26/25, at 10:16 a.m., (Staff BB), a Facility Administrator from another facility, who came to fill in for the Clinical Coordinator, was notified of the observation but made no comments. A review of facility Policy #1-06-01 titled, “Medication Policy”, dated October 2023, stated: 20. If medications are prepared and administered immediately by the same licensed nurse teammate, they do not need to be labeled. If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient’s name, date, time prepared, dose, and initials of the teammate preparing the medication. - The facility P&P did not to include that all medications shall be administered by the individual who prepared them. 3. Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and review of facility Policies and Procedures (P&P), it was determined that the Medical Director failed to ensure that two of two Registered Nurses (RN AA and RN BB), who were responsible for administering medications, adhered to facility P & P relative to proper labeling of three of three opened and accessed medication vials located in one of three medicaltion drawers, in order to track shelf life after they were opened and for preventing the administration of expired products. Two of three medication vials were single-dose vials and any leftover should never be saved and must be discarded. Harmful bacteria can grow and infect a patient if leftover from a single-dose vial was used. This failure had the potential to negatively affect the health and safety of 60 in-center hemodialysis (ICHD) patients who were under the care of this facility. Findings include: During a tour of the Patient Treatment Room with the Facility Administrator (Staff AA) and another Facility Administrator (Staff BB) from another clinic, who was filling in for the Clinical Coordinator, on 6/24/25, between 11:00 a.m. to 11:15 a.m., the following was revealed: In the Medication Drawer: - There were three opened and accessed vials of the following medications, which did not have a time and date indicating when they were opened: 1. Ondansetron (used to treat nausea and vomiting), 4 milligrams (mg) per 2 miliLiter (mL); single-dose vial 2. Diphenhydramine Hydrochloride (used to relieve allergy symptoms, like skin itching), 50 mg/mL; single-dose vial 3. Doxercalciferol (used to treat bone disease), 4 micrograms (mcg) per 2 ml; multi-dose vial - During an interview with Staff BB on 6/24/25, at 11:05 a.m., who was present at the time of the observation, she stated that the medication vials mentioned above were not labeled with the staff initials as well as the time and date of opening. - During an interview with the Facility Administrator on 6/24/25, at 11:07 a.m., who was also present at the time of the observation, he stated that opened and accessed vials that are not labeled with the time and date of opening should have been discarded. According to CDC Guidelines, multi-dose vials typically contain an antimicrobial preservative to help prevent the growth of bacteria. If a multi-dose vial has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Additionally, according to CDC Guidelines, leftover medication from single-dose vials should not be saved. Harmful bacteria can grow and infect a patient. Single dose vials must be discarded after every use. A review of the facility’s Policy: 1-06-01, titled, “Medication Policy”, with the latest revision date of October 2023, stated: 15. Medication containers labeled single-dose or single-use (e.g., saline bags, single-dose vials, ampules) may not be used to prepare flush syringes for more than one patient. Any unused saline in the opned single-dose or single-use container must be discarded and may not be stored for future use on the same patient. 29. Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date ... Each vial is labeled with the initials of the person opening the vial and the expiration date ...”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 52051 Based on observation, staff interviews, a review of facility records, and a review of facility Policy and Procedures (P & P) it was determined that the Facility Administrator failed to ensure the facility had adequate number of qualified staff to meet the needs of all patients as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis, for every 12 patients who were receiving dialysis care; and that each care giver was not assigned more than four patients each shift. This deficient practice had the potential to cause a delay in monitoring patients for issues such as fluid overload (an excessive amount of fluid in the body), changes in vital signs, access sites, or problems with the dialysis equipment. Additionally, insufficient staffing could mean slower responses to alarms, missed complications including but not limited to intradialytic hypotension (sudden drops in blood pressure which can occur when fluid is removed too rapidly), arrhythmias (irregular heartbeat), and other medical issues and emergencies related to hemodialysis. The facility had 60 in-center hemodialysis (ICHD) patients under their care. Findings include: During observation in the Patient Treatment Room on 6/24/25 between 9:45 a.m. and 10:45 a.m., the following was revealed: - At 9:45 a.m., there were 11 patients who were receiving hemodialysis (HD) treatment at Stations (S)1, S2, S3, S4, S8, S6, S10, S11, S13, S14, and S16, with two Registered Nurses (RNs) (RN AA and RN BB) and two Patient Care Technicians (PCTs) (PCT AA and PCT GG). - RN AA was assigned to Pod #3 (Pod - a section of four patients), at S9, S10, S11, and S12, as a dialysis care giver in addition to her nursing responsibilities. - RN BB was assigned to Pod #4 at S13, S14, S15, and S16, as a dialysis care giver, in addition to her nursing responsibilities. In addition to her assigned section (Pod #4), as a dialysis care giver, RN BB also discontinued HD treatment for P#12 at S4 (who was assigned to a PCT, but because P#12 had a Central Venous Catheter (CVC- a soft plastic tube inserted into a large vein in the neck or groin, used as an access for HD treatment), and CVC care can only be done by licensed nurses, RN BB had to perform termination of P#12’s HD treatment as well. During the entrance conference with the Facility Administrator on 6/24/25, at 11:58 a.m., he was informed about the observation regarding staffing issues. He mentioned that one staff member from another clinic had come to help manage a Pod. In an interview with RN BB on 6/24/25, at 3:35 p.m., she stated that she was from the float pool, and it was only her second day working at the facility. RN BB confirmed that there were only two nurses and two PCTs working in the Patient Treatment Room, with each individual assigned to a Pod. She added that she was quite busy as she was responsible for performing nursing assessments and other nursing responsibilities which included CVC care for patients with CVCs who were assigned to the PCT’s Pod. During an interview with RN AA on 6/24/25, at 4:15 p.m., she confirmed that they were short-staffed throughout the first shift. RN AA stated that she was assigned to Pod #3 (S9, S10, S11, and S12) as a dialysis care giver, while RN BB was assigned to Pod #4 (S13, S14, S15, and S16), as a dialysis care giver, in addition to their nursing responsibilities. However, she added that on the second shift, a PCT from another clinic arrived to assist at around 10:30 a.m. RN AA also mentioned that on 6/21/25, which was a Saturday, she was the only nurse working and there were 16 patients on first shift and 12 patients on second shift, where she performed nursing assessments for all patients across all four Pods as well as other nursing responsibilities, while also being responsible to her assigned Pod, as a dialysis caregiver. A review of the facility’s “Patient and Teammate Schedule”, (schedule of the number of ICHD patients dialyzing each shift and the number of Patient Care Technicians and licensed nurses providing patient care services), from June 10, 2025 to June 24, 2025, revealed the following: -The Patient Treatment Room was divided into four Pods (sections): - Pod #1 (consisted of S1, S2, S3 and S4) - Pod #2 (consisted of S5, S6, S7, and S8) - Pod #3 (consisted of S9, S10, S11, and S12) - Pod #4 (consisted of S13, S14, S15, and S16) - The MWF (Mondays, Wednesdays, and Fridays) schedule had two shifts, with a total of 16 ICHD patients on the first shift and 14 ICHD patients on the second shift. - The TTS (Tuesdays, Thursdays, and Saturdays) schedule had two shifts, with a total of 16 ICHD patients on the first shift and 12 ICHD patients on the second shift. -A review of the daily schedule (Monday through Saturday), between 6/17/25 through 6/24/25 indicated that the licensed staff members (RNs and Licensed Practical Nurse-LPN), were assigned as dialysis care givers, (providing total care to four patients in a Pod during the first shift and two or three patients during the second shift), in addition to their nursing responsibilities which included but not limited to: pre and post dialysis nursing assessments, preparing and administering medications, communicating with doctors as necessary, responding to complications and other medical issues and emergencies related to hemodialysis that may arise, and supervising the care provided by the PCTs assigned to other patients on the schedule. The daily schedule showed that there were two licensed nurses and two PCTs on the schedule, except on 6/21/25 (Saturday), when there were three PCTs and only one RN (RN AA), as charge nurse for 16 patients on first shift and 12 patients on second shift, and as a dialysis care giver to four patients on first shift and two patients on second shift. A review of Policy: 8-02-01, titled, “Teammate Qualifications, Licensure and Adequate Teammate Staffing”, revised October 2017, stated: 1. This is a general policy based on the CMS Conditions for Coverage. State regulations, if applicable, will supersede this general policy. 4. An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients. A review of the facility’s QAPI (Quality Assessment and Performance Improvement) Meeting Minutes from January 2024 to April 2025, revealed no report or discussion about staffing issues, nor action plans regarding staffing shortages. During an interview with the Clinical Coordinator (RN CC) on 6/25/25, at 9:12 a.m., she stated that staffing had been an issue at this facility, raising significant safety concerns for the patients, and this needed to change. She confirmed that there had been a pattern of short staffing. On 6/25/25, at 12:10 p.m., the Medical Director was notified of this observation. He stated that staffing, specifically in a chronic dialysis facility, had been a challenge for so many years, but the management was doing its best to hire people.”

“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: 03383 Based on observation, staff interview, and a review of facility policy, it was determined that the Infection Control Committee failed to ensure that all Direct Patient Care Staff cleaned blood on one of 18 chairs used for dialysis per facility policy. This deficient practice had the potential for cross contamination and increased risk of infection and could affect 38 patients who were dialyzing at this facility. Findings include: During a tour on 10/1/24 at 10:15 a.m., the following was revealed: Station (S) 9 had brownish red drips that appeared to be dried blood on the panel on right side of chair. This surveyor informed Patient Care Technician (PCT) HH about discovery at 10:30 a.m.. The station had been cleaned and set-up for dialysis for the next shift. PCT HH cleaned the side of chair with bleach solution and the dripped reddish-brown solution came off. A review of Policy 1-05-01 titled, “Infection Control For Dialysis Facilities” dated April 2023 showed: Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials... At the end of each treatment, the dialysis station will be cleaned and disinfected.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 03383 Based on observation and staff interview, it was determined that the facility failed to maintain a clean, orderly, and safe environment. These environmental concerns were observed in four of four rooms formerly used for home training, the back area in front of the storage area, and the corridor, which was cluttered with unopened and opened boxes that could potentially interfere with egress out of the facility. This deficient practice could impede the ability of all staff and 38 patients to quickly and safely leave the building during an emergency evacuation. Findings include: While walking out of the exit located in the storage area with the Charge Nurse (CN) on 10/1/24 at 5:03 p.m., this surveyor observed many unopened NxStage dialysis machine boxes and Styrofoam (combustibles) stacked nearly up to the ceiling in four rooms that were formerly used for home dialysis training. Opened boxes, and Styrofoam boxes were also stacked up to the ceiling in the nurse’s station area and corridor located in the back of the facility near the storage area. The corridor was cluttered with unopened and opened boxes that could potentially interfere with egress out of the facility. During an interview on 10/1/24 at 5:03 p.m., the CN confirmed the above findings and stated that their facility was being used for storage of boxes.”

“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: 03383 Based on a review of medical records, staff interviews and review of facility policies, it was determined that the medical director failed to ensure that all Direct Patient Care Staff adhered to facility policies pertaining to hypertension [elevated blood pressure (BP)] of two of three sampled patients (P) (P#18 and P#30) who experienced high BP readings during treatment and received medical care/interventions appropriate to the patient’s dialysis needs. High BP can lead to many complications, including heart disease and stroke. The facility census was 38. Findings include: A review of P#30’s medical record revealed the following: Medication order on 7/19/23: Clonidine (medication used to treat high blood pressure) (at Dialysis Facility) 0.1 milligram, every 30 minutes as needed. A review of the “Treatment Detailed Report” (TDR) dated 6/3/24 showed the following: - P#30’s BP was 202/110 mm/Hg (milliliters of mercury) during the initiation of dialysis treatment by Licensed Practical Nurse (LPN) DD at 5:52 a.m. - At 5:54 a.m., BP decreased to 189/103 mm/Hg. - At 6:03 a.m., BP increased to 199/103 mm/Hg. Entry made by Patient Care Technician (PCT) EE stated “bp high; recheck”. - At 6:05 a.m., BP increased to 206/113 mm/Hg. PCT EE entered “cuff adjusted”. - At 6:08 a.m., BP increased to 219/115 mm/Hg. PCT EE entered “bp remains high; nurse aware; pt asymptomatic; cuff remains on”. - At 6:33 a.m., BP 208/125 mm/Hg. LPN DD entered “bp still high; nurse aware”. - At 7:03 a.m., BP decreased to 171/112 mm/Hg. PCT EE entered “Treatment paused; patient using restroom.” Treatment ended at this point. The Close Treatment Reason section showed, “Patient is Symptomatic (sent to ER, feels unwell) Discharged/Transferred to ER or hospital”. No additional documentation was provided to determine the outcome of review of incident. There was no documented evidence that RN II notified the physician about high blood pressures or that Clonidine was administered per physician order for elevated BP until patient experienced symptoms at 7:05 a.m. The patient’s BP readings were extremely elevated at the beginning of dialysis at 5:52 a.m. until P#30 went to the hospital at 7:27 a.m. A review of P#18’s medical record revealed the following: Medication order on 6/21/24: Clonidine 0.3 Patch, one time a week. Transdermal (application of drug through the skin with a patch). TDR dated 9/16/24 showed the following: - P#18’s BP was 184/91 during the initiation of dialysis treatment by LPN BB at 5:35 a.m. - At 6:03 a.m., BP decreased to 155/87 mm/Hg. - At 6:33 a.m., BP increased to 180/133 mm/Hg. Entry made by LPN BB stated “will recheck elevated diastolic (bottom number)”. - At 6:36 a.m., BP decreased to 160/109 mm/Hg. LPN BB entered “BP improved, pt (patient) stable” - At 7:03 a.m., BP increased to 188/106 mm/Hg. LPN BB entered “Patient states no complaints at this time, pt denies distress”. - At 7:33 a.m., BP decreased to 180/93 mm/Hg. LPN BB entered “Patient awake; alert and states no complaints at this time, pt talking”. - At 8:03 a.m., BP increased to 196/97 mm/Hg. LPN BB entered “Patient appears to be tolerating treatment well at this time”. - At 8:30 a.m., BP increased to 218/90 mm/Hg. LPN BB entered “Will recheck BP; pt moving arm while taking”. - At 8:55 a.m., BP decreased to 200/106 mm/Hg. LPN BB entered “Treatment terminated.” - At 8:58 a.m., BP decreased to 201/90 mm/Hg. LPN BB entered “Patient awake; alert; and states no complaints at this time; pt denies all s/s (signs and symptoms) of HTN”. There was no documented evidence that LPN BB notified the RN and physician about high BP readings. This surveyor requested policy for hypertension and was provided with Policy 1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” dated April 2024. A review of this policy showed the following: Intradialytic Data Nursing Assessment 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. Abnormal Findings Blood Pressure: Pre Dialysis: - Systolic (top number) greater than 180 mm/Hg or less than 90 mm/Hg - Diastolic (bottom number) greater than or equal to 100 mm/Hg or less than 50 mm/Hg Blood Pressure-Intradialytic (during dialysis): - Systolic (top number) greater than 180 mm/Hg or less than 90 mm/Hg - Diastolic (bottom number) greater than or equal to 100 mm/Hg or less than 50 mm/Hg... During an interview on 10/1/24 at 5:15 p.m., the Facility Administrator was informed about the lack of interventions for patients who experienced hypertension on 10/1/24. The Facility Administrator indicated that the nurse had been going back and forth with the physician regarding hypertension. The Facility Administrator stated the patient was on a Clonidine patch, but patch was ineffective. Also stated staff received additional training on blood pressure monitoring, interventions, and reporting. An interview on 10/1/24 at 5:15 p.m. with the Charge nurse (CN) revealed that staff were to make sure BP was under 185/90 before patient left the facility and they tried not to dialyze patients with a SBP (systolic blood pressure) of 200.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 03383 Based on a review of facility records and staff interviews, it was determined that the Facility Administrator failed to ensure that the facility had sufficient qualified staff to meet the needs of all patients and provide safe patient care; and to be in compliance with the minimum state required staffing ratios of one licensed and qualified nurse for every 12 patients who were receiving dialysis care and one qualified dialysis care giver for every four patients. This deficient practice had the potential to negatively affect the health and safety of 38 patients who dialyzed at this facility. Findings were: A review of facility records revealed the following: On 9/16/24: - Patient Care Technician (PCT) EE was assigned to care for seven patients on the first shift; and five patients on the second shift. - Licensed Practical Nurse (LPN) BB was assigned to six patients on the first and second shifts. One of the patients had a central venous catheter (CVC - a thin, flexible tube that is inserted into a large vein used for dialysis and medications) access on the first shift and three of the patients had a CVC on the second shift. - RN II was assigned to three patients with a CVC patient on the first shift and one CVC patient on the second shift in addition to her charge nurse duties. - PCT GG did not show up for work on 9/16/24 as scheduled per Facility Administrator. A review of “Treatment Detail Reports” dated 9/16/24 revealed the following: - Monday, 9/16/24: Total census was 29 patients; First Shift Census: 17 and Second Shift Census: 12. - On the first shift, 13 of 17 patients (P) (P#2, P#4, P#5, P#6, P#7, P#8, P#9, P#13, P#18, P#19, P#23, P#24, and P# 26) had dialysis treatment started late and terminated late. - On the second shift, eight of 12 patients (P#3, P#10, P#11, P#15, P#21, P#25, P#27, and P#28) had dialysis treatment started late and terminated late. During an interview on 10/1/24 at 3:30 p.m., the Facility Administrator provided a copy of text messages to and from PCT GG from the Facility Administrator asking her to “Please get to clinic we are already short” and PCT GG responded that she could barely walk, “My whole body hurts, I am trying too”. The Facility Administrator stated the facility had two call outs on 9/16/24 and he was unable to find anyone else to come in. A staffing policy was requested from the Facility Administrator but was not provided during the survey.”