Davita Savannah Gateway Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 49321 Based on observations, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and a review of facility Policy and Procedures (P&P), it was determined that the Infection Control Committee failed to ensure that the staff practiced infection control techniques to prevent transmission of dangerous pathogens in the hemodialysis unit. This failure could lead to the transmission of dangerous bloodborne pathogens through cross contamination and had the potential to negatively affect the health and safety of 70 in-center hemodialysis patients who were receiving dialysis treatment at this facility. Findings include: Cross references: V113- Failure of Direct Patient Care Staff (Registered Nurses -RN AA and RN BB; Patient Care Technicians -PCT AA, and PCT DD), to wear gloves and perform hand hygiene (washed hands or used an alcohol-based hand sanitizer), after removal of contaminated gloves, between glove changes, and after touching contaminated equipment. V 122 - Failure of Direct Patient Care staff ( RN AA, RN BB, PCT AA, PCT BB, PCT CC, and PCT DD) to clean and disinfect surfaces that were contaminated with blood or body fluids; and surfaces that could become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients. V 126 - Failure of the Infection Control Committee to ensure that patients (P#2, P#4, and P#8), who were susceptible to Hepatitis B infection, were offered the Hepatitis vaccination; and PCT AA, who was susceptible to Hepatitis B infection, was tested for Hepatitis B surface antibody (HBsAb or anti-HBs - a blood test for susceptibility or immunity to Hepatitis B) upon hire, and was tested for Hepatitis B surface Antigen (HBsAg - a protein found on the surface of the hepatitis B virus), at least monthly; and was not assigned as a caregiver of a Hepatitis B infected patient, (P#11). V 128 - Failure of the Direct Patient Care staff, (RN BB and PCT AA ) to keep the isolation room door closed during initiation and discontinuation of hemodialysis treatment when there was a potential for splattering of blood, body fluids, and other contaminates.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 49321 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 three of three Patient Care Technicians (PCTs), (PCT AA, PCT BB, and PCT DD) observed, 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 eight of eight patients, (P), (P#9, P#10, P#11, P#12, P#13, P#14, P#15, and P#16), who were receiving hemodialysis treatment at Stations (S)1, S2, S5, S8, S10, S11 S15 and S16, at the time of 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. 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 70. Findings include: Cross Reference: 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: 49321 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 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 70 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross Reference: V 250 - Failure of three of three Patient Care Technicians (PCTs), (PCT AA, PCT BB, and PCT DD) observed, to accurately perform independent testing of the machine’s dialysate (a solution of pure water, electrolytes and minerals) 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.”

“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 guidelines, and a review of facility policies and procedures (P&P), it was determined that the Infection Control Committee implemented facility P&P for the prevention and control of infections as evidenced by failure of four of four Direct Patient Care Staff (Registered Nurses - RN AA and RN BB; and Patient Care Technicians - PCT AA and PCT DD) observed, to wear gloves, perform hand hygiene (washed hands or used an alcohol-based hand sanitizer), after removal of contaminated gloves, between glove changes, and after touching contaminated equipment. Additionally, seven of seven patients (P) (P#12, P#14, P#15, P#16, P#17, P#18 and P#19), who held pressure to their access sites for hemostasis (stopping of the flow of blood) after dialysis, performed hand hygiene after glove removal and prior to leaving the treatment room. 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. The facility census was 70. Findings include: During observation in the Patient Treatment Room on 3/5/25 between 5:00 a.m. and 7:05 a.m., and between 7:35 a.m. and 9:00 a.m., the following was revealed: - PCT AA was observed at Station (S)15 applying blood pressure (BP) cuff on P#10’s arm (dirty) without wearing a pair of gloves. Then without performing hand hygiene, PCT AA touched the keyboard (clean) to enter data. Then without performing hand hygiene, PCT AA proceeded to put on gloves to insert fistula needles on P#10’s arterio-venous-fistula (AVF- dialysis access). - PCT AA was observed at S2 touching the dialysis machine (dirty) without wearing gloves. PCT AA was also holding her personal cell phone in her hand. During an interview on 3/5/25 at 5:45 a.m., PCT AA was asked if she always worked at the patients’ stations without wearing gloves. PCT AA stated that the dialysis machines were not transmitting the vitials signs to the computer, so she had to take a picture with her phone and then manually input the information. PCT AA also stated that she did not realize she did not have gloves on. - RN AA was observed at S10 without wearing gloves, then she picked up P#12’s three blood collection tubes (dirty) and transported them to the laboratory station. Then without performing hand hygiene, RN AA put on gloves to assist with fistula needle insertion at S15. During an interview on 3/5/25 at 6:15 a.m., RN AA was asked if she realized she picked up the three blood collection tubes without gloves; and without performing hand hygiene before putting on a new pair of gloves to assist with needle insertion at S15. RN AA stated, she did not realize. - RN BB was observed going into the Isolation Room without wearing gloves, then she touched the dialysis machine (dirty), to reset P#11’s (Hepatitis B Virus positive patient), machine alarm. RN BB was wearing the same gown she was wearing in the treatment room (general patient population) when she entered the Isolation Room. When RN BB was about to step out of the Isolation Room, she saw this surveyor observing her. RN BB then removed her gown and left it inside the Isolation Room. RN BB walked out of the Isolation Room without performing hand hygiene. RN BB, then walked approximately 30 feet to wash her hands at the sink which was located next to the Medication Station. On 3/5/25 at 7:01a.m, RN BB was asked by this surveyor, why she did not wear gloves when touching the patient’s (P#11’s), machine in the Isolation Room and why she walked out without performing hand hygiene. RN AA stated that she was not paying attention and she did not know there was a sink in the Isolation Room. - PCT AA was observed going into the Isolation Room to silence P#11’s dialysis machine’s alarm . PCT AA touched the dialysis machine (dirty) without wearing gloves. PCT AA washed her hands before exiting the Isolation Room. During an interview on 3/5/25 at 7:37 a.m., PCT AA was notified of this breach in infection control. PCT AA stated, she was having a bad day. - PCT DD was observed at S11 touching the dialysis machine (dirty). Without removing dirty gloves and without performing hand hygiene, PCT DD touched the computer key board (clean), then she adjusted P#13’s BP cuff (dirty), and touched the dialysis machine (dirty) again. PCT DD removed her gloves, then without performing hand hygiene, PCT DD entered data in computer keyboard (clean) again. During an interview on 3/5/25 at 7:45 a.m., PCT DD was asked if the computer keyboard was considered dirty or clean. PCT DD stated, she did not know. PCT DD was then asked why she did not wash her hands or use the hand sanitizer after glove removal. PCT DD stated, she was not paying attention. - The patients (P#12, P#14, P#15, P#16, P#17, P#18 and P#19), who were seated at stations (S1, S5, S6, S8, S10, S12, and S16), held their access sites with one gloved hand until the bleeding stopped (hemostasis), then they discarded their gloves and proceeded to the weighing station, without performing hand hygiene. All seven patients touched the digital screen on the weighing scale and went out of the treatment room without performing hand hygiene. They were not offered a hand sanitizer nor were they reminded by all Direct Patient Care Staff (PCT AA, PCT BB, PCT CC, PCT DD, RN AA or RN BB) who were present during these observations, to wash their hands after glove removal and prior to leaving the treatment room. The digital screen on the weighing scale was not disinfected after each use. According to CDC recommendations, 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 Policy #1-05-01 titled, “Infection Control for Dialysis Facilities” with latest revision date of April 2023, showed the following: Hand Hygiene: 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene 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... g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse 2. Patients and caregivers will be encouraged to a. Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis. b. Perform hand hygiene after treatment before leaving the treatment area.”

“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: 49321 Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and a review of facility policies and procedures (P&P), 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 of two of two Registered Nurses (RNs), (RN AA and RN BB), and four of four Patient Care Technicians (PCTs) (PCT AA, PCT BB, PCT CC, and PCT DD), who were present during this observation, to immediately and thoroughly clean and disinfect surfaces contaminated with visible blood on five of 21 hemodialysis chairs, on the cover and outside of 10 of 12 sharps containers, six of six trolleys (used to roll/move sharps containers from one station to another station), and one of one canvas picture. Additionally, 10 of 18 dialysis wall boxes (frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water, and dispose of waste products) were cleaned and disinfected at least daily and more frequently (when visibly dirty). Dialysis wall boxes can become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients. This breach in infection control techniques had the potential for the transmission of dangerous pathogens through cross-contamination that could negatively affect the health and safety of 17 of 17 patients (P) (P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, P#22, P#23, P#24, P#25 and P#26), who were undergoing hemodialysis treatment at the time of this observation. The facility census was 70. Findings include: Hemodialysis Chairs: - On 3/4/25 at 10:30 a.m., the Isolation Room was empty. The Hepatitis B positive patient (P#11), was scheduled for treatment the following day, (3/5/25). This surveyor went into the Isolation Room and observed that the area towards the back end of the patient’s hemodialysis chair, (between the farthest left side wing of the armchair and farthest end of the hemodialysis chair’s seat), had small, blackish, round, dry pieces of substance at the crease and right above this crease was a light creamy-colored stain. - The Group Facility Administrator was notified of this observation on 3/4/25 at approximately 12:00 p.m., and she stated that she would have it cleaned. - On 3/5/25, between 7:00 a.m. and 7:30 a.m., the following hemodialysis chairs were observed to have dried blood: - Two hemodialysis chairs that were located in the hallway across from the Dietitian’s office, had dried splatters of dark red stains in between the seat and the backrest of these chairs. - The hemodialysis chair at S7 had four streaks of dried blood on the left side of the chair. - There was a hemodialysis chair inside the the facility’s conference room. There were long streaks of brownish substance on the right front side of the armchair. This surveyor wiped an area of this brownish substance with an alcohol pad. There was a reddish brown color on this alcohol pad after use. - The Manager of Clinical Services was notified of this observation on 3/5/25 at approximately 3:00 p.m. During observation in the Patient Treatment Room on 3/5/25 between 5:00 a.m. and 7:05 a.m., and between 7:35 a.m. and 9:00 a.m., the following was revealed: Sharps Containers and Trolleys: There were 10 medium sharps containers in trolleys that were located in the following areas: - one sharps container on a trolley in the Isolation Room - two sharps containers on a trolley in front of S3 and S4 - one sharps container on a trolley in front of S7 and S8 - two sharps containers on a trolley accross from dirty sink #1 - four sharps containers on two trolleys in front of S11 and S12 - There were two or more splattered blood and approximately 2-5 centimeters (cm) of dried drops of blood on the trolleys. - There were small splattered blood (different sizes and shapes) and droplets of dried blood on the tops and sides of the above-mentioned sharps containers. - These sharps containers and trolleys were not cleaned and disinfected between patient use. - During an interview with PCT AA on 3/5/25 at 6:00 a.m., she stated that sharps containers were wiped down at the end of the day. - During an interview with PCT BB on 3/5/25 at 6: 30a.m., she stated that the sharps containers or trolleys were never wiped down. - During an interview with PCT CC on 3/5/25 at 7:00 a.m., she stated that sharps containers should be wiped down at the end of the day. - During an interview with RN AA on 3/5/25 at 7:05 a.m., she stated that the sharps containers should be wiped down after each patient’s use, and the trolleys were to be wiped down at the end of the treatment day. Canvas picture: - At the wall in front of S2, was a canvas picture. There were two round stains, approximately 2 cm in diameter at the bottom right side of this picture. This surveyor wiped one of the stains with an alcohol pad and the alcohol pad had a brownish-red color after use. - During a telephonic interview with P#10 on 3/6/25 at approximately 10:00 a.m., P#10 stated that he used to sit at S2. About six months ago, he saw two drops of blood on the bottom right corner of the canvas picture. He further stated that a staff member was carrying used bloodlines and dialyzer and disposed them at the biohazard box that was located against the wall, under the canvas picture. He further explained that two drops of blood ended at the lower end of the canvas picture and he had seen the same dried drop of blood since then. Dialysis Wall Boxes: - There were white residue inside the dialysis wall boxes and thick dried sediment on the black thick hoses that was connected to the wall boxes and the machines, located at S1, S2, S5, S6, S7, S11, S14, S16, S17, and S18. According to CDC guidelines, failure in environmental cleaning and disinfection has led to the 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 floor, sharps containers, patients’ chairs or bed surfaces, dialysis equipment surfaces, etc., especially with blood splatters) must be performed between patient use to prevent transmission of dangerous pathogens. A review of facility Policy # 1-05-01, titled, “Infection Control for Dialysis Facilities”, revised 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 (i.e. used or brought into the stations) and prior to returning to clean/designated area or removal from treatment area. iii. Cleaning of visible blood should be performed when first observed. According to CDC, there are several infection prevention and control issues unique to wall boxes. They can become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients, a vulnerable group at high risk of infection. Thus, wall boxes need to be cleaned, disinfected, and properly maintained to decrease risk of patient infections. Wall box surfaces should be disinfected at least daily (at the end of the day after all patients have dialyzed); cleaning and disinfection might be needed more frequently (when visibly dirty). Wall boxes contributed to a large number of infections in patients on dialysis in “Multicenter Outbreak of Gram-Negative Bloodstream Infections in Hemodialysis Patients”. - The Group Facility Administratior was notified of the above findings on 3/5/24 at 9:00 a.m. - On 3/6/25 at approximately 9:00 a.m., this surveyor went back to check if the blood drops/splatters mentioned above had been cleaned off . However, the blood splatters/ blood drops had not been cleaned off. - The Group Facility Administrator was again notified of the above findings on 3/6/25 at 12:00 p.m., during the exit interview.”

“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: 49321 Based on a review of facility records, staff interview, a review of the Centers for Disease Control and Prevention (CDC) recommendations, and a review of OSHA (Occupational Safety and Health Administration - responsible for ensuring safe and healthy working conditions for employees) requirements, it was determined that the Infection Control Committee failed to ensure that three of eight patients (P) (P#2, P#4, and P#8) sampled, 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); and one of one Patient Care Technician (PCT AA) sampled, who was susceptible to Hepatitis B infection, was tested for Hepatitis B surface Antibody (HBsAb or anti-HBs - a test for Hepatitis B susceptibility or immunity) upon hire; was tested for Hepatitis B surface Antigen (HBsAg - a protein found on the surface of the hepatitis B virus), at least monthly; and was not assigned as a caregiver of a Hepatitis B infected patient, (P#11). This failure could lead to the transmission of dangerous bloodborne pathogens through cross contamination and had the potential to negatively affect the health and safety of (P#2, P#4, and P#8) and PCT AA and all susceptible Direct Patient Care Staff (nurses and PCTs), and other susceptible patients. Findings include: A positive HBsAb or anti-HBs test result (10 or greater) indicates that a person has developed immunity to the Hepatitis B virus, 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#2 was tested for HBsAb on 1/18/25, with 7 mIU/mL (milli-international units per milliliter) result. - P#4 was tested for HBsAb on 1/18/25 with a 4 mIU/mL result. - P#8 was tested for HBsAb on 1/20/25 with a 5 mIU/mLresult. There were no documentary evidences that P#2, P#4 and P#8 were offered nor received the Hepatitis B vaccine and there were no documentary evidences that all three patients declined 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 PCT AA’s personnel file revealed that she was hired at this facility on 7/29/25. Her HBsAb test was done on 11/14/24 (greater than three months after hire), and the result was 3 mIU/mL (susceptible). - PCT AA signed a declination form for Hepatitis B vaccination on 2/6/25 (greater than two months since the result of her HBsAb). - There was no documentary evidence that PCT AA was tested for HBsAg, at least monthly. - There was no documentary evidence that PCT AA had prior Hepatitis B vaccinations, nor prior HBsAb and HBsAg tests. - PCT AA was assigned as direct caregiver to P#11 at the Isolation Room on 3/5/25, and at least the last four successive weeks. For additional information, please review the following cross references: V113- Failure of Direct Patient Care Staff (Registered Nurses -RN AA and RN BB; Patient Care Technicians -PCT AA, and PCT DD), to wear gloves and perform hand hygiene (washed hands or used an alcohol-based hand sanitizer), after removal of contaminated gloves, between glove changes, and after touching contaminated equipment. V 128 - Failure of the Direct Patient Care staff, (RN BB and PCT AA ) to close the door of the isolation room during initiation and discontinuation of hemodialysis treatment when there was a potential for splattering of blood, body fluids, and other contaminates. - During an interview with PCT AA on 3/5/25 at approximately 11:00 a.m., PCT AA stated that she just worked where she was assigned to work at (whichever patient stations, including the Isolation Room) and did what she was told to do. - A review of Policy: 4-06-03, titled, “Teammate Hepatitis B Monitoring and Follow-Up Guidance”, with latest revision date of April 2024, stated: Acceptable documentation of anti-HB titers will be either a copy of: 1. An official laboratory results. 2. Or a prior employer’s health monitor form. Documentation must contain testing dates and NUMERIC titer results. Results documented as only positive will not be accepted. - According to the CDC, dialysis staff susceptible to Hepatitis B should be screened monthly for HBsAg to detect early seroconversion (development of HBV infection) so that appropriate isolation procedures can be implemented to prevent transmission to other patients and staff. The CDC also recommends that dialysis staff susceptible to Hepatitis B should not be assigned as direct caregivers to Hepatitis-infected patients to prevent transmission. - According to OSHA, facilities are required to maintain a record of their employee’s Hepatitis B immunization history and to contact past employers to obtain records of vaccination, if applicable. Patient medical and personnel records respectively must show whether susceptible patients and staff are offered Hepatitis B vaccination. There must be a system in place to track vaccination administration to assure completion of the ordered course. Since patients and staff have the right to refuse a vaccination, this rule is interpreted to mean that all susceptible patients and staff are “offered” an appropriate Hepatitis B vaccination schedule in an appropriate timeframe. “Appropriate timeframe” means that vaccinations should be offered and initiated at hire for employees and upon admission or earlier for patients, and the course completed according to the timeline suggested by the manufacturer of the vaccine. - The Group Facility Administrator and Manager of Clinical Services were informed of the above findings on 3/6/25 at 12:00 p.m. The Group Facility Administrator responded, we will work on it.”

“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, staff interviews and a review of facility policies and procedures (P&P), 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 of Registered Nurse (RN BB) and Patient Care Technician (PCT AA) observed, to ensure that the isolation room door remained closed during initiation and termination of hemodialysis treatment of P#11, who had Hepatitis B (a highly infectious disease of the liver caused by the hepatitis B virus, and transmitted from person to person through blood and other body fluids), to prevent possible splatters of blood, body fluids, and other contaminates and to prevent cross contamination to the areas outside of the isolation room. This deficient practice had the potential to negatively affect the health and safety of 17 of 17 patients (P) (P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, P#22, P#23, P#24, P#25 and P#26), who were undergoing hemodialysis treatment at the time of this observation, and six of six Direct Patient Care Staff (Registered Nurses - RN AA and RN BB and Patient Care Technicians (PCTs) (PCT AA, PCT BB, PCT CC, and PCT DD), who were present during this observation. The facility had a census of 70. Findings include: During an observation in the Patient Treatment Room on 3/5/25 between 5:00 a.m. and 7:05 a.m., and between 7:35 a.m. and 9:00 a.m., the following was revealed: - During initiation and termination of P#11’s hemodialysis treatment by PCT AA, the Isolation Room door remained open. - During an interview with RN BB on 3/5/25 at 7:15 a.m., RN BB stated, the isolation room door was always propped open. No one told her that the door had to be closed during initiation and termination of hemodialysis treatment. - During an interview with PCT AA on 3/5/25 at 8:45 a.m., PCT AA stated, no one ever told her the isolation room door had to be closed. It had always remained open. - The Group Facility Administrator was notified of the above findings on 3/5/25 at 9:00 a.m. A review of facility Policy # 1- 05 -02, titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance”, last revised April 2024, stated: 15. CONFIRMED POSITIVE: ii When using a designated isolation room, a door is required to the isolation room and it must be closed during times when spurting or splattering of blood is possible, for example at initiation and termination of treatment.”

“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: 49321 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 three of three Patient Care Technicians (PCTs), (PCT AA, PCT BB, and PCT DD) observed, 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 eight of eight patients, (P), (P#9, P#10, P#11, P#12, P#13, P#14, P#15, and P#16), who were receiving hemodialysis treatment at Stations (S)1, S2, S5, S8, S10, S11 S15 and S16, at the time of 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. 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 70. Findings include: During observation in the Patient Treatment Room on 3/5/25 between 6:00 a.m. and 9:00 a.m., the following was observed: - PCT AA was observed testing the machine’s dialysate pH and conductivity at S15. PCT AA poured the dialysate sample into the Myron-L Meter cell cup, then pressed the black button and documented the conductivity result. PCT AA dipped the pH test strip (RPC K100 - 0117 CT E-Z pH test strip), into the dialysate sample, then immediately compared the test strip color to the color chart on the test strip bottle. During an interview on 3/5/25 at 06:15 a.m., PCT AA was asked what the procedure was for verifying the pH and conductivity of the dialysate. PCT AA confirmed the steps mentioned in the above observation. - PCT BB was observed as she verified the machine’s dialysate pH and conductivity at S10. PCT BB obtained the dialysate sample from the blue Hansen connector (used on the venous [return] side of the dialysis fluid lines), using a medication cup. She then poured the dialysate sample into the Myron-L Meter cell cup, inserted the plunger, then pressed the black button, and documented her conductivity reading. PCT BB did not verify the machine’s dialysate pH. During an interview on 3/8/25 at 06:45 a.m., PCT BB was asked how many times should the Myron-L Meter be rinsed with dialysate before reading the conductivity result. PCT BB stated that she was trained to pour the dialysate sample into the Myron-L Meter cell cup, then read the conductivity result. PCT BB also acknowledged that sometimes, she forgot to independently test the dialysate pH using the RPC strips. Instead, she just documented the pH displayed on the dialysis machine screen. It was later verified by this surveyor that there was no pH self test for the Fresenius 2008K2 machines that this facility were using. -PCT DD was observed verifying the machine’s dialysate pH and conductivity at S13. PCT DD obtained the dailysate sample using two (30 milliLiters) medication cups. PCT DD poured the dialysate sample from medication cup #1 into the Myron-L Meter cell cup, pressed the black button and immediately read the conductivity result. PCT DD then proceeded to test the machine’s dialysate pH using RPC K100 - 0117 CT E-Z pH test strip. PCT DD submerged the test strip into the dialysate sample in medication cup #2 for 15 seconds, then removed the strip and immediately compared the color of the test strip to the color chart in the test strip bottle. During an interview with PCT DD on 3/5/25 at 7:15 a.m., PCT DD was asked what the procedure was for verifying the pH of the machine’s dialysate. PCT DD stated that they were just trained and she was told to submerge the strip for 5-10 seconds, then immediately read the results. PCT DD also stated that she was taught to pour the dialysate sample into the Myron-L cell cup one time, then read the conductivity result. 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: 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.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 49321 Based on a review of personnel files and staff interview, it was determined that the facility failed to ensure that one of one Biomedical Technician (BMT AA) sampled, had a current annual Water, Dialysate, and Machine competency skills checklist completed. Findings include: - During a review of personnel files, it was revealed that BMT AA’s last Water, Dialysate, and Machine competency skills checklist was completed on 2/28/2024. - During an interview with BMT AA on 3/6/25 at 11:00 a.m., BMT AA stated that the water, dialysate, machine competency skills class was not due until 3/15/25. He also added that his boss was responsible for conducting the class or training. The Facility Administrator was notified of the above findings on 3/6/25 at 11:30 a. m., and she stated that the hurricane and the snow storm put everything behind.”

“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: 49321 Based on observation and staff interview, it was determined that the facility failed to ensure that the building in which dialysis services were provided, was clean and maintained free from trash, damage and defects 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 Patient Treatment Room. The facility census was 70. Findings include: During a tour of the facility with the Group Facility Administrator on 3/4/25 between 10:00 a.m. and 10:30 a.m., the following was observed: In the Dialysate Preparation Room: - The floor around the Bicarbonate Mixing Tank #1 and Bicarbonate Mixing Tank #2, was covered with a dry, white, powdery substance and scattered on top of the white, powdery substance on the floor behind Bicarbonate Mixing Tank #2, were old, used residual chlorine strips (used to ensure chlorine bleach, used for disinfecting equipment, has been adequately rinsed off to prevent harmful patient exposure). - The two ports used to drain the bicabonate solution was covered with a thick, white crystalized substance. - There were two pallets on the floor next to the two Bicarb Tanks. On the bottom decks of the two pallets, the space between the deck boards, were covered with leaves, dirt, and dust particles. - There was a thick layer of white, crystalized substance that covered the floor under and around the Acid Holding Tank. - There was a thick, white, flaky substance that covered the top and the base of the Acid Mixer. - The inside part of the clear tubing that was used to transfer the mixed acid to the Acid Holding Tank, was coated with a dark brown substance. The silver hose clamp on the tubing was covered with a fuzzy, blackish brown substance. - There were thick cobwebs that covered above the Multi Media Tank. The floor around the Multi Media Tank, was covered with dirt and dust particles. - The floor drain on the left side of the Central Water Processing System and the floor drain under the Deionization (DI) Resistivity Sign, were covered with a fuzzy, blackish brown substance. In the Patient Treatment Room: - The floor from the Medication Preparation Station all the way to patient Station (S) (S5), was covered with a thick, white film. - The floor in front of patient S14 all the way to S10, was also covered in a thick white film. - The wall next to Station 15 was splattered with a dark brown substance. - The exit door leading to the outside (close to the Dietitian’s office), had a wide gap (approximately 1.5 inches) from the floor, allowing light to come in from under the door. This had the potential for insects and rodents to come through the gap. - The middle part of the bulletin board in front of the patients’ scale had brownish streaks from top to bottom. - The P- trap (connects the tailpiece at the sink end and drain line) under the sink at the laboratory (lab) station had a thick streak of brown substance on it. - The plastic material that covered the P-trap under the patients’ handwashing sink by the patient’s weighing scale, had streaks of light brown substance. - Scattered on the floor of the Isolation Room, in front of S11 and S12, in front of the medication station, around the patients’ scale and infront of the lab station, were small pieces of papers/trash. The Group Facility Administrator acknowledged all of the above findings on 3/4/25 at 11:00 a. m.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 49321 Based on a review of medical records, staff interviews, and review of facility Policy and Procedures (P&P), it was determined that the Medical Director (MD) failed to ensure that one of one patient (P), (P#4) sampled, who experienced elevated blood pressure (BP) readings, received medical care/interventions appropriate to P#1’s dialysis needs. The professionally accepted clinical practice standards for volume status for an adult hemodialysis patient was euvolemic (normal volume of blood or fluids in the body) and BP below 140/90 mmHg (millimeters of mercury) before dialysis and below 130/80 mmHg after dialysis. This was based on the Kidney Disease Outcomes Quality Initiative (KDOQI) recommendations and the Measures Assessment Tool (MAT) per Centers for Medicare and Medicaid Services (CMS) - Version 2.5. Uncontrolled BP in dialysis patients can lead to severe consequences such as increased risk of heart attack, stroke, and heart failure, as the damaged kidneys are unable to regulate fluid and BP effectively, making cardiovascular complications a major concern for dialysis patients. The facility census was 70. Findings include: A review of P#4’s “Treatment Details Report”, from 2/18/25 to 2/27/25 revealed the following: - On 2/18/25, P#4’s pre-treatment BP was 163/109 mmHg and pre-treatment assessment was performed by Registered Nurse (RN AA). - At 5:59 a.m., P#4’s Hemodialysis (HD) treatment was started by Patient Care Technician (PCT CC), with BP reading of 155/106 mmHg. - At 6:29 a.m., BP was 174/110 mmHg - At 7:06 a.m., BP was 186/114 mmHg - At 7:29 a.m., BP was 197/107 mmHg - At 7:31 a.m., BP was 184/101 mmHg - At 7:59 a.m., BP was 200/111 mmHg - Post-treatment standing BP was 172/103 mmHg. P#4 was discharged to home. Throughout P#4’s HD treatment, there was no documentary evidence that RN AA was notified by PCT CC of P#4’s high BP readings, no documentary evidence that the physician was notified, nor any documentary evidence if RN AA offered P#4, Clonidine (for high BP) 0.1 milligram (mg), every six hours orally, as needed (PRN), per doctor’s standing order for high BP. In addition, the doctor’s standing order did not have specific systolic/diastolic BP parameters for PRN clonidine. - On 2/27/25, P#4’s pre-treatment standing BP was 169/105 mmHg. Pre-treatment assessment was performed by Licensed Practical Nurse (LPN AA), with no mention of P#4’s high diastolic BP reading. - P#4’s treatment was started at 5:55 a.m., by PCT EE with BP reading of 164/104 mmHg. - At 6:30 a.m., BP was 167/105 mmHg - At 07:00 a.m., BP was 172/108 mmHg - Between 7:00 a.m. and 8:30 a.m., there were no vital signs recorded, nor 30-minute check/monitoring by PCT EE or by LPN AA (nor other PCTs and licensed nurses). - At 8:30 a.m., BP was 172/108 mmHg - P#4’s standing post BP reading was 169/105 mmHg. P#4 was discharged to home. Throughout P#4’s HD treatment, there was no documentation if LPN AA was notified by PCT EE of P#4’s high diastolic BP readings or if any assessment/intervention was offered by a licensed nurse. - During an interview on 3/5/25 at 12:36 p.m., RN AA was asked how high BP readings were handled. RN AA stated that the PCTs were supposed to notifiy the nurse of elevated BP readings. RN AA also added that no one notified her of P#4’s high BP readings, as mentioned in the above findings. During an interview on 3/6/25 at 7:46 a.m., PCT CC stated that she was aware of the policy for monitoring patients’ BP readings, but sometimes she forgot to notify the nurse. During an interview on 3/6/25 at 7:54 a.m., PCT EE stated that if a patient’s BP reading was high, she would re-adjust the BP cuff because a loosed BP cuff could be the reason why the BP reading was high. PCT EE also added that she forgot sometimes to notify the nurse when a patient’s BP readings were abnormal. A review of Policy #1-03-08, titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, last revised April 2024, stated: PRE-TREATMENT DATA COLLECTION ASSESSMENT 4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse... ABNORMAL FINDINGS ... Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Blood Pressure: Pre-dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Blood Pressure-Intradialytic: Systolic greater than 180 mm/Hg or less than 90 mm/Hg Diastolic greater than or equal to equal to 100 mm/Hg or less than 50 mm/Hg Blood Pressure Post Treatment: If the patient can stand: Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg. Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg. INTRADIALYTIC DATA COLLECTION/ASSESSMENT: 9. Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: a. Vital signs and treatment monitoring iii. Non-nocturnal treatments are completed at least every thirty (30) minutes... b. At a minimum, obtain and document the following: i. Blood pressure ii. Heart or pulse rate iii. Blood and dialysate flows, arterial and venous pressures iv. Fluid removal and/or replacement v. Vascular access visible and line connections intact vi. Patient subjective statement(s) i.e. patient report on overall health, any complaints...”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 49321 Based on a review of Fiscal Year (FY) 2025 Quarterly Dialysis Facility Report (QDFR: A report prepared by the Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients of this facility, as compared to other facilities in the U.S.), a review of facility records, and staff interview, it was determined that the Quality Assessment and Performance Improvement (QAPI) Committee failed to track and trend, perform root cause analysis, develop and implement plans of action, evaluate its effectiveness and make changes to plans of action if necessary, to improve and sustain patient outcomes for dialysis adequacy (the effectiveness of dialysis treatment in removing waste products and toxins from the blood in patients with kidney failure, measured by Kt/V - a clinical metric used to assess the adequacy of dialysis treatments) and anemia outcomes specifically, management of patients with Hemoglobin (Hgb - Protein in red blood cells that carries oxygen throughout the body) less than (<) 10 grams per deciliter (g/dL) for in-center hemodialysis (ICHD) patients, in six of six months (August 2024 - January 2025) of QAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the health and safety of 70 ICHD patients who were receiving dialysis services at this facility. Findings include: 1. Anemia: - A review of FY 2025 QDFR revealed that Hgb <10 g/dL should not exceed 23.4 %, the United States (US) national threshold. In comparison, the facility’s FY 2025 QDFR revealed that ICHD patients who had Hemoglobin <10 g/dL was 33.1%. - A review of the facility’s QAPI meeting minutes from (August 2024 - January 2025), revealed the following percentages of patients with Hemoglobin <10 g/dL: August - 50.7% September - 52.2 % October - 46.6 % November - 28.6% December - 33.8% January - 41.3% 2. Adequacy: - A review of FY 2025 QDFR revealed that the national US threshold for Kt/V <1.2 should not exceed 1.5% for ICHD hemodialysis patients. In comparison, the facility’s FY 2025 QDFR revealed that ICHD patients who had Kt/V < 1.2 was 8.4 %. - A review of the facility’s QAPI meeting minutes from (August 2024 - January 2025) revealed the following percentages of patients with Kt/V < 1.2: August - 9% September- 8 % October - 11 % November- 15 % December - 8 % January - 22 % There was a lack of documentary evidence that the Interdisciplinary Team (IDT) or QAPI Committee tracked and trended anemia and adequacy outcomes, performed root cause analysis, developed and implemented action plans, evaluated its effectiveness or changed action plans to improve and sustain patient outcomes. The Group Facility Administrator stated on 3/6/25 at approximately 12:00 p.m., that the Facility Administrator had resigned but the IDT will work towards improvements.”