Siouxland Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 44475 Based on review of policies, medical records, observation, and interviews the End Stage Renal Disease (ESRD) facility failed to: 1.Ensure hand hygiene was performed before staff donned gloves prior administering medication for 1 of 1 observation of medication administration. (Refer to V 113) 2.Ensure the dialysis station was disinfected for 1 of 2 observations. (Refer to V122) 3. Ensure all patients were screened appropriate for medical conditions, including accurately screening for HBV (Hepatitis B Virus) prior to admission. (Refer to V124) 4. Ensure while a HBV+ (Hepatitis B Virus Positive meaning the patient has tested positive for the presence of hepatitis B surface antigen; HBsAg [Hepatitis B surface antigen] positive) patient was on census at the facility receiving dialysis treatments in the isolation room, that the isolation room was dedicated only for the HBV+ patient dialysis treatments and not used for HBV- (meaning the patient does not have the Hepatitis B surface antigen; HBsAg negative) patients on other shifts or days. (Refer to V 128) 5. Separately dedicate machines, equipment, instruments, and supplies to a HBV+ (Hepatitis B Virus positive [Patients who are infected with the Hepatitis B virus]) patient. (Refer to V 130) 6. Ensure that staff caring for a HBsAg (Hepatitis B surface antigen) positive patient did not care for HBV (Hepatitis B Virus) susceptible patients at the same time in accordance with the facility’s policy. (Refer to V 131) 7. Ensure that clinical staff demonstrate aseptic technique when dispensing and administering intravenous medications for 1 of 1 medication administration observations. (Refer to V143) 8. Contact appropriate state or local public health authorities regarding the potential exposure of a communicable disease (hepatitis B virus) to susceptible patients at the facility. (Refer to V145) 9. Ensure that central venous catheter dressing (CVC) changes are performed as ordered for 1 of 7 patients reviewed with CVCs. (Refer to V 147) The facility reported a census of 122 hemodialysis patients at the time of the survey. The cumulative effect of these systemic failures and deficient practices in infection control resulted in the facility’s inability to ensure the safe provision of care to the ESRD (End Stage Renal Disease) 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: 44475 Based on observation, policy, and staff interview, the facility failed to ensure hand hygiene was performed before staff donned gloves prior administering medication for 1 of 1 observation of medication administration. The End Stage Renal Disease (ESRD) facility reported a census of 122 in center hemodialysis patients at the time of the survey. Findings include: The “Hand Hygiene” policy dated 11/6/23 directed, in part, that the purpose of this policy is to prevent transmission of pathogenic microorganisms to patient and staff through cross contamination. All staff must follow the same requirements for hand hygiene. Hand hygiene shall be performed using alcohol-based hand rub or by washing hands with antimicrobial soap and water before direct contact with patients and before performing any invasive procedure such as administration of parental medications. The Medication Preparation and Administration Procedure” policy dated 8/30/24 directed, in part, that the purpose of the policy is to provide direction for safely, therapeutically, and aseptically administering medication. The medication administration procedure directed staff to wash and apply PPE (personal protective equipment) before taking the medication to the patient ’ s chair. In an observation on 11/10/25 at 1:26 PM, Staff A, Registered Nurse (RN) administered venofer (intravenous iron medication) via IV (intravenous) administration. Staff A did not perform hand hygiene before putting on gloves prior to administrating the medication. In an interview on 11/13/25 at 4:08 PM, the Facility Administrator (FA) reported that she will audit the hand hygiene process to ensure staff are performing hand hygiene before putting gloves on.”

“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: 44475 Based on observation, policy, and staff interview, the facility failed to ensure the dialysis station was disinfected for 1 of 2 observations. The End Stage Renal Disease (ESRD) facility reported a census of 122 in center hemodialysis patients at the time of the survey. Findings include: The “Cleaning and Disinfecting the Dialysis Station” policy dated 9/2/25 directed, in part, that the purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair is used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses. Also, the nature of dialysis treatments with frequent exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients made dialysis a high risk area for spreading infectious disease. The dialysis station is defined as an area including the chair/bed utilized during dialysis treatment. The dialysis station could become contaminated with blood and other body fluids during treatment. After use, any non-disposable equipment and supplies brought into the dialysis station must be disinfected with 1:100 bleach or EPA (Environmental Protection Agency) registered disinfectant before being removed from the dialysis station. In an observation on 11/10/25 at 1:35 PM, Staff B, Patient Care Technician (PCT) did not disinfect the slide out footrest part of the patient chair that protrudes from the bottom of the chair. In an interview on 11/13/25 at 4:08 PM, the Facility Administrator (FA) reported that the slide out footrest part of the patient chair should be disinfected as part of the treatment station disinfection process”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 34810 Based on Review of facility policy, patient records, and interviews, the facility failed to ensure all patients were screened appropriately for medical conditions, including accurately screening for HBV (Hepatitis B Virus) prior to admission. Hepatitis B is a liver disease that results from infection with the Hepatitis B virus (HBV). The spread of hepatitis B can occur through contact with infected blood or other body fluids or through contact with the hands, surfaces, equipment, or supplies contaminated with the hepatitis B virus. Hepatitis B virus is a concern in a dialysis facility where exposure to blood and body fluids could potentially occur. Failure to accurately screen patients for HBV prior to admission could lead to staff failing to implement HBV+ (Hepatitis B Virus Positive [patients who have the Hepatitis B infection]) policies to isolate the patient in an isolation room to prevent exposure of the Hepatitis B virus to other patients. This could potentially result in other patients becoming infected with the hepatitis B virus. At the time of the survey, the facility staff reported a hemodialysis patient census of 122. Findings for 1 of 1 Patient (Patient #1) admitted to the facility with an active HBV infection include: 1. Review of the facility policy titled, “Patient Admission”, with a published date of 5/5/25 included in part, “ ...To guide facility management on the admission process for all patients being admitted to an FKC dialysis facility ...This policy applies to New Patients, Transfer Patients or Transient Patients ...At a minimum, the required documents to admit a patient include ...History and Physical or nephrology consult note or discharge summary or the most recent physician progress note ...Hepatitis B panel (HBsAg, anti-HBs, anti-HBc) ...” 2. Review of the Facility policy titled, “Dialyzing Patients with Positive Hepatitis B Antigen”, with a published date of 6/4/25, included in part, “...Purpose To prevent transmission of Hepatitis B ...all patients with hepatitis B infection (hepatitis B surface antigen positive (HBsAg+) treated in the dialysis facility require additional infection control precautions as outlined in this policy ...Caring for HBsAg positive patients requires adherence to strict guidelines. The hepatitis B virus is highly infectious because the concentration of virus particles in the blood is very high and the hepatitis B virus can live outside the body on surfaces for at least 7 (seven) days. Outbreaks of hepatitis B have been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not been vaccinated for hepatitis B ...Ensure that staff caring for HBsAg positive patients care only for HBV antibody positive (immune) patients at the same time ...Staff having any contact with the HBsAg positive patient must at the same time have NO contact with susceptible patients ...All patients who are HBsAg positive must dialyze under isolation precautions ...Patients that are HBsAg positive must dialyze in the separate room ...If there are current HBsAg positive patients on census, the isolation area/room and equipment cannot be used for HBV (Hepatitis B Virus) negative patients on other shifts or days due to the risk of cross-contamination ...Separated dedicated supplies and equipment ...must be used to provide care to the HBsAg positive patient ...” 3. Review of Patient #1’s hospital medical record showed that Patient #1 tested Reactive to the Hepatitis B surface Antigen (indicating an active Hepatitis B infection) on 10/7/2025 (8 days prior to admission to the outpatient dialysis facility). Closer review of Patient #1’s medical record showed that Patient #1 was admitted to the dialysis facility on 10/13/25. Upon Patient #1’s admission to the facility (10/13/25), the dialysis facility staff obtained blood tests for Hepatitis B infection with a result of HBsAg positive (indicating an active hepatitis B infection). Closer review of Medical records showed the facility placed Patient #1 at station #11 (located in the main treatment area) for the first dialysis treatment on 10/13/25 instead of the isolation room. 4. During an interview on 11/04/2025 at 11:13 AM, the Facility Administrator (FA) reported the facility misinterpreted Patient #1’s hepatitis lab studies from the hospital test completed on 10/7/25 and placed Patient #1 on the main treatment floor among other patients instead of in the isolation room. The FA (Facility Administrator) went on to report Patient #1 was treated as a patient without an active Hepatitis B infection because the test results were misinterpreted that way. The FA reported that when it was discovered that Patient #1 was HBV+, Patient #1 was moved to the facility isolation room beginning on 10/15/25 and every treatment thereafter. The FA reported that Patient #1 received a full dialysis treatment in the main treatment area among other patients on 10/13/25 and should have been placed in the isolation room. 5. In an interview on 11/13/25 at 8:51 AM, PCT (Patient Care Technician) C reported he treated Patient #1 at admission on 10/13/25. PCT C reported Patient #1 was not treated in the isolation room. PCT C reported that he did not know Patient #1 was HBV+ and would have liked to know that before treating the patient. PCT C reported that HBV+ patients are not to be treated in the main treatment area among other patients. 6. During an interview on 11/13/25 at 9:00 AM the Medical Director reported that he would not expect HBV+ patients to be dialyzed in the main treatment area and the expectation is that policies were to be followed regarding the situation.”

“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: 34810 Based on policy review, medical records, and staff interview, the facility staff failed to ensure while a HBV+ (Hepatitis B Virus Positive meaning the patient has tested positive for the presence of hepatitis B surface antigen; HBsAg [Hepatitis B surface antigen] positive) patient was on census at the facility receiving dialysis treatments in the isolation room, that the isolation room was dedicated only for the HBV+ patient dialysis treatments and not used for HBV- (meaning the patient does not have the Hepatitis B surface antigen; HBsAg negative) patients on other shifts or days. Failure to dedicate the isolation room for only the HBV+ patient’s dialysis treatments, while the HBV+ patient was on the facility’s census receiving treatments in the facility, and not use the isolation room for HBV- patients puts the patients at risk for cross-contamination with the Hepatitis B virus and could potentially result in patients becoming infected with the hepatitis B virus. Hepatitis B virus infection/disease can lead to a serious, lifelong illness that can result in long-term health problems and even death. At the time of the survey, the facility staff reported a hemodialysis patient census of 122. Findings for 1 of 1 isolation room and for 4 of 4 HBV- patients (Patient #5, Patient #7, Patient #8, and Patient #10) that dialyzed in the isolation room while the facility had a HBV+ patient (Patient #1) on the facility’s census receiving dialysis treatments in the facility’s isolation room include: 1. Review of the facility policy titled, “Patient Admission”, with a published date of 5/5/25 included in part, “ ...To guide facility management on the admission process for all patients being admitted to an FKC dialysis facility ...This policy applies to New Patients, Transfer Patients or Transient Patients ...At a minimum, the required documents to admit a patient include ...History and Physical or nephrology consult note or discharge summary or the most recent physician progress note ...Hepatitis B panel (HBsAg, anti-HBs, anti-HBc) ...” 2. Review of the Facility policy titled, “Dialyzing Patients with Positive Hepatitis B Antigen”, with a published date of 6/4/25, included in part, “...Purpose To prevent transmission of Hepatitis B ...all patients with hepatitis B infection (hepatitis B surface antigen positive (HBsAg+) treated in the dialysis facility require additional infection control precautions as outlined in this policy ...Caring for HBsAg positive patients requires adherence to strict guidelines. The hepatitis B virus is highly infectious because the concentration of virus particles in the blood is very high and the hepatitis B virus can live outside the body on surfaces for at least 7 (seven) days. Outbreaks of hepatitis B have been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not been vaccinated for hepatitis B ...Ensure that staff caring for HBsAg positive patients care only for HBV antibody positive (immune) patients at the same time ...Staff having any contact with the HBsAg positive patient must at the same time have NO contact with susceptible patients ...All patients who are HBsAg positive must dialyze under isolation precautions ...Patients that are HBsAg positive must dialyze in the separate room ...If there are current HBsAg positive patients on census, the isolation area/room and equipment cannot be used for HBV (Hepatitis B Virus) negative patients on other shifts or days due to the risk of cross-contamination ...Separated dedicated supplies and equipment ...must be used to provide care to the HBsAg positive patient ...” 3. Review of Patient #1’s hospital medical record showed that Patient #1 tested reactive to the Hepatitis B surface Antigen (indicating an active Hepatitis B infection) on 10/7/2025, 8 days prior to admission to the facility. Closer review of Patient #1’s medical record showed that Patient #1 was admitted to the dialysis facility on 10/13/15. Upon Patient #1’s admission to the facility (10/13/25), the dialysis facility obtained blood tests for Hepatitis B infection with a result of HBsAg positive (Indicating an active hepatitis B infection). Closer review of the medical records showed the facility placed Patient #1 at station #11 (located in the main treatment area) for the first dialysis treatment on 10/13/25 instead of the isolation room. Additional review of dialysis treatment flow sheets showed that Patient #1 received dialysis treatments in the facility’s isolation room beginning on 10/15/25 including 10/17/25, 10/20/25, and 10/22/25. 4. Review of the facility Medical Records showed the following: -Patient #5, a HBV negative patient, received a dialysis treatment in the facility isolation room on 10/16/25. -Patient #7, a HBV negative patient, received dialysis treatments in the facility isolation room on 10/17/25, 10/20/25, and 10/22/25. -Patient #8, a HBV negative patient, received dialysis treatments in the facility isolation room on 10/16/25, 10/18/25, and 10/21/25. -Patient #10, a HBV negative patient, received dialysis treatments in the facility isolation room on 10/17/25 and 10/20/25. The facility failed prevent the isolation room from being used for HBV (Hepatitis B Virus) negative patients when a HBsAg positive patient on census was using the same isolation room. 5. During an interview on 11/04/2025 at 11:13 AM, the Facility Administrator (FA) reported the facility misinterpreted Patient #1’s hepatitis lab studies from the hospital test completed on 10/7/25 and placed Patient #1 on the main treatment floor among other patients instead of in the isolation room. The FA (Facility Administrator) went on to report Patient #1 was treated as a patient without an active Hepatitis B infection because the test results were misinterpreted that way. The FA reported that when it was discovered that Patient #1 was HBV+, Patient #1 was moved to the facility isolation room beginning on 10/15/25 and every treatment thereafter. The FA reported that the facility then treated other patients who were immune to hepatitis in the same room. The FA then reported that she found out on 10/22/25 that the isolation room must be dedicated only for Patient #1 and no other patients. The FA reported that she mistakenly understood that the isolation room could be used for other patients who were HBV- if they were HBV immune. 6. During an interview on 11/13/25 at 9:00 AM the Medical Director reported the expectation is that policies were to be followed regarding the caring for patients with hepatitis B.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 34810 Based on review of policy, medical records, and interview, the facility staff failed to separately dedicate machines, equipment, instruments, and supplies to a HBV+ (Hepatitis B Virus positive [Patients who are infected with the Hepatitis B virus]) patient. Hepatitis B is a liver disease that results from infection with the Hepatitis B virus (HBV). The spread of hepatitis B can occur through contact with infected blood or other body fluids or through contact with the hands, surfaces, equipment, or supplies contaminated with the hepatitis B virus. Hepatitis B virus is a concern in a dialysis facility where exposure to blood and body fluids could potentially occur. Failure to separately dedicate the machines, equipment, and supplies for only the HBV+ patient’s dialysis treatments puts the HBV- (Hepatitis B Negative ) patients at risk for cross-contamination with the Hepatitis B virus and could potentially result in patients becoming infected with the hepatitis B virus. Hepatitis B virus infection/disease can lead to a serious, lifelong illness that can result in long-term health problems and even death. At the time of the survey, the facility staff reported a hemodialysis patient census of 122. Findings for 1 of 1 Patient (Patient #1) admitted to the facility with an active HBV infection including 4 of 4 HBV- patients (Patient #5, Patient #7, Patient #8, and Patient #10) that utilized the same isolation room as Patient #1 and findings for the main treatment area include: 1. Review of the facility policy titled, “Patient Admission”, with a published date of 5/5/25 included in part, “ ...To guide facility management on the admission process for all patients being admitted to an FKC dialysis facility ...This policy applies to New Patients, Transfer Patients or Transient Patients ...At a minimum, the required documents to admit a patient include ...History and Physical or nephrology consult note or discharge summary or the most recent physician progress note ...Hepatitis B panel (HBsAg, anti-HBs, ...” 2. Review of the Facility policy titled, “Dialyzing Patients with Positive Hepatitis B Antigen”, with a published date of 6/4/25, included in part, “...Purpose To prevent transmission of Hepatitis B ...all patients with hepatitis B infection (hepatitis B surface antigen positive (HBsAg+) treated in the dialysis facility require additional infection control precautions as outlined in this policy ...Caring for HBsAg positive patients requires adherence to strict guidelines. The hepatitis B virus is highly infectious because the concentration of virus particles in the blood is very high and the hepatitis B virus can live outside the body on surfaces for at least 7 (seven) days. Outbreaks of hepatitis B have been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not been vaccinated for hepatitis B ...Ensure that staff caring for HBsAg positive patients care only for HBV antibody positive (immune) patients at the same time ...Staff having any contact with the HBsAg positive patient must at the same time have NO contact with susceptible patients ...All patients who are HBsAg positive must dialyze under isolation precautions ...Patients that are HBsAg positive must dialyze in the separate room ...If there are current HBsAg positive patients on census, the isolation area/room and equipment cannot be used for HBV (Hepatitis B Virus) negative patients on other shifts or days due to the risk of cross-contamination ...Separated dedicated supplies and equipment ...must be used to provide care to the HBsAg positive patient ...” 3. Review of Patient #1’s hospital medical record showed that Patient #1 tested Reactive to the Hepatitis B surface Antigen (indicating an active Hepatitis B infection) on 10/7/2025 (8 days prior to admission to the outpatient dialysis facility). Closer review of Patient #1’s medical record showed that Patient #1 was admitted to the dialysis facility on 10/13/25. Upon Patient #1’s admission to the facility (10/13/25), the dialysis facility staff obtained blood tests for Hepatitis B infection with a result of HBsAg positive (indicating an active hepatitis B infection). Closer review of Medical records from 10/13/25 showed Patient #1 received a dialysis treatment at station #11, located in the center of main treatment area where the facility stored shared common supplies, including but not limited to, medical tape, dialysis needles, dialysis tubing, dialysis filters, clamps, staff gloves and dressing supplies, potentially affecting all 122 patients on census at the facility. 4. Review of Patient #1’s hospital medical record also showed Patient #1 received dialysis treatments in the facility’s isolation room beginning on 10/15/25 including 10/17/25, 10/20/25, and 10/22/25. 5. Review of the facility Medical Records showed the following: -Patient #5, a HBV negative patient, received a dialysis treatment in the facility isolation room on 10/16/25. -Patient #7, a HBV negative patient, received dialysis treatments in the facility isolation room on 10/17/25, 10/20/25, and 10/22/25. -Patient #8, a HBV negative patient, received dialysis treatments in the facility isolation room on 10/16/25, 10/18/25, and 10/21/25. -Patient #10, a HBV negative patient, received dialysis treatments in the facility isolation room on 10/17/25 and 10/20/25. The facility failed prevent the isolation room and it’s contents from being used for HBV (Hepatitis B Virus) negative patients when a HBV positive (a patient with active hepatitis) patient was using the same isolation room resulting in the facility’s failure to dedicate machines, equipment, instruments, supplies in the isolation room to Patient #1 only. 6. During an interview on 11/04/2025 at 11:13 AM, the Facility Administrator (FA) reported the facility misinterpreted Patient #1’s hepatitis lab studies from the hospital test completed on 10/7/25 and placed Patient #1 on the main treatment floor among other patients instead of in the isolation room. The FA (Facility Administrator) went on to report Patient #1 was treated as a patient without an active Hepatitis B infection because the test results were misinterpreted that way. The FA reported that when it was discovered that Patient #1 was HBV+, Patient #1 was moved to the facility isolation room beginning on 10/15/25 and every treatment thereafter. The FA reported that the facility then treated other patients who were immune to hepatitis in the same room. The FA then reported that she found out on 10/22/25 that the isolation room must be dedicated only for Patient #1 and no other patients. The FA reported that she mistakenly understood that the isolation room could be used for other patients who were HBV- if they were HBV immune. The FA went on to report that the facility did not evaluate the commonly stored supplies present in the main treatment area when Patient #1 dialyzed at treatment station #11. 7. During an interview on 11/13/25 at 9:00 AM the Medical Director reported that he would not expect HBV+ patients to be dialyzed in the main treatment area and the expectation is that policies were to be followed regarding the situation.”

“IC-HBV-ISOLATION-STAFFING CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients Staff members caring for HBsAg positive patients should not care for HBV susceptible patients at the same time, including during the period when dialysis is terminated on one patient and initiated on another. This Standard is not met as evidenced by: 34810 Based on review of policies, medical records, and interview, the facility failed to ensure that staff caring for a HBsAg (Hepatitis B surface antigen) positive patient did not care for HBV (Hepatitis B Virus) susceptible patients at the same time in accordance with the facility’s policy. Hepatitis B is a liver disease that results from infection with the Hepatitis B virus (HBV). The spread of hepatitis B can occur through contact with infected blood or other body fluids or through contact for example with the hands, surfaces, equipment, or supplies contaminated with the hepatitis B virus. Hepatitis B virus is a concern in a dialysis facility where exposure to blood and body fluids could potentially occur. Hepatitis B virus is stable in the environment and can survive on surfaces (and remain infectious) for at least 1 week. Failure to ensure staff caring for a HBsAg positive patient (HBV+ [Hepatitis B Virus Positive] meaning the patient has tested positive for the presence of hepatitis B surface antigen) did not care for HBV susceptible patients at the same time, puts the patients at risk for cross-contamination with the Hepatitis B virus and could potentially result in patients becoming infected with the hepatitis B virus. Hepatitis B virus infection/disease can lead to a serious, lifelong illness that can result in long-term health problems and even death. At the time of the survey, the facility staff reported a hemodialysis patient census of 122. Findings for 1 of 1 treatment day (October 13, 2025), showed the following: 1. Review of the Facility policy titled, “Dialyzing Patients with Positive Hepatitis B Antigen”, with a published date of 6/4/25, included in part, “...Purpose To prevent transmission of Hepatitis B ...all patients with hepatitis B infection (hepatitis B surface antigen positive (HBsAg+) treated in the dialysis facility require additional infection control precautions as outlined in this policy ...Caring for HBsAg positive patients requires adherence to strict guidelines. The hepatitis B virus is highly infectious because the concentration of virus particles in the blood is very high and the hepatitis B virus can live outside the body on surfaces for at least 7 (seven) days. Outbreaks of hepatitis B have been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not been vaccinated for hepatitis B ...Ensure that staff caring for HBsAg positive patients care only for HBV antibody positive (immune) patients at the same time ...Staff having any contact with the HBsAg positive patient must at the same time have NO contact with susceptible patients ... 2. Review of Patient #1’s hospital medical record showed that Patient #1 tested Reactive to the Hepatitis B surface Antigen (indicating an active Hepatitis B infection) on 10/7/2025 (8 days prior to admission to the outpatient dialysis facility). Closer review of Patient #1’s medical record showed that Patient #1 was admitted to the dialysis facility on 10/13/25. Upon Patient #1’s admission to the facility (10/13/25), the dialysis facility staff obtained blood tests for Hepatitis B infection with a result of HBsAg positive (indicating an active hepatitis B infection). Closer review of Medical records from 10/13/25 showed Patient #1 received a dialysis treatment at station #11 in the main treatment area among other patients. 3. Review of Patient Flowsheets showed Patient Care Technician (PCT) D Cared for Patient #1 and Patient # 11 concurrently on 10/13/25. Closer review of Patient #11s Medical Record revealed Patient #11 was susceptible to HBV (Susceptible means the patient has no immunity to the hepatitis B virus). 4. Review of Patient Flowsheets showed PCT C and PCT D Cared for Patient #1 and Patient # 12 concurrently on 10/13/25. Closer review of Patient #12s Medical Record revealed Patient #12 was susceptible to HBV. 5. Review of Patient Flowsheets showed PCT D, RN (Registered Nurse) E, and RN F Cared for Patient #1 and Patient # 13 concurrently on 10/13/25. Closer review of Patient #13s Medical Record revealed Patient #13 was susceptible to HBV. 6. During an interview on 11/04/2025 at 11:13 AM, the Facility Administrator (FA) reported the facility misinterpreted Patient #1’s hepatitis lab studies from the hospital test completed on 10/7/25 and placed Patient #1 on the main treatment floor among other patients instead of in the isolation room. The FA (Facility Administrator) went on to report Patient #1 was treated as a patient without an active Hepatitis B infection because the test results were misinterpreted that way. The FA reported that when it was discovered that Patient #1 was HBV+, Patient #1 was moved to the facility isolation room beginning on 10/15/25 and every treatment thereafter. 7. During an interview on 11/13/25 at 9:00 AM the Medical Director reported that he would not expect HBV+ patients to be dialyzed in the main treatment area and the expectation is that policies were to be followed regarding the situation.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 44475 Based on observation, policy, and staff interview, the facility failed to ensure that clinical staff demonstrate aseptic technique when dispensing and administering intravenous medications for 1 of 1 medication administration observations. The End Stage Renal Disease (ESRD) facility reported a census of 122 in center hemodialysis patients at the time of the survey. Findings include: The “Medication Preparation and Administration Procedure” policy dated 8/30/24 directed, in part, that the purpose of the policy is to provide direction for safely, therapeutically, and aseptically administering medication. The medication administration procedure directed staff to take the medication to the patient ’ s chair. The policy did not direct staff to place medication in their uniform pocket located underneath her PPE (personal protective equipment) gown. In an observation on 11/10/25 at 1:26 PM, Staff A, Registered Nurse (RN), took a syringe containing venofer (intravenous iron medication) and a 10 mL (milliliter) syringe of normal saline out of the pocket of her uniform which was under her PPE gown. Staff A then administered venofer and normal saline to Patient #2. In an interview on 11/13/25 at 4:08 PM, the Facility Administrator (FA) reported that Staff A reported that she carried medication in her pocket to administer to Patient #2.”

“IC-REPORT COMMUNICABLE DISEASES CFR(s): 494.30(c) The facility must report incidences of communicable diseases as required by Federal, State, and local regulations. This Standard is not met as evidenced by: 34810 Based on review of policy, medical records, and interview the facility failed to contact appropriate state or local public health authorities regarding the potential exposure of a communicable disease (hepatitis B virus) to susceptible patients at the facility. Failure to report the potential exposure of a communicable disease could lead to missed opportunities of guidance from the public health authoritties to prevent the spread of a communicable disease to other patients. The facility reported a census of 122 hemodialysis patients at the time of the complaint investigation and full survey. 1. Review of the facility Policy titled, “Reporting of Communicable Diseases”, with a published date of 9/3/23 included in part. “...The purpose of this procedure is to provide guidance for reporting of communicable diseases...contact local department of health office according to state requirements. If required, complete specific forms as required by the local department of health...” 2. Review of policy, medical records, and interview showed the following regarding a potential exposure of the HBV (Hepatitis B Virus): a. The facility failed to ensure all patients were screened appropriate for medical conditions, including accurately screening for HBV (Hepatitis B Virus) prior to admission. (Refer to V 124) b. The facility staff failed to ensure while a HBV+ (Hepatitis B Virus Positive meaning the patient has tested positive for the presence of hepatitis B surface antigen; HBsAg [Hepatitis B surface antigen] positive) patient was on census at the facility receiving dialysis treatments in the isolation room, that the isolation room was dedicated only for the HBV+ patient dialysis treatments and not used for HBV- (meaning the patient does not have the Hepatitis B surface antigen; HBsAg negative) patients on other shifts or days. (Refer to V 128) c. The facility staff failed to separately dedicate machines, equipment, instruments, and supplies to a HBV+ (Hepatitis B Virus positive [Patients who are infected with the Hepatitis B virus]) patient. (Refer to V 130) d. The facility failed to ensure that staff caring for a HBsAg (Hepatitis B surface antigen) positive patient did not care for HBV (Hepatitis B Virus) susceptible patients at the same time in accordance with the facility’s policy. (Refer to V131) 3. During an interview on 11/17/25 at 11:30 AM the Facility Administrator reported that the facility staff did not reach out to the Local Health department or State Department of health regarding the potential exposure of Hepatitis B. The Facility administrator went on to report that policy review did not indicate notification was needed. The Facility Administrator reported that she did not consider calling the local or state health departments to inquire if HBV exposure was a reportable situation.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 44475 Based on medical record review, policy, and staff interview, the facility failed to ensure that central venous catheter dressing (CVC) changes are performed as ordered for 1 of 7 patients reviewed with CVCs. The End Stage Renal Disease (ESRD) facility reported a census of 122 in center hemodialysis patients at the time of the survey. Findings include: The “Changing the Catheter Dressing Procedure” policy dated 5/2/25 directed, in part, that the purpose of this policy is to provide instruction for changing the catheter dressing in order to prevent infection. Catheter related infections are one of the leading causes of hospitalization and death. Strict infection control practices and adherence to the catheter dressing change procedure is essential to prevent serious complications. The Orders Summary Report revealed an order for Patient #1 for catheter care every treatment starting 10/13/25 signed by the facility ’ s Medical Director. Review of Treatment Sheets from 10/13/25 to 11/3/25 for Patient #1 revealed catheter care was not performed on 10/13/25, 10/15/25, 10/17/25, 10/20/25, 10/24/25, 10/27/25, 10/29/25, and 10/31/25. In an interview on 11/17/25 at 10:21 AM, the Facility Administrator (FA) reported that they are having a hard time with the PCTs (Patient Care Technicians) completing charting before their shift is over, that CVC dressing changes were probably done as ordered. A nurse reviews patient charts at the end of the day and if the nurse was not 100% sure the CVC dressing change occurred, the nurse charts that it did not occur.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 44475 Based on medical record review, policy, and staff interview, the facility failed to ensure the time ordered for patient treatment was followed as ordered for 2 of 10 (Patient #3 and Patient #4) patients. The End Stage Renal Disease (ESRD) facility reported a census of 122 in center hemodialysis patients at the time of the survey. Findings include: 1. The “Early Termination or Arriving Late for Treatment” policy dated 6/18/25 directed, in part, that the purpose of this policy is to provide guidelines for staff when patients request early termination of treatment. Treatment duration is prescribed by a patient ’ s provider and the facility expects that all patients will adhere to their prescribed treatment time. Serious health related consequences may result from terminating treatments earlier than prescribed. If a patient insists on terminating treatment early, and this has not been previously approved by the patient ’ s provider, the patient must take full responsibility for consequences of the missed or shortened treatment. If a patient requests to leave treatment early, the RN (Registered Nurse) is responsible to document on the AMA (Against Medical Advice) form. AMA forms are signed by the patient and witnessed by the supervising nurse, signed with each early termination event and filed in the patient ’ s medical record. 2. The Order Summary Report for Pt #3 revealed an order signed by the Medical Director for a 4 hour treatment time starting 10/3/25. The Treatment Sheet dated 11/3/25 revealed Patient #3 had treatment for 3 hours and 12 minutes. 3. The Order Summary Report for Patient #4 revealed an order signed by the Medical Director for 3 hours and 30 minutes treatment time starting 11/7/25. The Treatment Sheet dated 11/10/25 revealed Patient #4 had treatment for 3 hours and 5 minutes. The Treatment Sheet dated 11/12/25 revealed Patient #4 had treatment for 3 hours and 4 minutes. 4. In an interview on 11/17/25 at 10:22 AM, the Facility Administrator (FA) reported that she could not find AMA forms for either patient.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 36083 Based on documents review, observations, and interviews, the facility failed to ensure dialysis treatments according to prescriptions for 3 of 4 patients in the sample for prescription verification (Patient #11, Patient #12, and Patient #13), and 6 of 10 patients’ medical records reviewed (Patient #7, Patient #3, Patient #4, Patient #5, Patient #6, and Patient #10). The facility reported a census of 120 in-center hemodialysis patients at the time of the survey. Findings include: 1. The policy titled, Pre-Treatment Safety Checks Procedure, published 2/06/2023, provides guidance on performing safety checks prior to initiating hemodialysis treatment. The policy indicates that 2 staff members are to verify elements prior to initiation of treatments including the prescribed dialysate composition, dialyzer and dialysate flow rate. The policy also provides that after the patient is seated, the clinician initiating the treatment must verify the prescribed set up matches the patient, including the dialyzer, dialysate flow rate, and temperature. 2. On 7/7/25, beginning at 1:30 PM, observations showed patients treatments were not set according to orders, as follows: a) Patient #11’s treatment flowsheet, dated 7/7/25, showed hemodialysis orders including bicarbonate of 35, and treatment time of 3.5 hours. On 7/7/25 at 1:35 PM, Patient #11 was on treatment at Station #2, where the dialysis machine indicated, Patient #11 had run treatment for 2 hours, and had 1.5 hours left of her 3.5 hours prescribed treatment time. Further observation showed that Patient #11’s bicarbonate was set at 20 instead of the ordered 35. Patient Care Technician (PCT) A, who was reviewing the prescription with surveyor, verified that Patient #11’s had an incorrect bicarbonate setting. PCT A stated “not sure” why the bicarbonate was at 20. PCT A then changed the setting to 35. b) Patient #12’s treatment flowsheet, dated 7/7/25, showed hemodialysis orders including dialysate of 3 K (potassium) and 2.5 Ca (Calcium), a dialysis flow rate (DFR) of 600, and treatment time of 3 hours. On 7/7/25 at 2:00 PM, Patient #12 had an ongoing treatment at Station #9. The dialysis machine indicated Patient #12 had been into treatment for 2 hours, and had an hour left for treatment. Further observation showed that Patient #12 was running treatment with a dialysate of 2 K and 2.5 Ca and a dialysis flow rate (DFR) of 800. PCT B, who was present during the observation, verified that Patient #12 was dialyzing with an incorrect dialysate and DFR. PCT B stated that these were errors. PCT B then changed the settings of the dialysate from the wall box (dialysate delivery connection port) to 3 K and 2.5 Ca. c) Patient #13’s treatment flowsheet, dated 7/7/25, showed hemodialysis orders including dialyzer 180 NRe Optiflux, DFR of 700, blood flow rate (BFR) of 450, temperature of 37, and treatment time of 3.5 hours. On 7/7/25 at 2:15 PM, Patient #13 was at Station #15, where the dialysis machine indicated the ongoing treatment went for 3 hours and 0.5 hour left. Further observation showed Patient #13 was running with a dialyzer of 200 NRe, a DFR of 800, a BFR of 400, and a temperature of 36. While reviewing the prescription with PCT C, she confirmed observations that Patient #13 was dialyzing with the wrong dialyzer, DFR, BFR, and temperature. 3. The medical records included Patient #7’s treatment flowsheet dated 7/4/25 that showed a dialysis prescription including a DFR of 800. However, the treatment flowsheet also showed that on the same date (7/4/25), Patient #7 was on dialysis treatment with a DFR of 700 for the whole duration of the treatment. 4. Patient #3’s hemodialysis orders dated 6/26/25, showed orders of treatment time of 3 hours 30 minutes, a Blood Flow Rate (BFR) of 350, and a Dialysate Flow Rate (DFR) of 600. a) The treatment flowsheet for Patient #3 dated 7/525 showed Patient #3 ran at a BFR of 325 for 1 hour 33 minutes of their prescribed treatment time. b) The treatment flowsheet for Patient #3 dated 7/3/25 showed Patient #3 ran at a DFR of 800 for 50 minutes of the prescribed treatment time. c) The treatment flowsheet for Patient #3 dated 7/01 showed Patient #3 ran at a BFR of less than 350 for their entire prescribed treatment time. d) The treatment flowsheet for Patient #3 dated 6/28/25 showed Patient #3 ran at a DFR of 800 for their entire prescribed treatment time. 5. Patient #4’s hemodialysis orders dated 6/20/25, showed orders of DFR at 800, BFR at 450, and a treatment time of 3 hours. a) The treatment flowsheet for Patient #4 dated 7/02/25 showed Patient #4 ran with a BFR of 400 for their entire treatment time. b) The treatment flowsheet for Patient #4 dated 6/25/25 showed Patient #4 ran with a DFR of 700 for 1 hour 30 minutes of their prescribed treatment time. c) The treatment flowsheet for Patient #4 dated 6/23/25 showed Patient #4 ran with a DFR of 700 for their entire treatment time. 6. Patient #5’s hemodialysis orders dated 6/07/25, showed orders of treatment time of 2 hours 30 minutes, a BFR of 350, and a DFR of 700. a) The treatment flowsheet for Patient #5 dated 7/01/25 showed Patient #5 ran with a DFR of 800 for their entire treatment. b) The treatment flowsheet for Patient #5 dated 6/26/25 showed Patient #5 ran with a DFR of 800 for 1 hour 36 minutes of their treatment time. c) The treatment flowsheet for Patient #5 dated 6/24/25 showed Patient #5 ran with a DFR of 600 for 1 hour of treatment and then 800 for the rest of treatment. 7. Patient #6’s hemodialysis orders dated 5/17/25, showed orders of BFR at 400, DFR at 600, and a treatment time of 3 hour 45 minutes. a) The treatment flowsheet for Patient #6 dated 6/28/5 showed Patient #6 ran with a DFR of 800 for their entire treatment time. b) The treatment flowsheet for Patient #6 dated 6/24/25 showed Patient #6 ran with a DFR of 800 for their entire treatment time. 8. Patient #10’s hemodialysis orders dated 6/02/25, showed orders of BFR at 400, a DFR at 800, and a treatment time of 4 hours. a) The treatment flowsheet for Patient #10 dated 7/02/25 showed Patient #10 ran with a BFR of 375 for 2 hours 25 minutes of their treatment time. b) The treatment flowsheet for Patient #10 dated 6/27/25 showed Patient #10 ran with a DFR of 700 for 3 hours 24 minutes of their treatment time. c) The treatment flowsheet for Patient #10 dated 6/23/25 showed Patient #10 ran with a BFR less than 400 for their entire treatment time. 9. During interview on 7/10/25 at 9:29 AM, the Clinic Manager (CM) acknowledged the importance of dialyzing patients with the correct prescriptions. 10. During interview on 7/10/25 at 10:29 AM, the Medical Director (MD) also stated expectations for staff members to ensure patients receive their treatments according to their respective prescriptions. 51639”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 51639 Based on policy review, medical records review, observation, documents review and interviews, the facility failed to ensure adverse occurrences were recorded for 4 of 4 reviewed patients (Patient #3, Patient #11, Patient #12, Patient #13). Findings include: 1. Review of the policy title, “Patient Safety Even Reporting and Documentation,” published 2/06/23 states, “When a Near Miss, Safety Event or Serious Safety Event occurs, staff are required to report, document, and review the event as noted in this policy...” The document lists the following as occurrences that should be documented by staff: Clotting of an access during dialysis that results in termination of treatment; Prescribed dialyzer not utilized for dialysis treatment; Prescribed dialysate solution not utilized for dialysis. 2. Patient #3’s treatment flowsheet dated 6/28/25 showed a note indicating Patient #3’s treatment was ended early due to clotting. 3. Refer to V544 for Patient #11, Patient #12, and Patient #13. 4. Review of the document titled, “Adverse Events Reports”, showed that none of these occurrences were reported by staff. 5. In an interview with the Facility Administrator (FA) on 7/10/25 at 9:20 AM, the FA reported that items including clotted dialyzers and accesses, wrong prescriptions including dialysate and dialyzers should be reported as an adverse event. It is expected that prescriptions should be implemented as prescribed.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 36083 The survey found an Immediate Jeopardy (IJ) situation related to the facility’s failure to test chemical (Minncare) residual after disinfection and prior to initiation of patients’ treatments. Prior to survey exit, the facility’s administrative staff took action and removed the immediacy of the identified concern that placed patients in the Immediate Jeopardy situation. However, condition level deficiency remained under the Condition for Water and Dialysate. Based on review of manufacturer’s directions for use, facility’s policies and procedures, interviews, and observations, the facility failed to ensure: 1) Tests for the presence of residual chemical (Minncare) disinfectant were performed and reflected in documentation after each weekly disinfection for 4 of 12 weeks (1/8/24, 2/5/24, 2/12/24, and 3/4/24) reviewed for chemical disinfection of the reversed osmosis (RO) water system. (Refer to V 219). 2) Disposal of expired solutions used to calibrate the facility’s instruments such as the pHoenix meters (used for monitoring the acid-base balance in dialysis solutions used to treat patients) and the facility’s Hydra (an instrument used to measure water quality). (Refer to V 250). 3) Instruments (pHoenix meter and Hydra) were rinsed with fresh reverse osmosis (RO) water to remove Neo-Care (cell cleaning solution), after an overnight dwell in the instruments. (Refer to V 250). 4) Integrity of chemical residual test strips according to manufacturer’s direction by not storing expired supply for use, as observed for 1 of 1 container labeled, Minncare HD Residual Test Strips, placed on top of work table in the water purification area. (Refer to V 276). The facility reported a census of 96 hemodialysis patients at the time of the survey. The cumulative effect of this failure resulted in the facility’s inability to ensure safe water and dialysate for the treatments of the ESRD (End Stage Renal Disease) in-center hemodialysis patients. The surveyor notified the Area Technical Operations Manager (ATOM) and the Clinical Manager (CM) regarding the Immediate Jeopardy situation and provided them the IJ (Immediate Jeopardy) Template on 3/21/24 at 10:15 AM. In response to this, the administrative staff developed and implemented an IJ removal action plan, which removed immediacy of the IJ situation prior to the survey exit. A summary of facility actions include: On 3/21/24 at 10:21 AM, the ATOM checked the RO system for residual Minncare, which resulted negative; on 3/21/24 at 10:54 AM, the ATOM set up an alert in the facility’s documentation system called Technical Maintenance System (TMS), in order to notify/remind staff to complete chemical residual tests and documentation after the procedure, and to escalate notification if documentation remains not completed beginning at 4:00 AM and later; staff members were re-educated regarding RO chemical disinfection and post disinfection process; the leadership team and governing body held a meeting on 3/21/24 at 11:30 AM for developing an IJ removal plan and root cause analysis of the incident.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 36083 Based on documents review, interviews, and observations, the facility did not ensure a safe and sanitary environment by its failure to discard multiple expired and outdated supplies from facility circulation, which create risk for usage. The facility reported a census of 96 patients at the time of the survey. Findings include: 1. The policy titled, Storage of Supplies, dated 4/5/21, provides the guidelines for storage and handling of supplies, noting that proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired, contaminated or damaged. The policy also provides that all supplies must be stored in a clean environment, and stored and handled in accordance with manufacturer’s instructions for use. The policy directs staff to appropriately dispose items that have reached the expiration date. 2. The policy titled, Medication Preparation and Administration, dated 2/6/23, indicates monitoring of expired medications on a monthly basis, and expired medications are to be discarded. The policy also provides that multi dose vials must be discarded 28 days after opening or per manufacturer’s expiration date. 3. During observations on 3/18/24 showed the following: -At 3:35 PM, the medication cart situated to the left when standing at the nurses’ station and facing the treatment area, stored a container labeled “Blood Leak Test Strip” containing 11 strips and with an expiration date of 10/31/23. Registered Nurse (RN) E verified that the strips were expired. RN E stated that the expired strips need to be discarded. -At 3:40 PM, the medication refrigerator stored 1 vial of Tubersol (tuberculosis solution) that was opened as dated on 10/13/23. RN I acknowledged that the Tubersol was expired, and should have been discarded 30 days after opening, ad directed by the manufacturer’s label. -At 3:41 PM, there were 79 laboratory (lab) specimen tubes (light blue top) for aluminum and zinc that were expired on 6/6/23, but were sitting on counter top at the lab area for use. RN I verified the specimen tubes expired and should be discarded. -At 3:50 PM, there were multiple expired glucometer control solutions found for 5 of 6 glucometer sets in the storage cabinets behind the nurses’ station, as follows: control 1 and control 2 expired 11/2/23 (2 vials); control 1 and control 2 expired 11/20/23 (2 vials); control 1 and control 2 expired 8/3/23 (2 vials); control 1 and control 2 expired 2/19/24 (2 vials); and control 1 and control 2 expired 2/19/24 (2 vials). In addition, 1 of 6 containers of glucometer strips expired on 11/16/23. RN I and RN E verified the presence of expired glucometer supplies, and indicated they will discard the expired items and replace them. 4. On 3/25/24 at 11:40 AM, the Clinic Manager (CM) acknowledged the expired supplies should have been discovered and discarded when expired during the monthly supply inventory/monitoring. The CM also acknowledged the potential adverse effects of using expired supplies such as getting inaccurate results and/or infection.”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 36083 Based on manufacturer’s instructions for use and records review, and interviews, the facility did not ensure tests for the presence of residual chemical (Minncare) disinfectant were performed and reflected in documentation after each weekly disinfection for 4 of 12 weeks (1/8/24, 2/5/24, 2/12/24, and 3/4/24) reviewed for chemical disinfection of the reversed osmosis (RO) water system. The facility reported a census of 96 patients during the survey. Findings include: 1. The manufacturer’s document titled, Mar Cor Purification CWP 100 Operator’s Guide, copyright 2012, provides the procedural steps for chemical disinfection of the water purifying system, which indicates the use of peracetic acid. The document also directs operators (staff members) to verify with a separate test that no residual disinfectant can be detected in the water, and shows a warning as noted, “Do not connect patients until a test for residual disinfectants has been performed.” 2. The manufacturer’s document titled, Minncare HD Disinfectant (2016), defines Minncare HD as a peracetic acid solution developed specifically for use on hemodialysis RO membranes and their associated distribution systems. The document also indicates the use of test strips to verify complete disinfectant rinse out of the disinfectant. 3. The facility’s procedure titled, Disinfection of the Indirect Treated Water Distribution Systems, dated 3/2/20, directs staff members to refer to manufacturer’s instructions for use (IFU) for peracetic acid disinfection. The procedure also indicates verifying the absence of disinfectant by residual testing and documenting the results. 4. The facility’s printout document titled, CWP Stop Disinfection, undated, directs staff members to follow the procedural steps after chemical disinfection, to include letting the water “run for a couple of minutes and test with Minncare Residual strip.” The document also indicates a residual reading should be entered thereafter. 5. The document titled, CWP Disinfect Logs, from 1/2/24 through 3/18/24, indicates weekly chemical disinfection performed every Sunday. However, the log shows 4 incidents where the tests for residual chemical disinfectant (Minncare) were not performed after the tests and before patients’ treatments on the following Mondays: 1/8/24, 2/5/24, 2/12/24, and 3/4/24. 6. On 3/18/24 at 4:45 PM, Patient Care Technician (PCT) D stated the “opener” or the staff member who will turn on the water system for the day after chemical disinfection, will be the one to test the RO water for residual Minncare using the provided test strips, and then to document. 7. On 3/20/24 at 9:25 AM, PCT A indicated herself as 1 of 3 staff members who have been signed off to disinfect and open the facility’s water system for patients’ use. PCT A stated she had “always” tested the RO water for residual disinfectant when “opening” the water system on Mondays. However, on 3/21/24 at 11:30 AM, PCT A verified the documentation in the CWP Disinfect Log which lacked entries to show tests to ensure negative results for residual chemicals were performed on 1/8/24, 2/5/24, 2/12/24, and 3/4/24. PCT A stated she may have missed to document the procedure on the day she was scheduled for opening the water system. 8. On 3/20/24 at 11:35 AM, the Biomedical Staff (BS) indicated that the patient care technicians are the ones responsible for disinfecting the RO with Minncare and verifying that the RO is free from residual Minncare. The BS verified that the CWP Disinfect Log did not reflect if residual chemical (Minncare) tests were performed on 1/8/24, 2/5/24, 2/12/24, and 3/4/24. 9. On 3/20/24 at 11:40 AM, the Area Technical Operations Manager (ATOM) also verified the lack of documentation to show residual chemical was tested on 1/8/24, 2/5/24, 2/12/24, and 3/4/24. The ATOM acknowledged he was responsible in auditing the water system logs and did not notice the dates of missed tests for chemical residual. 10. On 3/25/24 at 11:54 AM, PCT B stated the RO would not work unless “taken out of disinfect and testing for residual is part of the process that should be done.” PCT B said, “There is no reason not to test.” PCT B added that the facility’s “old” system for documenting the process (chemical residual test) did not prompt staff to document. PCT B stated she would “sometimes” remember, “oh yeah I still have to document that step” and would then enter the time of the actual test. PCT B indicated documentation could be missed if one would not remember to do it. 11. On 3/25/24 at 12:57 PM, PCT C stated she “opened” on a Monday (day after chemical disinfection) if one of the regular staff is not available, and that one of the things she did was to test for residual chemical (Minncare). PCT C stated that “the water will run for you” to do it (indicated being prompted by the running water). When asked about the possibility of failing to test or missing the test procedure as that shown in the log, PCT C replied, “I would not say it was missed, we fell into the issues logging in.” 12. On 3/25/24 at 11:40 AM, the ATOM stated expectations for staff members to follow all the steps of the procedure for RO disinfection including actual chemical residual testing and documentation.”

“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: 36083 Based on documents review, interviews, and observation, the facility did not ensure expired solutions used to calibrate the facility’s instruments such as the pHoenix meters (used for monitoring the acid-base balance in dialysis solutions used to treat patients) and the facility’s Hydra (an instrument used to measure water quality). In addition, the facility did not ensure to rinse the instruments with fresh reverse osmosis (RO) water to remove Neo-Care (cell cleaning solution), after an overnight dwell in the instruments. The facility reported a census of 96 patients at the time of the survey. Findings include: 1. The manufacturer’s document titled, Tri-Station Super Station, undated, and posted on the wall by the facility’s tri-station, indicates care for the instruments and directs users (facility staff members) to perform procedures to include drawing Neo-Care into the instruments for overnight storage, and then expelling the Neo-Care and rinsing with RO water on the following day before calibration and use. The document notes the tri-station maintenance including a daily rinse and refill of the “Rinse bottle” with fresh RO, and a direction to replace standard solutions as indicated: conductivity solutions - 30 days after opening, pH solutions - 90 days after opening, any solution - if the bottle expiration date is past, or if color, turbidity or visible microbial growth develops. 2. The document titled, ALL TEST STRIPS AND SOLUTIONS WHEN OPENED, MUST BE LABELED WITH EXPIRATION DATE. PLEASE ADHERE TO THE FOLLOWING MANUFACTURER’S EXPIRATIONS, dated as revised on 7/19/07, provides that conductivity solutions expire 30 days from the date they were opened or the manufacturer’s expiration date, whichever comes first; and the pH solutions expire 90 days from the date they were opened or the manufacturer’s expiration date, whichever comes first. 3. On 3/18/24 at 4:31 PM, observations of the tri-station in the water room, showed multiple outdated/expired solutions (7 of 9 bottles/containers on the tri-station table), as follows: - Conductivity standard solution 1 mS/cm (millisiemens/centimeter) expired 12/21/23; - Conductivity standard solution 50 mS/cm opened 11/18/23 with discard date of 12/18/23; - Standard Buffer Solution 10 pH opened 11/18/23 with a discard date of 2/18/23; - Standard Buffer Solution (red) 4 pH opened 11/18/23 with a discard date of 2/18/23; - Conductivity standard solution 14 mS/cm opened 2/12/24 discard 3/12/24; - RO water - no date; - Conductivity solution 150 uS/cm (microsiemens/centimeter) opened 2/12/24 with a discard date 3/12/24. 4. On 3/18/24 at 4:33 PM, the Biomedical Staff (BS) verified that the above-listed solutions were expired. The BS stated the patient care technicians are the ones using the solutions that he had not paid attention to these. 5. On 3/18/24 at 4:45 PM, Patient Care Technician (PCT) D and Registered Nurse (RN) E also verified that the solutions in the tri-station were expired and outdated, and that the RO water bottle had thick dust build-up on its surface and especially around its cap. PCT D stated the RO water was used to rinse the meters and the solutions were used to calibrate the meters in the morning as part of the process for opening the water system and the clinic. PCT D and RN E acknowledged that the expired solutions should be discarded. 6. On 3/20/24 at 11:40 AM, the Area Technical Operations Manager (ATOM) stated expired and outdated solutions should not be out in the tri-station for use. 7. On 3/26/24 at 11:18 AM, when asked about the presence and use of outdated/expired conductivity solutions for testing pH and conductivity during calibration of instruments, the Medical Director (MD) reported the expectation that solutions out for use should not be expired.”

“IC USE PRECONFIG HD SYS-FOLLOW FDA LABEL CFR(s): 494.40(e) When using a preconfigured, FDA-approved hemodialysis system designed, tested and validated to yield AAMI quality (which includes standards for chemical and chlorine/chloramine testing) water and dialysate, the system’s FDA-approved labeling must be adhered to for machine use and monitoring of the water and dialysate quality. This Standard is not met as evidenced by: 36083 Based on record review, interviews, and observation, the facility failed to ensure the integrity of chemical residual test strips according to manufacturer’s direction by not storing expired supply for use, as observed for 1 of 1 container labeled, Minncare HD Residual Test Strips, placed on top of work table in the water purification area. The facility reported a census of 96 patients during the survey. Findings include: 1. The document titled, MarCor Minncare HD Disinfectant (2016), indicates that the Minncare HD Residual Test Strips may be used up to and including the last day of the month indicated by the expiration date printed on the container. 2. On 3/18/24 at 4:45 PM, Patient Care Technician (PCT) D and Registered Nurse (RN) E showed a container of Minncare HD Residual Test Strips and indicated the facility use the strips for testing residual after chemical disinfection. The container showed an expiration label of 1/16/24, with approximately 3/4 of contents remaining. PCT D and RN E verified the test strips were expired. PCT D removed the container of strips from the water purification area and stated the need to secure a new container to be used for the next test procedure. 3. On 4/21/24 at 11:40 AM, the Area Technical Operations Manager (ATOM) stated expired Minncare residual strips should be discarded and not used. The ATOM acknowledged that accuracy of test results are not guaranteed with the use of expired test strips. 4. On 3/26/24 at 11:18 AM, the Medical Director (MD) indicated surprise that expired test strips were found in the facility, especially in the immediate procedure/test area. The MD stated he was not notified about this and further stated expectation that expired supplies should be discarded.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 50072 Based on observations and interviews, on 03/18/24, surveyors observed litter throughout the treatment floor, including syringe caps in the walkways of Pod 2, creating potential slipping/tripping hazards. Syringe caps were observed on the floor in front of the island storage cabinets, a main walkway for patients to and from treatment. Medical supply wrappers were observed in walkways, with gloves and other trash on the floor around the trash cans. The facility reported a census of 96 hemodialysis patients at the time of the survey. On 03/18/24 at 1:18 pm, waste baskets (between 15 and 16; between 22 and 27) were observed overflowing with trash, gloves, plastic wrappers, plastic caps, paper cups, food/snack wrappers scattered on the floor, and dirt on the floor around cabinets/island cabinets. Surveyors observed sticky notes stuck to multiple sanitizer dispensers indicating they were not working. At 4:18 pm, PCT G, and at 5:10 pm, RN J, were observed throwing items in the direction of trash cans but missed with the items landing on the floor. Those items were left on the floor and not picked up. On 03/19/24 at 4:30 pm, surveyors observed the waiting area of the facility to have dust and dirt particles under the chairs and along the baseboards. There was an obvious line of visible dirt under the chairs consistent with not being cleaned. The floor of the entryway into the facility is an industrial carpeted surface observed to be littered with ice melt salt pellets along the baseboards and ground into the carpet. The carpet is a dark gray color that appears lighter and inconsistent in color due to the use of salt during the colder temperatures. Surveyors observed chipping paint on the walls and doorways in the entryway and waiting area. On 03/20/24 at 2:18 pm, during an interview with Staff K, they acknowledged the condition of the waiting room, and reported the appearance and cleanliness of the waiting room is something they would like to address. Staff K reported the facility contracts with a cleaning company. Staff K is aware of issues with contracting company’s poor performance but does not know what is being done for follow up.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 36083 Based on documents review, interviews, and observations, the facility did not ensure correct dialysis prescriptions during treatments for 3 of 5 patients observed (Patient #8, Patient #9, and Patient #11), and 2 of 7 patients’ medical records reviewed (Patient #2, and Patient #3). The facility reported a census of 96 patients at the time of the survey. Findings include: 1. The document titled, Pre-Treatment Safety Checks Procedure, dated 2/6/23, provides guidance for performing pre-treatment safety checks prior to each hemodialysis treatment. The document indicates verification of prescriptions to include the following: prior to treatment initiation - dialysate flow rate, dialysate composition by verifying that machine is connected to an acid concentrate that matches prescription, and displayed machine temperature; after the patient is seated - dialysate composition, dialysate flow rate, time, and temperature; prior to turning on the blood pump - the dialysate and blood flow should be moving in opposite directions. The document directs staff members to document completion of the pre-treatment safety checks in the patient’s medical record. 2. During prescription verifications on 3/19/24, observations showed patients’ prescriptions were not followed during treatments as follows: -At 12:50 PM, Patient #8’s treatment was ongoing at station #6. Patient Care Technician (PCT) F showed Patient #8’s prescription including blood flow rate (BFR) of 400. However, Patient #8’s actual ongoing BFR was set at 350. PCT F denied setting the BFR, saying, “I did not change it, probably the nurse did.” -At 3:48 PM, Patient #9 was at station #7 with an ongoing treatment. PCT F showed Patient #9’s prescription to include dialysate of 3 K (Potassium) and 2.5 Ca (Calcium), and a BFR of 425. However, Patient #9’s treatment was running at 2 K and 2.5 Ca, and with a BFR of 400. PCT F verified Patient #9 was on the wrong dialysis bath (dialysate), and then PCT F immediately moved the connector to the 3 K and 2.5 Ca port. PCT F also verified Patient #9 had been on the wrong bath and BFR since treatment started at 12:50 PM, until the observation time (3 hours). -At 3:50 PM, PCT G showed Patient #11’s prescription for the ongoing treatment at station #20, to include temperature of 37. However, PCT G also verified that Patient #11’s actual treatment was with temperature set at 35.5. 3. Review of patients’ medical records also showed the following: A) Patient #8’s treatment flowsheets on 3/19/24, showed prescription including a BFR of 400. The treatment flowsheets showed Patient #8 started treatment at 10:25 AM with a BFR of 400 but at 12:30 PM, the BFR was lowered to 350 without documentation of the rationale. B) Patient #9’s treatment flowsheets on 3/19/24, showed prescription for dialysate of 3 K and 2.5 Ca and BFR of 425. The treatment flowsheets showed Patient #9 started treatment at 12:49 PM with BFR of 400, however, the documentation lacked indication that Patient #9 did not actually receive the prescribed dialysate, as found during observation. C) Patient #11’s treatment flowsheets on 3/19/24, showed prescription for temperature of 37. The treatment flowsheets lacked indication that Patient #11’s actual treatment was run at a temperature of 35.5. D) Patient #2’s patient transfer document (Kardex) showed prescription dated 2/16/24, with BFR of 400, dialysate flow rate (DFR) of 800, and treatment time of 3.5 hours. Patient #2’s treatment flowsheets on 3/18/24, also showed the prescribed BFR as 400 and DFR as 800. However, the treatment flowsheets on the same date (3/18/24), showed that Patient #2 dialyzed with incorrect BFR at 350 and DFR at 600 for the whole duration of the treatment (3 hours and 30 minutes). E) Patient #3’s patient transfer document (Kardex) showed prescription dated 3/15/24, with BFR of 450 and treatment time of 3.5 hours. Patient #3’s treatment flowsheets on 3/15/24 also showed the prescribed BFR as 450, however, Patient #3 dialyzed with incorrect BFR of 300 for the duration of treatment (3 hours and 27 minutes). 4. On 3/25/24 at 1:44 PM, the Clinical Manager (CM) verified the entries in the above-patients’ treatment flowsheets, which indicated when they did not dialyze according to prescriptions. The CM acknowledged the importance of following treatment prescriptions, and to document and notify the physician of any errors or deviation from the orders.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 50072 Based on record and policy review, observations and interviews, the facility failed to ensure staff are completing comprehensive assessments on all patients, including pre and post treatment standing blood pressures for all patients in accordance with the facility’s policy. The facility reported a census of 96 hemodialysis patients at the time of the survey. Findings for review of 3 of 4 medical records dated 03/05/24-03/16/24 include the following: Medical record review shows Patient #7 did not have a pre-treatment standing blood pressure on 03/02/24, 03/07/24, 03/09/24, or 03/14/24. Medical record review for Patient #6 shows no standing pre-treatment blood pressure on 03/06/24, and no standing post treatment blood pressure on 03/06/24. Patient #5’s medical records were reviewed and indicate no standing pre or post blood pressures on 03/09/24 or 03/16/24. On 03/26/24 at 9:38 am, during an interview with Facility Administrator (FA), it was reported blood pressures are supposed to be checked pre and post treatments. “The goal is for them to always have a pre and a post, sitting and standing” blood pressure. The FA indicated if the post dialysis blood pressure is greater than 140, the patients sits for a few minutes and is rechecked.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 36083 Based on documents review, and interview, the facility failed to investigate and analyze root causes of trends related to patients’ deaths considering their relationship to patients’ dialysis treatments for 5 of 5 months (September 2023, October 2023, November 2023, December 2023, and January 2024) mortality data under the Quality Assessment and Performance Improvement (QAPI) program. The facility reported a census of 96 patients at the time of the survey. Findings include: 1. The policy titled, Quality Assessment and Performance Improvement Program (QAPI), dated 5/2/22, indicates the QAPI program must develop, implement, maintain, and evaluate an effective data-driven quality assessment and performance improvement program. The policy indicates the QAPI program is a continuous ongoing process that “includes monitoring the data, prioritizing areas of improvement, determining root causes, developing action plans, and focusing on patient safety and improving outcomes.” The policy enumerates the elements to be reviewed under the program including patient care outcomes. 2. The facility’s mortality data showed a trend for “unknown” cause of death as follows: 1 in September 2023, 1 in October 2023, 1 in December 2023, and 2 in January 2024. The QAPI documentation does not show root cause investigation and analysis for this trend. 3. The facility reported the dates of deaths for 3 patients sampled as identified in the trend (unknown cause of death) are as follows: Patient #12 on 9/5/23, Patient #13 on 12/22/23, and Patient #14 on 1/20/24. 4. The medical records requested for review for 3 of 3 patients’ deaths in the sample for “unknown” cause of death, include 2 weeks treatment records prior to death, and 2 months of interdisciplinary (IDT) notes/clinical notes prior to death, showed the following: A) Patient #12’s clinical notes dated 9/12/23, indicated Patient #12 expired on 9/5/23. The QAPI records did not indicate facility’s review or investigation and analysis of Patient #12’s death.. B) Patient #13’s IDT/clinical notes dated 12/23/23, indicated Patient #13 was was found deceased at home. The QAPI records did not indicate the facility’s review or investigation and analysis of Patient #13’s death. C) Review of Patient #14’s medical records included clinical notes dated 1/23/24. The notes showed Patient #14 passed away the prior night. The QAPI documentation lacked information that showed the facility staff reviewed Patient #14’s death. 5. On 3/25/24 at 1:44 PM, the Clinical Manager (CM) indicated lack of thorough or in-depth review and analysis of individual patients’ cause of death, which could lead in identifying trends. The CM acknowledged facility data showed a trend for “unknown” cause of death and the lack of investigation and analysis of the data. The CM also acknowledged the importance of data analysis, identifying issues or areas for improvement, and developing and implementing action plans to address these issues. 6. On 3/26/24 at 11:17 AM, the Medical Director (MD) reported mortality is among the areas of concern that the facility needs to addressin QAPI.”