Veritas Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 33921 Based on observations, staff interviews, a review of Centers for Disease Control and Prevention (CDC) guidelines, and a review of facility Policy and Procedures (P&P), it was determined that the facility failed to ensure that the staff practiced infection control techniques to prevent transmission of dangerous pathogens in the hemodialysis unit. This deficient practice had the potential to negatively affect the health and safety of all 44 in-center hemodialysis patients who were receiving dialysis treatment at this facility. Findings include: Cross references: V 113 - Failure of Registered Nurse (RN AA) to change gloves and perform hand hygiene between patients and/or patient stations. V 115 - Failure of RN AA to wear appropriate Personal Protective Equipment (PPE) during intiation of hemodialysis treatment to a patient (P#5) with a Central Venous Catheter (CVC). V 122 - Failure of Direct Patient Care Staff (RN AA), Licensed Practical Nurse (LPN AA) and Patient Care Technicians (PCTs AA, BB, CC and DD) to clean and disinfect surfaces that were contaminated with blood or body fluids.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 33921 Based on observation, staff interview, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis), and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that one of one Patient Care Technician (PCT AA) observed, who was assigned the task of testing the water quality and one of one Registered Nurse (RN AA), who was responsible for validating the test result, performed and validated, respectively, the Total Chlorine Test according to the manufacturer’s DFU. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis) and had the potential to cause harm to six in-center hemodialysis patients (P), (P#1, P#2, P#3, P#5, P#6, and P#7) who were undergoing hemodialysis treatment at the time of this observation. The facility census was 44. Findings include: Cross References: V 196 - Failure of the facility to follow the manufacturer’s DFU to accurately determine the level of Total Chlorine in the water used for dialysis.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 33921 Based on observations, facility record review, staff interviews, and a review of the Centers for Disease Control and Prevention (CDC) Recommendations, 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 44 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross References: V 113 - Failure of Registered Nurse (RN AA) to change gloves and perform hand hygiene between patients and/or patient stations. V 115 - Failure of RN AA to wear appropriate Personal Protective Equipment (PPE) during intiation of hemodialysis treatment to a patient (P#5) with a Central Venous Catheter (CVC). V 122 - Failure of Direct Patient Care Staff (RN AA), Licensed Practical Nurse (LPN AA) and Patient Care Technicians (PCTs AA, BB, CC and DD) to clean and disinfect surfaces that were contaminated with blood or body fluids. V 196 - Failure of the Governing Body to ensure that Direct Patient Care Staff (Patient Care Technician - PCT AA and Registered Nurse - RN AA) responsible for monitoring and validating, respectively, the level of Total Chlorine in the water used for dialysis. V 556 - Failure of the facility to complete an individualized Plan of Care that reflected participation and collaboration of the entire IDT including the patient or patient representative.”

“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: 33921 Based on observation, staff interview, and a review of the Centers for Disease Control and Prevention (CDC) recommendations, it was determined that the Infection Control Committee failed to ensure that one of one Registered Nurse (RN AA) observed, removed contaminated gloves, performed hand hygiene, and changed gloves between patient Stations (S). Failure to perform infection control techniques such as hand hygiene and glove changes, increases the risk for cross contamination with the potential to expose patients and staff to blood-borne pathogens in the dialysis environment. This breach in infection control techniques could negatively affect the health and safety of 44 in-center hemodialysis patients who were under the care of this facility. Findings include: During observation in the Patient Treatment Room on 12/6/23 between 10:20 a.m. and 12:45 p.m., the following was revealed: - RN AA administered Heparin IV Bolus (anticoagulant) to a patient at (S8) and discarded the used syringe at the Sharps Container located at S9. Then without changing gloves, and without performing hand hygiene, RN AA touched the machine at S9 to reset the machine alarm. 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 ... RN AA acknowledged breach in infection control techniques (not changing gloves and not performing hand hygiene between glove changes), between patient stations, on 12/7/23 at 12:40 p.m., but did not make a comment.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 33921 Based on observation, a review of the facility’s Policy and Procedure (P&P), and staff interview, it was determined that the facility failed to ensure that one of one Registered Nurse (RN AA) observed, wore appropriate personal protective equipment (PPE) during the initiation of patient’s, (P), (P#5’s) hemodialysis treatment through a Central Venous Catheter (CVC). This deficient practice had the potential to negatively affect the health and safety of RN AA. Findings include: During observation in the Patient Treatment Room on 12/6/23 between 10:20 a.m. and 12:45 p.m., the following was revealed: - RN AA was observed during the initiation of hemodialysis treatment of P#5 with a CVC, at Station (S), (S3). RN AA was not wearing a faceshield or eye goggles. - A review of the facility’s P & P: DCC-IC-DA-400-006, titled, “Initiating Dialysis Treatment with a Central Venous Catheter using ClearGuard HD Antimicrobial End Caps”, with latest revision date of April 25, 2023, stated: VI. Procedure: 2. Perform hand hygiene to prevent contamination and spread of infection. Put on appropriate PPE (staff): gown, face-shield, mask, and gloves. During an interview with RN AA on 12/7/23 at 12:40 p.m., she acknowledged with a nod, regarding the above observation but did not make a comment.”

“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: 33921 Based on observation, staff interviews, a review of Centers for Disease Control and Prevention (CDC) guidelines, and a review of the facility’s policies and procedures (P & P), it was determined that the facility failed to ensure that one of one Registered Nurse (RN AA), one of one Licensed Practical Nurse (LPN AA) and four of four Patient Care Technicians (PCTs AA, BB, CC, and DD), who were present during this observation, immediately and thoroughly cleaned and disinfected blood-contaminated surfaces on the cover of two of 10 sharps containers observed, between patient use. This failure could lead to the transmission of dangerous pathogens through cross contamination. This deficient practice had the potential to negatively affect the health and safety of six of six in-center hemodialysis patients (P) (P#1, P#2, P#3, P#5, P#6, and P#7), who were undergoing hemodialysis treatment at the time of this observation. Findings include: During observation in the Patient Treatment Room on 12/6/23 between 10:20 a.m. and 12:45 p.m., there were two sharps containers observed between Stations (S), S9 and S10, and between S14 and S15 that had one - three dried drops of blood on the top covers of the sharps containers, and were not cleaned and disinfected between patient use. According to CDC guidelines, failure in environmental cleaning and disinfection have led to transmission of bloodborne pathogens (e.g., Hepatitis B virus) and other infections from one patient to another in hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including floors, patient chair or bed surfaces, dialysis equipment surfaces, adjacent tables and work surfaces, etc., especially with blood splatters) must be performed between patient uses to prevent transmission of dangerous pathogens. A review of the facility’s P and P: DCC/HDS-IC-HD-240-015, titled, “Disinfecting the Exterior Surface of the Fresenius 2008K”, with issue date of April 2, 2018, stated: 4. If visible soiling of blood or body fluids is present, clean the visibly soiled areas by scrubbing vigorously with a 1:10 bleach solution, taking care to prevent excess moisture from reaching sensitive electronics. There was no specific facility Policy and Procedure provided for cleaning and disinfecting top covers of sharps containers soiled with blood between patient use. When LPN AA was notified of this observation, she stated on 12/6/23 at approximately 11:00 a.m., “Okay, I’ll take care of that”. When notified of this observation, PCT CC stated on 12/6/23 at approximately 11:05 a.m., “okay”.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 33921 Based on observation, staff interview, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis), and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that one of one Patient Care Technician (PCT AA) observed, who was assigned the task of testing the water quality and one of one Registered Nurse (RN AA), who was responsible for validating the test result, performed and validated, respectively, the Total Chlorine Test according to the manufacturer’s DFU. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis) and had the potential to cause harm to six in-center hemodialysis patients (P), (P#1, P#2, P#3, P#5, P#6, and P#7) who were undergoing hemodialysis treatment at the time of this observation. The facility census was 44. Findings include: During observation of PCT AA’s performance of the Total Chlorine test on 12/6/23 at 2:00 p.m., the following was observed: - PCT AA was observed performing the Total Chlorine Test using RPC Ultra Low Total Chlorine Test strip (K100-0118) on 12/6/23 at 2:00 p.m. PCT AA informed this surveyor that she was going to swish the test strip in the water sample for 60 seconds, then compare the test strip to the color chart. PCT AA then proceeded to perform the Total Chlorine Test by swishing the test strip for 60 seconds and immediately compared the test strip to the color chart. RN AA who validated the test result did not correct PCT AA regarding the need to wait 20 seconds for the color to develop. - A review of the manufacturer’s DFU, stated to wait 20 seconds before comparing the result to the color chart for the test strip color to develop. - A review of the facility’s Policy: DCC-IC-WS-950-005 titled, “Testing for Total Chlorine using the RPC Ultra Low Total Chlorine Test Strips”, with latest revision date of December 28, 2020, stated: 4. Remove the test strip and shake once briskly, to remove excess water. 5. Wait 20 seconds for the test strip color to develop... 6. After the 20 second wait period, immediately compare the strip color to the color chart to determine the Total Chlorine level in the sample... PCT AA, stated on 12/6/23 at 2:10 p.m., that she forgot to wait for 20 seconds before comparing the strip color to the color chart. RN AA remained quiet during this interview. The Clinic Manager was notified of this observation on 12/6/23 at 2:25 p.m., and he stated that the staff should follow the facility’s Policy and Procedure for an accurate Total Chlorine Test result.”

“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: 33921 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 maintained free from damage and defects to ensure the safety of the patients and staff. This failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus providing a potential for microbial growth. This deficient practice was observed in one of one Dialysate Preparation Room. Findings include: During observation in the Dialysate Preparation Room on 12/7/23 at 11:50 a.m., the following was observed: - The bottom of the booster pump was covered with a rust-colored substance. - The floor around the Acid Mixing Tank and the Acid Holding tank, as well as the connection pipes, were covered with dried, white sediment. - The floor surface towards the supply entrance/exit door, was chipped and peeled off, exposing the porous subfloor, which could hinder effective cleaning and disinfection thus providing a potential for microbial growth. - The Area Biomedical Technician acknowledged these observations on 12/7/23 at 11:50 a.m., and stated that these issues needed to be fixed.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 33921 Based on medical record review, a review of facility policy, and staff interview, it was determined that the facility failed to ensure that two of two in-center hemodialysis (ICHD) patients (P), (P#3 and P#4) sampled who were due for Patient Plan of Care, had Care Plans that reflected participation of all members of the Interdisciplinary Team (IDT), including the patient or patient representative. This lack of IDT collaboration and participation had the potential failure to identify new patient concerns and outcomes that were not achieved. This deficient practice had the potential to negatively affect the health and safety of all 44 patients who were under the care of this facility. Findings include: During a review of patients’ medical records, the following was revealed: - P#3 was admitted on 10/20/23 with a diagnosis of End Stage Renal Disease (ESRD) and was receiving hemodialysis treatment three times per week. The Initial Care Plan did not reflect IDT collaboration, there was no date of meeting, no IDT signatures and there was no evidence that P#3 (or P#3’s representative) was included in the development nor discussion of this initial care plan as required. The Social Worker notes dated 11/6/23, stated: Unable to complete KDQOL (Kidney Disease Quality of Life) and PHQ2 (Patient Health Questionnaire-2) due to “diminished cognition”. Social Worker evaluation report was dated, 12/7/23. Registered Dietitian evaluation report was dated 11/15/23, and Registered Nurse Evaluation report was dated 11/30/23. - P#4 was admitted on 2/7/22 with a diagnosis of ESRD and was receiving hemodialysis treatment three times per week. The Care Plan presented to this surveyor was for P#4’s 90-day re-assessment and care plan, which was dated 7/27/23 as finalized, but there was no date of the actual meeting and there were no IDT signatures, no patient or patient representative signature. There was no evidence that P#4 (or P#4’s representative) was included in the development nor discussion of this care plan as required. In addition, there was no current annual care plan available, and there was no evidence of patient participation. The Clinical Manager stated on 12/8/23 at approximately 3:00 p.m., that the Care Plans should have reflected participation of all members of the IDT, including the patient or patient representative with a documentation of the actual meeting date.”