Emory Dialysis at Candler

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 33921 Based on observations, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and a review of facility Policy and Procedures (P&P), it was determined that the 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 139 in-center hemodialysis patients who were receiving dialysis treatment at this facility. Findings include: Cross references: V 114 - Failure of the facility to ensure that two of four sinks (near Stations 1B and 1A) designated as “clean” sinks, had warm water available to facilitate hand washing. V 122 - Failure of Direct Patient Care staff [Charge Nurse, Registered Nurse (RN) AA, RN BB, RN CC, RN DD, Patient Care Technician (PCT) AA, PCT BB, PCT CC, PCT DD, PCT EE, PCT FF, PCT GG, and Lab Technician] to clean and disinfect surfaces that were contaminated with blood or body fluids; and surfaces that could become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients. V 128 - Failure of the Direct Patient Care staff, (RN EE, PCT BB and PCT CC) to close the door of the isolation room during initiation and discontinuation of hemodialysis treatment when there was a potential for splattering of blood, body fluids, and other contaminates. V 130 - Failure of PCT BB, PCT CC and RN EE to practice infection control techniques while caring for Hepatitis B Virus positive patients (P#24 and P#25) in the Isolation Room, and failure of the facility to provide dedicated equipment such as Myron L for use in the Isolation Room and failure of PCT BB to disinfect the Myron L after use and for placing them back in the clean area of the general patient population. In addition, the clean supplies in the Isolation Room was too close to the patients’ station with risk for cross contamination. V 147 - Failure of RN EE to practice infection control techniques during initiation of hemodialysis treatment of P#24 who had a Central Venous Catheter (CVC) as his primary access, in the isolation room.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 33921 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis), and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that four of four Patient Care Technicians (PCTs DD, EE, FF, and GG) observed, who was assigned the task of testing the water quality, performed the Total Chlorine Test according to the manufacturer’s DFU and facility procedure; and failure of Registered Nurse (RN) EE and PCT BB to test the dialysate’s pH (test for acid) and conductivity (test for the ability of the dialysate to conduct electricity) after switching the patient’s (P) (P#24) dialysate’s strength/concentration. These deficient practices had the potential to cause harm to 15 of 15 in-center hemodialysis patients (P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, P#22, P#23, and P#24) who were undergoing hemodialysis treatment at the time of this observation. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis). Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. And if conductivity is off, the effectiveness of the treatment is reduced and patient electrolyte balance could be altered. The facility census was 139. Findings include: Cross References: V 196 - Failure of Patient Care Technicians (PCTs DD, EE, FF, and GG), to correctly test the dialysis water for Total Chlorine. V 250 - Failure of PCT BB and RN EE to independently re-test the dialysate’s pH and conductivity after changing the dialysate’s concentration/strength, and failure of PCT BB and RN EE to know the acceptable ranges for both pH and conductivity. V 260 - Failure of PCT BB and RN EE to know the acceptable ranges for both pH and conductivity to ensure that the results were within range and safe.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 33921 Based on observations, facility record review, staff interviews, a review of the manufacturer’s Directions for Use (DFU) and a review of facility Policies and Procedures (P & P), it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 139 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross References: V 122 - Failure of Direct Patient Care Staff [Charge Nurse, Registered Nurse (RN) AA, RN BB, RN CC, RN DD, Patient Care Technician (PCT) AA, PCT BB, PCT CC, PCT DD, PCT EE, PCT FF, PCT GG, and Lab Technician] to clean and disinfect surfaces that were contaminated with blood or body fluids; and surfaces that could become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients. V 128 - Failure of the Direct Patient Care (DPC) staff, (RN EE, PCT BB and PCT CC) to close the door of the isolation room during initiation and discontinuation of hemodialysis treatment when there was a potential for splattering of blood, body fluids, and other contaminates. V 130 - Failure of PCT BB, PCT CC and RN EE to practice infection control techniques while caring for Hepatitis B Virus positive patients (P#24 and P#25) in the Isolation Room, and failure of the facility to provide dedicated equipment such as Myron L for use in the Isolation Room and failure of PCT BB to disinfect the Myron L after use and for placing them back in the clean area of the general patient population. In addition, the clean supplies in the Isolation Room was too close to the patients’ station with risk for cross contamination. V 147 - Failure of RN EE to practice infection control techniques during initiation of hemodialysis treatment of P#24 who had a Central Venous Catheter (CVC) as his primary access, in the isolation room. V 196 - Failure of Patient Care Technicians (PCTs DD, EE, FF, and GG), to correctly test the dialysis water for Total Chlorine. V 250 - Failure of PCT BB and RN EE to independently re-test the dialysate’s pH and conductivity after changing the dialysate’s concentration/strength, and failure of PCT BB and RN EE to know the acceptable ranges for both pH and conductivity. V 260 - Failure of PCT BB and RN EE to know the acceptable ranges for both pH and conductivity to ensure that the results were within range and safe.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 32734 Based on observation, a review of the Centers for Disease Control (CDC) recommendations and staff interview, it was determined that the facility failed to ensure that two of four handwashing sinks (near Station (S) 1B and S1A) in one of one patient treatment room were in good working condition, to encourage seven direct patient care staff and the ancillary staff who interacted with the patients on the treatment floor such as the social worker; dietitian; and physicians to wash their hands according to the CDC recommendations; and that warm water was available for 139 patients to wash their hands and access sites prior to treatment and their hands after treatment. Failure to perform hand hygiene/handwashing and failure to wash access sites increased the risks for contaminant transmission. Findings include: During a tour of the patient treatment room on 9/24/24 at 11:53 a.m., it was observed that the handwashing sinks, designated as “clean” sinks near S1B and S1A had no warm or hot water after running for more than three minutes. According to the CDC, handwashing is the most important measure to prevent contaminant transmission. During an exit interview on 10/2/24 at 4:30 p.m., the clinical manager was advised and acknowledged that the water in the sinks did not warm up.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and a review of policies and procedures (P&P), it was determined that the Infection Control Committee (ICC) failed to ensure that one of one Charge Nurse (CN), four of four Registered Nurses (RN) (RN AA, RN BB, RN CC, RN DD), seven of seven Patient Care Technicians (PCT) (PCT AA, PCT BB, PCT CC, PCT DD, PCT EE, PCT FF, PCT GG), and one of one Laboratory Technician (LT) who were present during this observation, immediately and thoroughly cleaned and disinfected surfaces contaminated with visible blood on the cover and outside of four of four sharps containers and three of three trolleys (used to roll/move large sharp containers from one station to another station) in Bay Area A1, Bay Area A2, Bay Area B1, Bay Area B2, and in the laboratory (lab) area. This failure to immediately (or as soon as possible) clean visible blood had the potential to lead to the transmission of dangerous pathogens through cross-contamination; and had the potential to negatively affect the health and safety of twenty three patients (P) (P#1, P#2, P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, P#22, and P#23), who were undergoing hemodialysis treatment at the time of this observation. In addition, the ICC also failed to ensure that six of 38 dialysis wall boxes (frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water, and dispose of waste products) were cleaned and disinfected at least daily and more frequently (when visibly dirty) to decrease risk of patient infections. The facility census was 139. Findings include: During observation in the patient treatment area on 9/24/24 from 11:00 a.m. to 12:36 p.m., the following was revealed: Sharps Containers: - There were three large sharps containers in trolleys and one medium sharps container in Bay Area A1, Bay Area A2, Bay Area B1, Bay Area B2, and in the lab area. - These sharps containers and trolleys had numerous splattered blood droplets, dime sized and quarter sized blood on the plastic top and sides of the sharps containers and trolleys. These were not cleaned and disinfected between patient use. During an interview with the LT on 9/24/24 at 11:15 a.m., it was revealed that sharps containers are removed from the lab when they are full. The sharps container was never wiped down. An interview with PCT FF on 9/24/24 at 11:30 a.m., revealed that the sharp containers or trolleys were never wiped down. PCT FF stated that they were changed out when they were full. During an interview with PCT GG on 9/24/24 at 11:45 a.m., it was revealed that sharps containers should be wiped down throughout the day or if blood was on the outside of the container. During an interview with the CN on 9/24/24 at 12:36 p.m., it was revealed that she was unsure if sharp containers or trolleys should be wiped down after each patient’s use, but the containers are to be wiped down at the end of the treatment day. According to the CDC guidelines, failure in environmental cleaning and disinfection has led to the transmission of bloodborne pathogens (e.g., Hepatitis B virus) and other infections from one patient to another in hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including floor, sharps containers, patients’ chairs or bed surfaces, dialysis equipment surfaces, etc., especially with blood splatters) must be performed between patient use to prevent transmission of dangerous pathogens. A review of the facility policy titled, “Bloodborne Pathogens & Hazard Communications” developed on 3/8/24 using the Occupational Health and Safety Administration (OSHA) bloodborne pathogens standard showed the following: Page 10: All contaminated work surfaces will be disinfected after completion of procedures, between patients, immediately (or as soon as feasible) after any spill of blood or OPIM (other potentially infectious materials), and at the end of the workday. The required surfaces include but are not limited to, the chairs, machines, BP (blood pressure) cuffs, and other equipment used. A review of the facility’s “Infection Control and Prevention Plan” developed on 3/27/24 showed: Page 4: All reusable supplies, including clamps, blood pressure cuffs, stethoscopes, etc., are disinfected between patients and when visibly soiled. Any blood or body fluid spills should be cleaned immediately. Absorbent towels should be used to soak up the spill. Then, the area should be thoroughly cleansed with a bleach solution, or other approved disinfectant, as per facility policy. Dialysis Wall Boxes: - There were white residue and sediment on the chase wall boxes located at Station (S) 1D, S4D, S5D, S6D, S7D, and S8D. The CN was notified of the above findings on 9/24/24 at 12:45 p.m. According to the CDC, there are several infection prevention and control issues unique to wall boxes. They can become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients, a vulnerable group at high risk of infection. Thus, wall boxes need to be cleaned, disinfected, and properly maintained to decrease risk of patient infections. Wall box surfaces should be disinfected at least daily (at the end of the day after all patients have dialyzed); cleaning and disinfection might be needed more frequently (when visibly dirty). Wall boxes contributed to a large number of infections in patients on dialysis in “Multicenter Outbreak of Gram-Negative Bloodstream Infections in Hemodialysis Patients”.”

“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: 33921 Based on observation and staff interviews, it was determined that the facility failed to ensure that the isolation room door during two of two Hepatitis B positive patients’ (P #24 and P#25), initiation and discontinuation of hemodialysis treatment, remained closed to prevent possible splatters of blood, body fluids, and other contaminates and to prevent cross contamination to the areas outside of the isolation room. Findings include: During an observation in the Patient Treatment Room on 9/25/24 between 10:40 a.m. 11:10 a.m., the following was revealed: - PCT CC was observed during discontinuation of P#25’s hemodialysis treatment (at Isolation Room #1). PCT CC left the Isolation Room door open while he was disconnecting P#25’s used bloodlines and while removing P#25’s fistula needles. This failure to close the Isolation Room door had the potential for splattering of blood and body fluids during disconnection of used bloodlines and fistula needles. - On 9/30/24 between 11:50 a.m. and 1:25 p.m., the following was revealed: - P#24 was brought to the Isolation Room #1 via a stretcher. The Isolation Room door was stuck and could not be closed because the Transport personnel had difficulty trying to get P#24 into his dialysis chair. The Biomed Technician came (after the Transport personnel left) and was able to unstock the door so it could be opened or closed. - During initiation of P#24’s dialysis treatment using a Central Venous Catheter, (when there was a potential for splattering of blood and body fluids), the isolation door remained open the whole time (even after the isolation door was fixed). PCT BB and RN EE stated on 9/30/24 at approximately 12:30 p.m., that they forgot to close the door.”

“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: 33921 Based on observation, staff interviews, and a review of facility policy, it was determined that the Infection Control Committee failed to ensure that a dedicated equipment such as Myron L (an equipment used to test pH - test for dialysate acidity and conductivity - test for the ability of the dialysate to conduct electricity) was available for use in the Isolation Room to prevent cross contamination. Failure to practice infection control techniques and not having a dedicated Myron L for isolation patient use, increased the risk of cross contamination with the potential to expose all susceptible Hepatitis B surface Antigen patients who dialyzed at this facility and all susceptible staff, to Hepatitis B Virus. The facility census was 139. Findings include: - During observation on 9/30/24 at 11:55 a.m., PCT BB stated that she had to use the Myron L from the general patient population because there was no dedicated Myron L for isolation room use only. PCT BB further stated that she had to get another one from the general patient population again because the first Myron L she used did not work. After using both Myron L equipment, PCT BB returned both Myron L back to the clean counter in the middle of the Treatment floor next to the clean supplies and computer without disinfecting both Myron L equipment. - When this observation was brought to the attention of PCT BB on 9/30/24 at approximately 12:10 p.m., she stated that she forgot to disinfect them. - It was also observed by this surveyor on 9/30/24 at 12:20 p.m., that the backrest of P#24’s hemodialysis chair was barely touching the back wall counter where the clean supplies were stored. This had the potential for cross contamination between P#24’s station (considered dirty) and the clean supplies. - This was brought to the attention of RN EE and PCT BB on 9/30/24 at 12:30 p.m., who stated that the Isolation Room was very small and they didn’t know where to put the clean supplies. - After performing assessment of P#24’s lungs and heart sounds using her stethoscope, RN EE did not disinfect her stethoscope after assessment, instead RN EE slung her stethoscope around her neck after patient use. - After initiating P#24’s hemodialysis treatment, RN EE reminded PCT BB to change the standard bath to P#24’s prescribed bath. PCT BB had removed her isolation gown, and without wearing her isolation gown, PCT BB reached behind the back of P#24’s chair to disconnect the lines from the chase box (or a dialysis wall box which is a frame recessed into the wall at each dialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water, and dispose of waste products. Failure to wear a gown as a personal protective equipment had the potential for PCT BB to be exposed to contaminated surfaces and fluid. - A review of facility Procedure (no number), titled, “ Infection Control Practices for Hemodialysis”, with latest revision date of 5/2023, stated: Cleaning and Disinfection Practices: - Non-disposable equipment (... stethoscope, Phoenix Meters, Myron L...) taken to the patient’s station must be disinfected with a 2:100 bleach solution for a minimum of 1 full minute... There was no specific procedure for isolation room practices nor any mention of dedicated equipment for isolation room use.”

“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: 33921 Based on observation, a review of the Centers for Disease Control and Prevention (CDC) guidelines and recommendations, a review of facility Procedures, and staff interview, it was determined that the Infection Control Committee failed to ensure that one of one Registered Nurse, (RN EE), observed during initiation of hemodialysis (HD) treatment on one of one Patient, (P), (P#24), who had a Central Venous Catheters (CVCs), utilized appropriate infection control techniques in the isolation room to prevent cross contamination. This breach in infection control techniques could negatively affect the health and safety of P#24 and other patients who had CVCs, as their primary dialysis access. The facility had 139 in-center hemodialysis patients. Findings include: During observation in the Patient Treatment Room (Isolation Room #1) on 9/30/24 between 11:50 a.m. and 12:30 p.m., the following was revealed: - RN EE returned used gauze, alcohol pads and swabs (dirty), as well as bloody syringes (used to draw the old blood and Heparin lock from the catheter limbs, back to the white liner where the other clean supplies were located (such as Heparin syringe, Normal Saline prefilled syringes and clean gauze). - According to the CDC, cross contaminating (going from dirty to clean tasks), could cause the spread of bacteria/infections. - During a discussion with RN EE on 9/30/24 at approximately 12:25 p.m., she acknowledged the potential for cross contamination when returning used supplies back to the clean liner with the other clean and sterile supplies.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 33921 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis), and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that four of four Patient Care Technicians (PCTs DD, EE, FF, and GG) observed, who was assigned the task of testing the water quality performed the Total Chlorine Test according to the manufacturer’s DFU and facility procedure. 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 14 of 14 in-center hemodialysis patients (P), (P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, P#22, and P#23) who were undergoing hemodialysis treatment at the time of this observation. The facility census was 139. Findings include: During observation of each PCT’s (PCTs DD, EE, FF, and GG) performance of the Total Chlorine test on 9/24/24 between 12:20 p.m. and 1:10 p.m., the following was observed: - PCT DD was observed performing the Total Chlorine Test using RPC Ultra Low Total Chlorine Test strip (K100-0118). PCT DD checked the RO (Reverse Osmosis) water temperature located at the front panel of the RO, which registered at 77 degrees Fahrenheit (F). Then PCT DD proceeded to perform the Total Chlorine Test by swishing the test strip for 20 seconds and immediately compared the test strip to the color chart after folding the test strip. When asked if she was supposed to wait for the color to develop, she stated, “No, we compare the test strip to the color chart immediately”. - PCTs EE, FF, and GG were also observed consecutively, one at a time. All three PCTs stated at 12:30 p.m., 12:45 p.m. and 1:10 p.m., respectively, that they compare the test strip to the color chart immediately after taking the strip out of the sample water and after shaking it once briskly. All four PCTs stated that they bring the resulted test strip to the Charge Nurse in the Patient Treatment Room for validation after the Total Chlorine test. NOTE: This surveyor observed that by the time PCTs (DD, EE, FF, and GG) compared the strip to the color chart, the 20 seconds wait had lapsed, while the four PCTs were trying/fumbling to fold the strip. During this time, all four PCTs did not look at the clock to wait for 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 Procedure (no number), titled, “Total Chlorine Test Ultra-Low Total Chlorine Test Strips”, with latest revision date of 3/2020, (noted below the first page “@Copyright RPC Ultra-Low Total Chlorine Test Strips), stated: 1. Collect a fresh 100 mL sample of water from location to be tested... 2. Check and document the Temp from the front panel. 3. Remove one test strip from its foil package and dip it in the water sample for the amount of time indicated according to the temp of the sample. POINTS OF EMPHASIS: 75 degrees F to 88 degrees F dip sample for 20 seconds... 5. Remove the strip and shake once, briskly, to remove excess water. 6. Wait 20 seconds for the test strip color to develop. 7. After the 20 second wait period, immediately compare the strip color to the color chart to determine the Total Chlorine level in the sample.... POINTS OF EMPHASIS: While waiting, fold the white plastic handle of the test strip under the test pad area so that it provides a consistent viewing background...”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 33921 Based on observation, staff interviews, and a review of facility records, it was determined that the facility failed to ensure that there was a safe environment for one of one patient, (P#24) observed, as evidenced by failure of one of one Patient Care Technician (PCT BB), and one of one Registered Nurse (RN EE) observed, to correctly verify the hemodialysis (HD) machine’s dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), when changing the concentration of P#24’s dialysate according to the manufacturer’s Directions For Use (DFU) and facility’s procedure. This failure had the potential to negatively affect the health and safety of P#24. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. And if conductivity is off, the effectiveness of the treatment is reduced and patient electrolyte balance could be altered. Findings include: During observation in the Patient Treatment Room on 9/30/24 between 11:50 a.m. and 1:25 p.m., the following was revealed: - PCT BB was observed independently verifying the dialysate’s conductivity and pH using the Myron L Conductivity Meter at Isolation Room #1. The dialysate sample taken from the machine was at a 2K/2.5 Ca (K - potassium; Ca - Calcium) concentration (standard bath) from the wall. P#24 was assessed and prepared for initiation of hemodialysis by RN EE, assisted by PCT BB. When P#24’s treatment was initiated by RN EE, she reminded PCT BB to change P#24’s bath (dialysate) with his specifically ordered strength/concentration that was 3K/2.5 Ca. PCT BB changed the dialysate to the prescribed bath (that was in a jug). PCT BB left the Isolation Room and did not re-check the new dialysate’s pH and Conductivity (with the new concentration/strength), and was not reminded by RN EE to re-check pH and conductivity. - PCT BB and RN EE acknowledged on 9/30/24 at 12:45 p.m. that the pH and conductivity should have been re-checked whenever the dialysate’s concentration/strength was changed.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 33921 Based on observation, staff interviews and a review of facility records, it was determined that the facility failed to conduct personnel audits, specifically, of the operation and management of the water treatment system, to ensure that four of four Patient Care Technicians (PCTs DD, EE, FF, and GG) correctly tested the sample RO (Reverse Osmosis) water for Total Chlorine according to the manufacturer’s directions for use (DFU); and one of one Registered Nurse (RN EE) and one of one Patient Care Technician (PCT BB), observed and interviewed, were competent to perform their job responsibilities, such as correctly testing the dialysate sample for pH (test for acidity) and conductivity (ability of the dialysate to conduct electricity) whenever the dialysate’s concentration/strength was changed, and to ensure that PCT BB and RN EE were knowledgeable in the acceptable ranges for pH and conductivity. This deficient practice had the potential to negatively affect the health and safety of all 139 patients who were dialyzing at this facility. Findings include: - During interviews with PCT BB and RN EE on 9/30/24 between 12:35 p.m. and 12:48 p.m., the following was revealed: - When this surveyor asked PCT BB the acceptable range of pH and Conductivity on 9/30/24 at 12:35 p.m., she stated that she could not remember but would check the log book and get back to me as soon as she found out. PCT BB came back to notify this surveyor on 9/30/24 at 12:48 p.m. that according to the log book she read, the pH range was 6.9 - 7.1 and the conductivity’s acceptable range was 14.0 - 14.7. - RN EE stated on 9/30/24 at 12:45 p.m., that the acceptable range for pH was 6.5 to 8.3 and the acceptable range for conductivity was between 13.2 to 14.7. - A review of the facility’s Procedure, titled, “Using the Myron L Meters”, with latest revision date of 2/2023, stated: Acceptable Ranges: Conductivity - 12.8 - 14.4 pH - 6.5 - 8.0 - A review of the latest personnel audit for testing pH and conductivity revealed that all direct patient care (DPC) staff, including PCT BB and RN EE were done on 2/3/23 and on 6/2/23 and on 6/6/23 (quarterly), although the water and dialysate skills competency checks of RN EE for water and dialysate was dated 9/27/24 and PCT BB’s was on 8/17/24. - According to the Biomed Technician on 9/25/24 at approximately 11:00 a.m., the Quality Manager was the one who conducted personnel audits.”

“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: 32734 Based on observation, staff interview, and a review of record, it was determined that the facility failed to maintain a safe and sanitary environment for all staff and 139 patients who dialyzed at this facility as evidenced by unsanitary equipment and damaged floor and door that posed risks for trips and falls, infection control risks, and entry of insects and vermin. These environmental concerns were observed in one of one water treatment room, one of one storage room, and one of one patient treatment room. Findings include: During a tour of the facility on 9/24/24 at 11:00 a.m., accompanied by the Clinical Manager (CM), the following was observed: In the Water Treatment Room: - The floor drain behind the bicarbonate holding tank had visible dirt and debris. - Two black metal base frames holding the acid tanks had white crystalized substance on the bars, the finish was peeling off, and the legs were rusted. In the Storage Room: - There were three coffee- colored stains (approximately 5 inches long x 5 inches wide), black scuff marks, and cracks in the concrete in multiple areas across the floor. - There was 1 inch gap between the floor and across the bottom of the door that led to the outside, that could allow entry of insects and vermin. - There was a standing water in a crevice in the concrete floor approximately 1 foot in length. In the Patient Treatment Room: - There were white residue and sediment on the chase wall boxes (ceramic type boxes built into the wall that housed acid and bicarbonate hoses and a drain for the water connected to the dialysis machine) located at Station (S) 1D, S4D, S5D, S6D, S7D, and S8D. - There were black dirt build-up on the floor in front of dialysis machines at S11 and S12. During an interview on 9/24/24 at 11:23 a.m., the Biomed Technician (BT) acknowledged the findings in the water treatment room and storage room. On 9/25/24 at approximately 10:45 a.m., the BT presented a work order that he created dated 9/24/24 that showed “Acid buid-up on the floor. Needs to be scraped”.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 32734 Based on observations, staff interviews, and a review of Policy and Procedures, it was determined that the facility failed to ensure that four of 26 patients [seated at Station (S) 2C, S3C, S9C, and S2C] observed on multiple days, had their face and/or vascular access (dialysis needle insertion sites) covered. This deficient practice could provide an opportunity for occurrence of accidental needle dislodgement or a line disconnection to go undetected and could result in exsanguination (severe loss of blood) and death in minutes. Findings include: - On 9/24/24 at 11:42 a.m., the patient who was seated at S2C had access covered with a blanket. - On 9/24/24 at 11:46 a.m., the patient who was seated at S3C had access covered with a blanket. - On 9/25/24 at 10:51 a.m., the patient who was seated at S9C had face (wore a mask, sunglasses, and a hoodie) and access covered. - On 9/30/24 at 11:43 a.m., the patient seated at S2C had face covered with a blanket. During an interview on 9/24/24 at 11:58 a.m., PCT EE was asked if he was aware of the patients’ access being covered after being observed by this surveyor for 10 minutes. PCT EE stated he just came back from break and has told the patients who were seated at S2C and S3C to uncover their access sites so he could see them, but the patients said they were cold. Stated that he documented it. However, when PCT EE was asked to show the documentation, he again stated, “I just came back from break” and did not produce the documentation. During an interview on 9/25/24 at 10:58 a.m., LPN BB stated she has told the patient who was seated in S9C earlier about having her access covered but LPN BB did not document it. During an interview with PCT AA on 9/30/24 at 12:30 p.m., when asked about the patient seated in S2C who had covered access, PCT AA stated “I believe we documented that we spoke to patient in S2C about uncovering access. PCT AA then checked for documentation on the patient’s electronic flowsheet and did not find documentation. PCT AA then stated, “I guess they did not do it”. A review of policy titled, “Initiating, Monitoring, and Discontinuing Hemodialysis Treatments Utilizing AVF/AVG” revised 6/2023 showed the following: Page 3: Monitoring During Treatment: Access: The patient’s access must be visible throughout the treatment. Patients may not cover the AVF (arteriovenous fistula) or AVG (arteriovenous graft) with a blanket, etc. as it prevents the staff from verifying issues such as infiltrations, needle dislodgement, bleeding, line separation, etc. If access is found covered, patient education should be provided and documentation completed. Failure to comply should be reported to the charge nurse. Face: Visualization of the patient’s face is required and should occur with the routine vital signs as needed to assist with identification of adverse effects during treament. Patients are not allowed to cover their face and/or eyes from staff view. This includes covering head wiith a blanket, wearing dark sunglasses, clothing that covers face/eyes, large brim hats pulled down/tilted to hide face, etc.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 33921 Based on a review of facility records and staff interview, it was determined that the interdisciplinary team (IDT) failed to investigate, develop, and implement a plan of care for patient’s unique anemia management needs in order to attain and maintain appropriate blood levels of Hemoglobin (Hgb - protein in red blood cells that carries oxygen), for one of one sampled patient (P#1), whose Hgb levels were below 10 g/dL (grams/deciliter) and continued to drastically drop or trended down from August 21, 2024 through September 18, 2024 (last Hgb result). Normal hemoglobin is 12-14 g/dL, with 10 g/dL being considered low for dialysis patients. This deficient practice had the potential to negatively affect the health and safety of P#1 and all the other 138 in-center hemodialysis patients who were under the care of this facility. Findings include: - A review of P#1’s Hgb lab values, anemia management reports, and patient care plans revealed that her Hgb levels were below 10 g/dL and drastically trended down between August 21, 2024 through September 18, 2024 (last Hgb result). - On 8/12/24 - Hgb - 10.0 - On 8/21/24 - Hgb - 8.0 - On 9/4/24 - Hgb - 7.2 - On 9/18/24 - Hgb - 6.6 P#1 received Epoetin (medication to treat anemia) on the following dates and corresponding doses: - Epoetin 9,000 units 3 times per week between 6/22/24 - 7/26/24 - Epoetin 12,900 units 3 times per week between 7/27/24 - 8/23/24 - Epoetin was increased to 15,000 units 3 times per week on 9/18/24. A review of the facility’s Protocol, titled, “ESA/Iron Management Protocol (ESA/Venofer)” (ESA - Erythropoeitin Stimulating Hormone, sic), with last revision date of 2/17/23, stated: - If Hgb has increased or decreased by 2 or more points since last draw date, redraw sample to verify prior to dose adjustment. - If Hgb has decreased by 1 or more points between the 1st and 2nd draw, monitor for trending and identify reasons for decrease. - If Hgb has decreased by 2 or more points since last draw date you should give Hemoccult card to evaluate for GI bleed. (GI - Gastrointestinal, sic)... - Look for trends with consistent low Hgb’s - suggest to MD possible order for CRP (C-Reactive Protein, is a protein produced by the liver in response to inflammation or infection, - sic), Aluminum, Retic Counts, B-12, and Folic Acid... - If it is determined that the patient missed their scheduled ESA dose during their hospitalization... and was hospitalized for <3 days, just administer the missed dose on day of return... - P#1 was hospitalized on 7/15/24 and 8/5/24, with an unknown cause. - A review of P#1’s Dialysis Treatment Flowsheets revealed that P#1 had dialysis treatment at the facility on 8/26/24, 8/30/24, 9/2/24, 9/4/24, 9/9/24, 9/13/24, 9/16/24, and 9/18/24. - The Medical Director had ordered Hgb lab draws for P#1 every week (an increase in frequency from every two weeks to weekly), on 8/23/24, when Hgb result on 8/21/24 dropped by two points from Hgb 10.0 on 8/12/24 to Hgb 8.0 on 8/21/24. The subsequent Hgb lab draws were only performed on 9/4/24 and 9/18/24. Although the Epoetin dosage was increased to 15,000 units on 9/18/24, there was no documentary evidence that the drop in P#1’s Hgb counts was investigated. There was no documentary evidence that a hemoccult was performed or if P#1 was offered a hemoccult card. - There was no documentary evidence that the doctor/Medical Director was notified of the above information regarding the continued drop in the Hgb count since his order on 8/23/24. - During a discussion with the Facility Administrator/Clinic Manager on 9/30/24 at 12:40 p.m., she stated that if a patient’s Hgb was less than seven, the doctor will be notified. She also added that the doctor was the one to make a decision whether to send a patient to the hospital to receive a blood transfusion or not. - On 10/1/24 at 12:28 p.m., the Facility Administrator/Clinic Manager stated that the doctor will be the one to put an order for a hemoccult test (a test that checks for hidden blood in the stool), to be performed when there was an unexplained drop in Hgb. She also added that the Registered Nurses (RNs) can also put in the order if they see a drop in Hgb count with an unknown cause. - On 10/2/24 at 4:45 p.m., the Facility Administrator/Clinic Manager acknowledged the above information.”

“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: 33921 Based on a review of facility records and staff interview, it was determined that the facility failed to analyze the causes of all patient deaths, to develop action plans that addressed mortality, in five of six months (where there were deaths), of Quality Assurance Performance Improvement (QAPI) meeting minutes reviewed between (March 2024 - August 2024). This deficient practice had the potential to negatively affect the health and safety of all 139 patients who were under the care of this facility. Findings include: A review of the QAPI mortality meeting minutes from March 2024 - August 2024, revealed that the facility had at least one patient death every month, except on the month of April. There was no documentation that the facility reviewed, evaluated, and analyzed trends in the causes of patient deaths; and the relationship to the care received at the facility. There was no documentation in the QAPI meeting minutes that the causes of deaths were reviewed and analyzed to ensure that clinical standards were met . The Facility Administrator was not able to provide a documentary evidence that a mortality analysis was completed. She also confirmed on 10/2/24 at approximately 4:00 p.m., that a mortality analysis was not completed for each of the five patient deaths.”