Davita Mcafee Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 49321 Based on observations, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and a review of facility Policy and Procedures (P&P), it was determined that the facility failed to ensure that the staff practiced infection control techniques to prevent transmission of dangerous pathogens in the hemodialysis unit. This failure could lead to the transmission of dangerous bloodborne pathogens through cross contamination and had the potential to negatively affect the health and safety of 75 patients who received dialysis treatment at this facility. Findings include: Cross References: V 113 - Failure of the facility to ensure that two of two Patient Care Technicians (PCT BB and PCT CC), two of two Registered Nurses (RN AA and RN BB) and four of four patients who were seated at Station (S) 9, S11, S12, and S19, wore gloves as appropriate and performed hand hygiene (wash hands or use an alcohol based hand sanitizer) after removal of contaminated gloves. V 122 - Failure of the facility to ensure that two of two Patient Care Technicians (PCT BB and PCT CC) and one of one Registered Nurse (RN AA), clean the visible blood off sharps containers and floor and thoroughly disinfected the affected surfaces as soon as feasible.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 50523 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 one of one Patient Care Technician (PCT AA) observed, who was assigned the task of testing the water quality, performed the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis). The facility also failed to ensure that two of two Patient Care Technicians (PCT BB and PCT CC) and one of one Registered Nurse (RN AA) observed, verified the machine’s dialysate (dialysis solution) conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s Directions For Use (DFU) and facility P&P. This failure had the potential to negatively affect the health and safety of 12 patients who were receiving hemodialysis treatment at S1, S2, S3, S4, S8, S11, S12, S13, S14, S15, S16, and S17 at the time of observation. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. And if conductivity is off, the effectiveness of the treatment is reduced and patient electrolyte balance could be altered. The facility census was 75. Findings include: Cross References: V 196 - Failure of the facility to ensure that one of one Patient Care Technician (PCT AA) observed, who was assigned the task of testing the water quality, performed the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. V 250 - Failure of the facility to ensure that two of two Patient Care Technicians (PCT BB and PCT CC) and one of one Registered Nurse (RN AA) observed, verified the machine’s dialysate conductivity and pH, according to the manufacturer’s Directions For Use (DFU) and facility P&P.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of the Centers for Disease Control and Prevention (CDC) recommendations, it was determined that the facility failed to ensure that all equipment and the building in which dialysis services were furnished were sanitary and maintained free from damage and defects, to ensure safe environment for all patients and staff. Unsanitary environment and excessive moisture could contribute to the growth of mold on surfaces and materials that could cause a range of respiratory issues, including allergic reactions, asthma attacks, and infections; and the failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus providing a potential for microbial growth. These environmental concerns were observed in one of one Patient Treatment Room and could negatively affect the health and safety of all staff and 75 patients who were dialyzing at this facility. Findings include: Cross References: V 402 - Failure of the facility to maintain a safe environment for all patients and staff as evidenced by clogged drains that resulted in water leakage and/or unsanitary surfaces in nine of 20 wall boxes (frames recessed into the wall at each hemodialysis station, which allows dialysis machine to receive acid and base concentrates and treated water, and dispose of waste products), several tiles that were wet and separated from the floor, and unsanitary grout between tiles. V 403 - Failure of the facility to have a system in place to ensure that the outside case cover and hose of 20 of 20 hemodialysis machines were maintained and free from rust-colored stains and substances at the bottom of each machine and hose.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 50523 Based on observations, a review of records, staff interviews, review of the manufacturer’s Directions for Use (DFU) and a review of facility Policy 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 75 patients who dialyzed at this facility. Findings include: Cross References: V 113 - Failure of the facility to ensure that two of two Patient Care Technicians (PCT BB and PCT CC), two of two Registered Nurses (RN AA and RN BB) and four of four patients who were seated at Station (S) 9, S11, S12, and S19, wore gloves as appropriate and performed hand hygiene (wash hands or use an alcohol based hand sanitizer) after removal of contaminated gloves. V 122 - Failure of the facility to ensure that two of two Patient Care Technicians (PCT BB and PCT CC) and one of one Registered Nurse (RN AA), clean the visible blood off sharps containers and floor and thoroughly disinfected the affected surfaces as soon as feasible. V 196 - Failure of the facility to ensure that one of one Patient Care Technician (PCT AA) observed, who was assigned the task of testing the water quality, performed the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. V 250 - Failure of the facility to ensure that two of two Patient Care Technicians (PCT BB and PCT CC) and one of one Registered Nurse (RN AA) observed, verified the machine’s dialysate conductivity and pH, according to the manufacturer’s Directions For Use (DFU) and facility P&P. V 402 - Failure of the facility to maintain a safe environment for all patients and staff as evidenced by clogged drains that resulted in water leakage and/or unsanitary surfaces in nine of 20 wall boxes (frames recessed into the wall at each hemodialysis station, which allows dialysis machine to receive acid and base concentrates and treated water, and dispose of waste products), several tiles that were wet and separated from the floor, and unsanitary grout between tiles. V 403 - Failure of the facility to have a system in place to ensure that the outside case cover and hose of 20 of 20 hemodialysis machines were maintained and free from rust-colored stains and substances at the bottom of each machine and hose.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) recommendations, and a review of Policy and Procedures, it was determined that the Infection Control Committee (ICC) failed to ensure that two of two Patient Care Technicians (PCT BB and PCT CC) and two of two Registered Nurses (RN AA and RN BB) wore gloves when touching dialysis machines and/or performed hand hygiene (wash hands or use an alcohol based hand sanitizer) after removal of contaminated gloves. The ICC also failed to ensure that four of four patients who were seated at Station (S) 9, S11, S12, and S19, who held pressure to their access sites for hemostasis (stopping of the flow of blood) after dialysis, performed hand hygiene after glove removal and prior to leaving the treatment area. Failure to perform hand hygiene increased the risk for cross contamination with the potential to expose all patients and staff to bloodborne pathogens in the dialysis environment. The facility census was 75. Findings include: During observation in the Patient Treatment Room on 10/29/24 between 10:15 a.m. and 12:00 p.m., the following was revealed: - PCT BB held a glove on her hand and silenced the dialysis machine at S17 with a glove (did not wear the glove). PCT BB did not perform hand hygiene before going to the next station. - PCT BB was again observed silencing the dialysis machine at S19 with a glove in her hand (did not wear the glove) and did not perform hand hygiene when done. - While PCT CC was at S5, she removed used/contaminated supplies from the patient’s side table, picked up an alcohol swab from the floor, and discarded them in the trash can. While she wore contaminated gloves, PCT CC proceeded to S6, obtained a blanket from a bag and covered the patient with the blanket. PCT CC did not change gloves or perform hand hygiene between stations and from dirty task to clean task. - PCT CC also held a glove on her hand (did not wear the glove) and used it to silence the dialysis machine at S1. PCT CC did not perform hand hygiene when done. - RN AA was observed while setting up the dialysis machine at S10 without wearing gloves. When finished, she used a hand sanitizer, donned gloves, and inserted the patient’s needles. She then took one glove off, went to a clean supply drawer and obtained two blood tubes, put a clean glove on, and drew blood from the patient. RN AA did not perform hand hygiene after she removed her glove and prior to obtaining supplies from a clean supply drawer. During an interview on 10/29/24 at 10:30 a.m., RN AA stated she was rushing and was not paying attention. - RN BB was observed preparing medications at the medication station. The IV (intravenous) tubing wrapper fell on the floor. RN BB picked up the wrapper from the floor and put it in the trash container. RN BB did not perform hand hygiene and picked up the tubing to connect it to an IV protein (an intravenous formula, infused during dialysis). At this moment, RN BB was made aware of the observation by this surveyor on 10/29/24 at approximately 10:45 a.m. RN BB discarded the tubing and washed her hands. - The patients who were seated at S9, S11, S12, and S19 held their access sites with one gloved hand until the bleeding stopped, then discarded their gloves. At the weighing station, these patients touched the scale and went out of the treatment room without performing hand hygiene. They were not offered hand sanitizer nor were reminded by PCT BB, PCT CC, RN AA or RN BB to wash their hands after glove removal and prior to leaving the treatment area. According to CDC recommendations, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal ... A review of Policy #1-05-01 titled, “Infection Control for Dialysis Facilities” with latest revision date of April 2023, showed the following: Hand Hygiene: 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact... g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse 2. Patients and caregivers will be encouraged to a. Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis. b. Perform hand hygiene after treatment before leaving treatment area.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 49321 1. Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and a review of Policy and Procedures, it was determined that the facility failed to ensure that two of two Patient Care Technicians (PCT BB and PCT CC) and one of one Registered Nurse (RN AA), who were present during this observation, immediately and thoroughly cleaned and disinfected blood contaminated surface and potentially contaminated equipment. This failure could lead to the transmission of dangerous pathogens through cross contamination and had the potential to negatively affect the health and safety of 11 of 11 incenter-hemodialysis patients (P) (P#8, P#9, P#10, P#11 P#12, P#13, P#14, P#15, P#16, P#17, P#18 and P#19), who were undergoing hemodialysis treatment at the time of observation. The facility census was 75. Findings include: During observation in the Patient Treatment Room on 10/29/24 between 10:15 a.m. and 12:00 p.m., the following was revealed: - The sharps containers at Station (S) 10, S14, and between S3 and S4, had one to four drops of dried blood on the lid of the sharps containers, that were not cleaned and disinfected between patient uses. - There were too numerous to count drops of blood the size of a large ballpoint pen point and one drop of blood the size of a dime, on the floor under the right side of the treatment chair at S14. On 10/29/24 at approximately 10:25 a.m., RN AA was notified of the blood on the floor at S14. RN AA stated she’ll clean it up. During staff interviews on 10/29/24 between 10:45 a.m. and 11:15 a.m., PCT BB and PCT CC were notified of the blood on the sharps containers. When asked about disinfection of sharps containers, PCT CC stated that sharps containers were cleaned and disinfected at the end of the day. - The Myron L Meter [A device used to test dialysate (dialysis solution) conductivity (ability to conduct electricity)] was used at S19 and then used at S12. Disinfection of the meter was not performed after it was used at S19 and prior to using it at S12. During an interview on 10/29/24 at approximately 11:30 a.m., PCT CC stated that she forgot to disinfect the Myron L Meter. According to the CDC guidelines, failure in environmental cleaning and disinfection have led to transmission of bloodborne pathogens (e.g., Hepatitis B virus) and other infections from one patient to another in hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including floors, patient chair or bed surfaces, dialysis equipment surfaces, adjacent tables and work surfaces, etc., especially with blood splatters) must be performed between patient uses to prevent transmission of dangerous pathogens. A review of facility Policy: 1-05-01, titled, “Infection Control for Dialysis Facilities” with latest revision date of April 2023, showed: 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials... ... iii. Cleaning of visible blood should be performed when first observed... 14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station... 2. Based on observation, staff interviews, and a review of the Centers for Disease Control and Prevention (CDC) Dialysis Safety, it was determined that the facility failed to ensure that 12 of 20 wall boxes (frames recessed into the wall at each hemodialysis station, which allows dialysis machine to receive acid and base concentrates and treated water, and dispose of waste products) were cleaned and disinfected at least daily, at the end of each dialysis day. This deficient practice increased the risk for the growth of microorganisms, which can subsequently be transferred to 75 patients who were dialyzing at this facility, a vulnerable group at high risk of infection. Findings include: During observation on 10/29/24 from 10:15a.m. to 12:00 p.m., the following was revealed: In the Patient Treatment Room: - The wall box at S1, S2, S3, S4, S7, S8, S10, S11, and S13 had thick accumulation of white crystalized substance around the acid, bicarbonate, and treated water ports/connections. - The wall box at S6 and S19 had thick accumulation of green and slimy substance. - The wall box at S20 was yellow and had yellow crystalized substance. During an interview on 10/29/24 at 3:30 p.m., the Facility Administrator confirmed the above findings and stated that Direct Patient Care Staff should have been cleaning and disinfecting the wall boxes at the end of the day, and the Biomed Technician was supposed to be conducting audits. A review of CDC Dialysis Safety showed the following: Wall boxes contributed to a large number of infections in patients on hemodialysis... 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 (e.g., at the end of the day after all patients have gone). Cleaning and disinfection might be needed more frequently (e.g., when visibly dirty).”

“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: 50523 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 one of one Patient Care Technician (PCT AA) observed, who was assigned the task of testing the water quality, performed the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. 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 12 of 12 in-center hemodialysis patients at Station (S) 1, S2, S3, S4, S8, S11, S12, S13, S14, S15, S16, and S17 who were undergoing hemodialysis treatment at the time of this observation. The facility census was 75. Findings include: During observation of PCT AA’s performance of the Total Chlorine test on 10/29/24 between 11:35 a.m. and 11:56 a.m., the following was observed: PCT AA performed the Total Chlorine Test using RPC Ultra Low Total Chlorine Test strip (K100-0118). PCT AA proceeded to collect the sample of water in a 30 milliliter (mL) medicine cup, swished the test strip for 15 seconds and compared the test strip to color chart after 10 seconds. PCT AA performed the Total Chlorine test again. PCT AA again used a 30 mL medicine cup to collect the water sample, swished test strip for 10 seconds and compared the test strip to color chart after 15 seconds. When asked how many seconds was he supposed to swish test strip, PCT AA stated “I always thought it was 10 seconds”. When asked how many seconds was he supposed to wait until comparing test strip to color chart, PCT AA revealed that he didn’t know the amount of time to wait to compare test strip to color chart. A review of Procedure: 1-18-05 titled, “Total Chlorine Test Using RPC Ultra Low Total Chlorine Test Strip” with latest revision date of October 2023 showed the following: 1. Fill the sample cup to the line marked 100 mL with the sample. 2. Remove one test strip from the foil package and dip it in the water sample for 60 seconds .... dipping the strip, move it back and forth at a constant gentle rate. 3. Remove the test strip and shake once, briskly, to remove excess water. 4. Wait 20 seconds for the test strip color to develop... 5. After the 20 seconds wait period, immediately compare strip. The facility used a CM130 Automated Monitoring System (The HACH CM130 monitors total chlorine levels in pre-treatment water used in hemodialysis). A review of Policy: 1-18-09 titled, “Daily Water System Total Chlorine Monitoring for Facilities with the CM130 Automated Monitoring System” with latest revision date of October 2022 showed: 3. The CM130 Total Chlorine Analyzer, requires a comparison to a manual total chlorine test on a daily basis prior to the first patient treatment of the day to verify operation... The Facility Administrator was notified of the above findings on 10/29/24 at 12:55 p.m., and stated the staff should have known the correct procedure because they just had an inservice a month or so ago.”

“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: 50523 Based on observation, staff interviews, and a review of records, it was determined that the facility failed to ensure that there was a safe environment for 12 of 12 patients who were seated at Station (S) 1, S2, S3, S4, S8, S11, S12, S13, S14, S15, S16, and S17, as evidenced by failure of two of two Patient Care Technicians (PCT BB and PCT CC) and one of one Registered Nurse (RN AA) observed, to correctly verify the hemodialysis (HD) machine’s dialysate (dialysis solution) conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s Directions For Use (DFU) and facility’s Policy and Procedures. This failure had the potential to negatively affect the health and safety of 12 patients who were receiving hemodialysis treatment at S1, S2, S3, S4, S8, S11, S12, S13, S14, S15, S16, and S17 at the time of observation. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. And if conductivity is off, the effectiveness of the treatment is reduced and patient electrolyte balance could be altered. The facility census was 75. Findings were: During observation in the Patient Treatment Room on 10/29/24 between 10:16 a.m. and 12:45 p.m., the following was revealed: - PCT BB was observed verifying the dialysate conductivity using the Myron L Conductivity Meter at S15. PCT BB obtained a dialysate sample from the machine and proceeded to fill the Myron L meter with a sample and immediately read the results. During an interview on 10/29/24 at 11:15 a.m., PCT BB stated she knew she was supposed to obtain and agitate at least three samples before reading the results. Stated she remembered the procedure after she already performed the test incorrectly. - PCT CC was observed at S11 using the Myron L Conductivity Meter to check the machine conductivity. PCT CC obtained a dialysate sample, filled the meter, and agitated them before reading the results. This procedure was done twice. PCT CC was also observed checking the machine pH. She dipped the test strip (RPC E-Z Chek K100-0117CT - 6.8 - 8.5 Test Strip) in the sample and immediately compared the test strip to the color chart. - PCT CC was also observed at S6. PCT CC checked the machine pH but did not test the conductivity. PCT CC dipped the test strip into the sample and immediately compared it to color chart. During an interview on 10/29/24 at 12:29 p.m., PCT CC stated no one told her that three samples were needed and that they were supposed to be agitated before checking the results for the conductivity. PCT CC also confirmed that she did not look at the clock or her stopwatch while she checked the pH, but she knew to wait for 20 to 25 seconds before comparing the strip to color chart. When asked why the conductivity was not checked for the machine at S6, PCT CC stated that the Myron L Conductivity Meter was at S19 during that time. - RN AA was observed initiating dialysis treatment on a patient at S10 at 10:35 a.m. At 11:44 a.m., RN AA was agin observed during initiation of dialysis treatment on a patient at S9. - RN AA did not test the final dialysate for conductivity and pH for each machine prior to initiation of dialysis on patients at S9 and S10. During an interview on 10/29/24 at 12:45 p.m., RN AA acknowledged that the pH and conductivity were not checked at S9 and S10 prior to starting those patient’s treatments. The Facility Administrator was notified of the above findings on 10/29/24 at 12:55 p.m., and stated the staff should have known the correct procedure because they just had an inservice a month or so ago. A review of “Fresenius Medical Care 2008K2 Hemodialysis Machine Operator’s Manual” showed the following DFU: Page 55 - Recirculation and Final Set-Up Procedure 2. Check the conductivity and pH of the dialysate... Warning! Always verify the conductivity and approximate pH of the dialysate solution through independent means (e.g. using a conductivity meter or pH paper or meter, as applicable) before initiating each dialysis treatment. Verify that the conductivity is reasonably close to the theoretical conductivity value (TCD) and the pH is between 6.9 and 7.6. If they are not, do not initiate dialysis. - A review of facility Procedure: 2-08-01B titled, “Operation of Portable Myron L Conductivity Meter (D-1)” with latest revision date of April 2020 showed the following: 3. Fill meter cell cup with sample so upper electrode is immersed. Insert plunger. RATIONALE: If electrode is not immersed, results may be affected. Verify the plunger is completely seated in the cell cup. 4. Agitate sample with plunger by moving up and down 3 or 4 times and then discard sample. 5. Repeat steps #3 and #4 - at least 3 times. RATIONALE: Verifies that any prior sample solution has been rinsed free from the cell. 6. Obtain another proportioned dialysate sample and fill the meter, drop plunger in the solution and press the black button. When the pointer stops, immediately read and release the button. 7. Repeat step #6 twice and press. Read/Check button and record conductivity reading. RATIONALE: Helps assure accurate reading. A review of facility Procedure: 1-21-09 titled, “Testing pH for Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8 - 8.5 Test Strips” with latest revision date of February 2024 showed the following: 2. Obtain dialysate sample using a disposable collection cup, then dip the strip into the solution for one (1) second... 3. Remove the strip from the fluid and shake off excess dialysate. 4. Within 20 to 25 seconds, compare the color reaction on strip to the color chart.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of the Centers for Disease Control and Prevention (CDC) recommendations, it was determined that the facility failed to maintain a safe environment for all patients and staff as evidenced by clogged drains that resulted in water leakage and/or unsanitary surfaces in nine of 20 wall boxes (frames recessed into the wall at each hemodialysis station, which allows dialysis machine to receive acid and base concentrates and treated water, and dispose of waste products), several tiles that were wet and separated from the floor, and unsanitary grout between tiles. Unsanitary environment and excessive moisture could contribute to the growth of mold on surfaces and materials that could cause a range of respiratory issues, including allergic reactions, asthma attacks, and infections. The failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus provided a potential for microbial growth. These environmental concerns were observed in one of one Patient Treatment Room and could negatively affect the health and safety of all staff and 75 patients who were dialyzing at this facility. Findings include: During observation on 10/29/24 from 10:15a.m. to 12:00 p.m., the following was revealed: In the Patient Treatment Room: - The wall box drains at Station (S) 1, S5, S7, S8, S10, S13, S15, and S19 were leaking a moderate amount of water onto the floor. - The wall box at S6 and S19 had thick accumulation of green and slimy substance. - There was a cardboard box (approximately 60 inches by 36 inches) that was saturated with water at S5. - There was a clear plastic container (approximately 36 inches in diameter) that was catching water at S8. - There were several (approximately 15) floor tiles at S1 and S15 that were wet and were separated from the floor. - The grout between the tiles had black and fussy/spongy substances with very tiny holes in them, that began to spread out into the tiles throughout the treatment floor. During an interview on 10/29/24 at 3:30 p.m., the Facility Administrator confirmed that the drains in the wall boxes were clogged, and water has been leaking onto the floor for a while. Stated that a work order was done on 9/19/24 to unclog the drains. It was also revealed that the loose tiles resulted from the floor being wet. According to the CDC, dialysis wall boxes need to be properly maintained to decrease risk of patient infections.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 49321 Based on observation and staff interviews, it was determined that the facility failed to have a system in place to ensure that the outside case covers and hoses of 20 of 20 hemodialysis machines were maintained free from rust-colored stains and substances at the bottom of each machine and hose. Uncleaned surfaces could act as a reservoir for bacteria. The facility census was 75. Finding includes: During observation on 10/29/24 between 10:15 a.m. and 12:00 p.m., the following was revealed: - The dialysis machines at Station (S) 1, S2, S3, S4, S5, S6, S7, S8, S9, S10, S11, S12, S13, S14, S15, S16, S17, S18, S19, and S20 had brown spots and rust-like stains on the bottom of each machine. - The black hose of the machines at S1, S2, S3, S4, S6, S11, S13, S15, and S19 were covered with thick accumulation of white crystallized substance. During an interview with the Biomedical Technician on 10/29/24 at 3:00 p.m., he stated that the machines were old and had a lot of hours on them and the facility is supposed to be getting new dialysis machines. On 10/29/24 at 3:30 p.m., the Facility Administrator confirmed that the facility is getting new dialysis machines. However, before the machines could be placed on the treatment floor, the drains in the wall boxes have to be unclogged and new electrical outlets will need to be installed at each station. The Facility Administrator also stated that the floor in the treatment area was in need of repair.”