Davita Lakewood Dialysis Center

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 45020 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.60 Physical environment, was out of compliance. V403 - 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. Based on observations, document review, and staff interviews the facility failed to implement and maintain a program to ensure that all equipment was maintained in accordance with facility policy. Specifically, 10 out of 18 treatment chairs had torn surfaces in the seat cushion or armrests, which created the potential for infection or cross-contamination between patients in the dialysis facility. Additionally, the facility failed to maintain the storage of peracetic acid (a highly corrosive liquid used as an antimicrobial agent and sanitizer) at the temperature instructed by the manufacturer in one of one storage areas which contained this acid. Also, the facility failed to ensure staff performed the safety check on the dialysis machine before starting a patient treatment for one of 16 patients observed receiving dialysis treatments. Furthermore, the facility failed to ensure supplies were stored in a sanitary manner and that expired supplies were removed in three of three storage areas observed.”

“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: 45020 Based on observations, document review, and staff interviews the facility failed to implement and maintain a program to ensure that all equipment was maintained in accordance with facility policy. Specifically, 10 out of 18 treatment chairs had torn surfaces in the seat cushion or armrests, which created the potential for infection or cross-contamination between patients in the dialysis facility. Additionally, the facility failed to maintain the storage of peracetic acid (a highly corrosive liquid used as an antimicrobial agent and sanitizer) at the temperature instructed by the manufacturer in one of one storage areas which contained this acid. Also, the facility failed to ensure staff performed the safety check on the dialysis machine before starting a patient treatment for one of 16 patients observed receiving dialysis treatments. Furthermore, the facility failed to ensure supplies were stored in a sanitary manner and that expired supplies were removed in three of three storage areas observed. Findings include: Facility policies: The Physical Environment policy read, the purpose of this policy is to provide guidance on the physical environment of the dialysis facility and treatment area. The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and water treatment systems are maintained and operated in accordance with manufacturer’s recommendations. Supplies are stored as to minimize deterioration, contamination or breakage. The Preventive Maintenance Schedules for Equipment policy read, the purpose of this policy is for the dialysis delivery systems and all ancillary equipment, to be maintained in good working condition and operating according to the manufacturer ’ s specifications. Preventive maintenance (PM) schedules must be made in accordance with the manufacturer ’ s recommendation for all equipment used to perform a patient treatment. A copy of the equipment PM schedule will be filed in the appropriate Equipment Maintenance Manual. All miscellaneous equipment will receive PM performed by a trained Biomed teammate or outside vendor per manufacturer ’ s recommendations. The Chemical Use policy read, the purpose of this policy is to provide guidance for preparation of approved specific chemicals used in a facility. Peracetic acid is to be stored separate from other chemicals, especially bleach. It is to be stored in a cool, dry area (32°F-75°F). The Fresenius 2008 K, K2, T Pressure Holding/Alarm test policy read, This procedure is performed prior to each treatment. When testing is complete, a failure of any of the tests is indicated by an X in the error box to the right of the test name. Warning: If the dialysis delivery system fails any of the tests and the cause cannot be corrected, or if it fails subsequent tests, it should not be used for treatment. The Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment policy read, The purpose of this policy is to obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patients response to the treatment and status prior to discharge. The nursing assessment will be performed and documented by a registered nurse (RN). This assessment includes verification that the machine safety checks have been completed and documented. The Infection Control for Dialysis Centers policy read, supplies will be stored in a manner that maintains their integrity. Expiration date and package integrity will be verified prior to use. Anytime the integrity of a package is in question, i.e., torn, ripped, wet or contaminated, the package and its contents must be disposed of and not used. References: The Champion Chair Operations Instructions and Service Manual read, general maintenance and care of chairs: Each facility should check their chairs and set their own maintenance schedule. The Minncare HD (peracetic acid) Safety Data Sheet read, Use of substance/mixture: Sanitizing of RO (reverse osmosis) systems. Precautionary statements: Keep away from heat. Conditions for safe storage, Store at temperatures not exceeding 23.9 degrees C (75 degrees F). The Fresenius Medical Care 2008K2 Hemodialysis machine Operator’s Manual read, before beginning treatment the machine should undergo Pressure and Alarm tests to ensure that it is functioning properly. The test of the level detector system must run as a precaution and aid in identifying potential failures. The Naturalyte Liquid Acid Concentrate for Hemodialysis instructions for use read, do not use if package is damaged. Keep container sealed when not in use. 1. The facility failed to maintain and repair patient treatment chairs to allow effective cleaning and disinfection. a. A tour of the patient treatment area on 2/6/24 at 1:23 p.m. revealed 10 out of 18 dialysis treatment chairs had torn surfaces on the seat cushion and/or armrests which had not been effectively repaired. The torn surfaces did not allow effective disinfection due to the broken surfaces. For example: i. Station #5’s patient dialysis chair was noted to have a large rip in the seat cushion, which measured approximately 12 inches long. ii. Station #8’s patient dialysis chair was noted to have a large rip in the seat cushion, measuring approximately 8 inches long, as well as a 1 inch rip in the left chair arm. iii. Station #15’s patient dialysis chair was noted to have five 1 inch rips in the seat cushion, as well as one large rip, measuring approximately 18 inches on the seat knee area. iv. Multiple other dialysis chairs were noted to have torn, ripped, and open areas in the seat and armrest cushions. b. On 2/13/24 at 11:49 a.m., an interview was conducted with patient care technician (PCT) #4. PCT #4 stated dialysis chairs were cleaned with a bleach solution after each patient to remove any blood to prevent any cross-contamination between patients. PCT #4 stated the ripped and cracked chair surfaces had foam underneath and these surfaces could not be wiped well. PCT #4 stated the facility used disposable drapes to cover each chair seat, but these drapes sometimes ripped while the patient was on treatment as they moved in their seat and the drapes did not cover the dialysis chair arms. c. On 2/12/24 at 2:59 p.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated they were aware some of the dialysis chairs had ripped chair covers. RN #5 stated it took a long time to order new chairs, but was unsure why. RN #5 stated the dialysis chair surfaces were to be cleaned between each patient but could not ensure the treatment chairs were cleaned throughout to minimize the risk of cross-contamination of blood-borne pathogens. d. On 2/14/24 at 3:52 p.m., an interview was conducted with clinical services specialist (Director) #6. Director #6 stated there was no schedule for dialysis chair preventative maintenance. Director #6 stated all new chairs were ordered on 2/9/24, which was three days after the initial observation. e. On 2/13/24 at 8:45 a.m., an interview was conducted with medical director (Director) #7. Director #7 stated cleaning the dialysis chairs between patients was important because as a facility it was the goal to maintain the risk of infection. Director #7 stated there was a risk of MRSA (Methicillin-resistant Staphylococcus aureus is an infection caused by a type of staph bacteria) and C-diff (Clostridioides difficile, an infection which causes diarrhea and an inflammation of the colon) if the dialysis chairs were not cleaned per policy. 2. The facility failed to maintain storage of peracetic acid in accordance with the manufacturer’s IFU. a. A review of the temperature log for the storage area where peracetic acid was stored revealed from 10/10/23 to 2/6/24 five days had no temperature recorded on days the facility had patients who received treatment. In addition, the log revealed 15 days with temperatures noted to have been out of the range specified by the manufacturer with no evidence of the biomedical technician being notified or of interventions implemented to decrease the temperature. For example: i. On 10/10/23 the temperature was recorded at 77 degrees Fahrenheit (F). ii. On 11/14/23 the temperature was recorded at 77 degrees F. iii. On 12/6/23 the temperature was recorded at 79 degrees F. iv. On 1/1/24 the temperature was recorded at 77 degrees F. v. On 2/2/24 the temperature was recorded at 79 degrees F. b. On 2/13/24 at 11:49 a.m., an interview was conducted with patient care technician (PCT) #4. PCT #4 stated it was the nurse’s responsibility to check the room temperature where the peracetic acid was the registered nurse. PCT #4 stated if any readings were out of range, the process was to notify the facility’s biomedical technician. c. On 2/12/24 at 2:59 p.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated it was the nurse’s responsibility to check the temperature in the room where the peracetic acid was stored. RN #5 stated peracetic acid needed to stay cool to keep it stabilized. RN #5 stated the peracetic acid was in the process of being replaced and that an order had been placed on the same day of the observation. RN #5 stated they were aware some temperatures were out of range, and they rechecked it but did not record the recheck and stated they should have documented it. d. On 2/12/24 at 8:45 a.m., an interview was conducted with biomedical technician (Biomed) #9. Biomed #9 stated peracetic acid was a chemical used to disinfect the reverse osmosis machine in the water room. Biomed #9 stated the temperature was to be monitored where the peracetic acid was stored because it was to be stored within a specific temperature parameter. Biomed #9 stated if any temperatures were noted to be out of range, the process was for staff to immediately contact the facility’s biomedical technician. Biomed #9 stated there was a risk the peracetic acid might not work as well if it was stored at temperatures out of range. e. On 2/13/24 at 1:50 p.m., an interview was conducted with facility administrator (FA) #10. FA #10 stated the peracetic acid at the facility was replaced on 2/12/24 because the temperature log showed the temperatures in the room were out of range. FA #10 stated the temperature range was listed in the facility policy. FA #10 stated the facility’s process when any readings were out of range was to notify the biomedical technician right away. 3. The facility failed to ensure direct patient care staff conducted a safety check of the dialysis machine before a treatment was provided. a. On 2/7/24 at 8:17 a.m., an observation was conducted in the patient treatment area with PCT #8. PCT #8 went to each dialysis station to verify the machine test process had been completed before patient treatments were started. Station #4 machine was observed to have failed the Level Detector portion of the series of tests and the patient had been on dialysis since 6:13 a.m., for a total of 2 hours and 4 minutes. PCT #8 stated patients were not to have treatment started on a machine with a failed alarm. PCT #8 stated the machine test process was to be done before each patient treatment to ensure the machine was safe to use. PCT #8 stopped the treatment in station #4, changed the lines, put the machine through the testing process and at 8:47 a.m., the machine in station #4 was observed to have passed all tests with the patient back on treatment. b. On 2/13/24 at 11:49 a.m., an interview was conducted with patient care technician (PCT) #4. PCT #4 stated dialysis machines were to be put through a test process before each use. PCT #4 stated it was important for machines to be tested to ensure the machine was safe to be used. PCT #4 stated if a machine failed any tests it should be retested and if it failed again the machine was to be pulled from use. c. On 2/12/24 at 2:59 a.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated dialysis machines were to be tested before each use. RN #5 stated if the tests were not performed, and each test passed the machine could not be used. RN #5 stated there was a risk the machine might not alarm if it was not functioning correctly. 4. The facility failed to ensure expired medical supplies were discarded and not available for patient use and to store supplies in a sanitary manner to prevent deterioration. a. On 2/6/24 at 1:35 p.m., an observation of the patient treatment area revealed the following expired supplies: i. In pod #1, a cabinet by the sink area revealed shelves with a large amount of white crystallized residual with containers of Naturalyte Liquid Acid Concentrate for Hemodialysis (a solution used for hemodialysis) stored on the shelves. One jug contained 2K (potassium), 3.5Ca (calcium), and had expired on 7/31/22. Another jug contained 2K, 2.5Ca, and had expired on 12/31/23. ii. In pod #2, a cabinet by the sink area revealed shelves with a large amount of white crystallized residual with containers of Naturalyte Liquid Acid Concentrate for Hemodialysis stored on the shelves. One jug contained 2K, 2.5Ca, and had expired on 1/31/21. A second jug contained 2K, 2.5Ca, and had expired on 12/31/23. A third jug contained 3K, 2Ca, and had expired on 9/31/21. iii. In pod #3, a cabinet by the sink area revealed shelves with a large amount of white crystallized residual with containers of Naturalyte Liquid Acid Concentrate for Hemodialysis stored on the shelves. Two jugs contained 2K, 2.5Ca, and had expired on 12/31/23. b. On 2/13/24 at 11:49 a.m., an interview was conducted with patient care technician (PCT) #4. PCT #4 stated the acid jugs were stored on the shelves and staff rotated them out, but staff needed to do better with this process. PCT #4 stated the jugs could be used until the expiration date. PCT #4 stated there was a potential risk to the patient if expired acid concentrate was used, which included the effectiveness of the dialysis treatment, or affecting the patient’s potassium and calcium blood levels. c. On 2/12/24 at 2:59 a.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated acid jugs contained a specific solution for use in dialysis treatments. RN #5 stated it was policy for staff to check the expiration dates of supplies before use but it was possible for the expired jugs to have been used on a patient.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 45020 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.30 Infection Control, was out of compliance. V113 - 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. Based on observations, interviews, and document review, the facility failed to ensure patient care staff performed hand hygiene. Specifically, staff did not perform hand hygiene in four of six observations of patient care. Additionally, the facility failed to ensure two of two patients, who were observed holding pressure to their access sites (locations where needles were inserted and then removed for treatment), performed hand hygiene following the removal of soiled gloves and prior to leaving the facility. V122 - Procedures for infection control. The facility must demonstrate that it follows standard infection control precautions by implementing-] [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. Based on observations, interviews, and document reviews, the facility failed to ensure patient care staff cleaned and disinfected the patient treatment station chair per facility policy in three of four observations of dialysis station cleaning. Specifically, staff did not fully recline the dialysis chair to clean all surfaces or leave the dialysis chair open to fully dry.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 45020 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.60 Physical environment, was out of compliance. V407 - Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). Based on observations, interviews, and document reviews, the facility failed to ensure patient safety during hemodialysis treatment. Specifically, the facility failed to ensure patient access sites for dialysis treatments remained visible for one of eight patients observed receiving treatment (station #12).”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 45020 Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §494.80 Condition: Patient assessment, was out of compliance. V-511 - Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). Based on observations and interviews, the facility failed to ensure staff assessed arteriovenous (AV) fistulas prior to placing dialysis access needles in the site. The failure was identified in three of three patients observed undergoing initiation of dialysis.”

“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: 45020 Based on observations, interviews, and document review, the facility failed to ensure patient care staff performed hand hygiene. Specifically, staff did not perform hand hygiene in four of six observations of patient care. Additionally, the facility failed to ensure two of two patients, who were observed holding pressure to their access sites (locations where needles were inserted and then removed for treatment), performed hand hygiene following the removal of soiled gloves and prior to leaving the facility. Findings include: Facility policy: The Infection Control for Dialysis Facilities policy read, the purpose of this policy is to minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. All teammates, physicians and non-physicians will perform hand hygiene prior to gloving and immediately after removal of gloves, after patient and dialysis delivery system contact. Patients and caregivers will be encouraged to perform hand hygiene after treatment before leaving the treatment area. 1. The facility failed to ensure staff performed hand hygiene between each patient, workstation, or task when putting on and removing gloves. A. Observations i. On 2/7/24 at 7:05 a.m., patient care technician (PCT) #8 was observed at station #18 as they accessed the patient’s arteriovenous fistula (AVF) (a connection between an artery and a vein for dialysis access). PCT #8 inserted the needles and removed their gloves, however, no hand hygiene was performed. PCT #8 then obtained gauze from the top of the dialysis machine in station #18. PCT #8 put on a new pair of gloves, placed the gauze over the patient’s access site, secured it with tape, and started the patient’s dialysis treatment. PCT #8 removed their gloves, and did not perform hand hygiene. PCT # 8 again donned new gloves and retrieved a pillow from the patient’s personal bag. ii. On 2/7/24 at 7:19 a.m., PCT #8 was observed assisting at station #5. No hand hygiene was performed. PCT #8 was observed putting on gloves, touched the machine at station #5, then removed their gloves, and did not perform hand hygiene before leaving the treatment floor, touching the door on the way out. iii. On 2/7/24 at 8:00 a.m., PCT #8 was observed at station #9, adjusting the dialysis machine. After completing the machine task, PCT #8 removed their gloves and no hand hygiene was performed. PCT #8 then went to station #15, donned new gloves, and adjusted the blood pressure cuff on the patient’s arm. PCT #8 removed their gloves, no hand hygiene was performed. iv. On 2/7/24 at 11:24 a.m., PCT #12, a trainee, was observed attending to a machine alarm at station #16 with gloves on, but hand hygiene was not observed before gloves were put on. PCT #12 touched the dialysis machine at station #16, and removed their gloves, however, no hand hygiene was observed after gloves were removed. PCT #12 donned new gloves, went to dialysis station #13, used the phoenix meter (a hand held machine used to measure conductivity and pH of a dialysis machine) on the dialysis machine in station #13, removed their gloves and did not perform hand hygiene. B. Interviews i. On 2/13/24 at 11:49 a.m., an interview was conducted with PCT #4. PCT #4 stated hand hygiene was to be performed between glove changes and after a dialysis machine or patient was touched. PCT #4 stated gloves were to be worn when cannulating a patient’s access site, when checking vitals, when hooking up a patient to the dialysis machine, and after performing any specific task ii On 2/13224 at 2:59 p.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated hand hygiene was expected to be completed before putting on gloves and after taking off gloves. RN #5 stated if new gloves were put on without first sanitizing hands there was a risk of cross-contamination of pathogens (a bacterium, virus, or microorganism that could cause disease) which could cause infection. PCT #4 stated not performing hand hygiene before, between, and after glove use placed the patients at risk of illness, which included MRSA (Methicillin-resistant Staphylococcus aureus, an infection caused by a type of staph bacteria) and HIV (human immunodeficiency virus, a virus that attacks the body’s immune system). 2. The facility failed to ensure patients performed hand hygiene following the removal of soiled gloves. A. Observations i. On 2/7/24 at 10:08 a.m., an observation was conducted at station #3. The patient was observed holding pressure to their own dialysis access site with a gloved hand following the removal of needles used for treatment. After stabilization of the site, a staff member applied a dressing to the site. The patient then removed the soiled glove and, without performing hand hygiene, packed their belongings and left the facility. The staff did not educate or request the patient to perform hand hygiene following glove removal. The patient was observed touching the door upon exit. ii. On 2/7/24 at 10:46 a.m., an observation was conducted at station #16. The patient was observed holding pressure to their own dialysis access site with a gloved hand following the removal of needles used for treatment. After stabilization of the site, a staff member applied a dressing to the site. The patient then removed the soiled glove and, without performing hand hygiene, packed their belongings and went to the scale area. The patient was observed touching the scale and the door upon exit. This was in contrast to facility policy which read, patients would be encouraged to perform hand hygiene after treatment before leaving the treatment area. B. Interviews i. On 2/13/24 at 11:49 a.m., an interview was conducted with patient care technician (PCT) #4. PCT #4 stated after the patient’s access site was stabilized, the patient was to remove their glove and perform hand hygiene. PCT #4 stated their process was to give the patient hand sanitizer after their glove was removed. PCT #4 stated there was a risk of the patient having blood on their hand which could spread germs and cause illness. ii. On 2/12/24 at 2:59 p.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated hand hygiene should have been offered to patients after treatment. RN #5 stated it was important for patients to perform hand hygiene before leaving the treatment area because patients touched their access sites and there was a risk of cross-contamination and infection.”

“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: 45020 Based on observations, interviews, and document reviews, the facility failed to ensure patient care staff cleaned and disinfected the patient treatment station chair per facility policy in three of four observations of dialysis station cleaning. Specifically, staff did not fully recline the dialysis chair to clean all surfaces or leave the dialysis chair open to fully dry. Findings include: Facility policy: The Infection Control for Dialysis Facilities policy (revised April 2023) read, the purpose of this policy is to minimize the spread of infections or blood borne pathogens in the dialysis facility environment. At the end of each treatment, the dialysis station will be cleaned and disinfected. Surfaces to disinfect include but are not necessarily limited to all surfaces in contact with the patient or their belongings (e.g., dialysis chair). Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. Disinfection should be completed by using a wiping motion with friction. Sufficient disinfectant should be applied so that surfaces are visibly wet. Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time. Reference: According to the manufacturer’s instructions for use for Pure Bright germicidal ultra bleach, for sanitizing non-porous surfaces, prepare a solution of this product, wash the surface, and let stand for 5 minutes to air dry. 1. The facility failed to clean and disinfect the dialysis chair between patient treatments according to facility policy. Direct patient care staff did not place the dialysis chair into the fully reclined position to clean all surfaces of the chair and did not leave the dialysis chair open to fully dry. A. Observations i. On 2/8/24 at 10:24 a.m., patient care technician (PCT) #1 was observed as they disinfected the dialysis chair in station #8. PCT #1 wiped all visible surfaces of the chair with a bleach solution and opened the side armrests to clean the surfaces in between the chair and the armrest, however, they did not place the chair into a fully reclined position to wipe the crevices of the chair seat. When asked if the dialysis chair was fully reclined, PCT #1 pulled the lever on the back of the chair and fully reclined the chair, and stated the chair had not been fully reclined. ii. On 2/8/24 at 10:42 a.m., PCT #2, a trainee, was observed as they disinfected the dialysis chair in station #12. PCT #2 wiped all visible surfaces of the chair with a bleach solution and opened the side armrests to clean the surfaces in between the chair and the armrest, however, they did not place the chair into a fully reclined position to wipe the crevices of the chair seat. When asked if the dialysis chair was fully reclined, PCT #2 stated they were not aware of the process to place the chair in a reclined position. iii. On 2/12/24 at 8:59 a.m., PCT #3 was observed as they disinfected the dialysis chair in station #6. PCT #3 fully reclined the chair, opened both side arms of the chair, and wiped all visible surfaces of the chair with a bleach solution, including the crevices, but closed both side arms while the chair remained visibly wet. B. Interviews i. On 2/13/24 at 11:49 a.m., an interview was conducted with PCT #4. PCT #4 stated dialysis chairs were to be fully reclined using a lever on the back of the chair, both side arms opened and the footrest up and all surfaces were to be cleaned with a bleach solution and left fully open and reclined until dry to make sure the bleach was effective to kill any bacteria or viruses. PCT #4 stated it was important to clean dialysis chairs between patients because some patients could have wounds, weeping edema (skin swelling so severe that fluid will leak out), or illness. ii. On 2/12/24 at 2:59 p.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated the process for a dialysis chair was to completely recline it, open both side arms and clean all surfaces, including any crevices. RN #5 stated the chairs were to be left reclined and open until fully dry so the bleach would have contact time and pathogens would be destroyed. RN #5 stated it was important for dialysis chairs to be cleaned between patients because it prevented and minimized the risk of infection and cross-contamination between patients.”

“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: 45020 Based on observations, interviews, and document reviews, the facility failed to ensure patient safety during hemodialysis treatment. Specifically, the facility failed to ensure patient access sites for dialysis treatments remained visible for one of eight patients observed receiving treatment (station #12). Findings include: Facility policies: The Pre-Intra Post Treatment Data Collection, Monitoring, and Nursing Assessment policy read, the vascular access site, blood line connections, and the patient’s face should be visible throughout the dialysis treatment. The Physical Environment policy read, The purpose of this policy is to provide guidance on the physical environment of the dialysis facility and treatment area. Teammates will be able to visualize patients at all times during hemodialysis treatments for patient safety. 1. The facility failed to ensure staff visualized and monitored patients’ hemodialysis access sites during treatment according to facility policy. a. On 2/8/24 at 7:52 a.m., observations of the patient treatment area revealed Patient #4 at station #12 was receiving treatment in station #12 with a red plaid blanket covering their right arm. Patient care technician (PCT) #1 and RN #11 were at the nurse’s station, away from the treatment area. PCT #2 was in this patient treatment area, but was at a sink area with their back towards the patients. At 7:59 a.m., RN #11 and PCT #1 walked by station #12 and did not ensure the patient’s access was visible. At 8:01 a.m., PCT #2 walked by station #12 two times for supplies and returned to a counter in the patient treatment area, with their back towards the patients. PCT #2 did not ensure the patient’s access was visible. At 8:05 a.m., RN #11 walked by station #12 and did not observe the patient in station #12’s access sites, ensuring they were visible. PCT #1 was then observed obtaining vital signs at station #12 and uncovered the patient access at this time. A total of 13 minutes passed without staff observation of patient #12’s access sites. b. On 2/8/24 at 8:05 a.m., an interview was conducted with PCT #1. PCT #1 stated it was important for patient access sites to remain visible at all times because the needle could become dislodged. PCT #1 stated the risk of needle dislodgement was a patient could bleed and possibly die. c. On 2/13/24 at 11:49 a.m., an interview was conducted with PCT #4. PCT #4 stated access sites for all patients were to remain uncovered at all times. PCT #4 stated staff were to remain diligent at all times to ensure access sites remained visible. PCT #4 stated if a needle were to become dislodged, the machine might not alarm and the patient could bleed to death. d. On 2/8/24 at 8:49 a.m., an interview was conducted with RN #11. RN #11 stated patient access sites were to remain visible at all times. RN #11 stated it was the expectation of staff to monitor patient access sites to ensure they remained visible. RN #11 stated there was a risk of blood loss, cardiac arrest, and death if a needle were to become dislodged. e. On 2/12/24 at 2:59 p.m., an interview was conducted with RN #5. RN #5 stated staff were expected to monitor patient access sites to ensure they remained visible. RN #5 stated it was important to visualize and monitor access sites because if a needle were to become dislodged, or a connection in the tubing at the access site were to become loose and start leaking blood the patient could lose blood quickly and there was a risk of death. f. On 2/13/24 at 8:45 a.m., an interview was conducted with medical director (Director) #7. Director #7 stated it was important for patient access sites to remain uncovered at all times. Director #7 stated if a needle were to become dislodged the patient could experience a serious blood loss in a short period of time which could lead to hypovolemia, cardiac arrest, and death.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 45020 Based on observations and interviews, the facility failed to ensure staff assessed arteriovenous (AV) fistulas prior to placing dialysis access needles in the site. The failure was identified in three of three patients observed undergoing initiation of dialysis. Findings include: Facility policies: The AV Fistula or Graft Cannulation policy read, perform inspection, auscultation, and palpation on the entire length of access. Determine the presence of bruit and thrill. The presence of a bruit and thrill indicates flow through the access. If a bruit or thrill is not present or if signs and symptoms of infection are present, do not cannulate. Absence of a bruit or thrill could indicate a clotted access. The Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment policy read, The purpose of this policy is to obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. Data collection includes vascular access status. Abnormal findings: The following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record: Vascular access: Any swelling, pain, redness, warm to touch, pustules, sores, open areas, hematoma, new aneurysm or changes to existing aneurysm, bleeding or reduced or absent thrill or bruit. 1. The facility failed to give patients a comprehensive assessment before starting dialysis. Specifically, staff did not evaluate AV fistulas (surgically created dialysis access sites) before placing needles in them for the start of dialysis. A. Observations i. On 2/7/24 at 9:46 a.m., an observation was conducted at patient dialysis station #10. PCT #13 was observed as they placed needles within the arteriovenous fistula (AVF) (a connection between an artery and a vein for dialysis access) without listening with a stethoscope for a bruit (a loud, rushing sound caused by blood flow moving through the surgical dialysis access). PCT #13 stated the nurse was to auscultate the access site after the patient’s dialysis treatment had started. ii. On 2/12/24 at 7:13 a.m., an observation was conducted at patient dialysis station #6. PCT #3 was observed as they placed needles within the AVF without listening with a stethoscope for a bruit. PCT #3 stated they had not auscultated the access site before inserting the needles. iii. On 2/12/24 at 7:21 a.m., an observation was conducted at patient dialysis station #13. PCT #14 was observed as they placed needles within the AVF without listening with a stethoscope for a bruit. After the observation, PCT #14 stated they had not auscultated the access site before inserting the needles. PCT #14 stated there was a risk to the patient when the access site was not assessed with a stethoscope before inserting needles. PCT #14 stated the risk was the access site could be narrowed and the blood flow could be compromised. These observations were in contrast to the facility policy AV Fistula or Graft Cannulation policy which read, perform inspection, auscultation, and palpation on the entire length of access. Determine the presence of bruit and thrill. The presence of a bruit and thrill indicates flow through the access. If a bruit or thrill is not present or if signs and symptoms of infection are present, do not cannulate. B. Interviews i. On 2/13/24 at 11:49 a.m., an interview was conducted with PCT #4. PCT #4 stated a patient’s access was to be auscultated with a stethoscope for a bruit and felt with their hand for a thrill, before inserting needles to ensure the access was working. PCT #4 stated if there was an absence of a bruit or thrill, they would immediately notify the nurse. PCT #4 stated there was a risk the patient’s access could be clotted and the patient would be sent to the emergency room. ii. On 2/7/24 at 10:51 a.m., an interview was conducted with registered nurse (RN) #15. RN #15 stated they listened to the patient’s access site when the assessment was completed, which was after the patient’s treatment had started. RN #15 stated there was no risk to auscultation of access sites after treatment was initiated. iii. On 2/12/24 at 2:59 p.m., an interview was conducted with RN #5. RN #5 stated a stethoscope was to be used to listen for the bruit before treatment was started. RN #5 stated there was a risk if a patient’s access was not auscultated for a bruit before needles were inserted. RN #5 stated there was a risk of a clot that could dislodge and cause a cardiac event, a stroke, or a pulmonary embolism (a sudden blockage in the pulmonary arteries, the blood vessels that send blood to the lungs).”