Davita Denver Dialysis Center

“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 for Coverage §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 four of seven patients, who were observed after their dialysis treatment ended, performed hand hygiene prior to exiting the facility according to facility policy. V122 - [Standard: 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 review, the facility failed to ensure patient care staff cleaned and disinfected the patient treatment station chair per facility policy in two of four observations of dialysis station cleaning. Specifically, staff did not fully recline the dialysis chairs to ensure all surfaces were cleaned.”

“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 for Coverage §494.60 Physical environment, was out of compliance. V403 - Standard: Equipment maintenance. 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 interviews, the facility failed to implement and maintain a program to ensure all equipment was maintained in accordance with facility policy. Specifically, five of sixteen treatment chairs had torn surfaces in the seat cushions, which created the potential for infection or cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred with harmful effect) between patients in the dialysis facility. V407 - Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). Based on interviews and document reviews, patient care staff failed to ensure hemodialysis patients’ access sites were visualized during hemodialysis treatments in four of six in-center hemodialysis patients’ medical records reviewed. (Patients #2, #3, #4, and #5)”

“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 for Coverage §494.80 Patient assessment, was out of compliance. V511 - (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). Based on observations, interviews, and document review, the facility failed to ensure heparin was administered according to facility policy in two of four dialysis initiations observed and in six of six in-center patient medical records reviewed. (Patients #1, #2, #3, #4, #5 and #6)”

“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 four of seven patients, who were observed after their dialysis treatment ended, performed hand hygiene prior to exiting the facility according to facility policy. 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. Patients and caregivers will be encouraged to perform hand hygiene after treatment before leaving the treatment area. 1. The facility failed to ensure patients were asked to perform hand hygiene after treatment, before leaving the treatment floor, according to facility policy. A. Observations i. On 9/8/25 at 10:27 a.m., an observation was conducted at station #15. Patient care technician (PCT) #7 removed clamps from the patient’s arm, changed the gauze dressing to the access sites, and applied tape. The patient got themselves into a wheelchair, went to the scale, obtained their weight, and exited the facility. Staff did not educate or request the patient to perform hand hygiene before the patient left the facility. ii. On 9/8/25 at 12:49 p.m., an observation was conducted at station #9. The patient received dialysis treatment through a central venous catheter (CVC) (a thin, flexible tube inserted into a large vein near the heart). PCT #8 secured the CVC, the patient gathered their belongings, ambulated to the scale, and obtained their weight. The patient exited the facility. Staff did not educate or request the patient to perform hand hygiene before the patient exited the facility. iii. On 9/8/25 at 1:36 p.m.., an observation was conducted at station #4. PCT #9 secured the patient’s CVC, the patient ambulated to the scale, obtained their weight, ambulated back to station #4, and gathered their belongings. At 2:00 p.m., the patient exited the facility. Staff did not educate or request the patient to perform hand hygiene before the patient left the facility. iv. On 9/9/25 at 11:08 a.m., an observation was conducted at station #7. The patient was observed holding pressure to their own access sites with a gloved right hand following the removal of the needles used for treatment. After stabilization of the sites, a staff member secured the access sites with tape. The patient ambulated to the scale, touched the scale with their gloved hand, obtained their weight, touched the automatic door opener button, and exited the facility with the glove on their right hand. Staff did not educate or request the patient remove the glove or to perform hand hygiene. B. Interviews i. On 9/10/25 at 11:38 a.m., an interview was conducted with PCT #1. PCT #1 stated patients were to perform hand hygiene before and after dialysis treatments. PCT #1 stated hand sanitizer was to be offered to patients because there was a risk of illness and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred with harmful effect), which could cause an access site to become infected. ii. On 9/10/25 at 10:01 a.m., an interview was conducted with registered nurse (RN) #4. RN #4 stated patients were to perform hand hygiene before leaving the facility. RN #4 stated patients were to remove gloves before they went to the scale because there was a risk of cross contamination. RN #4 stated if a patient did not perform hand hygiene after treatment, there was a risk of infection, including hepatitis (a liver disease), HIV (human immunodeficiency virus, a virus that attacks the body’s immune system) and coronavirus disease (COVID).”

“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 review, the facility failed to ensure patient care staff cleaned and disinfected the patient treatment station chair per facility policy in two of four observations of dialysis station cleaning. Specifically, staff did not fully recline the dialysis chairs to ensure all surfaces were cleaned. 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 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. 1. The facility failed to ensure dialysis chairs were cleaned and disinfected between patient treatments according to facility policy. Dialysis chairs were not placed into the fully reclined position to ensure all surfaces of the chair were cleaned. A. Observations i. On 9/9/25 at 10:12 a.m., patient care technician (PCT) #10 was observed as they disinfected the dialysis chair at station #3. PCT #10 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. ii. On 9/9/25 at 11:17 a.m., PCT #10 was observed as they disinfected the dialysis chair at station #6. PCT #10 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. This was in contrast to the Infection Control for Dialysis Facilities policy which read, all surfaces in contact with the patient or their belongings should have been cleaned and disinfected to minimize the spread of infections or blood borne pathogens in the dialysis facility environment. B. Interviews i. On 9/10/25 at 11:38 a.m., an interview was conducted with PCT #1. PCT #1 stated when dialysis chairs were cleaned, staff were supposed to pull the lever on the back of the chair to ensure the chair was completely reclined. PCT #1 stated it was important to clean dialysis chairs thoroughly between patients because there was a risk of infection, including Hepatitis C (a liver disease spread primarily through blood). ii. On 9/10/25 at 10:01 a.m., an interview was conducted with registered nurse (RN) #4. RN #4 stated chairs were to be fully reclined when cleaned to ensure the crevices were disinfected. RN #4 stated if dialysis chairs were not cleaned appropriately, there was a risk of cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred with harmful effect). RN #4 stated cross-contamination increased the risk of patient infections, such as Hepatitis and HIV (human immunodeficiency virus, a virus that attacks the body’s immune system). These interviews were in contrast to the observations which revealed dialysis chairs were not fully reclined when cleaned.”

“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 interviews, the facility failed to implement and maintain a program to ensure all equipment was maintained in accordance with facility policy. Specifically, five of sixteen treatment chairs had torn surfaces in the seat cushions, which created the potential for infection or cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred with harmful effect) between patients in the dialysis facility. 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. 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. Reference: 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. 1. The facility failed to maintain and repair patient treatment chairs to allow for effective cleaning and disinfection. A. Observations i. A tour of the patient treatment area on 9/8/25 revealed five dialysis treatment chairs with torn surfaces in the seat cushions. The torn surfaces did not allow for effective disinfection. a. Station #2’s dialysis chair was noted to have a large rip in the seat cushion, which measured approximately 12 inches long. b. Station #3’s dialysis chair was noted to have a large rip in the seat cushion, which measured approximately 10 inches long. c. Station #6’s dialysis chair was noted to have a large rip in the seat cushion, which measured approximately 12 inches long. d. Station #7’s dialysis chair was noted to have two large rips in the seat cushion, which measured approximately 5 inches and 9 inches long. e. Station #9’s dialysis chair was noted to have a large rip in the seat cushion, which measured approximately 6 inches long. B. Interviews i. On 9/10/25 at 11:38 a.m., an interview was conducted with patient care technician (PCT) #3. PCT #3 stated dialysis chairs were cleaned with a bleach solution after each patient to prevent cross-contamination. PCT #3 stated ripped seat cushions could cause patients to become uncomfortable and end treatment early. PCT #3 stated patients could become ill if they ended their treatments early. ii. On 9/10/25 at 10:01 a.m., an interview was conducted with registered nurse (RN) #4. RN #4 stated they were aware some of the dialysis chairs had ripped seats. RN #4 stated the dialysis chair surfaces were to be cleaned between each patient. RN #4 stated they could not ensure the treatment chairs with ripped seat cushions were cleaned thoroughly to minimize the risk of cross-contamination of blood-borne pathogens. iii. On 9/10/25 at 12:43 p.m., an interview was conducted with clinical services manager (Manager) #5 and Facility Administrator (Administrator) #6. Manager #5 stated there was not a preventative maintenance log for dialysis chairs. Administrator #6 stated new dialysis chairs had been ordered, however, they were unable to provide evidence.”

“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 interviews and document reviews, patient care staff failed to ensure hemodialysis patients’ access sites were visualized during hemodialysis treatments in four of six in-center hemodialysis patients’ medical records reviewed. (Patients #2, #3, #4, and #5) Findings include: Facility policy: The Pre-Intra-Post Treatment Collection, Monitoring and Nursing Assessment policy read, intradialytic (occurring during hemodialysis) treatment, treatment monitoring will be at least every 30 minutes, including vital signs. At a minimum, registered nurses (RNs) or patient care technicians (PCTs) obtain and document the following: blood pressure, heart or pulse rate, blood and dialysate flows, arterial and venous pressures, fluid removal and/or replacement, vascular access visible and line connections intact. The vascular access site, blood line connections and the patient’s face should be visible throughout the dialysis treatment. All findings, interventions and patient response will be documented in the patient’s medical record. 1. The facility failed to ensure patients were monitored during their dialysis treatments according to facility policy. Specifically, patients’ access sites were not visualized every 30 minutes. A. Document Review i. Review of medical records revealed access site checks were not performed during hemodialysis treatment. a. Review of Patient #2’s treatment sheet, dated 9/2/25, revealed the patient’s access site was not documented as visualized every 30 minutes. Patient #2’s treatment started at 5:40 a.m. There was no documentation of access site visualization between 8:10 a.m. and 9:40 a.m., when treatment ended. Similar findings were discovered during Patient #2’s treatment on 9/6/25. b. Review of Patient #3’s treatment sheet, dated 9/2/25, revealed the patient’s access site was not documented as visualized every 30 minutes. Patient #3’s treatment started at 11:44 a.m. There was no documentation of access site visualization between 1:11 p.m. and 2:41 p.m. c. Review of Patient #4’s treatment sheet, dated 9/5/25, revealed the patient’s access site was not documented as visualized every 30 minutes. Patient #4’s treatment started at 7:03 a.m. There was no documentation of access site visualization between 7:34 a.m. and 9:04 a.m. Similar findings were discovered during Patient #4’s treatment on 8/29/25. d. Review of Patient #5’s treatment sheet, dated 8/27/25, revealed the patient’s access site was not documented as visualized every 30 minutes. Patient #5’s treatment started at 11:28 a.m. There was no documentation of access site visualization between 11:58 a.m. and 2:29 p.m. B. Interviews i. On 9/10/25 at 12:16 p.m., an interview was conducted with PCT #7. PCT #7 stated patients’ access sites were to be visualized and documented every 30 minutes during treatment. PCT #7 stated it was important to visualize patient access sites to ensure the lines to the machine were intact and the access site was not bleeding, which could cause blood loss and death. ii. On 9/10/25 at 10:01 a.m., an interview was conducted with RN #4. RN #4 stated vital signs, including visualization of the patient’s access site, was to be performed and documented every 30 minutes during treatment. RN #4 stated the needle could become dislodged from the access site if the patient’s access was not visualized every 30 minutes during treatment, which put patients at risk for blood loss 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, interviews, and document review, the facility failed to ensure heparin was administered according to facility policy in two of four dialysis initiations observed and in six of six in-center patient medical records reviewed. (Patients #1, #2, #3, #4, #5 and #6) Findings include: Facility policy: The Anticoagulation policy read, heparin is the primary anticoagulant used to prevent clotting. The purpose of this policy is to deliver anticoagulation therapy that reduces clotting within the extracorporeal circuit and prevents complications such as blood loss, optimizes dialyzer efficiency and adequacy of dialysis, and prevents bleeding secondary to over-anticoagulation during the hemodialysis treatment. To anticoagulate the patient, the initial loading dose of heparin is administered through the venous fistula needle or venous port of the central venous catheter (CVC) at least three to five minutes prior to the initiation of the hemodialysis treatment. 1. The facility failed to ensure patient care staff waited three to five minutes after heparin was administered before starting dialysis treatment. A. Observations i. On 9/8/25 at 11:30 a.m., an observation was conducted at station #9. Patient care technician (PCT) #1 prepared the patient for dialysis treatment. After needles were placed, heparin was administered at 11:32 a.m. The dialysis lines were connected and treatment was started at 11:33 a.m., one minute later. ii. On 9/8/25 at 11:42 a.m., an observation was conducted at station #7. PCT #1 prepared the patient for dialysis treatment. After needles were placed, heparin was administered at 11:50 a.m. The dialysis lines were connected and treatment was started at 11:51 a.m., one minute later. These observations were in contrast to the Anticoagulation policy which stated, the initial loading dose of heparin should have been administered at least three to five minutes prior to the initiation of the hemodialysis treatment. B. Document Review i. Review of the medical record for Patient #1 revealed on 8/26/25, dialysis treatment was initiated at 12:46 p.m., and heparin 2000 units (U) was administered at 12:48 p.m., two minutes after dialysis treatment had been initiated. ii. Review of the medical record for Patient #2 revealed on 9/6/25, dialysis treatment was initiated at 5:43 a.m., and heparin 1000 U was administered at 5:49 a.m., six minutes after the dialysis treatment had been initiated. On 9/2/25, dialysis treatment was initiated at 5:40 a.m., and heparin 1000 U was administered at 5:53 a.m., 13 minutes after dialysis treatment had been initiated. iii. Review of the medical record for Patient #3 revealed on 9/2/25, heparin 500 U was administered at 11:43 a.m., and treatment was initiated at 11:44 a.m., one minute after heparin administration. iv. Review of the medical record for Patient #4 revealed on 9/5/25, dialysis treatment was initiated at 7:03 a.m., and heparin 600 U was administered at 11:10 a.m., however, treatment had ended at 11:05 a.m. On 9/3/25, dialysis treatment was initiated at 6:47 a.m., and heparin 600 U was administered at 6:50 a.m., three minutes after dialysis treatment had been initiated. On 8/29/25, dialysis treatment was initiated at 7:08 a.m., and heparin 600 U was administered at 7:39 a.m., 31 minutes after dialysis treatment had been initiated. On 8/27/25, dialysis treatment was initiated at 7:09 a.m., and heparin 600 U was administered at 7:14 a.m., five minutes after dialysis treatment had been initiated. v. Review of medical record for Patient #5 revealed on 9/5/25, dialysis treatment was initiated at 12:03 p.m., and heparin 1000 U was administered at 12:04 p.m., one minute after dialysis treatment had been initiated. On 9/1/25, dialysis treatment was initiated at 11:28 a.m., and heparin 1000 U was administered at 11:34 a.m., six minutes after dialysis treatment had been initiated. On 8/25/25, heparin 1000 U was administered at 11:36 a.m., and treatment was initiated at 11:37 a.m., one minute after heparin administration. vi. Review of medical record for Patient #6 revealed on 9/3/25, dialysis treatment was initiated at 6:07 a.m., and heparin 800 U was administered at 6:14 a.m., seven minutes after dialysis treatment had been initiated. On 8/27/25, dialysis treatment was initiated at 6:40 a.m., and heparin 800 U was administered at 8:00 a.m., one hour and 20 minutes after dialysis treatment had been initiated. On 8/25/25, dialysis treatment was initiated at 6:16 a.m., and heparin 800 U was administered at 6:19 a.m., three minutes after dialysis treatment had been initiated. These medical record reviews were in contrast to the Anticoagulation policy which stated, the initial loading dose of heparin should have been administered at least three to five minutes prior to the initiation of the hemodialysis treatment. C. Interviews i. On 9/10/25 at 11:38 a.m., an interview was conducted with PCT #3. PCT #3 stated heparin was a medication administered to prevent blood from clotting during dialysis treatment. PCT #3 stated after heparin was administered, there was a three to five minute wait time before dialysis treatment was started. PCT #3 stated if a patient’s blood clotted during dialysis treatment, there was a risk of blood loss. ii. On 9/10/25 at 8:57 a.m., an interview was conducted with registered nurse (RN) #2. RN #2 stated heparin was administered to ensure the patient’s blood did not clot during dialysis treatment. RN #2 stated there was a five minute wait time after heparin was administered before dialysis treatment was started to ensure the medication circulated throughout the patient’s body. RN #2 stated there was a risk of blood clots in the dialysis system, blood loss, and loss of treatment time if staff did not wait five minutes after heparin was administered before dialysis treatment started.”