Davita Country Hills 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: 39802 Based on document review, observation, and interview, it was determined that for 3 of 7 staff (E#2, E#3 and E#7 ) observed, the Facility failed to ensure that gloves were removed and hand hygiene performed when going from dirty to clean tasks. Findings include: 1. The Facility’s policy titled, “Infection Control for Dialysis Facilities” (revised April 2023), was reviewed and required, “...All teammates... will perform hand hygiene... g. before touching clean areas such as supplies, supply cart...” 2. During a tour of the dialysis treatment area on 03/18/2024, the following were observed: - At approximately 9:45 AM, a Patient Care Technician/PCT (E#3) was preparing to remove the dialysis access needle from a patient following treatment. E#3 pulled the sharps container closer to the station with gloved hands. E#3 then started to remove the tape from the access without changing gloves and performing hand hygiene. After E#3 removed the dialysis needle, E#3 put the needle into the sharps container; however, E#3’s gloved hand touched the opening of the sharps container as E#3 was pushing the needle into the opening. E#3 then returned to tape up the access with the same gloves. - At approximately 10:38 AM, a PCT (E#2) was preparing to remove the dialysis access needle from a patient following treatment. E#2 touched E#2’s mask then proceeded to touch the patient’s access to remove the tape and needle without changing gloves and performing hand hygiene. - At approximately 11:16 AM, Registered Nurse (E#8) went to a patient’s station to administer IV (intravenous) medication. E#8 pulled up E#8’s face mask with gloved hands and then proceeded to administer the medication without changing gloves and performing hand hygiene. 3. An interview conducted with PCT (E#5) on 3/18/2024, at approximately 1:15 PM. E#5 stated that any time staff touch something dirty, they need to change gloves and perform hand hygiene before they continue care for a patient. E#5 stated that the sharps container and face masks are considered dirty.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 39802 Based document review, observation, and interview, it was determined that for 2 of 2 staff (E#3 and E#4), the Facility failed to ensure that staff performed arteriovenous fistula (AVF) / graft (AVG) access site cannulation (needle insertion) according to infection control guidelines/policies. Findings include: 1. The Facility’s policy titled, “AV Fistula or Graft Cannulation with JMS Sysloc Mini Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” (revised October 2022), was reviewed and required, “...Skin Antiseptic: Povidone Iodine: Effective Contact Time 30 seconds, Air Drying Time 2 minutes; Isopropyl Alcohol 70%: Effective Contact Time 60 seconds... Do not palpate [touch] insertion site once area has been prepped. Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation...” 2. During a tour of the dialysis treatment area on 3/18/2024, the following was observed: - At approximately 11:11 AM, a Patient Care Technician (E#4) was preparing a patient’s AVF for dialysis treatment. E#4 wiped the first access site with an iodine pad for approximately 16 seconds (not the required 30 seconds). E#4 then wiped the second access site with an iodine pad for approximately 12 seconds (not the required 30 seconds). Within 30 seconds, E#4 then wiped off the iodine (did not allow to dry for 2 minutes as required). At approximately 11:13 AM, E#4 palpated the first access site with a gloved finger before inserting the needle. E#4 repeated the same process for the seconds access site. E#4 did not disinfect the access sites again after touching them. - At approximately 11:36 AM, PCT (E#3) was preparing a patient’s AVF for dialysis treatment. E#3 wiped the first access site with an alcohol pad for approximately 30 seconds (not the required 60 seconds) before inserting the dialysis needle. E#3 then wiped the seconds access site with alcohol for approximately 38 seconds (not the required 60 seconds) before inserting the needle. 3. An interview conducted with PCT (E#5) on 3/18/2024, at approximately 1:15 PM. E#5 stated that AVFs should be wiped with alcohol for 60 seconds or with iodine for 30 seconds. E#5 stated that if using iodine, the site should be allowed to dry, without wiping off, for 2 minutes. E#5 stated that the site should not be touched once it’s been cleaned, otherwise, it needs to be cleaned again before inserting the needles.”

“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: 39802 Based on document review, observation, and interview, it was determined that for 3 of 5 staff (E#2, E#4, and E#6), the Facility failed to ensure that pH (measure of acidity/alkalinity) testing was conducted according to the manufacturer’s instructions for use (IFU) and policy. This had the potential to affect all in-center dialysis patients as of 3/18/2023. Findings include: 1. The dialysis machine instructions for use (dated May 2016) was reviewed and included, “...Once the machine completes the blood side self tests measure the pH using an approved test method...” 2. The Facility’s procedure titled, “Testing pH of Citric Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8-8.5 Test Strips” (dated October 2020), was reviewed and required, “...2. Obtain dialysate sample by using a disposable cup, then dip the strip in the solution for one (1) second. Or using new syringe, obtain dialysate sample from sample port, then allow fluid to flow over the pad for one (1) second. 3. Remove the strip from the fluid and shake off excess dialysate. 4. At 10 seconds, immediately compare the color reaction on strip to the color chart on bottle to determine the closest match...” 3. During a tour of the dialysis treatment area on 3/18/2024, the following was observed: - At approximately 10:07 AM, a Patient Care Technician/PCT (E#2) obtained a sample of dialysate from the machine to test for pH. The blood side self-tests were still in progress and were not yet completed when the sample was drawn for testing. - At approximately 10:27 AM, PCT (E#6) obtained a sample of dialysate for pH testing. E#6 dipped the pH test strip into the sample, waited 10 seconds, and looked at the strip color; however, E#6 did not compare the strip to the color chart on the bottle as required. - At approximately 11:07 AM, PCT (E#4) obtained a sample of dialysate for pH testing. E#4 dipped the test strip in the sample for 1 second, took the strip out and shook off excess fluid, and then read the test strip right away (without waiting the required 10 seconds). 4. An interview was conducted with E#2 on 3/18/2024, at approximately 10:08 AM. E#2 stated that the pH test sample should be drawn after the machine completes the self-tests. E#2 stated that a green man would show up on the side when the tests were complete. E#2 stated that E#2 should have waited for the tests to complete before drawing the sample for testing. 5. An interview was conducted with E#6 on 3/18/2024, at approximately 10:30 AM. E#6 stated that E#6 knew the result of the pH test because E#6 remembered the color in E#6’s head. E#6 stated that E#6 should have compared it to the bottle’s color chart. 6. An interview was conducted with E#4 on 3/18/2024, at approximately 11:08 AM. E#4 stated that E#4 should have waited 10 seconds and then read the result of the test. .”

“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: 39802 Based on document review, observation, and interview, it was determined that for 2 of 10 patients (Pts. #3 and #6) observed, the Facility failed to ensure that the patient’s face, access, and/or bloodlines remained visible throughout treatment. Findings include: 1. The Facility’s policy titled, “CWOW-Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” (revised April 2021), was reviewed and required, “...Intradialytic Data Collection/Assessment: ...The vascular access site, blood line connections and the patient’s face should be visible throughout the dialysis treatment...” 2. The clinical records of Pt. #3 and #6 were reviewed on 03/19/2024 and included: - Pt. #3 had a central venous catheter access on the left chest. - Pt. #6 had a arteriovenous fistula access on the left forearm. 3. During a tour of the dialysis treatment area on 03/18/2024, the following was observed: - At approximately 9:15 AM, Pt. #6 was noted to be covered by a large green jacket that covered Pt. #6’s face, access site, and bloodline connections. Pt. #6’s face, access, and bloodlines remained covered until staff were ready to terminate the patient’s treatment at approximately 9:50 AM. - At approximately 12:30 PM, Pt. #3 was noted to be wearing a dark sweatshirt and had a black blanket over the lap. The bloodlines were noted to come out from underneath the blanket; however, the patient’s access site and bloodline connections were not visible. The access site and connections remained covered until at least 1:00 PM. 4. An interview was conducted with the Facility Administrator (E#1) on 03/19/2024, at approximately 2:00 PM. E#1 stated that access sites should remain uncovered during treatment so that staff can monitor for bleeding. E#1 stated that if the sites are covered, staff are expected to uncover the sites and educate the patient’s on the importance of keeping their face, access, and lines visible.”

“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: 39802 A. Based on document review, observation, and interview, it was determined that for 2 of 2 patients (Pts. #7 and #8), the Facility failed to ensure that vascular access sites were assessed post dialysis treatment for the presence of a bruit (sound of blood flowing through access) and a thrill (vibration felt on palpation indicating flow). Findings include: 1. The Facility’s procedure titled, “Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles” (Revised April 2023), was reviewed and required that “ ...Observe for edema, redness, prolonged bleeding and presence of thrill/bruit ...” 2. The Facility’s policy titled, “Utilizing Vascular Access Clamps”(Revised April 2019), was reviewed and required that “ ...During use, the thrill and bruit of the access will be checked above and below the clamp ...” 3. During a tour of the dialysis treatment area, on 3/18/24, the following was observed: - At approximately 9:43 am PCT (Patient care technician) E#3 was observed removing the first dialysis access needles from Pt. #7 and placed a clamp on the site. E#3 did not assess the vascular access site while the clamp was in use. At approximately 9:51 am, RN (registered nurse) E#7 was observed removing the first clamp and taped the site. E#7 then placed a clamp on the 2nd needle site (after needle removal). E#3 and E#7 did not assess the patient’s access while the clamp was in use. At approximately 10:03 am, E#3 removed the clamp from patient’s access and did not perform an assessment for thrill or bruit prior to the patient leaving the treatment floor. - At 10:38 am, PCT E#2 removed the dialysis access needles from Pt. #8. E#2 did not assess the access for thrill or bruit after hemostasis (bleeding stopped) was achieved and prior to the patient leaving the treatment floor. 4. An interview conducted with PCT (E#5) on 3/18/2024, at approximately 1:15 pm. E#5 stated that the thrill and bruit should be assessed while a clamp is being used on an AVF/AVG (arteriovenous fistula/arteriovenous graft). E#5 stated that the thrill and bruit would only be assessed post-treatment if a clamp was used. B. Based on document review, observation, and interview it was determined that 1 of 2 patients (Pt. #7), the Facility failed to ensure that vascular access sites had an appropriate physician’s order to utilize vascular access clamps. Findings include: 1. The Facility’s Policy titled “Utilizing Vascular Access Clamps” (Revised April 2019), was reviewed and required “ ... 2. A physician’s order is always required for utilization of vascular access clamps ...” 2. The clinical record for Pt. #7 was reviewed with Facility Administrator (FA) E#1 on 3/18/2024, at approximately 2:50 pm. The record lacked active orders to utilize vascular access clamps. 3. During a tour of the Facility’s treatment area on 3/18/2024, between approximately 9:43 am and 10:03 am, a clamp was used on each of Pt. #7’s access sites after the dialysis needles were removed. 4. An interview was conducted with E#1 on 3/18/2024, at approximately 2:50 pm. E#1 stated that an order is always required in order to utilize vascular access clamps for all patients.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 1 of 5 clinical records (Pt. #3) reviewed, the Facility failed to ensure that the fluid volume removed did not exceed the maximum ordered by the physician. Findings include: 1. The Facility’s policy titled “The Facility’s policy titled, “CWOW-Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” (revised April 2021), was reviewed and required, “...Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time... Fluid Status: ...Removal goal not to exceed maximum ordered by physician...” 2. The clinical record of Pt. #3 was reviewed on 03/19/2024. Pt. #3 was admitted on 12/21/2016, with a diagnosis of end-stage renal disease (ESRD). Dialysis treatment orders active from 1/15/2024-3/19/2024 included 3 dialysis treatments per week; 180 minutes each treatment; with a maximum ultrafiltration rate (UFR) of 13 mL (milliliters) / kg (kilogram) / hr (hour). Six consecutive treatment records from 3/6/2024-3/18/2024 were reviewed and included the following actual UFRs: - 3/6/2024 UFR = 17.0 mL/kg/hr (4 mL/kg/hr more than the maximum ordered) - 3/8/2024 UFR = 20.3 mL/kg/hr (7.3 mL/kg/hr more than the maximum ordered) - 3/11/2024 UFR = 20.4 mL/kg/hr (7.4 mL/kg/hr more than the maximum ordered) - 3/13/2024 UFR = 21.9 mL/kg/hr (8.9 mL/kg/hr more than the maximum ordered) - 3/15/2024 UFR = 23.1 mL/kg/hr (10.1 mL/kg/hr more than the maximum ordered) - 3/18/2024 UFR = 17.5 mL/kg/hr (4.5 mL/kg/hr more than the maximum ordered) - The record did not include any orders or notes from the physician to increase the maximum UFR. - The record lacked documentation to address why the maximum UFR ordered was exceeded and whether the physician was notified. 3. An interview was conducted with the Facility Administrator (E#1) on 3/19/2024, at approximately 12:08 PM. E#1 stated that staff should have notified the doctor of the patient’s gains and if they needed to exceed the maximum UFR. E#1 stated that the doctor would put in a note at the time to allow them to exceed the maximum.”