Davita Huntley 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, for 2 of 4 (E#3 and E#5) staff observed, the Facility failed to ensure that hand hygiene was conducted when going from dirty to clean tasks and after removing gloves. 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... prior to gloving and immediately after removal of gloves... after patient and dialysis delivery system contact... before touching clean areas such as supplies, supply cart and chairside keyboard/mouse...” 2. The Facility’s policy titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” (revised April 2025), was reviewed and required, “...Remove old dressing and discard... Remove gloves and discard. Perform hand hygiene per procedure and re-glove...” 3. During a tour of the dialysis treatment area on 07/28/2025, the following were observed: - At approximately 9:14 AM, a Patient Care Technician/PCT (E#5) had disconnected a patient’s blood lines following a dialysis treatment. E#5 then removed gloves and started charting on the computer (clean area) without first performing hand hygiene. - At approximately 9:48 AM, PCT (E#5) was preparing to start a treatment for a patient. E#5 had touched the patient’s access site with gloved hands. E#5 then removed the gloves and went to grab a bag of clean supplies from the clean storage area without first performing hand hygiene. - At approximately 10:07 AM, PCT (E#3) had finished inserting a dialysis needle into a patient’s access site with gloved hands. E#3 had removed gloves and performed hand hygiene and placed a new glove on the right hand. E#3 used the right hand to undo the tourniquet on the arm, and then went to grab a clean glove from the box with the gloved right hand. - At approximately 10:32 AM, PCT (E#3) had removed the old dressing from a patient’s CVC (central venous catheter) exit site. E#3 then continued to swab the site using the same gloves. After wiping the exit site, E#3 removed gloves and did not perform hand hygiene prior to going to the nurse’s station/clean storage area to obtain more wipes. 4. An interview was conducted with PCT (E#6) on 07/28/2025, at approximately 11:35 AM. E#6 stated that gloves should be changed and hand hygiene performed whenever going from a dirty task to a clean task. E#6 stated that the old CVC dressing is considered dirty, so once it’s removed, gloves should be changed and hand hygiene done prior to cleaning the site with swabs/wipes. E#6 stated that hands should definitely be clean before going to get clean supplies from the common storage area.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, for 1 of 1 nurse (E#7) observed, the Facility failed to ensure that medications were not stored in the pockets and that medications taken to a station were dedicated for that patient, in order to prevent potential cross-contamination. Findings include: 1. The Facility’s policy titled, “Infection Control for Dialysis Facilities” (revised April 2023), was reviewed and required, “...medications taken into the station should be used only for that patient and should not be returned to a common clean area or used on other patients... Medication vials, syringes, tape, alcohol swabs, gloves or other supplies will not be carried in pockets...” 2. During a tour of the dialysis treatment area on 07/28/2025, at approximately 11:19 AM, the Nurse (E#7) brought approximately 7 syringes of prepared medications to station #6 and set them on the computer cart and then pulled the cart right in front of the dialysis machine. E#7 then took one of the syringes and administered it to the patient at station #6. After that, E#7 changed gloves and performed hand hygiene, then took the remaining syringes and placed them in E#7’s pant pocket. Thereafter, E#7 went to 2 other patient stations to administer the medications in E#7’s pocket. 3. An interview was conducted with Nurse (E#7) on 07/28/2025, at approximately 11:54 AM. E#7 stated that E#7 should have just taken the medications for that one patient to each station at a time instead of bringing them all and putting them in E#7’s pocket.”

“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: 39802 Based on document review, observation, and interview, for 2 of 3 patient care technicians/PCTs (E#3 and E#5) observed performing dialysis station cleaning, the Facility failed to ensure that staff disinfected all potentially contaminated surfaces. Findings include: 1. The Facility’s policy titled, “Infection Control for Dialysis Facilities” (revised April 2023), was reviewed and required, “...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, tray table, blood pressure cuffs) and frequently contacted by healthcare personnel...” 2. During a tour of the dialysis treatment area on 07/28/2025, the following were observed: - At approximately 9:31 AM, PCT (E#5) was cleaning a dialysis station following a patient treatment. E#5 did not wipe the TV (television) screen. - At approximately 9:40 AM, PCT (E#3) was was cleaning a dialysis station following a patient treatment. E#3 did not wipe the TV screen and did not fully recline the dialysis chair in order to clean in between the seat cushions. 3. An interview was conducted with PCT (E#6) on 07/28/2025, at approximately 11:35 AM. E#6 stated that all equipment and surfaces (such as the TV) should be cleaned during station turnover. E#6 stated that the chair should be completely opened and flat/reclined to visualize the crevices and make sure that all surfaces are disinfected.”

“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, for 1 of 3 patient care technicians/PCT (E#3) observed initiating dialysis treatments, the Facility failed to ensure that pH testing was completed prior to each dialysis treatment and that the test was performed according to the manufacturer’s instructions. Findings include: 1. The Facility’s policy titled, “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate” (revised October 2024), was reviewed and required, “...Manual pH testing must be performed prior to each patient treatment...” 2. The Facility’s procedure titled, “Test of pH of Citric Acid Base Dialysate using RPC E-Z Chek K100-0117CT 6.8-8.5 Test Strips” (revised February 2024), was reviewed and required, “...Obtain dialysate sample by using a disposable collection cup, then dip the strip in the solution for one (1) second... Remove the strip from the fluid and shake off excess dialysate. Within 20 to 25 seconds, compare the color reaction on strip to the color chart on bottle to determine the closest match... pH test results should be between 6.9-7.6...” 3. The pH test strip manufacturer’s instructions for use (IFUs) and application notes (undated) were reviewed and included “...Briskly shake off excess solution. Compare test results to color scale on bottle between 20 and 25 seconds. Retest if the results are not read within the 25 second time frame... For every test, use a stop watch or second hand of a clock/watch to make sure the dip/swish time and wait time called for in the IFUs is correct. Proper test sample exposure time and wait time are critical for test strip accuracy..” 4. During a tour of the dialysis treatment area on 07/28/2025, at approximately 10:10 AM, PCT (E#3) was preparing a patient for dialysis treatment. E#3 had prepared the patient’s access site and was about to connect the patient to the dialysis machine without first performing a pH test. When asked about the pH test, E#3 wasn’t sure if it had been completed and went to get the test strips. E#3 obtained a sample from the machine, dipped the test strip in, and then waited approximately 10 second before comparing the strip to the color chart on the bottle. E#3 did not look at a clock or watch during the test. 5. An interview was conducted with E#3 on 07/28/2025, at approximately 10:13 AM. E#3 stated that a pH test should be completed prior to every dialysis treatment to ensure the machine is safe to use. E#3 stated that after dipping the strip in the solution, they have to wait before reading the result; however, E#3 was not sure how long E#3 should wait. E#3 stated that the acceptable pH range is from 6.8 to 7.5. 6. An interview was conducted with the Facility Administrator (E#1) on 07/30/2025, at approximately 1:37 PM. E#1 stated that pH testing is important to ensure that the pH of the dialysate is within appropriate range and is safe for the patient. E#1 stated that if it is not in range, they can not proceed with treatment on that machine. E#1 stated that pH deals with acid/base balance and goes into the system of the patient and if not within the appropriate range can cause respiratory changes, failure, and may potential be fatal.”

“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: 39802 A. Based on document review and interview, for 1 of 1 RO (reverse osmosis) water purification system, the Facility failed to ensure that weekly maintenance procedures were completed as required by the manufacturer. Findings include: 1. The Facility’s policy titled, “Monthly Water Treatment System Monitoring” (revised October 2018), was reviewed and required, “...Biomed teammates who have been trained to perform the observations and testing required to complete the Monthly Water Treatment Log will observe, test and document their findings...” 2. The RO manufacturer’s “Operation and Maintenance Manual” (dated April 5th, 2016), was reviewed and required, “...Weekly Requirements: The actions below should be performed in additional to the daily requirements... Observe and record the permeate conductivity using a hand held/independent meter. Recalibrate ECM-100 [RO monitor] as necessary...” 3. The Facility’s Daily (from June 2025-July 2025) and Monthly (for all of 2025) Water Treatment Logs were reviewed and indicated that the permeate conductivity reading from the RO itself (not independent) and a final product water conductivity (at the end of water treatment system - not permeate conductivity) was documented daily and were within normal limits (less than 30 microsiemens). However, the logs lacked documentation that weekly checks of the permeate conductivity were conducted using a hand held/independent meter as required by the manufacturer’s manual to determine whether the RO’s conductivity sensor required recalibration. The logs indicated that monthly (instead of weekly) checks of the permeate conductivity using an independent meter were completed by a Biomed teammate. 4. An interview was conducted with Biomed Technician (E#4) on 07/29/2025, at approximately 10:00 AM. E#4 stated that E#4 only does a monthly check of the permeate conductivity using an independent meter per the Facility’s policy. 5. An interview was conducted with Biomedical Operations Manager (E#8) on 07/30/2025, at approximately 9:30 AM. E#8 stated that the the final product water quality meter (a separate meter at the end of the treatment) system does another check of the conductivity before it reaches the treatment floor; however, stated that the conductivity at the end of the system may not be the same as the one the RO reads since there could be changes (i.e. temperature) in between those two points that will affect the conductivity readings. B. Based on document review, observation, and interview, for 1 of 1 glucometer, the Facility failed to ensure that quality control test solutions were maintained and out-of-range results were addressed as required by policy and manufacturer’s instructions for use. Findings include: 1. The Facility’s policy titled, “EmbracePro Blood Glucose Monitor: Quality Control (QC)” (revised September 2020), was reviewed and required, “...QC procedures are performed and documented every day the monitor is used... The first QC procedures of the day are performed before the monitor is used for patient testing... Check high and low control solutions expiration date... When opening a new control solution, write the open and discard dates on the side of the bottle... 90 day expiration is per the manufacturer’s directions for use (DFU)... A low and high control test will be performed on the meter... If control solution results are out of range, repeat the test... If the monitor does not read control solution values accurately, it may not read patient blood glucose values accurately and is not safe to use. Following the manufacturer’s DFU, the meter must be assessed for the cause of the malfunction. Date and document any needed interventions for monitor problems on the reverse side of the QC Log sheet...” 2. The Glucometer QC Logs from 04/01/2025-07/28/2025 were reviewed on 07/28/2025 and included out of range control results on 04/02/2025, 04/15/2025, 06/09/2025, 07/05/2025, 07/10/2025, and 07/19/2025. The logs (front and reverse sides) lacked documentation of a repeat test or any follow-up interventions to address the out-of-range results. 3. During a tour of the dialysis treatment area on 07/28/2025, at approximately 12:00 PM, it was observed that the high and low control solutions for the glucometer were opened; however, the bottles were not labeled with the opened or discard date. 4. An interview was conducted with the Nurse (E#7) on 07/28/2025, at approximately 11:54 AM. E#7 stated that the control solutions are only good for a few months and should be labeled when opened so that they know when to discard them. E#7 stated that if the result of the controls are out of range, a repeat test should be done and documented. E#7 stated that if the results continue to be out of range, they will have to try and troubleshoot what the problem is and may have to replace or have it serviced. E#7 stated that any steps taken should be documented on the log.”

“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 Based on document review, observation, and interview, for 2 of 2 patient care technicians/PCTs (E#3 and E#5) observed performing fistula/graft cannulation (needle insertion), the Facility failed to ensure that the access sites were assessed for functionality prior to starting dialysis treatment. Findings include: 1. The Facility’s policy titled, “Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) Vascular Access Care” (revised April 2025), was reviewed and required, “...Inspection of the AVF or AVG access includes the following: ...presence/absence of thrill [vibration felt when touching the access] and/or bruit [swishing sound heard over access]... signs of stenosis... Inspection of the access and access extremity should be performed each dialysis pre, during and post treatment...” 2. 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 April 2025), was reviewed and required, “...Perform inspection, auscultation [listening with a stethoscope], and palpation [touch/feel] on entire length of access. Determine presence of bruit and thrill. The presence of a bruit and thrill indicates flow through the access... If bruit or thrill is not present or if signs and symptoms of infection are present, do not cannulate. Notify licensed nurse of access status... Absence of a bruit or thrill could indicate a clotted access...” 3. During a tour of the dialysis treatment area on 07/28/2025, the following were observed: - At approximately 9:48 AM, PCT E#5 was preparing a patient with a graft access for dialysis treatment. E#5 palpated (touched) the site just prior to cannulating the access; however, did not have a stethoscope to auscultate (listen) for the presence of a bruit. E#5 did not extend the patient’s arm to assess the access site. - At approximately 10:07 AM, PCT E#3 was preparing a patient with a fistula access for dialysis treatment. E#3 did not palpate or auscultate the access for the presence of a thrill or bruit prior to cannulating the patient’s access. E#3 did not extend the patient’s arm to assess the access site. 4. An interview was conducted with PCT E#6 on 07/28/2025, at approximately 11:35 AM. E#6 stated that fistula and grafts should be assessed by both touching and listening with a stethoscope to ensure blood flow is present. E#6 stated that additionally, the arm should be extended up to check for any concerns such as stenosis (narrowing of the blood vessel).”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 39802 A. Based on document review, observation, and interview, for 1 of 1 nurse (E#7) observed, the Facility’s Medical Director (MD#1) failed to ensure that staff secured medications when left unattended, as required by policy. Findings include: 1. The Facility’s policy titled, “Medication Policy” (revised October 2023), was reviewed and required, “...Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations...” 2. During a tour of the dialysis treatment area on 07/28/2025, at approximately 9:14 AM, there was a bag containing 2 medication syringes left at station #4. The nurse (E#7) was not present on the treatment floor at the time. In addition another bag with two medication syringes was hanging on the IV (intravenous) pole at station #2. The nurse returned to the floor at approximately 9:22 AM and administered the medications to the patient at station #4. At approximately 9:27 AM, E#7 administered the syringes to the patient at station #2. 3. An interview was conducted with the Nurse (E#7) on 07/28/2025, at approximately 11:54 AM. E#7 stated that E#7 should not have left the syringes at the station while E#7 was not there to supervise them. 4. A telephone interview was conducted with the Medical Director (MD#1) on 07/29/2025, at approximately 12:10 PM. MD#1 stated that all staff are trained regarding the Facility’s policies upon hire and then periodically throughout the year (different topics once or twice a month). MD#1 stated that the manager has oversight of the staff on a more frequent basis and will report and concerns to MD#1. MD#1 stated that medications should not be left at the station with the patient and should always be in possession of the nurse/licensed staff member. MD#1 stated that if the medications are not going to be given right away, they need to be stored in a locked cabinet/drawer to ensure a safe environment. B. Based on document review, observation, and interview, for 1 of 1 nurse (E#7) observed, the Facility’s Medical Director failed to ensure that staff labeled prepared medications when not administered immediately, as required by policy. Findings include: 1. The Facility’s policy titled, “Medication Policy” (revised October 2023), was reviewed and required, “...If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of teammate preparing the medication...” 2. During a tour of the dialysis treatment area on 07/28/2025, at approximately 11:44 AM, there were at least 10 syringes in the medication drawer of which 5 were not labeled with either the time or initials of the staff member who had prepared the medications. 3. An interview was conducted with the Nurse (E#7) on 07/28/2025, at approximately 11:54 AM. E#7 stated that E#7 prepared all of the medications around the same time this morning (about 9 AM) and forgot to label some of them. E#7 stated that E#7 should also initial the syringes since E#7 was the one who prepared them. 4. A telephone interview was conducted with the Medical Director (MD#1) on 07/29/2025, at approximately 12:10 PM. MD#1 stated that all staff are expected to adhere to the Facility’s policies and procedures including labeling of prepared medications.”