Davita West Side Dialysis

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 34411 Based on document review, observation, and interview, it was determined that for 2 of 3 staff (E #3, E #5) observed, the Facility failed to ensure that staff demonstrated knowledge of the Facility’s infection control practices for the disinfection of AVF/AVG (arteriovenous fistula/graft - used for dialysis access) sites, as required. 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” (dated 10/2022), was reviewed and required, “ ...Skin antiseptic: Isopropyl alcohol 70 %...Effective contact time ...60 seconds ...” 2. On 6/3/2024, between 9:25 AM and 11:15 AM, an observational tour of the dialysis treatment area was conducted, and the following was observed: -At Station #9, at 10:30 AM, a Registered Nurse (RN/E #5) was observed initiating treatment on a patient with a AVF access (Pt #9). E #5 wiped both sites (arterial and venous) for less than 10 seconds with alcohol prep pads (not the required 60 seconds). -At Station #7, at 10:40 AM, a Patient Care Technician (PCT/ E #3) was observed initiating treatment on a patient with a AVG access (Pt #8). E #3 wiped both sites (arterial and venous) for less than 10 seconds with alcohol prep pads (not the required 60 seconds). 3.On 6/3/2024 at 11:05 AM, an interview was conducted with the Lead PCT (E #4). E #4 stated that the AVF/AVG sites should be wiped for 60 seconds each.”

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 34411 Based on document review, observation, and interview, it was determined that for 1 of 1 brine tank (holds salt solution for water softening), the Facility failed to ensure that the tank contained the required amount of salt pellets needed to prevent water hardness. Findings include: 1. The Facility’s daily water checklist was reviewed on 6/3/2024. One of the checks required on the checklist is the brine tank that included, “Salt level in brine tank? (Y/N). At the start of each operation day, check salt level in the brine tank ...” 2. Signage/guidance posted on the water softener tank (located next to brine tank) included, “ ...Check brine tank daily to be sure salt pellet level is above liquid level, adding salt pellets if necessary. Water may become ‘hard’ if salt pellet level is low ...” 3. On 6/3/2024 at 12:00 PM, a tour of the Facility’s water room was conducted. The water room contained a brine tank that works in conjunction with the water softener tank (remove calcium and magnesium to prevent water hardness). The brine tank was noted with salt pellets less than half full. The water level was approximately 1 foot above the salt pellets (not below as required). This finding was confirmed with the Biomedical Technician (E #6) 4. On 6/4/2024 at 9:40 AM, an interview was conducted with the Lead Patient Care Technician (PCT/E #4). E #4 stated that the PCTs check the brine tank daily to see if there is enough salt in the tank. E #4 stated that the salt pellets should be above the water level.”

“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: 34411 Based on document review, observation, and interview, it was determined that for 1 of 3 Patient Care Technician (E #3) observed performing pH (measure of acidity/alkalinity) testing during machine setup, the Facility failed to ensure that staff correctly performed the test to measure the approximate pH of dialysate in accordance with the manufacturer’s instructions for use. This has the potential to affect the 29 in-center hemodialysis patients on census as of 6/3/2024. Findings include: 1. The Facility’s policy titled, “Testing pH of Citric Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8-8.5 Test Strips” (revised 2/2024), was reviewed and required, “...Obtain dialysate sample 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...” 2. The RPC K100-0117CT (pH testing strips) Manufacturer’s “Instructions for Use (IFUs)” (undated) was reviewed and included, “... 2) Remove one strip from the bottle ... 3) Dip or wet the strip into the solution to be tested... 4) Briskly shake off excess solution. Compare test results to color scale on bottle between 20 and 25 seconds...” 3. On 6/3/2024 between 9:25 AM and 11:15 AM, an observational tour of the dialysis treatment area was conducted, and the following was observed: -At 10:10 AM, a Patient Care Technician/PCT (E #3) was observed performing a pH test (with a RPC K100-0117CT pH test strip) for the dialysis machine at station #7. E #3 obtained the sample using a syringe, placed the sample on the test strip, and then compared the strip to the color chart on the bottle at 10 seconds (not the required 20-25 seconds). 4. On 6/3/2024 at 10:15 AM, an interview was conducted with the PCT (E #3). E #3 stated that the strips should be compared to the bottle at 10 seconds. After looking at the strip’s bottle instructions, E #3 acknowledged that the strip should have been compared at 20-25 seconds. E #3 stated that E #3 missed the training on the new strips that the Facility is using now.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 32741 Based on document review and interview, it was determined that for 1 of 4 (Pt.#1)) in-center hemodialysis clinical records reviewed, the Facility failed to monitor the DFR (Dialysis Flow Rate) to ensure that the prescribed DFR was maintained for adequate hemodialysis. Findings include: 1. On 6/4/2024, the Facility’s policy titled, “Treatment Initiation Utilizing B Braun Dialog Dialysis Delivery Systems with All Single Use Dialyzer Types and Streamline Blood Lines” (dated October 2021) was reviewed and required, “Verify and document on patient electronic and/or manual flowsheet the following prior to every dialysis treatment. Prescribed - Blood flow and dialysate flow...” 2. On 6/4/2024, Pt. #1’s clinical record (dated 5/30/2023 thru current) was reviewed and indicated: -Pt. #1 was admitted to the Facility on 3/27/2021 with the diagnosis of end stage renal disease. -Pt. #1’s physician orders dated 5/7/2024 required DFR 800. -Pt. #1’s treatment record dated 5/20/2024 thru 5/31/2024 noted the following: -Pt. #1’s treatment record dated 5/22/2024 documented DFR was 490-500 (not the prescribed 800). -Pt. #1’s treatment record dated 5/29/2024 documented DFR was 500 (not the prescribed 800). 3. On 6/4/2024 at 1:00 PM, an interview was conducted with the Facility Administrator (E #1). E #1 stated that the prescribed DFR should be followed for each patient.”

“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: 32741 Based on document review and interview, it was determined that for 1 of 4 (Pt. #1) in-center hemodialysis clinical records reviewed for shortened treatments, the Medical Director failed to ensure that the staff adhered to patient care policies, by notifying the physician of shortened hemodialysis treatments and ensuring that an AMA (against medical advice) form was completed. Findings include: 1. On 6/4/2024, the Facility’s policy titled, “Refusal of Care/Treatment Against Medical Advice” (dated October 2022) was reviewed and required, “Completion of the Refusal of Care/Treatment Against Medical Advice Form - The RN will verify that a patient’s signs the [Refusal of Care/Treatment Against Medical Advice] form if a patient - refuses their entire dialysis treatment...” 2. The clinical record for Pt. #1 was reviewed on 6/4/2024. Pt. #1 was admitted to the Facility on 3/27/2021, with a diagnosis of ESRD (end stage renal disease). The treatment orders (dated 4/15/2021), included a treatment time of 180 minutes (3 hours). Pt. #1’s treatment sheets, from 5/20/2024 thru 5/31/2024, were reviewed and included the following days with shortened treatments: -5/20/2024 treatment time 143 minutes (2 hours 23 minutes) not the prescribed order 180 minutes (3 hours). The treatment was shortened by 37 minutes. Pt. #1’s clinical record lacked documentation of an AMA form for the shortened treatment. -5/22/2024 treatment time -123 minutes (2 hours 3 minutes) not the prescribed order 180 minutes (3 hours). The treatments was shortened by 57 minutes. Pt. #1’s clinical record lacked documentation of an AMA form for the shortened treatment. 3. On 6/4/2024 at 1:00 PM, an interview was conducted with the Facility Administrator (E #1). E #1 stated that the treatment time should be followed for each patient. E #1 stated that if a patient shortens their treatment, an AMA form should be filled out.”