Davita St Luke’s Tamaqua Dialysis

“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: 21832 Based on review of facility policy, manufacturer’s directions for use, clinic floor observations, clinical records (CR), and staff interviews, the facility failed to ensure the policy was followed for documentation of manual conductivity testing using an independent method per policy for four (4) of four (4) in-center hemodialysis clinical records reviewed (CR1 - CR4). Findings included: Review of facility policy on 7/3/24 at 1:15 PM Testing pH and conductivity of proportioned dialysate and verification of temperature of proportioned dialysate states, “Manual pH testing must be performed prior to each patient treatment. Requirments for independent conductivity testing is determined by the manufacture’s guidelines. Refer to specific hemodialysis machine priming policies and procedures to determine the requirments of performing independent conductivity testing in the facility.” Review of facility policy machine start up and priming a single use dialyzer utilizing Fresenius 2008 series dialysis delivery systems and streamline blood lines for the first shift of the day, on 7/3/24 at 1:30 PM states, “If using the Fresenius 2008T or T BlueStar model, no manual conductivity is required unless required by state regulation...40. If using Fresenius 2008T or T BlueeStar model, no manual conductivity is required. Fresenius 2008T or T BlueStar machine performs independent conductivity at the end of pressure holding and alarm test. A pass or fail will show on the screen. The pre-treatment conductivity reading will be displayed in the dialysis screen.” Review of facility procedure: 1-03-06W on 7/3/24 at 1:00 PM states, “33. If using Fresenius 2008T or T BlueStar machines enter “NA” or “N/A” in the manual conductivity field. Manufacturer does not require independent conductivity test when using 2008T or T BlueStar machines.” Review of Davita facility documentation, Changed to Independent Conductivity Testing FMC 2008T & T BlueStar Dialysis Machines, on 7/3/24 at 12:45 PM, states “While Center for Medicare and Medicaid Services (CMS) regulations require PH testing before initiating a dialysis treatment, they defer to manufacture’s guidance with regard to testing independent conductivity. Per regulation V250: ANSI/AAMI RD52:2004 Requirments as Adopted by reference 42 CFR 494.40 (a)5.6 Dialysate proportioning” monitor pH/conductivity. It is necessary for the operator to follow the manufacture’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient....Independent pH testing is still required using approved facility test method. Facilitites that performed pH testing with an independent meter...are recommended to change to an alternate testing method using test strips appropriate for the acid concentrate prescribed for the treatment.” Observations of the clinical treatment area on 7/2/24 from approximately 9:30 AM through 11:30 AM and 7/3/24 from approximately 9:00 AM through 10:30 AM failed to show that any staff member was conducting independent conductivity testing outside of the testing being conducted within the machine. Review of clinical records on 7/8/24 at approximately 10:00 AM revealed the e following: CR#1: Treatment sheets reviewed from 5/28/24 through 6/20/24 showed Machine Set up documentation included a number for manual conductivity testing which was not being conducted manually by the facility. CR#2: Treatment sheets reviewed from 6/18/24 through 6/27/24 showed Machine Set up documentation included a number for manual conductivity testing which was not being conducted manually by the facility. On 7/6/24 manual conductivity documentation showed N/A. CR#3: Treatment sheets reviewed from 6/18/24 through 6/29/24 showed Machine Set up documentation included a number for manual conductivity testing which was not being conducted manually by the facility. CR#4: Treatment sheets reviewed from 6/17/24 through 6/28/24 showed Machine Set up documentation included a number for manual conductivity testing which was not being conducted manually by the facility. Interview with the facility administrator on 7/2/24 at approximately 9:15 AM confirmed no manual conductivity checks were being performed since the facility has been utilizing the Fresenius 2008T machines with BlueStar technology.”