Davita Ames Mary Greeley Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 36083 Based on review of policies and procedures, observations, and inteviews, the facility failed to ensure: 1) Testing of dialysate pH prior to initiation of patients treatments. (Refer to V250). 2) Integrity of pH test strips according to manufacturer’s directions when they put them at risk for contamination and spoilage on top of bare dialysis machine, together with other supplies such as marker pens, dialysis kits, alcohol swabs, and others. (Refer to V 250). The facility reported a census of 41 hemodialysis patients at the time of the survey. The cumulative effect of this failure resulted in the facility’s inability to ensure safe water and dialysate for the treatments of the ESRD (End Stage Renal Disease) in-center hemodialysis patients.”

“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: 36083 Based on documents review, observations, and interviews, the facility failed to ensure testing of the dialysate pH (refers to the acidity or alkalinity of the dialysis fluid, which is typically maintained within a specific range between 6.8 and 7.8 to ensure patient safety) for 2 of 4 patients (Patient #10 and Patient #14) prior to initiation of dialysis treatments. In addition, the facility did not ensure pH test strips were stored properly to prevent risk for contamination according to manufacturer’s direction. The facility reported a census of 41 in-center hemodialysis patients at the time of the survey. Findings include: 1. The policy # 1-03-02, titled, “TESTING pH AND CONDUCTIVITY OF PROPORTIONED DIALYSATE AND VERIFICATION OF TEMPERATURE OF PROPORTIONED DIALYSATE” with latest revision date of October 2024, provided guidance for testing and documenting pH of proportioned dialysate. The policy notes, “Manual pH testing must be performed prior to each patient treatment.” The policy provides guideline for pH testing including the following: each facility will maintain a test device/test strip to perform independent pH readings of final dialysate; independent pH is required to be performed prior to each treatment; the acceptable range for final dialysate pH is 6.9 to 7.6; check independent pH with approved test method for final dialysate. 2. The procedure # 1-21-09, titled, “TESTING pH OF CITRIC ACID BASE DIALYSATE USING RPC E-Z CHEK K100-0117CT 6.8-8.5 TEST STRIPS” with latest review date of February 2024, notes the materials required as follows: RPC K100-0117CT E-Z Chek 6.8 - 8.5 pH Test Strips, disposable collection cup (if applicable) or one (1) 3 milliliter syringe (if applicable), stopwatch or clock with second hand, PPE or personal protective equipment (face protection, disposable gloves, fluid resistant/fluid impervious barrier garment). The procedure provides the steps to be followed by user/staff member as follows: 1. Put on PPE, remove strip from the vial and immediately recap the vial; 2. Obtain dialysate sample by using a disposable collection cup, then dip the strip in the solution for one (1) second or using a 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. Within 20 to 25 seconds, compare the color reaction on strip to the color chart on the bottle to determine the closest match (rationale: manufacturer’s directions); 5. Match the strip as closely as possible to one of the color scales on the bottle and read the pH range listed above the matched color; 6. pH test results should be between 6.9 - 7.6; 7. Repeat test on another dialysate sample if results are outside the limit of 6.9 - 7.6; 8. If repeat test is outside limit, the dialysis delivery system is unsafe to use for patient treatment, and needs to be removed from patient treatment area; 9. If results are within range of 6.9 - 7.6, document results and proceed with dialysis set up. The procedure also directs the user/staff member not to touch the indicator pads, keep all test strips in original container, replace cap immediately/tightly after removing strip, and not to allow test strip to come in contact with work surfaces that may contaminate the strip. 3. On 12/16/24 at 8:59 AM, the registered nurse (RN) A started to set up station #14 by “stringing” machine or connecting the lines to the dialysis, and connecting the line to a one-liter bag of normal saline to prime the lines. At 9:00 AM, Patient #10 arrived at station #14 and sat in the dialysis chair. At 9:02 AM, the patient care technician (PCT) B was at station #14 in the process of cleaning the central venous catheter (CVC) site. At 9:24 AM, PCT B initiated Patient #10’s treatment without first testing the dialysate pH. 4. On 12/16/24 at 9:27 AM, during inquiry as to why PCT B did not perform a manual test of the dialysate pH before initiating the treatment, PCT B said she “did it quickly and dumped the strip” in the waste bin. PCT B added, “that’s why you did not see me do it.” PCT B acknowledged that she did not open (and did not touch) the vial containing the pH test strips during the procedure. PCT B said she already had a pH strip out sitting on top of the machine behind the monitor with other supplies (alcohol swabs, tapes, marker pen, CVC initiation kit) where she picked up the test strip from there to use, and threw it immediately without comparing results with the color code in the test strip vial. PCT B explained that the process for testing the dialysate pH was to disconnect the line from the dialyzer and get the test strip wet from the dialysate coming out form the line. 5. On 12/16/24 at 9:40 AM, PCT B was observed in the process of setting up station #15 for Patient #14. PCT B opened the pH test strips vial, removed a test strip and put it on top of the dialysis machine (behind the monitor) and directly above the prime waste container where the dialysis lines were draining normal saline solution. Also, on top of the machine with the test strip were other supplies such as alcohol swabs, tapes, a marker pen, and unidentified item/supply. After the dialysis lines were primed, PCT B picked up the pH test strip from the top of the machine, disconnected the dialysis line from the dialyzer and then soaked the pH test strip with dialysate. Some fluid/dialysate flowed from the disconnected site and dripped to the floor. PCT B re-connected the line to the dialyzer, briefly looked at the test strip and threw it into the waste bin. PCT B acknowledged that she did not use the color code in the pH test strip vial to verify results. PCT B stated, “I did not compare I just went of knowledge to be honest with you.” When asked how she knew the pH result, PCT B replied, “I know because I have been doing this.” PCT B indicated she has been working at the facility for 2 months and practiced the same process. 6. On 12/16/24 at 10:30 AM, PCT C indicated during interview that the correct procedure to test dialysate pH was to open the test strip vial container immediately prior to testing, obtain dialysate sample from the sample port on the side of the dialysis machine using a syringe, let the test strip be wet from the dialysate sample drawn, and then read by comparing the test strip with the color code on the pH test strip container. PCT C also demonstrated the procedure immediately following the interview. 7. On 12/16/24 at 10:33 AM, the facility administrator (FA) stated expectations that staff members follow the facility policy and procedure related to dialysate pH testing. The FA stated that not testing dialysate pH prior to initiation of treatment “that’s a big deal! I will go and retrain right 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: 51639 V503Based on document review, observations, and interviews, the facility did not ensure correct dialysis prescription for 1 of 5 patients (Patient 10) observed for prescription verification. The facility reported a census of 41 in-center hemodialysis patients at the time of the survey. Findings include: 1. The Policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessments” effective date April 2024, indicates that staff verify patient prescriptions including machine parameters prior to the initiation of treatment. The prescription components are to be confirmed within one hour of treatment initiation along with the nursing assessment. 2. During an observation and interview on 12/16/2024 at 12:07 showed patient number 10 was receiving a dialysis treatment with a dialysis solution of 3 K (potassium) and 2.5 Ca (calcium) instead of the prescribed 2K 2.5Ca. The observation also showed 30 minutes remaining in Patient #10’s dialysis treatment. During the observation Staff B reported to the surveyor that when patients are placed on incorrect dialysate solutions the nurse should be notified. Staff B then changed Patient #10’s dialysis treatment solution to the prescribed 2K 2.5Ca for the remainder of the dialysis treatment. 3. Review of Patient #10’s Labs showed the patient had a blood potassium level of 5.7 when blood was obtained on 12/2/2024.”