Dialysis - Loyola Center for Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 39802 Based on document review, observation, and interview, it was determined that the Facility failed to comply with the Condition for Coverage 42 CFR 494.40, Water and Dialysate Quality. Findings include: 1. The Facility failed to ensure that staff measured the approximate pH (measure of acidity or alkalinity) and conductivity of the final dialysate with an independent method prior to starting treatment for each patient. (V-250 A) 2. The Facility failed to ensure that solutions used to calibrate meters for pH and conductivity testing of dialysate were not expired. (V-250 B) 3. The Facility failed to ensure that samples for microbial monitoring were collected before sanitization/disinfection of the water distribution system. (V-254)”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, it was determined that for 3 of 3 sink areas, the Facility failed to ensure that handwashing sinks remained clean and only used/contaminated items should be handled in the designated utility sink. This had the potential to affect the 111 in-center hemodialysis patients on census. Findings include: 1. The Facility’s policy titled, “Environmental Control” (dated November 2023), was reviewed and required, “Sinks at the patient care areas are double sink; the right side is dedicated for hand washing only and must be kept clean; the left side sink is for draining leftover used dialysate and IV [intravenous] solutions.” 2. During a tour of the dialysis treatment area on 01/08/2024, between approximately 9:00 AM-1:00 PM, the following was observed: - Patient stations were divided into three pods that were in use during the time of the tour; each with there own supply station and a sink area. Each sink area had one faucet on the right side of the sink which was labeled as “clean sink”. The left side was labeled as “dirty sink.” - At approximately 9:17 AM, a Patient Care Technician (E#5) was observed washing hands on the dirty side of the sink where IV fluids were draining. E#5 used a paper towel to dry the sink counter after washing and crossed over from the dirty to the clean side. - Staff were emptying jugs of used acid concentrate in the dirty side of the sink; however, the solution was splashing onto the counter and into the clean side of the sink. 3. An interview was conducted with Patient Care Technician (E#2) on 01/10/2024, at approximately 1:05 PM. E#2 stated they should only wash their hands on the clean side of the sink. E#2 stated that the dirty side is only for drain bags or jugs. E#2 stated that staff should be careful not to have solution splash over onto the clean side of the sink or else it needs to be wiped down/disinfected.”

“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, it was determined that for 2 of 2 staff (E#7 and E#8)observed cleaning dialysis stations, the Facility failed to ensure that all potentially contaminated surfaces were disinfected in between patient treatments. Findings include: 1. The Facility’s policy titled, “Environmental Control” (dated November 2023), was reviewed and required, “Fully recline hemodialysis chair and clean with Sani-Cloth AF3 wipes or bleach wipes... Wipe all internal and external surfaces at the end of each patient dialysis treatment...” 2. During a tour of the dialysis treatment on 01/08/2024, the following was observed: - At approximately 9:20 AM, a Patient Care Technician (E#7) was cleaning a dialysis station after patient treatment. E#7 did not fully recline the dialysis chair when cleaning and did not wipe the external surface of the acid jug that remained connected to the dialysis machine. - At approximately 9:43 AM, a Patient Care Technician (E#8) was cleaning a dialysis station after patient treatment. E#8 did not fully recline the dialysis chair when cleaning and did not wipe the external surface of the acid jug that remained connected to the dialysis machine. 3. An interview was conducted with the Case/Nurse Manager (E#1) on 01/11/2024, at approximately 12:15 PM. E#1 stated that dialysis chairs should be fully reclined when cleaning the station. E#1 stated that wiping the acid jugs are not a part of their practice; however, stated, “We should be incorporating that into our practice because the jugs from the previous patient can be a source of cross contamination.””

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 34411 Based on document review, and interview, it was determined that for 1 of 2 (Pt #8), clinical records reviewed for newly admitted dialysis patients, the Facility failed to ensure that the Hepatitis B status was known before admission. Findings include: 1. The Facility’s policy titled, “Infection Control for Dialysis Unit”, was reviewed, “...Dialysis Patients: d. Obtain HBV [hepatitis B] serologic results (HBsAg, total anti-HBc and anti-HBs) prior to patient admission to the dialysis center...” 2. The clinical record for Pt #8 was reviewed on 1/10/2024. Pt #8 was admitted on 11/20/2023, with a diagnosis of ESRD (end stage renal disease). The hepatitis B laboratory result (antigen) from the Hospital, prior to admission to the facility, was resulted on 4/17/2023 (6 months prior to admission). 3. On 1/10/2024 at 10:30 AM, an interview was conducted with the Case Manager (E #1). E #1 acknowledged that Pt #8’s hepatitis B panel was not drawn right before admission. E #1 stated that 6 months is a long time, and they generally get that the hepatitis results within 30 days of admission.”

“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 A. Based on document review, observation, and interview, it was determined that for 2 of 3 staff (E#2 and E#4) observed setting up and initiating dialysis treatments, the Facility failed to ensure that staff measured the approximate pH (measure of acidity or alkalinity) and conductivity of the final dialysate with an independent method prior to starting treatment for each patient. This had the potential to affect all 111 in-center hemodialysis patients on census as of 01/08/2024. Findings include: 1. The Facility’s policy titled, “Testing of Dialysate pH and Conductivity Level’ (revised November 2023), was reviewed and required, “For safe and effective operation of a dialysis system, the pH and conductivity of each machine must be tested using a hand held meter before every dialysis treatment and whenever a different composition of concentrate is used...” 2. During a tour of the dialysis treatment area on 01/08/2024, the following was observed: - At approximately 10:35 AM, a Patient Care Technician/PCT (E#4) tested the dialysate of a machine when it was using an acid concentrate jug with a composition of 0.75 mEq (milliequivalents) / L (Liter) of magnesium. At approximately 11:00 AM, the acid concentrate jug was changed to one with a composition of 1.0 mE/L of magnesium. The pH and conductivity were not re-tested after changing the composition of the concentrate prior to initiating treatment for the next patient. - At approximately 11:10 AM, a PCT (E#2) began setup of a dialysis machine. At approximately 11:45 AM, E#2 connected the patient to the dialysis machine without measuring the pH and conductivity with an independent meter. 3. During an interview with PCT (E#2) on 01/08/2024, E#2 stated that the pH and conductivity must be measured with the hand held meter prior to starting each patient treatment. E#2 stated that the test must be done once the machine has finished preparing the dialysate. E#2 stated that the machine was setup by someone else and thought the test had been done already. 4. An interview was conducted with PCT Preceptor (E#3) on 01/08/2024, at approximately 1:30 PM. E#3 stated that E#3 is paired with E#4 because E#4 is still on orientation. E#3 stated that the pH and conductivity is tested after the machine is done preparing the dialysate and the machine is in the priming phase. E#3 stated that they have the machine prepare with the jug that is currently connected if there is still concentrate present. E#3 stated that before the connect the next patient, they will verify the dialysate prescription and change the jug before they connect the patient to the machine to start treatment. E#3 stated that they do not test the pH and conductivity again, even if the acid concentrate is changed. B. Based on document review, observation, and interview, it was determined that for 1 of 5 pH/conductivity meter calibration solutions observed, the Facility failed to ensure that solutions used to calibrate meters for pH and conductivity testing of dialysate were not expired. This had the potential to affect all 111 in-center hemodialysis patients on census as of 01/08/2024. Findings include: 1. The pHoenix Meter Test Instrument User’s Guide (dated 2012), was reviewed and required, “Discard solution the appropriate number of days after opening the bottle or after the expiration date.” 2. During a tour of the dialysis treatment area on 01/08/2024, the calibration solution station was observed and the 100 mS (millisiemens) standard conductivity solution was opened on 12/13/2023 (date of last monthly Level II calibration per logs); however, the manufacturer’s expiration date was 12/2/2023. 3. An interview was conducted with the Patient Care Technician (E#2) on 01/08/2024, at approximately 12:30 PM. E#2 stated that they use the Level II solutions to calibrate all the meters every month. E#2 verified that the solution was expired at the time it was last used and should have been discarded.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 39802 Based on document review, observation, and interview, it was determined that for 3 of 3 months (October-December 2023) reviewed, the Facility failed to ensure that samples for microbial monitoring were collected before sanitization/disinfection of the water distribution system. This had the potential to affect the 111 in-center dialysis patients on census. Findings include: 1. The Facility’s policy titled, “Microbial Testing of Dialysis Water and Dialysate” (November 2023), was reviewed and required, “Sample water and dialysate must be collected prior to disinfection of the water purification system...” 2. The Facility’s Water Culture/Endotoxin Logs from October-December 2023 were reviewed and indicated that water cultures were drawn shortly (1-2 days) after weekly RO (reverse osmosis water purification system) disinfections on Saturdays on the following dates: Sunday 10/08/2023, Monday 10/16/2023 (repeat culture); Monday 11/27/2023, and Sunday (12/10/2023). 3. An interview was conducted with a Patient Care Technician (E#6) on 01/10/2024, at approximately 1:10 PM. E#6 stated that they start the RO disinfection every Saturday evening after treatments are completed. E#6 stated that the disinfection cycle lasts a little over 2 hours. E#6 stated that the Technicians who come in on Monday morning will test for the residual. 4. An interview was conducted with the Case Manager (E#1) on 01/11/2024, at approximately 10:30 AM. E#1 stated that the cultures/endotoxins are drawn by a contracted company every month. E#1 stated that the cultures/endotoxins should be drawn prior to the weekly RO disinfections on Saturday. E#1 stated that they will have to speak to the company about there schedule.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 34411 Based on document review, observation, and interview, it was determined that for 2 of 2 patient restrooms, the Facility failed to maintain a functioning call light system to ensure patient safety. This had the potential to affect all current dialysis patients on census. Findings include: 1.The Facility’s “[Hospital] Regional Ambulatory Tracer” monthly audit tool, dated 2023, was reviewed and included a section that monitors the patient’s bathroom pull cords to ensure that they are accessible and within reach of the patient; however, lacked documentation if the call lights/cords were operational. 2. The Facility’s Environmental Rounding sheet (dated 8/16/2023), conducted by the affiliated Hospital’ Life Safety department, was reviewed. The environmental sheet did not include any assessment of the patient’s bathrooms. 3. On 1/10/2024 at approximately 1:30 PM, an observational tour of the facility was conducted. During the tour, it was noted that the call light systems in both the patient’s restrooms (one in waiting room and one within the treatment area) were not functioning or alarming when the cord was pulled. 4. On 1/11/2024 at 9:30 AM, an interview was conducted with the Regulatory Manager (E #13). E #13 stated that the facility’s manager is responsible for completing the monthly environmental rounds to make sure that the call lights are functioning.”

“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 4 of 25 patients (Pts. #7 and #11-#13) observed, the Facility failed to ensure that access sites were uncovered and visible throughout dialysis treatment. Findings include: 1. The Facility’s policy titled, “Patient Assessment and Monitoring” (dated 05/01/2023), was reviewed and required, “...During Treatment: ...Observe connections are secure and visible... Ensure access remains uncovered throughout the treatment...” 2. During a tour of the dialysis treatment area on 01/08/2024, between 9:00 AM and 10:30 AM, Pts. #7 and #11-#13) had their access sites covered by blankets or clothing and their access sites and/or connections were not fully visible. The access sites remained covered and during this time staff (nurses and patient care technicians) were observed at these patients’ stations; however, staff did not uncover the access sites before leaving the stations. 3. An interview was conducted with Patient Care Technician (E#2) on 01/10/2024, at approximately 1:05 PM. E#2 stated that access sites should be fully visible throughout treatment, so that staff can check the connections and make sure there’s no leaks or dislodgement. E#2 stated that if a site is covered, staff should speak to the patient about it and uncover it.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 39802 Based on document review and interview, it was determined that for 2 of 2 deaths between July-November 2023, the Facility failed to ensure that a mortality review was completed for each death in order to measure, analyze, and track for possible trends. Findings include: 1. The Facility’s policy titled, “Quality Assessment and Performance Improvement” (dated November 2023), was reviewed and required, “Patient care outcome will be evaluated and analyzed by the Interdisciplinary Health Team through the monthly meetings... Data concerning the particular patient outcomes would be collected prior to the meetings... In addition, any specific data related to certain particular patients or unit operation would also be reviewed by the team...” 2. Monthly Quality Assessment and Performance Improvement (QAPI) data from July to November 2023 was reviewed with the Case Manager (E#1) on 01/11/2024, at approximately 9:30 AM. The data indicated that there were 2 deaths during this time period (1 in July and 1 in October). The records lacked documentation of mortality reviews completed for these deaths. 3. An interview was conducted with E#1 on 01/11/2024, at approximately 10:00 AM. E#1 stated, “We talk about the deaths during the meeting, but it’s not documented. We should be documenting what we discussed/reviewed.””