Valparaiso Dialysis

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to ensure collaboration with local/regional emergency management officials was documented annually to confirm officials were aware of the dialysis facility needs in an emergency in 1 of 1 agency. Findings include: A revised policy, dated 05/20/2022, titled, “Emergency Preparedness Overview,” indicated the Clinic Manager would contact the local emergency management agency annually to ensure that the agency was aware of the dialysis facility’s needs in the event of an emergency. The policy indicated a record of the contact would be kept in the emergency preparedness manual. Dialysis facility letters, dated 12/19/2018 and 01/09/2019, to an Emergency Management Disaster Services, indicated the local emergency management was to be notified annually to ensure the Emergency Management was aware of the dialysis facility needs in the event of an emergency. During an interview on 02/24/2025, beginning at 1:00 PM, the Clinical Manager indicated the dialysis facility did not have documentation their local emergency management officials were contacted since 2019.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 51199 Based on observation, record review, and interview, the dialysis facility failed to ensure a sanitary environment to minimize the transmission of infectious agents in 2 of 3 observations of prepared bleach during 1 of 3 observations of the incenter and failed to ensure all staff [PCT 4] minimized the transmission of infectious agents when cleaning nondisposable equipment between clean and dirty areas in 1 of 2 observations of staff preparing an HD [a process to filter the blood of a patients whose kidneys do not work normally] station. Findings include: 1. A revised policy, dated 06/20/2024, titled “G45 Cleaning & Disinfection of Equipment, Supplies & Treatment Area”, indicated that bleach solutions must be covered with a lid to prevent contamination. 2. A policy, dated 06/20/2024, titled, “Checking Conductivity and Ph of Dialysate - Using Phoenix Meter,” indicated after the dialysate sample was collected and discarded in dirty sink or prime bucket the external meter would be wiped with 1:100 prepared bleach solution if the meter was to be stored in a clean designated area. 3. A revised policy, dated 11/29/2022, titled, “Infection Control,” indicated each center would maintain a clean and dirty work area, clean items such as medications and gloves are kept in the designated clean areas. The policy indicated reusable supplies would not be shared between patients without being disinfected between each use per the appropriate procedure. 4. During an observation on 02/21/2025, beginning at 10:16AM, a container on the treatment floor, identified as a bleach 1:100 solution, was observed near station 14; the container was uncovered and remained uncovered at the conclusion of observation, at 11:25AM. 5. During an interview on 02/25/2025, beginning at 10:10AM, The Clinical Manager indicated that bleach solutions on the treatment floor were to remain covered when not in use. 47022 6. During an observation, on 02/21/2025 beginning at 9:55 AM, PCT 4 retrieved the Phoenix meter from the top of a cabinet, where other supplies were stored, and included packaged saline, packaged tubing, packaged dialyzers, a container labeled as clean ancillary supplies, and gloves. PCT 4 then entered station #3 where Patient #9 was present. PCT 4 completed a conductivity test, with the Phoenix meter, and returned the Phoenix meter to the top of the cabinet, with the other supplies, without decontaiminating / cleaning the meter. 7. During an interview on 02/21/2025, beginning at 10:55 AM, PCT 4 indicated the Phoenix meter did not need to be cleaned prior to returning to the clean cabinet because she did not put the Phoenix meter on the HD machine nor place near computer at the station. PCT 4 indicated the Phoenix meter would be cleaned in the morning and at the end of the day. 8. During an observation on 02/21/2025, beginning at 9:55 AM, a 1:100 bleach solution, with submerged clamps, was observed next to the dirty sink in the pod with Stations #1 to #8; the lid was off, and staff was not present at the dirty sink area. At 10:05 AM, PCT 5 went to the dirty sink area, placed a clamp in the 1:100 bleach solution and covered the bleach solution container. 9. During an interview on 02/21/2025, beginning at 10:55 AM, PCT 4 indicated bleach solutions should be covered with a lid.”

“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: 51199 Based on observation, record review, and interview, the facility failed to ensure PCT 5 performed hand hygiene when they performed central venous catheter [CVC] (large catheter into vein) care in 1 of 2 CVC discontinuations observed (PCT 5 with Patient #14) and the facility failed to ensure that PCT 6 performed hand hygiene and a change of gloves in 1 of 3 observation of CVC exit site care (PCT 6 with Patient #6). Findings include: 1. A revised policy, dated 11/29/2022, titled “G40 Infection Control”, indicated that hands should always be washed after gloves are removed. 2. A revised policy, dated 11/29/2022, titled, “Infection Control,” indicated hands are washed after gloves are removed, between patient contacts, and after touching contaminated items. The policy indicated that all blood line and CVC connections would be handled using proper aseptic technique 3. During an observation on 02/21/2025, beginning at 10:09AM, PCT 6 and PCT 3, at station #10, changed the CVC dressing on Patient #6. During the observation, after removing the old dressing, PCT 6 failed to perform hand hygiene and don new gloves prior to cleansing area and applying new dressing. 4. During an interview on 02/21/2025, beginning at 10:15AM, PCT 3 indicated that hand hygiene and glove change should occur after discarding old dressing. 47022 5. During an observation on 02/24/2025, beginning at 2:30 PM, PCT 5 was at station #8, with Patient #14. PCT 5 was wearing gloves and touched the buttons on the hemodialysis machine [HD] (a process to filter the blood of a patient whose kidneys do not work normally), PCT 5 then returned to Patient’s CVC and began to clean the hubs [HD access] of the CVC without changing gloves or performing hand hygiene.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 51199 Based on interview and record review, the facility failed to evidence all staff were tested and passed a color-blindness test to ensure their ability to accurately interpret colors on test strips in 1 of 3 PCT employee files reviewed [PCT 3]. Findings include: 1. A policy, dated 04/24/2024, titled “IC30 Color Blindness Testing,” indicated that upon hire, all staff responsible for interpreting results of any testing strips must have documentation of completing and passing the Ishihara Color Blind Test with results maintained in their training record. Additionally, it indicated that the Clinic Manager should administer the test and document the results on the testing form. 2. During a personnel record review on 02/25/2025, the dialysis facility presented a blank color-blindness test with no results for PCT 3, dated 07/17/2023. 3. During a review of daily water logs and chlorine logs on 02/25/2025, it was noted that PCT 3 performed water testing, that included reading test strips, on multiple days in December 2024, January 2025, and February 2025. 4. During an interview on 02/25/2025, beginning at 10:20 AM, The clinical manager admitted that they did not input test results, after administering the color blind test of PCT 3 on 07/17/2023.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to evidence PCT 1 and PCT 2 notified RN 2 of patient’s low blood pressure prior to initiation of hemodialysis [HD] (a process to filter the blood when kidneys do not work normally) in 1 of 3 in center HD clinical records reviewed (Patient #5). Findings include: 1. A revised policy, dated 01/13/2025, titled, “Charge Nurse Notification Protocol,” indicated a systolic blood pressure less than 90 or a diastolic blood pressure less than 50 should be reported to the nurse by the direct patient care staff prior to initiation of HD. 2. A revised policy, dated 11/29/2022, titled, “Monitoring and Documentation of Patient Care During Treatment,” indicated patient status observations and interventions must be documented. The policy indicated patient care data entered manually must be documented at the time those actions are performed by the person providing the patient care. The policy indicated patient care data that cannot be documented when done must be documented as a late entry along, with a reason for the late entry, and include the time that activity occurred. The policy indicated information that was manually entered included notes documenting the patient status at each check, and interventions for unexpected situations. 3. A Treatment Flowsheet, dated 01/24/2025, for Patient #5 evidenced, at 10:29 AM, a pre-treatment dialysis low blood pressure of 87/47 (normal blood pressure 120/80) and failed to evidence documentation PCT 3 notified RN 2 of the low blood pressure and evidenced the following: A. The Treatment Flowsheet indicated at 10:31 AM HD treatment was initiated with a blood pressure of 90/60. B. The Treatment Flowsheet indicated at 10:32 AM blood pressure 103/63 followed by a 10:32 note by RN 2 that patient’s blood pressure dropped systolic [top number of blood pressure indicates pressure on the arteries when heart beating] less than 100 with Patient complaints of nausea/vomiting, 300 milliliters flush given and ultrafiltration [fluid removal] was turned off. C. 10:47 AM blood pressure 78/25. 4. A Treatment Flowsheet, dated 01/22/2025, for Patient #5 indicated, at 10:34 AM, HD treatment was initiated with a low blood pressure of 85/54 and failed to evidence documentation PCT 3 notified the RN of the low blood pressure prior to initiating treatment and evidenced the following: A. The Treatment Flowsheet indicated at 11:02 AM Patient’s blood pressure was 95/49. A RN 2 note at 11:03 AM indicated systolic blood pressure at start of HD was less than 100 and would continue to monitor. 5. A Treatment Flowsheet, dated 01/31/2025, for Patient #5 indicated, at 10:41 AM, HD treatment was initiated with a low blood pressure of 82/53 and failed to evidence documentation PCT 1 notified RN 2 of the low blood pressure prior to initiating treatment and evidenced the following: A. The Treatment Flowsheet indicated at 10:51 AM Patient’s blood pressure was low at 78/52, the RN was notified, and the ultrafiltration was turned off. B. The Treatment Flowsheet indicated at 11:02 AM Patient’s blood pressure was 100/67. 6. During an interview on 02/26/2025, beginning at 10:00 AM, RN 2 indicated the PCT should notify the RN of low blood pressure and document notification prior to initiating HD. 7. During an interview on 02/26/2025, beginning at 10:05 AM, PCT 1 indicated the PCT should notify the RN of systolic blood pressure less than 90 prior to initiating HD and the notification should be documented.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to ensure patient hemodialysis [a process to clean the blood when kidneys do not work normally] prescription orders were adhered to in order to achieve and sustain the prescribed dose of dialysis to meet the adequacy of dialysis in 2 of 3 in center hemodialysis patient’s clinical records reviewed (Patient #5 and Patient #1). Findings include: 1. A revised policy dated 11/29/2022, titled, “Monitoring and Documentation of Patient Care During Treatment,” indicated before starting the patient treatment the treatment prescription would be documented indicating the staff reviewed and verified the patient treatment data. The policy indicated information that would be entered manually included but not limited to interventions for unexpected situations such as slowing blood flow for access problem, and if the patient’s prescription was not met for any reason a detailed progress note would be entered explaining why the prescription was not met and actions taken to address the situation. The policy indicated all patient care data that would be entered manually would be documented at the time those actions are performed by the person providing the patient care. The policy indicated if patient care data could not be documented when done would be documented as a late entry along with the time the activity actually occurred. The policy indicated information that would be entered manually would include interventions for unexpected situations such as slowing blood flow for access problems 2. A Treatment Flowsheet, dated 01/22/2025, indicated Patient #5’s blood flow rate[BFR] was to be 400 milliliters/minute [ml/min] and evidenced the following: A. During patient treatment, initiation at 10:31 AM, the BFR from 11:17 AM to 12:04 PM was at 375 ml/min, and failed to evidence documentation of the reason Patient did not receive the prescribed BFR. B. During patient treatment, the BFR from 12:17 PM to 12:32 PM was at 350ml/min, and failed to evidence documentation of the reason Patient did not receive the prescribed BFR. C. During patient treatment the BFR from 12:47 PM to 1:33 PM was at 300ml/min and failed to evidence documentation of reason Patient did not receive the prescribed BFR. 3. A Treatment Flowsheet, dated 01/31/2025, indicated Patient #5’s BFR was to be 400 ml/min and evidenced the following: During patient treatment, initiation at 10:41 AM, the BFR from 10:51 AM to 2:32 PM was at 350 ml/min, and failed to evidence documentation of the reason Patient did not receive the prescribed BFR. 4. A Treatment Flowsheet, dated 02/03/2025, indicated Patient #5’s BFR was to be 400ml/min and evidenced the following: A. During patient treatment, initiation at 10:34 AM, the BFR from 11:03 AM to 11:47 AM was at 375 ml/min, and failed to evidence documentation of the reason Patient did not receive the prescribed BFR. B. During patient treatment the BFR from 12:02 PM to 2:19 PM was at 350 ml/min, and failed to evidence documentation of the reason Patient did not receive the prescribed BFR. 5. During an interview on 02/26/2025, beginning at 10:00 AM, RN 2 indicated BFR changes from the prescription orders should be documented by the PCT or RN. 6. During an interview on 02/26/2025, beginning at 10:05 AM, PCT 1 indicated BFR changes should be documented after discussion with the RN. 51199 7. The clinical record for Patient #1 included two dialysis prescriptions, one dated 02/12/2025 and the other 02/21/2025, which indicated a Dialysis Flow Rate [DFR] (speed at which blood is pumped through a dialyzer during hemodialysis) of 400. A. A dialysis treatment record, dated on 02/12/2025, indicated that initiation of treatment, at 10:25 AM, began with a DFR at 800. The DFR was changed to 400 at 10:32 AM for the remainder of treatment. No progress note was entered explaining why the prescription was not followed. B. A treatment run sheet, dated 02/14/2025, indicated initiation of treatment was 6:28 AM and began with DFR of 400. The DFR was changed to 800 at 7:04 AM and remained at 800 for the remainder of treatment. No progress note was entered explaining why the prescription was not followed. C. A treatment run sheet, for 02/17/2025, indicated that initiation of treatment was at 7:24 AM and began with DFR at 600. The DFR remained at 600 for the remainder of treatment. No progress note was entered explaining why the prescription was not followed. D. A treatment run sheet for 02/19/2025 indicated that the initiation of treatment was at 6:24 AM and began with a DFR of 800. The DFR remained at 800 for the remainder of the treatment. No progress note was entered explaining why the prescription was not followed. E. A treatment run sheet for 02/21/2025 indicated that the initiation of treatment was at 6:14 AM and began with a DFR of 800. The DFR remained at 800 for the remainder of the treatment. No progress note was entered explaining why the prescription was not followed. 8. During an interview, on 02/25/2025 beginning at 10:10 AM, RN 2 indicated that they wrote the orders for DFR of 400, indicated the order should have been for DFR of 800 and was transcribed incorrectly by RN2. RN 2 indicated that he/she verbally instructed staff that Patient #1 should have a DFR of 800. RN 2 additionally indicated that a note was not entered with reason why prescription is not followed.”

“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: 51199 Based on clinical record review, interview, and record review, the dialysis facility failed to ensure patients were evaluated by an RN, prior to their first dialysis treatment at the dialysis facility, in 1 of 1 clinical record reviewed of a new patient admission [Patient #1]. Findings include: 1. A revised policy, dated 06/20/2024, titled “IC07 Patient Assessment: Pre & Post Dialysis,” indicated that a new admission patient must have a full pre-dialysis assessment before the initiation of or at the beginning of the first treatment in the dialysis center. 2. During a clinical record review on 02/25/2025, a Nursing Initial Assessment, dated 02/14/2025, at 06:00, was noted as a late entry for admission date of 01/12/2025, no time noted. 3. During an interview on 02/25/2025, beginning at 10:10 AM, RN 2 indicated that he/she entered a late entry on 02/14/2025 for initial assessment of Patient #1 on 02/12/2025, and failed to include the time of the initial assessment.”