Merrillville North Dialysis Center

“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 dialysis facility failed to ensure staff removed gloves, performed hand hygiene, and donned clean gloves in 1 of 2 observations of Central Venous Catheter [CVC] (catheter into vein) exit site care [PCT3] and 1 of 2 observations of discontinuation of dialysis with a CVC [PCT 4]. 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 and between patient contacts, as well as after touching blood, body fluids, secretions, excretions, and contaminated items. 2. A revised policy, dated 09/01/2023, titled “IC05C CVC: Dressing Change”, indicated that hand hygiene and donning clean gloves should be performed after discarding the old dressing. 3. A revised policy, dated 06/11/2025, titled “IC05A CVC: Initiation & Discontinuation of Treatment”, indicated that once a patient’s blood is returned, gloves should be removed, hand hygiene performed, and clean gloves should be donned prior to disconnecting the blood lines. 4. During an observation on 06/27/2025, beginning at 9:47 AM, at station #17, PCT 3 was performing CVC exit site care to Patient 1. PCT 3 removed and discarded Patient 1’s old dressing, then cleansed area around CVC exit site with antiseptic without removing gloves, performing hand hygiene, and donning clean gloves. 5. During an interview on 06/27/2025, beginning at 10:02 AM, PCT 3 indicated that hand hygiene should occur after removing the old dressing during CVC exit site care. 6. During an observation on 06/27/2025, beginning at 9:38 AM, at station #3, PCT 4 was performing discontinuation of dialysis with a CVC on Patient 14. PCT 4 reifused the extracorporeal circuit (returned blood to patient) and disconnected the blood lines by closing clamps and disconnecting the CVC connections without removing gloves, performing hand hygiene, and donning clean gloves. 7. During an interview on 06/27/2025, beginning at 10:25 AM, PCT 4 indicated that hand hygiene and glove change should occur after returning blood to the patient and before disconnecting the patient from the HD machine.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 41135 Based on record review and interview, the dialysis facility failed to ensure that the RN completed an initial assessment prior to the first in-center hemodialysis (HD, a process to filter the blood of a patient whose kidneys do not work normally) treatment in 1 of 1 clinical record reviewed with an admission date in the last 90 days. (Patient #1) Findings include: A policy revised 06/20/2025 titled “Patient Assessment: Pre [and] Post Dialysis” indicated the RN must perform a full assessment prior to the initiation of the first treatment. A clinical record review for Patient 1 showed an admission date of 04/09/2025. The HD Treatment Flowsheet dated 04/09/2025 indicated that in-center HD treatment started at 10:23 AM. The Nursing Initial Assessment dated 04/09/2025 indicated the RN completed the assessment at 12:52 PM and failed to evidence the assessment was performed prior to the initiation of the first treatment. On 06/26/2025, at 2:47 PM, the FA indicated the initial assessment was not documented prior to the initiation of treatment.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 41135 Based on record review and interview, the dialysis facility failed to ensure the medication was offered for elevated blood pressure during treatment to manage patient’s volume status in 2 of 5 clinical records reviewed for patients receiving in-center hemodialysis (HD, the process to filter the blood when the kidneys do not function properly). (Patient #1, 4) The findings include: 1. A clinical record review for Patient #4 evidenced a standing order effective 08/27/2024 which indicated the Patient was to take clonidine (medication to treat high blood pressure) as needed when the systolic blood pressure (top number of the blood pressure value) was greater than 170 or the diastolic (bottom number of the blood pressure value) was greater than 100 and to notify the physician if persistent or post treatment systolic blood pressure was greater than 170 or diastolic blood pressure was greater than 100. HD Treatment Flowsheets evidenced: A. On 06/04/2025 the predialysis blood pressure was 198/119, 165/108 at 10:14 AM at the initiation of treatment, 10:30 AM 181/107, 11:00 AM 165/104, 11:30 AM 184/111, 12:01 PM 173/116, 12:14 PM 186/125, and post treatment 189/119. The treatment sheet failed to evidence the staff offered the Patient clonidine. B. On 06/06/2025 the predialysis blood pressure was 210/128, 188/118 at the initiation of treatment at 7:00 AM, 7:30 AM 176/119, 197/117, 8:30 AM 194/122, and 178/124 post treatment. The treatment record failed to evidence the staff notified the physician of the persistent elevated blood pressure and of the Patient’s refusal of clonidine. C. On 06/09/2025 the predialysis blood pressure was 193/126, 190/118 at 6:45 AM, 183/112 at 7:00 AM, 187/119 at 7:15 AM, 187/137 at 7:30 AM, 194/134 at 8:00 AM, 192/119 at 8:30 AM, 183/128 at 9:00 AM, and 204/140 post treatment. The treatment record failed to evidence the staff notified the physician of the persistent elevated blood pressure and of the Patient’s refusal of clonidine. D. On 06/11/2025 the predialysis blood pressure was 196/131, 190/123 at initiation of treatment at 8:14 AM, 8:30 AM 195/124, 9:00 AM 189/120, 9:31 AM 188/122, 10:04 AM 196/130, 191/124 10:30 AM, and 191/124 post treatment. The treatment record failed to evidence the staff notified the physician of the persistent elevated blood pressure and of the Patient’s refusal of clonidine. E. On 06/13/2025 the predialysis blood pressure was 212/129, 184/130 at initiation of treatment at 10:16 AM, 10:32 AM 202/128, 11:31 AM 193/122, 12:00 PM 208/133, and 187/124 post treatment. The treatment record failed to evidence the staff notified the physician of the persistent elevated blood pressure and of the Patient’s refusal of clonidine. F. On 06/18/2025 the predialysis blood pressure was 155/107, 196/132 at initiation of treatment at 11:01 AM, 11:15 AM 178/111, 11:30 AM 190/127, 12:00 PM 192/114, 12:15 PM 199/118, 12:30 PM 185/111, 1:01 PM 206/128, and 199/121 post treatment. The treatment record failed to evidence the staff notified the physician of the persistent elevated blood pressure and of the Patient’s refusal of clonidine. G. On 06/20/2025 the predialysis blood pressure was 171/120, 190/124 at initiation of treatment at 9:55 AM, 10:00 AM 199/127, 10:30 AM 159/110, 11:01 AM 205/124, 11:30 AM 180/131, 12:00 PM 178/118, 12:28 PM 208/129, and 199/120 post treatment. The treatment record failed to evidence the staff offered clonidine during treatment and failed to notify the physician of the persistent elevated blood pressure until after treatment ended. H. On 06/25/2025 the predialysis blood pressure was 192/123, 213/185 at initiation of treatment at 5:41 AM, 6:00 AM 156/110, 6:30 AM 188/131, 7:00 AM 189/126, 7:30 AM 182/126, 8:00 AM 197/135, and 197/123 post treatment. The treatment sheet failed to evidence the staff offered the Patient a clonidine until 2 hours and 19 minutes into treatment which the Patient refused. The treatment record failed to evidence the staff notified the physician of the persistent elevated blood pressure and of the Patient’s refusal of clonidine. I. On 06/27/2025, at 3:03 PM, the FA indicated the corporate office did not want the facility to add blood pressure parameters in the policy regarding the initiation of treatment even though a sister facility was cited for Immediate Jeopardy. The FA indicated she would like blood pressure parameters, but corporate said “no”. The FA indicated in her clinical judgment, a predialysis blood pressure greater than 200/100 was “too high” for treatment. The FA indicated there was no specific policy on when to notify the physician of persistent elevated blood pressure during treatment and indicated it was “nursing judgement”. J. On 06/30/2025, beginning at 12:15 PM, the Medical Director indicated he was more concerned with an elevated post treatment blood pressure, and he would like to know of a systolic blood pressure post treatment greater than 180 for this Patient. The Medical Director indicated he should be notified when the Patient refuses the clonidine and the blood pressure continues to stay elevated. 2. A clinical record review for Patient #1 evidenced a standing order effective 04/07/2025 which indicated the Patient was to take clonidine as needed when the systolic blood pressure was greater than 170 or the diastolic was greater than 100 and to notify the physician if persistent or post treatment systolic blood pressure was greater than 170 or diastolic blood pressure was greater than 100. HD Treatment Flowsheets evidenced: A. On 06/11/2025, the predialysis blood pressure at initiation of treatment at 9:47 AM was 180/94, 10:00 AM 184/94, 10:30 AM 186/97, 11:00 AM 183/91, and 11:31 AM 180/94. The treatment flowsheet failed to evidence the staff offered or administered clonidine prior to 2 hours into the treatment. B. On 06/16/2025, the blood pressure was 191/107 at 10:30 AM, 191/99 at 11:00 AM, and 194/92 at 11:30 AM and failed to evidence the staff offered or administered clonidine prior to 1 hour and 51 minutes into the treatment. On 06/26/2025, at 2:47 PM, the FA indicated the staff should have offered clonidine earlier than what was administered. On 06/27/2025, beginning at 3:35 PM, RN 3 indicated she typically does not offer clonidine for elevated blood pressure until the patient is 1 hour into treatment and if the standing protocol does not work, then she would call the physician. RN 3 indicated she would call the physician for a blood pressure greater than 180/90.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 41135 Based on record review and interview, the facility failed to ensure the interdisciplinary team adjusted the plan of care when the expected outcome was not achieved and failed to identify and document the potential causes of patient non-adherence and efforts to address those causes in 1 of 5 clinical records reviewed for patients receiving in-center hemodialysis (HD, the process to filter the blood when the kidneys do not function properly). (Patient #4) The findings include: A policy revised 06/11/2025 titled “Comprehensive Assessment, Plan of Care CAPOC” indicated if a patient’s expected outcome is not achieved, the interdisciplinary team must adjust the POC to achieve the specified goals. The policy indicated if the patient is unable to meet specified goal, the interdisciplinary team should document the reasons why the goal was not achieved and the changes implemented to address the identified issue. A clinical record review for Patient #4 evidenced a Comprehensive Assessment/POC Nursing Assessment Report dated 11/01/2024 which indicated the desired pre and post dialysis blood pressure was less than 160 systolic (the pressure against the arteries when the heart is pumping and represented by the top number of the blood pressure value) and less than 110 diastolic (the pressure against the arteries when the heart is at rest and represented by the bottom number of the blood pressure value). HD Treatment Sheet dated 06/06/2025 indicated the blood pressure was 210/128 predialysis and 178/124 post treatment; 193/126 predialysis and198/134 post treatment on 06/09/2025; 196/131 predialysis and 191/123 post treatment on 06/11/2025; 199/136 predialysis and 190/113 post treatment on 06/13/2025, 192/123 predialysis and 197/123 post treatment on 06/16/2025; 199/121 post treatment on 06/18/2025; 171/120 predialysis and 199/120 post treatment on 06/20/2025; 189/135 predialysis and 211/131 post treatment on 06/23/2025; 192/123 predialysis and 197/123 post treatment; 212/129 predialysis and 187/124 post treatment on 06/16/2025. The standing orders effective 08/27/2025 indicated the Patient was to take clonidine (medication to treat high blood pressure) as needed when the systolic blood pressure was greater than 170 or the diastolic was greater than 100. The treatment sheet indicated the Patient refused clonidine during treatment on 06/09/2025, 06/13/2025, 06/16/2025, 06/18/2025, 06/20, 2025, 06/23/2025, and 06/25/2025. HD Treatment Sheets dated 06/06/2025, 06/11/2025, 06/13/2025, 06/16/2025, 06/18/2025, 06/20/2025, 06/23/2025, and 06/25/2025 indicated the Patient ended treatment 21 minutes to 1 hour and 13 minutes early when ordered to run for 3 hours. The monthly nursing progress notes dated 05/12/2025 and 06/11/2025 indicated the blood pressure was not within target range and Patient was chronically hypertensive (high blood pressure). The dietician’s monthly review dated 06/10/2025 indicated the Patient had poor adherence to medication and dialysis treatment. The social worker quarterly review dated 05/30/3035 indicated the Patient had a long history of noncompliance with treatment. The interdisciplinary team failed to adjust the plan of care related to the Patient’s blood pressure and failed to identify potential causes and address those causes related to the Patient’s noncompliance with medication and dialysis treatment. On 06/27/2025, at 3:03 PM, the FA indicated there was no consistent reason why the Patient ended treatment early. On 06/27/2025, at 3:30 PM, RN 3 indicated the Patient was noncompliant with staying for the entire treatment time and with the home medication regimen. On 06/30/2025, at 11:47 AM, the MSW indicated the Patient was “very antsy” during treatment and regularly requested to end early. The MSW indicated she offered to arrange therapy for the Patient in the past to address her behavior during treatment, but the Patient refused. The MSW indicated there had not been any recent discussion with the Patient regarding the medication noncompliance and was not sure why the Patient did not take the medication as ordered. The MSW indicated there was no documentation regarding the offer to arrange therapy for the Patient until 06/27/2025. On 06/30/2025, at 11:10 AM, the FA indicated if the facility had been tracking the blood pressure, the Patient would have been made an unstable Patient to be addressed more frequently. The FA indicated the Patient’s non-compliance should’ve been addressed in the POC but had not been probably because the Patient at least showed up for treatment.”

“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: 51199 Based on record review and interview, the dialysis facility’s Quality Assessment and Performance Improvement [QAPI] Program failed to measure, analyze and track quality indicators for patient outcomes related to fluid and blood pressure management in 1 of 1 facility. Findings include: 1. A revised policy, dated 01/13/2025, titled, “G09 Quality Assurance and Performance Improvement (QAPI),” indicated the QAPI program would look at indicators for patients and trend outcomes to identify commonalities among patients who do not reach expected targets. Additionally, the policy indicated that the dialysis facility should regularly review data to identify areas for improvement and take appropriate action to improve outcomes and processes. 2. A Dialysis Facility Report, for 2023, indicated the dialysis facility ultrafiltration rate (removal of fluid from a patient) for hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work normally) was missing (not reported) in 43.2% of the facility’s patients. 3. During QAPI Program review on 06/30/2025, the QAPI program failed to evidence an indicator for tracking fluid and blood pressure management. 4. During an interview, on 06/30/2025, beginning at 10:59 AM, the Facility Administrator [FA], indicated the dialysis facility’s QAPI Program does not include or monitor fluid and blood pressure management.”

“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 record review and interview, the dialysis facility failed to ensure that all policies and procedures relative to patients ending treatment Against Medical Advice [AMA] were adhered to in 3 of 3 clinical record reviews of patients who ended treatment early AMA. (Patients #2, 4, 5) Findings include: 1. A revised policy, dated 01/13/2025, titled “G26 Against Medical Advice,” indicated for matters that are not likely to cause serious or immediate harm to the patient, there must be a detailed progress note entered on the patient’s treatment sheet that explains the situation and provide details of patient counseling, potential risks to the patient of not following medical orders/advice, and the patient’s response. The policy additionally indicated that for matters that are likely to result in acute or immediate harm or injury, the RN will intervene, and if a patient continues to decline, the RN will complete and obtain the patient signature on the AMA form. 2. The clinical record review for Patient #5 indicated the following: A. A Treatment Flowsheet, dated 06/18/2025, indicated that Patient 5 was taken off treatment 28 minutes early due to transportation. The record and Flowsheet failed to evidence documentation that explained the situation or provided details of patient counseling, potential risks to the patient of not following medical orders/advice, or the patient’s response. B. A Treatment flowsheet, dated 06/25/2025 indicated Patient was taken off treatment 28 minutes early due to patient request. The record and Flowsheet failed to evidence documentation that explained details of patient counseling, potential risks to the patient of not following medical orders/advice, or the patient’s response. C. During an interview on 06/30/2025, the Facility Administrator [FA] indicated that no AMA form was filled out for 06/18/2025 or 06/25/2025, nor was the MD notified, nor were there any RN notes further explaining the situation/patient response/MD notification. 4. During an interview on 06/30/2025, beginning at 12:15 PM, the Medical Director [MD] indicated that patients who wish to leave AMA should be educated by staff about the risks of leaving AMA and that the patient physician should be notified each time a patient leaves AMA. 41135 5. A clinical record for Patient #4 evidenced a HD treatment sheets which indicated the ordered treatment time was 3 hours and indicated the Patient ended HD treatment early on the following treatment days: 06/04/2025 ended 59 minutes early, 06/06/2025 ended 1 hour and 13 minutes early, 06/11/2025 ended 38 minutes early, 06/13/2025 36 minutes early, 06/16/2026 ended 59 minutes early, 06/18/2025 ended 54 minutes early, 06/20/2025 ended 27 minutes early, 06/23/2025 ended 33 minutes, and 06/25/2025 ended 21 minutes early. The clinical record failed to evidence the facility provided patient education to the risks of ending treatment early and notified the physician on 06/06/2025, 06/11/2025, 06/13/2025, 06/16/2025, 06/18/2025, 06/20/2025, 06/23/2025, and 06/25/2025. On 06/27/2025, at 3:05 PM, the FA indicated the treatment sheets did not include the documentation of the patient education to the risks of ending treatment early and physician notification per agency policy. 6. A clinical record review for Patient #2 evidenced a HD treatment sheet which indicated the ordered treatment time was 3 hours and 30 minutes and indicated the Patient ended HD treatment 1 hour and 7 minutes early. On 06/30/2025, at 11:29 AM, the FA indicated there was no documentation the facility notified the physician and educated the patient on the risks of ending treatment early per agency policy.”