Home Dialysis Services Merrillville, LLC

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to vaccinate a susceptible patient (Patient 7) for Hepatitis B upon admission in 1 of 1 clinical record reviews of susceptible patients who had not declined a Hepatitis B vaccine. Findings include: A revised policy, dated 12/16/2019, titled “ Hepatitis B Vaccine”, indicated that the Hepatitis B vaccine will be offered to all susceptible patients upon admission. A Hepatitis Vaccine Report, provided by the Clinical Manager [CM] on 08/26/2025, indicated that Patient 7 had a Hepatitis B status of susceptible upon admission on 03/25/2025. The report additionally indicated that Patient 7 had not yet received the Hepatits B vaccine. During an interview on 08/26/2025 beginning at 3:30 PM, the Clinical Manager [CM] indicted that Patient 7 not receiving the Hepatitis vaccine was a miss by the dialysis facility. The CM denied that there was any delay in administration due to supply availability.”

“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 record review and interview, the dialysis facility failed to ensure that staff responsible for testing Home Hemodialysis [HHD] solutions were able to discern colors in 1 of 1 RN. Findings include: A policy, titled “Testing For Color Blindness” dated 03/10/2017, indicated that all staff who will be utilizing test kits or strips that rely on color differention for test results are required to be tested upon hire and as needed, and test results should be documented. A document, titled “Ishihara Color Vision Test Results” dated 08/08/2022, for the Clinical Manager [CM], showed the CM’s answers to the test, but did not indicate a result of pass or fail. During an interview on 08/26/2025 beginning at 9:42 AM, the CM indicated that there was no result of pass or fail on the Ishihara Color Vision Test. The CM additionally indicated that color test strips are used routinely by her for home hemodialysis dialysate preparation.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to offer the pneumococcal vaccine to Patient 2 in 1 of 3 clinical record reviews of peritoneal dialysis patients. Findings include: A revised policy, dated 07/27/2023, titled “Pneumococcal Vaccine Administration” indicated that patients should be offered the pneumococcal vaccine upon admission, and every 5 years. Admission documents for Patient 2, dated 04/28/25, indicated that Patient 2 wished to receive the pneumococcal vaccine. During an interview on 08/26/2025 beginning at 3:30 PM, the Clinical Manager [CM] indicted that Patient 2 not receiving the pneumococcal vaccine was a miss by the dialysis facility. The CM denied that there was any delay in administration due to supply availability.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to ensure that the patient or patient designee signed the plan of care to acknowledge the information in the plan in 1 of 2 clinical record reviews of home hemodialysis patients. Findings include: A revised policy, dated 01/06/2016, titled “Comprehensive Assessment and Plan of Care”, indicated that the plan of care must be signed by the patient or designated care partner/caregiver. If the patient is unable or chooses not to sign the plan of care, the reason must be documented. A clinical record review for Patient 4 failed to evidence a plan of care that was signed by Patient 4. Governing Body minutes, dated 08/26/2025, indicated that multiple patients did not have signed plans of care. The minutes indicated that Patient 4 had four plans of care that were not signed with the following dates: 09/15/2022, 12/15/2022, 12/18/23, and 12/19/2024. During an interview on 08/26/2025, the Clinical Manager [CM] indicated that there was no signed plan of care for Patient 4. During an interview on 08/27/2025 beginning at 10:47 AM, the Medical Director indicated that the plan of care is discussed with patients during monthly clinic and staff should ensure that the plan of care is signed at that time.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to maintain accurate patient records in 2 of 4 clinical record reviews of home dialysis patients. Findings include: 1. A revised policy, dated 12/07/2018, titled “Medical Records General Policy”, indicated that the facility will maintain an accurate record of care for each patient and that all medical records are properly documented. 2. During a clinical record review on 08/26/2025, for Patient 1, A Nephrologist Rounding Note was dated 08/25/2025 and indicated that this note was a late entry. The note did not contain the date or time of when the assessment occurred. 3. During a clinical record review on 08/26/2025, for Patient 4, A Nephrologist Rounding Note was dated 08/25/2025 and indicated that this note was a late entry. The note did not contain the date or time of when the assessment occurred. 4. During an interview on 08/27/2025 beginning at 10:47 AM, the Medical Director [MD] indicated that the rounding notes dated 08/25/2025 were based on assessments completed on 07/28/2025. The MD indicated he did not notate the date/time the assessment took place, only the date that the entry was placed in the electronic medical record. The MD indicated that the late entry should have contained the date and time the event actually took place.”