Fmc - Portage Dialysis Center

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to provide appropriate emergency preparedness emergency orientation and training to a new admission patient in 1 of 1 clinical record review of new admission (Patient 5). Findings include: A policy, dated 09/02/2025, titled “Guidelines for Emergency Preparedness,” indicated the facility staff must educate patients about evacuation procedures and emergency disconnection procedures. The clinical record for Patient 5 indicated Patient was admitted on 10/05/2025. The record failed to evidence documentation Patient was trained to emergency evacuation procedures nor emergency disconnection procedures. During an interview on 12/08/2025, beginning at 12:00 PM, the facility administrator indicated there was no documentation that emergency preparedness training or emergency disconnect training had been completed with Patient 5.”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to notify the Indiana Department of Health of an allegation of abuse, by an in-center hemodialysis patient, in 1 of 1 dialysis facility. Findings include: A review of the facility grievance log evidenced a grievance, dated 05/06/2025, in which a patient complained that they believed they were punched in the head by a staff member, on 05/05/2025. During an interview on 12/08/2025 beginning at 12:00, the FA indicated the Indiana Department of Health had not been notified of the abuse allegation. She indicated the PCT involved in the grievance resigned without notice the next day.”

“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 record review, observation, and interview, the dialysis facility failed to ensure a sanitary environment in 2 of 2 treatment floor observation periods. Findings include: 1. A policy, dated 02/03/2025, titled “Mixing Bleach,” indicated that bleach solution containers should be covered with a lid. 2. During an observation of the treatment floor on 12/03/2025, from 11:00 AM to 12:42 PM, 1 container labeled “1:100 bleach” was left uncovered with the container lid located next to the container for the duration of the observation. A different container labeled “1:100 bleach” was left partially covered with the lid laying halfway off of the container for the duration of the observation. 3. During an observation of the treatment floor on 12/04/2025, beginning at 10:32 AM, one container labeled “1:100 bleach solution” was left uncovered with the lid laying next to the container until the end of the observation period 11:47 AM. A different container labeled “1:100 bleach” was left partially uncovered with the lid laying halfway on the container from 10:32 AM until 11:10 AM, and again from 11:21 until the end of the observation period 11:47 AM. 4. During an interview on 12/04/2025 beginning at 2:30 PM, PCT 2 indicated that bleach solutions should be covered at all times. 5. During an interview on 12/04/2025 beginning at 1:56 PM, PCT 1 indicated that bleach solutions need to remain covered at all times and discarded and remade if found uncovered.”

“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 record review, observation, and interview the dialysis facility failed to perform hand hygiene and don clean gloves in 1 of 2 observations of initiation of dialysis with a central venous catheter [CVC] (large catheter into vein) (PCT 1), in 1 of 2 observations of discontinuation of dialysis and post dialysis access care for and arteriovenous fistula [AVF] (dialysis access site) or arteriovenous graft [AVG] (dialysis access site) (PCT 4), and 1 of 1 observation of preparation of the hemodialysis [HD] (a process to clean the blood in a patient whose kidney’s do not work normally) machine (PCT 2). Findings include: 1. A policy, dated 11/06/2023, titled “Hand Hygiene”, indicated that hands will be decontaminated with alcohol-based hand rub or by washing hands before performing any invasive procedures such as vascular access or after contact, immediately after removing gloves, after contact with wound dressings, or after contact with objects within the patient station. 2. During an observation, on 12/03/2025 beginning at 12:11 PM at station 12, PCT 1 failed to perform hand hygiene, remove soiled gloves, and don new gloves prior to initiation of hemodialysis on Patient 4’s CVC. 3. During an observation on 12/04/2025 beginning at 10:57 AM, at station 15, PCT 4 failed to remove soiled gloves, perform hand hygiene, and don clean gloves after disconnecting the bloodlines from the HD machine and prior to removing the needles from Patient 11. 4. During an observation on 12/03/2025 beginning at 11:44 AM, PCT 2 was preparing the HD machine by inserting the filter and tubing at station 15 when an alarm at station 16 began to sound. PCT 2 removed gloves and performed hand hygiene, then attended to the patient and alarm at station 16 (Patient 9). After PCT 2 was finished attending to Patient 9 and the sounding alarm, PCT 2 removed soiled gloves and donned new gloves without performing hand hygiene before returning to station 15 to complete the preparation of the HD machine. 5. During an interview on 12/04/2025 beginning at 1:56 PM, PCT 1 indicated that a glove change and hand hygiene should be performed prior to connecting a patient to the HD machine. 6. During an interview on 12/04/2025 beginning at 2:30 PM, PCT 2 indicated that hand hygiene and glove change should occur when switching between the dialysis station and a patient.”

“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 evidence they vaccinated a susceptible patient against Hepatitis B in 1 of 1 clinical record review of Hepatitis B susceptible patients. (Patient 17) Findings include: A policy, dated 02/07/2022, titled “Patient Vaccination for Hepatits B,” indicated the Hepatitis B vaccine should be offered to all susceptible patients and that each patient should sign a vaccination consent or declination form. A clinical record review for Patient 17 evidenced an admission date of 11/08/2025 and Hepatitis testing results, dated 11/08/2025, indicating Patient 17 was susceptible to Hepatitis B. The record failed to evidence a Hepatitis B vaccine consent or declination form. During an interview, on 12/08/2025 beginning at 12:00 PM, the FA indicated the Hepatitis B vaccine was not administered, nor offered to Patient 17. The FA indicated the lab results indicated Patient 17 was susceptible; the facility failed to follow up by offering the Hepatitis B vaccine.”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to ensure monitoring of weekly chemical disinfection of the reverse osmosis system in 1 of 1 dialysis facility. Findings include: 1. A review of the reverse osmosis water system logs for October 2025 indicated no chemical disinfection record entries for the month. 2. A review of the reverse osmosis water system logs for November 2025 indicated chemical disinfection record entries for 11/14/2025 and 11/19/2025. There were chemical disinfection record entries from 11/01/2025 to 11/13/2025 or 11/20/2025 to 11/30/2025. 3. During an interview on 12/03/2025 beginning at 4:10 PM, Biomed 1 indicated he was aware of missing entries for chemical disinfection and was reported in the monthly QAPI meetings.”

“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: 51199 Based on record review, observation, and interview, the dialysis facility failed to ensure patients access sites were in view of staff during hemodialysis [HD] (a process to clean the blood of a person whose kidneys do not work normally) treatments to ensure patient safety in 1 of 2 observation periods of the treatment floor. (Patient 6, Patient 10, Patient 7, and Patient 4) Findings include: 1. A policy, dated 05/01/2023, titled “Patient Assessment and Monitoring,” indicated access sites should remain uncovered throughout the treatment. 2. During an observation of the dialysis treatment floor on 12/03/2025, observed the following: Patient 6 was in station 8 and had a blanket covering their HD access site from 11:05 AM until 12:18 PM, when RN 1 removed the blanket and visualized the dialysis access site. At 12:25 PM, Patient 6’s dialysis access site was again covered by a blanket until the conclusion of the treatment floor observation at 12:42 PM. Patient 10 was in station 3 and had a blanket covering their dialysis access site beginning at 11:33 AM until the conclusion of the treatment floor observation at 12:42 PM. Patient 7 was in station 5 and had a blanket covering their HD access site from 11:39 AM until the conclusion of the treatment floor observation at 12:42 PM. Patient 4 was in station 12 and had a blanket covering their HD access site beginning at 12:21 PM until the conclusion of the treatment floor observation at 12:42 PM. 3. During an interview on 12/04/2025 beginning at 2:30 PM, PCT 2 indicated that HD access must remain visible throughout treatment. 4. During an interview on 12/04/2025 beginning at 1:34 PM, RN 1 indicated that HD access must be visible at all times during dialysis. 5. During an interview on 12/04/2025 beginning at 1:56, PCT 1 indicated that HD access must remain visible at all times and if a patient refuses, then there must be documentation stating such.”

“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 administer the pneumococcal vaccine to a patient who consented for administration in 1 of 1 clinical record review of patients who had not received the pneumococcal vaccine prior to admission. (Patient 2) Findings include: A clinical record review, for Patient 2, evidenced a Pneumococcal Vaccination Consent form, dated 08/08/2025, that indicated Patient 2 consented to have the pneumococcal vaccine administered. The clinical record review failed to evidence documentation that the pneumococcal vaccine had been administered by the dialysis facility. During an interview on 11/08/2025, beginning at 12:00 PM, the FA indicated that the pneumococcal vaccine was not administered to Patient 2.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 51199 Based on record review, observation, and interview, the dialysis facility failed to ensure PCT 2 performed aseptic technique when accessing the arteriovenous fistula [AVF] (dialysis access) for initiation of dialysis in 1 of 2 observations of access of an AVF for initiation of dialysis. (Patient 9) Findings include: A policy, 05/05/2025, titled “Access Assessment and Cannulation,” indicated that once skin asepsis is completed, the cleaned site should not be touched prior to cannulation. During an observation, on 12/03/2025 beginning at 11:35 AM, PCT 2 accessed the AVF of Patient 9 for initiation of dialysis and after skin asepsis, touched and repalpated the site prior to cannulation. During an interview on 12/04/2025 beginning at 2:30 PM, PCT 2 indicated that if repalpation is necessary after skin asepsis, then the cannulation site must be cleaned again prior to cannulation.”

“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 facility failed to analyze and track the quality indicators related to personnel and ESRD Network communications in 1 of 1 dialysis facility. Findings include: A review of the facility’s QAPI failed to evidence personnel qualifications and issues nor communication with the ESRD Network were addressed or monitored. During an interview, on 12/08/2025 beginning at 12:00, the FA indicated that personnel qualifications and issues as well as ESRD Network relationship and communication is not an area that is addressed in QAPI.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 51199 Based on record review and interview, the clinic failed to evidence their interventions or actions taken in QAPI to monitor, improve, and track performance in 1 of 1 dialysis facility. Findings include: A review of the facility QAPI evidenced incomplete water log entries reported by the Technical Department for the months of October 2025, September 2025, August 2025, July 2025, and May 2025; the QAPI documentation failed to evidence documentation of a plan to improve and track performance in this area. During an interview, on 12/08/2025 beginning at 12:00 PM, the FA indicated the incomplete log entries were entered into QAPI, but there was no action plan to improve performance.”

“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 their policies and procedures were adhered to in regards to accurately administering the dialysis prescription in 1 of 1 clinical record reviewed of a new admission (Patient 5), and in 1 of 1 personnel record reviewed of a Social Worker in regards to TB testing of employees (SW1). Findings include: 1. A policy, dated 05/01/2023, titled “Patient Assessment and Monitoring,” indicated during hemodialysis treatment, dialysate flow rate [DFR] should be checked for accuracy to ensure the prescribed flow rate matches what is being delivered. A clinical record review, for Patient 5, evidenced the prescribed DFR was 800 and on 11/28/2025 the DFR was run at 500 for the duration of the treatment. During an interview on 12/08/2025 beginning at 12:00 PM, the FA indicated there would be no reason a DFR would be administered differently than prescribed, other than error. 2. A policy, dated 05/05/2025, titled “Employee Tuberculosis Testing,” indicated that Tuberculosis skin testing should be performed at the time of hire and the results should be documented in the employee medical record. A personnel record review for SW 1 evidenced a hire date of 12/08/2018, and failed to evidence a Tuberculosis skin test results nor a negative history. During an interview on 12/08/2025 beginning at 12:30, SW 1 indicated that she was originally hired by the company for a different location in 2018 and received a Tuberculosis skin test at that time. SW 1 indicated she has transferred to several different locations over the years and had the skin test repeated when the original test results could not be located. She relayed the test was not repeated when she transferred to this facility, nor evidence that she had previously had a negative test.”