Fmc - East Chicago 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: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure PCT 2 and PCT 3 performed hand hygiene, hand sanitizing with an alcohol based antiseptic or hand washing, after glove removal, between patients and when moving between patients’ hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work normally) stations durin 1 of 5 observations conducted of PCT 2 and 1 of 1 observations of PCT 3. Findings include: 1. A policy dated 11/06/2023, titled, “Hand Hygiene,” indicated an alcohol-based hand rub or hand washing with an antimicrobial soap and water should be performed before and after direct contact with patients, immediately after removing gloves, and after contact with inanimate objects near a patient. 2. During an observation on 01/09/2025, beginning at 9:42 AM, PCT 2 was typing on the computer keyboard at station #16, PCT 2 removed her gloves, and applied new gloves; without completing hand hygiene she entered station #14 and obtained Patient #16’s blood pressure and placed a barrier under Patient’s right arm. Without hand hygiene PCT 2 entered station #13, she picked up Patient #15’s coat and escorted Patient #15 to the scale, then PCT 2 opened the door to the foyer, and Patient #15 left. PCT 2 then returned to station #13, typed on the computer keyboard with the same gloves, then removed their gloves and applied new gloves without performing hand hygiene. 3. During an observation on 01/09/2025, beginning at 9:42 AM, PCT 2 was at station #14 with Patient #16, she removed 1 line from Patient’s arteriovenous fistula [AVF](access for HD), PCT 2 removed gloves and gown, applied new gown and gloves without performing hand hygiene. 4. During an observation, on 01/09/2025, beginning at 9:42 AM, PCT 2 was at station #13 cleaning the station chair and then entered station #14 with the same gloves to clean the front of the computer while Patient #16 remained at station #14, PCT 2 then removed her gloves, applied new gloves without performing hand hygiene. 5. During an observation on 01/09/2025, beginning at 10:15 AM, PCT 2 went to station #15 with Patient #17, PCT 2 removed her gloves, applied new gloves without performing hand hygiene and typed on station #15’s computer keyboard, PCT 2 then entered station #14 with the same gloves and touched the HD supplies on the tray side table, PCT 2 removed her gloves without performing hand hygiene and entered station #13 to set up the intravenous saline tubing, PCT 2 then removed her gloves, and applied new gloves without performing hand hygiene, PCT 2 then entered station #14 with Patient #16 and removed the 2nd line of the AVF, PCT 2 then removed her gloves and applied new glove without performing hand hygiene. 6. During an observation on 01/09/2025, beginning at 10:25 AM, PCT 2 entered station #17 with Patient #18, due to the AVF removal site was bleeding, and touched Patient’s AVF site and then entered Station #14 with Patient #16 wearing the same gloves from station #17 and touched the supplies Patient #16’s chair tray. During the observation, the Clinical Manager spoke to PCT 2, PCT 2 then removed her gloves and applied new gloves without performing hand hygiene, PCT 2 entered station #14 with Patient #16 and applied a new gauze to the AVF site, a red substance was visible on the barrier under the AVF and the barrier was disposed of in the garbage, PCT 2 removed her gloves, applied new gloves without performing hand hygiene and returned to station #14. 7. During an observation on 01/09/2025, beginning at 10:30 AM, PCT 2 was at station #16 with Patient #31, disconnected Patient’s left central venous catheter [CVC](catheter into large vein), PCT 2 removed her gloves, applied new gloves without performing hand hygiene and then escorted Patient #31 to the scale, PCT 2 touched the scale buttons with gloves on, returned to station #16 and touched the computer keyboard without changing gloves. 8. During an observation on 01/09/2025, beginning at 11:00 AM, PCT 3 cleaned station #18’s HD machine and bucket was emptied into the dirty sink, PCT 3 then removed her gloves, applied new gloves without performing hand hygiene, entered station #18 and cleaned the blood pressure cuff and chair. 9. During an observation on 01/09/2025, beginning at 12:45 PM, PCT 2 was at station #14 typing on the keyboard with gloves on, wearing the same gloves PCT 2 then went to the scale to weigh Patient #17, PCT 2 then returned to station #15 with Patient #17 and typed on the keyboard without changing gloves. 10. During an interview on 01/09/2025, beginning at 10:45 AM, PCT 2 indicated hands should be cleaned with hand sanitizer between each patient and station and after each glove change.”

“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: 47022 Based on record review and interview, the dialysis facility failed to ensure 27% of qualified patients susceptible to Hepatitis B (liver infection) were offered the Hepatitis B vaccine in 1 of 1 agency (Patient #1, 5, 6, 9, 18, 32, and 35). Findings include: 1. A policy dated 02/07/2022, titled, “Patient Vaccination for Hepatitis B,” indicated a patient with a Hepatitis B anti-HB (antibody to Hepatitis B) level less than 10 (susceptible to Hepatitis B) and had a reported previous vaccination the patient should be vaccinated, and if a patient had a previous Hepatitis B anti-HB level greater than or equal to 10 and the level falls below 10 the physician should be notified to discuss administration of a Hepatitis B booster dose. 2. An Infection Surveillance Platform, dated 01/13/2025, indicated 63% of patients were immune to Hepatitis B, 33% of patients were susceptible to Hepatitis B, and 1% of susceptible patients had a valid excuse. 3. An undated Patient Detail Report for Hepatitis B, received on 01/10/2025, indicated of the 26 patients that were susceptible to Hepatitis B, 42% of patients were in the process of receiving the Hepatitis B vaccine series, 12% patients refused, 4% of patients did not qualify due to a diagnosis of acute kidney injury, 8% of patients were non-responders to the vaccine, 8% patients had the Hepatitis B antibody checked after 12/22/2024, and 27% of patients that qualified for the Hepatitis B vaccine were not offered the Hepatitis B vaccine. 4. An undated Patient Detail Report for Hepatitis B indicated Patient #1 had a Hepatitis B surface antibody result (anti-HB) less than 10 on 10/24/2024 and failed to evidence a reason Patient was not offered a Hepatitis B vaccine. 5. An undated Patient Detail Report for Hepatitis B indicated Patient #5 had a Hepatitis B anti-HB less than 10 on 10/22/2024 and failed to evidence a reason Patient was not offered a Hepatitis B vaccine. 6. An undated Patient Detail Report for Hepatitis B indicated Patient #6 had a Hepatitis B anti-HB less than 10 on 10/17/2024 and failed to evidence a reason Patient was not offered a Hepatitis B vaccine. 7. An undated Patient Detail Report for Hepatitis B indicated Patient #9 had a Hepatitis B anti-HB less than 10 on 05/14/2024 and failed to evidence a reason Patient was not offered a Hepatitis B vaccine. 8. An undated Patient Detail Report for Hepatitis B indicated Patient #18 had a Hepatitis B anti-HB less than 10 on 05/14/2024 and failed to evidence a reason Patient was not offered a Hepatitis B vaccine. 9. An undated Patient Detail Report for Hepatitis B indicated Patient #32 had a Hepatitis B anti-HB less than 10 on 11/22/2024 and failed to evidence a reason Patient was not offered a Hepatitis B vaccine. 10. An undated Patient Detail Report for Hepatitis B indicated Patient #34 had a Hepatitis B anti-HB less than 10 on 05/13/2024 and failed to evidence a reason Patient was not offered a Hepatitis B vaccine. 11. During an interview on 01/10/2025, the Clinical Manager (Administration Person 2) indicated Patient #1, Patient #9, Patient #32, and Patient #34 should have been offered the Hepatitis B vaccine and was not offered the vaccine, Patient #5 should have been offered the Hepatitis B vaccine and was not offered the vaccine due to Patient could not consent for it by themselves and the dialysis facility would need to reach out to a family member to consent due to Patient resided in a skilled nursing facility, Patient #6 should have been offered the Hepatitis B vaccine and was not offered the vaccine due to Patient was noncompliant with treatments, and Patient #18 should have been offered the Hepatitis B vaccine and was not offered the vaccine due to was a Spanish speaking patient and would need to be offered Patient Hepatitis B information in Spanish.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure central venous catheter [CVC](catheter into large vein) standard infection control precautions were implemented by PCT 2 to prevent catheter related infections in 1 of 2 CVC initiations observed (Patient #1). Findings include: A Center for Disease Control website CDC.gov, titled, “Hemodialysis Central Venous Catheter,” indicated a CVC should be disinfected with an antiseptic pad for each hub(end of catheter access), the threads (sides of the hub) should be scrubbed thoroughly to remove any residue, and an antiseptic pad should be used to clean the limbs (catheter lines) at least several centimeters towards the body. A policy dated 05/06/2024, titled, “Initiation of Treatment Using a Central Venous Catheter (CVC) ....” indicated catheter threads and ends of the hub must be scrubbed with 70% alcohol for 10-15 seconds any time caps are removed, use a 70% alcohol pad to remove any exude on the limbs, and use an alcohol pad to clean from the hub at least several centimeters towards the body of the catheter and then attach a sterile syringe. During an observation on 01/09/2025, beginning at 11:45 AM, PCT 2 was observed at station #14 initiating access of Patient #1’s CVC. During the observation, PCT 2 removed the CVC’s hub caps on 2 lines and cleaned the 1st hub with an alcohol pad for 5 seconds; then she cleaned the 2nd hub with an alcohol pad for 3 seconds and inserted syringes into the hub. PCT 2 failed to clean the 1st or 2nd lines of the CVC, prior to insertion of the syringes, per policy and infection prevention standards of care. During an interview on 01/09/2025, beginning at 12:50 PM, PCT 2 indicated CVC hubs should be cleaned with an alcohol pad for 1 minute prior to insertion of syringes. During an interview on 01/10/2025, beginning at 3:00 PM, the Clinical Manager (Administration Person 2), indicated CVC site care would include cleaning the hub for 30 seconds with alcohol and the threads of the CVC should be cleaned.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure cannulations (insertion of needles) of arteriovenous fistula [AVF] (access for hemodialysis) [a process to filter the blood of a patient whose kidneys do not work normally] and arteriovenous graft [AVG] (access for hemodialysis) were completed by PCT 1 and PCT 2 to prevent AVF/AVG site infections in 4 of 4 AVF/AVG cannulations observed (Patient #8, #20, #23, and #30). Findings include: 1. A Center for Disease Control website CDC.gov titled, “AV Fistula, Graft Cannulation Observations,” indicated the AVF/AVG site should not be contacted after antiseptic was applied. 2. During an observation on 01/09/2025, beginning at 11:00 AM, PCT 2 was cannulating Patient #20’s right upper arm AVF at station #13, PCT 2 cleansed the AVF site with an alcohol prep pad and cannulated with the first line; she then recleaned with an alcohol prep pad, repalpated (touched) the site, and then cannulated the second line without recleaning the access site. 3. During an observation on 01/09/2025 beginning at 12:20 PM, PCT 2 was cannulating Patient #23’s left arm AVF at station #16; PCT 2 cleaned the AVF site with an alcohol prep pad and therepalpated the insertion site prior to cannulating the first line. PCT 2 then repalpated the insertion site, prior to cannulating the second line. 4. During an interview on 01/09/2025, beginning at 12:50 PM, PCT 2 indicated an AVF/AVG site should not be repalpated after the insertion site was cleansed with alcohol. 51199 5. During an observation on 01/09/2025, beginning at 10:53 a.m., observed PCT 1 cannulating Patient #8’s AVF at station #8; PCT 1 cleaned the AVF site with an alcohol prep pad and repalpated the insertion site, prior to cannulating the first line without recleaning the insertion site. PCT 1 then repalpated the insertion site prior to cannulating the second line without recleasing the insertion site before cannulation. 6. During an observation on 01/09/2025, beginning at 12:30 p.m., PCT 1 was cannulating Patient #30’s AVF at station #6. PCT 1 cleaned the AVF site with an alcohol prep pad and then repalpated the insertion site, prior to cannulating the first line. PCT 1 then repalpated the insertion site prior to cannulating the second line. PCT 1 did not reclean the insertion sites prior to cannulation.”

“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: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure PCT 6 administered the correct hemodialysis [HD] (a process to clean the blood of a patient whose kidneys do not work normally) prescription in 1of 5 active in-center hemodialysis prescriptions reviewed with the Clinical Manager, while on the observation floor (Patient #24). Findings include: A job description dated 07/12/2022, titled, “PCT 1,” indicated the PCT was responsible for the setup and operation of the HD machine. The job description indicated the PCT responsibilities would include initiate dialysis treatment according to the prescribed orders. During an observation on 01/09/2025, beginning at 11:22 AM, Patient #24, at Station #9 was receiving HD dialysate 2.0 K (potassium) 2.5 Ca (calcium). The elctronic medical record revealed the most recent prescription was dated 12/04/2024, Patient #24’s prescription for dialysate was 3.0 K 2.5 Ca. A Treatment Sheet dated 01/10/2025, indicated PCT 6 performed the machine set up and the HD was initiated by PCT 6. During an interview on 01/09/2025, beginning at 11:22 AM, the Clinical Manager (Administration Person 2) indicated Patient was receiving the incorrect HD dialysate. During an interview on 01/09/2025, beginning at 11:22 AM, PCT 6 indicated the HD prescription dialysate set up was incorrect and Patient received the incorrect dialysate bath.”

“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: 47022 Based on record review and interview, the dialysis facility failed to ensure the treatment records were complete and accurate in 4 of 8 active in-center hemodialysis [HD](a process to filter the blood of a patient whose kidneys do not work normally) patients clinical records reviewed (Patient #4, 5, 7, 8). Findings include: 1. A PCT job description dated, 07/12/2022, indicated the responsibilities for a PCT would include but not limited to initiating HD according to the prescribed orders including the blood flow rate [BFR] and DFR [dialysate flow rate], and record accurate documentation of information related to the patients’ treatment on the hemodialysis treatment sheet. 2. A Treatment Sheet, dated 01/09/2025, indicated Patient #4’s HD treatment began at 1:24 PM; the record failed to evidence the BFR and DFR were documented from 3:00 PM until the end of treatment at 4:33 PM. 3. A Treatment Sheet, dated 01/07/2025, indicated Patient #5’s HD treatment was initiated at 12:53 PM; the record failed to evidence the BFR and DFR were documented from 1:36 PM until the end of treatment at 3:57 PM. 4. A Treatment Sheet dated 01/04/2025, indicated Patient #7’s HD treatment was initiated at 7:08 AM; the record failed to evidence the BFR and DFR were documented from 9:32 AM until the end of treatment at 11:06 AM. 5. A Treatment Sheet dated 01/09/2025, indicated Patient #8’s HD treatment was initiated at 11:13 AM; the record failed to evidence the BFR and DFR were documented from 11:13 AM until the end of treatment at 2:37 PM. 6. During an interview on 01/13/2025, beginning at 11:40 AM, the Clinical Manager (Administration Person 2) indicated that the DFR and BFR should be documented by PCT’s manually if the HD machine fails to sync with the documentation system. The Clinical Manager indicated the BFR and DFR for Patient #4, Patient #5, Patient #7, and Patient #8 were not documented correctly and should have been documented by the PCT.”