Davita South Bend West Dialysis

“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: 44599 Based on observation, policy review and interview, the dialysis facility failed to maintain a sanitary environment within the ICHD treatment area during 2 of 2 days of ICHD treatment area observations, which had the potential to affect 44 active ICHD patients. Findings include: 1. During the flash tour on 12/13/2024 from 9:30 AM - 10:35 AM, in the treatment room observed a kleenex on the floor at Station 12, gloves on the floor at Station 3, and gloves and wrappers from dressings on the floor at Station 2. In the water treatment room, observed scissors with rust lying on the floor between the two carbon filters, scraps of paper in numerous areas and a discolored film on the floor. 2. During an observation in the treatment room on 12/13/2024 at 12:40 PM, observed a yellow-green colored sticky substance on the bottom of a drawer at the catheter station. 3. During an interview on 12/13/2024 at 4:13 PM, when asked who is responsible to pick up debris in the water treatment room, the biomed technician indicated all staff. 4. During an interview on 12/13/2024 at 4:41 PM, when asked why rusted scissors and debris would be on the floor in the treatment room and water treatment room, the director of clinical services indicated those items shouldn’t be on the floor. When asked why a sticky substance would be on the bottom of a drawer in the treatment room, the director of clinical services indicated it shouldn’t be.”

“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: 44599 Based on observation, record review, and interview, the facility failed to ensure employees performed proper hand hygiene in 4 of 12 observations over 2 of 4 observation periods (PCT 2, 3). Findings include: 1. Review of an agency policy titled “Infection Control for Dialysis Facilities” indicated hand hygiene will be performed prior to gloving and immediately after removal of gloves. 2. During an observation on 12/13/2024 at 9:45 AM, PCT 2, cleaned the HD machine at Station 5, removed gloves without performing hand hygiene typed on the keyboard at Station 5, then applied gloves without performing hand hygiene, and completed the cleaning of Station 5. 3. During an observation on 12/13/2024 at 10:00 AM, observed PCT 3 at Station 2, PCT 2 applied gloves without performing hand hygiene, placed a clean field under the central venous catheter ports, and then disinfected and connected the central venous catheter (tube inserted into a vein to provide access to the superior vena cava used for dialysis) bloodline of Patient #1. 4. During an observation on 12/16/2024 at 10:00 AM, observed PCT 3 at Station 6, PCT 3 applied gloves without performing hand hygiene, placed a clean field under the central venous catheter ports of Patient #7, and then disinfected and connected the central venous catheter bloodline. PCT 3 removed gloves and without performing hand hygiene moved to station 5 and touched the tubing to begin HD machine testing. During an interview on 12/16/2024 at 10:15 AM, when asked what should be done after removing gloves and putting on clean gloves, PCT 2 indicated she should have used hand sanitizer and had not. 5. During an observation on 12/16/2024 at 10:52 AM, observed PCT 3 at Station 2 PCT 3 removed gloves without performing hand hygiene typed on the keyboard, then applied gloves without performing hand hygiene, and touched the bloodline of Patient #1. PCT 3 removed gloves, applied gloves without performing hand hygiene, and touched the bloodline again of Patient #1. During an interview on 12/16/2024 at 10:59 AM, when asked when hand hygiene is to be completed, PCT 3 indicated she performs hand hygiene between patients. When asked what is done after removing gloves and applying new gloves, PCT 3 indicated nothing unless moving to a different patient.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 44599 Based on record review, observation, and interview, the facility failed to provide warm running water to facilitate hand washing in 3 of 3 sinks in which the running water was checked on the treatment floor. Findings include: 1. Review of an agency policy titled “Infection Control for Dialysis Facilities” indicated sinks should be easily accessible in the treatment area and in other appropriate areas and must be plumbed with both hot and cold water. 2. While on the treatment floor on 12/13/2024, at 12:00 PM and again at 12:25 PM, ran the water at an automatic sink in the medication preparation area for two minutes and the water temperature remained cold. At 12:35 PM, ran the water at an automatic sink in the isolation room for two minutes and the water temperature remained cold. At 12:49 PM, ran the water at an automatic sink at the eyewash station for two minutes and the water temperature remained cold. 5. During an interview on 12/13/2024 at 4:41 PM, when asked how long it should take for the water to run warm at the sinks in the treatment area, the director of clinical services indicated there is no timeframe. 6. While on the treatment floor on 12/16/2024 at 10:46 PM, observed PCT 1 washing hands at a clean sink in front of Station 9. When asked how long it takes for the water to warm up, PCT 1 indicated the water at the automatic sinks never warms up and had reported it a while back.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 44599 Based on observation and interview, the facility failed to ensure staff stored disinfectants in the treatment area to prevent loss of disinfectant properties to clean and disinfect the dialysis stations and equipment in 1 of 4 treatment floor observation periods completed creating the potential to affect all the facility’s 44 current incenter patients. Findings include: 1. Review of an agency policy titled “Utilizing Vascular Access Clamps” indicated vascular access clamps are reusable and disinfected between each use with a bleach solution. 2. Review of an agency policy titled “Infection Control for Dialysis Facilities” indicated a bleach solution is used for routine disinfection of the dialysis station. 3. During an observation 12/16/2024 at 9:46 AM, across from Station 3, observed one uncovered bleach container used for disinfecting clamps. Further observations at 10:08 AM, 10:16 AM, and 10:27 AM evidenced the same container remained uncovered. During an interview on 12/16/2024 at 10:28 AM, when asked when the bleach container should be uncovered, RN 2 indicated the container should be covered. 4. During an observation on 12/16/2024 at 10:44 AM, across from the isolation room, observed an uncovered bleach container used for cleaning the dialysis stations.”

“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: 44599 Based on record review and interview, the facility failed to offer the hepatitis B vaccination (protects against the hepatitis B virus which can lead to liver damage, cirrhosis, and liver cancer) to all employees when hired for 1 of 1 PCT hired in 2024 (PCT 2). Findings include: 1. Review of an agency policy titled “Teammate Health Monitoring Program” indicated new teammates will be offered the Hepatitis B Vaccination. 2. Review of the personnel records of PCT 2, with hire date of 09/09/2024, included a form titled “Hepatitis B Vaccine Teammate Consent/Declination” that indicated PCT 2 had been offered the hepatitis vaccine series by the facility on 12/13/2024. Documentation failed to evidence the facility offered the hepatitis B vaccination at time of hire. During an interview on 12/17/2024 at 1:10 PM, when asked why PCT 2 did not receive an offer for the hepatitis B vaccine upon hire, the FA indicated the offer of the hepatitis B vaccine fell through the cracks.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 44599 Based on record review, observation, and interview, the medical director failed to ensure the policies and procedures related to patient care and safety were followed in 1 of 1 observation of the use of a muti use medicaiton vial. Findings include: 1. Review of an agency document titled “Parenteral (intravenous) Medication Preparation and Administration” indicated multiple dose vials are labeled with the date opened. 2. During an observation on 12/16/2024 at 9:40 AM, observed an opened multiple dose vial of Heparin (prevents clotting in the blood circuit) at the medication prep area. Observation of the vial failed to evidence the date opened. During an interview on 12/16/2024 at 10:55 AM, when asked to look at the vial of Heparin at the medication prep area, RN 2 indicated the vial was missing the date of when opened.”