Fmc - Indianapolis-West

“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: 38262 Based on observation, record review, and interview, the dialysis facility failed to provide and monitor a sanitary environment to minimize the transmission of infectious agents in 1 of 1 facilities. Findings include: 1. A policy dated 02/03/2025 titled “Mixing Bleach” states that staff must label bleach solution containers with the date, time prepared, preparer’s initials, and cover the container with a lid. 2. During an observation on 12/09/2025 at 9:50 AM, CCHT 2 dipped a cleaning cloth into a bleach container labeled 12/04/2025 at 4:30 AM, initialed by OW. Staff failed to label the disinfectant solution with the correct date, time, and preparer’s initials. 3. During an observation on 12/09/2025 at 9:59 AM, the surveyor observed an unattended 1:100 bleach container with the lid off next to a sink. Staff had written the date 12/04/2025 on the lid of the container, indicating the date they changed it. The facility failed to properly date and store the bleach solution. During an interview on 12/09/2025 at 10:05 AM, CCHT 3 stated the opening technician should change the bleach solution daily.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 48387 Based on observation, record review, and interview, the facility failed to store clean supplies in an appropriate, designated clean area as required in 1 of 1 supply rooms observations. Findings include: A policy dated 11/04/2024 titled “General Cleanliness and Infection Control Guidelines” indicates that staff must keep all areas clean and organized. During an observation on 12/09/2025 at 9:05 AM, the surveyor observed the following items on the floor of the supply room: a bedpan, an opened syringe, a box of band-aids, and an opened sodium chloride box that staff used to store an oxygen mask. During an interview on 12/09/2025 at 9:05 AM, the Biomed indicated that nothing is usually on the floor. He explained that someone used the sodium chloride box for the oxygen mask because weather damaged the original boxes. He confirmed that he is responsible for the storage room and that nothing should be on the floor.”

“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: 38262 Based on observation, record review, and interview, the facility staff failed to follow applicable infection control procedures during cleaning and disinfection of contaminated surfaces for 2 of 2 cleaning and disinfection observations at the dialysis station. (Stations 1 & 14) Findings include: 1. A 09/02/2025 policy titled “Cleaning and Disinfecting the Dialysis Station” stated staff should clean any surfaces with the potential to be contaminated. Staff should clean and disinfect all surfaces of the dialysis machine. 2. During an observation on 12/09/2025 at 9:42 AM, CCHT 4 removed the prime waste container from Station 1’s dialysis machine and dumped the fluids down the sink. CCHT 4 then placed the prime waste container back onto the side of the dialysis machine without disinfecting it. CCHT 4 failed to disinfect the prime waste container. CCHT 4 also failed to disinfect the countertop and wall box located behind the treatment chair. During an interview on 12/09/2025 at 2:30 PM the Director of Operations stated staff should know to disinfect the prime waste container. 3. During an observation on 12/09/2025 at 9:50 AM, CCHT 2 removed the prime waste container from Station 14’s dialysis machine and dumped the fluids down the sink. CCHT 2 then placed the prime waste container back onto the side of the dialysis machine without disinfecting it. CCHT 2 also failed to disinfect the countertop and wall behind the treatment chair. During an interview on 12/09/2025 at 9:55 AM, CCHT 2 indicated that the CCHT should clean each station between patients and disinfect all counters behind the station at the end of the day. She confirmed that the CCHT assigned to the station is responsible for cleaning the station and counter.”

“ENVIRONMENT-SCHEMATIC DIAGRAMS/LABELS CFR(s): 494.40(a) 8 Environment: schematic diagrams/labels Water systems should include schematic diagrams that identify components, valves, sample ports, and flow direction. Additionally, piping should be labeled to indicate the contents of the pipe and direction of flow. If water system manufacturers have not done so, users should label major water system components in a manner that not only identifies a device but also describes its function, how performance is verified, and what actions to take in the event performance is not within an acceptable range. This Standard is not met as evidenced by: 48387 Based on observation, record review, and interview, the facility failed to perform a daily check and maintain the brine tank located in the water room during 1 of 1 water room observations. Findings include: 1. A policy dated 05/05/2025 titled “Water Softener Policy” states that staff must check the brine tank daily to ensure it is at least half-filled with salt and add salt pellets if necessary. 2. A document titled “FKC Log Readings Grid Report” dated 12/09/2025 shows staff documented that the brine container was more than half full and above the water level from 12/01/2025 to 12/09/2025. 3. During an observation on 12/09/2025 at 9:05 AM, the Biomed opened the brine container in the water room and found it contained only water, with no salt. 4. During an interview on 12/09/2025 at 9:05 AM, the Biomed stated that he is responsible for checking and refilling the brine container. He mentioned that he is on site three times per week and that staff fill out a daily log sheet for checked items in the water room. 5. During an interview on 12/09/2025 at 12:13 PM, the Area Tech Operation Manager indicated that the Biomed oversees the supply room, and facility staff assist when possible. He confirmed that nothing should be on the floor in the supply room. He confirmed that the brine container in the water room did not contain salt. He indicated that staff should fill the brine tank daily and that the opening PCT should check it. He was unsure when the staff last added salt, despite the daily log indicating checks. 6. During an interview on 12/09/2025 at 1:13 PM, the Director of Operations indicated that she was informed by a staff member about the brine container not being checked or filled. She indicated she reported the brine container concerns to the Biomed department.”

“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: 38262 Based on record review and interview, the facility staff failed to ensure the nurse completed a timely assessment for 3 of 3 active patient record reviews. (Patients #1, #2, #3) Findings include: 1. A 11/06/2023 policy titled “Nursing Supervision and Delegation” indicates the registered nurse should evaluate the patient within an hour of initiating treatment. 2. A review of Patient #1’s record failed to evidence timely assessments for the following dates: A Treatment Sheet dated 09/05/2025 indicated a treatment start time of 5:33 AM; RN 3 documented a pretreatment assessment time of 7:44 AM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. A Treatment Sheet dated 09/01/2025 indicated a treatment start time of 5:29 AM; RN 2 documented a pretreatment assessment time of 7:08 AM. The RN failed to perform a pretreatment assessment within one hour of starting treatment. During an interview on 12/09/2025 at 9:00 AM, Charge Nurse 1 stated an assessment should be completed within the first hour of treatment. During an interview on 12/09/2025 at 1:14 PM, Director of Operations stated staff should know they have to complete the assessment within the first hour of treatment and was unsure why staff did not complete it timely. 3. A review of Patient #2’s record included a Treatment Sheet dated 11/15/2025. The document did not show evidence of a nursing evaluation during the patient’s treatment. 4. A review of Patient #3’s record included a Treatment Sheet dated 11/24/2025. The document did not show evidence of a nursing evaluation during the patient’s treatment. 5. During an interview on 12/09/2025 at 1:13 PM, the Director of Operations reviewed Patient #2’s Treatment Sheet (11/15/2025) and Patient #3’s Treatment Sheet (11/24/2025) and confirmed that a nurse did not complete nursing assessments for either patient. She indicated that the same nurse missed both assessments and that a nurse must complete nursing assessments within one hour of treatment start.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to maintain emergency supplies according to manufacturer instructions for 1 of 2 Emergency Code Carts observed. Findings include: 1. On 11-02-2023 at 10:45 AM, a dated 07-06-2020, Fresenius Kidney Care policy titled, “Emergency Medication, Equipment, and Supplies” was provided by the Director of Operations (DO). The policy indicated but was not limited to, “Emergency Cart ... The emergency cart must be: ... Checked monthly or after use for contents, expiration dates ... An itemized log must be kept indicating the contents and expiration dates of contents. Items approaching expiration must be reordered and replaced prior to the actual expiration date ... “ 2. During the flash tour observation on 11-02-2023 at 9:25 AM, 2 packages of Intravenous (IV) therapy administration line kits (used for controlled infusion of medications to the needle) were found in the Emergency Cart by the scale of the Home Program with the expiration date of 11-30-2022, and an Ambu bag face mask (a disposable mask designed for patient ventilation and oxygen) that expired 06-18-2022. 3. On 11-02-2023 at 10:45 AM, a facility document dated October 2023, titled, “Emergency Code Cart and Medication Checklist” was provided by the DO. The document indicated a review of the contents monthly was to be completed and to discard and replace any expired items. The checklist was checked as completed October 2023, and signed by the Registered Nurse (RN) 4. During an interview on 11-02-2023 at 10:40 AM, the DO, confirmed the IV administration kits had expired on 11-22-2022. The DO further indicated that the Emergency Code Cart had been checked off for the month of October 2023, by RN 4.”

“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: 44232 Based on observation, record review, and interview, the facility failed to ensure the staff used Personal Protective Equipment (PPE) and hand hygiene appropriately while on the treatment floor by 6 of 8 Patient Care Technicians. (Patients: #4, 8, 9, 10, 24, and 25) (Employees: Patient Care Technician (PCT) #1 (three times), 2 (twice), 4 (twice), 7, 8 and 9) Findings Include: 1.On 11-03-2023 at 4:00 PM a dated 03-17-2023, Fresenius Kidney Care policy, titled, “Hand Hygiene” was provided by the Director of Operations (DO). The policy indicated but was not limited to “Purpose: The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination. Responsibility: All staff, patients ... Policy: Hand hygiene includes either washing hands with soap and water or using a waterless alcohol based antiseptic hand rub with 60-90% alcohol content ... When ... Before and after direct contact with patients. Entering and leaving the treatment area ... Hand Hygiene: Patients: Patients should perform hand hygiene if able, prior to and after each dialysis treatment ... “ 2. On 11-02-2023 at 12:00 PM, a sign posted on the wall above the sink at the entrance to the treatment area was reviewed. The sign titled, “Hand Hygiene Techniques “provided pictures and written instructions on how to complete a hand wash and how to complete a hand rub with hand sanitizer which indicated the best practice to prevent infection. 3. On 11-02-2023 at 1:10 PM, a facility document dated December 2022 through October 2023, titled, “Clinic Audit Checklist, Category: Infection Prevention” was provided by the DO. The document indicated a review of the monthly infection prevention audits completed. 4. During an observation on 11-02-2023 at 11:02 AM, PCT 2, discontinued the treatment for Patient #24, at Station #8. Patient #24 held pressure on their left vascular access site with a gloved right hand. Patient #24 discarded their glove in the trash receptacle beside their chair. PCT 2 obtained Patient #24’s weight prior to the patient leaving the treatment area. Patient #24 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 5. During an observation on 11-02-2023 at 12:26 PM, Patient #4 was observed entering the treatment area. PCT 4, assisted Patient #4 to the scale, obtained their weight, and assisted Patient #4 to Station #18. PCT 4 was then observed initiating dialysis treatment for Patient #4 who had a Central Venous Catheter (CVC). Patient #4 was not offered hand sanitizer or instructed to perform hand hygiene upon entering the treatment area. 6. During an observation on 11-02-2023 at 3:20 PM, PCT 1, was observed assisting Patient #10, at Station #3, after the patient held pressure on their left vascular access site with a gloved right hand. The PCT applied a new dressing and removed Patient #10’s glove. Patient #10 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 7. During an observation on 11-02-2023 at 3:45 PM, PCT 1, was observed assisting Patient #9, at Station #24, after the patient had held pressure on their right vascular access site with a gloved left hand. Patient #9 discarded their glove in the trash receptacle beside their chair. Patient #9 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 8. During an observation on 11-03-2023 at 9:45 AM, PCT 8, was observed discontinuing treatment at Station #13 for Patient #25 who had a right upper thigh graft. The PCT applied a new dressing and removed Patient #25’s glove. Patient #25 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 9. During an observation on 11-03-2023 at 10:24 AM, PCT 9, was observed assisting Patient #8, at Station #24, after the patient had held pressure on their right vascular access site with a gloved left hand. The PCT applied a new dressing and removed Patient #8’s glove. Patient #8 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. During an interview on 11-03-2023 at 2:45 PM, PCT 8, the Preceptor Trainer PCT, indicated they train all the PCTs regarding infection control including hand hygiene being performed after gloves are removed. 10. During an interview on 11-03-2024 at 4:50 PM, the Clinical Manager, and DO, confirmed that hand hygiene should be offered or instructed to the patients after they held the pressure dressing on their access. 47343 11. On 11-02-2023 at 12:10 PM, Patient Care Technician (PCT) 1 was observed initiating the arteriovenous fistula (a connection that’s made between an artery and vein for dialysis access) for Patient #10 at Station #3. PCT 1 inserted the cannulation needles then touched the dialysis machine. The PCT then connected the blood lines to the cannulation needles to initiate dialysis treatment. PCT 1 failed to remove their gloves, perform hand hygiene and donning new gloves after touching the dialysis machine. 12. On 11-02-2023 at 12:30 PM, PCT 4 was observed accessing an arteriovascular fistula for Patient #14 at Station 19 to start Dialysis. PCT 4 connected the sterile syringes to the Patient #14’s lines, then adjusted the settings on the Dialysis machine with the same gloves. PCT 4 used those same gloves to connect the blood lines to the patient’s access. The PCT failed to change gloves when going from a dirty surface to the patient. 13. On 11-02-2023 at 12:45 PM, PCT 2 was observed accessing a central venous catheter (a tube placed in a large vein which delivers medication and blood products) prior to initiating treatment for Patient #13 at Station 11. PCT 2 connected the sterile syringes then adjusted the settings on the Dialysis machine. PCT 2 used the same gloves to hook the patient up to the Dialysis machine. PCT 2 failed to ensure they donned new gloves after touching the Dialysis machine and before attaching the lines to Patient #13’s access. 14. On 11-03-2023 at 10:10 AM, PCT 7 was observed removing their dirty gloves after cleaning and disinfecting Station 1. PCT 7 grabbed clean gloves and failed to perform hand hygiene prior to doffing soiled gloves and before donning clean gloves.”

“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: 44232 Based on observation, record review, and interview, the facility failed to ensure the staff initialed and dated opened medications in 1 of 1 medication rooms. Findings Include: 1. On 11-03-2023 at 4:00 PM a dated 02-06-2023, Fresenius Kidney Care policy, titled, “Medication Preparation and Administration” was provided by the Director of Operations (DO). The policy indicated but was not limited to, “ ... When preparing medications if the vial is not used immediately in its entirety, the nurse or PCT (Patient Care Technician) ... must place the date and time the vial was opened on the medication label along with their initials ... Expiration dates for all stored medications are to be monitored on a monthly basis ... Any multi-dose vials must be discarded 28 days after opening or per the manufacturer’s expiration date ... “ 2. During an observation on 11-03-2023 at 10:35 AM, noted in the second drawer of the medication room 4 vials of Adrenalin (a medication used for severe allergic reactions) 1 milligram (mg)/1 milliliters (ml) per vial with an expiration date of 07-2023. During an interview on 11-03-2023 at 10:40 AM, the Registered Nurse (RN) 3 confirmed the medication had expired. 3. During an interview on 11-03-2023 at 10:40 AM, RN 5 indicated the secretary goes through the medication room and re stocks. RN 5 further stated “Obviously that was missed.””

“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: 44232 Based on observation and interview the facility failed to ensure a patient’s access site remained uncovered during dialysis treatments for 1 of 1 stand alone in-center dialysis facilities. (Patients: #26) Findings Include: 1. On 11-03-2023 at 4:00 PM a dated 05-01-2023, Fresenius Kidney Care policy, titled, “Patient Assessment and Monitoring” was provided by the Director of Operations (DO). The policy indicated but was not limited to “Purpose: The purpose of this policy is to provide guidance to the Fresenius Kidney Care direct patient care staff on assessment and monitoring patients before, during, and after treatment ... Access: Ensure access remains uncovered throughout treatment ... “ 2. During an observation on 11-03-2023 at 10:34 AM to 11:05 AM, Patient #26 was observed at Station #3. Patient #26’s arteriovenous fistula (an abnormal connection between an artery and vein that provides access for dialysis treatment) was fully covered. 3. During an interview on 11-03-2023 at 4:44 PM, the Clinical Manager and DO, confirmed all patient’s accesses are to be visible at all times during their treatment.”