Fmc - Liberty Dialysis - Crawfordsville

“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: 50833 Based on observation, interview, and record review, the clinic failed to ensure a sanitary environment was maintained to minimize patients’ exposure to pathogens, and to adjacent public areas when the diaysis staff granted non-staff access to the incenter clinic, during the provision of hemodialysis treatment, and failed to direct and provide the non-staff to don Personal Protective Equipment [PPE] for 1 of 1 day of observation when non-staff were observed on the incenter floor during the provision of hemodialysis (Day 1 on 9/24/2024). Findings include: 1. A policy titled “Visitor Policy” states no vendors are allowed on the treatment floor while patients receive dialysis. Visitors are provided appropriate PPE as necessary and standard precautions maintained. 2. During an observation on 09/24/2024 at 3:40 PM, a housekeeping staff member from the hospital was noted on the incenter treatment floor; they gathered trash and biohazard bags without donning PPE. 38262 3. During an interview on 09/24/2024 at 3:50 PM, RN 1 relayed when patients are present and receiving dialysis treatment, the hospital staff are to don and wear PPE, to include a gown and gloves, when handling / removing trash from the incenter treatment floor during dialysis. She indicated the hospital staff were educated to wear PPE.”

“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: 48387 Based on observation, record review, and interview, the facility staff failed to remove gloves and perform hand hygiene during 3 of 3 days of observations of care within the incenter (September 24, 25, and 26, 2024) Findings include: 1. A policy titled “Hand Hygiene” with revision date of 11/06/2023, indicated hand hygiene should be performed before and after direct contact with patients, upon entering and leaving the treatment area, before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications, immediately after removing gloves, and after contact with objects near the patient. 2. A policy titled “Cleaning and Disinfecting the Dialysis Station” with revision date 09/05/2023, indicated staff should use clean hands, without gloves, when touching screen computers and keyboards; if gloves are worn, they must be clean gloves, and hand hygiene must be performed after contacting electrical devices and before patient contact. 3. During an observation on 09/24/2024 beginning at 10:45 AM, Registered Nurse (RN) 2 used gloved hands, to assess Patient #10 with a stethoscope and then touched the screen of the dialysis machine screen; RN 2 failed to doff gloves and perform hand hygiene after touching Patient and before touching the dialysis machine. During the observation, Patient Care Technician (PCT 1) palpated Patient #10’s arteriovenous (AV) fistula, cleansed and accessed the fistula. PCT 1 failed to change their gloves and perform hand hygiene after palpating the fistula, after cleasing the site, and before accessing the AV fistula. 4. During an observation on 09/24/2024 at 11:15 AM, PCT 1 accessed Patient #7’s AV fistula with gloved hands, then touched the dialysis machine and keyboard. PCT 1 failed to change gloves and perform hand hygiene after accessing the fistula and before handling the equipment. 5. During an observation on 09/24/2024 at 12:00 PM, RN 1 removed the old dressing from Patient #1’s central venous catheter (CVC) site, cleansed the exit site, and applied a new dressing. RN 1 failed to change gloves and perform hand hygiene after removing the old dressing and before cleaning the site. 6. During an observation on 09/24/2024 at 12:45 PM, PCT 1 with gloved hands, touched the dialysis machine and then touched Patient #6’s CVC hub. PCT 1 failed to change their gloves and perform hand hygiene after touching the machine and before contact with Patient’s CVC and provision of care. 38262 7. During an observation on 09/24/2024 at 2:37 PM, RN 1 disconnected Patient #10’s bloodlines and disposed of them without removing gloves or performing hand hygiene. RN 1 then removed needles from the AV access sites and applied pressure with soiled gloves. Without removing the gloves or performing hand hygiene, RN 1 applied clean gauze dressings and secured with tape. 8. During an observation on 09/24/2024 at 3:15 PM, RN 1 removed soiled gauze dressings from Patient #7’s AV access sites and applied clean gauze dressings, and secured with tape. RN 1 failed to remove gloves and perform hand hygiene after handling the soiled dressings and before applying the clean dressings. 9. During an observation on 09/25/2024 at 8:45 AM, PCT 7 used gloved hands to assist Patient #16 with personal items, touched the dialysis machine, and then placed a blood pressure cuff on patient’s arm. PCT 7 failed to change their gloves and perform hand hygiene after handling the items and before patient care. 10. During an observation on 09/26/2024 at 10:35 AM, RN 1 completed CVC exit site care for Patient #11 and accessed Patient’s CVC hubs. RN 1 failed to change their gloves and perform hand hygiene after completing exit site care and before starting treatment. 11. During an observation on 09/26/2024 at 10:40 AM, RN 1 touched the dialysis machine with gloved hands and then attached bloodlines to Patient #11’s CVC lines. RN 1 failed to change gloves and perform hand hygiene before handling the bloodlines. 12. During an interview on 09/24/2024 at 12:53 PM, RN 1 indicated gloves should be changed between patients, between stations, and anytime gloves are removed. 13. During an interview on 09/24/2024 at 3:50 PM, PCT 1 indicated hand hygiene should be performed whenever gloves are changed.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 48387 Based on observation, record review, and interview, the facility staff failed to ensure the staff decontaminated the stethoscope before and after use on 6 of 6 observed staff handling of stethoscope (RN 1, RN 2, RN 6, PCT 1). Findings included: 1. A 09/05/2023 policy titled, “Cleaning and Disinfecting the Dialysis Station” states that non-disposable equipment brought into the dialysis station must be disinfected. The dialysis station, including the chaise wall behind the chair, should be disinfected with a 1:100 bleach solution after each dialysis treatment. 2. A 05/06/2024 policy titled, “Access and Assessment and Cannulation” states that stethoscopes be cleaned after assessing a patient. 3. A 07/01/2024 policy titled, “General Cleanliness and Infection Control Guidelines” indicates that noncritical medical equipment, such as equipment that touches only intact skin, must be cleaned with a low-level disinfectant. 4. During an observation on 09/24/2024 at 10:45 AM, Registered Nurse (RN 2) used a stethoscope to assess Patient #7 and then placed the stethoscope around their neck. RN 2 gave the stethoscope to PCT 1, who used it to assess Patient #7’s Arteriovenous (AV) Fistula. Neither RN 2 nor PCT 1 disinfected the stethoscope before or after using it on Patient #7. 5. During an observation on 09/24/2024 at 11:24 AM, RN 1 removed a stethoscope from the dirty area and used it to assess the lung sounds of Patient #1. RN 1 then placed the stethoscope around her neck, later using it to assess the AV fistula, without disinfecting it before or after each use. 6. During an observation on 09/24/2024 at 11:55 AM, RN 2 accepted an undisinfected stethoscope from PCT 1 and placed it on the counter next to the computer. RN 2 failed to disinfect the stethoscope before placing it in the clean area. 7. During an observation on 09/26/2024 at 10:30 AM, RN 6 used a stethoscope to assess Patient #11’s lungs, then placed the stethoscope around their neck without disinfecting it before or after the assessment. 8. During an observation on 09/26/2024 at 10:35 AM, RN 6 used a stethoscope to assess Patient #11’s AV fistula and then returned the stethoscope to their neck without disinfecting it. 38262 9. During an interview on 09/26/2024 at 5:00 PM, the Director of Operations stated that staff should not store unused blood pressure cuffs on the countertop.”

“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: 48387 Based on observation, record review, and interview, the staff failed to clean and disinfect contaminated surfaces and equipment at dialysis stations, affecting 2 of 2 observations of Patient Care Technician [PCT] 1 cleaning and disinfection of dialysis stations (PCT 1). Findings include: 1. A 09/05/2023 policy titled “Cleaning and Disinfecting the Dialysis Station” indicates all work surfaces at dialysis stations should be cleaned and disinfected. 2. During an observation on 09/24/2024 at 10:20 AM, PCT 1 did not disinfect the blood pressure cuff nor the lines from the cuff to the machine and failed to disinfect the counter at the back of the station 3 between patients. 3. During an observation on 09/24/224 at 2:55 PM, PCT 1 did not disinfect the blood pressure cuff nor the lines from the cuff to the machine and failed to disinfect the counter at the back of station #1 between patients. 4. During an interview on 09/25/2024 at 1:53 PM, the interim Facility Administrator indicated the station, including the machine, chair, and counter behind chair, should be disinfected between patients.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 38262 Based on observation, record review, and interview, the facility failed to ensure two staff members verified the pH (a measurement of the acidity or alkalinity of a solution) before each patient’s treatment for 2 of 3 preparations of the Hemodialysis machine observations (Patient Care Technician (PCT) 2 & 7) and failed to record the pH numeric value before treatment for 3 of 5 records reviewed (Patient #1, #3, and #4), and failed to ensure staff labeled and identified all solutions for 1 of 1 flash tour observation (RN 1). Findings include: 1. A 05/06/2024 policy titled “Checking Conductivity and pH of Final Dialysate” indicated a manual pH test number should be documented in the treatment notes. 2. A 05/06/2024 titled “Clinical Services” indicated two staff members are to verify the pH before each patient treatment. 3. A 06/14/2017 policy titled “pHoenix Meter, pHoenix XL and Tri-Station Care and Maintenance” indicates bottles should be labeled with the date the solution was opened and the expiration date. 4. During an observation on 09/25/2024 at 11:15 AM, PCT 2 performed a pH test with a handheld meter without a second staff member present to verify the reading. 5. During an interview on 09/25/2024 at 2:35 PM, Bio Med 2 stated that given the type of dialysis machine this facility used, staff should perform a two-person verification check for pH testing. 6. The clinical record for Patient #3 failed to evidence a recorded pH numeric value, was entered before the start of hemodialysis treatment on August 28 and 30th of 2024 and on September 02, 06, 09, 11, and 20th, of 2024. 7. A review of Patient #4’s record failed to evidence a recorded pH numeric value before the start of treatment for the following dates: September 02, 04, 20, and 23, 2024. 8. During an interview on 09/25/2024 at 11:15 AM, PCT 2 stated she records either a pH number or a pass/fail; she relayed the dialysis machine would run with a recorded pH number or a pass / fall. 9. During an interview on 09/25/2024 at 2:35 PM, Bio Med 2 stated two staff members should test, verify, and record the pH number in the machine setup section of the treatment record. He stated the facility currently uses 2008T machines, which require a recorded pH number on the treatment sheet. He stated if the machine had a BiBag (single-use bicarbonate disposable bag) system, they could record pass or fail instead of a number. 10. During an interview on 09/26/2024 at 9:20 AM, the Director of Operations 1 stated staff were expected to record a pH number into the dialysis machine. She stated this facility has many out-of-state staff who float and may need to be made aware that they should record a pH number. 48387 11. During the day 1 flash tour on 09/24/2024, at 11:00 AM observed an unlabeled bottle on the counter next to the dirty sink, in the treatment area. 12. During an interview on 09/24/2024, RN 1 indicated the bottle was Reverse Osmosis (RO) water; she had filled it however had yet to label the bottle. 13. During an observation on 09/25/2024 at 9:48 AM, PCT 7 performed a pH test with a handheld meter without a second staff member to verify the reading. PCT 7 failed to have a second verification of pH test results per facility policy. 14. A review of Patient #5’s treatment records for the dates August 28 and 30th of 2024 and dated September 02, 04, 09, 11, 13, and the 16th of 2024, failed to evidence the pH was recorded before the start of each days treatment. 15. A review of Patient #6’s treatment records for the dates August 24 and September 05, 10, 12, and the 14th, of 2024 each failed to evidence the pH number was recorded before the start of each treatment.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 50833 Based on observation, record review, and interview, the agency failed to ensure a safe environment when they propped open the door to the dialysis water treatment room in 2 of 3 observation days (September 24 and 25, 2024). Findings include: 1. A policy titled “Physical Security and Facility Access” indicated restricted access must be maintained to prevent both the tampering with the water treatment equipment, as well as unwanted entry into the water treatment area. The policy relayed the that doors should remain locked to block access to the water treatment room. 2. During an observation flash tour at 09/24/2024 at 9:45 AM, the water room door was propped open using multiple bleach bottles. 3. During an interview at 09/24/2024 at 9:45 AM, Registered Nurse (RN) 1 relayed the door to the water treatment area was usually propped open because they have so many float staff who do know the code to the door. 4. During an interview at 09/24/2024 at 9:30 AM, Bio Med (BM) 2 stated the water treatment area door should not be propped open, was to remain closed and secured. 38262 5. During an observation on 09/25/2024 at 8:10 AM, the water room door was propped open using multiple bleach bottles. 6. During an interview on 09/25/2024 at 8:26 AM, Patient Care Technician (PCT) 2 stated that staff should not prop open the water room door. She relayed the facility relied heavily on float staff and they often forget the code to enter the water oom, therefore they leave the door open.”