Fmc - Dupont 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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to maintain a sanitary environment specific to the preparation of bleach solution for 1 of 1 observations of bleach solution mixing, which had the potential to affect 46 active patients. Findings include: 1. The “Mixing Bleach” policy, dated 02/03/2025, indicated a 1:10 concentration would be made with 1 part bleach to 9 parts water (10% bleach and 90% water). A 1:100 concentration would be made with 1 part bleach to 99 parts water (1% bleach and 99% water). The policy indicated when mixing the bleach solution, staff should measure water and bleach to ensure proper concentration. 2. During an observation on 5/28/25 at 4:24 AM, Charge Nurse 3 mixed bleach solution to be used on the ICHD treatment floor. The nurse mixed 3,000 milliliters (mL) water and 30 mL of bleach into two containers labeled 1:100 bleach solution, resulting in a bleach concentration of 0.9%. Charge Nurse 3 also mixed 900 mL water and 30 mL of bleach into one container labeled 1:10 bleach solution, resulting in a total bleach concentration of 3.2%. Review of the labels on containers used to store the bleach solution evidenced the following: a. A label on the two 1:100 bleach solution containers indicated the solution was to be made by mixing 2,970 mL of water and 30 mL of bleach. b. A label on the 1:10 bleach solution container indicated the solution was to be made by mixing 270 mL of water and 30 mL of bleach. During an interview on 5/28/25 beginning at 10:14 AM, Charge Nurse 3 reported the 1:100 mL bleach solution was made with 3,000 mL water and 30 mL bleach. Charge Nurse 3 then reviewed the label on the 1:10 bleach solution container and reported the solution should be made with 270 mL water. When asked how the staff measure to 270 mL, the nurse reported staff use a Pyrex measuring cup to measure the water, which had a “thick” line immediately beneath the 300 mL mark. Charge Nurse 3 reported staff should fill the water this line to measure approximately 270 mLs.”

“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: 45607 Based on observation, record review, and interview, the dialysis facility failed to ensure infection control policies related to hand hygiene were followed for 1 of 2 PCTs observed who discontinued dialysis for patients with an arteriovenous fistula or graft (PCT 1). Findings include: 1. The Hand Hygiene policy, revised 11/06/2023, indicated “ ... Hands Will Be ... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water ... Before and after direct contact with patients ... After contact with inanimate objects near the patient ... After contact with other objects within the patient station or treatment space ...” 2. The Termination of Treatment Using an Arteriovenous Fistula or Graft policy, revised 11/04/2024, indicated “ ... Disconnect the blood lines from the needle lines and remove the needles according to the Post Treatment Needle Removal Procedure ...” 3. The Post Treatment Fistula Needle Removal Procedure, revised 07/01/2024, indicated “ ... The person removing needles will perform hand hygiene and don clean gloves ...” 4. During a treatment floor observation on 05/27/2025 at 10:42 AM, PCT 1 reinfused the extracorporeal circuit and disconnected the blood lines aseptically for Patient #1. PCT 1 then removed one of the two needles without first performing hand hygiene and a glove change. PCT 1 failed to perform hand hygiene and don new gloves after touching the dialysis machine and before removing the first needle. 5. During an interview on 05/29/2025 at 12:00 PM, PCT 1 indicated she wouldn’t necessarily perform hand hygiene and don new gloves after touching the dialysis machine in the patient’s station and before removing needles because it’s the patient’s machine. 6. During an interview on 05/29/2025 at 12:03 PM, the Administrator indicated staff should perform hand hygiene and don new gloves after touching the dialysis machine in the patient’s station and prior to needle removal.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff did not consume food on the ICHD treatment floor for 1 of 2 days of ICHD floor observations (Charge Nurse 3). Findings include: 1. The “General Cleanliness and Infection Control Guidelines” policy, dated 11/04/24, indicated staff were prohibited from eating in work areas “where there is reasonable likelihood of occupational exposure.” 2. During an ICHD treatment floor observation on 5/28/25, the following was observed: a. At 5:52 AM, Charge Nurse 3 was in Station 5 while PCT 4 was performing CVC site care and initiating Patient #13’s dialysis. The nurse was chewing gum in the station. b. At 6:17 AM, Charge Nurse 3 was in Station 1 while Patient #14 was receiving dialysis. The nurse was chewing gum in the station. 3. During an interview on 5/28/25 beginning at 10:14 AM, Charge Nurse 3 reported staff were not permitted to have food or drinks on the treatment floor, including gum.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 42617 Based on observation, policy and procedure review, and interview, the dialysis facility failed to ensure staff performed appropriate infection control measures specific to CVC care for 1 of 2 CVC exit site care observations (Patient #13) and 1 of 2 CVC discontinuation of dialysis observations (Patient #13). Findings include: 1. The “Changing the Catheter Dressing Procedure,” dated 5/02/25, indicated when cleaning a CVC with Chloraprep (antiseptic solution comprised of 2% Chlorohexidine and 70% alcohol), staff should “clean the exit site beginning in the center and continuing outward ... in a concentric circle ....” 2. The “Termination of Treatment Using a Central Venous Catheter ...” policy, dated 11/04/24, indicated prior to disconnecting a patient from dialysis, staff should “ensure that a clean under pad is below the catheter limbs to protect the work area and the clothing.” During an interview on 5/28/25 beginning at 10:14 AM, Charge Nurse 3 reported when performing CVC exit site care, staff should clean with Chloraprep from the inside by the insertion point (“clean”) towards the outside (“dirty”) in circles. 3. During an observation on 5/28/25 beginning at 6:36 AM, PCT 3 was in Station 3 performing exit site care to Patient #13’s CVC. The technician cleaned the site using a Chloraprep swab around the exit site in a concentric circle, then moved the swab back towards the exit site (“dirty” to “clean” area). 4. During an observation on 5/28/25 beginning at 9:55 AM, PCT 3 was in Station 3 discontinuing Patient #13’s dialysis. The technician failed to place a clean under pad under the CVC prior to disconnecting Patient from dialysis. 5. During an interview on 5/28/25 beginning at 1:19 PM, PCT 3 reported when performing CVC exit site care, he would clean with a Chloraprep swab from the outside (dirty) in towards the exit site (clean). When discontinuing a patient from dialysis with a CVC, the technician reported he would only place a clean under pad if the current under pad was visibly soiled.”

“MIXING SYSTEMS-CLEANING CFR(s): 494.40(a) 6.4.1 Mixing systems: cleaning Concentrate mixing equipment should be either: (1) completely emptied, cleaned, and disinfected according to the manufacturer’s instructions; or (2) cleaned and disinfected using a procedure demonstrated by the facility to be effective in routinely producing concentrate meeting [these regulations related to allowable bacterial and endotoxin levels]. The disinfection data should be recorded for each ...disinfection cycle using a dedicated log. This Standard is not met as evidenced by: 42617 Based on observation, manufacturer’s instructions, and interview, the dialysis facility failed to ensure staff performed post-bleach testing of the bicarbonate distribution tank according to manufacturer’s instructions for 1 of 1 observation of ICHD treatment floor opening procedures, which had the potential to affect 46 active patients. Findings include: 1. Manufacturer’s instructions for RPC Ultra-Low Total Chlorine Test Strips indicated when performing a total chlorine test, staff should remove the test strip from the solution, shake the strip once “to remove excess water,” then wait 20 seconds for the test strip color to develop before reading the result. 2. During an observation of ICHD treatment floor opening procedures on 5/28/25 beginning at 3:42 AM, PCT 3 reported the bicarbonate system was bleached at the end of the 5/27/25 shift, and the bicarbonate concentrate would need to be tested for residual bleach. After preparing the bicarbonate batch, PCT 3 transferred the solution to the distribution tank and drew a sample to check for bleach. PCT 3 dipped the Total Chlorine test strip in the bicarbonate sample for one minute, removed the strip, shook the strip once to remove excess fluid, and immediately read the test result. The technician failed to wait 20 seconds after removing the test strip to read the result. 3. During an interview on 5/28/25 beginning at 4:37 AM, PCT 3 reported the total chlorine test strip could be read immediately after removing it from the sample. 4. During an interview on 5/28/25 beginning at 10:14 AM, Charge Nurse 3 reported when performing a total chlorine test, staff should wait 20 seconds after removing the strip from the sample before reading the result.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff transferred a patient with a Hoyer mechanical lift according to facility policy for 1 of 1 observation of a patient transfer using a Hoyer lift (Patient #13). Findings include: 1. The “Guidelines for Use of the Hoyer Lift” policy, dated 8/30/24, indicated when positioning the Hoyer lift to transfer a patient from a wheelchair to the treatment chair, staff should “not lock the brakes or block the wheels when lifting the patient. The wheels must be free to roll to allow the lift to center itself beneath the patient.” 2. During an observation on 5/28/25 beginning at 6:25 AM, PCT 3 and Charge Nurse 3 transferred Patient #13 from a wheelchair to the treatment chair using a mechanical Hoyer lift. The staff locked the wheels of the Hoyer when lifting Patient up from the wheelchair. 3. During an interview on 5/28/25 beginning at 1:19 PM, PCT 3 reported the Hoyer lift wheels should be locked when lifting a patient up from a wheelchair. 4. During an interview on 5/28/25 beginning at 1:54 PM, Charge Nurse 3 reported the Hoyer lift wheels should be locked when lifting a patient up from a wheelchair.”

“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: 42617 Based on observation and interview, the dialysis facility failed to ensure all patient access sites were visible for 1 of 2 days of ICHD treatment floor observations (Patients #14, 15). Findings include: 1. The policy “Patient Assessment and Monitoring,” dated 5/01/23, indicated staff were to ensure the patient’s access site “remains uncovered throughout the treatment.” 2. During an ICHD treatment floor observation on 5/28/25 beginning at 4:50 AM, the following was observed: a. At 5:25 AM, Patient #15 was receiving dialysis in Station 2. Patient’s access site was not visible. At 5:40 AM, PCT 3 was in Station 2 at the dialysis machine. Patient’s access was not visible. The technician failed to instruct Patient to keep their access visible. b. At 5:46 AM, Patient #14 was receiving dialysis in Station 1. Patient’s access site was not visible. c. At 6:00 AM, RN 2 was in Station 2 obtaining performing safety checks. Patient #15’s access site was not visible. The nurse failed to instruct Patient to keep their access site visible. d. At 6:04 AM, PCT 5 silenced alarms in Stations 1 and 2. Patients #14 and #15’s access sites were not visible. The technician failed to instruct the patients to keep their access sites visible. e. At 6:33 AM, Charge Nurse 3 was in Station 1 performing safety checks. Patient #14’s access site was not visible. The nurse failed to instruct Patient to keep their access site visible. 3. During an interview on 5/28/25 beginning at 10:14 AM, Charge Nurse 3 reported staff should be monitoring patient access sites for visibility every 30 minutes, and staff also “keep an eye on” patients throughout their treatment. If an access site was covered, staff should “uncover it.” 4. During an interview on 5/28/25 beginning at 1:19 PM, PCT 3 reported staff should be monitoring patient access sites for visibility every 30 minutes and “whenever walking by” the patient. 5. During an interview on 5/28/25 beginning at 1:47 PM, PCT 5 reported staff should be monitoring patient access sites for visibility every 30 minutes. Staff also “glance” at the access sites while walking by. If a patient’s access site was covered, staff should educate the patient and ask them to uncover the site. 6. During an interview on 5/28/25 beginning at 1:58 PM, RN 2 reported staff should be monitoring patient access sites for visibility every 30 minutes. If access sites were not visible, staff should move blankets or other items to ensure the access was visible.”