Fmc - Grant County Dialysis

“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: 51751 Based on observation, record review, and interview, the facility failed to ensure emergency supplies located in the emergency cart were monitored for expiration in 1 of 1 facility observed. Findings Include: 1. A policy titled, Storage of Supplies” dated 04/05/2021 Version 2 indicated but was not limited to, “Supplies must be rotated First in-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date”. 2. A policy titled, Guidelines for Emergency Preparedness” dated 07/03/2023 Version 11 indicated but was not limited to, “The following minimum emergency supplies and equipment must be on the premises at all times, clean, functional, accessible, and immediately available: ... Automated External Defibrillator (AED)”. 3. During an observation on 02/20/2025 at 6:30 PM, the crash cart located on the treatment floor evidenced 5 Automated External Defibrillator (AED) pads (pads that adhere to patients to monitor breathing and heart rate during CPR) with an expiration date of 02/20/2023. 4. During an interview on 2/20/2025 at 6:30 PM, the Clinic Manager indicated that the night shift nurses oversee checking the crash cart for expired medications and supplies. 5. During an interview on 02/26/2025 at 8:50 AM, RN 4 indicated that RN 1 oversees checking the crash cart nightly for any expired supplies. 6. During an interview on 02/26/2025 at 10:00 AM, PCT 8 indicated the Administrative Assistant, and Nurses oversee the crash cart and check for expired supplies.”

“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: 51751 Based on observation, record review, and interview the facility staff failed to follow adequate hand hygiene and glove changes to prevent the spread of communicable diseases in 4 of 8 patients observed. (Patient # 7,11,13,14) Findings include: 1. A policy titled, “Hand Hygiene” dated 11/06/2023, Version 8, indicated but was not limited to, “Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand scrub with 60-90% alcohol content ... Before and after direct contact with patients ... before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications ... immediately after removing gloves ... after contact with body fluids or excretion ... after contact with an inanimate object near the patient ... when moving from a contaminated body site to a clean body site of the same patient”. 2. During an observation on 02/20/2025 at 7:25 PM, PCT 9 initiated treatment for Patient #7. With gloved hands, PCT 9 removed the old CVC dressing, discarded it and immediately began CVC exit site care. PCT 9 failed to remove her gloves and complete hand hygiene before disinfecting the CVC exit site. 3. During an observation on 02/20/2025 at 8:04 PM, PCT 9 initiated Patient #11’s CVC treatment. PCT 9 attached the dialysis lines to the dialyzer (filter used to cleanse the blood) and removed her gloves. New gloves were donned. PCT 9 failed to complete hand hygiene after removal of gloves. 4. During an observation on 02/20/2025 at 7:30 PM, PCT 2 canulated (inserted dialysis needled) Patient #13, removed her gloves, donned clean gloves, and finished connecting Patient #13 up to dialysis. PCT 2 failed to perform hand hygiene after performing patient #13’s care and before applying new gloves. 5. During an observation on 02/20/2025 at 8:00 PM, PCT 2 canulated Patient #14 with gloves on, removed the gloves, and began typing on the hemodialysis machine. PCT 2 failed to perform hand hygiene after performing care on Patient #14 and before transitioning to the machine. 6. During an interview on 02/20/2025 at 8:20 PM, PCT 2 indicated that hand hygiene should be performed between patient care and touching a hemodialysis machine and before applying gloves and after taking gloves off. 7. During an interview on 02/26/2025 at 8:50 AM, RN 4 indicated that hand sanitizing should occur before applying gloves and anytime gloves are taken off. 8. During an interview on 02/26/2025 at 10:00 AM, PCT 8 indicated that hand hygiene should be done before applying gloves. 9. During an interview on 02/20/2025 at 8:15 PM, PCT 9 staff must sanitize their hands between glove changes. She also indicated that after removing a Central Venous Catheter dressing, gloves should be removed, hands sanitized, and new gloves put on before going forward with connecting the dialysis patient lines. 10. During an interview on 02/20/2025 at 8:20 PM, RN 1 indicated gloves should be changed after removing a CVC dressing and hands sanitized prior to putting on new gloves.”

“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: 51751 Based on observation, record review, and interview the facility failed to provide a supply of hand soap and paper towels for staff and patient use for 3 of 3 clean sinks observed on the treatment floor.. Findings include: 1. A policy titled, “Hand Hygiene” dated 11/06/2023, Version 8, indicated but was not limited to, “Soap and a supply of paper towels protected from contamination must be available at each sink”. 2. During an observation on 02/20/2025 at 6:32 PM, a clean sink located near the patient scale failed to include soap and paper towels to complete adequate handwashing. 3. During an observation on 02/20/2025 at 6:35 PM, a clean sink located on the treatment floor between Station #1 and Station # 2 failed to include soap to complete adequate handwashing. 4. During an observation on 02/20/2025 at 6:36 PM, a clean sink located on the treatment floor near Station #4 failed to include paper towels for use after handwashing was completed. 5. During an interview on 02/26/2025 at 8:50 AM, RN 4 indicated that soap and paper towels are required to be at all clean sinks and staff have access to more if needed. 6. During an interview on 02/26/2025 at 10:00 AM, PCT 8 indicated that both soap and paper towels are required at all clean sinks and that housekeeping does a good job with keeping soap and paper towels at clean sinks, but if unavailable staff can refill.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 51751 Based on record review and interview the facility failed to ensure Hepatitis B Core Antibody status was known prior to admission for 1 of 2 new patient admissions to the facility. (Patient #4) Findings Include: 1. A policy titled, “Patient Hepatitis B Testing Requirements” dated 02/03/2025 Version 3 indicated but was not limited to, “The CDC recommends the results of Hepatitis B Virus (HBV) testing be known before the patient begins dialysis ... The CDC recommends the following tests: 1) Hepatitis B surface antigen (HBsAg); 2) Hepatitis B surface antibody (anti-HBs); 3) Hepatitis B core antibody “total” (anti-HBc)”. 2. A record review for Patient #4, admission date 12/19/2024 evidenced, a Hepatitis B Surface Antigen and a Hepatitis B Surface Antibody drawn prior to admission on 12/03/2024. The record failed to complete a Hepatitis B core antibody prior to admission. 3. During an interview on 02/24/2025 at 3:21 PM, RN 7 indicated a Hepatitis B core antibody test prior to admission is not required and was not drawn until the day of admission. 4. During an interview on 02/24/2025 at 3:22 PM, the Clinic Manager indicated being unaware of the requirement that a Hepatitis B core antibody was required prior to admission. 5. During an interview on 02/26/2025 at 8:50 AM, RN 4 indicated a Hepatitis B antibody, Hepatitis B antigen, and Hepatitis B core status is to be known prior to starting treatment on all new admissions.”

“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: 51751 Based on observation, record review, and interview the facility failed to maintain aseptic techniques for the care of the vascular access for 2 of 2 CVC initiations observed. (Patient #7, 11) Findings Include: 1. A policy titled, “Changing the Catheter Dressing Procedure” dated 02/05/2024 Version 8, indicated but was not limited to, “Removal of dressing and inspection of site ... 1. Place an underpad under catheter limbs to protect work area and clothing ... Cleaning the Site ... 2. 2% Chlorhexidine and 70% alcohol: Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward the area of the size of the dressing to be applied (2 inches) in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds”. 2. A policy titled, “Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer” dated 05/06/2024 Version 8 indicated but was not limited to, “Prior to Initiation ... 2. Place an underpad under the access limbs to protect the work area and the patient ’ s clothing ... Preparing the Catheter ... 2. Remove the cap from clamped arterial limb ... 3. Using a sterile alcohol pad ... scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue ... 4. Using the same sterile alcohol pad ... applying friction to remove any blood or residue, move from the hub at least several centimeters towards the body of the catheter. (Steps 3 and 4 should take 10-15 seconds.) ...7. Repeat with venous catheter limb”. 3. During an observation on 02/20/2025 at 7:25 PM, PCT 9 initiated Patient #7’s CVC treatment. No underpad was placed under the CVC limbs. The CVC dressing was removed and discarded. PCT 9 proceeded to clean the CVC exit site using Chlorhexidine (skin disinfectant) for 10 seconds and a clean dressing was reapplied. PCT 9 failed to use an underpad and disinfect the CVC exit site with Chlorhexidine for 30 seconds. 4. During an observation on 02/20/2025 at 8:04 PM, PCT 9 initiated Patient #11’s CVC treatment. PCT 9 disinfected the CVC exit site for five seconds using Chlorhexidine. The arterial and venous caps were removed and disinfected with an alcohol pad for 5 seconds. PCT 9 failed to disinfect the CVC exit site using Chlorhexidine for 30 seconds and failed to disinfect the arterial and venous CVC lines using alcohol for 10-15 seconds. 5. During an interview on 02/20/2025 at 8:15 PM, PCT 9 indicated a clean underpad is to be placed under the CVC limbs when initiating CVC treatments. Chlorhexidine is used to disinfect the CVC exit site and should be disinfected for a total of 30 seconds and allowed to dry. She did not know the timing of the dry time, just that it needed to be dry. PCT 9 indicated she uses her watch or counts in her head to ensure the appropriate amount of time for disinfection. 6. During an interview on 02/20/2025 at 8:20 PM, RN 1 indicated she was not sure if an underpad was required when completing the initiation of treatment for a CVC. She further indicated it had been awhile since she last initiated a treatment and thought they had done away with using the under pads. A CVC exit site is disinfected with Chlorhexidine for 30 seconds. RN 1 indicated being overall responsible for the nocturnal PCT’s, ensuring infection control practices and policies were followed. 7. During an interview on 02/26/2025 at 8:50 AM, RN 4 indicated that an underpad is required under a CVC when initiating treatment. Staff should disinfect the exit site with Chlorhexidine at least 30 seconds and allow to dry. After removing the arterial and venous caps and hubs are disinfecteed with an alcohol pad for at least 30 seconds. 8. During an interview on 02/26/2025 at 10:00 AM, PCT 8 indicated that an underpad is required under a CVC when initiating treatment. The old dressing is removed, and the catheter exit site is disinfected with Chlorhexidine for 30 seconds. After the arterial and venous caps are removed, the catheter hubs are disinfected with an alcohol pad for at least 15 seconds, then a saline filled syringe is attached.”

“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: 51751 Based on observation, record review, and staff interviews, the facility ’ s medical director failed to ensure staff followed all policies and procedures, including failure to follow policy regarding heparin dwell time for 2 of 2 central venous catheters (CVCs) observed (Patients #7, #11), failure to monitor and properly discard expired supplies and medications (1 of 1 facility reviewed), failure to properly store supplies as per policy (1 of 1 facility reviewed), failure to adhere to infection control protocols during 2 of 2 CVC observations and 3 of 4 fistula observations (Patients #12, #13, #15),and failure to adhere to physician orders for blood flow rates (BFR) and blood pressure (BP) monitoring for 7 of 7 in-center hemodialysis patients (Patients #1, #2, #3, #4, #5, #6, #7). Findings Include: Heparin Bolus Administration: 1. According to the ’ Heparin Bolus Administration ’ policy (Version 2, 11/01/2021), staff must allow heparin to circulate for at least 3-5 minutes before treatment to prevent clotting. 2. During an observation on 02/20/2025 at 7:25 PM, PCT 9 administered heparin into Patient # 7’s CVC and started treatment after only 1 minute and 35 seconds, instead of the required 3-5 minutes. 3. During an observation on 02/20/2025 at 8:04 PM only 2 minutes and 5 seconds, instead of the required 3-5 minutes. 4. During an interview on 02/26/2025 at 8:50 AM, RN 4 indicated that the heparin dwell time is 3-5 minutes before the treatment is initiated. 5. During an interview on 02/26/2025 at 10:00 AM, PCT 8 indicated the dwell time frame for heparin is 3-5 minutes before starting dialysis. Medication and Storage Supply A policy titled, “Storage of Supplies” (Version 2, 04/05/2021) states that supplies must be rotated First-In-First-Out (FIFO) and expired items discarded. A policy titled, “Medication Preparation and Administration” (Version 9, 02/06/2023) states that all stored medications must be monitored monthly and discarded per regulations. Observations on 02/20/2025 between 06:39 PM through 06:50 PM evidenced one Crit Line Blood Champer with an expiration date of 01/31/2025 and one Crit Line Blood Chamber with an expiration date 03/31/2024. Observation on 02/20/2025 at 06:50 PM evidenced RPC Strip EZ Blood Leak Strips with an expiration date of 10/31/2024 on the medication prep counter. Observation of the medication cabinet on 02/20/2025 at 06:50 PM evidenced ½ used bottle of Clonidine Hydrochloride[used to lower blood pressure] (0.1 mg tablets), with an expiration date of 10/2024. During an interview on 02/20/2025 at 06:14 PM the Clinic Manager stated it is the nocturnal nurses responsibility to check for and discarded and expired supplies. During an interview on 02/26/2025 at 08:50 AM RN 4 stated the Administrative Assistant performs monthly checks, and staff are responsible for verifying expiration dates before use. Infection Control 1. A policy titled, “Access Assessment and Cannulation” (Version 4, 05/06/2024) states that skin disinfection must last at least 30 seconds using alcohol pads. 2. During an observation on 02/20/2025 at 7:40 PM, PCT 9 disinfected the permanent access site for Patient #12 using an alcohol pad for 4-5 seconds prior to cannulating (inserting dialysis needles). 3. During an observation on 02/20/2025 at 7:30 PM, PCT 2 failed to clean the access site for 30 seconds and failed to allow it to fully dry before canulating patient #13. 4. During an observation on 02/20/2025 at 7:55 PM, PCT 9 disinfected the permanent access site for Patient #15 using an alcohol pad for 4-5 seconds prior to cannulating the patient. 5. During an interview on 02/20/2025 at 8:15 PM, PCT 9 indicated an alcohol pad is used to disinfect the skin prior to cannulating a fistula or graft (dialysis access) for 5-10 seconds. 6. During an interview on 02/26/2025 at 8:50 AM, RN 4 indicated that fistula and graft sites are to be disinfected with an alcohol pad for at least 30 seconds and allowed to dry before cannulating the patient. Patient Monitoring 1. A policy titled, “Patient Assessment and Monitoring” (Version 4, 05/01/2023) requires blood pressure readings every 30 minutes (not exceeding 45 minutes) and physician orders must be followed unless a documented reason is provided including prescribed blood flow rate (BFR). 2. The clinical record for Patient #1 was reviewed and evidenced the following: A treatment sheet dated 02/15/2025 indicating a BP recorded at 11:40 AM but not checked again until 12:34 PM. A treatment sheet dated 02/18/2025 indicating a BP recorded at 11:11 AM but not checked again until 12:33 PM. 3. The clinical record for Patient #2 was reviewed and evidenced the following: An 11/19/2024 treatment sheet indicating BP checks at 12:33 PM and 01:32 PM. (Missing Check) A treatment sheet dated 02/04/2025 with an ordered BFR of 400 but a 300 BFR delivered. A treatment sheet dated 02/18/2025 indicating an ordered BFR of 400 but a delivered BFR fluctuating between 300-375. 4. The clinical record for Patient #3 was reviewed and evidenced the following: A treatment sheet dated 11/19/2024 indicating a BP recorded at 11:21 AM (189/170), and post-treatment BP at 11:38 AM (172/134) that were not reported to RN. A treatment sheet dated 12/19/2024 with an ordered BFR: 450, but patient received 400 BFR (undocumented deviation). A treatment sheet dated 12/21/2024 with an ordered BFR: 450, but patient received 300 BFR. During an interview on 02/25/2025 at 03:40 PM RN 7 stated that manual documentation is only used if the system is down, but could not provide evidence supporting this for Patient #3. 5. The clinical record for Patient #4 was reviewed and evidenced the following: An 02/20/2024 treatment sheet indicating BP checks at 11:03 AM and 012:32 PM. (Missing Check) 6. The clinical record for Patient #5 was reviewed and evidenced the following: A 02/11/2025 treatment sheet indicating a BP recorded at 12:02 PM, not checked again until 1:04 PM. A 02/18/2025 treatment sheet – Pre-dialysis vitals recorded at 11:16 AM, but BP not checked again until 12:39 PM. 7. The clinical record for Patient #6 was reviewed and evidenced the following: A 02/10/2025 treatment sheet indicating BP readings ranged from 186/113 to 178/125, abnormal readings were not reported to RN. A 02/12/2025 treatment sheet indicating BP readings ranged from 210/75 to 235/114, not reported to RN. A 02/19/2025 treatment sheet indicating BP readings ranged from 218/109 to 212/89, not reported to RN. A 02/17/2025 treatment sheet indicating BP recorded at 2:31 PM, not checked again until 3:31 PM. A 02/19/2025 treatment sheet indicating BP recorded at 2:03 PM, not checked again until 3:00 PM. 8. The clinical record for Patient #7 was reviewed and evidenced the following: A treatment sheet dated 02/11/2025 with BP checks at 08:11 PM and 9:04 PM and between 12:02 AM and 01:01 AM. A treatment sheet dated 02/16/2024 indicating BP checks at 10:02 PM and the next BP check at 11:02 PM (Missing Check) 9. During an interview on 02/26/2025 at 08:50 AM RN 4 indicated BP checks must be every 30 minutes, or 15 minutes if abnormal. 10. During an interview on 02/26/2025 at 10:00 AM, PCT 8 stated monitoring starts when the patients enter and continues until they leave.”