Gateway St Louis Dialysis, LLC

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 36473 Based on record reviews and interviews the facility failed to develop and implement a process to ensure the interdisciplinary team (IDT, patient, attending physician, registered nurse, social worker and dietician) members gathered and interacted to share information from the comprehensive assessment to facilitate the development of a plan of care for seven (#9, #11, #19, #24, #28, #29 and #31) out of seven patient care plans reviewed (V542) and the facility failed to ensure a qualified social worker completed a standardized mental and physical (KDQOL-36) at regular intervals or as needed on patients and use the results to develop patient psychosocial goals for all patients that presented to the facility (V552). The cumulative effects of these systemic failures resulted in the facility’s inability to ensure all patients had completed care plans and KDQOL-36s and potentially effect healthcare goals and outcomes.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 36473 Based on observation, interview and record review, the facility’s Governing Body failed to ensure the facility consistently provided the services of a dietician and master’s degree social worker to meet with the patients in-person to address their ongoing needs and perform the essential functions of the jobs. (V758) The cumulative effects of these systemic failures resulted in the facility’s inability to ensure all patients had qualified staff to be available for patient’s ongoing needs. These failures potentially effected the patient’s healthcare goals and outcomes.”

“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: 18018 Based on observation, policy review, and interview, the facility failed to ensure staff: - Performed hand hygiene (washing hands with soap and water or use of appropriate hand sanitizer) when indicated when staff provided care and treatments to patients. - Wore gloves when indicated and performed hand hygiene after glove removal and before re-gloving after removal. - Removed gloves, performed hand hygiene, and re-gloved after staff removed and discarded the old dressing on patients’ Central Venous Catheter (CVC, a line placed in a large vein used to deliver dialysis treatments) exit site prior to cleansing the CVC exit site and applying a sterile dressing for four (#12, #13, #14 and #15) out of six observations conducted of staff providing CVC exit site care. - Removed gloves, performed hand hygiene, and re-gloved after completing CVC exit site dressing change and before initiating dialysis for three (#13, #14 and #15) out of four observations conducted of staff initiating dialysis per patients’ CVC. - Repeated the cleansing process of patients’ access sites before cannulation (insertion of a needle into the blood vessels to enable blood to be circulated between the patient and dialysis machine during dialysis treatment) when staff touched the area after the area was cleansed/disinfected for two (#8 and #22) out of five observations conducted of staff cannulating patients’ access sites. These failures to ensure staff practiced appropriate infection control prevention had the potential for cross-contamination and the spread of infections to both patients and staff. The In-Center Hemodialysis (Hemodialysis, a machine used to filter wastes, fluids, and salts from blood when the kidneys are no longer able to perform the filtering process) census was 56 and the Home Peritoneal Dialysis (Peritoneal Dialysis, a treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) census was seven for a total census of 63. Findings included: HAND HYGIENE - GLOVE USE 1. Observation on 12/18/24 at 10:45 AM, showed Staff C, Certified Clinical Hemodialysis Technician (CCHT), changed gloves, however, Staff C failed to perform hand hygiene after glove removal or before re-gloving. Observations on 12/18/24, showed Staff H, CCHT: -At 12:45 PM, turned off the dialysis machine alarm at patient Station #6 with a glove wrapped around staff’s finger. Staff H failed to place the glove on the hand before turning off the alarm. -At 1:00 PM, turned off the dialysis machine alarm at patient Station #6 without gloves. Observation on 12/19/24 at approximately 10:30 AM, showed Staff F, Registered Nurse (RN), removed the used bloodlines and dialyzer from patient Station #15 and discarded the used items. After Staff F discarded the used items, wearing the same gloves, Staff F began to cleanse/disinfect the patient Station. Staff F failed to remove gloves, perform hand hygiene and re-glove after disposing the used items and before cleaning/disinfecting the patient Station. Observation on 12/19/24 at 1:21 PM, showed Staff C, CCHT, changed gloves and re-gloved without performing hand hygiene after glove removal or before re-gloving. Observation on 12/19/24 at 2:20 PM, showed Staff F, RN, failed to perform hand hygiene before gloving. Observation on 12/19/24 at 2:25 PM, showed Staff G, CCHT, failed to perform hand hygiene before gloving. CVC EXIT SITE CARE 2. Observation on 12/18/24 at 10:45 AM, showed Staff C, CCHT, prepared Patient #12 for a CVC exit site dressing change. Staff C removed the old dressing and placed it on the gauze wrapper located on the dialysis chair side tray. After Staff C removed the old dressing, Staff C failed to remove gloves, perform hand hygiene and re-glove. Wearing the same gloves worn to remove the old dressing, Staff C cleansed the patient’s CVC exit site and applied a sterile dressing. Observation on 12/19/24 at 9:10 AM, showed Staff C, CCHT, prepared Patient #14 for a CVC exit site dressing change. Staff C removed the old dressing and placed it on the gauze wrapper located on the dialysis chair side tray. After Staff C removed the old dressing, Staff C failed to remove gloves, perform hand hygiene and re-glove. Wearing the same gloves worn to remove the old dressing, Staff C cleansed the patient’s CVC exit site and applied a sterile dressing. Observation on 12/19/24 at 9:40 AM, showed Staff F, RN, prepared Patient #13 for a CVC exit site dressing change. Staff F removed and discarded the old CVC dressing, removed gloves, however, Staff F failed to perform hand hygiene after removal of gloves or before re-gloving to cleanse the patient’s CVC exit site and applying a sterile dressing. Observation on 12/19/24 at approximately 10:30 AM, showed Staff C, CCHT, prepared Patient #15 for a CVC exit site dressing change. Staff C removed the old dressing and placed it on the gauze wrapper located on the dialysis chair side tray. After Staff C removed the old dressing, Staff C failed to remove gloves, perform hand hygiene and re-glove. Wearing the same gloves worn to remove the old dressing, Staff C cleansed the patient’s CVC exit site and applied a sterile dressing. 3. Observation on 12/19/24 at 9:12 AM, showed Staff C, CCHT, failed to remove gloves, perform hand hygiene and re-glove after completion of a CVC exit site dressing change for Patient #14. Wearing the same gloves worn during the dressing change, Staff C started the process to initiate dialysis treatment per the patient’s CVC by: -Closing the catheter clamps; -Disinfecting the CVC hubs; -Connecting sterile syringes aseptically to each port; -Removing indwelling solutions; -Flushing the ports; and -Initiating dialysis treatment. Observation on 12/19/24 at 9:45 AM, showed Staff F, RN, failed to remove gloves, perform hand hygiene and re-glove after completion of a CVC exit site dressing change for Patient #13. Wearing the same gloves worn during the dressing change, Staff F started the process to initiate dialysis treatment per the patient’s CVC by: -Closing the catheter clamps; -Disinfecting the CVC hubs; -Connecting sterile syringes aseptically to each port; -Removing indwelling solutions; -Flushing the ports; and -Initiating dialysis treatment. Observation on 12/19/24 at 10:51 AM, showed Staff C, CCHT, failed to remove gloves, perform hand hygiene and re-glove after completion of a CVC exit site dressing change for Patient #15. Wearing the same gloves worn during the dressing change, Staff C started the process to initiate dialysis treatment per the patient’s CVC by: -Closing the catheter clamps; -Disinfecting the CVC hubs; -Connecting sterile syringes aseptically to each port; -Removing indwelling solutions; -Flushing the ports; and -Initiating dialysis treatment. AVF - AVG ACCESS CARE AND CANNULATION 4. Observation on 12/18/24 at 9:16 AM, showed Staff H, CCHT, prepared Patient #3 for cannulation of the patient’s Arteriovenous Fistula (AVF, a permanent access that is surgically created by sewing an artery to a vein, usually located in the arm) access sites. After Staff H assessed and palpated the patient’s access sites, Staff H failed to remove gloves, perform hand hygiene and re-glove before Staff H applied antiseptic to the patient’s skin for cannulation. Observation on 12/18/24 at 9:52 AM, showed Staff D, CCHT, prepared Patient #21 for cannulation of the patient’s AVF access sites. After Staff D assessed and palpated the patient’s access sites, Staff D removed gloves and re-gloved without performing hand hygiene before re-gloving and applying antiseptic to the patient’s skin for cannulation. Observation on 12/18/24 at 10:00 AM, showed Staff I, CCHT, prepared Patient #18 for cannulation of the patient’s Arteriovenous Graft (AVG, a permanent access made by connecting an artery and a vein using synthetic material) access sites. After Staff I assessed and palpated the patient’s access sites, Staff I removed gloves and re-gloved without performing hand hygiene before re-gloving and applying antiseptic to the patient’s skin for cannulation. Observation on 12/19/24 at 11:20 AM, showed Staff E, CCHT, prepared Patient #22 for cannulation of the patient’s AVF access sites. After Staff E assessed and palpated the patient’s access sites, Staff E failed to remove gloves, perform hand hygiene and re-glove before Staff E applied antiseptic to the patient’s skin for cannulation. Observation on 12/19/24 at 10:23 AM, showed Staff E, CCHT, cannulated Patient #8’s AVF access sites for dialysis treatment. Staff E touched the top access site, however, Staff E failed to repeat the skin antisepsis process before Staff F cannulated the patient’s top access site. Observation on 12/19/24 at 11:20 AM, showed Staff E, CCHT, cannulated Patient #22’s AVF access sites for dialysis treatment. Staff E touched both bottom and top access sites, however, Staff E failed to repeat the skin antisepsis process before Staff E cannulated the patient’s access sites. Observation on 12/18/24 at 12:51 PM, showed Staff I, CCHT, failed to remove gloves, perform hand hygiene and re-glove at the completion of holding gauze to Patient #2’s access sites after removal of the needles. After hemostasis (when bleeding has stopped) was achieved of the patient’s access sites, Staff I failed to remove gloves, perform hand hygiene and re-glove before replacing the soiled gauze on the access sites. Observation on 12/19/24 at 10:09 AM, showed Staff C, CCHT, failed to remove gloves, perform hand hygiene and re-glove at the completion of holding gauze to Patient #19’s access sites after removal of the needles. After hemostasis was achieved of the patient’s access sites, Staff C failed to remove gloves, perform hand hygiene and re-glove before replacing the soiled gauze on the access sites. Observation on 12/19/24 at 2:08 PM, showed Staff F, RN, failed to perform hand hygiene before gloving to replace the soiled gauze on Patient #8’s access sites. 5. Review of the facility’s policy titled, “G40 Infection Control,” dated 11/29/2022, showed staff directives: - Gloves are required whenever caring for a patient or touching the patient’s equipment or supplies. - Wrapping items such as gauze, gloves, or gowns around the finger to touch contaminated items is prohibited. - Hands are always washed after gloves are removed and between patient contact, as well as after touching blood, body fluids, secretions, excretions, and contaminated items. - Aseptic (process that is free from germs or bacteria) technique will be used to prepare the access site prior to needle insertion and to clean the CVC exit site. 6. During an interview on 12/20/24 at 1:21 PM, Staff A, RN, Clinical Manager/Facility Manager, stated the expectation of staff was to: - Perform hand hygiene before gloving, after glove removal and before re-gloving. - Wear gloves when touching patients’ dialysis machine and not wrap a glove around staff’s hand. - Remove gloves after staff removed and discarded the old dressing from the CVC exit site, perform hand hygiene, re-glove and clean the CVC exit site and apply a new dressing. - At the completion of the CVC exit site dressing change, staff should remove gloves, perform hand hygiene, and re-glove before staff start the process to initiate dialysis treatment per patients’ CVC. - Before staff cannulated a patient’s access site, staff needed to assess and palpate the access sites and if staff wore gloves to palpate the access sites, staff was expected to remove gloves, perform hand hygiene and re-glove. - If staff touched a patient’s access sites after being cleaned/disinfected, staff was expected to repeat the cleaning/disinfection process before staff cannulated the access sites. - If staff touch a patient’s access site and failed to repeat the cleansing/disinfection process increased the risk of contamination to the access sites. - After staff completed holding patients’ access sites when hemostasis was achieved, staff should remove gloves, perform hand hygiene and re-glove to replace the soiled gauze. - Follow the facility’s policy and procedure related to infection control prevention.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 18018 Based on observation, policy review, and interview, the facility failed to ensure staff appropriately disposed of bio-hazardous waste (blood and/or body fluids) for 15 out of 15 observations conducted of staff disposing bio-hazardous waste materials/items (used bloodlines and dialyzer) after patients’ dialysis treatments. This failed practice had the potential for increased exposure to blood and/or body fluids to both patients and staff. The In-Center Hemodialysis census was 56 and the Home Peritoneal Dialysis census was seven for a total census of 63. Findings included: 1. Observation on 12/18/24 at 10:30 AM showed Staff C, Certified Clinical Hemodialysis Technician (CCHT), carried used bloodlines/dialyzer without being contained in a fluid resistant red bio-hazardous waste bag from patient Station #12 to the large red bio-hazardous cart located next to the dirty sink. 2. Observation on 12/18/24 at 10:35 AM, showed Staff D, CCHT, carried used bloodlines/dialyzer without being contained in a fluid resistant red bio-hazardous waste bag from patient Station #3 to the large red bio-hazardous cart located next to the dirty sink. 3. Observation on 12/18/24 at 1:24 PM, showed Staff H, CCHT, carried used bloodlines/dialyzer without being contained in a fluid resistant red bio-hazardous waste bag from patient Station #8 to the large red bio-hazardous cart located next to the dirty sink. 4. Observation on 12/18/24 at 1:35 PM, showed Staff G, CCHT, carried used bloodlines/dialyzer without being contained in a fluid resistant red bio-hazardous waste bag from patient Station #2 to the large red bio-hazardous cart located at the end of the hand washing sink. 5. Observation on 12/18/24 at 1:58 PM, showed Staff H, CCHT, carried used bloodlines/dialyzer without being contained in a fluid resistant red bio-hazardous waste bag from patient Station #6 to the large red bio-hazardous cart located next to the dirty sink. 6. Observation on 12/18/24 at 2:15 PM, showed Staff I, CCHT, removed used bloodlines/dialyzer from patient Station #17 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located next to the dirty sink. 7. Observation on 12/18/24 at 2:20 PM, showed Staff G, CCHT, removed used bloodlines/dialyzer from patient Station #3 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located next to the dirty sink. 8. Observations on 12/18/24 showed Staff C, CCHT: - At 2:30 PM, removed used bloodlines/dialyzer from patient Station #10 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located next to the dirty sink. -At 2:35 PM, removed used bloodlines/dialyzer from patient Station #12 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located next to the dirty sink. 9. Observation on 12/18/24 at 2:41 PM, showed Staff G, CCHT, removed used bloodlines/dialyzer from patient Station #15 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located next to the dirty sink. 10. Observation on 12/19/24 at 10:19 AM, showed Staff C, CCHT, removed used bloodlines/dialyzer from patient Station #1 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located next to the dirty sink. 11. Observation on 12/19/24 at 1:25 PM, showed Staff C, CCHT, removed used bloodlines/dialyzer from patient Station #14 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located next to the dirty sink. 12. Observation on 12/19/24 at 2:04 PM, showed Staff E, CCHT, removed used bloodlines/dialyzer from patient Station #8 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located next to the dirty sink. 13. Observation on 12/20/24 at 9:00 AM, showed Staff G, CCHT, removed used bloodlines/dialyzer from patient Station #16 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located next to the dirty sink. 14. Observation on 12/20/24 at 9:22 AM, showed Staff C, CCHT, removed used bloodlines/dialyzer from patient Station #10 and carried the used bio-hazardous items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located next to the dirty sink. 15. Review of the facility’s policy titled, “RM100 Bloodborne Exposure Control Plan,” dated 12/22/2023, showed staff directives: - All procedures involving blood or other potentially infectious materials will be performed in such a manner as to minimize splashing, spattering, and generating droplets of these substances. - During collection, handling, processing, storage, transport, or shipping, specimens of blood or other potentially infectious materials will be placed in containers that prevent leakage. 16. During an interview on 12/20/24 at 1:21 PM, Staff A, Registered Nurse, Clinical Manager/Facility Manager, stated expectation of staff was to dispose of used bloodlines and dialyzers in the large red bio-hazardous carts located throughout the treatment floor. Staff A stated going forward the expectation of staff will be for staff to bring the large red bio-hazardous cart to the patient Station, remove the bloodlines and dialyzer and dispose of the items in the large red bio-hazardous cart brought to the patient Station. Staff A stated going forward staff should not carry uncontained used bio-hazardous items from patient Stations to the location of the large red bio-hazardous carts to prevent splashing and spattering of the uncontained used bio-hazardous items removed after a patient’s dialysis treatment.”

“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: 18018 Based on observation, policy review, and interview the facility failed to ensure staff consistently thoroughly, and properly cleaned/disinfected patient Stations at the end of a patient’s dialysis treatment and prior to the initiation of the next patient’s dialysis treatment and only cleaned/disinfected the patient Stations after the patient had vacated with their belongings for nine out of nine observations conducted of staff performing Station disinfection. These failures to properly clean external surfaces that are frequently touched by patients and to ensure the patient vacated the patient Station prior to the cleaning/disinfection process increased the potential for cross-contamination that could cause infection risks to all patients and staff. The In-Center Hemodialysis census was 56 and the Home Peritoneal Dialysis census was seven for a total census of 63. Findings included: 1. Observation on 12/18/24 at 1:15 PM, showed Staff I, Certified Clinical Hemodialysis Technician (CCHT), failed to clean/disinfect the following items at a patient Station: - The back of the dialysis machine; - The supply/wall box and the chase wall; - The plastic bag that contained a stethoscope located on the Intravenous (IV, in a vein) pole hook; - The television (TV), TV arm; and - The outside surface of the red sharps container. Observation on 12/18/24 at 1:38 PM, showed Staff H, CCHT, failed to clean/disinfect the following items at patient Station #8: - The dialysis machine’s supply lines and cords; - The back of the dialysis machine; - The supply/wall box and chase wall; - The plastic bag that contained a stethoscope located on the IV pole hook; - Failed to clean the crevices of the dropped side trays on the dialysis chair; - The TV arm; - The IV pole and hooks; and - The outside surface of the red sharps container. Observation on 12/18/24 at 2:00 PM, showed Staff C, CCHT, failed to clean/disinfect the following items at patient Station #13: - Only clean/disinfect the patient Station after the patient had completely left the patient Station with their belongings; - The back of the dialysis machine; - The prime bucket’s interior and exterior surfaces; - The supply/wall box and chase wall; - The plastic bag that contained a stethoscope located on the IV pole hook; - Failed to clean the crevices of the dropped side trays on the dialysis chair; - The IV pole and hooks; and - The outside surface of the red sharps container. Observation on 12/18/24 at 2:53 PM, showed Staff G, CCHT, failed to clean/disinfect the following items at patient Station #4: - The dialysis machine’s supply lines and cords; - The supply/wall box and chase wall; - The plastic bag that contained a stethoscope located on the IV pole hook; - Failed to clean the crevices of the dropped side trays on the dialysis chair; - The TV arm; - The IV pole and hooks; and - The outside surface of the red sharps container. Observation on 12/19/24 at approximately 10:00 AM, showed Staff E, CCHT, failed to clean/disinfect the following items at patient Station #9: - The dialysis machine’s supply lines and cords; - The dialysis machine’s base and back; - The chase wall; - The plastic bag that contained a stethoscope located on the IV pole hooks; - Failed to clean the crevices of the dropped side trays on the dialysis chair; - The blood pressure cuff; - The TV, TV remote and TV arm; - The IV hooks; and - The outside surface of the red sharps container. Observation on 12/19/24 at approximately 10:30 AM, showed Staff F, Registered Nurse (RN) failed to clean/disinfect the following items at patient Station #15: - The dialysis machine’s supply lines and cords; - The dialysis machine’s base and back; - The prime bucket’s interior and exterior surfaces; - The supply /wall box and chase wall; - The plastic bag that contained a stethoscope located on the IV pole hook; - Place the dialysis chair in the reclined position prior to the cleaning/disinfection process; - Failed to drop the dialysis chair’s side trays and clean all areas/surfaces/crevices of the side trays; - The TV, TV remote and TV arm; - The IV pole and hooks; and - The outside surface of the red sharps container. Observation on 12/19/24 at 2:23 PM, showed Staff E, CCHT, failed to clean/disinfect the following items at patient Station #8: - The dialysis machine’s back; - The plastic bag that contained a stethoscope located on the IV pole hook; - The blood pressure cuff; - The TV arm; - The IV hooks; and - The outside surface of the red sharps container. Observation on 12/20/24 at 9:23 AM, showed Staff C, CCHT, failed to clean/disinfect the following items at patient Station #10: - The dialysis machine’s supply lines and cords; - The dialysis machine’s back; - The prime bucket’s interior and exterior surfaces; - The supply/wall box and chase wall; - The plastic bag that contained a stethoscope located on the IV pole hook; - Failed to clean the crevices of the dropped side trays on the dialysis chair; - The blood pressure cuff and cord; - The TV arm; - The IV pole and hooks; and - The outside surface of the red sharps container. Observation on 12/20/24 at 9:30 AM, showed Staff G, CCHT, failed to clean/disinfect the following items at patient Station #16: - The supply/wall box; - The plastic bag that contained a stethoscope located on the TV pole hook; - Failed to drop the dialysis chair’s side trays and clean all areas/surfaces/crevices of the side trays; - The IV pole and hooks; and - The outside of the red sharps container. 2. Review of the facility’s policy titled, “G45 Cleaning & Disinfection of Equipment, Supplies & Treatment Area,” dated 06/20/24, showed staff directives: - All routinely reusable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment. Caregivers will ensure that cracks/crevices come in contact with the bleach solution. This includes, but is not limited to the: - dialysis machine - chair, including the top and bottom of the chair-side table(s) - bedside table - television, phone - counters and wall boxes - Containers used to discard saline prime dialyzers will be disinfected after each treatment and when visibly contaminated with blood. The external and internal surfaces of the container will be wiped with a disposable cloth soaked with the bleach/water mixture used to disinfect the rest of the machine. The cloth is discarded after use. 3. During an interview on 12/20/24 at 1:21 PM, Staff A, Registered Nurse, Clinical Manager/Facility Manager stated expectation of staff was to clean/disinfect all surfaces of the patient Station that included all surfaces of the dialysis machine, all surfaces and crevices of the dialysis chair, supply/wall box, chase wall, TV, TV arm, prime bucket’s interior/exterior surfaces and the outside of the red sharps container. Staff A stated staff was expected to follow the facility’s policy and procedure related to cleaning and disinfection of surfaces throughout the dialysis facility.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 36473 Based on interview, record review and policy review, the facility failed to ensure the interdisciplinary team (IDT, patient, attending physician, registered nurse, social worker and dietician) members gathered and interacted to share information from the comprehensive assessment to facilitate the development of a plan of care for seven (#9, #11, #19, #24, #28, #29 and #31) out of seven patient care plans reviewed. These failures had the potential to inhibit the integrated development of care plans for all patients seeking care at the facility. The In-Center Hemodialysis census was 56 and the Home Peritoneal Dialysis census was seven for a total census of 63. Findings included: 1. During an interview on 12/20/24 at 10:00 AM, Staff A, Registered Nurse, Clinic Manager/Facility Manager, stated they expected staff to be current on patient care plans. 2. Review of Patient #9’s incomplete annual care plan documented on 08/14/23 (four months and six days late) showed the patient was stable with no patient signature. Review of Patient #11’s incomplete annual care plan was documented on 07/23/24 without a social worker’s evaluation and signature and without the patient’s signature. Review of Patient #19’s incomplete annual care plan showed the patient was stable with the last care plan documented on 09/01/23 (three months and 19 days late) with no patient signature. Review of Patient #24’s incomplete annual care plan showed the patient was stable with the last care plan documented on 03/27/23 (eight months and seven days late) with no patient signature. Review of Patient #28’s first date of treatment at the facility was on 07/17/23 with the 90-day incomplete care plan documented on 11/07/23 (21 days late for 90-day and 44 days late for an annual) that showed the patient was stable and had no patient signature. Review of Patient #29’s incomplete annual care plan documented on 05/13/24 without a social worker’s evaluation and signature and no patient signature. Review of Patient #31’s incomplete annual care plan showed the patient was stable with the last care plan documented on 10/06/23 (two months and 14 days late) with no patient signature. 3. Review of the facility’s policy titled, “G35 Comprehensive Patient Assessments,” last reviewed on 03/28/23, showed the facility’s interdisciplinary team consisted of the patient or patient’s representative, Registered Nurse (RN), Nephrologist, Social Worker and Dietician with 90-day assessments for new patients, annual for stable patients and monthly for unstable patients.”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 36473 Based on interview and policy review the facility failed to ensure a qualified social worker completed a standardized mental and physical assessment (KDQOL-36) at regular intervals or as needed on patients and use the results to develop patient psychosocial goals for all patients that presented to the facility. These failures had the potential to have a detrimental affect on all patients. The In-Center Hemodialysis census was 56 and the Home Peritoneal Dialysis census was seven for a total census of 63. Findings included: 1. During an interview on 12/20/24 at 10:00 AM, Staff A, Registered Nurse, Clinical Manager/Facility Manager, stated they had not had an in-person social worker since 05/23/24 and no KDQOL-36 assessment surveys were current per policy. 2.Review of the facilities policy titled, “G35 Comprehensive Patient Assessments,” last reviewed on 03/08/23, showed the direction for social workers to perform the KDQOL-36 survey within four months for new patients and then annually.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 36473 Based on interview, observation, record review and policy review, the facility failed to have an effective system in place to identify failures to administer medications per physician orders for three in-center hemodialysis patients (#28, #30 and #31) out of three that had heparin infusion orders. The facility also failed to ensure staff observed patients take medications when administered and ensure medications were not left unattended on the patients’ dialysis chair side trays for nine ( #3, #4 #5, #6, #7, #8, #9, #10 and #11) patients per observations, policy review, and an interview conducted with staff. These failures had the potential to affect all patients who were to receive medications used to improve their health to include the prevention of blood clots. The In-Center Hemodialysis census was 56 and the Home Peritoneal Dialysis census was seven for a total census of 63. Findings included: HEPARIN ADMINISTRATION 1. During an interview on 12/20/24 at 10:00 AM, Staff A, Registered Nurse (RN), Clinical Manager/Facility Manager (CM/FM), stated they expected staff to follow physician orders and be accurate on heparin infusions. 2. Review of Patient #28’s medication orders for 11/16/24, 11/19/24, 11/23/24, 11/30/24, 12/03/24 and 12/05/24 showed a heparin infusion ordered dose was 1000 units every 2 hours for 3.45 hours. The following errors were identified: - 11/16/24, No infusion given during treatment with no documented reason. - 11/19/24, heparin infusion given was 3900 units (2175 units over) with no documented reason. - 11/23/24, heparin infusion given was 3400 units (1675 units over) with no documented reason. - 11/30/24, heparin infusion given was 3600 units (1875 units over) with no documented reason. - 12/03/24, heparin infusion given was 3000 units (1275 units over) with no documented reason. - 12/05/24, No infusion given during treatment with no documented reason. Review of Patient #30’s medication orders for 12/05/24 and 12/06/24 showed a heparin infusion ordered dose was 0.5 milliliters (ml, unit of measurement) per hour for 3.5 hours totaling 1.7 ml. On 12/05/24 staff administered 1.3 ml (.4 ml short) and on 12/06/24 staff administered 2.5 ml (.8 ml over) with no documented reasons. Review of Patient #31’s medication orders for 12/06/24 and 12/11/24 showed a heparin infusion ordered dose was 2000 units per hour for four hours totaling 8000 units. On 12/06/24 staff administered 3000 units (5000 units short) and on 12/11/24 staff administered 7300 units (700 units short) with no documented reason. 3. Review of the facility’s policy titled, “IC07 Patient Assessment: Pre & Post Dialysis,” last reviewed on 06/20/24, showed the direction for Registered Nurses (RNs) to assess medications to include changes or new prescriptions since the patient’s last dialysis treatment. MEDICATIONS LEFT UNATTENDED ON DIALYSIS CHAIR SIDE TRAYS 4. Observation on 12/18/24 from 12:14 PM to 12:49 PM, showed a plastic medication cup located on the dialysis chair side tray that contained four green-colored pills and two orange-colored pills for a total of six pills. Staff failed to ensure Patient #3 took the six pills at the time staff administered the medications. Observation on 12/18/24 from 12:18 PM to 12:50 PM, showed a plastic medication cup located on the dialysis chair side tray that contained three green-colored pills. Staff failed to ensure Patient #4 took the three pills at the time staff administered the medications. Observation on 12/18/24 from 12:19 PM to 2:30 PM, showed a plastic medication cup located on the dialysis chair side tray that contained one orange-colored pill. Staff failed to ensure Patient #5 took the pill at the time staff administered the medication. Patient #5’s dialysis treatment ended and the orange-colored pill remained in the medication cup located on the side tray. Patient #5 informed staff that they would take the medication when they returned back home. Patient #5 left the dialysis facility at 2:45 PM with the medication cup with the orange-colored pill inside. Observation on 12/19/24 from 8:55 AM to 9:55 AM, showed a plastic medication cup located on the dialysis chair side tray that contained one orange-colored pill. Staff failed to ensure Patient #6 took the pill at the time staff administered the medication. Patient #6 took the pill at 9:35 AM before leaving the facility at the end of their treatment. Observation on 12/19/24 from 8:55 AM to 9:30 AM, showed a plastic medication cup located on the dialysis chair side tray that contained five green-colored pills and five orange-colored pills for a total of 10 pills. Staff failed to ensure Patient #7 took the pills at the time staff administered the medications. Observation on 12/19/24 from 1:19 PM to 2:15 PM, showed a plastic medication cup located on the dialysis chair side tray that contained three green-colored pills and two orange-colored pills for a total of five pills. Staff failed to ensure Patient #8 took the five pills at the time staff administered the medications. Observation on 12/20/24 at 9:19 AM, showed a plastic medication cup located on the dialysis chair side tray that contained two green-colored pills and three orange-colored pills for a total of five pills. Staff failed to ensure Patient #9 took the five pills at the time staff administered the medications. Observation on 12/20/24 at 9:20 AM, showed a plastic medication cup located on the dialysis chair side tray that contained four green-colored pills and two orange-colored pills for a total of six pills. Staff failed to ensure Patient #10 took the six pills at the time staff administered the medications. Observation on 12/20/24 at 9:38 AM, showed a plastic medication cup located on the dialysis chair side tray that contained two green-colored pills and two orange-colored pills for a total of four pills. Staff failed to ensure Patient #11 took the four pills at the time staff administered the medications. 5. Review of the facility’s policy titled, “G48 Medications: Handling, Administration, Storage & Disposal,” dated 06/2023, showed staff directive: Medications must never be left unsecured or unattended. 6. During an interview on 12/20/24 at 1:21 PM, Staff A, RN, CM/FM, stated the expectation of staff administering medication to patients was to stay with the patient until they took the medication and staff was never to leave medication(s) unattended. Staff A stated staff was expected to follow the facility’s policy and procedure related to administration of medications. 18018”

“PQ-SW-MSW;GRANDFATHER IF HIRED BEFORE 1976 CFR(s): 494.140(d) The facility must have a social worker who- (1) Holds a master’s degree in social work with a specialization in clinical practice from a school of social work accredited by the Council on Social Work Education; or (2) Has served at least 2 years as a social worker, 1 year of which was in a dialysis unit or transplantation program prior to September 1, 1976, and has established a consultative relationship with a social worker who qualifies under §494.140 (d)(1). This Standard is not met as evidenced by: 36473 Based on interview and policy review, the facility failed to ensure they provided a qualified social worker with a master’s degree in social work with required state licensure. This failure had the potential to negatively affect all patient evaluations and the continued care in a safe and secure environment. The In-Center Hemodialysis census was 56 and the Home Peritoneal Dialysis census was seven for a total census of 63. Findings included: 1. During an interview on 12/20/24 at 10:00 AM, Staff A, Registered Nurse, Clinical Manager/Facility Manager, stated the last time a licensed social worker was employed at the facility was 05/23/24. During an interview on 12/20/24 at 10:45 AM, Staff K, Medical Director, stated they were aware they had no master’s degree social worker. 2. Review of the facility’s policy titled, “G06 Staffing: Medical & Clinical,” last reviewed on 09/01/23, showed the direction for the facility to have a social worker who held a master’s degree in social work and was a licensed clinical social worker.”

“GOV-RN, MSW, & RD AVAIL TO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- The registered nurse, social worker and dietitian members of the interdisciplinary team are available to meet patient clinical needs; This Standard is not met as evidenced by: 18018 36473 Based on interview and job description review, the facility failed to ensure a dietician and master’s degree social worker were available to meet with the patients in-person to address their ongoing needs and perform the essential function of the jobs. These failures had the potential to negatively affect all patient evaluations and the continued care in a safe and secure environment. The In-Center Hemodialysis census was 56 and the Home Peritoneal Dialysis census was seven for a total census of 63. Findings included: 1. During an interview on 12/10/24 at 10:00 AM, Staff A, Registered Nurse, Clinical Manager/Facility Manager, stated the last time a social worker performed in-person patient assessments was on 05/23/24 and the last time a dietician performed in-person patient assessments was in 03/2024. During an interview on 12/18/24 at 2:00 PM, Staff M, Dietician, stated the last time they were at the facility in-person was 03/2024 and the company failed to provide coverage. The dietician performed her duties remotely. During an interview on 12/18/24 at 3:00 PM, Staff L, Licensed Social Worker, stated they just received their current state licensure and had not been at the facility in-person since 05/23/24. The company failed to provide coverage. During interviews conducted on 12/18/24, 12/19/24 and 12/20/24, with current In-Center Hemodialysis patients, nine out of 12 patients stated they had not seen a Social Service Worker (SSW) and some patients questioned if the facility had a current SSW on staff. During interviews conducted on 12/18/24, 12/19/24 and 12/20/24, with current In-Center Hemodialysis patients, seven out 12 patients stated they had not seen a dietician and some patients questioned if the facility had a current dietician on staff. 2. Review of the facility’s social work job description, dated 07/2024, showed one of the requirements of the social worker was they must be able to exchange accurate information in-person. 3. Review of the facility’s dietician job description, dated 07/2024, showed one of the requirements of the dietician was they must be able to exchange accurate information in-person.”