Fmc Dialysis Services of Raytown

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 18018 Based on review of the facility’s Mortality Analysis, Adverse Events Report, policy review, and interview, the facility failed to ensure the facility’s Quality Assessment and Performance Improvement (QAPI) Program: - Evaluated and investigated the facility’s Mortality Analysis reports to identify if patients’ cause of death was related to treatments, cares, and services provided by the dialysis facility. - Evaluated and investigated the facility’s Adverse Events Report to identify high risk and problem prone areas that impact patient health and safety related to treatments, cares, and services provided to dialysis patients. - Performed and/or implemented Root Cause Analysis (RCA, a tool used to help study events where harm or undesired outcomes occurred in order to find the root cause) and implemented action plans when indicated. - Provided staff with education/training when indicated as a result of the evaluation, investigation, RCA and implementation of an action plan to improve identified areas that require improvements in dialysis patients’ health and safety. These failed practices had the increased risk of affecting the health and safety of all patients that received dialysis treatments, cares, and services at the dialysis facility. 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 53. The cumulative effects of these systemic issues resulted in the lack of on-going effective QAPI Program to ensure continuous improvements for the health and safety of all patient seeking dialysis services and treatments.”

“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: 18018 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff provided and maintained a clean environment when staff failed to: - Maintain surfaces that are clean, free from scrapes, and split/worn-out areas in the material of equipment located on the Treatment Floor. - Maintain clean surfaces and the floor in the Storage Area. - Maintain clean surfaces of various equipment, pipes, and floor in the Water Treatment Area. These failed practices had the potential for increased risk of cross-contamination and transmission of pathogens to all 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 53. Findings included: 1. Observations conducted during the Flash Tour on 04/28/25 from 3:23 PM to 4:29 PM showed: Treatment Floor - The chase walls located behind Patient Stations #1, #3, #4, #6, #7, #10, #12, #13, #14, #15, #16, #17, #18, #19, #20, #21, and #23 contained several scraped areas that varied in size and shape that exposed a white colored surface from the scraped-out areas. - The dialysis machines’ screen located at Patient Stations #6, #19 and #21 contained dried white streaks across the screen surface. - The wall behind Patient Stations #1, #2. #3, #4, #5 and #6 contained various amounts of streaks running down the wall surface. - Two black rolling stools had the seams worn-out around the edges exposing white colored material and one black rolling stool contained a worn-out area approximately the size of a dime on the seat of the stool that exposed gray colored mesh like material. Storage Area - The storage unit shelves contained various amounts of a white dried substance and dust on the surfaces. - The light gray and light tan colored portable carts contained areas with dried white substance on the surface of the carts’ shelves. - The floor to the right of the row of dialysis chairs contained large amounts of black colored scuffed marks that varied in size and length on the floor’s surface. - A plastic cup and two wadded pieces of paper were on the floor. Water Treatment Area - A light tan colored portable cart with chlorine testing supplies contained areas with a dried white substance on the top and bottom shelf and the bottom shelf also contained a rust-like substance around the bolts. - Two portable carts contained areas with a white dried substance on the top shelf and one cart’s bottom shelf had areas with a rust-like colored substance in the corners. - Hot Water Heater #1 contained: - White particles and dust on the top surface. - The pipes contained a rust-like substance with bluish green colored areas. - The area behind the hot water heater had concrete missing that exposed the surface under the missing concrete. - The floor drain contained a large amount of a dark brownish orange colored substance on the inside surface and the outside surface contained areas with a dark brown reddish colored substance with dust on top. - Hot Water Heater #2 contained dust particles on the top surface. - Hot Water Heater #3 contained: - Dust and white particles on the top surface. - A rust-like substance on the side of the hot water heater. - The pipes contained a bluish green colored substance. - The floor between the hot water heaters contained areas with cracked concrete, dust and dark brown areas that varied in size and amount. - The doorway contained dust, dirt, a rust-like substance on the corner of the door frame and dust was along the length of the doorway. - The drain under the Booster Pump contained dark gray colored areas on the outside surface and the inside surface contained a thick gray colored build-up. - The Back Flow pipes contained a rust-like substance and a bluish green colored substance on the pipes’ surface. - The floor under the fire extinguisher contained a large area with an orange-colored substance. - The Yellow Chemical Injector System contained dark colored areas on the surface and the black top contained a rust-like substance, dirt and dust. - The floor under the Booster Pump contained a large area with chipped and missing areas of concrete that exposed the surface under the chipped missing areas. -The floor under the motor contained a rust-like substance and the white tank contained areas with dirt and dust. - The two black Brine tank lids contained areas with a dried white substance. - The surfaces of the blue Multi Media Filter, Green Tank, and five blue Carbon Tanks contained areas with dust. - The floor behind the five blue Carbon Tanks contained: - Dust and dirt build-up. - A large area with missing concrete that exposed the surface under the missing concrete. - Three dark brownish tan colored areas on the floor. - The floor drain at the end of the five blue Carbon Tanks contained a dark blackish orange colored substance on the outside surface and a dark blackish gray substance on the inside surface. - The floor throughout the Water Treatment Area contained various amounts and sizes of cracked/missing concrete, dust and dirt build-up. - The wall behind the tanks contained gray, yellowish orange, and rust colored streaks running down the wall. - The Reverse Osmosis System contained light tan-colored streaks on the end of the system and the front of the system contained light tan spots that varied in size. - Under the Endotoxin Filter contained a large amount of rust-like substance under the pipes. - The computer workstation on wheels contained areas with a dried white substance on the surface. - The Mixing Tank contained: - A red bucket placed under the Mixing Tank that contained large areas with a dried white substance on the outside and inside surface. - A plastic cup was on the floor in front of the Mixing Tank. - The Mixing Tank and control panel contained various amounts of a dried white substance. - The wall behind the Mixing System and Dry Acid contained light tannish brown colored streaks running down the wall. - The floor between the Dry Acid and Red 2K (K-Potassium) and 2.5 Ca (Ca-Calcium) Tank contained large areas with a dark blackish brown colored substance and areas with a dried white substance. - A red bucket between the 2K - 2.5 Ca Tank and 3K - 2.5 Ca Tank contained a large amount of a dried white substance on the inside surface. - The floor drain next to the Granuflo contained dark gray areas with dirt and the Granuflo surface was dirty. - The Eyewash Station floor contained dirt. 2. Observation on 04/29/25 at 1:37 PM, showed several areas of tape residual from missing labels on the storage unit shelves located in the Storage Area. 3. Observations on 04/30/25 at 2:42 PM, showed on the Treatment Floor: - The wall column next to Patient Station #21 and #6 contained several scrapped areas on the outer edge of the column that exposed white material. - The wall column behind Patient Station #12 contained several scrapped areas that exposed white material. Tape residual and scrapped areas in surfaces made the surfaces non-cleanable and increased the risk to harbor pathogens and bacteria. 4. Observations on 04/30/25 at 2:46 PM, showed on the Treatment Floor: South 1 Pod - Three ceiling vents located at the third ceiling tile/vent space, 15th ceiling tile/vent space, and 22nd ceiling tile/space contained various amounts of dark brownish black substance on the vents outside surface. North 1 Pod - Four ceiling vents located at the second ceiling tile/vent space, sixth ceiling tile/vent space, 10th ceiling tile/vent space, and 14th ceiling tile/vent space contained various amounts of a dark brownish black substance on the vents outside surfaces. - The 18th ceiling tile/vent space contained a dried white substance on the outer edge of the vent. 5. Review of the facility’s policy titled, “General Cleanliness and Infection Control Guidelines,” dated 11/04/24, showed staff directives: All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms and offices. 6. During an interview on 04/28/25 at 4:56 PM, Staff A, Registered Nurse, Clinical Manager, stated the environment in the Treatment Floor, Storage Area, and Water Treatment Area needed cleaning. 7. During an interview on 04/29/25 at 1:37 PM, Staff C, Bio-Med, Area Technical Operations Manager, acknowledged the missing labels and tape residual on the storage units’ shelves and the scraped areas in the chase wall on the Treatment Floor.”

“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) and wore gloves when indicated and performed hand hygiene before and after glove removal when staff provided cares and treatments for patients. 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 53. Findings included: 1. Observations on 04/30/25 showed Staff P, Certified Clinical Hemodialysis Technician (CCHT): - At approximately 10:55 AM, removed gloves, failed to perform hand hygiene and retrieved supplies from the supply drawer and re-gloved without performing hand hygiene - At 10:54 AM, prepared Patient #16 for initiation of dialysis per the patient’s Central Venous Catheter (CVC, a line placed in a large vein used to deliver dialysis treatments). Staff P put on gloves, however, Staff P failed to perform hand hygiene before gloving. - At 10:49 AM, prepared Patient #16 for a CVC exit site dressing change. Staff P removed the old dressing from the patient’s CVC exit site, discarded the old dressing, however, Staff P failed to remove gloves, perform hand hygiene and re-glove before Staff P cleansed the CVC exit site. - At approximately 7:00 AM, removed gloves, however, Staff P failed to perform hand hygiene before re-gloving. Staff P’s failure to: - Perform hand hygiene after glove removal and before retrieval of supplies from the supply drawer increased the risk of contamination of the remaining supplies. - Remove gloves, perform hand hygiene and re-glove after removal and discarding the old dressing and prior to the cleansing process increased the risk of contamination to the CVC exit site. - Perform hand hygiene after glove removal and before re-gloving increased the risk of Staff P contaminating gloves during re-gloving. 2. Observations on 04/30/25 showed Staff J, CCHT: - At 10:15 AM, removed gloves three times, failed to perform hand hygiene after each time gloves were removed or before re-gloving and programmed the dialysis machine by touching the dialysis machine’s screen without wearing gloves. - At 10:00 AM, removed gloves, however, Staff J failed to perform hand hygiene after glove removal and before re-gloving. - At 9:30 AM, gloved without performing hand hygiene before gloving, removed gloves and failed to perform hand hygiene after glove removal. - At 8:25 AM, removed gloves, however, Staff J failed to perform hand hygiene after glove removal. - At 7:45 AM, gloved without performing hand hygiene before gloving and removed gloves without performing hand hygiene after glove removal. - At 7:30 AM, changed gloves three times, however, Staff J failed to perform hand hygiene after each time gloves were removed or before re-gloving. Staff J’s failure to perform hand hygiene before gloving, after glove removal and before re-gloving increased the risk of Staff J contaminating the gloves during re-gloving. 3. Observations on 04/30/25 at 6:20 AM, showed Staff O, CCHT: - At 10:40 AM, removed gloves and re-gloved without performing hand hygiene after removal of gloves and before re-gloving. - AT 10:27 AM, placed a glove against the dialysis machine’s screen twice without the glove being on Staff O’s hand to program and adjust the settings on the dialysis machine. - At 10:10 AM, failed to remove gloves, perform hand hygiene and re-glove after Staff O assessed/evaluated Patient #21’s access sites and before cannulating the patient’s access sites for dialysis. - At 6:20 AM, gloved without performing hand hygiene before gloving. Staff O’s failure to: - Perform hand hygiene after glove removal and before re-gloving increased the risk of Staff O contaminating the gloves during re-gloving. - Remove gloves, perform hand hygiene and re-glove before applying antiseptic to Patient #21’s skin/access sties increased the risk of contamination to the skin/access sites from the gloves worn to assess/palpate the patient’s access sites. 4. Observation on 04/30/25 at 11:10 AM, showed Staff L, Registered Nurse (RN) gloved without performing hand hygiene before gloving. 5. Review of the facility’s policy titled, “Hand Hygiene,” dated 11/06/23, showed staff directives: 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. - Before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications. - Immediately after removal of gloves. - After contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled. - After contact with inanimate objects near the patient. - When moving from a contaminated body site to a clean body site of the same patient. - After contact with other objects within the patient Station or treatment space. 6. During an interview on 05/01/25 at 2:02 PM, Staff A, RN, Clinical Manager, and Staff B, RN, Director of Operations, stated the expectations of staff was to follow proper hand hygiene and gloving practice and to follow the facility’s hand hygiene policy.”

“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 eight out of eight 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 patients, visitors, 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 53. Findings included: 1. Observations on 04/29/25, 04/30/25, and 05/01/25, showed staff removed used bloodlines/dialyzer from the dialysis machine at the end of patients’ treatment and carried the used items without being contained in a fluid resistant red bio-hazardous waste bag to the large red bio-hazardous cart located in either South 1 - South 2 Pods or in North 1 - North 3 Pods. 2. Observations on 04/29/25 Showed Staff: - At 10:12 AM, Staff I, Certified Clinical Hemodialysis Technician (CCHT), carried uncontained used bio-hazardous waste items from patient Station #2 to the large red bio-hazardous cart. Staff I carried the uncontained bio-hazardous waste items in front of Patient #1 and Patient #24 as the patients sat in the dialysis chairs receiving dialysis treatment. - At 3:07 PM, Staff I, CCHT, carried uncontained used bio-hazardous waste items from patient Station #1 to the large red bio-hazardous waste cart. 3. Observations on 04/30/25 Showed Staff: - At 9:40 AM, Staff K, CCHT, carried uncontained used bio-hazardous waste items from patient Station #1 to the large red bio-hazardous waste cart. - At 9:55 AM, Staff J, CCHT, carried uncontained used bio-hazardous waste items from patient Station #8 to the large red bio-hazardous cart. Staff J carried the uncontained bio-hazardous waste items in front of Patient #13, Patient #25, and Patient #26 as the patients sat in the dialysis chairs receiving dialysis treatment. - At 10:04 AM, Staff J, CCHT, carried uncontained used bio-hazardous waste items from patient Station #5 to the large red bio-hazardous cart. Staff J carried the uncontained bio-hazardous waste items in front of Patient #28, Patient # 29, Patient #8, Patient #2, and Patient #26 as the patients sat in the dialysis chairs receiving dialysis treatment. - At 10:10 AM, Staff K, CCHT, carried uncontained used bio-hazardous waste items from patient Station #2 to the large red bio-hazardous cart. Staff K carried the uncontained bio-hazardous waste items in front of Patient #26 as the patient stood in front of the dialysis chair. - At 3:15 PM, Staff M, CCHT, carried uncontained used bio-hazardous waste items from patient Station #21 to the large red bio-hazardous cart. Staff M carried the uncontained bio-hazardous waste items in front of Staff Q, Patient Care Technician (PCT). 4. Observations on 05/01/25 showed Staff: - At 10:44 AM, Staff Q, PCT, carried uncontained used bio-hazardous waste items from patient Station #11 to the large red bio-hazardous cart. Staff Q carried the uncontained bio-hazardous waste items in front of Patient #5 as the patient sat in the dialysis chair receiving dialysis treatment. - At 10:52 AM, Staff N, CCHT, carried uncontained used bio-hazardous waste items from patient Station #4 to the large red bio-hazardous cart. Staffs’ failure to either bring a fluid resistant red bio-hazardous waste bag or move the large red bio-hazardous cart to the patient Station to dispose of used bloodlines and dialyzer removed from the dialysis machine after a patient’s dialysis treatment increased the risk of splashing, spraying, splattering, or generation of droplets, and exposing patients, visitors, and staff to infections and cross-contamination when staff carried the uncontained bio-hazardous waste without being contained in a fluid resistant container. 5. Review of the facility’s policy titled, “General Cleanliness and Infection Control Guidelines,” dated 11/04/24, showed staff directives: - Regulated medical waste shall be placed in a container that is in accordance with OSHA bloodborne standard 1910.1030 and is closeable, leak proof and labeled and/or color-coded. - Regulated waste shall be placed in containers which are: - Closable; - Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport, or shipping; and - Closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping. 6. During an interview on 05/01/25 at 2:02 PM, Staff B, Registered Nurse, Director of Operations, stated the expectation of staff was to either bring the large red bio-hazardous cart to the patient Station to dispose of used bio-hazardous waste items or to dispose of used bio-hazardous items in a fluid resistant red bio-hazardous waste bag and follow the facility’s policy related to disposal of regulated waste.”

“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: 18018 Based on observation, policy review, and interview, the facility failed to ensure patients’ dialysis vascular (blood vessels) access sites/bloodline connections and face remained uncovered and in view during dialysis treatment for four patients (#12, #18, #20 and #23) observed for non-visible access/bloodline connections and/or face. A non-visible access/bloodline connection or patient’s face could result in staffs’ failure to quickly detect needle dislodgement or bloodline disconnection, which could result in significant bleeding episodes and affect the safety of all patients that received dialysis treatment at the facility. 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 53. Findings included: 1. Observations on 04/29/25 showed: - From 7:55 AM to 9:55 AM, Patient #12’s access sites, bloodline connections and face was covered by a blanket and not visible to staff during the patient’s dialysis treatment. - At 10:00 AM, Patient #20’s access sites and face was covered by a blanket and not visible to staff during the patient’s dialysis treatment. 2. Observations on 04/30/25 showed; - At 12:36 PM, Patient #18’s access sites, bloodline connections and face was covered by a blanket and not visible to staff during the patient’s dialysis treatment. - At 2:35 PM, Patient #23’s access sites and bloodlines was covered by a blanket and not visible to staff during the patient’s dialysis treatment. 3. Review of the facility’s policy titled, “Blood Loss: Prevention and Management of Needle Dislodgement/System Separation,” dated 07/01/24, showed: - One of the most common causes of blood loss is a dislodged needle, which may go undetected due to the patient’s access being covered preventing adequate observation by staff members. For this reason, it is extremely important that the patient’s access and bloodline connections are always visible. - The possibility of needle dislodgement and blood loss is the primary reason the patient’s vascular access, needles, and needle-to-line connections must be always visible. Visibility must never be blocked by blankets, pillows, under pads, or clothing. - Vascular access related measures to prevent a blood loss: - Always keep patient’s access and blood line connections uncovered and visible while on hemodialysis. - Educate patients on importance of keeping their access and blood line connections uncovered and visible during hemodialysis. - Patients who continue to cover their access will require education, documentation of intervention and notification to physician if nonadherent to safety requirements. 4. During an interview on 05/01/25 at 2:02 PM, Staff B, Registered Nurse, Director of Operations, stated the expectation of staff was to ensure patients’ access sites, bloodline connections and face remain visible during patients’ dialysis treatment. Staff B stated staff was expected to follow the facility’s policy related to prevention of needle dislodgement.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 18018 Based on review of patients’ Treatment Sheets, policy review, and interview, the facility failed to ensure staff followed physician orders for: - Heparin bolus (medication used to thin blood and/or prevent blood clot formation) administration for one patient (#1) out of four patients’ Treatment Sheets reviewed for administration of heparin bolus. The failure to follow the heparin order had the potential for dialysis complications including excessive bleeding or clotting for all patients that received heparin. - Blood flow rate (BFR, how fast blood is pumped through the dialyzer - artificial kidney and then pumped back into the patient during their hemodialysis treatment) for three patients (#1, #2 and #4) out of four patients’ Treatment Sheets reviewed for BFR. - Dialysate flow rate (DFR, how fast toxins are removed from blood into the dialysate) for one patient (#3) out of four patients’ Treatment Sheets reviewed for DFR. The failure to follow the BFR and DFR order had the potential to affect the adequacy of patients’ dialysis treatments. - Duration of dialysis treatment for one patient (#4) out of four patients’ Treatment Sheets reviewed for duration of dialysis treatment. The failure to follow the prescription time had the potential for dialysis complications due to inadequate treatment time. -Monitor patients’ blood pressure throughout the dialysis treatment for four patients (#1, #2, #3 and #4) out of four patients’ Treatment Sheets reviewed for blood pressure monitoring during dialysis treatment. These failures had the potential to affect all In-Center Hemodialysis patients that received dialysis treatments at the facility. 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 53. Findings included: 1. Review of Patient #1’s Treatment Sheets showed: Heparin Bolus Administration - On 04/19/25, the documented heparin bolus was administered at 6:10 AM and the patient’s hemodialysis treatment was initiated at 6:12 AM. Staff failed to administer the heparin bolus within three to five minutes before the start of the dialysis treatment. BFR - The BFR was ordered to run at 450 milliliters (mL, unit of measurement) per minute (min). - The patient’s documented BFR was not ran at the ordered rate of 450 mL/min on 04/29/25, 04/26/25, 04/24/25, 04/22/25, and 04/19/25. Staff failed to document the reason the BFR was not ran at the ordered rate. Blood Pressure Monitored Every 30 Minutes During Dialysis Treatment - On 04/29/25 the patient’s blood pressure was not taken every 30 minutes throughout the dialysis treatment. 2. Review of Patient #2’s Treatment Sheets showed: BFR - The ordered BFR was ordered to run at 450 mL/min. - The patient’s documented BFR was not ran at the ordered rate of 450 mL/min on 04/25/25, 04/21/25, 04/18/25, and 04/16/25. Staff failed to document the reason the BFR was not ran at the ordered rate. Blood Pressure Monitored Every 30 Minutes During Dialysis Treatment - On 04/21/25 and 04/18/25 the patient’s blood pressure was not taken every 30 minutes throughout the dialysis treatment. 3. Review of Patient #3’s Treatment Sheets showed: DFR - The ordered DFR was ordered to run at 600 mL/min. - The patient’s documented DFR was not ran at the ordered rate of 600 mL/min on 04/12/25. Staff failed to document the reason the DFR was not ran at the ordered rate. Blood Pressure Monitored Every 30 Minutes During Dialysis Treatment - On 04/23/25, 04/21/25, and 04/18/25 the patient’s blood pressure was not taken every 30 minutes throughout the dialysis treatment. 4. Review of Patient #4’s Treatment Sheets showed: BFR - The ordered BFR was ordered to run at 400 mL/min. - The patient’s documented BFR was not ran at the ordered rate of 400 mL/min on 04/29/25. Staff failed to document the reason the BFR was not ran at the ordered rate. Blood Pressure Monitored Every 30 Minutes During Dialysis Treatment - On 04/29/25 the patient’s blood pressure was not taken every 30 minutes throughout the dialysis treatment. Duration of Dialysis Treatment - The ordered dialysis treatment was 3.5 (three and a half hours - 210 minutes) hours. - On 04/29/25 staff documented the patient’s dialysis treatment was initiated at 12:22 PM and at 2:27 PM staff documented the treatment was discontinued, which was approximately 1.5 (one and a half) hours earlier than the ordered time. Staff failed to document the reason the patient’s dialysis treatment was ended early. 5. Review of the facility’s policy titled, “Heparinization,” dated 08/03/20, showed staff directives: - Heparin Administration: Heparin must be given at least 3-5 minutes prior to dialysis. This allows time for full anticoagulation at the start of treatment. - Heparin prolongs clotting time and prevents blood coagulation in the extracorporeal circuit. - Method of Administration: Bolus only at initiation - A bolus loading dose is administered 3-5 minutes pretreatment. 6. Review of the facility’s policy titled, “Physician Order Documentation,” dated 07/03/23, showed staff directive: Nurse practice acts require nurses to carry out treatment care, medication administration, lab tests, procedures, and other treatments, based on physician orders. 7. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, showed staff directive: During Treatment obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. 8. During an interview on 05/01/25 at 2:02 PM, Staff B, Registered Nurse, Director of Operations, stated staff was expected to: - Administer the heparin bolus 3-5 minutes pretreatment. - Follow physician orders and if there was any deviation from the physician order, staff was expected to document the reason and to notify the physician of the deviation. - Monitor patients’ blood pressure every 30 minutes during patients’ dialysis treatment. - Follow the facility’s policy and procedures.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 18018 Based on review of the facility’s Mortality Analysis, Adverse Events Report, policy review, and interview, the facility failed to ensure the facility’s Quality Assessment and Performance Improvement (QAPI) Program: - Evaluated and investigated the facility’s Mortality Analysis reports to identify if patients’ cause of death was related to treatments, cares, and services provided by the dialysis facility. - Evaluated and investigated the facility’s Adverse Events Report to identify high risk and problem prone areas that impact patient health and safety related to treatments, cares, and services provided to dialysis patients. - Performed and/or implemented Root Cause Analysis (RCA, a tool used to help study events where harm or undesired outcomes occurred in order to find the root cause) and implemented action plans when indicated. - Provided staff with education/training when indicated as a result of the evaluation, investigation, RCA and implementation of an action plan to improve identified areas that require improvements in dialysis patients’ health and safety. These failed practices had the increased risk of affecting the health and safety of all patients that received dialysis treatments, cares, and services at the dialysis facility. 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 53. Findings included: Mortality Analysis Review 1. Review of the facility’s document titled, “Mortality Analysis,” report end date 03/2025, showed documentation for 11/2024 that Patient #27’s cause of death was septicemia (an infection that occurs when bacteria enters the bloodstream and spreads) due to vascular access catheter (Central Venous Catheter, CVC, a line placed in a large vein used to deliver dialysis treatments). Further review showed the facility did not initiate neither an investigation, Root Cause Analysis nor an action plan to prevent infections of patients’ CVC, Arteriovenous Fistula (AVF, a permanent access that is surgically created by sewing an artery to a vein to deliver dialysis) and Arteriovenous Graft (AVG, a permanent access made by connecting an artery and a vein with synthetic material used to deliver dialysis treatment). Staff also failed to provide education/training to patients and staff on how to prevent infections of patients’ CVC, AVF and AVG. The facility’s failure to investigate and provide both patients and staff education related to infection control practices during dialysis treatments placed all patients and staff at increased risk for cross-contamination and the spread of infections. Adverse Events Review Review of the facility’s document titled, “Adverse Events Report,” dated 04/28/25, showed: 2. On 04/29/24, Patient #28 experienced a total needle dislodgement from the patient’s AVG during dialysis treatment. During a 30-minute check performed by staff, the patient grabbed the blanket off the patient’s access sites and the needles became dislodged. Further review showed the facility did not initiate neither an investigation, Root Cause Analysis nor an action plan to prevent this type of incident from occurring in the future. Staff also failed to provide education/training to patients and staff on how to prevent needle dislodgement during dialysis treatment. The facility’s failure to investigate and provide both patients and staff education related to prevention of needle dislodgement during dialysis treatments placed all patient receiving dialysis at increased risk for the patients’ health and safety during dialysis. A needle dislodgement could cause a patient to experience excessive blood loss, exsanguination (severe blood loss from the entire body of a person within a short amount of time), or death. 3. On 12/04/24, Patient #12 experienced blood loss - clotted dialyzer/extracorporeal circuit (designed to remove blood from the patient’s circulation, deliver it to some form of blood purification device, and then return the purified blood to the patient) hemodialysis. Review of Patient #12’s Treatment Sheet dated 12/04/24, showed staff did not document administration of heparin bolus (medication used to thin blood and/or prevent blood clot formation) 3-5 minutes before dialysis treatment was initiated. The facility’s failure to investigate and provide staff education related to staffs’ failure to administer the heparin bolus 3-5 minutes before initiation of dialysis placed all patient receiving dialysis at increased risk for complications for the patient’s blood to clot during dialysis. 4. Review of the facility’s policy titled, “Heparinization,” dated 08/03/20, showed staff directives: - Heparin Administration: Heparin must be given at least 3-5 minutes prior to dialysis. This allows time for full anticoagulation at the start of treatment. - Heparin prolongs clotting time and prevents blood coagulation in the extracorporeal circuit. - Method of Administration: Bolus only at initiation - A bolus loading dose is administered 3-5 minutes pretreatment. 5. Review of the facility’s policy titled, “Quality Assessment and Performance Improvement Program,” dated 11/04/24, showed staff directives: - The QAPI program is a collaboration among the interdisciplinary team that must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program. QAPI requires the use of aggregated patient data to evaluate the facility patient outcomes. - QAPI is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes. QAPI Meeting Objectives - The QAPI Committee will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement, evaluate, and revise action plans that result in sustainable improvements in patient care. - Elements to be reviewed will include: - Patient care outcomes; - Infection surveillance; - Patient safety; - Patient satisfaction and grievances; - Medical records; - Internal and external regulatory reviews; and - Technical operations, including water and dialysate quality and safety, and safe machine maintenance; - Staff training and education; and - Special populations (ex. AKI [Acute Kidney Injury], pediatrics, nocturnal home therapy SNF [Skilled Nursing Facility]). - Following a Root Cause Analysis, action plans will be determined and prioritized by the QAPI Committee, considering the prevalence and severity of identified problems and by ranking those which have potential to affect patient health and safety as a higher priority than those that do not have such potential. The facility must take immediate and appropriate actions to address any serious threats and ensure patient safety. 5. During an interview on 05/01/25 at 11:18 AM, Staff A, Registered Nurse (RN), Clinical Manager, stated when the Interdisciplinary Team (IDT) reviews Mortality reports and if the report indicates the death could be related to treatments, care, and services provided by the dialysis facility, the IDT was expected to: - Perform an investigation to determine if a correlation could be identified of the patient’s cause of death to dialysis treatments, cares and services provided by the dialysis facility. - Look at the patient’s co-morbidities. - If the cause of death was related to infection control practice, for example, septicemia, staff education/re-training in infection control practice would be provided to staff. - Review facility reports and look for trends. - Review with staff policy and procedures related to the incident/event. - Perform real time audits of staff providing treatments and cares to patients to identify breaks in infection control practice by staff and other cares, for example following dialysis prescription orders. - Review audits, for example, infection control audits and audits of patients’ Treatment Sheets. Staff A stated for Adverse Events, the facility’s IDT reviews the events, performs and investigation to determine what caused the event to happen and if indicated provide staff with education/training. 6. During an interview on 05/01/25 at 11:46 AM, Staff B, RN, Director of Operations, acknowledged and stated was not able to: - Find an event report, investigation, RCA, or action plan related to Patient #27’s cause of death from septicemia related to the patient’s CVC and did not find any documentation that staff received education/training in prevention of infection when staff provided care to patients’ CVC, AVG and AVF access sites. - Find any documentation that patients and staff received education/training in the importance of keeping patients’ access sites visible at all times throughout the patient’s dialysis treatment. - Find an event report, investigation, RCA, or action plan related to Patient #12’s blood loss - clotted dialyzer/extracorporeal circuit and did not find any documentation that staff received education/training in the importance of administering heparin bolus before the initiation of patients’ dialysis treatment. Staff B stated the expectation was for staff to receive education/training after an incident or event occurred in the dialysis facility.”