Davita Titletown Dialysis

“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: 29972 Based on record review, observation, and interview staff failed to perform hand hygiene before donning gloves, after removing gloves, between glove changes, and before touching “clean” equipment and/or obtaining clean supplies in 4 of 8 patient observations (Patient (Pt) # 6, 7, 8, 12), in a total sample of 8 patient’s observed; and failed to perform hand hygiene after removing gloves while cleaning and disinfecting the dialysis station in 1 of 2 observations of station cleaning (Station 13), in a total of 2 observations of station cleaning; and failed to ensure patients perform hand hygiene after dialysis treatment using an Arteriovenous Fistula/Graft (AVF/G) in 2 of 2 patients observed with an AVF/G post treatment (Pt #7, 11), in a total sample of 4 patients observed with an AVF/G. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last reviewed April 2023 revealed the following: -“All Teammates...will perform hand hygiene...b. prior to gloving and immediately after removal of gloves...d. after patient and dialysis delivery system contact...g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse.” - “Patients and caregivers will be encouraged to...b. Perform hand hygiene after treatment before leaving treatment areas.” - “Disposable glove will be worn when caring for the patient or touching the patient’s equipment at the dialysis station...a. Gloves should be changed when: ...ii. When going from a “dirty” area or task to a “clean” area or task...iv. After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system.” - “The chair side cart...monitor and keyboard are considered clean areas.” Staff observations: On 11/01/2023 beginning at 12:03 PM, observed Patient Care Technician (PCT) H at station 10 initiating Pt #8’s dialysis treatment using an AVF/G. PCT H wrapped a glove around her/his index finger than proceeded to touch the monitor on the dialysis machine; PCT disposed of the glove than began typing on the chairside keyboard without performing hand hygiene. PCT H than donned gloves to cannulate Pt #8’s AVF/G, and did not perform hand hygiene prior to donning gloves. On 11/01/2023 beginning at 12:15 PM, observed PCT E at station 13 discontinuing Pt #7’s dialysis treatment using an AVF/G. PCT E missed 5 opportunities to perform hand hygiene between glove changes while discontinuing Pt #7’s treatment. PCT E removed Pt #7’s blood lines from the dialysis machine and placed the lines in the biohazard container, PCT E than removed gloves, removed faceshield and placed it on the “clean” chairside computer cart, and proceeded to type on the keyboard; PCT E did not perform hand hygiene after removing gloves. On 11/01/2023 beginning at 12:40 PM, observed PCT E cleaning and disinfecting station 13. PCT E cleaned the equipment at the station, removed gloves, and did not perform hand hygiene before donning a new pair of gloves. On 11/01/2023 beginning at 12:49 PM, observed PCT E at station 13 setting up the dialysis machine for the next patient (unknown). Wearing the same gloves used to set up the machine, PCT E picked up a cardboard box placed it on the counter, obtained a box cutter to open the box, and retrieved “clean” supplies. PCT E continued setting up the dialysis machine wearing the same gloves used to access the card board box and box cutter, potentially contaminating the “clean” patient blood lines and equipment. On 11/02/2023 at 10:00 AM, observed PCT E at station 13 discontinuing Pt #12’s dialysis treatment using a Central Venous Catheter (CVC). PCT E missed 5 opportunities to perform hand hygiene between glove changes while discontinuing Pt #12’s treatment. PCT E wrapped a glove around her/his index finger than proceeded to touch the monitor on the dialysis machine; PCT E did not dispose of the glove and placed it on Pt 12’s dialysis machine for later use; PCT E did not perform hand hygiene prior to typing on chairside computer keyboard. On 11/02/2023 at 10:11 AM, observed Registered Nurse (RN) D at station 13 assessing Pt #12. RN D wrapped a glove around her/his index finger than proceeded to touch the monitor on the dialysis machine; RN D disposed of the glove and did not perform hand hygiene. On 11/02/2023 at 10:37 AM, observed Registered Nurse (RN) D at station 3 initiating Pt #6’s dialysis treatment using a CVC. RN D connected the blood lines to Pt #6’s CVC hubs and started Pt #6’s dialysis treatment, RN D than removed his/her gloves and began typing on the chairside computer keyboard without performing hand hygiene after glove removal. Patient observations: On 11/01/2023 beginning at 12:15 PM, observed PCT E at station 13 discontinuing Pt #7’s dialysis treatment using an AVF/G. Pt #7 donned a glove and proceeded to hold pressure on his/her access site to achieve hemostasis (stop bleeding). Pt #7 did not perform hand hygiene after removing glove and before touching the scale and exiting the dialysis treatment area. On 11/01/2023 beginning at 1:00 PM, observed PCT F at station 14 discontinuing Pt #11’s dialysis treatment using an AVF/G. Pt #11 donned a glove and proceeded to hold pressure on his/her access site to achieve hemostasis. Pt #11 did not perform hand hygiene after removing glove and before touching the scale and exiting the dialysis treatment area. During interview on 11/02/2023 beginning at 4:15 PM, while discussing observations with Facility Administrator (FA) A, Clinical Services Manager (CSM) B, and Dietician C; FA A agreed that staff should be performing hand hygiene as per policy, and that staff should ensure that patients are performing hand hygiene after glove removal and before leaving the facility. FA A stated that staff should not be wrapping the glove around their finger to touch patient equipment and should be placing all fingers in the glove. During interview with RN D on 11/02/2023 beginning at 2:12 PM, when asked about wrapping a glove around the finger to touch the machine, RN D stated that it was not an appropriate practice to wrap the glove around the index finger, and stated that the hand and fingers should be inserted into the glove. RN D confirmed that she does wrap the glove around her/his finger to quickly silence machine alarms.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 29972 Based on record review, observation and interview the facility staff failed to wear personal protective equipment (PPE) appropriately to protect from potential blood splatter and contaminants in 3 of 5 observations of staff (Patient Care Technician (PCT) E, F, and Registered Nurse (RN) D), in a total of 5 staff observed. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last reviewed April 2023 revealed the following: - “Appropriate PPE will be worn whenever there is potential for contact with body fluids...contaminated equipment and environmental surfaces...” - “Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates...when in the treatment area.” On 11/01/2023 beginning at 12:15 PM, observed PCT E at station 13 discontinuing Pt #7’s dialysis treatment using an Arteriovenous Fistula/Graft (AVF/G). PCT E’s gown was not buttoned all the way down (only top 2 buttoned) exposing his/her scrub top and pants to potential blood splatter and contaminated equipment. On 11/01/2023 beginning at 1:00 PM, observed PCT F at station 14 discontinuing Pt #11’s dialysis treatment using a AVF/G. PCT F applied tape and gauze to Pt #11’s AVF/G and Pt #11’s vascular access site began bleeding onto the chair and the floor. PCT F cleaned the blood off the patient’s arm, chair, and the floor; PCT F was not wearing eye glasses with side covers to protect PCT F’s eyes from potential blood splatter and contaminants. On 11/02/2023 beginning at 11:04 AM, observed Registered Nurse (RN) D at station 6 administering Pt #13’s intravenous medication via Pt #13’s dialysis machine. RN D’s faceshield was on top of RN D’s head and not covering his/her face for protection from potential blood splatter and contaminants. During interview on 11/02/2023 beginning at 4:15 PM, while discussing observations with Facility Administrator (FA) A, Clinical Services Manager (CSM) B, and Dietician C; FA A stated that gowns should be buttoned all the way down and staff should be wearing a faceshield or eye goggles and a mask for protection.”

“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: 29972 Based on observation, record review, and interview staff failed to clean and disinfect equipment/supplies and blood spills at the dialysis station to prevent cross contamination in 2 of 2 observations of station cleaning (Station 13, 14), in a total sample of 2 station cleanings observed. Findings include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last reviewed April 2023 revealed the following: -“Cleaning and/or disinfecting of equipment and work surfaces will be performed as soon as possible following exposure to blood...a. Prior to routine disinfection, remove all visible blood...i. For visible blood...a 1:10 (one to ten) bleach solution must be utilized.” -“At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not limited to: all surfaces in contact with the patient or their belongings (e.g.,dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g.,control panel: top, front and sides of dialysis machine; touchscreens; countertops)...ii. Priming containers are to be emptied prior to disinfection...” On 11/1/2023 beginning at 12:40 PM, observed Patient Care Technician (PCT) E cleaning and disinfecting station 13. PCT E did not clean the following: -Inside of the Primewaste container attached to the dialysis machine -All areas of the front of the dialysis machine -Basket attached to the dialysis machine -Recline chair and clean the downsides of the seat cushion -IV pole attached to the dialysis machine -TV and TV arm -Blue plastic back hanging on the back of the TV -Garbage can -Biohazard container -Blood Pressure cuff and tubing On 11/01/2023 beginning at 1:31 PM, observed PCT F cleaning and disinfecting station 14. PCT F did not clean the following: -IV pole and hooks -Marker hanging from IV pole -Stethoscope hanging from IV pole -TV and TV arm -Blue plastic bag hanging on the back of the TV -Garbage Can -Biohazard container On 11/01/2023 beginning at 1:00 PM, observed PCT F at station 14 cleaning up visible blood on the dialysis chair and floor after Pt #14 bled from his/her vascular access site post treatment. PCT F used wipes soaked in a bleach concentrate of 1:100 (1 to 100) to disinfect surfaces with visible blood; per policy staff should use 1:10 (more concentrated) when cleaning and disinfecting surfaces containing visible blood. Per observations, dried blood remained on the floor after PCT F completed cleaning the station. During interview on 11/02/2023 beginning at 4:15 PM, while discussing observations with Facility Administrator (FA) A, Clinical Services Manager (CSM) B, and Dietician C; FA A and CSM B agreed that the above areas should be cleaned and disinfected during station cleaning.”

“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: 29972 Based on record review, observation, and interview staff failed to ensure Central Venous Catheters (CVCs) are handled in a manner to prevent potential cross contamination in 2 of 2 patients observed with a CVC (Patient (Pt) #6, 12) in a total sample of 2 patients observed with a CVC. Findings include: Review of policy and procedures #1-04-02B titled, “Central Venous Catheter....” last reviewed October 2023 revealed the following: -“Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason.” -“Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds...” -“Teammate and patient will wear masks covering the nose and mouth during this procedure...These measures are vital to preventing the exposure of the catheter and exite site to nasal droplets and infectious bacteria...” -“If teammate performing this procedure assist the patient to put on their face mask...” -“Holding catheter with the non-dominant hand and using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol (ChloraPrep) swab for a minimum of 30 seconds, apply to the CVC exit site in a ‘back and forth’ pattern, using gentle friction progressing from the insertion site to the periphery using both sides of the swab...wait 60 seconds for air dry time. On 11/02/2023 at 10:00 AM, observed Patient Care Technician (PCT) E at Station 13 discontinuing Pt #12’s dialysis treatment using a CVC. PCT E did not perform a 15 second scrub of the CVC hubs during the process of disconnecting the blood lines as per policy. On 11/02/2023 at 10:30 AM, observed Registered Nurse (RN) D at Station 3 performing Pt #6’s CVC exit site care/dressing change. RN D scrubbed the CVC exit site with ChloraPrep swab for 20 seconds, not 30 seconds as per policy. RN D scrubbed above and below the CVC exit site in a horizontal motion, RN D did not scrub all areas of the skin surrounding the CVC exit site. On 11/02/2023 at 10:37 AM, observed RN D at Station 3 initiating Pt #6’s dialysis treatment using a CVC. RN completed Pt #6’s CVC dressing change, then asked if Pt #6 wanted to remove his/her face mask. Pt #6 removed his/her facemask, and RN D proceeded to open the CVC hubs and connect the syringes and the blood lines while Pt #6 was not masked, allowing for potential cross contamination of the CVC. During interview on 11/02/2023 beginning at 4:15 PM, while discussing observations with Facility Administrator (FA) A, Clinical Services Manager (CSM) B, and Dietician C; FA A stated that staff should be following the policy when performing CVC care. Per FA A, the patient should have a mask on during CVC initiation including CVC dressing changes, and CVC connection and disconnection.”

“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: 29972 Based on record review and interview staff failed to ensure Heparin is administered as per physician orders in 7 of 7 in-center hemodialysis patients with Heparin orders (Patients (Pt) #1, 2, 3, 4, 5, 6, 7), in a total sample of 7 medical records reviewed. Findings include: Review of policy and procedure #1-06-02 titled, “Anticoagulation” last reviewed October 2023 revealed the following: -“Heparin is administered per physician’s order.” -“To anticoagulate (inhibit blood clotting) the patient, the initial loading dose of heparin is administered through the venous fistula needle or venous port of the central venous catheter (CVC) as least 3 to 5 minutes prior to the initiation of the hemodialysis treatment.” -“It is recommended that the heparin hourly infusion be discontinued 60 minutes prior to end of treatment for patients with arterio-venous (AV) fistulas and/or AV grafts per physician order. It is recommended that the heparin hourly infusion be continued for the entire treatment for patients with CVCs.” Review of Pt #1’s Treatment Sheets revealed treatment orders for a heparin bolus of 2000 units and a Heparin infusion of 600 units/hour, stopped at 0 minutes before the end of treatment. Review of Pt #1’s Treatment Sheets revealed the following: 10/31/2023: Treatment ended at 12:45 PM and the Heparin infusion was documented as stopped at 1:26 PM; 41 minutes after treatment ended (should be 60 minute before the end of treatment). Review of Pt #2’s Treatment Sheets revealed treatment orders for a Heparin bolus of 2000 units and a Heparin infusion of 600 units/hour, stopped 60 minutes before the end of treatment. Review of Pt #2’s Treatment Sheets revealed the following: -10/31/2023: Treatment started at 10:46 AM, and the Heparin bolus was documented as given at 10:53 AM; 7 minutes after treatment started (should be 3 to 5 minutes before as per policy). -10/21/2023: Treatment started at 10:58 AM and the Heparin bolus was documented as given at 11:02 AM; 4 minutes after treatment started (should be 3 to 5 minutes before as per policy). Pt #2’s dialysis treatment ended at 2:04 PM and the Heparin infusion was documented as stopped at 2:20 PM; 16 minutes after treatment ended (should be 60 minute before the end of treatment). Review of Pt #3’s Treatment Sheets revealed treatment orders for a Heparin bolus of 7000 units and a Heparin infusion of 1000 units/hour, stopped 60 minutes before the end of treatment. Review of Pt #3’s Treatment Sheets revealed the following: -10/31/2023: Treatment started at 6:00 AM and the Heparin bolus was documented as given at 6:14 AM; 14 minutes after treatment started (should be 3 to 5 minutes before as per policy). Pt #3’s Heparin infusion started at 6:15 AM; 15 minutes after treatment started (should begin when treatment starts). Pt #3’s dialysis treatment ended at 9:54 AM and the Heparin infusion was documented as stopped at 9:56 AM; 2 minutes after treatment ended (should be 60 minute before the end of treatment). -10/26/2023: Treatment started at 5:59 AM and the Heparin bolus was documented as given at 6:01 AM; 2 minutes after treatment started (should be 3 to 5 minutes before as per policy). Pt #3’s dialysis treatment ended at 9:51 AM and the Heparin infusion was documented as stopped at 9:57 AM; 6 minutes after treatment ended (should be 60 minute before the end of treatment as per orders). -10/21/2023: Treatment started at 5:44 AM and the Heparin bolus was documented as given at 5:45 AM; 1 minute after treatment started (should be 3 to 5 minutes before as per policy). Pt #3’s dialysis treatment ended at 9:52 AM and the Heparin infusion was documented as stopped at 9:53 AM; 1 minute after treatment ended (should be 60 minute before the end of treatment as per orders). Review of Pt #4’s Treatment Sheets revealed treatment orders for a Heparin bolus of 3000 units and a Heparin infusion of 600 units/hour, stopped at 0 minutes before the end of treatment. Review of Pt #4’s Treatment Sheets revealed the following: -10/30/2023: Treatment started at 4:49 AM and the Heparin bolus was documented as given at 4:50 AM; 1 minute after treatment started (should be 3 to 5 minutes before as per policy). -10/27/2023: Treatment started at 4:44 AM and the Heparin bolus was documented as given at 4:47 AM; 3 minutes after treatment started (should be 3 to 5 minutes before as per policy). Pt #4’s dialysis treatment ended at 8:15 AM and the Heparin infusion was documented as stopped at 7:57 AM; 18 minutes before treatment ended (should be 0 minute before the end of treatment as per orders). -10/23/2023: Treatment started at 4:50 AM and the Heparin bolus was documented as given at 5:06 AM; 16 minutes after treatment started (should be 3 to 5 minutes before as per policy). Pt #4’s Heparin infusion was documented as started at 5:06 AM; 16 minutes after treatment started (should begin at the start of treatment). Review of Pt #5’s Treatment Sheets revealed treatment orders for a Heparin bolus of 600 units. Review of Pt #5’s Treatment Sheets revealed the following: 10/28/2023: Treatment started at 7:07 AM and the Heparin bolus was documented as given at 7:09 AM; 2 minutes after treatment initiated (should be 3 to 5 minutes before as per policy). -10/17/2023: Treatment started at 7:16 AM and the Heparin bolus was documented as given at 7:16 AM; same time as treatment initiated (should be 3 to 5 minutes before as per policy). Review of Pt #6’s Treatment Sheets revealed treatment orders for a Heparin bolus of 2000 units and a Heparin infusion of 600 units/hour, stopped at 0 minutes before the end of treatment. Review of Pt #6’s Treatment Sheets revealed the following: -10/28/2023: Treatment started at 9:50 AM and the Heparin bolus was documented as given at 9:50 AM; same time as treatment initiated (should be 3 to 5 minutes before as per policy). -10/24/2023: Treatment started at 10:50 AM and the Heparin bolus was documented as given at 10:52 AM; 2 minutes after treatment started (should be 3 to 5 minutes before as per policy). Pt #6’s dialysis treatment ended at 2:03 PM and the Heparin infusion was documented as stopped at 3:01 PM; 58 minutes after treatment ended (should be 0 minute before the end of treatment as per orders). Review of Pt #7’s Treatment Sheets revealed treatment orders for a Heparin bolus of 2000 units and a Heparin infusion of 600 units/hour, stopped 60 minutes before the end of treatment. Review of Pt #7’s Treatment Sheets revealed the following: -10/30/2023: Treatment started at 11:19 AM and the Heparin infusion was documented as stopped at 11:22 AM; 3 minutes after treatment ended (should be 60 minute before the end of treatment). -10/27/2023: Treatment started at 7:27 AM and the Heparin bolus was documented as given at 7:29 AM; 2 minutes after treatment started (should be 3 to 5 minutes before as per policy). -10/20/2023: Treatment started at 7:15 AM and the Heparin bolus was documented as given at 7:20 AM; 5 minute after treatment started (should be 3 to 5 minutes before as per policy). Pt #7’s dialysis treatment ended at 11:49 AM and the Heparin infusion was documented as stopped at 11:51 AM; 2 minute after treatment ended (should be 60 minute before the end of treatment as per orders). During interview on 11/03/2023 beginning at 1:35 PM, while discussing medical record findings with Facility Administrator (FA), FA A stated that staff should be administering the Heparin bolus 3 to 5 minutes prior to treatment initiation as per policy. Per interview, FA A stated that staff should start the Heparin infusion on treatment initiation and should administer Heparin as per physician orders.”

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- (1) At least annually for stable patients; This Standard is not met as evidenced by: 29972 Based on record review and interview staff failed to ensure that a Comprehensive Patient Assessment and Plan of Care was completed annually on all patients in 1 of 7 medical records reviewed (Patient (Pt) #4), in a total sample of 7 medical records reviewed. Findings Include: Review of policy and procedure #1-14-01 titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” last reviewed July 2023 revealed, “A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: At least annually for stable patients...” Review of Pt #4’s medical record on 11/03/2023 at 10:55 AM, revealed that Pt #4’s most recent IDT plan of care was completed on 09/26/2022 (13 months and 8 days ago). During interview with Dietician C while reviewing Pt #4’s medical record, Dietician C stated that Pt #4’s annual Plan of Care and Patient Assessments have not been completed; Dietician C stated that Pt #4’s annual Plan of Care and Patient Assessments should have been completed in September.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 29972 Based on record review and interview staff failed to ensure that patients with frequent and extended hospitalizations are classified as unstable as per policy in 1 of 1 medical record reviewed with frequent hospitalizations (Patient (Pt) #1), in a total sample of 7 medical records reviewed. Findings Include: Review of policy and procedure #1-14-01 titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” last reviewed July 2023 revealed the following: -“A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: At least monthly for unstable patients including, but not limited to, patients with the following: Extended or frequent hospitalizations...” Review of Pt #1’s medical records revealed the following hospitalizations: -08/23/2023 to 08/30/2023 (7 days) -09/04/2023 to 09/19/2023 (15 days)--Readmission within 30 days -10/11/2023 to 10/16/2023 (5 days)--Readmission within 30 days Review of Pt #1’s medical record revealed Pt #1’s Patient Plan of Care meeting dated 10/10/2023 revealed that Pt #1 was deemed “stable.” Per interview with Dietician C on 11/2/2023 at 8:52 AM, Dietician C stated that Pt #1’s first day of dialysis was on 8/14/2023 and Pt #1 was unable to have a Plan of Care meeting within 30 days due to the extended hospitalizations. Per Dietician C Pt #1 was not currently deemed unstable. During interview with Facility Administrator (FA) A on 11/03/2023 beginning at 1:35 PM while discussing medical record findings, FA A stated that Pt #1 should have been made unstable due to the frequent and extended hospitalizations.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 29972 Based on record review and interview, staff failed to ensure that the nursing assessments and evaluations address fluid management needs in 5 of 7 records reviewed (Patients (Pt) #1, 2, 3, 6, 7); and failed to ensure that nursing staff assess patients when blood pressures (BP) are out of parameters as per policy in 2 of 7 medical records reviewed (Pt #1, 3), in a total sample of 7 medical records reviewed. Findings Include: Review of policy and procedure #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” last reviewed October 2023 revealed the following: -“The Nursing Assessment will be performed and documented by...specifically a Registered Nurse...a. The assessment includes the following components:...vi. A physical assessment of the patient includes...1. Apical heart rate and rhythm...2. Auscultation (listen) of the lungs...3. Evaluation of volume status including edema...” -“If abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis.” -“The nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one hour of dialysis treatment initiation.” -“Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary.” -“All findings, interventions and patient response will be documented in the patient’s medical record.” -Abnormal findings include, “Removal goal not to exceed maximum ordered by physician;” “If patient is above or below 1 kilogram from the target weight;” “Systolic (blood pressure) greater than 180...or less than 90...Diastolic (blood pressure) greater than or equal to 100...” “Difference of 20...increase or decrease from patient’s last intradialytic treatment BP (blood pressure) reading.” -“Vital signs and treatment monitoring... is completed at least every 30 minutes.” Fluid Assessment and Evaluations: Review of Pt #1’s Treatment Sheets revealed the following: 10/31/2023: Pt #1’s dialysis treatment started at 8:38 AM and the nurse did not document a pre-treatment assessment until 11:32 AM; 2 hours and 54 minutes later (Should be within 1 hour per policy). 10/28/2023: Pt #1’s dialysis treatment started at 11:11 AM and the nurse did not document a pre-treatment assessment until 12:30 PM; 1 hours and 19 minutes later (Should be within 1 hour per policy). Pt #1’s treatment ended at 3:44 PM and the post-treatment nursing assessment was not documented until 10/30/2023 at 5:11 AM; 2 days later. 10/19/2023: Pt #1’s dialysis treatment started at 11:19 AM and the nurse did not document a pre-treatment assessment until 1:50 PM; 2 hours and 9 minutes later (Should be within 1 hour per policy). Review of Pt #2’s Treatment Sheets revealed the following: 10/24/2023: Pt #2’s dialysis treatment started at 11:00 AM and the nurse did not document a pre-treatment assessment until 1:52 PM; 3 hours and 52 minutes later (Should be within 1 hour per policy). 10/19/2023: Pt #2’s dialysis treatment ended at 11:20 AM and the nurse did not document a post-treatment assessment until 1:39 PM; 2 hours and 20 minutes later. 10/17/2023: Pt #2’s dialysis treatment started at 8:38 AM and the nurse did not document a pre-treatment assessment until 11:32 AM; 2 hours and 54 minutes later (Should be within 1 hour per policy). Review of Pt #3’s Treatment Sheet revealed the following: 10/31/2023: Pt #3’s dialysis treatment started at 6:00 AM and the nurse did not document a pre-treatment assessment until 7:15 AM; 1 hours and 15 minutes later (Should be within 1 hour per policy). 10/24/2023: Pt #3’s Target Weight (TW) pre treatment was 138 kilograms (kg), Post weight was 139.8 kg; 1.8 kg above target weight. There was no documentation of nursing staff addressing Pt #3’s post weight being >1 kg above TW as per policy. 10/21/2023: Pt #3’s dialysis treatment started at 5:44 AM and the nurse did not document a pre-treatment assessment until 8:12 AM; 2 hours and 29 minutes later (Should be within 1 hour per policy). Review of Pt #6’s Treatment Sheet revealed the following: 10/31/2023: Pt #6’s dialysis treatment started at 10:09 AM and the nurse did not document a pre-treatment assessment until 11:40 AM; 1 hours and 32 minutes later (Should be within 1 hour per policy). Pt #6’s TW pre treatment was 83.5 kg and Post Weight was 84.9; 1.4 kg above TW. There was no documentation of nursing staff addressing Pt #6’s post weight being >1 kg over the TW as per policy. 10/24/2023: Pt #6’s dialysis treatment started at 10:50 AM and the nurse did not document a pre-treatment assessment until 1:37 PM; 2 hours and 47 minutes later (Should be within 1 hour per policy). Review of Pt #7 Treatment Sheet revealed the following: 10/30/2023: Pt #7’s ordered Maximum Ultrafiltration rate (UFR) is 13 Milliliter(ml)/kg/hour (Removal Goal as per policy); Pt #7’s Actual UFR during treatment was 14.1 ml/kg/hour (more than maximum ordered UFR). There was no documentation addressing why Pt #7’s UFR exceeded the prescribed rate. 10/25/2023: Pt #7’s ordered Maximum Ultrafiltration rate (UFR) is 13 Milliliter(ml)/kg/hour; Pt #7’s Actual UFR during treatment was 13.2 ml/kg/hour (more than maximum ordered UFR). There was no documentation addressing why Pt #7’s UFR exceeded the prescribed rate. 10/20/2023: Pt #7’s ordered Maximum Ultrafiltration rate (UFR) is 13 Milliliter(ml)/kg/hour; Pt #7’s Actual UFR during treatment was 13.3 ml/kg/hour (more than maximum ordered UFR). There was no documentation addressing why Pt #7’s UFR exceeded the prescribed rate. Blood Pressure Assessments and monitoring: Review of Pt #1’s Treatment Sheets revealed the following: 10/24/2023: Vital signs (including Blood Pressure (BP) and heart rate) were documented at 1:10 PM and than not again until 2:15 PM; 1 hour and 10 minutes later (should be every 30 minutes as per policy). 10/19/2023: At 2:52 PM, Pt #1’s BP was 84/54 (Systolic < 100); at 2:54 PM BP was 90/43. There was no documented evidence of a RN assessment addressing Pt #1’s low BP, as per policy. Review of Pt #3’s Treatment Sheets revealed the following: 10/19/2023: At 7:09 AM Pt #3’s BP was 148/60 and at 7:41 PM BP dropped to 97/75 (51 points); there was no documented evidence of a RN assessment addressing Pt #3’s BP drop of > 20 points as per policy. During interview with Facility Administrator (FA) A on 11/03/2023 beginning at 1:35 PM while discussing medical record findings, FA A stated the nursing staff should be documenting an assessment when BP is out of parameters. Per FA A nurses should document interventions completed when a patient has a post weight < or > 1 kg. FA A stated that the nurse should be completing a pre-treatment assessment with in 1 hour of a treatment initiation, and completing a post nursing assessment prior to the patient leaving the facility.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 29972 Based on record review and interview, staff failed to follow prescribed blood flow rates (BFR) and/or dialysate flow rates (DFR) for 4 of 7 medical records reviewed (Patients (Pt) #1, 2, 5, 6); and failed to recognize and address dialysis Adequacy when patients are not meeting goal in 2 of 7 medical records reviewed (Pt #1, 2), in a total sample of 7 medical records reviewed. Findings Include: Review of policy and procedure #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” last reviewed October 2023 revealed the following: -“If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed.” Review of policy and procedure #1-04-05 titled, “Blood Flow Problems” last reviewed October 2023 revealed the following: -“The licensed nurse will assess the patient, their vascular access and extracorporeal circuit...and include the following: Assess the effectiveness of...interventions...Determine need to reduce blood flow and extend treatment time...Notify nephrologist for further evaluation and/or interventions.” -“Document findings and interventions in patient’s electronic health record.” A review of Pt #1’s Treatment Sheets revealed orders for a BFR of 400. Review of Pt #1’s Treatment Sheets revealed the following: -On 10/28/2023 the BFR was set at 350 for the entire treatment; there were no documented interventions addressing Pt #1 not dialyzing at the prescribed BFR. -On 10/24/2023 the BFR was set at 350 for the entire treatment; there were no documented interventions addressing Pt #1 not dialyzing at the prescribed BFR. -On 10/19/2023 the BFR was set at 340 and for the entire treatment; there were no documented interventions addressing Pt #1 not dialyzing at the prescribed BFR. Review of Pt #1’s labs revealed on 09/20/2023 Pt #1’s Kt/V (Dialysis Adequacy) was 0.89 (normal >1.2). Per review of Pt #1’s Patient Plan of Care signed by the interdisciplinary team on 10/10/2023, “Maintain adequacy goal” was documented under “Adequacy.” There was no documentation of a plan to address Pt #1 not meeting the Adequacy goal. A review of Pt #2’s Treatment Sheets revealed orders for a DFR of 500. Review of Pt #2’s Treatment Sheets revealed the following: -On 10/24/2023 the DFR was set at 0 for the entire treatment; there were no documented interventions addressing Pt #2 not dialyzing at the prescribed DFR. Review of Pt #2’s labs revealed on 10/10/2023 Pt #2’s Kt/V was 0.94 (normal > 1.2). Per review of Pt #2’s Patient Plan of Care signed by the interdisciplinary team on 10/24/2023, “Maintain adequacy goal” was documented under “Adequacy.” There was no documentation of a plan to address Pt #2 not meeting the Adequacy goal. A review of Pt #5’s Treatment Sheets revealed orders for a BFR of 400. Review of Pt #5’s Treatment Sheets revealed the following: -On 10/24/2023 the BFR was set at 350 from 7:47 AM to 8:46 AM; there were no documented interventions addressing Pt #5 not dialyzing at the prescribed BFR. A review of Pt #6’s Treatment Sheets revealed orders for a BFR of 400. Review of Pt #6’s Treatment Sheets revealed the following: -On 10/31/2023 the BFR was set at 280 and/or 290 from 12:13 PM to 1:12 PM; there were no documented interventions addressing Pt #6 not dialyzing at the prescribed BFR. -On 10/28/2023 the BFR was set at 300 for the entire treatment; there were no documented interventions addressing Pt #6 not dialyzing at the prescribed BFR. -On 10/26/2023 the BFR was set at 300 for the entire treatment; there were no documented interventions addressing Pt #6 not dialyzing at the prescribed BFR. During interview with Facility Administrator (FA) A on 11/03/2023 beginning at 1:35 PM while discussing medical record findings, FA A stated that nursing staff should document an assessment and interventions if they are unable to maintain the prescribed BFR and DFR. FA A that staff should be documenting a plan in the Patient Plan of Care to address Adequacy labs that are out of paramters.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 29972 Based on record review, observation, and interview staff failed to ensure patients wash the skin over the Arteriovenous Fistula/Graft (AVF/G) access site before treatment in 1 of 2 observations of treatment initiation using an AVF/G (Patient (Pt) #8); failed to perform skin antisepsis prior to cannulation as per policy in 2 of 3 observations of treatment initiation using an AVF/G (Pt # 8, 9); and failed to assess the AVF/G after applying a clamp as per policy in 2 of 2 observations of treatment discontinuation using an AVF/G (Pt #7, 11), in a total sample of 5 patients observed with an AVF/G. Findings Include: Review of policy and procedure #1-04-01D titled, AV Fistula or Graft Cannulation...” last reviewed October 2022 revealed the following: -“Have patient wash access site with appropriate antibacterial soap...If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent and pat dry.” -“Locate and palpate the needle cannulation sites prior to skin preparation.” - Skin antiseptic--Povidone Iodine (betadine); effective contact/scrub time is 30 seconds. Review of policy and procedure #1-04-08A titled, “Utilizing Vascular Access Clamp Procedure” last reviewed April 2023 revealed the following: -“After placement of clamp, check for thrill (feel vibration indicating movement of blood) and bruit (sound of blood moving through access) above and below clamp. If thrill cannot be palpated or bruit heard, release clamp slightly and recheck until thrill can be palpated or bruit heard.” -“Clamp may remain in place for 5-10 minutes before checking to see if bleeding has stopped.” On 11/01/2023 at 12:03 PM, observed PCT H at Station 10 initiating Pt #8’s dialysis treatment using an AVF/G. PCT H removed the Band-Aid covering Pt #8’s AVF/G; PCT H did not wash the access site with soap and water prior to applying the antiseptic. PCT H cleansed the skin over the access site with betadine pad for 19 seconds (should be 30 seconds per policy) then touched access sites immediately prior to cannulating, allowing for potential contamination. On 11/01/2023 at 12:55 PM, observed PCT G at Station 9 initiating Pt #9’s dialysis treatment using an AVF/G. PCT G cleansed the skin over the access site with betadine pad for 63 seconds (should be 30 seconds per policy) then touched access sites immediately prior to cannulating, allowing for potential contamination. On 11/01/2023 at 1:15 PM, observed PCT E at Station 13 discontinuing Pt #7’s dialysis treatment using an AVF/G. PCT E applied a clamp to Pt #7’s AVF/G and did not check for bruit and thrill to ensure the access site was not occluded. On 11/01/2023 at 1:00 PM, observed PCT F at Station 14 discontinuing Pt #11’s dialysis treatment using an AVF/G. PCT F applied a clamp to Pt #11’s AVF/G and did not check for bruit and thrill to ensure the access site was not occluded. PCT F applied the clamp at 12:15 PM and did not remove the clamp and check if bleeding stopped until 12:32 PM; 17 minutes later (per policy should be 5 to 10 minutes) During interview on 11/02/2023 beginning at 4:15 PM, while discussing observations with Facility Administrator (FA) A, Clinical Services Manager (CSM) B, and Dietician C; FA A stated that betadine should be applied to skin over the vascular access site for 30 seconds. FA A stated that staff should be checking for bruit and thrill after applying clamps and the clamp should be rechecked within 10 minutes after applying.”

“POC-PT/FAMILY EDUCATION & TRAINING CFR(s): 494.90(d) The patient care plan must include, as applicable, education and training for patients and family members or caregivers or both, in aspects of the dialysis experience, dialysis management, infection prevention and personal care, home dialysis and self-care, quality of life, rehabilitation, transplantation, and the benefits and risks of various vascular access types. This Standard is not met as evidenced by: 29972 Based on record review and interview the staff failed to ensure all new patients receive education on the dialysis process/experience, infection prevention, and vascular access care in 1 of 2 new patients medical records reviewed (Patient (Pt) #2), in a total of 7 medical records reviewed. Findings Include: Review of Pt #2’s medical record on 11/02/2023 at 9:45 AM, revealed that Pt #2’s first day of dialysis treatment at the facility was on 10/10/2023 and Pt #2 was new to dialysis. Per interview with Dietician C on 11/02/2023 during Pt #2’s medical record review, Dietician C stated that she/he was unable to find documented evidence that Pt #2 had been educated on the dialysis process/experience, infection prevention, and care of the vascular access site.”

“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: 29972 Based on record review and interview, staff failed to ensure that quality indicators are reviewed and trended to identify issues in dialysis equipment repair and maintenance, and hospital readmissions within 30 days for 1 of 1 dialysis program quality data reviewed (In-center Hemodialysis), in a total of 1 dialysis program reviewed. Findings include: Review of policy and procedure #1-14-06 titled, “Continuous Quality Improvement Program” last revised April 2021, revealed the following: -“The facility will measure, analyze, and track quality indicators or other aspects of performance, The program must include, but not limited to, the following:..Review...Equipment...Hospitalizations...Continuous monitoring of the above indicators will be reflected in the meeting minutes...” Review on 11/03/2023 beginning at 2:18 PM of the Quality Program data for April 2023, May 2023, and June 2023 revealed there was no evidence of the facility reviewing and addressing dialysis equipment repair and maintenance and hospital readmissions. During interview with Facility Administrator (FA) A, while reviewing the Quality Program data on 11/03/2023 beginning at 2:18 PM, when asked if there was any documented evidence of the facility reviewing and addressing dialysis repair and maintenance and hospital readmissions in the Quality meetings, FA A stated that there was no documentation of this discussion in the Quality meeting minutes.”

“QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This Standard is not met as evidenced by: 29972 Based on record review and interview, staff failed to ensure that quality indicators are reviewed and trended to identify issues in Anemia Management for 1 of 1 dialysis program quality data reviewed (In-center Hemodialysis), in a total of 1 dialysis program reviewed. Findings include: Review of policy and procedure #1-14-06 titled, “Continuous Quality Improvement Program” last revised April 2021, revealed the following: -“The facility will measure, analyze, and track quality indicators or other aspects of performance, The program must include, but not limited to, the following:..Anemia Management...Continuous monitoring of the above indicators will be reflected in the meeting minutes...” Review on 11/03/2023 beginning at 2:18 PM of the Quality program data for April 2023, May 2023, and June 2023 revealed there was no evidence of the facility reviewing and addressing Anemia Management for patients with Hemoglobin less than 10 (Normal >10) in April 2023 and May 2023. During interview with Facility Administrator (FA) A, while reviewing the Quality program data on 11/03/2023 beginning at 2:18 PM, when asked if there was any documented evidence of the facility reviewing and addressing Anemia Management (Hemoglobin Less than 10) in the Quality meetings for April 2023 and May 2023, FA A stated that there was no documentation of this discussion in the Quality meeting minutes.”

“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: 29972 Based on record review and interview, staff failed to ensure that quality indicators are reviewed and trended to identify issues in adverse events/occurrences for 1 of 1 dialysis program quality data reviewed (In-center Hemodialysis), in a total of 1 dialysis program reviewed. Findings include: Review of policy and procedure #1-14-06 titled, “Continuous Quality Improvement Program” last revised April 2021, revealed the following: -“The facility will measure, analyze, and track quality indicators or other aspects of performance, The program must include, but not limited to, the following:..Review of trends of adverse patient occurrences...Continuous monitoring of the above indicators will be reflected in the meeting minutes...” Review on 11/03/2023 beginning at 2:18 PM of the Quality program data for April 2023, May 2023, and June 2023 revealed in April 2023 there were 5 adverse occurrences for “Gen (general) Dialysis Access Issues” and in May 2023 there were 4 adverse occurrences for “Gen (general) Dialysis Access Issues”. Review of the Quality Program data revealed there was no evidence of the facility reviewing and discussing trends in adverse occurrences and developing a plan to address. During interview with Facility Administrator (FA) A, while reviewing the Quality program data on 11/03/2023 beginning at 2:18 PM, when asked if there was any documented evidence of the facility discussing trends and commonalities in adverse occurrences for April and May 2023 Quality meetings, FA A stated that there was no documentation of this discussion in the Quality meeting minutes.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 29972 Based on record review and interview facility staff failed to ensure all Patient Care Technicians (PCT) demonstrate skills and competency to perform job duties in 1 of 4 personnel files reviewed (PCT E), in a total sample of 4 files reviewed. Findings Include: Review of the personnel file worksheet on 11/01/2023 beginning at 4:00 PM, revealed that PCT E’s most recent annual skills/competency check list was completed on 10/20/2022 (more than 1 year ago). Per interview with Facility Administrator (FA) A on 11/01/2023 at 5:10 PM, FA A stated that PCT E’s annual skills/competency check list is overdue and should have been completed prior to 10/20/2023. FA A stated a skills/competency check list should be done annually on all PCTs.”

“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: 29972 Based on observation, record review, and interview the facility failed to ensure medications are secured from unauthorized access in 1 of 1 emergency crash carts observed (In-center Hemodialysis), in a total of 1 crash cart reviewed. Findings Include: Review of policy and procedure #1-06-01 titled, “Medication Policy” last revised October 2023 revealed the following: -“Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under the supervision by the licensed teammate...” On 11/02/2023 at 8:55 AM, observed the crash cart on the treatment floor secured with a pull tab. Per observations, the crash cart contained the following medications: 4 vials of Diphenhydramin (Antihistamine), 100 tabs of Nitro (Vasodilator), 2 vials of Heparin (blood thinner), 2 injectors of Epinephrine (Adrenaline), 2 vials of Calcium Gluconate. Per interview with Facility Administrator (FA) A on 11/02/2023 beginning at 9:00 AM, FA A stated that housekeeping contracted staff clean the facility and treatment area in the evening after staff leave. Per FA A, the medication in the crash cart is not locked up at the end of the day and the crash cart remains in the treatment area.”