Davita Leeds 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: 30952 Based on observations, the Centers for Medicare and Medicaid Services (CMS) ESRD (End Stage Renal Disease) Core Survey Observations of Hemodialysis Care and Infection Control (IC) Practices, the Center for Disease Control (CDC) Hand Hygiene Guidance, the facility policy, and interviews, it was determined the facility failed to ensure: 1. Staff performed hand hygiene after AVG (arteriovenous graft) evaluation and before access site antisepsis and cannulation, in one of two observations for access of the AVF/AVG(arteriovenous fistula/graft) for initiation of dialysis including PI (Patient Identifier) # 6. 2. Patients performed hand hygiene after holding access sites and prior to leaving the treatment area in one of two observations for discontinuation of dialysis and post dialysis access care for AVF)/AVG, including PI # 7, and one random observation with an unsampled patient. 3. Staff performed hand hygiene after glove removal, before retrieving clean gloves from the glove box supply and before administration of intravenous (IV) medication, in two of three observations of IV medication preparation/administration, including PI # 6 and PI # 5. This had the potential to negatively affect all twenty-four patients who dialyze at the facility, staff, and visitors. Findings include: CMS ESRD Core Survey Version 1.6 Access of AVF or Graft for Initiation of Dialysis... ...Action ...Wash skin over access with soap and water... Evaluate access: Locate/palpate... Hand Hygiene (remove gloves, if worn); don clean gloves... Apply antiseptic to skin over cannulation sites... Insert cannulation needles... Remove gloves, hand hygiene... CDC Hand Hygiene in Healthcare Settings... Healthcare Providers ...Glove Use When and Where to Wear Gloves ...Wear gloves, according to Standard Precautions, when it can be reasonably anticipated that contact with blood or other potentially infectious materials, mucous membranes, non-intact skin, potentially contaminated skin, or contaminated equipment could occur. Gloves are not a substitute for hand hygiene. If your task requires gloves, perform hand hygiene prior to donning gloves, before touching the patient or the patient environment. Perform hand hygiene immediately after removing gloves. Change gloves and perform hand hygiene during patient care, if gloves become damaged, gloves become visibly soiled with blood or body fluids following a task, moving from work on a soiled body site to a clean body site on the same patient or if another clinical indication for hand hygiene occurs. Last Reviewed: January 8, 2021 Facility In-center Hemodialysis Policy: 1-05-01 Title: Infection Control for Dialysis Facilities Revision Date: April 2023 Policy... Hand Hygiene 1. All teammates...will perform hand hygiene ...b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact, ...g. before touching clean areas such as supplies... 2. Patients...will be encouraged to a. Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis. b. Perform hand hygiene after treatment before leaving treatment area. 3. Use of an alcohol-based hand rub may be substituted for hand washing... ...7. Gloves should be changed when: i....soiled with...dialysate or other...fluids ii. When going from a “dirty” area or task to a “clean” area or task ...iv. After touching...their dialysis delivery system... Findings include: 1. An observation of care was conducted on 1/29/24 at 11:00 AM with EI (Employee Identifier) # 5, Certified Clinical Hemodialysis Technician (CCHT), to initiate dialysis with an AVG on PI # 6 at station eleven. At 11:10 AM the surveyor observed EI # 5, with gloved hands, evaluate PI # 6’s thigh AVG, apply the antiseptic solutions, cannulate, and initiate treatment. EI # 5 failed to perform hand hygiene after access evaluation, don clean gloves, then complete access site antisepsis. An interview was conducted on 1/31/24 at 11:20 AM with EI # 1, Interim Facility Administrator and EI # 2, Director of Clinical Services who confirmed staff failed to follow infection control guidance and regulations for hand hygiene. 2. An observation of care was conducted on 1/29/24 at 11:15 AM at station eleven with EI # 3, RN (Registered Nurse). After medication preparation, EI # 3 entered the station, retrieved gloves from the clean glove supply, and donned gloves. EI # 3 failed to perform hand hygiene before accessing the clean glove supply and donning clean gloves. EI # 3 proceeded to administer the intravenous medication. 3. An observation of care was conducted on 1/29/24 at 11:30 AM at station five with EI # 4, RN. Wearing gloves, EI # 4 prepared two doses of IV heparin, exited the medication preparation area, and entered the dialysis station. EI # 4 removed/discarded the gloves, retrieved clean gloves from the clean glove supply, and donned the gloves. EI # 4 failed to perform hand hygiene before accessing the clean glove supply and donning clean gloves. EI # 4 proceeded to administer the intravenous heparin. 4. An observation of care was conducted on 1/29/24 at 11:39 AM at station nine to discontinue dialysis and post access care of an AVF/AVG with EI # 5. At 11:43 AM, the surveyor observed PI # 7 with a gloved hand, holding the access sites. At 11:50 AM, PI # 7 signed an early termination for treatment, removed the glove, exited the station to the scale, then exited the treatment floor without performing hand hygiene per facility policy. Staff failed to ensure patients performed hand hygiene after holding access sites, glove removal, and prior to leaving the treatment floor. An interview was conducted on 1/31/24 at 11:15 AM with EI # 1, and EI # 2 who confirmed staff failed to ensure patients performed hand hygiene per facility policy. 5. A random observation was conducted on 1/29/24 at 12:40 PM at station six when the surveyor observed an unsampled patient, wearing gloves, and holding the access site. At 1:10 PM, the patient, with the glove on the right hand, exited station six to the scales, call out to the staff the post treatment weight, then exited the treatment floor to the lobby with the dirty glove. Staff failed to ensure the patient removed the glove after holding the access site and performed hand hygiene before leaving the treatment floor. An interview was conducted on 1/31/24 at 11:15 AM with EI # 1, and EI # 2 who confirmed staff failed ensure the patient performed hand hygiene per facility policy.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 30952 Based on observations, review of facility policy, and interviews, it was determined the facility failed to ensure the staff cleaned and disinfected equipment before returning it to a common clean area or being used on another patient. This affected PI (Patient Identifier) # 6, PI # 9, and an unsampled patient and had the potential to affect all twenty-four patients served by this facility. Findings Include: Facility Policy Number: 1-05-01 Policy Title: Infection Control for Dialysis Facilities Revision Date: October 2020 Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ...13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings ...dialysis chair, tray tables....and frequently contacted by healthcare personnel... 14. Non-disposable items are to be disinfected after each patient use... b. Hemostats (blood line clamps) should be in the open position and fully submerged in an appropriate disinfectant solution... ...Teammate/Patient Safety ...25. Non-disposable items are to be disinfected between patients. ...34. If electronic thermometers ...are used, measures will be taken to prevent cross contamination between patients... If the potential for contamination exists, the device outercasing is wiped with an appropriate disinfectant before being returned to clean area or using on another patient. ...Dialysis Station Management ...65. Items taken into the dialysis station will be... cleaned and disinfected before taken to a common area or used on another patient... 66. Teammates will thoroughly wipe down all non-disposable items and equipment...with an appropriate disinfectant... 1. An observation for cleaning and disinfection of the dialysis station was conducted on 1/29/24 at 10:25 AM at station four with Employee Identifier (EI) # 4, Registered Nurse (RN). EI # 4 failed to remove the hemostats from the IV (intravenous) pole, failed to place the hemostats in the disinfection solution to soak, and failed to ensure the hemostat, a non-disposable item, taken to the dialysis station was disinfected. 2. During observations of care on 1/29/24 at 11:00 AM, the surveyor observed EI # 5, Certified Clinical Hemodialysis Technician, retrieve the electronic thermometer from the bleach container cart, take the electronic thermometer to station eleven, check PI # 6’s temperature, and return the thermometer to the bleach container cart, without first cleaning the thermometer, per policy. On 1/29/24 at 12:00 PM, the surveyor observed EI # 5, retrieve the electronic thermometer from the bleach container cart, check PI # 9’s temperature at station 12, then return the thermometer to the bleach container cart, without first cleaning the thermometer, per policy. At 12:02 PM on 1/29/24, EI # 4 retrieved the electronic thermometer that EI # 5 failed to clean after use, enter station two and check an unsampled patient’s temperature. An interview was conducted on 1/31/23 at 11:15 AM with EI # 1, Interim Facility Administrator, and EI # 2, Director of Clinical Services, who confirmed the hemostat and thermometer, both re-usable equipment, should be cleaned after use.”

“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: 30952 Based on observations, facility policy, and interviews, it was determined the facility failed to ensure staff followed the facility policy for cleaning and disinfection of the dialysis station in two of two observations of dialysis station disinfection. This had the potential to affect the twenty-four patients who dialyze at this facility. Findings include: Facility Policy Number: 1-05-01 Title: Infection Control for Dialysis Facilities Revision Date: April 2023 Purpose: To minimize the spread of infections or blood borne pathogens in the dialysis facility environment. Disinfection ...12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or potentially infectious materials (i.e., used or brought into the station) ...b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. ...ii. Sufficient disinfectant should be applied so that surfaces are visibly wet. iii. Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time... 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings ...dialysis chair, tray tables....and frequently contacted by healthcare personnel ... 14. Non-disposable items are to be disinfected after each patient use... b. Hemostats (blood line clamps) should be in the open position and fully submerged in an appropriate disinfectant solution... 1. An observation for cleaning and disinfection of the dialysis station was conducted on 1/29/24 at 10:25 AM at station four with Employee Identifier (EI) # 4, Registered Nurse (RN). EI # 4 cleaned the dialysis machine but failed to clean the Hansen Connectors and failed to remove the hemostats from the IV (intravenous) pole and clean the top of the IV pole. EI # 4 failed to clean the treatment chair vinyl surfaces underneath the right tabletop. An interview was conducted on 1/31/24 at 11:15 AM with EI # 1, Interim Facility Administrator, and EI # 2, Director of Clinical Services, who confirmed the dialysis station was not cleaned/disinfected per facility policy. 2. An observation for cleaning and disinfection of the dialysis station was conducted on 1/29/24 at 10:30 AM at station two with EI # 3, RN. EI # 3 removed and discarded the dialyzer and blood lines, and at 10:33 AM returned to the station and placed bleach cloths on top of the dialysis machine and at the chairside tabletop and exited the station. From 10:33 AM until 11:10 AM, the bleach cloths lay at station two, when EI # 4, RN entered the station, retrieved the bleach cloths, and cleaned the station using the bleach cloths that lay at the station for 37 minutes, uncovered and exposed to light. An interview was conducted on 1/31/24 at 11:15 AM with EI # 1 and EI # 2 who confirmed staff failed to ensure the dialysis station was disinfected between patients as the integrity of the bleach cloths could not be ensured after 37 minutes uncovered, and exposed to light.”

“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: 30952 Based on observations, facility policy and procedure, and interviews, it was determined the facility failed to ensure staff: 1. Performed Central Venous Catheter (CVC) care per facility policy in one of two CVC exit site care observations, including PI (Patient Identifier) # 4. 2. Performed a 15 second hub scrub of the CVC during disconnection from the blood lines in two of two observations for discontinuation of dialysis with a CVC, including PI # 1, PI # 8. This had the potential to negatively affect all patients with CVC’s who dialyze at the facility. Findings include: Facility Policy: Central Venous Catheter With Clearguard HD (Hemodialysis) Antimicrobial End Caps Procedure Procedure Number: 1-04-02B Revised Date: October 2023 Notes: ...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...Effective contact time, 15 seconds. Procedure ...4. Remove old dressing and discard. ...8...using aseptic technique, clean exit site with 2 % Chlorhexidine Gluconate/70 % Isopropyl Alcohol (Chloraprep) swab for a minimum of 30 seconds... 16. 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 including the sides, threads, and end of hub thoroughly with friction making sure to remove any residue, for example blood... 1. An observation was conducted on 1/29/24 at 2:25 PM at station eight with EI (Employee Identifier) # 4, Registered Nurse (RN), to observe CVC exit site care and dialysis initiation on PI # 4. During CVC exit site care, EI # 4 cleaned the CVC exit site with a Chloraprep swabstick for 20 seconds, and not the minimum 30 seconds per policy. An interview conducted on 1/31/24 at 11:15 AM with EI # 1, Interim Facility Administrator, and EI # 2, Director of Clinical Services who confirmed staff failed to follow the facility procedure for CVC exit site care. 2. An observation was conducted on 1/29/24 at 5:02 PM at station nine with EI # 3, RN, to observe discontinuation of dialysis with the CVC on PI # 1. EI # 3 removed the bloodline from the venous hub, scrubbed the hub for 10 seconds, and not the minimum 15 seconds per policy. An interview conducted on 1/31/24 at 11:15 AM with EI # 1, and EI # 2, who confirmed staff failed to follow the facility procedure for CVC hub disinfection. 3. During discontinuation of dialysis with the CVC for PI # 4 on 1/29/24 at 5:25 PM as station eight, EI # 4 disconnected the bloodline from the arterial hub, scrubbed the hub for 10 seconds, and not the minimum 15 seconds per policy. An interview conducted on 1/31/24 at 11:15 AM with EI # 1, and EI # 2, who confirmed staff failed to follow the facility procedure for CVC hub disinfection.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 30952 Based on review of the CWP (the type of water purification) Daily Water Treatment (DWT) Log documentation, and staff interviews, it was determined the facility failed to ensure staff performed and documented: 1. The CWP RO (reverse osmosis) Unit Chemical Disinfection, and Test for Chemical Residual after disinfection was performed, and the chemical consumption jug was marked with date/time, and teammate initials who completed the weekly CWP RO disinfect. 2. The End of Day Hardness Test result, and teammate initials who performed the test. This had the potential to negatively affect the twenty-four patients served by this facility. Findings include: Facility Incenter Hemodialysis Equipment, Water and Testing Devices Procedure: 2-05-01B Title: Hardness Test Using RPC Water Hardness Test Strips Revision Date: September 2015 ...Procedure ...4. Flush the post-softener sample port for 30 seconds...Obtain sample...and insert...test strip... ...7. Document test results on the Daily Water Treatment Log. 8. Notify Biomed teammate...if end of day hardness test results is greater than one (1) grain/gallon. Facility: CWP Daily Water Log Procedure: 2-04-02E Facility’s Daily Water Treatment Log Explanation Revision Date: 10/2018 ...30. End of Day Hardness Test Result, Acceptable limit(s) <= (less than equal to); Monitor Location Post Softener Sample Port; Line Item Explanations-At the end of the treatment day, perform the unit specific Hardness Test on treated water collected from the designated Post Softener Sample Port. Enter the Hardness Test result...If the Hardness Test Result is equal to or greater than 1 grain (gr) contact the Biomedical Team for direction and assistance. 31...The Teammate entering end of day hardness test result...needs to enter the time and their initials... 36. CWP RO Unit Chemical Disinfection 37. Chemical Disinfection Initiated, Time of Day, Enter the time...the “RO Chemical Disinfection” was initiated. This should be completed weekly... 38. Test for Chemical Residue After Disinfection...Using appropriate test for residual chlorine... 39. Check for chemical consumption...Note the proper consumption of Minncare is used per cycle... 1. Review of the CWP DWT log revealed no documentation the week of 1/15/24 (for days 1/15/24, 1/17/24, 1/18/24, 1/19/24), the weekly chemical disinfection was initiated, no documentation of the chemical residual test following the disinfection was completed, and no documentation of the check for chemical consumption. 2. Review of the CWP DWT log on 1/30/24 at 11:45 AM revealed no documentation on 1/29/24, the end of day Hardness test result was performed. An interview was conducted on 1/30/24 at 3:15 PM with Employee Identifier (EI) # 6, Biomedical Technician, who confirmed there was no documentation staff completed the weekly CWP chemical disinfection between 1/15/24 and 1/19/24, and no documentation the end of day water hardness test was completed on 1/29/24. An interview was conducted on 1/31/24 at 8:10 AM with EI # 1, Interim Facility Administrator who reported the Governing Body approved shortened treatments 1/15/24 and 1/17/24 treatments and a staff member was assigned to complete the weekly RO disinfect 1/18/24 when no patients dialyzed. EI # 1 confirmed there was no CWP DWT log documentation staff completed the weekly RO chemical disinfect 1/18/24. An interview was conducted on 1/31/24 at 1:15 PM with EI # 1, and EI # 2, Director of Clinical Services, who confirmed staff failed to document the CWP RO unit weekly chemical disinfect and monitoring post disinfection for the week of 1/15/24 and failed to perform the end of day hardness test on 1/29/24.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 30952 Based on observations, facility policy and procedures, and staff interviews, it was determined the facility failed to ensure staff followed facility procedure testing the pH (potential of hydrogen) of the dialysate. This affected two of two observations of preparation of the hemodialysis machine prior to treatment initiation including PI (Patient Identifier) # 6, and PI # 1. This had the potential to negatively affect the twenty-four patients who dialyze at the facility. Findings include: Facility Procedure: Testing pH For Acetate Based Dialysate Using PRC (brand) E-Z Check K100-0017 6.8-8.5 Test Strips Procedure: 2-08-01K Revision Date: October 2023 Materials required: RPC K100-00117 E-Z Check 6.8-8.5 pH Test Strips Disposable collection cup Stopwatch or clock with second hand PPE (personal protective equipment) ... Procedure 1....Remove strip from the vial and immediately recap the vial. 2. Obtain dialysate sample using a disposable collection cup, then dip the strip into the solution for one (1) second... 3. Remove the strip from the fluid and shake off excess dialysate. After 10 seconds, compare the strip to the color chart on the bottle. 4. Match the strip as closely as possible to one of color scales...and read the pH range listed above the matched color. 5. pH test results should be between 6.9-7.6. 6. If results are outside the limit...repeat test on another dialysate sample. 7. If repeat test is outside limit...the dialysis delivery system is unsafe to use for patient treatments... 8. If results are within range of 6.9-7.6, document results and proceed with dialysis set up....is within acceptable pH limits for use. 1. An observation was conducted on 1/29/24 at 10:50 AM to observe EI # 5, CCHT (Certified Clinical Hemodialysis Technician), perform conductivity and pH testing at station eleven prior to treatment initiation for PI # 6 EI # 5 collected the dialysate sample in a collection cup, entered the test station, inserted the pH test strip into the dialysate sample, moved the pH test strip back and forth for 8-10 seconds, removed the strip, compared the test strip to the color chart on the vial bottle, then read the results pH 7.4. EI # 5 failed to dip the pH test strip into the dialysate solution for one (1) second, remove the strip from the solution, shake off excess dialysate, wait 10 seconds, then compare the strip to the color chart on the bottle. An interview was conducted on 1/31/24 at 11:10 with EI # 2, Director of Clinical Services, who confirmed EI # 5 failed to follow the facility procedure for testing dialysate pH. 2. An observation was conducted on 1/29/24 at 12:35 PM to observe EI # 5 perform conductivity and pH testing at station nine prior to treatment initiation for PI # 1. EI # 5 collected the dialysate sample, entered the test station, inserted the pH test strip into the dialysate sample, moved the pH test strip back and forth for 7-8 seconds, removed the strip, and immediately compared the test strip to the color chart on the vial bottle and read the results pH 7.4. An interview was conducted on 1/31/24 at 7:00 AM with EI # 5 who confirmed he/she failed to dip the pH test strip in the dialysate, wait 10 seconds, then read the pH test results per procedure. An interview was conducted on 1/31/24 at 11:10 with EI # 2 who confirmed EI # 5 failed to follow the facility procedure for testing dialysate pH.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 30952 Based on review of the medical record (MR), the facility Hospitalizations and Treatment Behaviors log, facility policy, and interview, it was determined the facility failed to ensure the initial Plan of Care (POC) was completed within 30 days or 13 treatments for one of one record reviewed for newly admitted patients. This affected Patient Identifier (PI) # 1 and had the potential to negatively affect all patients newly admitted to this facility. Findings include: Facility Policy: Interdisciplinary Team (IDT) Patient Assessment and Plan of Care Policy Number: 1-14-01 Revision Date: July 2023 Policy: Plan of Care: ...8. The facility’s IDT will develop and implement a written, individualized comprehensive POC that specifies the services necessary... ...10. An initial POC...will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment... 1. PI # 1 was admitted to the facility on 12/6/23 with a diagnosis of Acute Kidney Injury and Diabetes Mellitus. Review of the MR revealed the initial POC was signed/dated by the Registered Nurse, Social Worker, and Provider (medical doctor) on 1/24/24, which was 49 days after admission. The patient and Registered Dietician had not reviewed/signed the Patient Plan of Care dated 1/24/24 which identified PI # 1 as a stable patient. Review of the Hospitalizations and Treatment Behaviors log documentation for December 2023 and January 2024 revealed PI # 1 dialyzed 20 times from 12/6/23 to 1/22/24. The IDT failed to complete and develop the POC for PI # 1 within 30 calendar days of admission and 13 inpatient dialysis treatments. An interview was conducted on 1/31/24 at 10:09 AM with Employee Identifier (EI) # 1, Interim Facility Administrator, and EI # 2, Director of Clinical Services, who confirmed the POC was not developed within 30 calendar days of the first outpatient dialysis treatment per facility policy.”

“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: 30952 Based on medical record (MR) reviews, facility policy, and interviews, it was determined the facility failed to ensure staff: 1. Documented the dosage of Clonidine administered. 2. Administered prn (as needed) Clonidine per physician orders. 3. Notified the physician when the post weight was greater than 1 kg (kilogram). 4. Ensured the UFR (ultrafiltration rate, which is the ratio of fluid removed to dialysis treatment time) pull was not greater than 13/mL/kg/hr (milliliters per kilogram per hour), and notified the physician when the UFR was above 13 mL/kg/hr. 5. Documented the amount of prime administered. This did affect PI (Patient Identifier) # 3, PI # 2, PI # 4 in three of five record reviews and had the potential to negatively affect all twenty-four patients who dialyze at the facility. Findings include: Facility Policy: Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment Policy Number: 1-03-08 Date Revised: October 2023 Purpose: To obtain and document baseline and ongoing information... Policy: 1. Patient data will be obtained and documented... a. Data collection includes... ...ii. Measurement of Blood Pressure... iv. Patient weight... Intradialytic Data Collection/ Assessment ...9. Intradialytic treatment monitoring and data collection which may be performed by the PCT (Patient Care Technician), or licensed nurse includes: b. At a minimum, obtain and document the following: i. Blood pressure ...iv. Fluid removal and/or replacement... 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately... 12. The licensed nurse notifies the physician... as needed of changes in patient status. 13. All findings, intervention and patient response will be documented in the patient’s MR. 14 Additional documentation includes a. All medications, including...dose... Post Treatment Data Collection/Assessment ...16. If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the...nurse... 17. Licensed nurse...determine if...notification of physician is necessary prior to discharge... Abnormal Findings Fluid Status: ...Pre-treatment: ...Removal goal not to exceed maximum ordered by physician. ...Post-treatment: If patient is above or below 1 kg from the target weight (TW). 1. PI # 3 was admitted to the facility on 3/13/23 with a diagnosis of ESRD (End Stage Renal Disease). Review of the IDT (interdisciplinary team) Rounding Worksheet (RW) revealed active medications in-center included Clonidine 0.10 mg (milligram), oral every four hours prn, if no BP response, notify provider, start date 4/3/23. Review of the Treatment Detail Report (TDR) dated 1/12/24 revealed the TW was 74.0 kg, and the PCT (Patient Care Technician) documented at 10:16 AM, treatment start, the BP (blood pressure) was 232/143, RN (Registered Nurse) aware. Further review of the 1/12/24 TDR revealed at 10:30 AM and 12:00 PM Clonidine was given. There was no documentation of the dosage of Clonidine administered. Further review of the 1/12/24 TDR revealed the post weight was 79.9 kg. There was no documentation the physician was notified of the post-treatment weight 5.9 kg above TW. Review of the TDR dated 1/15/24 revealed at 11:01 AM Clonidine 0.1 mg given, 12:00 PM, response-slight improvement, and at 12:01 PM, Clonidine 0.1 mg given. The two Clonidine’s were administered 60 minutes apart and not every four hours per the 4/3/23 order. Further review of the 1/15/24 TDR revealed the actual UFR 14.6 mL/kg/hr. There was no documentation the physician was notified the UFR was above 13 ml/kg/hr. Review of the TDR dated 1/17/24 revealed at 1:45 PM, at 2:32 PM, and 3:32 PM, Clonidine 0.1 mg was given. The Clonidine’s were administered 47 minutes apart, and 60 minutes apart, and not every four hours as ordered. Further review of the 1/17/24 TDR revealed the actual UFR 18.3 mL/kg/hr. There was no documentation the physician was notified the UFR was above 13 mL/kg/hr. Review of the TDR dated 1/19/24 revealed no documentation of the amount of prime administered. Further review of the 1/19/24 TDR revealed the TW 74.0 kg, post weight 76.5 and the actual UFR 14.4 mL/kg/hr. There was no documentation the physician was notified the post weight was 2.5 kg above TW and the UFR was above 13 mL/kg/hr. Review of the TDR dated 1/22/24 revealed the TW 74.0 kg, post weight 75.5 kg, and the actual UFR was 18.4 mL/kg/hr. There was no documentation the physician was notified the post weight was 1.5 kg above TW, and the UFR above 13 mL/kg/hr. Review of the TDR dated 1/26/24 revealed no documentation of the amount of prime administered. Further review of the 1/26/24 TDR revealed the actual UFR was 16.5 mL/kg/hr. There was no documentation the physician was notified the UFR was above 13 mL/kg/hr. An interview was conducted on 1/31/24 at 9:51 AM with Employee Identifier (EI) # 1, Interim Facility Administrator who confirmed staff failed to follow the prn Clonidine orders, notify the physician post weight greater than 1 kg, and actual UFR above 13 mL/kg/hr, and document the prime amount administered. 2. PI # 2 was admitted to the facility on 9/25/23 with a diagnosis of ESRD. Review of the TDR dated 1/19/24 revealed the TW 99.0 kg, post weight 101.1 kg. There was no documentation the physician was notified the post weight was 2.1 kg above TW. Review of the TDR dated 1/22/24 revealed the TW 99.0 kg, post weight 101.5 kg. There was no documentation the physician was notified the post weight was 2.5 kg above TW. Review of the TDR dated 1/26/24 revealed no documentation of the amount of prime administered. An interview was conducted on 1/31/24 at 10:17 AM with EI # 2, Director of Clinical Services, who confirmed staff failed to notify the physician when the post weight was greater than 1 kg above TW and document the amount of prime administered. 3. PI # 4 was admitted to the facility on 6/5/23 with a diagnosis of ESRD. Review of the TDR dated 12/29/23 revealed no documentation of the amount of prime administered. Further review of the 12/29/23 TDR revealed the actual UFR was 17.6 mL/kg/hr. There was no documentation the physician was notified the UFR was above 13 mL/kg/hr. An interview was conducted on 1/31/24 at 10:29 AM with EI # 2 who confirmed staff failed to document the prime rinse administered and notify the physician the actual UFR was above 13 mL/kg/hr.”

“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: 30952 Based on review of medical records (MR), facility policy and interviews, it was determined the facility failed to ensure staff followed the physician’s orders for Blood Flow Rate (BFR) and Dialysate Flow Rate (DFR). This deficient practice affected two of five records reviewed and did affect Patient Identifier (PI) # 5, PI # 4, and had the potential to negatively affect all 24 patients who dialyzed at this facility. Findings include: Facility Policy: Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment Policy Number: 1-03-08 Revision Date: 10/2023 Purpose: To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment... Policy: ...3. Patient identity, prescription, and machine settings are verified by teammate prior to initiation of treatment with the exception of BFR which is verified and documented when the ordered rate is obtained after onset of treatment... Intradialytic Data Collection/Assessment: ...9. ...b. At a minimum, obtain and document the following: ...iii. Blood and dialysate flows... ...10. If the dialysis prescription is not being met (including DFR or change to/inability to obtain prescribed BFR) the reason will be documented... 1. PI # 5 was admitted to the facility on 2/22/23 with a diagnosis of ESRD (End Stage Renal Disease). Review of the IDT (Interdisciplinary Team) Rounding Worksheet (RW) Active Treatment Orders dated 1/16/24 revealed PI # 5 had an ordered BFR 400 ml/min (milliliters per minute) and DFR 500 ml/min. Review of the Treatment Details Report (TDR) dated 1/22/24 revealed the DFR ran at 600 from beginning of treatment, 10:17 AM until end of treatment, 1:48 PM, and the BFR was 405 from 10:32 AM to 1:34 PM. There was no physician order for DFR 600, and BFR 405. Review of the TDR dated 1/24/24 revealed the DFR ran at 600 from beginning of treatment 10:12 AM until end of treatment 2:02 PM. There was no physician order for the 600 DFR and no reason the DFR was not delivered as ordered. Review of the TDR dated 1/26/24 revealed the DFR ran at 600 from 11:41 AM until end of treatment 2:32 PM. There was no physician order for the 600 DFR and no reason the DFR was not delivered as ordered. An interview was conducted on 1/31/24 at 10:23 AM with Employee Identifier (EI) # 2, Director of Clinical Services, who confirmed the staff failed to follow the physician order for DFR. 2. PI # 4 was admitted to the facility on 6/5/23 with a diagnosis of ESRD. Review of the TDR dated 1/3/24 revealed dialysis prescription orders for BFR 400, and DFR 500. Further review of the 1/3/24 TDR revealed the BFR was 300 and DFR was 600 from the beginning of treatment, 1:39 PM until treatment end at 4:37 PM. There was no documentation the reason the BFR was 300 and DFR 600, and no physician’s order for the BFR 300 and 600 DFR. Review of the IDT RW Active Treatment Orders dated 1/4/24 revealed PI # 4 had a prescribed BFR of 400, DFR 500. Review of the TDR dated 1/5/24 revealed the DFR was 300 from the beginning of treatment at 1:54 PM until end of treatment at 4:51 PM. There was no physician order for the DFR 300 and no reason the DFR was not delivered as ordered. Review of the TDR dated 1/8/24 revealed the DFR was 600 from beginning of treatment 2:00 PM until end of treatment 4:49 PM. There was no physician order for the 600 DFR and no reason the DFR was not delivered as ordered. An interview was conducted on 1/31/24 at 10:29 AM with EI # 2 who confirmed the staff failed to follow orders for BFR and DFR and document why the BFR was not run at the ordered rate.”

“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: 30952 Based on observations, review of the facility procedure, and interviews, it was determined the facility failed to ensure staff performed AVF/AVG (arteriovenous fistula/graft) site preparation per facility procedure in two of three observations conducted for AVF/AVG access and initiation of dialysis, including PI (Patient Identifier) # 6, and PI # 5. This had the potential to negatively affect all patients who dialyze with an AVF/AVG at the facility. Findings include: Facility Procedure Number: 1-04-01E Facility Procedure: AV (Arteriovenous) Fistula or Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose. Revision Date: October 2022 ...Materials required: Liquid soap or other skin cleansing agent 70 % alcohol preps Clean, moisture proof barrier Skin antiseptic... Notes: Check for patient sensitivity to preferred antiseptic/skin disinfectant listed in table below. Use Isopropyl Alcohol 70 % as the single skin antiseptic ONLY when the patient has documented allergies to other skin antiseptics. Notes: ...Skin Antiseptic Povidone Iodine...Effective Contact Time 30 seconds, Air Drying Time 2 minutes ...Isopropyl Alcohol 70 %...Effective Contact Time 60 seconds, Air Drying Time 15 seconds Procedure ...Procedure: 1. 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...Rationale 1. Verified that access extremity has been cleaned... 5. Perform inspection, auscultation, and palpation on entire length of access... 10. While maintaining aseptic technique, prep each planned needle site by applying a 70% alcohol prep pad to each site... 11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic... ...13. Do not palpate insertion site once area has been prepped...Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation. 16. Remove gloves, perform hand hygiene, and put on clean gloves prior to cannulation. 1. An observation of care was conducted on 1/29/24, at 11:00 AM with EI (Employee Identifier) # 5, Certified Clinical Hemodialysis Technician (CCHT), for access of an AVG for initiation of dialysis for PI # 6 at station eleven. The surveyor observed PI # 6 enter the treatment floor and proceed to the station without washing his/her access with soap and water. At 11:10 AM the surveyor observed EI # 5, with gloved hands, evaluate PI # 6’s thigh AVG, apply the antiseptic solutions, cannulate the AVG, and initiate treatment. EI # 5 failed to ensure the skin over the access was washed with soap and water before proceeding with antisepsis. An interview was conducted on 1/29/24 at 2:45 PM with PI # 6 who confirmed the AVG was not washed with soap and water before antisepsis and cannulation. An interview was conducted on 1/31/24 at 11:20 AM with EI # 1, Interim Facility Administrator, and EI # 2, Director of Clinical Services, who confirmed staff failed to follow the facility procedure for AVG access and dialysis initiation. 2. An observation of care was conducted on 1/29/24 at 11:21 AM with EI # 4, Registered Nurse (RN), at station 5 for access of an AVG for initiation of dialysis on PI # 5. The surveyor observed PI # 5 enter the treatment floor and proceed to the station without washing his/her access with soap and water. Using an alcohol pad, EI # 4 performed antisepsis to one site of the AVG for three seconds, and after dry time, performed antisepsis with a povidone pad for six seconds, then allowed the site to dry. To the second site, EI # 4 utilized another alcohol pad, performed antisepsis for eight seconds, and allowed dry time, then performed site antisepsis with a second povidone pad for eight seconds. EI # 5 failed to ensure the skin over the access was washed with soap and water before proceeding with antisepsis and failed to perform antisepsis to each access site for the minimal effective contact time of 60 seconds per facility procedure. An interview was conducted on 1/31/24 at 11:15 AM with EI # 1, and EI # 2, Director of Clinical Services, who confirmed staff failed to perform access site cleaning and antisepsis of the cannulation sites per facility procedure.”

“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: 30952 Based on medical record (MR) review, facility policy, and interview, it was determined the Medical Director failed to ensure the Registered Nurse (RN) followed the facility policy, completed, and documented an initial nurse assessment evaluation prior to initiation of the first in-center dialysis treatment, in one of one new patient record reviews including PI (Patient Identifier) # 1. This had the potential to negatively to affect all new patients admitted to this facility. Findings include: Facility Incenter Policy: 1-03-07 Title: New Patient Pre-Treatment Evaluation Revision Date: October 2017 Purpose: To provide guidance for all new patients to be evaluated by a registered nurse (RN) prior to the initiation of their first treatment at the facility. Policy: 1. A RN as required by federal regulation will perform an initial pretreatment evaluation of all new patients prior to initiation of their first treatment at the facility. ...4. This pre-treatment evaluation will be documented... 1. PI # 1 was admitted to the facility on 12/6/23 with a diagnosis including Acute Kidney Injury and Diabetes Mellitus. Review of the Treatment Details Report dated 12/6/23 revealed the initial facility dialysis treatment started at 1:19 PM, and the Initial Patient Nursing Assessment was completed on 12/6/23 at 2:18 PM, which was 59 minutes after the initial dialysis treatment start time. An interview was conducted on 1/31/24 at 10:09 AM with Employee Identifier # 2, Director of Clinical Services, who confirmed staff failed to complete and document the initial RN assessment findings prior to the initial dialysis treatment initiation.”