Davita North Vernon Dialysis

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [The facility must demonstrate that it follows standard infection control precautions by implementing-] (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 44230 Based on observation, record review, and interview, the facility failed to ensure biohazard supplies were discarded appropriately in 2 of 2 observations. (Patient #6, #5) Findings Include: 1. A policy titled, “Biohazardous Cleanup” indicated but was not limited to, “Teammate(s) will dispose of items used to clean the spill as well as disposable PPE in the biohazard waste receptacle or as required by state and/or local regulations”. 2. During an observation on 10/07/2024 at 9:58 AM, RN 1 completed cannulation of an Arterial Venous Fistula (AVF) on 10/07/2024 at 9:58 AM for Patient #6. A significant amount of blood had soaked through the gauze pads and under pad and these items were discarded in the regular trash. RN 1 failed to dispose of the biohazard supplies appropriately. 3. During an observation on 10/07/2024 at 10:27 AM, RN 1 discontinued treatment of an AVF on 10/07/2024 at 10:27 AM for Patient #5. A significant amount of blood had soaked through to the under pad and gauze pads and were disposed of in the regular trash. RN 1 failed to dispose of the biohazard supplies appropriately. 4. During an interview on 10/08/2024 at 11:30 AM, RN 1 indicated that blood soaked biohazard items are to be discarded in the biohazard receptacle, not the regular trash can.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 44230 Based on record review and interview the facility failed to ensure that initial Hepatitis B screenings were completed upon hire for 2 of 3 personnel records reviewed. (PCT 1, Assistant FA) Findings Include: 1. A document titled, “Morbidity and Mortality Weekly Report (MMWR)” indicated that healthcare professionals should be assessed for current or past anti-HBs results upon hire, followed by one or more additional doses of the Hepatitis B vaccine with anti-HBs <10 mIU/mL, if necessary, to ensure that HCP will be protected if they have an exposure to HBV-containing blood or body fluids. 2. The facility was unable to provide Hepatitis B screenings completed upon hire for PCT 1 and Assistant FA. 3. During an interview on 10/11/2024 at 3:05 PM, the Assistant FA indicated that the new Human Resources (HR) electronic system was replaced in 2021. All HR records were uploaded, and the originals were shredded and cannot provide initial hepatitis B screening for PCT 1 and the Assistant FA.”

“ENVIRONMENT-SCHEMATIC DIAGRAMS/LABELS CFR(s): 494.40(a) 8 Environment: schematic diagrams/labels Water systems should include schematic diagrams that identify components, valves, sample ports, and flow direction. Additionally, piping should be labeled to indicate the contents of the pipe and direction of flow. If water system manufacturers have not done so, users should label major water system components in a manner that not only identifies a device but also describes its function, how performance is verified, and what actions to take in the event performance is not within an acceptable range. This Standard is not met as evidenced by: 50833 Based on observation, record review, and interview, the facility failed to label the carbon tanks describing their functions, how performance is verified, and actions to take if not within acceptable range in 1of 1 facility reviewed. Findings include: 1. A policy titled, “Water Treatment System Minimum Components”, indicated but was not limited to, “12. All water system components will be identified with DaVita labeling, as well as manufacturer labels, to describe its function, performance and action to be taken if not in acceptable ranges .... 24. All carbon tanks will be labeled with the type of carbon, amount of cubic feet installed, the date of re-bed, or install date, [empty bed contact time] EBCT, lot number and manufacturer’s name”. 2. During an observation of the water room on 10/8/2024 at 9:05 AM, both carbon tanks lacked signage identifying the component, function, performance, and actions to be taken if not within acceptable range. 3. During an interview on 10/08/2024 at 10:40 AM, the Biomed indicated neither carbon tank had signage posted since February 2024. Biomed indicated the signs were on his desk. 4. During an interview on 10/08/2024 at 11:41 AM, RN 1 indicated she was unaware the signs were not posted on the carbon tanks. RN 1 indicated she thought the signs should identify the tanks.”

“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: 44230 Based on record review and interview the agency failed to ensure that monthly comprehensive assessments with revision to the plan of care were completed for 1 of 1 unstable patient reviewed. (Patient #1) Findings Include: 1. A policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” indicated but was not limited to, “A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted ... At least monthly for unstable patients”. 2. A document titled, “Patient Plan of Care” dated 06/19/2024 listed an assessment reason of “Annual.” 3. A document titled, “Patient Plan of Care” dated 07/31/2024 listed an assessment reason of “Unstable.” 4. A document titled, “Patient Plan of Care” dated 08/21/2024 listed an assessment reason of “Unstable.” 5. A document titled, “Patient Plan of Care” dated 10/02/2024 listed an assessment reason of “Unstable.” The facility failed to ensure unstable comprehensive assessments and plan of cares was completed monthly for September 2024. 6. During an interview on 10/09/2024 at 3:02 PM, RN 1 indicated that unstable comprehensive assessments and plan of cares are to be completed monthly. 7. During an interview on 10/08/2024 at 1:55 PM, the Regional Operations Director (ROD) 2 indicated that the comprehensive assessment and plan of care were not completed in September of 2024 for Patient #1. The electronic health record will alert staff when a plan of care is due but failed to alert for the month of September of 2024.”

“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: 44230 Based on record review and interview the agency failed to ensure that the physician prescribed Blood Flow Rates (BFR) and Dialysate Flow Rates (DFR) were followed in 4 of 5 clinical record reviewed. (Patient #1, #2, #3, #4) Findings Include: 1. A policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment”, indicated but was not limited to, “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....Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately....The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status.... All findings, interventions, and patient response will be documented in the patient’s medical record”. 2. A document titled, “Patient Summary Report” for Patient #1 indicated a physician ordered BFR of 450 and a DFR of 800. The treatment sheets from 09/23/2024--10/04/20224 for Patient #1 evidenced the following BFR and DFR: 09/23/2024: A BFR of 370 the last 31 minutes of treatment and a DFR of 600-610 throughout treatment. 09/25/2024: A DFR of 590-610 throughout treatment. 09/27/2024: A DFR of 600-610 throughout treatment. 09/30/2024: A BFR of 300-350 and a DFR of 600-610 throughout treatment. 10/02/2024: A BFR of 500 and DFR of 600-610 throughout treatment. 10/04/2024: A DFR of 600-610 throughout treatment. The facility failed to ensure Patient #1 ran a BFR and DFR per physician order and/or document a reason for the change in prescription. 3. A document titled, “Patient Summary Report” for Patient #2 indicated a physician ordered BFR of 450. The treatment sheets from 09/09/2024--10/07/20224 for Patient #2 evidenced the following BFR: 09/09/2024: A BFR of 350-400 throughout treatment. 09/25/2024: A BFR of 400 throughout treatment. 09/27/2024: A BFR of 350-400 throughout treatment. The facility failed to ensure Patient #2 ran a BFR per physician order and/or document a reason for the change in prescription. 4. A document titled, “Patient Summary Report” for Patient #3 indicated a physician ordered BFR of 400. The treatment sheets from 09/23/2024 to 10/04/2024 for Patient #3 evidenced the following BFR: 09/23/2024: A BFR of 350 throughout treatment. 09/25/2024: A BFR of 400 the first 2 minutes of treatment and a BFR of 350 throughout treatment. 09/30/2024: A BFR of 350 throughout treatment. 10/02/2024: A BFR of 200 for 31 minutes and then a BFR of 310 throughout treatment. 10/04/2024: A BFR of 350 throughout treatment. The facility failed to ensure Patient #3 ran a BFR per physician order and/or document a reason for the change in prescription. 5. A document titled, “Treatment Details Report” for Patient #4 indicated a physician ordered BFR of 400 and DFR of 600. The treatment sheets from 09/16/2024--10/02/20224 for Patient #4 evidenced the following BFR and DFR: 09/16/2024: A BFR of 350 throughout treatment. 09/18/2024: A BFR of 350 for the first 10 minutes of treatment, a BFR of 300 the remaining treatment time. 09/20/2024: A BFR of 350 throughout treatment. 09/23/2024: A BFR of 300 for the first 30 minutes of treatment. 09/30/2024: A BFR of 350 throughout treatment. 10/02/2024: A document titled, “Treatment Details Report” for Patient #4 indicated a physician ordered BFR of 350. The document evidenced a BFR of 450 throughout treatment. The facility failed to ensure Patient #4 ran a BFR per physician order and/or document a reason for the change in prescription. 6. During an interview on 10/08/2024 at 1:45 PM, RN 1 indicated that blood flow rates and dialysate flow rates ordered by the physician should be followed. If unable to obtain ordered rates, staff are to document the reason in the clinical record. 7. During an interview on 10/09/2024 at 11:13 AM PCT 1 indicated that blood flow rates and dialysate flow rates are ordered by the physician. The expectation is that these orders are followed and if unable to follow, the nurse is made aware, and the reason is documented in the clinical record. The dialysis machines default to a DFR of 600 and if the physician ordered prescription is 800, this needs to be changed. PCT 1 indicated that all prescriptions receive a second verification to ensure accuracy.”

“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: 44230 Based on observation, record review, and interview, the facility failed to follow policy when initiating an Arterial Venous Fistula (AVF) in 2 of 2 AVF observations. (Patient #6, #7) Findings Include: 1. A policy titled, “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” indicated but was not limited to, “Have patient wash access site with appropriate antibacterial soap, if able. If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent and pat dry ... While maintain aseptic technique, prep each planned needle site by applying a 70% alcohol prep pad to each site using a circular rubbing motion, center out ... While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular rubbing motion, moving from the center out and allow to dry. (For contact and dry time refer to the table above) ... Isopropyl Alcohol 70% Effective Volume: At least 4 prep pads per site ... Effective Contact Time: 60 seconds ... Air Drying Time: 15 seconds”. 2. A document titled, “Disinfection Timing” indicated but was not limited, alcohol contact time is 60 seconds with dry time of 15 seconds. 3. During an observation of an initiation of an AVF on 10/07/2024 at 9:58 AM, RN 1 was observed disinfecting the cannulation sites (point where needles are inserted in the patient’s access) with an alcohol pad for approximately 5 seconds for Patient #6. 4. During an observation on an initiation of an AVF on 10/09/2024 at 8:52 AM, PCT 1 was observed initiating an AVF for Patient #7. The cannulation sites were disinfected with an alcohol pad for 5 seconds prior to inserting the needles. 5. During an interview on 10/07/2024 at 10:10 AM, RN 1 indicated she was unsure of the access site disinfection requirement (scrub and dry time) and would refer to the policy and get back with surveyor with an answer. Could not verbalize what disinfectant was used to clean the access site for Patient #6. 6. During an interview on 10/08/2024 at 11:50 AM, RN 1 indicated that alcohol pads require a 60 second contact time for disinfection. Could not recall what disinfection (alcohol, Personal Antimicrobial Wipes (PAWS pad), or betadine) was used on Patient #6 on 10/07/2024 at 9:58 AM. 7. During an interview on 10/09/2024 at 9:35 AM, PCT 1 indicated a PAWS pad is used to clean the access of debris if the patient is unable to wash their access with soap and water. No specific contact time for the PAWS pad. An alcohol pad used for disinfection requires a 30-second dry time but was unsure of the contact time.”

“QAPI-QAPI-IMMEDIATELY CORRECT ANY IJ ISSUES CFR(s): 494.110(c) The facility must immediately correct any identified problems that threaten the health and safety of patients. This Standard is not met as evidenced by: 50833 Based on record review and interview, the facility failed to evidence appropriate actions to notify the Biomed of water test results above expected limits and document immediate action steps in 1 of 1 facility reviewed. Findings Include: 1. A policy titled, “Daily Water Treatment System Monitoring” indicated but was not limited to, “to verify the dialysis water system operates safely and reliably through daily observations and/or testing of specific component performance parameters ... All observations and test results are found outside the specified limits, follow the instructions given on the Daily Water Treatment Log for the parameter(s) in question. In addition to following the log form instructions, the teammate completing the log will notify the Facility Administrator/designee and Biomed teammate assigned to the facility of any observation or test result found outside the limit specified on the Daily Water Treatment Log”. 2. During a record review on 10/8/2024 at 2:00 PM, the water room log evidenced that the Water Hardness Test was documented above the acceptable limit of </= 1 grain per gallon on each of the following dates: 09/02/2024, 09/03/2024, 09/04/2024, 09/06/2024. Each date the water hardness was documented as 3 gr/gal. Staff failed to inform the FA, biomed or designee of the out-of-range limits. The water room log indicated, “If required, time when Biomed contacted for direction or assistance.” 3. During a record review on 10/08/2024 at 2:00 PM, the water room log evidenced that the Pure Water Flow Rate was documented below the acceptable limit of >/=15 L/min on each of the following dates: 09/02/2024 1.1 L/min, 09/03/2024 1.3 L/min, 09/04/2024 1.3 L/min, 09/06/2024 1.3 L/min, 09/09/2024 7.1 L/min, 09/11/2024 13.7 L/min, 09/13/2024 1.1 L/min, 09/14/2024, 8.9 L/min. Staff failed to inform the FA, biomed or designee of the out-of-range limits. The water room log indicated, “If required, time when Biomed contacted for direction or assistance.” 4. During a phone interview on 10/08/2024 at 2:48 PM, the Biomed indicated that staff did not notify him of the abnormal Water Hardness levels.”

“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: 44230 Based on observation, record review, and interview, the facility to lock/secure the Heparin (medication to prevent clotting of blood), with the potential to affect all patients and failed to complete a nursing assessment prior to starting the initial treatment for 1 of 1 new patient admissions reviewed, (Patient # 2) Findings Include: 1. A policy titled, “Medication Policy”, (included but not limited to) “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 or per state regulations”. 2. A policy titled, “Initial Patient Nursing Assessment for New Patients” indicated but was not limited to, “A registered nurse (RN) as required by federal regulation will perform an initial pre-treatment evaluation of all patients prior to the initiation of their first treatment at the facility”. 3 . A document titled, “Treatment Details Report” dated 08/14/2024 indicated the initial hemodialysis treatment start time of 12:44 PM. 4. A document titled, “Initial Patient Nursing Assessment” dated 08/14/2024 at 3:57 PM indicated an initial assessment was completed by RN 1. 5. During an observation on 10/09/2024 at 10:12 AM, the RN 2 demonstrated medication preparation and administration by utilizing a multidose bottle of Heparin from a drawer, however failed to evidence this drawer had a working lock to secure it. She indicated the drawer had not locked since she started her position, around four weeks prior and had not reported it to anyone. 6. During an interview on 10/07/2024 at 11:00 AM, RN 2 indicated that the drawer lock housing the Heparin was broken and was unable to be locked. RN 2 indicated that she recently hired approximately one month ago and noted that the lock has been broken since hire. 7. During an interview on 10/09/2024 at 10:10 AM, RN 2 indicated that Biomed was not made aware of the broken lock housing the Heparin on the treatment floor. 8. During an interview on 10/09/2024 at 12:13 PM, the Assistant FA indicated that the heparin drawer on the treatment floor will lock, it’s just difficult to lock, but a work order was entered and will be completed within 24 hours. 9. During an interview on 10/09/2024 at 12:13 PM, the Assistant FA indicated that the initial assessment was time stamped after treatment started but was completed prior to initiating dialysis. Unsure why the assessment shows completed after the initiation of treatment since the assessment has to be entered prior to starting the treatment. 10. During an interview on 10/09/2024 at 3:02 PM, RN 1 indicated that initial assessments must be completed prior to starting treatment for all new patients. Unsure why the electronic medical record is time stamping the assessment later than being completed.”