Davita Ozark 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, review of facility procedure and interview, it was determined the facility failed to ensure staff performed AVF/AVG (arteriovenous fistula/graft) site preparation per facility procedure in two of two observations conducted for AVF/AVG access for treatment initiation. This affected Patient Identifier (PI) # 6, PI # 7 and had the potential to negatively affect all patients who dialyze with an AVF/AVG at this 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: April 2022 ...Materials required: Liquid soap or other skin cleansing agent 70 % alcohol preps ...Skin antiseptic... Stethoscope... Notes: ...Procedure: 1. Have patient wash access site with...antibacterial soap...If unable...teammate will clean access...with skin cleansing agent and pat dry. 2. Perform hand hygiene. Put on PPE (personal protective equipment) ... 1. An observation to initiate dialysis with an AVF/AVG was conducted on 7/8/24 at 11:05 AM with Employee Identifier (EI) # 5, Certified Clinical Hemodialysis Technician (CCHT), at station 7 for PI # 6. After EI # 5 cleaned both access sites with a skin cleansing wipe, EI # 5 failed to remove gloves, perform hand hygiene, don clean gloves before access site antisepsis and cannulation. An interview was conducted on 7/10//24 at 12:20 PM with EI # 1, Facility Administrator, and EI # 2, Manager of Clinical Services who confirmed staff failed to follow the procedure for AVF/AVG cannulation. 2. An observation to initiate dialysis with an AVF/AVG was conducted on 7/8/24 at 11:30 AM with EI # 6, CCHT, at station 13 for PI # 7. EI # 6, gloved, evaluated the access sites with a stethoscope and palpated the sites with a gloved hand. Next EI # 6 cleaned the access sites with the skin cleansing wipe, applied alcohol preparation pads to the access sites, then cleaned each access site with one wipe using a gauze pad saturated with ExSept Plus skin antiseptic before access cannulation. EI # 6 failed to perform hand hygiene and don clean gloves after cleaning the access sites with the skin cleansing wipe. An interview was conducted on 7/10/24 at 12:20 PM with EI # 1, who confirmed staff failed to follow the facility procedure for cannulation of AVF/AVG during treatment initiation.”

“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 procedures, and interview, it was determined the facility failed to ensure staff: 1. Prepared, labeled, and stored bleach solution according to procedure. 2. Cleaned and disinfected the dialysis station between patients. This affected in two of two observations of dialysis station disinfection and had the potential to negatively affect all 47 patients who dialyzed at this facility. Findings include: Facility Procedure: 1-05-08A Title: Preparation of One to Ten (1:10) Bleach Solution Revision Date: October 2023 ...Procedure ...3. ...Bleach concentrate used after the expiration date may be ineffective... 4. Empty and rinse the disinfectant container with water...so the container is clean prior to mixing the new solution. 5. Remove previously applied mixing label, including expiration date, time, and initials...New mixing label will be applied at the completion of this procedure... 12...The solution must be changed when the maximum allowable time...exceed (24 hours) ... 13. When the solution is not being used, place a lid on the bleach container...open to air causes the solution to degrade...becomes less effective. Facility Procedure: 1-05-08B Title: Preparation of One to One Hundred (1:100) Bleach Solution Revision Date: October 2023 ...Procedure ...5. Remove previously applied mixing label ...New mixing label will be applied at the completion of this procedure... 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...b. Use an appropriate disinfectant such as 1:100 routine bleach solution for routine disinfection of environmental surfaces... ...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 ...and frequently contacted by healthcare personnel ...front and sides of the dialysis machine...countertops... ii. Priming containers... 14. Non-disposable items are to be disinfected after each patient use... 15. The chairside cart, terminals mounted on the counter, monitor and keyboards are considered clean areas. a. Wipe-able...covers are to be utilized. b. The chair side cart components will be cleaned at the end of each treatment day. e. The monitor screen is cleaned...at end of each treatment day... 1. Observations of care on 7/8/24 from 11:10 AM to 4:20 PM were conducted on the patient treatment floor. The 1:100 and 1:10 bleach containers located at the back of the treatment floor failed to contain a mix label with a 7/8/24 preparation date. An interview was conducted on 7/8/24 at 4:00 PM with Employee Identifier (EI) # 2, Manager of Clinical Services, who confirmed staff failed to ensure the bleach was labeled with the date the solution was prepared. 2. An observation for cleaning and disinfection of the dialysis station was conducted on 7/8/24 from 3:30 PM to 4:10 PM at station 1 with EI # 6, Certified Clinical Hemodialysis Technician (CCHT). On 7/8/24 at 3:30 PM, EI # 6 placed bleach cloths at the station, began station disinfection, then exited the station. At 4:05 PM, EI # 6 returned to the station, disinfected the station with the bleach cloths exposed to air and light for thirty-five minutes, potentially making the bleach solution less effective. EI # 6 failed to clean the inside of the wire basket on the dialysis machine prior to putting the blood pressure cuff in the basket. EI # 6 removed the prime container and placed the container in the dirty sink. EI # 6 failed to disinfect the prime container, allow to dry, and place the clean prime container on the dialysis machine. An interview was conducted on 7/10/24 at 12:50 PM with EI # 1, Facility Administrator, who confirmed the staff failed to store the bleach per policy and failed to disinfect the station per facility policy. 3. An observation for cleaning and disinfection of the dialysis station was conducted on 7/8/24 at 4:02 PM at station 3 with EI # 7, CCHT. EI # 7 failed to clean the blood pressure tubing and failed to disinfect the prime container. EI # 7 failed to disinfect the computer keyboard and surrounding surfaces. An interview was conducted on 7/10/24 at 12:50 PM with EI # 1, who confirmed the dialysis station was not disinfected per facility policy.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 30952 Based on observation, facility policy and interview, it was determined the facility failed to ensure multi-dose vials (MDV) were labeled when opened. This affected one of one observation for dialysis supply management and had the potential to negatively affect all 47 patients who dialyzed at this facility. Findings include: Facility Policy: Medication Policy Policy Number: 1-06-01 Revision Date: October 2022 Purpose: To provide guidance for medication management in the facility... Policy: ...29. Medications containing a preservative must be discarded 28 days after opening...Each vial is labeled with the initials of the person opening the vial and the expiration date. 1. During observations of care on 7/8/24 at 12:40 PM, a MDV of Purified Protein Derivative (PPD) was observed opened and stored in the medication refrigerator. There was no opened date, initials of who opened the MDV, or expiration date written on the vial. An interview was conducted on 7/8/24 at 12:50 PM with Employee Identifier # 3, Registered Nurse, who confirmed the PPD was opened and not labeled with an expiration date.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 30952 Based on observations, review of facility policy, and interview, it was determined the facility failed to ensure bicarbonate (bicarb) mixing systems were correctly labeled with the date the bicarb was prepared in accordance with the facility policy for one of two observations. This had the potential to affect all 47 patients who dialyzed at this facility. Findings include: Facility Specific Procedure: DaVita Ozark Dialysis 03092 Title: Better Water Dual 100 Bicarb Mixing and Delivery Using Rockwell CB (Central Bicarb)-25 Revision Date: 6/17/2020 ...Procedure... Mixing in # 1 (One) Tank 4...Add bicarb powder slowly... 6...fill level must be at exact mark... 15...verified all the water...is displaced with bicarb concentrate solution. ... 19. Verify Tank 1 is labeled with the bicarb label, including date, time, and initials. 1. A tour of the water treatment room was conducted on 7/8/24 at 11:00 AM with EI # 1. During this time, the surveyor observed the Bicarbonate concentrate mixing tank # one with approximately 40 gallons of solution labeled 7/6/24 4:45 AM. The surveyor asked EI # 1 if staff prepared bicarb today prior to patient treatments. An interview was conducted on 7/8/24 at 11:05 AM with Employee Identifier (EI) # 1, Facility Administrator, who reported bicarb was prepared daily before treatments and discarded at the end of the treatment day. EI # 1 confirmed the bicarb tank was not labeled with the preparation date.”

“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 review of medical records (MR), facility policy and interview, it was determined the facility failed to ensure staff documented the normal saline (NS) amount (s) used for prime and post treatment rinse. This deficient practice affected three of five MR reviews including Patient Identifier (PI) # 2, PI # 5, PI # 1, and had the potential to negatively affect all patients dialyzing at this facility. Findings include: Facility Policy: CWOW (Clinic Without Walls) Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment Policy: 1-03-08 Date Revised: April 2021 Purpose: To obtain...document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment... Policy: 1. Patient data will be obtained and documented ... ...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: a. Vital signs and treatment monitoring ...Monitoring. b. At a minimum, obtain and document the following: ...iv. Fluid removal and/or replacement ...13. All findings, interventions and patient response will be documented in the patient ’ s medical record. 1. PI # 2 was admitted to the facility on 8/25/22 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the Treatment Detail Reports (TDR) dated 6/24/24, 6/26/24, 7/3/24, and 7/25/24 revealed no documentation of the amount of NS administered for the prime at the start of treatment. An interview was conducted on 7/10/24 at 1:40 PM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed staff failed to document the amount of NS administered at treatment start. 2. PI # 5 was admitted to the facility on 7/23/22 with a primary diagnosis of ESRD. Review of the TDR dated 6/25/24 revealed no documentation of the amount of NS administered for the prime at the start of treatment. Review of the TDR dated 7/3/24 revealed no documentation of the amount of NS administered for the prime and no amount of NS administered for rinse at treatment end. An interview was conducted on 7/10/24 at 1:25 PM with EI # 1, who confirmed staff failed document the amount of NS administered as prime at the start of treatment and as rinse at the end of treatment. 3. PI # 1 was admitted to the facility 5/30/24 with a primary diagnosis of ESRD. Review of the TDR dated 7/3/24 revealed no documentation of the amount of NS administered for the prime at the start of treatment. An interview was conducted on 7/10/24 at 1:35 PM with EI # 1 who confirmed the staff failed to document the amount of NS administered as prime at the start of treatment.”

“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 facility procedure and interviews, it was determined the facility failed to ensure staff followed the facility procedure during one of two observations conducted with an AVF/AVG (arteriovenous fistula/graft) for dialysis initiation. This affected Patient Identifier (PI) #7 and had the potential to negatively affect all facility patients who dialyze with an AVF/AVG. Findings include: Facility Procedure Title: AV (Arteriovenous) Fistula or Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose. Procedure Number: 1-04-01E Revision Date: April 2022 ...Materials required: Liquid soap or other skin cleansing agent 70 % alcohol preps ...Skin antiseptic... Notes: ...Skin Antiseptic ...Hypochlorite (ExSept Plus)...Effective Contact Time 60 seconds, Air Drying Time 2 minutes ...Procedure: 1. Have patient wash access site with...antibacterial soap...If unable...teammate will clean access...with skin cleansing agent and pat dry. 2. Perform hand hygiene. Put on PPE (personal protective equipment). ...10. While maintain(ing) 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... 1. An observation of care to access an AVF/AVG for initiation of dialysis was conducted on 7/8/24 at 11:30 AM with Employee Identifier (EI) # 6, Certified Clinical Hemodialysis Technician at station 13 with PI # 7. EI # 6, with gloved hands, cleaned the access sites with a skin cleansing wipe, applied alcohol preparation pads to the assess sites, and wiped each access site one time with a gauze pad saturated with ExSept antiseptic solution. During antisepsis cleansing for access site, EI # 6 squeezed excess ExSept solution from the gauze onto the access site. EI # 6 failed to follow the ExSept Plus antiseptic contact time instructions, and thoroughly clean each site for 60 seconds before cannulation. An interview was conducted on 7/10/24 at 12:20 PM with EI # 1, Facility Administrator, who confirmed staff failed to prepare the AVF/AVG site using ExSept Plus per facility procedure.”

“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: 30952 Based on review of CMS (Centers for Medicare and Medicaid) Dialysis Facility Report (DFR), the facility 2023-2024 to date Mortality Reviews, facility policy, Facility Health Meeting (FHM) and FHR (Facility Health Report) documentation, and staff interviews, it was determined the CQI (Continuous Quality Improvement) Committee failed to ensure an action plan was initiated for performance improvement of facility mortality rates. This had the potential to negatively affect all 47 patients served by this facility. CMS DFR for Fiscal Year 2024 ...Standardized Mortality Ratio (SMR)... At this facility, the 2019-2022 SMR is 1.38, which is 38% more deaths than expected at this facility. Among all U.S (United States) facilities, 91 % of facilities had a four-year SMR lower than 1.38...The 2019-2022 SMR of expected deaths is 1.01 and 1.03 for your State and Network, respectively... Facility Policy: 1-14-06 Title: Continuous Quality Improvement Program Revision Date: April 2021 Purpose: To improve patient safety and outcomes...in accordance with the Quality Assessment and Performance Improvement (QAPI) requirements in the CMS Conditions for Coverage. Policy 1. Each dialysis facility will have a CQI Committee.... 2...the CQI committee to review issues and indicators regarding facility’s management and performance... 3. Written documentation and plans of action will be documented... 4. The Facility Medical Director is responsible for verifying the execution as well as participation in the Quality Improvement Program... ...7. The facility will measure, analyze, and track quality indicators...not be limited to, the following... Review of... Mortality-review of Deaths... 8. Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance...an action plan identified that will result in performance improvement and will track this change in performance over time to verify improvements are sustained. 1. A review of the facility CQI program was conducted on 7/10/24 at 1:14 PM with Employee Identifier (EI) # 1, Facility Administrator (FA) and EI # 2, Manager of Clinical Services. The surveyor asked EI # 1 how the Quality team conducts an analysis of individual patient deaths and recognize causes and contributory factors to deaths? EI # 1 reported he/she reviews last treatment record, collects death documentation from the family, physician practice, and a hospital discharge summary. EI # 1 reported death documentation is entered onto the DaVita Mortality Review Form and reviewed monthly with the medical director and quality team during the FHM. Review of the facility July 2023 through June 2024 Mortality Measurement Data documentation revealed a total of thirteen deaths. The following primary causes of death were documented: 1. August 2023-two infection deaths 2. September 2023- one “late” entry death-no cause of death was documented 3. November 2023- one cardiac death 4. December 2023-one cardiac death, one “other” death 5. January 2024-two cardiac deaths 6. February 2024-one infection death, one “other” death 7. April 2024-two cardiac deaths, one “other” death Further review of the Mortality Measurement Data documentation revealed the facility Gross Mortality Rate was 25 in July 2023, increased to 33 February 2023, increased in April 2024 to 40, and June 2024 was 36. There was no documentation a facility performance improvement plan for Mortality improvement was initiated over the past twelve months with an increase in the facility Gross Mortality Rate. An interview was conducted on 7/10/24 at 2:20 PM and EI # 1 confirmed the facility had not developed and implemented an action plan for improvement in the facility mortality rate.”