Davita Crimson 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: 41624 49894 Based on observations, review of facility policy, and staff interview, it was determined the facility failed to ensure staff performed hand hygiene per facility policy. This affected Patient Identifier (PI) # 8 and PI # 10 in two of two observations of accessing the Arteriovenous Fistula/Arteriovenous Graft (AVF/AVG), a random observation of patient care, one of two observations of cleaning the dialysis station, and PI # 9 in one of two observations of discontinuation of dialysis with an AVF/AVG, and had the potential to negatively affect all patients, visitors, and staff served by the facility. Findings include: Facility Policy: Infection Control for Dialysis Facilities Policy Number: 1-05-01 Revision Date: 4/23 Hand Hygiene 1. All teammates, Physicians, and Non-Physician will perform hand hygiene: a. Upon entering and exiting the treatment area. 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. e. After interacting with wall boxes... f. Between patients... g. Before touching clean areas such as supplies, supply cart, and chairside keyboard/mouse. ...4. It is a requirement for all DaVita teammates whose primary location is working in a facility to have only natural nails and fingernail length should not extend one quarter inch.... 1. An observation was conducted on 7/29/25 at 10:59 AM with Employee Identifier (EI) # 3, Certified Clinical Hemodialysis Technician, accessing an AVF/AVG for PI # 10 at station 7. EI # 3 failed to perform hand hygiene prior to donning new gloves three times during the observation. An interview was conducted on 7/31/25 at 2:00 PM with EI # 1, Facility Administrator, who confirmed staff failed to perform hand hygiene per facility policy. 2. A random observation was conducted on 7/29/25 at 12:27 PM. The surveyor observed EI # 3, assisting another employee at station 8. EI # 3 removed his/her gloves, exited the station, and without performing hand hygiene, sat down at the nurse’s station and began documenting in the Electronic Medical Record (EMR). EI # 3 then assisted a patient at station 4. EI # 3 failed to perform hand hygiene before changing gloves four times during the interaction at station 4. An interview was conducted on 7/31/25 at 2:00 PM with EI # 1, who confirmed staff failed to perform hand hygiene per facility policy. 3. An observation was conducted on 7/29/25 at 2:35 PM with EI # 3 cleaning and disinfecting at station 11. EI # 3 failed to perform hand hygiene prior to donning gloves and starting the station cleaning. After emptying the prime waste bucket, EI # 3 failed to perform hand hygiene and change gloves before continuing the station disinfection. An interview was conducted on 7/31/25 at 2:00 PM with EI # 1, who confirmed staff failed to perform hand hygiene per facility policy. 4. An observation was conducted on 7/30/25 at 8:50 AM with EI # 4, Patient Care Technician, discontinuing dialysis with an AVF/AVG for PI # 9 at station 1. EI # 4 failed to perform hand hygiene prior to donning new gloves two times during the observation. An interview was conducted on 7/31/25 at 2:00 PM with EI # 1, who confirmed staff failed to perform hand hygiene per facility policy. 5. An observation was conducted on 7/30/25 at 9:45 AM with EI # 3 accessing the AVF for initiation of dialysis for PI # 8 at station 5. EI # 3 failed to perform hand hygiene when changing gloves four times, after cleaning the access with soap and water, after cannulating the access, before and after documenting in the EMR, and at the completion of the procedure. EI # 3 exited and entered station 5 four times, retrieved supplies with dirty gloves, cleaned station 8, and documented in the EMR on the chairside computer at station 4, without changing gloves and performing hand hygiene. An interview was conducted on 7/31/25 at 2:00 PM with EI # 1, who confirmed staff failed to perform hand hygiene per facility policy.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 49894 Based on observation, facility policy and staff interview, it was determined the facility failed to store supplies per the facility policy. This deficient practice had the potential to negatively affect all 69 patients dialyzed at the facility. Findings include: Facility Policy: Infection Control for Dialysis Facilities Policy Number: 1-05-01 Revision Date: 4/23 Purpose: To minimize the spread of infections...in the dialysis facility environment. ...Supplies: 8. Supplies will be stored in a manner that maintains their integrity. ...b. Expiration date and package integrity will be verified prior to use. ...d. Anytime the integrity of a package with or without an expiration date is in question...the package and its contents must be disposed of and not used. A flash tour of the patient treatment area was conducted on 7/29/25 at 11:30 AM. The surveyor observed the following expired supplies in the lab area: An open pack of green top vaccutainer tubes (used for obtaining blood samples for lab testing) containing 72 out of 100 tubes with an expiration date of 4/30/25. The expired tubes were available for patient use. Three bags containing the expired green tubes with patient labels on them were on the countertop in the lab area. The drawer in the lab area contained 41 three milliliter syringes with attachable needles with an expiration date of 3/31/25, available for patient use. An interview was conducted on 7/31/25 at 2:00 PM with Employee Identifier # 1, Facility Administrator, who confirmed staff failed to store supplies per facility policy.”

“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: 41624 49894 Based on observations, facility policy, and staff interview, it was determined the facility failed to ensure staff cleaned and disinfected the dialysis station per the facility policy. This affected one of two observations of cleaning and disinfecting the dialysis station, one of two observations of preparation of the hemodialysis machine/extracorporeal circuit, and had the potential to negatively affect all 69 patients dialyzing at the facility. Findings include: Facility Policy: Infection Control for Dialysis Facilities Policy Number: 1-05-01 Revision Date: 4/23 Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ...Disinfection ...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 (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel, top, front, and sides of the dialysis machine, touchscreens, countertops). i. The wall box, drain and water supply lines are considered part of the dialysis delivery system... ii. Priming containers are to be emptied prior to disinfection... b. Dialysis station must be completely vacated by the previous patient before teammates can begin disinfection...and set up for the next patient. 1. An observation of cleaning and disinfection of dialysis station 5 was conducted on 7/29/25 at 11:35 AM with Employee Identifier (EI) # 4, Patient Care Technician (PCT). During the observation, EI # 4 failed to clean and disinfect the sides of the bedside tables, the prime bucket, wall box, hanson connectors and counter behind the dialysis machine. An interview was conducted on 7/31/25 at 2:00 PM with EI # 1, Facility Administrator, who confirmed staff failed to follow the facility policy for cleaning and disinfecting the dialysis station. 2. An observation was conducted on 7/30/25 at 10:10 AM with EI # 5, PCT, preparing the hemodialysis machine/extracorporeal circuit for the next patient treatment. After cleaning the dialysis machine, EI # 5 placed new hemodialysis blood lines on the machine, and then cleaned the patient chair, the blood pressure cuff, and the TV remote. EI # 5 failed to clean the entire station before preparing the dialysis machine for the next patient. An interview was conducted on 7/31/25 at 2:00 PM with EI # 1, who confirmed staff failed to follow the facility policy for cleaning and disinfecting the dialysis station.”

“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: 41624 Based on medical record (MR) review, facility policy, review of the facility’s Vaccinations and Surveillance Report (VSR), and staff interview it was determined the facility failed to: 1. Offer the Hepatitis B Vaccine (HBV) to a patient newly admitted that was susceptible to Hepatitis B (Hep B). 2. Obtain a HBV declination form for patients refusing the HBV. This deficient practice affected Patient Identifer (PI) # 1, PI # 4, and one of eight patients randomly chosen from the VSR, and had the potential to affect all patients susceptible to Hepatitis B. Findings include: Facility Policy: Hepatitis B Surveillance, Vaccination, Infection Control Measures, and Isolation Guidance Policy Number: 1-05-02 Revision Date: 4/24 Policy: 1. Hep B serological status...of all patients will be known before admission to the hemodialysis facility. ...9. Documentation of current laboratory values will be accepted if adherent to routine surveillance testing. (Refer to Routine Surveillance Testing table) Routine Surveillance Testing Antigen- Negative Core-Negative Antibody- less than (<) 10 Status- Susceptible Surveillance Testing- Monthly Antigen Hep B Vaccination 10. An order will be obtained for Hep B vaccination. The patient is provided the Vaccination Information Sheet (VIS) or will decline. The completed form will be kept in the patient’s health record. 1. PI # 1 was admitted to the facility on 6/18/25 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the MR revealed PI # 1 was tested for Hep B on 6/18/25 and results indicated PI # 1 was susceptible to Hep B. There was no documentation PI # 1 was offered or received the HBV. An interview was conducted on 7/31/25 with Employee Identifer # 2, Manager of Clinical Services, who confirmed there was no documentation the vaccine was offered or administered. 49894 2. PI # 4 was admitted to the facility on 2/13/24 with a primary diagnosis of ESRD. Review of the Patient Summary Report (PSR) dated 7/29/25 revealed Immunology Test for Hep B Antibodies on 6/3/25, which revealed he/she was susceptible. The Vaccinations section of the PSR revealed PI # 4 had received two of the four required HBV on 12/18/23 and 4/25/24. For doses ordered on 5/30/24, 7/25/24, and 7/27/24 it was documented the patient refused the vaccine. There was no documentation of a HBV declination in the patient’s MR. An interview was conducted on 7/31/25 at 2:00 PM with EI # 1, Facility Administrator, who confirmed staff failed to obtain a HBV declination for PI # 4, who was susceptible to Hep B and refused the HBV. 3. A review of the facility’s VSR was conducted on 7/31/25 at 10:00 AM. Eight random susceptible patients with HBV refusals documented were chosen from the VSR. The surveyor asked for documentation of HBV declination forms. One of the eight patients chosen did not have documentation of the HBV declination form in the MR. An interview was conducted on 7/31/25 at 12:45 PM with EI # 1, who confirmed staff failed to obtain a HBV declination for a susceptible patient who refused the HBV.”

“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: 41624 49894 Based on review of medical records (MR), facility policy, and staff interview, it was determined the facility failed to ensure staff: 1. Notified the physician for post treatment weights greater than one kilogram (kg) over the patient’s prescribed target weight. 2. Maintained the prescribed Ultrafiltration Rate (UFR-rate at which fluid is removed during treatment). 3. Reported high Blood Pressure (BP) to the physician. This affected Patient Identifier (PI) # 2, PI # 3, PI # 4, and PI # 6 in four of seven MRs reviewed and had the potential to negatively affect all 69 patients dialyzing at the facility. Findings include: Facility Policy: Pre-Intra-Post Treatment Data Collection, Monitoring, and Assessment Policy Number: 1-03-08 Revision Date: 4/24 Policy: Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. Data collection includes but is not necessarily limited to: ...ii. Measurement of BP 1. Sitting and standing BP measurement required pre and post treatment... 2. Intradialytic BP... iv. Patient weight 2. The Nursing assessment will be performed and documented by a licensed nurse... a. The assessment includes the following components: ...iii. Verification of prescription including machine parameters... 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of dialysis...The prescription components are confirmed by a licensed nurse within one hour of treatment initiation... Prescription components include but are not limited to: ...d. UFR and Max UFR... Pre-Treatment Data Collection/Assessment 4. Any abnormal findings...discovered during pre-treatment data collection will be reported to the licensed nurse... 6. The licensed nurse will use his/her clinical judgment...to determine if any clinical interventions are necessary. The physician (or non physician practitioner will be notified... Intradialilytic Data Collection/Assessment ...9. Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: a. Vital signs and treatment monitoring: iii. ...are completed at least every thirty minutes. b. At a minimum, obtain and document the following: i. BP... iv. Fluid removal and/or replacement... 11. Abnormal findings...will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment...to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician or non-physician provider as needed of changes in patient status... Post-Treatment Data Collection/Assessment ...16. If an abnormal finding is identified post-treatment, ...reported to the licensed nurse... 17. Licensed nurse will use their clinical judgment...to determine if any clinical interventions or notification of the physician...is necessary prior to discharge of the patient from the facility. Abnormal Findings Unless other abnormal parameters are established by the facility Governing Body (GB) and documented in the GB Meeting minutes, the following are considered abnormal and should be reported to the licensed nurse... Fluid Status: Pre-treatment: ...Removal goal is not to exceed the maximum ordered by the physician. Post-treatment: If patient is above or below one kilogram (kg) from the target weight Blood pressure Pre-Dialysis: Systolic greater than 180 millimeter/mercury (mm/Hg), Diastolic greater than or equal to 100 mm/Hg Blood Pressure Intradialytic: Systolic greater than 180 mm/Hg, Diastolic greater than 100 mm/Hg Blood Pressure Post-Treatment: If the patient can stand: Standing systolic BP greater than 140 mm/Hg, Standing diastolic BP greater than 90 mm/Hg 1. PI # 2 was admitted to the facility on 6/2/23 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the Patient Summary Report (PSR) revealed Hemodialysis orders dated 6/26/25 for a prescribed target weight (PTW) of 62.5 kilograms (kg). Review of Treatment Details Reports (TDR) dated 7/16/25, 7/23/25 and 7/25/25 revealed PI # 2 had a post treatment weight greater than one kg above his/her PTW and there was no documentation the physician was notified. An interview was conducted on 7/31/25 at 11:07 AM with Employee Identifier (EI) # 2, Manager of Clinical Services, who confirmed staff failed to notify the physician of the post treatment weights greater than one kg above the PTW. 2. PI # 3 was admitted to the facility on 4/23/25 with a primary diagnosis of ESRD. Review of the PSR dated 7/29/25 revealed hemodialysis orders that included a PTW of 86 kg and a max UFR of 13/milliters/kg/hour. Review of the TDRs dated 7/16/25, 7/23/25, and 7/25/25 revealed a post treatment weight greater than one kg above the PTW with no documentation the physician was notified. Review of the TDRs dated 7/16/25, 7/23/25, and 7/25/25 revealed staff failed to maintain the UFR per the physician’s order. An interview was conducted on 7/31/25 at 2:30 PM with EI # 2, who confirmed staff failed to notify the physician of post treatment weights greater than one kg above the PTW and maintain the UFR per the physician’s order. 3. PI # 4 was admitted to the facility on 2/13/24 with a primary diagnosis of ESRD. Review of the PSR dated 7/29/25 revealed hemodialysis orders that included a UFR of 13 milliliters/kg/hour. Review of the TDRs dated 7/15/25, 7/17/25, and 7/22/25 revealed staff failed to maintain the UFR per the physician’s order. Review of the TDRs dated 7/15/25, 7/17/25, 7/22/25, and 7/24/25 revealed pre-treatment BP, intradialytic BP, and post-treatment BP greater than 180 Systolic and 100 Diastolic were not reported to the physician. Review of the TDR dated 7/26/25 revealed pre-treatment and intradialytic BP greater than 180 Systolic and 100 Dialstolic were not reported to the physician. An interview was conducted on 7/31/25 at 2:36 PM with EI # 1, Facility Administrator, who confirmed staff failed to maintain the UFR per the physician’s order and report abnormally high pre-treatment BP, intradialytic BP, and post-treatment BP to the physician. 4. PI # 6 was admitted to the facility on 9/9/22 with a primary diagnosis of ESRD. Review of the PSR revealed Hemodialysis orders dated 6/16/25 for a PTW of 90 kg. Review of the TDR dated 7/16/25 revealed PI # 6 had a post treatment weight greater than one kg above his/her PTW and there was no documentation the physician was notified. An interview was conducted on 7/31/25 at 11:31 AM with EI # 2 who confirmed staff failed to notify the physician of the post treatment weight greater than one kg above the PTW.”

“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: 49894 Based on observation, review of facility policy and procedure, and staff interview, it was determined the facility failed to ensure staff followed the facility policy for preparing the Arteriovenous Fistula/Arteriovenous Graft (AVF/AVG) for cannulation. This affected Patient Identifier (PI) # 8 in one of two observations of accessing the AVF/AVG for initiation of dialysis and had the potential to negatively affect all patients dialyzing at the facility with an AVF/AVG. Facility Policy: AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles and Administration of Heparin Loading Dose Policy Number: 1-04-01E Revision Date: 4/25 Skin Antiseptic: Povidone Iodine Effective Volume: At least one prep pad per site Effective Contact Time: 30 Seconds Air Drying Time: 2 minutes Skin Antiseptic: Isopropyl Alcohol 70 percent (%) Effective Volume: At least 4 prep pads per site Effective Contact Time: 60 seconds Air Drying Time: 15 seconds Procedure: ...10. While maintaining aseptic technique, prep each planned needle site by applying a 70 % alcohol prep pad to each site using a circular motion, center out. Rationale: Using a single 70 % alcohol prep pad removes skin oil and debris from the skin surface only. This is not antisepsis for cannulation. 11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular motion, moving from the center out and allow to dry... 26. Repeat steps for second site. An observation was conducted on 7/30/25 at 9:45 AM with Employee Identifier (EI) # 3, Certified Clinical Hemodialysis Technician, accessing the AVF for initiation of dialysis for PI # 8 at station 5. EI # 3 cleaned the entire access at once with one 70 % alcohol prep pad for 30 seconds and allowed to dry for less than ten seconds. EI # 3 then cleaned the entire access at once with one povidone iodine pad for thirty seconds and allowed to dry. EI # 3 failed to clean each cannulation site separately, for the effective contact time, and allow to dry per the facility policy. An interview was conducted on 7/31/25 at 2:00 PM with EI # 1, Facility Administrator, who confirmed staff failed to follow the facility policy for preparing the AVF/AVG for cannulation.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 49894 Based on observation, review of facility policy and procedure, and staff interview, it was determined the facility failed to ensure staff performed auscultation and palpation of an Arteriovenous Fistula (AVF) prior to cannulation. This affected Patient Identifier (PI) # 8 in one of two observations of accessing the AVF/Arteriovenous Graft (AVG) for initiation of dialysis and had the potential to negatively affect all patients dialyzing at the facility with an AVF/AVG. Findings include: Facility Policy: AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles and Administration of Heparin Loading Dose Policy Number: 1-04-01E Revision Date: 4/25 Procedure: ...5. Perform inspection, auscultation, and palpation on entire length of access. Determine presence of bruit and thrill. Rationale: ...5. The presence of a bruit and thrill indicates flow through the access. 1. An observation was conducted on 7/30/25 at 9:45 AM with Employee Identifier (EI) # 3, Certified Clinical Hemodialysis Technician, accessing the AVF for initiation of dialysis for PI # 8 at station 5. EI # 3 failed to palpate and auscultate the access prior to prepping the access for cannulation. An interview was conducted on 7/31/25 at 2:00 PM with EI # 1, Facility Administrator, who confirmed staff failed to auscultate and palpate the AVF prior to cannulation per the facility policy.”