Davita Brownsburg 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: 44232 Based on observation, record review, and interview, the facility failed to ensure the staff instructed the patients on the proper use of hand hygiene after holding their access with a gloved hand during 1 of 3 treatment floor observations. (Patients: #11 and 10) (Employee: Registered Nurse (RN) 1 (twice)) Findings Include: 1. A review of a DaVita Incorporated policy revision dated April 2023, titled “Infection Control For Dialysis Facilities,” was provided by the Facility Administrator on 07-10-2024 at 1:38 PM. The policy indicated but was not limited to, “ ... Patients and caregivers will be encouraged to ... Perform hand hygiene after treatment before leaving the treatment area ... “ 2. On 07-09-2024 at 1:22 PM, the facility administrator provided facility documents dated 02-14-2024 through 06-16-202, titled “Monthly Infection Control Audit.” The documents indicated a review of infection control treatment floor observation audits completed by the Clinical Coordinator, Admin 4. 3. During an observation on 07-09-2024 at 2:40 PM, RN 1 discontinued the treatment for Patient #30 at Station #5. Patient #30 held pressure on their left upper vascular access site with a right gloved hand. RN 1 applied a new dressing to Patient #30’s access, and Patient #30 discarded their glove in the trash receptacle beside their chair. Patient #30 folded their blanket, and RN 1 assisted Patient #30 to the scale and obtained their weight strip. Patient #30 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment area. 4. During an observation on 07-09-2024 at 2:45 PM, RN 1 discontinued the treatment for Patient #11 at Station #10. Patient #11 held pressure on their right upper vascular access site with a left gloved hand. RN 1 applied a new dressing to Patient #11’s access, and Patient #11 discarded their glove in the trash receptacle beside their chair. RN 1 assisted Patient #11 to the scale and obtained their weight strip. Patient #11 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment area. 5. On 07-11-2024, a review of the employee record for RN 1 date of hire 02-12-2024, contained a document titled “Star Learning.” The document indicated RN 1 successfully completed mandatory exposure control, bloodborne pathogen, and infection control training on 02-14-2024. During an interview on 07-11-2024 at 12:45 PM, the RN 1 confirmed the patients were to be offered hand sanitizer or instructed to perform hand hygiene prior to leaving the treatment area after holding their access with a gloved hand.”

“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: 44232 Based on observation, record review, and interview, the agency failed to ensure all items were stored without risk of exposure to contaminants in 2 of 3 treatment floor observations. Findings Include: 1. A review of a DaVita Incorporated policy revision dated April 2018, titled “Physical Environment,” was provided by the Facility Administrator on 07-10-2024 at 8:00 AM. The policy indicated but was not limited to, “ ... The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public ... provide needed care and services, prevent cross contamination ... “ 2. On 07-09-2024 at 10:15 AM, observed during the flash tour a jug of Naturalyte dialysate solution ¼ full, 1 box of large gloves on the surround wall unit shelf behind Station #5. Observed a ½ jug full of Naturalyte dialysate on the floor under the wall unit shelf. 3. On 07-10-2024 at 8:45 AM, observed 2 boxes of gloves and an arm cushion on the surround wall unit shelf behind station #5. During an interview on 07-10-2024 at 12:49 PM, when queried regarding items on the wall unit shelf, the Patient Care Technician (PCT) 1 indicated nothing was to be on the wall unit shelf. PCT 1 further confirmed gloves were on the wall unit shelf.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 47022 Based on observation, record review and interview, the dialysis facility failed to follow the facility’s infection control policy during a dressing (bandage) change of a central venous catheter (CVC)(access for Patient to receive hemodialysis [process of filtering the blood of a Patient whose kidneys don’t work properly]) in 1 of 1 CVC dressing changes performed by a PCT (Patient #18). (Employee: Patient Care Technician (PCT) 2) Findings include: 1. A revised policy dated 10/2023, titled, “Central Venous Catheter ... Procedure,” indicated the CVC site should be cleaned using a back-and-forth pattern from the insertion site to the periphery (outer edge of an area) using chlorhexidine (antiseptic). 2. During an observation of Patient #18 on 07/10/2024, beginning at 11:47 AM, PCT 2 was observed removing the dressing from the right CVC site, then swabbed in a circular motion using chloraprep starting from the periphery to the insertion site of the CVC, PCT 2 was observed using another chloraprep swab and started cleaning from the right neck down to the insertion site using a back-and-forth motion and then applied a dressing. 3. During an interview on 07/10/2024, at 12:40 PM, PCT 1 indicated a CVC should be cleaned with chloraprep from inside near insertion site to outside. 4. During an interview on 07/10/2024, at 12:47 PM, PCT 3 indicated a CVC should be cleansed with chloraprep from top to bottom and then up and down.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to provide a safe and conformable environment for 1 of 1 stand-alone in-center dialysis facilities. Findings include: 1. A review of a DaVita Incorporated policy revision dated April 2018, titled “Physical Environment,” was provided by the Facility Administrator on 07-10-2024 at 8:00 AM. The policy indicated but was not limited to, “ ... The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates and the public ... “ 2. On 07-09-2024 at 9:40 AM, observed 6 blue chairs with the seat cushions torn and in disrepair in the main lobby upon entering the dialysis facility. During an interview on 07-09-2024 at 2:04 PM, the Facility Administrator (FA) confirmed the front lobby chairs needed replacing. The FA further indicated they had noticed the chairs were torn but had not completed a work order for repair or replacements.”

“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: 47022 Based on record review and interview the dialysis facility failed to ensure the Registered Nurse (RN) assessment was completed within 1 hour of the patient’s hemodialysis (process for filtering the blood of a patient whose kidneys do not work properly) start time in 4 of 5 clinical records reviewed (Patient #1, #3, #7, #8); and failed to address the orthostatic hypotension (a drop in blood pressure when a person stands up) in 1 of 2 clinical records reviewed with a documented orthostatic hypotension post treatment (Patient #5). (Employees: Registered Nurse (RN) 2) Findings include: 1. A revised policy dated April 2024, titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” indicated the licensed nurse would complete the nursing assessment within one (1) hour of dialysis treatment initiation. The policy indicated the Patient Care Technician (PCT) would report abnormal findings or concerns post treatment to the licensed nurse, and the licensed nurse would use their clinical judgement to determine if any clinical interventions or physician notification was necessary prior to discharge of the patient from the facility. 2. On 07/10/2024, the clinical record for Patient #1 was reviewed. The record contained facility documents titled, “Treatment Details Report”. A review of the treatment sheets dated 06/11/2024 through 07/08/2024, for Patient #1, evidenced the following: A. The treatment sheet dated 06/12/2024 indicated that PCT 3 started the hemodialysis treatment at 11:04 AM and RN 2 completed the pre-treatment assessment at 4:04 PM. B. The treatment sheet dated 06/26/2024 indicated that RN 2 started the hemodialysis treatment at 10:48 AM and RN 2 completed the pre-treatment assessment at 1:15 PM. C. The treatment sheet dated 07/01/2024 indicated the hemodialysis started at 10:57 AM and RN 2 completed the pre-treatment assessment at 2:07 PM. D. The treatment sheet dated 07/05/2024 indicated that RN 2 started the hemodialysis treatment at 11:02 AM and RN 2 completed the pre-treatment assessment at 1:53 PM. The treatment data sheets for 06/12/2024, 06/26/2024, 07/01/2024, and 07/05/2024 failed to evidence documentation why the RN assessment was not completed within 1 hour of the hemodialysis start time as per the facility policy. 3. On 07/10/2024, the clinical record for Patient #3 was reviewed. The record contained facility documents titled, “Treatment Details Report”. A review of the treatment sheets dated 06/11/2024 through 07/08/2024, for Patient #3, evidenced the following: A. The treatment sheet dated 06/20/2024 indicated PCT 3 started the hemodialysis treatment at 11:01 AM and RN 2 pre-assessment was completed at 1:59 PM. B. The treatment sheet dated 07/04/2024 indicated the PCT started the hemodialysis treatment at 11:10 AM and RN 2 completed the pre-assessment at 2:26 PM. C. The treatment sheet dated 07/06/2024 indicated RN 2 started the hemodialysis treatment at 11:10 AM and RN 2 completed the pre-assessment at 2:46 PM. The treatment sheets dated 06/20/2024, 07/04/2024, and 07/06/2024 failed to evidence documentation why the RN pre-assessment was not completed within the 1 hour of the hemodialysis start time as per the facility policy. 4. On 07/10/2024, the clinical record for Patient #8 was reviewed. The record contained facility documents titled, “Treatment Detail Report”. A review of the treatment sheets dated 06/10/2024 through 07/08/2024, for Patient #8, evidenced the following: A. The treatment sheet dated 06/12/2024 indicated PCT 1 started the hemodialysis treatment at 11:26 AM and RN 2 completed the pre-assessment at 2:37 PM. B. The treatment sheet dated 06/17/2024 indicated PCT 1 started the hemodialysis treatment at 11:06 AM and RN 2 completed the pre-assessment at 1:23 PM. C. The treatment sheet dated 07/05/2024 indicated PCT 2 started the hemodialysis treatment at 11:33 AM and RN 2 completed the pre-assessment at 1:39 PM. The treatment sheets dated 06/12/2024, 06/17/2024, and 07/05/2024 failed to evidence documentation on why the RN pre-assessment was not completed within 1 hour of the hemodialysis start time as per the facility policy. During an interview on 07/11/2024, beginning at 11:45 AM, the Administrator indicated the RN pre-assessment of the patient should be completed within 1 hour of the start of hemodialysis and indicated Patients #1, #3, and #8 had late RN pre-assessment completion documented and late entries should be documented. 5. On 07/10/2024, the clinical record for Patient #5 was reviewed. The record contained facility documents titled, “Treatment Details Report”. A review of the treatment sheets dated 06/10/2024 through 07/05/2024, for Patient #5, evidenced the following: A. A treatment sheet dated 06/17/2024 indicated the post treatment sitting blood pressure was 165/95 and standing blood pressure was 102/58. A systolic blood pressure (first blood pressure number indicating when heart beats blood pushing against artery walls) drop of >60 points. B. A treatment sheet dated 06/19/2024 indicated the post treatment sitting blood pressure was 163/91 and standing blood pressure was 102/62. A systolic blood pressure drop of >60 points. C. A treatment sheet dated 06/21/2024 indicated the post treatment sitting blood pressure was 173/94 and standing blood pressure was 105/71. A systolic blood pressure drop of >60 points. D. A treatment sheet dated 06/26/2024 indicated the post treatment sitting blood pressure was 161/188 and standing blood pressure was 116/65. A systolic blood pressure drop of >40 points. E. A treatment sheet dated 06/28/2024 indicated the post treatment sitting blood pressure was 161/82 and standing blood pressure was 118/70. A systolic blood pressure drop of >40 points. F. A treatment sheet dated 07/05/2024 indicated the post treatment sitting blood pressure was 184/103 and standing blood pressure was 121/79. A systolic blood pressure drop of >60 points. The treatment sheets dated 06/17/2024, 06/19/2024, 06/21/2024, 06/26/2024, 06/28/2024, and 07/05/2024 failed to evidence documentation the orthostatic blood pressures were reported to the licensed nurse, addressed by the PCT or nurse, interventions were provided, or a repeat of the orthostatic blood pressures were completed prior to the discharge of the patient from the facility. During an interview on 07/11/2024, beginning at 8:20 AM, RN 3 indicated the PCT should notify the RN of an orthostatic blood pressure drop greater than 20 points of a systolic blood pressure to be assessed by the RN. 6. During an interview on 07/11/2024, beginning at 10:53 AM, the Administrator indicated the Patient had issues with blood pressure dropping, indicated there was not documentations of interventions provided to the Patient with orthostatic hypotension, and the PCT and/or RN should have documented interventions provided to the Patient when the blood pressure drop was noted. 44232 7. On 07-11-2024, the clinical record for Patient #7 was completed. The record contained facility documents titled “Treatment Details Report.” A review of the treatment sheets dated 06-13-2024 through 07-06-2024, for Patient #7 evidenced the following: A. The treatment sheet dated 06-18-2024 indicated that the Patient Care Technician (PCT) 2 started treating Patient #7 at 6:43 AM, and RN 2 completed the pre-treatment nurse assessment at 8:35 AM, after the treatment had been initiated. B. The treatment sheet dated 06-20-2024 indicated that PCT 3 started treating Patient #7 at 6:12 AM, and RN 2 completed the pre-treatment nurse assessment at 9:23 AM, after the treatment had been initiated. C. The treatment sheet dated 06-29-2024 indicated that PCT 2 started treating Patient #7 at 6:36 AM, and RN 2 completed the pre-treatment nurse assessment at 8:28 AM, after the treatment had been initiated. D. The treatment sheet dated 07-04-2024 indicated that PCT 3 started treating Patient #7 at 6:10 AM, and RN 2 completed the pre-treatment nurse assessment at 7:39 AM, after the treatment had been initiated. During an interview on 07-11-2024 at 10:47 AM, RN 2 confirmed the pre-treatment nursing assessment was to be completed within 1 hour of the patient starting dialysis treatment.”

“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: 47022 Based on observation, record review and interview, the dialysis facility failed to ensure the dialysate flow rate (DFR) and blood flow rate (BFR) were provided to the hemodialysis (process for filtering the blood of a patient whose kidneys do not work properly) Patient as prescribed in 2 of 5 clinical records reviewed (Patient #3, #8), and observations of the prescription during hemodialysis in 2 of 7 Patients observed (Patient # 23, #24). Findings include: 1. A revised policy dated April 2024, titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” indicated the Patient’s hemodialysis prescription were to be verified by teammate prior to initiation of treatment, the prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation, and the prescription components were included but not limited to blood flow rate, dialysate flow rate and heparinization (blood thinner) during infusion. 2. Clinical record review for Patient #3 was completed on 07/10/2024 and evidenced an Order dated 07/02/2024 that indicated to discontinue heparin (blood thinner) and to start saline flush 50 ml every 30 minutes while on dialysis. On 07/04/2024 Ordered Saline Flush every 30 minutes was not given and failed to evidence documentation of why the Saline Flush was not given. On 07/06/2024 Ordered Saline Flush every 30 minutes was not given and failed to evidence documentation of why the Saline Flush was not given. On 07/06/2024 Order DFR = 600 ml/min, Patient #3 ran a DFR of 500 during treatment and failed to evidence documentation of why the DFR was not given as prescribed. During an interview on 07/10/2024, at 9:15 AM, RN 2 indicated hemodialysis machine prescriptions should match the prescribed DFR and BFR. 3. During an interview on 07/11/2024, beginning at 11:46 AM, the Administrator indicated the Patient should have received the Saline Flush every 30 minutes and should have been documented that the Saline Flush was given. The Administrator indicated the DFR was not given as prescribed and should have included documentation of why the DFR rate was changed. 4. Clinical record review for Patient #8 was completed on 07/10/2024 and evidenced the following incorrect BFR and DFR without documentation for the change in the physician’s prescribed orders: 06/12/2024 Order BFR = 400 Patient #8 ran a BFR of 350 during treatment. 06/12/2024 Order DFR = 600 Patient #8 ran a DFR of 700 during treatment. 06/17/2024 Order DFR = 600 Patient #8 ran a DFR of 700 during treatment. During an interview on 07/10/2024, at 9:15 AM, RN 2 indicated hemodialysis machine prescriptions should match the prescribed DFR and BFR. 5. During an interview on 07/11/2024, at 12:15 PM, the Administrator indicated the patient’s prescription was not given correctly as prescribed. 6. During observation on the hemodialysis treatment floor on 07/10/2024, beginning at 8:47 AM, Patient #23’s DFR was incorrect and failed to include documentation on the Treatment Sheet why the prescription was not given as prescribed. 07/10/2024, Patient #23 at Station #6 Ordered DFR = 500, Patient’s DFR was at 300 for partial treatment. During an interview on 07/10/2024, at 9:15 AM, RN 2 indicated after the facility experienced a power surge the Patient’s DFR changed to the default DFR and was not changed back to the correct DFR prescribed. 7. During observation on the hemodialysis treatment floor on 07/10/2024, beginning at 8:47 AM, Patient #24’s DFR was incorrect and failed to include documentation on the Treatment Sheet why the prescription was not given as prescribed. 07/10/2024, Patient #24 at Station #5 Ordered DFR = 500, Patient’s DFR was at 300 from 6:04 AM until 8:59 AM and treatment ended at 9:14 AM. During an interview on 07/10/2024, at 9:15 AM, RN 2 indicated the hemodialysis machine’s DFR and BFR should be given as prescribed and was not given as prescribed.”

“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: 47022 Based on observation, record review and interview, the dialysis facility failed to follow the facility’s infection control policy during cannulation (needle insertion) of an arteriovenous fistula (AVF)(entry point into the blood vessels for hemodialysis [filtering blood for a patient whose kidneys don’t work properly]) site in 2 of 6 AVF cannulations observed. (Patient #1, #21) (Employees: Registered Nurse (RN) 2, Patient Care Technician (PCT) 3) Findings include: 1. A revised policy dated 10/2022, titled, “AV Fistula or Graft Cannulation ... And Administration of Heparin Loading Dose,” indicated the AVF should be prepped by cleansing the site with skin antiseptic and do not palpate (touch) insertion site once area has been prepped (cleansed). 2. During an observation of an AVF cannulation on 07/10/2024, beginning at 11:05 AM for Patient #1 at Station #2, RN 2 cleaned the Patient’s right upper arm AVF with betadine, applied a tourniquet, palpated (touched) the upper portion of the AVF and then cannulated the AVF without recleaning the site after palpating the site and prior to cannulation. 3. During an observation of an AVF cannulation on 07/10/2024, beginning at 10:50 AM for Patient #21 at Station #3, PCT 3 cleaned the Patient’s left upper arm AVF with betadine, applied a tourniquet, palpated the upper and lower portion of the AVF and then cannulated the AVF without recleaning the site after palpating the site and prior to cannulation. During an interview on 07/10/2024, beginning at 12:47 PM, PCT 3 indicated when cannulating an AVF the site cannot be palpated after cleaning with alcohol and betadine.”