Davita Comprehensive Renal Care - Valparaiso

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure their staff prepared the 1:10 bleach solution per the facility’s policy, to minimize the transmission of infectious agents in 1 of 1 day of patient care operations where PCT 2 prepared the 1:10 bleach solution in preparing for the days incenter hempdialysis treatments on February 5, 2025, with the potential to affect all of the clinics patients that received HD services on February 05, 2025. Findings include: 1. A revised policy, dated October 2023, titled, “Bleach Policy,” indicated a 1:10 bleach solution was used to clean and decontaminate any environmental surface or non-disposable supplies which were visibly contaminated with blood or body fluids. 2. A revised policy, dated October 2023, titled, “Preparation of One To Ten [1:10] Bleach Solution,” indicated materials required would be a 1000 milliliter [ml] graduated cylinder calibrated in 10 ml increments. The policy indicated if mixing 500 ml of water 100 ml of bleach would be added to the cylinder. The policy indicated 10% meant 10 parts per hundred parts, or as a ratio it was written as 1 in 10 or 1:10. 3. During an observation on 02/05/2025, beginning at 9:05 PM, PCT 2 indicated she had made the bleach cleaning solution on 02/05/2025. PCT 2 indicated she had made the 1:10 bleach solution by filling the container up to the unmarked ridge with water, showed an unmarked cylinder that she filled to the top with bleach one time, and added to the water in the container. During the observation, PCT 2 indicated she did not know number measurements to make the bleach solution and was told to fill up the container with water to the ridge line and fill the bleach to the top of the cylinder. 4. During an observation on 02/05/2025, beginning at 2:45 PM, the Administrator (Administrative staff 1) used the container on the floor for the 1:10 bleach solution and filled the container with 2500 ml to the ridge of the container. The Administrator showed a similar sized cylinder to the one that PCT 2 used to make the bleach solution that had calibrations marked and indicated that 250 ml of bleach should be added to the water to make 1:10 bleach solution. During the observation, the Administrator indicated PCT 2 did not make the 1:10 bleach solution correctly on 02/05/2025 and did not use the correct cylinder that had number measurements. The Administrator indicated the cylinder that PCT 2 used to make the bleach solution would have contained 100 ml of bleach that was added to the 2500 ml of bleach and the 1:10 bleach solution was incorrect.”

“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: 47022 Based on observation, record review, and interview, the facility failed to ensure PCT 3 performed hand hygiene (hand sanitizing with an alcohol based antiseptic or hand washing) after removal of a central venous catheter [CVC] (access for hemodialysis [HD] [a process to filter the blood of a patients whose kidneys do not work normally]) dressing in 1 of 2 CVC exit site care observations, and failed to ensure PCT 1 and PCT 2 performed hand hygiene in 1 of 3 observations of arteriovenous fistula [AVF](access for HD)/arteriovenous graft [AVG](access for HD) initiations observed and in 1 of 3 AVF/AVG discontinuations observed (Patient #5, Patient #7, Patient #12, Patient #13). Findings include: 1. A revised policy, dated October 2024 and titled, “Central Venous Catheter With Clearguard HD Antimicrobial End Cap Procedure,” indicated the old CVC dressing would be removed and discarded, gloves would be removed, hand hygiene would be performed, reglove and perform cleaning of the exit site. 2. A revised policy, dated April 2023, titled, “Infection Control For Dialysis Facilities,” indicated hand hygiene would be performed after contamination with blood or other infectious materials and gloves would be changed when going from a dirty area or task to a clean area or task. 3. A revised policy, dated October 2024, titled, “AV Fistula or Graft Cannulation .... “ indicated the AVF/AVG site would be located and palpated prior to skin preparation, the site would be cleaned with alcohol prep pad, gloves would be removed, hand hygiene would be performed, and clean gloves would be put on prior to cannulation. 4. During an observation, on 02/03/2025 beginning at 10:37 AM, PCT 2 was at station #19, she was wearing gloves while discontinuing HD from Patient #12’s left arteriovenous fistula. During the observation, PCT 2 removed 1 line from the AVF and applied gauze to the site. PCT 2 manually lowered the chair /recliner, with both of her hands near Patient #12’s feet; without performing hand hygiene or changing gloves PCT 2 returned to the AVF site and removed the 2nd line. 5. During an interview, on 02/05/2025 beginning at 9:05 AM, PCT 2 indicated gloves should be changed between patients and stations, hand hygiene should be performed before and after gloves being changed, and between dirty and clean areas. 6. During an observation on 02/03/2025, beginning at 11:30 AM, PCT 3 was wearing gloves and performed CVC exit site care for Patient #13, at station #20. During the observation, PCT 3 removed the old dressing from the right CVC site, and without performing hand hygiene or changing her gloves she began to clean the CVC exit site with chloraprep (an antiseptic). 7. During an interview on 02/03/2025, beginning at 12:05 PM, PCT 3 indicated gloves should be changed and hand hygiene was to be performed after removing the old dressing from a CVC. 51199 8. During an observation, on 02/03/2025 beginning at 10:27 AM, PCT 1 was at station #1 accessing Patient # 5’s right thigh AVG for HD. PCT 1 located and palpated the cannulation site, applied antiseptic to the AVG site, and then cannulated (needle insertion) the AVG; PCT 1 failed to perform hand hygiene and don new gloves before applying antiseptic to AVG site and cannulating. 9. During an observation, on 02/03/2025 beginning at 10:52 AM, PCT 1 was at station #11, accessing Patient # 7’s left arm AVG for HD. During the observation, PCT 1 located and palpated the cannulation site, she failed to perform hand hygiene and don new gloves before she applied antiseptic to AVG site and cannulated the AVG.”

“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: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure PCT 2, PCT 3, and PCT 4 cleaned the hemodialysis [HD] (a process to filter the kidneys of a patient whose kidneys do not work normally) drain bucket and removed the clamps prior to initiating setting up of the HD station in 3 of 4 dialysis station cleaning observed ( Station #7, Station #8, Station #20). Findings include: 1. A revised policy dated April 2023, titled, “Infection Control For Dialysis Facilities,” indicated cleaning and/or disinfection of equipment would be performed following exposure to potentially infectious materials [i.e. used or brought into the station], priming containers are to be emptied prior to disinfection, and non-disposable items are to be disinfected after each patient use. The policy indicated blood line clamps should be fully submerged in an appropriate disinfectant solution. 2. During an observation on 02/03/2025, beginning at 10:05 AM, PCT 3 began to clean HD station #20, after Patient #10 had exited the facility. During the observation, PCT 3 cleaned the HD machine, chair, tv, back counter, intravenous [IV] pole, then exited station #20 and entered station #13. One clamp remained on the IV pole in station 20. During the observation, PCT 2 failed to empty and clean the drain bucket on the HD machine and failed to remove the one clamp from the IV pole and decontaminate. At 10:37 AM the clamp, on the IV pole, in station #20, remained on the IV pole without decontaimination. 3. During an observation, on 02/03/2025 beginning at 10:25 AM, PCT 4 entered station #20 with a saline bag and tubing; PCT 4 hung the saline on the IV pole, emptied the drain bucket, half full with a clear liquid, into the dirty sink, returned to station #20 and placed the drain bucket on the dialysis machine, without cleaning / decontaminating the bucket. Then PCT 4 set up the tubing on the HD machine. 4. During an interview, on 02/03/2025 beginning at 12:05 PM, PCT 3 indicated a drain bucket should be emptied and cleaned with a bleach solution at the end of each patients treatment. PCT 3 indicated that each station set up starts with 2 clamps and if 1 clamp was used and 1 remained on the IV pole both clamps should be placed in a bleach solution to clean when the station is cleaned. 5. During an observation, on 02/05/2025 beginning at 9:20 AM, PCT 2 was cleaning the HD station #7, after Patient #21 had exited the facility. During the observation, PCT 2 cleaned the HD station, 2 clamps remained on the IV pole when PCT 2 exited the station. During an observation, on 02/05/2025 beginning at 9:30 AM, PCT 2 returned to station #7 and hung a bag of saline on the IV pole and set up the HD machine tubing for the next patient; the 2 clamps, from the previous patients’ treatment, remained on the IV pole, without decontamination of the clamps. PCT 2 failed to remove the clamps prior to hanging the saline on the IV pole or setting up the HD machine tubing. During an interview, on 02/05/2025 beginning at 9:34 AM, PCT 2 indicated the 2 clamps should have been removed and new clamps set up on the IV pole between patients and she forgot to remove the clamps. 51199 6.. During an observation, on 02/03/2025 beginning at 10:17 AM, PCT 2, was at station #8 cleaning the HD station; a clamp was noted on the IV pole. PCT 2 failed to remove the clamp for disinfection. PCT 2 exited the station, and the dirty clamp remained on the IV pole. The obervation from 10:17 AM continued. At 10:23 AM, PCT 2 hung a new bag of saline onto the IV pole in station 8 and began preparation of the HD machine for initiation of a next patients’ dialysis treatment; the soiled clamp from the previous patient remained on the IV pole.”

“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: 47022 Based on record review and interview, the dialysis facility failed to evidence that 35% of their in-center hemodialysis [HD](a process to filter the blood of a patient whose kidneys do not work normally) patients, susceptible to Hepatitis B (liver infection) were offered the Hepatitis B vaccine in 12 of their 37 current patients (Patient #1, 3, 8, 9, 12, 13, 16, 19, 22, 23, 24, 25). Findings include: 1. A revised policy, dated April 2024, titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance,” indicated if the Hepatitis B antigen was negative, the total core was negative, and the antibody was less than 10 the next step would be to offer the Hepatitis B vaccination series. 2. Patient #1’s Hepatitis B core antibody, dated 12/11/2024, was negative; their Hepatitis B surface antigen, dated 01/15/2025, was negative, and Hepatitis B antibody, dated 12/11/2024 was less than 3 (susceptible to Hepatitis B virus). The clinical record failed to evidence documentation the Hepatitis B vaccine was offered or declined. 3. Patient #4’s Hepatitis B core antibody, dated 10/16/2023, was negative, their Hepatitis B surface antigen, dated 08/14/2024, was negative, and their Hepatitis B antibody, dated 04/10/2024, was less than 3. The clinical record failed to evidence documentation the Hepatitis B vaccine was offered or declined. 4. Patient #8’s Hepatitis B core antibody, dated 11/04/2024, was negative, their Hepatitis B surface antigen, dated 12/11/2024, was negative, and their Hepatitis B antibody, dated 11/04/2024, was 3. The clinical record failed to evidence documentation the Hepatitis B vaccine was offered or declined. 5. Patient #9’s Hepatitis B core antibody, dated 06/07/2023, was negative, their Hepatitis B surface antigen, dated 11/13/2024, was negative, and their Hepatitis B antibody, dated 11/06/2024, was less than 3. The clinical record failed to evidence documentation the Hepatitis B vaccine was offered or declined. 6. Patient #12’s Hepatitis B core antibody, dated 10/04/2024, was negative; their Hepatitis B surface antigen, dated 11/13/2024 was negative; their Hepatitis B antibody, dated 10/04/2024, was less than 3. The clinical record failed to evidence documentation the Hepatitis B vaccine was offered or declined. 7. Patient #13’s Hepatitis B core antibody, dated 10/16/2024, was negative; their Hepatitis B surface antigen, dated 10/16/2024 was negative; their Hepatitis B antibody, dated 10/16/2024, was 3. The clinical record failed to evidence documentation the Hepatitis B vaccine was offered or declined. 8. Patient #16’s Hepatitis B core antibody, dated 03/27/2024, was negative; their Hepatitis B surface antigen, dated 08/14/2024 was negative; their Hepatitis B antibody, dated 03/27/2024, was 5. The clinical record failed to evidence documentation the Hepatitis B vaccine was offered or declined. 9. Patient #19’s Hepatitis B core antibody, dated 09/11/2024, was negative; their Hepatitis B surface antigen, dated 09/11/2024, was negative; their Hepatitis B antibody, dated 09/11/2024, was less than 3. The clinical record failed to evidence documentation the Hepatitis B vaccine was offered or declined. 10. Patient #22 Hepatitis B core antibody, dated 10/02/2023, was negative; Hepatitis B surface antigen, dated 08/14/2024, was negative; Hepatitis B antibody, dated 04/10/2024, was less than 3. The clinical record failed to evidence documentation the Hepatitis B vaccine was offered or declined. 11. Patient #23 Hepatitis B core antibody, dated 10/25/2024, was negative; Hepatitis B surface antigen, dated 11/19/2024, was negative; Hepatitis B antibody, dated 11/19/2024 was 6. The clinical record failed to evidence documentation the Hepatitis B vaccine was offered or declined. 12. Patient #24 Hepatitis B core antibody, dated 06/14/2023, was negative; Hepatitis B surface antigen, dated 08/14/2024, was negative; Hepatitis B antibody, dated 04/10/2024, was less than 3. The clinical record failed to evidence documentation the Hepatitis B vaccine was offered or declined. 13. Patient #25 Hepatitis B core antibody, dated 09/16/2024, was negative; Hepatitis B surface antigen, dated 11/13/2024, was negative; Hepatitis B antibody, dated 09/16/2024, was less than 3. The clinical record failed to evidence documentation the Hepatitis B vaccine was offered or declined. 14. During an interview on 02/05/2025, beginning at 3:30 PM, the Administrator (Administrative staff 1) indicated there was not documentation of Patient #1 being offered the Hepatitis B vaccine nor the patient declining the vaccine while receiving treatments at antoehr ESRD Entity, that the patient had transferred from. 15. During an interview on 02/04/2025, beginning at 4:00 PM, the Administrator indicated Patients’ declination to Hepatitis B vaccine should be signed by the patient and be included in the patients’ medical record. The Administrator indicated there was no further patient documentation in patients’ charts, to be scanned documents, or the electronic medical record system documenting patients were offered or declined the Hepatitis B vaccine. 16. During an interview on 02/03/2025, beginning at 3:30 PM, the Clinical Coordinator (RN 1) indicated Hepatitis B surface antibodies were completed each year. If the surface antibody was less than 10, the patient should be offered the full series of the Hepatitis B vaccine. The Clinical Coordinator indicated Patient #9, Patient #23 and Patient #25 should have been offered the vaccine; Patient #8 and Patient #13 had yet to decide on their vaccination. Patient #16 and Patient #19 were interested in the vaccine, and Patient #1, Patient #4, Patient #12, and Patient #24 had declined the Hepatitis B vaccine and each patients’ signed declination should be in the clinical record. The Clinical Coordinator indicated he followed the Hepatitis B vaccine needs of patients on an excel sheet, however, the excel sheet, nor the information provided, was not included in the patients’ medical record.”

“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 facility failed to ensure PCT 1 and PCT 2 cleaned the arteriovenous fistula (AVF) (access into the blood vessel for hemodialysis [HD] (process to clean the blood of a patient whose kidneys do not work normally)/arteriovenous graft [AVG](HD access) site prior to cannulation (needle insertion) in 2 of 3 AVF/AVG cannulations observed (Patient #5, Patient #11). Findings include: 1. A revised policy, dated October 2024, titled, “AV Fistula or Graft Cannulation ....” indicated the AVF, and arteriovenous graft [AVG](access for HD) site would be palpated prior to skin preparation, cleaned with a 70% alcohol prep pad, and the insertion site should not be palpated once the area had been prepped. 2. During an observation on 02/03/2025, beginning at 10:15 AM, PCT 3 was initiating HD for Patient #11, at station #13. During the observation, PCT 3 palpated the cannulation site, cleaned the site with an alcohol prep pad, repalpated the 1st cannulation site and cannulated the 1st line, repalpated the 2nd cannulation site and cannulated the 2nd line without reapplying skin antiseptic. 3. During an interview on 02/03/2025, beginning at 12:05 PM, PCT 3 indicated an AVF site should be cleaned by the patient upon entrance to the facility observation floor, the site should be cleaned with an alcohol pad, auscultated (listen) to the site, and the site should be recleaned after auscultation and prior to cannulation. 51199 4. During an observation, on 02/03/2025 beginning at 10:27 AM, PCT 1 was in station #1 accessing Patient # 5’s right thigh AVG for HD. During the observation, PCT 1 applied antiseptic to the cannulation site and allowed it to dry, then repalpated cannulation site and inserted the first line, then repalpated and inserted the second line; PCT 1 failed to reapply antiseptic after each repalpation.”

“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 facility failed to ensure a dialysis prescription was written and provided for 1 of 1 Patient who was prescribed a 1 K (potassium) dialysate (Patient #3). Findings include: 1. A revised policy dated, June 2024, titled, “Adjusting Medication Doses Pursuant to Protocols,” indicated the administration procedure would include an order from a treating physician that specific therapeutic treatments are to be carried out for a specific patient, an order may be issued in writing or as a verbal order, and the physician’s order would be entered in the electronic health record and signed by the physician within 30 days. 2. A Registered Nurse Job Description indicated the nurse would analyze patient laboratory data and bring issues to the attention of the physician and document ordered laboratory work and would take and transcribe physician’s orders. 3. During an observation on 11/08/2024, beginning at 8:15 AM, Patient #3 was in the process of receiving their hemodialysis treatment, which was a 2 K 2.5 Ca (calcium) dialysate. 4. The clinical record for Patient #3 evidence Lab records which indicated Patient’s potassium level (normal level 3.5 - 5.0) on 09/27/2024 was elevated (high levels of potassium can affect heart function, muscle function) at 7.1. On 10/04/2024 their level was 5.5. On 10/16/2024, their level was elevated at 6.7. On 10/23/2024, their level was elevated at 5.7. On 11/01/2024, their level was 5.3, and on 11/06/2024 their level was normal at 4.9. A. A Physician Note, dated 10/07/2024, indicated Patient was to start a 1 K dialysate prescription due to elevated potassium levels. B. The record failed to evidence a 1 K Dialysate was requested until 10/16/2024. The request required approval which was not received until 10/21/2024. The facility received monthly deliveries. Orders were required to be placed by 09/30/2024 for delivery on 10/07/2024. For a November delivery on 11/04/2024, the order was required to be placed by 10/28/2024. C. A Hospital Discharge Planning Summary for hospital admission of 10/21/2024, discharged on 10/22/2024, indicated the Patient was hospitalized for an elevated potassium level. D. A Physician Note dated 11/04/2024 indicated Patient was to add Florinef (steroid for adrenal gland insufficiency). 5. During an interview on 11/12/2024, beginning at 1:35 PM, the Administrator indicated she was told by RN 1 to order the 1 K dialysate for Patient #3, she did not request approval of the 1 K dialysate until 10/16/2024, the facility did not have a supply of 1 K dialysate, and she did not attempt to expedite the 1 K dialysate for Patient #3. 6. During an interview on 11/12/2024, beginning at 3:36 PM, the Medical Director indicated he informed RN 1 to order the 1 K dialysate for Patient #3 on 10/07/2024. The Medical Director indicated during a recent hospitalization, further testing was completed and determined the Patient’s hormone levels were low; a new medication was started, and the Patient’s potassium level improved and therefore he told RN 1 the 1 K dialysate was not necessary. 7. During an interview on 11/13/2024, beginning at 10:10 AM, RN 1 indicated he told the Administrator on 10/07/2024 the need for 1 K dialysate for Patient #3. RN 1 indicated he did not write the order to change to the 1 K dialysate on 10/07/2024 when notified by the medical director and was waiting to write the order until the 1 K dialysate was delivered. RN 1 indicated the 1 K dialysate arrived at the facility on 11/08/2024.”