Davita Simi Valley Dialysis

“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: 47849 Based on observation, interview, and record review, the facility failed to monitor the 1:10 and 1:100 bleach solution containers, when: 1. The 1:100 bleach solution container on the in center hemodialysis (ICHD) treatment floor had an expired date listed as 8/24/24 and the current date was 8/26/24. 2. The 1:10 and 1:100 bleach solution containers in the home hemodialysis (HHD) nurses station were not labeled with expired dates, initials, or times. This failure had the potential to result in transmission-based infections within the facility. Findings: 1. During a concurrent observation and interview on 8/26/24 at 9:37 a.m. with Patient Care Technician 1 (PCT1) on the ICHD treatment floor at the dirty sink next to station 7, the 1:100 bleach container had the expiration date of 8/24/24. PCT 1 agreed that the bleach container date was wrong and needed to have the expiration date of 8/27/24. During a review of the facility’s policy and procedure titled, “Preparation of one to one hundred (1:100) bleach solution,” dated October 2023, indicated, “ ...12. With indelible marking pen and label, label container with expiration date, time and initials. The solutions is good for 24 hours only. The solution must be changed when the maximum allowable time is exceeded (24 hours) or when the solution becomes cloudy or turbid.” 2. During a concurrent observation and interview on 8/27/24 at 9:37 a.m. with licensed nurse (LN3) in the HHD nurses station, a container labeled bleach 1:10 and bleach 1:100 were without an expiration date, time, and initials of person who prepared. LN3 agreed that the bleach containers were not labeled with the expiration date, time and initials of person preparing and should be. During a review of the facility’s policy and procedure titled, “Preparation of one to one hundred (1:10) bleach solution,” dated October 2023, indicated, “...12. With indelible marking pen and label, label container with expiration date, time and initials. The solutions is good for 24 hours only. The solution must be changed when the maximum allowable time is exceeded (24 hours) or when the solution becomes cloudy or turbid.” During a review of the facility’s policy and procedure titled, “Preparation of one to one hundred (1:100) bleach solution,” dated October 2023, indicated,”...12. With indelible marking pen and label, label container with expiration date, time and initials. The solutions is good for 24 hours only. The solution must be changed when the maximum allowable time is exceeded (24 hours) or when the solution becomes cloudy or turbid.””

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [The facility must demonstrate that it follows standard infection control precautions by implementing-] (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 40861 Based on observation, interview and record review the facility failed to ensure the biohazard waste storage room was locked. This facility failure had the potential for unauthorized access and the spread infectious disease. Findings: During an observation and concurrent interview with the assistant facility administrator (AFA), on 8/26/24, at 15:15 P.M., in a hall where staff offices, conference room, supply room and break room are located, there was a door with a large sign that indicated “Biohazard Waste”. The door was unlocked and contained large storage containers labeled “Biohazard Waste”. The AFA agreed that this door is to be locked at all times. During a review of the facility’s policy and procedure titled California Medical Waste Management Plan, revised November 2023, indicated in part... “Medical waste that is stored in an area prior to transfer to the designated accumulation area, as defined in section 118310, shall be stored in an area that is either locked or under direct supervision or surveillance”.”

“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: 47849 Based on observation, interview, and record review, the facility failed to maintain a safe treatment environment when the drawer that contained Heparin (a prescription medication used to decrease the clotting ability of the blood) vials, was not locked. This failure had the potential to result in medications being unsecured against loss, tampering, destruction, and/or unauthorized use. During a concurrent observation and interview on 8/26/24 at 10:04 a.m. with the Licensed Nurse (LN2) on the in center hemodialysis (ICHD) treatment floor next to station 7, the drawer labeled “Heparin” was unlocked without nurse supervision and contained Heparin vials. LN2 agreed, that the drawer should have been locked as the drawer contained medication. During a review of the facility’s policy and procedure titled, “Medication Policy,” dated October 2023, indicated, “...11....Non-refrigerated medication are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations.””

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 48668 Based on interview and record review, the facility failed to verify hemodialysis prescription prior to starting treatment when a dialysate (a fluid mixture used in hemodialysis to achieve a balance in the body’s normal functioning) flow rate or DFR prescription was recorded at 0 milliliters per minute (mL/min) in one of six sampled patients (Patient 7). This failure had the potential for inaccuracies in treatment that may result to Patient 7 not achieving the health quality goals. Findings: During a review of six treatment flowsheets of Patient 7 dated 8/16, 8/19, 8/21, 8/22, 8/23 and 8/26, indicated a DFR prescription of 0 ml/min while flowsheets safety checks captured an average DFR at 500 ml/min. During the interview on 8/28/24 at 11:30 a.m. with the Licensed Nurse (LN1), LN1 stated that order for DFR was probably entered in error but there was no verification made with the physician to correct it. During a review of the facility’s policy and procedure (P&P) titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, dated April 2024, the P&P indicated “Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment.” and “Prescription components are confirmed by a licensed nurse within 1 hour of treatment initiation.””

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 48668 Based on interview and record review, the facility failed to ensure that a pre-treatment assessment of an abnormal fast heart rate (more than 100 beats per minute or bpm) was reported to the physician prior to starting hemodialysis (a process of cleaning the blood from impurities with the use of an artificial filters) by a licensed nurse on one of seven sampled patients (Patient 3). This failure had the potential to result in a heart complication that can progress to an emergency situation to Patient 3 during hemodialysis treatment. Findings: During a review of “Patient Summary Report” of Patient 3, dated 2/13/2024, it indicated a co-morbidity of cardiomyopathy (a condition when heart muscle is abnormally enlarged). During a review of six treatment flowsheets of Patient 3, indicated that three flowsheets dated 8/21, 8/23, and 8/26, had pre-treatment heart rate assessments greater than 100 bpm without physician notification prior to starting the dialysis treatments. During the interview on 8/27/24 at 3:45 p.m. with the clinical coordinator (CC), CC stated that there was no notification made to the physician of Patient 3’s increased heart rate before starting treatments therefore, there was no parameter of safe heart rate to start the treatment. During the interview on 8/28/24 at 10:40 a.m. with the Licensed Nurse (LN2), LN2 stated that the physician was verbally notified of Patient 3’s abnormal high heart rate during rounds but it was not documented in the medical records. During a review of the facility’s policy and procedure (P&P) titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, dated April 2024, P&P indicated “Any abnormal findings or findings outside of any specific physician ordered parameters discovered during pre-treatment data collection will be documented.” and “The physician or non-physician practitioner will be notified of any concerns that may preclude the initiation of dialysis.””

“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: 47849 Based on interview and record review the facility failed to monitor patients’ heart rates (HR), when: 1. The heart rate was too high and no follow up was done by a licensed nurse for Patient 2 2. The heart rate was too low and no follow up was done by a licensed nurse for Patient 4 This failure had the potential to result in an increased risk of death or other health complications. Findings: 1. During a review of “Patient Summary Report (PSR),” dated [undated], the “PSR” indicated, “87-year-old male with diagnosis of end stage renal disease (ESRD) and attends dialysis three times a week and has a central venous catheter (CVC) (flexible tube inserted into a large vein to provide access to the bloodstream).” During a review of “Treatment Details Report (TDR),” dated 8/21/24, the “TDR” indicated, at 12:30 p.m. HR was documented at 133, with no follow up from licensed nurse. During an interview on 8/27/24 at 3:04 p.m. with Clinical Coordinator (CC), CC agreed, that a nurse should have been alerted and documentation should have been done to address the increase in heart rate. 2. During a review of “PSR,” dated [undated], the “PSR indicated, “89-year-old male with diagnosis of Acute Kidney Injury (AKI) and attends dialysis twice a week and has a CVC.” During a review of “TDR,” dated 8/20/24, 8/17/24 and 8/13/24, the “TDR” indicated, 8/20/24 HR 55 at 11:26 a.m. HR 47 at 11:33 a.m. HR 52 at 12:12 p.m. 8/17/24 HR 32 at 13:55 p.m. HR 49 at 13:57 p.m. HR 55 at 14:15 p.m. HR 54 at 14:35 p.m. 8/13/24 HR 50 at 13:37 p.m. HR 41 at 13:57 p.m. With no follow up from a licensed nurse. During an interview on 8/28/24 at 10:55 a.m. with Clinical Service Specialist (CSS), CSS agreed that a nurse should have been notified for low heart rates. During a review of the facility’s policy and procedure titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” dated April 2024, indicated, “Intradialytic Data Collection/ Assessment-11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately ...” “Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heartbeat.””

“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: 47849 Based on interview and record review the facility failed to adhere to the prescribed dialysate flow rate (DFR)(the rate at which dialysate (cleansing fluid) is delivered during dialysis (a lifesaving treatment for kidney failure that removes waste and extra fluids from the blood) treatments), when the DFR order was for 800 and the machine was set at 500 for most of the treatment with no documentation for the change for Patient 5. This failure had the potential to result in poor dialysis adequacy (measurement of how well the removal of toxins and waste products from the patient’s blood). Findings: During a review of “Patient Summary Report (PSR),” dated [undated], the “PSR” indicated, “69-year-old male with diagnosis of end stage renal disease (ESRD) (kidneys lose the ability to remove waste and balance fluids), attends dialysis three times per week and has a central venous catheter (CVC) (flexible tube inserted into a large vein to provide access to the bloodstream).” During a review of “Treatment Details Report (TDR),” dated 8/22/24, the “TDR” indicated, “Dialysis Prescription: Dialysis Flow Rate: 800.0 milliliters (mL)/minute (min), Treatment Time: 3 hours 45 min ...Intradialytic vitals state line: time of 13:37 p.m. to 16:46 p.m.-DFR was set to 500 mL/min.” No notes in the “TDR” to explain the decrease in the DFR. During an interview on 8/28/24 at 11 a.m. with Clinical Service Specialist (CSS), CSS agreed, that the order was not followed, there was no documentation of the change, and the patient should have been on DFR of 800 as prescribed. During a review of the facility’s policy and procedure titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” dated April 2024, indicated, “Intradialytic Data Collection/Assessment: 10. If the dialysis prescriptions is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented, and the licensed nurse informed.””

“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: 48668 Based on interview and record review, the facility failed to notify a physician on a vascular access (a vein usually in the arm that is used to access patient’s blood to be filtered in the hemodialysis machine) that was running below the prescribed blood flow rate (BFR) of 350 milliliters/minute (mL/min) on one of seven sampled patients (Patient 6). This failure had the potential to result in vascular access related problems such as providing an inadequate hemodialysis and a shortened life span of the fistula (vascular access) for Patient 6. Findings: During a review of six treatment flowsheets of Patient 6 dated 8/14, 8/16,8/19, 8/21, 8/23, and 8/26, indicated all BFRs ran below the prescribed 350 mL/min without notations why the order was not being achieved. During the interview on 8/28/24 at 11:00 a.m. with a Patient Care Technician (PCT3), PCT3 stated that the nurse should be notified for any hemodialysis treatment issues including vascular access alarms but did not find any documentation in the flowsheets about not achieving prescribed blood flow rate. During the interview on 8/28/24 at 11:10 a.m. with the Licensed Nurse (LN1), LN1 stated that physician was made aware of the issue verbally during rounds but did not have documentation in the medical records of the notification. During a review of the facility’s policy and procedure (P&P) titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, dated April 2024, the P&P indicated “If the dialysis prescription is not being met (including inability to obtain prescribed blood flow rate), the reason will be documented, and the licensed nurse informed.” and “The licensed nurse notifies the physician as needed of changes in patient status.””