Davita Riverpoint Dialysis Unit

“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: 39965 Based on review of policies and procedure, observation, and staff interview, the facility failed to ensure all staff performed hand hygiene in accordance with the facility policies. Failure to follow approved infection control techniques in accordance with the facility policies could potentially cause bacterial and/or other infectious contaminants to remain on the skin of the dialysis staff or patient. The staff and/or patient could unknowingly touch equipment, surfaces, patients, and other staff causing the cross contamination of bacterial and/or other infectious contaminants which could lead to poor patient outcomes. The facility reported a census of 48 in-center hemodialysis patients and 21 peritoneal dialysis patients at the time of the survey. Findings for observation of 6 of 6 observed (RN [Registered Nurse] OO, RN N, and PCT [Patient Care Technician] L, PCT K, PCT P, and PCT J) staff includes: 1. Review of the facility policy titled “INFECTION CONTROL FOR DIALYSIS FACILITIES” policy 1-05-01 with a revision date of April 2023, included in part, “PURPOSE...To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment...HAND HYGIENE...All teammates, Physicians, and Non-Physician (NPP) will perform hand hygiene...upon entering and exiting the patient treatment area...prior to gloving and immediately after removal of gloves...after contamination with blood or other infectious material...before touching clean areas such as supplies, supply cart and chairside keyboard/mouse...Patients and caregivers will be encouraged to...Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis...Perform hand hygiene after treatment before leaving treatment area...Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station...Gloves should be changed when...soiled with blood, dialysate or other body fluids...When going from a “dirty” area or task to a “clean” area or task...When moving from a contaminated body site to a clean body site of the same patient...After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system...” 2. Observation on 11/20/23 beginning at 12:30 PM showed RN (Registered Nurse) OO donned (applied) gloves without performing hand hygiene prior to donning the gloves. 3. Observation on 11/20/23 at 12:36 PM showed PCT L failed to perform hand hygiene prior to donning gloves for patient care. 4. Observation on 11/20/23 at 12:40 PM showed PCT L failed to perform hand hygiene prior to donning gloves for the adjustment of a patient’s dialysis lines. 5. Observation on 11/20/23 at 12:42 PM showed PCT K removed gloves and donned new gloves without performing hand hygiene. 6. Observation on 11/20/23 at 1:15 PM showed PCT K failed to perform hand hygiene prior to donning gloves for patient care. 7. Observation on 11/20/23 at 1:20 PM showed PCT K failed to perform hand hygiene prior to donning gloves for patient care. 8. Observation on 11/20/23 at 1:21 PM showed PCT K failed to perform hand hygiene after removing the gloves and prior to donning (applying) new gloves. 9. Observation on 11/21/23 at 6:46 AM showed PCT P failed to perform hand hygiene prior to donning new gloves for patient care. 10. Observation on 11/21/23 at 6:53 AM showed PCT P failed to perform hygiene prior to leaving the treatment area. 11. Observation on 11/21/23 at 7:18 AM showed PCT L donned gloves without performing hand hygiene prior to silencing the dialysis machine alarm at station 3. 12. Observation on 11/21/23 at 7:19 AM showed PCT J failed to perform hand hygiene prior to donning gloves for the adjustment of patient dialysis blood lines. 13. Observation on 11/21/23 beginning at 9:55 AM showed RN N failed to perform hand hygiene prior to leaving the dialysis treatment area. 14. Observation on 11/21/23 at 10:24 AM showed PCT L failed to perform hand hygiene prior to leaving the dialysis treatment area. 15. Observation on 11/21/23 at 10:20 AM showed PCT J Failed to perform hand hygiene prior to leaving the dialysis treatment area. 16. During an interview on 11/28/23 beginning at 11:08 AM, the FA (Facility Administrator) acknowledged staff failed to follow infection control protocols in accordance with the facility’s policy.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 39965 Based on review of policy, observation, and staff interview, the facility failed to ensure all items in the dialysis station were disinfected following each dialysis treatment in accordance with the facility’s policy. Failure to ensure all items in the dialysis station are completely disinfected following each dialysis treatment could potentially result in transmission of infectious contaminants to other patients, staff, medical supplies, and environmental surfaces which could result in severe illness and/or poor patient outcomes to those exposed to the infectious contaminants. The facility reported a census of 48 in-center hemodialysis patients and 21 peritoneal dialysis patients at the time of the survey. Findings for observation of 2 of 2 station disinfection performed by PCT (Patient Care Technician) L and PCT K include: 1. Review of the facility policy titled “INFECTION CONTROL FOR DIALYSIS FACILITIES” policy 1-05-01, with the revision date of April 2023, included in part, “PURPOSE...To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment...Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for next patient...Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between users. Stethoscopes will be disinfected with alcohol pre pad and/or 1:100 (one to one hundred) bleach solution...At the end of each treatment, the dialysis station will be cleaned and disinfected. 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 dialysis machine; touchscreens; countertops)...” 2. Observation on 11/20/23 beginning at 12:43 PM showed PCT L disinfecting station 9 following a dialysis treatment. Continued observation failed to show PCT L completely disinfected the inside and outside of the blood pressure basket attached to the dialysis machine, failed to disinfect the outside of the recliner (recliner is the dialysis treatment chair) arms, the emergency preparedness kit within the treatment station, the hose attached to the front of the dialysis machine, and did not ensure the recliner (dialysis treatment chair) was positioned in an opened position to ensure the crevice between the back and seat of recliner are disinfected. 3. Observation on 11/20/23 beginning at 1:13 PM showed PCT K disinfecting station 1 following a dialysis treatment. Continued observation failed to show PCT K placed the recliner in an opened position to completely wipe with a disinfectant cloth. Continued observation showed PCT K did not completely disinfect the outside of the arms of the dialysis treatment chair. 4. During an interview on 11/28/23 beginning at 11:08 AM, the FA (Facility Administrator) acknowledged staff did not always ensure the dialysis recliner/chair was placed in a Trendelenburg position to ensure the crevice between the back and seat of the recliner was disinfected and did not always disinfect all items in the dialysis station in accordance with the facility’s policy.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 39965 Based on observation and staff interview, the facility failed to ensure outdated supplies were taken out of circulation prior to the expiration date. Failure to ensure all supplies were taken out of circulation prior to expiration could lead to staff using a product which the manufacturer no longer guarantees the effectiveness of the supply item which could lead to poor patient outcomes. The facility reported a census of 48 in-center hemodialysis patients and 21 peritoneal dialysis patients at the time of the survey. Findings include: 1. Observation and interview on 11/20/23 beginning at 1:42 PM of the facility’s medication preparation room showed 2 packages labeled extension set with an expiration date of 7/31/21 and 2 packages labeled intravascular administration set, one with an expiration date of 6/5/23 and one with an expiration date of 6/27/21. RN (Registered Nurse) OO acknowledged the supplies had outdated.”

“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: 39965 Based on review of policy, observation, and staff interview, the facility failed to ensure all medications were taken out of circulation prior to the expiration date. Failure to ensure all medications are taken out of circulation prior to expiration could lead to staff using a product which the manufacturer no longer guarantees the effectiveness of the medication. Use of expired/outdated medications could lead to poor patient outcomes. The facility reported a census of 48 in-center hemodialysis patients and 21 peritoneal dialysis patients at time of the survey. Findings include: 1. Review of the facility policy titled “MEDICATION POLICY” policy 1-06-01 with a revision date of October 2023, included in part, “...PURPOSE...To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications...All medications are checked monthly for expiration dates...” 2. Observation and interview on 11/20/23 beginning at 1:42 PM of the medication preparation room showed a bottle labeled nitroglycerin (medication to treat and prevent chest pain) with an expiration date of 4/9/23 and 1 opened bottle labeled liquaCel (protein supplement) that lacked documentation of an open date. Inspection of the liquaCel container provided instructions to discard the product 3 months from the open date. RN OO acknowledged the medications had outdated.”

“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: 39965 I. Based on review of policy, medical records, and staff interview, the facility failed to ensure all staff reported and documented treatment information and interventions during the patient’s dialysis treatment in accordance with the facility’s policy. The facility reported a census of 48 in-center hemodialysis patients and 21 peritoneal dialysis patients at the time of the survey. Findings for review of 2 of 6 (Patient #42 and #21) patient flow sheets (a part of the medical record used during a patient’s treatment to show patient information during a dialysis treatment) for treatments received between 11/7/23 and 11/20/23 showed staff failed to document interventions made, the rationale for the intervention with notification to the CN and/or physician include: 1. Review of the facility policy titled “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT” policy 1-03-08 with a revision date of October 2023, included in part, “...PURPOSE...To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge...PRE-TREATMENT DATA COLLECTION/ASSESSMENT...Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse...If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis...INTRADIALYTIC DATA COLLECTION/ASSESSMENT...The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation...If the dialysis prescription 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...The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status...POST TREATMENT DATA COLLECTION/ASSESSMENT...The PCT (Patient Care Technician) or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre-dialysis findings...If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge...ABNORMAL FINDINGS...Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse whenever there is concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings...Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time...” 2. Review of Patient #42’s medical record included 5 dialysis treatment run sheets dated 11/7/23 through 11/20/23. Review of the patient specific physician order showed Patient #42’s BFR (blood flow rate) to run at 300 mL/min (milliliter per minute). Closer review showed: a. Dialysis treatment Runsheet dated 11/7/23 showed a heart rate (HR) documented at 40 bpm (beats per minute) without documentation to show staff rechecked the HR and/or notified the nurse. b. Dialysis treatment runsheet dated 11/9/23 lacked documentation to show staff addressed an elevated BP (Blood Pressure) documented at 131/101 mm/Hg without notification to the RN (Registered Nurse). c. Dialysis treatment runsheet dated 11/13/23 lacked documentation to show staff addressed the elevated pre-dialysis BP (Blood Pressure) documented at 121/103. Further review of the documentation showed a HR at 109 bpm, 120 bpm, and 125 bpm without notification to the CN (Charge Nurse) and/or physician. Further review failed to show staff notified the physician when Patient #42 discontinued their treatment early and left 1.6 kilograms (kg) over the target weight (target weight is the desired weight of the patient after dialysis). d. Dialysis treatment runsheet dated 11/20/23 lacked documentation to show staff addressed the elevated pre-dialysis heart rate (HR) documented at 120 bpm without notification to the CN and/or physician. 3. Review of Patient #21’s medical record included 6 dialysis treatment runsheets dated 11/8/23 through 11/20/23. Review of the patient specific physician order showed Patient #21’s BFR (blood flow rate) to run at 350 mL/min. Closer review showed the following: a. Dialysis treatment runsheet dated 11/8/23 showed an elevated pre-dialysis BP documented at 204/122 mm/Hg and a BP documented at the start of treatment at 212/181 mmHg without notification to the CN and/or physician. Further review showed staff reduced the BFR to 300 mL/min without documentation to show the reason and notification to the CN and/or the physician. b. Dialysis treatment runsheet dated 11/10/23 showed the BFR reduced to 300 mL/min without documentation to show the reason and notification to the CN and/or physician. c. Dialysis treatment runsheet dated 11/13/23 showed a pre-dialysis HR documented at 132 bpm, and a BFR at 300 mL/min without documentation to show the reason the BFR was reduced with notification to the CN and/or physician. 4. During an interview on 11/28/23 beginning at 11:08 AM, the FA (Facility Administrator) reviewed the medical records and acknowledged staff failed to address abnormal vital signs with notification to the licensed nurse and did not include physician notification when the patient failed to received their physician ordered dialysis prescription. II. Based on review of policy, medical record, and staff interview, the facility failed to ensure the RN (Registered Nurse) performed the nursing assessment with verification of the dialysis prescription in accordance with the facility’s policy. Failure to ensure a nursing assessment was completed with verification of the dialysis prescription within 1 hour from the initiation of treatment could potentially lead to an ineffective dialysis treatment which could lead to adverse patient outcomes and/or severe illness. The facility reported a census of 48 in-center hemodialysis patients at the time of the survey. Findings for review of 3 of 5 (Patient #41, #31, and #42) records include: 1. Review of the facility policy titled “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT” policy 1-03-08 with a revision date of October 2023, included in part, “...PURPOSE...To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge...The Nursing assessment will be performed and documented by a licensed nurse; specifically a Registered Nurse (RN)...The assessment includes the following components...Review of patient reports, data collection, complaints and response to treatment ...Verification that machine safety checks have been completed and documented...Verification of prescription including machine parameters...Verification that the patients access is visible and face is not covered...Review of documentation of accuracy, completion and patient data...A physical assessment...The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation...” 2. Review of Patient #41’s medical record included 2 dialysis treatment runsheets dated 11/15/23 and 11/17/23. Closer review showed the following: a. Dialysis treatment runsheet dated 11/15/23 provided documentation to show Patient #41’s dialysis treatment was initiated at 11:28 AM with a nursing assessment and prescription verification documented at 12:33 PM. 3. Review of Patient #31’s medical record included dialysis treatment runsheets dated 11/14/23 and 11/17/23. Closer review showed the following: a. Dialysis treatment runsheet dated 11/14/23 provided documentation to show Patient #31’s dialysis treatment was initiated at 11:47 AM with a nursing assessment and prescription verification documented at 12:49 PM. b. Dialysis treatment runsheet dated 11/17/23 provided documentation to show Patient #31’s dialysis treatment was initiated at 1:50 PM with a nursing assessment and prescription verification documented at 4:29 PM. 4. Review of Patient #42’s medical record included 5 dialysis treatment runsheets dated 11/7/23 through 11/20/23. Closer review showed the following: a. Dialysis treatment runsheet dated 11/9/23 provided documentation to show Patient #42’s dialysis treatment was initiated at 11:18 AM with a nursing assessment and prescription verification documented at 12:42 PM. b. Dialysis treatment runsheet dated 11/11/23 provided documentation to show Patient #42’s dialysis treatment was initiated at 11:23 AM with a nursing assessment and prescription verification documented at 12:38 PM. c. Dialysis treatment runsheet dated 11/13/23 provided documentation to show Patient #42’s dialysis treatment was initiated at 12:30 PM with a nursing assessment and prescription verification documented at 1:58 PM. d. Dialysis treatment runsheet dated 11/20/23 provided documentation to show Patient #42’s dialysis treatment was initiated at 11:24 AM with a nursing assessment and prescription verification documented at 12:31 PM. 5. During an interview on 11/28/23 beginning at 11:08 AM, the FA (Facility Administrator) acknowledged staff did not always ensure the nursing assessment and prescription verification was performed within 1 hour from the initiation of the patient’s dialysis 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: 39965 Based on review of policy and procedure, observation, and staff interview, the facility failed to ensure staff cleaned/disinfected patients’ vascular access in accordance with the facility’s policy and procedure. Failure to clean/disinfect the patient’s vascular access in accordance with the facility’s policy and procedure prior to inserting the dialysis needles could potentially cause bacterial and/or viral pathogens to remain on the skin and enter into the patient’s blood stream upon cannulation, which could cause severe illness and adverse outcomes for the dialysis patient. The facility reported a census of 48 in-center hemodialysis patients and 21 peritoneal dialysis patients at the time of the survey. Findings for observation of 2 of 2 (PCT [Patient Care Technician] L and PCT P) staff who failed to disinfect the vascular access site in accordance with the facility’s policy and procedure include: 1. Review of the facility policy titled “ARTERIOVENOUS FISTULA (AVF) AND ARTERIOVENOUS GRAFT (AVG) VASCULAR ACCESS CARE” policy 1-04-01 with a revision date of October 2023, included in part, “PURPOSE...To reduce the risk of infection in the patient, to reduce trauma to the fistula or graft while minimizing blood loss and to maximize the lifetime of each access...Acceptable skin antiseptics may include...Povidone iodine...ExSept Plus only for skin...Isopropyl 70% alcohol...” 2. Review of the facility procedure titled “AV (arteriovenous) OR GRAFT CANNULATION WITH NIPRO OR MEDISYSTEMS SAFETY FISTULA NEEDLES...AND ADMINISTRATION OF HEPARIN LOADING DOSE” procedure 1-04-01E with a revision date of October 2022 provided instructions regarding use of skin antiseptic solutions. Closer review showed if alcohol was utilized to prep the vascular access site, the user should use at least 4 alcohol pads per site for 60 seconds then allow to dry to 14 seconds 3. Observation on 11/21/23 beginning at 7:08 AM showed PCT L disinfecting Patient #29’s vascular access sites with an alcohol prep pad for 6 seconds, then obtained a new alcohol prep pad and disinfected both vascular access sites for 4 seconds, obtained another new alcohol prep pad and disinfected both vascular access sites for 3 seconds, then obtained another alcohol prep pad and scrubbed both sites for 3 seconds prior to inserting the vascular access needle. PCT L failed to utilize the alcohol pads for 60 seconds. 4. Observation on 11/21/23 beginning at 9:58 AM showed PCT P standing at station 2. Continued observation showed PCT P obtain an alcohol prep pad and disinfected both vascular access sites for 7 seconds, then obtained a new alcohol prep pad and disinfected both vascular access sites for 6 seconds. Further observation showed PCT P obtained 1 Iodine prep pad and disinfected Patient #2’s vascular access sites for 6 seconds then obtained another Iodine prep pad and disinfected both access sites for 10 seconds prior to allowing the site to dry. 5. During an interview on 11/28/23 beginning at 11:08 AM, the FA (Facility Administrator) acknowledged staff did not always disinfect the patient’s vascular access site in accordance with the facility’s policy and procedure.”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 39965 Based on review of policy, facility document, QAPI (Quality Assessment and Performance Improvement) meeting minutes and staff interview, the facility failed to ensure a comprehensive review and analysis of the in-center hemodialysis deaths to reveal any trends and/or contributory factors in the provision of patient care. Failure to ensure review and analysis of dialysis patient deaths to identify any trends and/or contributory factors could potentially result in miss opportunities to ensure patient safety and prevent further threats to the dialysis patient. The facility reported a census of 48 in-center hemodialysis patients at the time of the survey. Findings for review of 5 of 5 QAPI meeting minutes (5/23, 6/23, 7/23, 8/23 and 10/23) include: 1. Review of the facility policy titled “CONTINUOUS QUALITY IMPROVEMENT PROGRAM” policy 5-15-06 with a revision date of April 2021, included in part, “...The facility will measure, analyze, and track quality indicators or other aspects of performance...Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to ensure improvements are sustained...” 2. Review of the facility document titled “Patient Events Report” showed 3 patient deaths in August 2023 and 1 patient death in June 2023. 3. Review of 5 of 5 QAPI monthly (5/23, 6/23, 7/23, 8/23 and 10/23) meeting minutes lacked documentation to show staff evaluated and reviewed the patient deaths. 4. During an interview on 11/29/23 at approximately 2:30 PM, the FA (Facility Administrator) acknowledged the QAPI team failed to provide documentation to show the team reviewed and analyzied the dialysis patient deaths in the QAPI program for the sampled months.”