Davita Oak Street 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: 50244 Based on observation, a review of facility policy and Centers for Disease Control and Prevention (CDC) recommendations, and staff interview, it was determined that the Infection Control Committee failed to ensure that one of three Patient Care Technicians (PCT BB) observed, performed hand hygiene (washed hands or used an alcohol-based hand sanitizer) after removal of contaminated gloves. This failure increased the risk for cross contamination with the potential to expose all staff and 68 patients who dialyzed at this facilty, to blood-borne pathogens in the dialysis environment. Findings were: During observation in the Patient Treatment Room on 1/23/24 between 12:00 p.m. and 1:45 p.m., the following was revealed: - Staff DD reset the alarm on the dialysis machine at Station (S) 3, removed her gloves and donned a new pair of gloves without performing hand hygiene. This deficient practice was repeated once again while she was at S3. - Staff DD also removed glove from her right hand with her left hand, obtained hand sanitizer and used it on her right hand only. - Staff DD performed a task at S4 while she wore gloves. When finished, she removed her gloves but failed to perform hand hygiene before donning new gloves. A review of the Policy #1-05-01 titled, “Infection Control for Dialysis Facilities” dated April 2023, stated: Hand Hygiene: 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene: b. prior to gloving and immediately after removal of gloves, According to CDC recommendations, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal ... The Facility Administrator was notified of the above findings on 1/25/24 at approximately 3:00 p.m.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 50244 Based on observation, a review of policy, and staff interview, it was determined that the medical director failed to ensure that one of one Registered Nurse (RN CC) observed during initiation and discontinuation of dialysis through a Central Venous Catheter (CVC - a large plastic tube placed in a vein in the neck or groin for exchange of blood to and from the hemodialysis machine during the hemodialysis treatment) access, adhered to facility policy pertaining to CVC. This deficient practice increased the relative risk for bacteremia in patients with dialysis catheters, and had the potential to affect all current and future facility patients with CVC. Findings were: During observation in the Patient Treatment Room on 1/23/24 at 8:15 a.m., RN CC was observed initiating dialysis treatment on Patient (P) #6 with a CVC access at Station (S) 8. When cleansing the CVC limb hubs (end of the CVC that connects to the blood lines or cap), RN CC was observed completing the scrub to each hub for two seconds only. On 1/23/24 at 1:00 p.m., RN CC was observed discontinuing dialysis treatment on a patient with CVC access at S7. RN CC did not scrub the CVC limb hubs for 15 minutes but performed two swipes to each hub. A review of Policy 1-04-02B titled, “Central Venous Catheter (CVC) with Cleaguard HD Antimicrobial End Caps and Tegaderm CHG Dressing Procedure” dated October 2023 stated: For initiation of hemodialysis: Scrub each hub for 15 seconds including the sides, threads and end of hub thoroughly. For termination of hemodialysis: Scrub the sides, threads and end of the hub thoroughly for 15 seconds. The Facility Administrator was notified of the above findings on 1/25/24 at approximately 3:40 p.m.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 50244 Based on observation and staff interview, it was determined that the facility failed to ensure that a wall in one of one Water Treatment Room was maintained free from damage and defects; and that the method for patients to call for help from two of two Restrooms (A & B) in the Patient Waiting Room, were maintained free from defects to ensure safety and functionality. This failure could negatively affect the health and safety of 66 patients who were dialyzing at this facility. Findings were: During a tour of the facility on 1/23/24 at 9:30 a.m. - 10:00 a.m., the following was observed: In the Patient Waiting Room: - The call lights (method for patients to summon immediate/emergency assistance) in the Patient Restrooms A & B were not functional. The Facility Administrator confirmed the above findings on 1/23/24 at 9:35 a.m. and stated that she will have the call lights fixed. In the Water Treatment Room: - The wall adjacent to the water heater closet had peeled off paint and damaged/deteriorated drywall approximately 10 x 10 inches. During an interview on 1/23/24 at 9:50 a.m., the Facility Administrator stated that a leaking water heater had caused the damage.”

“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: 50244 Based on a review of medical records, staff interview, and a review of facility policy, it was determined that the interdisciplinary team (IDT) failed to implement the patients’ plan of care to effectively manage patient outcomes for adequacy of dialysis [effectiveness of dialysis prescriptions to avoid symptoms of uremia (build up of toxins in the blood)], for two of six sampled in-center hemodialysis patients (P#3 and P#5). The facility census was 66. Findings were: A review of six dialysis flowsheets dated 1/3/24 - 1/22/24 revealed the following: P#3: P#3’s prescribed Blood Flow Rate (BFR) was 450 ml/min (milliliters per minute). - Five of six treatment records (dated 1/3/24, 1/10/24, 1/18/24, 1/19/24, and 1/22/24) reviewed, showed that P#3 dialyzed with a BFR of 400 ml/min. The prescribed BFR of 450 ml/min was not delivered. - And on 1/6/24, P#3 dialyzed with a BFR of 300 ml/min. - There was a lack of documented reasons as to why the prescribed BFR was not delivered on 1/3/24, 1/6/24, 1/10/24, 1/18/24, 1/19/24, and 1/22/24. P#5: P#5’s dialysis prescription for BFR was 400 ml/min. - Four of six treatment records (dated 1/4/24, 1/6/24, 1/11/24, and 1/13/24) reviewed, showed that P#5 dialyzed with a BFR of 350 ml/min. - There was a lack of documented reason for the decreased BFR on 1/4/24, 1/6/24, 1/11/24, and on 1/13/24. A review of Policy 1-30-08 dated October 2023 showed: Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment... Patient identity, prescription and machine settings stated: The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation... Prescription components include but are not necessarily limited to... Blood Flow Rate. “INTRADIALYTIC DATA COLLECTION/ASSESSMENT”...”Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes... Blood and dialysate flow rates”. The above findings were reviewed with the Facility Administrator on 1/25/24 at approximately 3:40 p.m.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 25727 Based on a review of facility records, staff interviews, and review of Dialysis Facility Report (DFR) for Fiscal Year (FY) 2024, it was determined that the facility failed to track, measure, and analyze quality indicators that reflected processes of care and operations to improve patient care, on six of six months (July - December 2023) Continuous Quality Improvement (CQI) meeting minutes reviewed. Findings were: A review of facility Facility Health Meetings (FHM - CQI) minutes for July - December 2023 revealed the following: The DFR (a report prepared for all facilities by the University of Michigan Kidney Epidemiology and Cost - contracted by Centers for Medicare and Medicaid Services, to provide a comparative summary of treatment patterns and patient outcomes for End Stage Renal Disease patients), was not discussed in CQI meetings to improve this facility’s outcomes where needed. Findings were: A review of DFR for FY 2024, revealed that the Standardized Mortality Ratio (SMR) at this facility in 2019 - 2022 was 1.76, which was 76% more deaths than expected at this facility. Among U.S. facilities, 97% of facilities had a four-year SMR lower than 1.76. The 2019 - 2022 SMR of observed to expected deaths is 1.06 and 1.03 for Georgia and Network, respectively. At this facility, the 2019 - 2021 SMR of observed and expected deaths was 2.52, which was 152% more deaths than expected at this facility. Among all U.S. facilities, 97% of facilities had a first-year SMR lower than 2.52. The first-year SMR (2019 - 2021) of observed to expected deaths is 1.14 and 1.05 for Georgia and Network, respectively. There was no documentary evidence that the above data or facility’s recent mortality was discussed in the CQI meetings reviewed. During an interview on 1/24/24 at 12:30 p.m., the Medical Director stated they discussed mortality and reviewed deaths during the meetings. However, the facility was unable to produce documentary evidence that mortality was included in their CQI meetings. The Facility Administrator stated on 1/25/24 at 10:20 a.m., that they discussed the number of deaths in their meetings but it was not documented in the minutes. A review of Policy: 1-14-06 titled, “Continuous Quality Improvement Program” dated April 2021 showed: 7. The facility will measure, analyze, and tract quality indicators or other aspects of performance. The program must include, but not be limited to, the following: ... - Mortality - review of deaths 8. Continuous monitoring of the above indicators will be reflected in the meeting minutes.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 50244 Based on observations, a review of facility policy, and employee interview, it was determined that the medical director failed to ensure that all direct patient care staff adhered to facility policy pertaining to vascular access care. This failure could lead to infection and loss of vascular access for eight of eight patients (P#4, P#9, P#10, P#11, P#12, P#14, P#16, and P#17) observed, during discontinuation of dialysis treatment. The facility census was 66. Findings were: During observations in the Patient Treatment Room on 1/23/24 between 8:00 a.m. and 13:30 p.m., and on 1/24/24 between 6:00 a.m. and 9:30 a.m., the following was observed: - After dialysis, fistula needles were removed from P#4, P#9, P#10, P#11, P#12, P#14, P#16, and P#17’s cannulation (needle insertion) sites. - The sites were covered with gauze and tape, and pressure was applied to the cannulation sites. - After hemostasis (stopping of the flow of blood) was attained, direct patient care staff did not discard the used gauze and did not apply new band-aid or sterile dressing over cannulation sites per facility policy, before P#4, P#9, P#10, P#11, P#12, P#14, P#16, and P#17 were discharged. A review of Policy 1-04-01B titled, “Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles” dated April 2023, stated: 13. Once bleeding has stopped, discard gauze or band-aid used to hold site. Inspect site for any trauma and for hemostasis. 14. Apply band-aid or sterile dressing over cannulation site.”