Davita Tempe Dialysis Center

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. 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 at 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. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 45999 Based on a review of policy/procedure, observation, and staff interview, it was determined by the Department, that the facility failed to ensure staff appropriately cleansed (2) of (2) patients (Patient #25 and #26) vascular access prior to cannulation with fistula needles. Failure to practice safe aseptic techniques when cleansing and disinfecting a patient’s vascular access increases the risk of vascular access and bloodstream infection. The facility policy titled “Assessment and Cannulation for AV Fistula/Graft and Patient Self Cannulation” requires “...cleanse the site by applying skin antiseptic using a circular motion, moving from the center out and allow to dry. (for contact and dry time refer to the table...) ...Iodine... 30-second contact time...Hypochlorite (exSeptPlus)... 60-second contact time .... Both with a 2-minute dry time...”. Observation on May 22, 2024 revealed Employee #30 accessing patient #26’s fistula site Employee #30 scrubbed the arterial site for 4 seconds with a Povidone Iodine pad and then scrubbed the venous site for 6 seconds, Employee #30 waited 2 minutes before cannulating the access. Observation on May 22, 2024 revealed Employee #29 preparing to cannulate Patient #25’s vascular access. Employee #29 used a hypochlorite-soaked gauze to cleanse the arterial cannulation site for 45 seconds prior to cannulating the site. Employee #29 used a hypochlorite-soaked gauze to cleanse the venous cannulation site for 47 seconds prior to cannulating the site. Employee # 29 waited 2 minutes before cannulating the access. Employee #1 confirmed during an interview on May 23, 2024 that the staff did not follow the facility’s policies and procedures.”

“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: 50568 Based on review of facility policy, observation, and staff interviews, the Department determined that the facility failed to ensure medications, supplies, and equipment have not expired. Failure of staff to follow facility policy regarding equipment and supply expiration dates has the potential risk of using expired supplies and equipment for patients which could lower the efficacy of the equipment or supplies and could expose patients to risk of infection. Furthermore, expired emergency supplies found inside of emergency carts could delay emergency treatment. Tour on May 22 2024 revealed the following expired medical supplies: 2 (two) Nippro touch safety fistula access needles 14G, expired 10/30/2021 30 (thirty) Covidien single use saline flushes 10 mL expired 6/30/2021 55 (fifty-five) BD Luer-Lok Tip with BD PrecisionGlide needle 21Gx1 Expired 6/30/2022 In an interview conducted on 05/22/2024 Employee #1 confirmed the expired supplies had not been discarded in accordance with manufacturer instructions and expiration dates.”

“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: 50568 Based on document review, observation, and interview, it was determined that the facility failed to ensure medications were locked when not in use at the medication preparation station. Failure to secure medications when not in use may result in unauthorized access to medication not prescribed to an individual and the potential for tampering or other compromise to the integrity of medications administered. Findings include: Facility policy titled “Medication Policy” states, “ ... All refrigerated medications ... and vaccines are to be locked at the close of each business or if not under the supervision by the licensed teammate or per state regulations ...” On 5/22/2024 a tour of the facility was conducted, and medication preparation areas were inspected. In a medication preparation area located in the South hallway of the facility, both cabinets and a refrigerator used for medication storage was noted. This area was between patient exam rooms, and not within direct line of sight of neither the nurses station nor front reception area. Upon further inspection of the refrigerator, it was noted to be unlocked at the time of inspection and contained medication to be used for patients receiving home hemodialysis. When reviewing the medications within the refrigerator, a plastic bag containing the manufacturer instructors and a key was located. The key was able to lock and unlock the refrigerator. During an interview conducted on 5/23/24, Employee #2 confirmed that the facility did not follow the facility procedure for securing medications.”

“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: 45999 Based on medical record review, review of facility policy and procedure, and interview, the Department has determined the facility failed to ensure that vital signs were monitored every 30 minutes while receiving dialysis by a personnel member for 4 (four) out of 4 (four) patients reviewed, Patients #18, # 19, # 20, and # 21. Failure to ensure patients are monitored by a personnel member every 30 minutes while on dialysis can result in a patient having an adverse event. Findings include: Facility policy titled, “...Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment....” revised April 2021, revealed, “...The Nursing assessment will be performed and documented by a licensed nurse...The assessment includes...Verification that patient access is visible and face is not covered...Vital signs and treatment monitoring...For non-nocturnal treatments is completed at least every thirty (30) minutes....” “ ...Post Treatment ....” Sheets revealed: Patient #18 April 30, 2024 07:01 to 07:32 May 2, 2024 08:30 to 09:01 May 14, 2024 07:01 to 07:32 Patient #19 April 24, 2024 17:13 to 17:44 17:44 to 18:15 April 26, 2024 15:40 to 11:30 May 13, 2024 16:12 to 16:44 Patient #20 May 9, 2024 09:55 to 10:26 May 11, 2024 06:59 to 07:30 07:59 to 08:30 May 14, 2024 07:27 to 07:58 10:00 to 10:32 May 18, 2024 07:01 to 07:41 07:41 to 08:31 09:31 to 10:03 Patient # 21 May 9, 2024 14:54 to 15:25 May 11, 2024 14:02 to 14:37 15:28 to 16:00 16:00 to 16:33 May 21, 2024 16:27 to 16:58 Employee #1 confirmed during an interview on May 23, 2024, that vital signs and safety checks were not performed every 30 minutes in accordance with facility policy.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 50568 Based on facility policy review, record review and interviews, the facility failed to conduct a comprehensive initial assessment for a newly admitted patients within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. The failure to conduct a timely initial assessment for a newly admitted patient significantly increases the risk of hospital admissions, hospital readmissions and death to the dialysis patient population due to a lack of an established baseline of a patient’s health. Finding includes: Policy Titled “Medical Records” states that “...medical records of all new patients are reviewed within 30 days of admission for completeness ...” Policy Titled “Dialysis Services and Patient History and Physical Examination” requires “...A physician preforms a medical history and physical examination on the patient within 30 days before admission or within 48 hours after admission and documents the medical history and physical examination in the patient’s medical record within 48 hours after admission ...” Review of patient # 14 chart noted a History and Physical conducted and signed by a medical provider on 3/26/2024. Chart review noted the patient first began at the facility on 02/23/2024. Review of patient #3 chart noted a History and Physical conducted and signed by a medical provider on 01/18/2024. Chart review noted the patient first began at the facility on 12/14/2023. Employee #1 confirmed the the History and Physicals were not conducted according to policy.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 50568 Based on review of policies and procedures, medical records and interview with staff, it was determined the facility failed to ensure timely completion of Comprehensive Interdisciplinary Patient Assessment/Plan of Care (CIPA) and was updated to reflect changes in patients’ health status. The failure to identify, assess and update the CIPA in a timely manner significantly increases the risk of hospital admissions, hospital readmissions and death to the dialysis patient population. Findings: Facility policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” states that, “ ...The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The comprehensive assessment will be used to develop the patient’s treatment plan and expectations of care ... Monthly (unstable patients): Monthly until patient is determined to by interdisciplinary team to be stable ...” Review of selected charts for patient #11, patient #22, patient #24, patient #27 revealed the following information: Patient #11, CIPA dated 04/10/24 deemed patient as unstable. CIPA dated 03/06/24 deemed patient as stable. CIPA dated 01/19/24 deemed patient as unstable. CIPA dated 12/13/23 deemed patient as unstable. CIPA dated 11/15/23 deemed patient as unstable. CIPA dated 10/18/23 deemed patient as unstable. CIPA dated 09/14/23 deemed patient as unstable. CIPA dated 06/21/23 deemed patient as stable. CIPA dated 5/10/23 deemed patient as unstable. No CIPA for 05/2024 was provided, and no documentation for the late unstable CIPA was noted. Patient #22 was noted to be a patient who was deemed with an Acute Kidney Injury AKI. CIPA dated 04/15/2024 deemed patient as stable. CIPA dated 03/25/2024 deemed patient as stable. CIPA dated 02/12/2024 deemed patient as stable. CIPA dated 01/22/2024 deemed patient as stable. No CIPA for 05/2024 was provided, and no documentation for the late CIPA was noted. Patient #24 CIPA dated 1/23/2024 deemed patient as stable. CIPA dated 12/19/2023 deemed patient as unstable. CIPA dated 09/26/2023 deemed patient as stable. No documentation for the late unstable CIPA was noted. Patient #27 CIPA dated 4/18/24 deemed patient as unstable. No documentation was provided for a CIPA for 05/2024. Employee #1 confirmed during an interview on May 23, 2024 that the dates of the provided care plans for patients #11, #22, #24, #27 did not follow policy and did not provide any further plans of care for missing months.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 50568 Based on document review and interview, it was determined that the facility failed to ensure that there was a documented discharge summary for patients were reviewed within 30 days of the patient’s discharge from the facility. The lack of timely medical record documentation poses the potential risk of lack of coordination and continuity of care for patients. Findings Include: Facility policy titled “Discharge Summary” states that, “ ... A Discharge Summary will be completed in a maximum of 30 days from a patient’s discharge date according to State Regulations ... All discharge summaries will be signed and dated by the attending nephrologist and nurse ...” Review of patient #15 chart noted a Discharge Summary signed by a medical provider on 05/02/2024, with a discharge date of 02/07/2024. Review of patient #18 chart noted a Discharge Summary signed by a medical provider on 5/20/2024, with a discharge date of 02/23/2024. Review of patient #6 chart noted a Discharge Summary signed by a registered nurse, however no date was present. Employee #1 confirmed during an interview on May 23, 2024 that the date signed by medical provider was more than 30 days past the discharge date, and no date provided for the signature of the registered nurse.”

“MR-COMPLETE RECORDS PROMPTLY CFR(s): 494.170(b)(1) (1) Current medical records and those of discharged patients must be completed promptly. This Standard is not met as evidenced by: 50568 Based on review of medical records and staff interview, it was determined the facility failed to ensure the medical record contained a sufficient and individualized MD note, Dietitian (RD) and Social Worker (SW) note. Failure to ensure a patient’s designated MD, RN and SW completes and signs a monthly note from each specialty may disrupt continuity of patient care due to an incomplete medical record. Findings include: A review of a the medical record for patient #8 revealed an incomplete and insufficient monthly note from a Social Worker dated 04/17/2024. The monthly note stated, “ SW called patient for check. Patient did not answer. LVM. SW plan to call again in the coming week.” No updated monthly note was provided, nor any monthly note for 05/2024 was provided. A review of medical record for patient #10 revealed an incomplete and insufficient monthly note from a Registered Nurse dated 04/30/24. The monthly note read, “ The following documentation reflects the RN care activities and notes with the corresponding patient data from the past 30 days, including the most recent Interdisciplinary Team Plan of Care goals, the progress those goals and planned interventions.” This documentation is consistent with documentation provided by the facility labeled, “RD Monthly Progress Notes” dated 5/15/2024, with the only changes present in the wording concerning the licensed role. Documentation provided revealed an Registered Dietician note dated 04/30/2024 that stated, “ ... Constipation-working with RN on bowel care ...”. No documentation to confirm this education or interaction by the Registered Nurse for this patient was provided. A review of a the medical record for patient #10 revealed an incomplete and insufficient monthly notes from a Medical Provider for the dates of 04/2024, 03/2024, 02/2024. The monthly note dated 02/2024 was repeated verbatim for the months of 03/2024, and 04/2024. During n an interview on 05/23/2024, Employee #1 confirmed the absences and lack of individualization within the notes provided.”