Davita Mountain Vista Dialysis Center of Arizona

“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 facility procedure, observation, and staff interview, the Department determined that the facility failed to ensure that the AV fistula or graft cannulation procedure was performed according to the facility procedure for one of the patients observed, which has the potential risk of development of bloodstream infection and hospitalization. Findings include: The policy titled “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” dated 10/2022, requires: “...Check for patient sensitivity to preferred skin antiseptic/skin disinfectant listed in the table below (povidone-iodine, hypochlorite ExSept Plus). Use Isopropyl Alcohol 70% as the single-skin antiseptic ONLY when the patient has documented allergies to other skin antiseptics...Isopropyl Alcohol 70%...At least 4 prep pads per site...Effective Contact Time...60 seconds ... Povidone-iodine at least 1 prep pad per site for 30 seconds contact time and a drying time of 2 minutes....” Observation on June 19, 2024, at station #17, revealed Employee # 5 cleansing and disinfecting patient #8 ‘s vascular access in preparation for cannulation. Employee #5 started cleaning the access with a soaped cloth and then used a povidone-iodine prep pad to cleanse the arterial cannulation site for a 10-second contact time. Employee #5 repeated the same process for the venous site with a contact time of 8 seconds, employee #5 then waited over two minutes to cannulate the access. Employee #1 confirmed during an interview on June 20, 2024, that Employee #5 did not follow the policies and procedures of the facility.”

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 51021 Based on review of facility documents and staff interview, the Department determined that the facility failed to ensure that the dialysis water system operates safely and reliably through daily observations and/or testing of specific component performance parameters. Failure to properly monitor and react increases the risk to patients through suboptimal/potentially dangerous hemodialysis treatments A policy titled “Daily Water Treatment System Monitoring” requires: “All observations and test results will be within the limits on the Daily Water Treatment Log. If observations of tests results are found outside the specified limits. Notify the Facility Administrator...and Biomed teammate assigned to the facility...”. Upon review of Facility’s Daily Water Treatment Log and daily Chlorine Check Log the following dates were missing: The following dates revealed missing chlorine checks: 06/12/2024 05/29/2024 05/02/2024 05/01/2024 04/30/2024 04/24/2024 04/10/2024 The following dates revealed missing water treatment logs: 05/02/24 05/01/24 During an interview conducted on June 20, 2024, Employee #1confirmed that no documentation was available for chlorine checks or water treatment logs for the listed dates, which did not follow facility policy.”

“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: 45999 Based on policy and procedure, observation, and staff interview, the Department determined that the facility failed to ensure staff locked or otherwise secured medications. Failure to secure medications when not in use has the potential risk for 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: The facility policy titled “Medication Policy” requires: “...medications 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....” Observation on June 19, 2024 revealed unsupervised medication lock boxes at two pod stations used by the technicians. The lock boxes contained pre-drawn syringes with Heparin. Two of the six medication lock boxes were open and unlocked. The unlocked box at pod 1 contained two heparin syringes. The unlocked box at pod 4 contained four syringes, that were not dated or contained the initials of the employee who drew them. Employee #1 confirmed during an interview on June 19, 2024 that medications at the technicians’ pod stations were not locked when unsupervised as required by facility policy.”

“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 a review of policy and procedure, medical records, and staff interviews, the Department determined the facility failed to ensure 1. Staff performed safety checks every 30 minutes per facility guidelines for (4) of (5) patients (Patients #1, #2, #5 and #6). Failure to monitor patients every 30 minutes during dialysis treatment has the potential risk of patient harm due to unidientified patient adverse reactions resulting in delayed interventions during treatment. 2. Require clinical staff to notify the nurse and the nurse provided a documented intervention for four (4) out of five (5) patients reviewed when the patient’s blood pressure (BP) and/or heart rate (HR) were out of range, per the facility policy, which poses the potential risk of cardiovascular compromise and hospitalization. 1. Findings include: The facility policy titled “ Monitoring and Documentation of Patient Care During Treatment” revealed: “...Data that must be documented at least every thirty minutes and PRN depending on the patient’s condition....” Patient #1 Review of treatment sheet dated January 1, 2024 revealed blood pressure/safety checks were not done every 30 minutes as follows: 14:20 to 15:50 (1 hour and 30 minutes) 16:50 to 17:30 (40 minutes) 17:50 to 18:51 (1 hour and 1 minute) Patient #2 Review of treatment sheet dated June 5, 2024, revealed blood pressure/safety checks were not done every 30 minutes as follows: 04:56 to 05:30 (34 minutes) 04:59 to 05:32 (33 minutes) Patient #6 Review of treatment sheet dated June 6, 2024, revealed blood pressure/safety checks were not done every 30 minutes as follows: 08:21 to 09:05 (44 minutes) 10:04 to 10:36 (32 minutes) Review of treatment sheet dated June 8, 2024, revealed blood pressure/safety checks were not done every 30 minutes as follows: 09:20 to 10:50 (1 hour and 30 minutes) Employee #1 confirmed during an interview conducted on June 20, 2024 that staff did not perform and document blood pressure and safety checks every 30 minutes as required by regulation and facility policy. 2. Findings include: Facility policy titled “Mountain Vista Facility Specific Orders” revealed “...Interdialytic parameters. Facility-specific...the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record... Systolic greater than 180mm/Hg or less than 99mm/Hg ...Diastolic greater than or equal to 110mm/Hg or less than 49mm/Hg...Heart or Pulse Rate Pre/Intra/Post: Less than 49 beats per minute or greater than 101 beats per minute and all blood pressures with an increase or decrease greater than 30mm/Hg...”. A medical record review of 5 patient’s treatment sheets revealed (3/5) patients had multiple occurrences, of blood pressure out of range without documentation of the licensed nurse being notified. Patient #1 Review of treatment sheet dated for December 29, 2023 revealed the following: 04:58 HR:104 Heart rate greater than 101mm/Hg was documented with no RN notification or intervention documented. Review of treatment sheet dated for January 1, 2024 revealed the following: 05:03 HR:104 Heart rate greater than 101mm/Hg was documented with no RN notification or intervention documented. Review of treatment sheet dated January 5, 2024 revealed the following: 07:35 BP:145/128 Diastolic greater than or equal to 110mm/Hg was documented with no RN notification or intervention documented. Review of treatment sheet dated for January 8, 2024 revealed the following: 16:33 HR: 106 Heart rate greater than 101mm/Hg was documented with no RN notification or intervention documented. 16:50 HR: 103 Heart rate greater than 101mm/Hg was documented with no RN notification or intervention documented. 17:30 HR: 105 Heart rate greater than 101mm/Hg was documented with no RN notification or intervention documented. 17:48 HR: 106 Heart rate greater than 101mm/Hg was documented with no RN notification or intervention documented. Patient #5 Review of treatment sheet dated June 4, 2024 revealed the following: 05:10 BP: 98/52 Systolic Blood Pressure less than 99mm/Hg was documented with no RN notification or intervention documented. 07:41 BP: 91/51 Systolic Blood Pressure less than 99mm/Hg was documented with no RN notification or intervention documented. 08:05 BP: 98/61 Systolic Blood Pressure less than 99mm/Hg was documented with no RN notification or intervention documented. 08:30 BP: 96/56 Systolic Blood Pressure less than 99mm/Hg was documented with no RN notification or intervention documented. 09:09 BP: 98/56 Systolic Blood Pressure less than 99mm/Hg was documented with no RN notification or intervention documented. Review of treatment sheets dated for June 15, 2024 revealed the following: 05:29 BP: 89/45 Systolic Blood Pressure less than 99mm/Hg was documented with no RN notification or intervention documented. 05:37 BP: 95/49 Systolic Blood Pressure less than 99mm/Hg was documented with no RN notification or intervention documented. 06:08 BP: 94/51 Systolic Blood Pressure less than 99mm/Hg was documented with no RN notification or intervention documented. Review of treatment sheet dated June 18, 2024 revealed the following: 07:02 96/53 Systolic Blood Pressure less than 99mm/Hg was documented with no RN notification or intervention documented. 08:55 95/53 Systolic Blood Pressure less than 99mm/Hg was documented with no RN notification or intervention documented. Patient #6 Review of treatment sheet dated for June 6, 2024 revealed the following: 07:04 BP: 158/138 Diastolic greater than or equal to 110mm/Hg was documented with no RN notification or intervention documented. 08:05 BP: 86/62 Systolic Blood Pressure less than 99mm/Hg was documented with no RN notification or intervention documented. 09:05 BP: 169/157 Diastolic greater than or equal to 110mm/Hg was documented with no RN notification or intervention documented. Review of treatment sheet dated for June 11, 2024 revealed the following: 05:41 HR: 104 Heart rate greater than 101mm/Hg was documented with no RN notification or intervention documented. 09:05 BP: 139/111 Diastolic greater than or equal to 110mm/Hg was documented with no RN notification or intervention documented. Employee #1 confirmed during an interview on June 20, 2024, that no documentation of RN notification or intervention was provided as required per facility policy.”

“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: 51021 Based on facility document review, observations and staff interview, it was determined the facility failed to require the Medical Director be actively involved in the oversight and implementation of the facility’s policies and procedures for the infection control program, water and dialysate quality, reuse of hemodialyzers and bloodlines, physical environment, patient’s rights, patient assessment, patient plans of care, care at home, and quality assessment and performance improvement. Findings include: Facility policy “TREATMENT INITIATION UTILIZING B BRAUN DIALOG+ DIALYSIS DELIVERY SYSTEMS WITH ALL SINGLE USE DIALYZER TYPES AND STREAMLINE BLOOD LINES” revealed: “...for treatment initiation on the braun dialysis delivery system...verify arterial and venous bloodlines are clamped ...separate the blood lines, leaving the recirculation connector on the end of the venous blood line ...before connecting blood lines one must flush arterial line for five (5) second approximately 35ml of saline through arterial line then attach arterial access tubing to arterial line ...flush 250ml of normal saline into priming container then connect to access tubing ... “ Observation on June 19, 2024, at station #4, revealed Employee # after separation of blood lines, connected the blood lines to the venous and arterial access tubing without arterial and venous priming. Observation on June 19, 2024, at station #11, revealed Employee # after separation of blood lines, connected the blood lines to the venous and arterial access tubing without arterial and venous priming. Employee #1 confirmed on June 20, 2024, that Employee #5 and Employee #3 did not follow the policies and procedures of the facility.”