Davita Maryvale 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 observation, review of policy and procedure, and staff interview, the Department determined the facility failed to ensure staff aseptically cleansed patients’ vascular accesses prior to cannulation with fistula needles appropriately according to facility policy. Failure to practice safe, aseptic techniques when cleansing and disinfecting a patient’s vascular access increases the risk for vascular access and bloodstream infection if bacteria are not sufficiently reduced at the cannulation sites prior to needle insertion. Findings include: Facility policy titled, “...AV FISTULA OR GRAFT CANNULATION WITH NIPRO OR MEDISYSTEMS SAFETY FISTULA NEEDLES AND ADMINISTRATION OF HEAPRIN LOADING DOSE...” revised October 2022 revealed: “...Acceptable skin antiseptics may include: Povidone Iodine...ExSept Plus...Isopropyl 70% Alcohol...Use Isopropyl Alcohol 70% as the single skin antiseptic ONLY when the patient has documented allergies to other skin antiseptics...Clean the arterial site with an alcohol pad in a circular motion repeat with a new alcohol pad on the venous site...Cleanse arterial site in circular motion (center out) with antiseptic--Betadine 30 secs (1 pad per site) or ExSept 60 secs (2 sterile gauze per site)...Cleans venous site in a circular motion (center out) with antiseptic...Betadine 30 secs (1 pad per site) or ExSept 60 secs (2 sterile gauze per site) ...Let dry for 2 minutes and monitor the access site to ensure contamination does not occur (do not leave chairside) ... Isopropyl Alcohol at least 4 pads per site with a 60-second contact time and 15-second dry time....” Observation on July 8, 2024 revealed: Employee #13 was observed conducting vascular access disinfection on patient #11. Employee #13 disinfected the arterial site for 12 seconds with two alcohol pads and disinfected the venous site for 14 seconds with two alcohol pads then proceeded to connect the patient to the machine. Employee #15 was observed conducting vascular access disinfection on patient #13. Employee #15 disinfected the arterial site for 1 minute and 15 seconds with ExSept-soaked gauze and disinfected the venous site for 1 minute and 7 seconds with ExSept-soaked gauze. Dry time with 2 minutes then proceeded to palpitate the site without disinfecting the cannulation site again. Observation on July 9, 2024 revealed: Employee #14 was observed conducting a vascular access disinfection on patient #12. Employee #14 disinfected the arterial site for 51 seconds with ExSept-soaked gauze and disinfected the venous site for 50 seconds with ExSept-soaked gauze. Dry time with 2 minutes and 41 seconds then proceeded to connect the patient to the machine. During an interview conducted with Employee #2 on July 10, 2024, Employee #2 verified that the disinfection was not completed in accordance with facility policy.”

“CARTRIDGE FILTERS-CONFIG & MONITORING CFR(s): 494.40(a) 5.2.3 Cartridge filters: config and monitoring The cartridge is contained within an opaque filter housing with seals to separate the feed and product water streams. When the maximum [pressure drop] ?P recommended by the filter manufacturer is reached, the cartridge should be replaced according to the manufacturer ’ s instructions. 6.2.3 Cartridge filters Cartridge filters should be monitored on a periodic .... basis for a [pressure drop] ?P across the filter [that] can be used to determine when the filter is retaining particulate matter to the point that the filter will no longer allow the required water flow without an excessive reduction in pressure at the outlet of the filter. A marked decrease in ?P without a corresponding decrease in flow rate may indicate a loss of filter integrity. Follow the manufacturer ’ s recommendations concerning when to replace cartridge filters. Replacement of the cartridge will usually be indicated by an increase in ?P to some specified value. A log sheet should be developed to record the pressure drop measurements. This Standard is not met as evidenced by: 45999 Based on a review of facility documents and staff interviews, the Department determined that the facility failed to ensure verification 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” revealed: ...” To verify the dialysis water system operates safely and reliably through daily observations and/or testing of specific component performance parameters ...The initials and signature of the teammate performing and recording all observations and test results are entered where indicated on the Daily Water Treatment Log ...a separate entry of time and initials is provided for the end-of-day harness testing ...A licensed nurse reviews the Daily Water Treatment Log for completeness and verifies that all parameters are within specified limits ...Upon satisfactory completion of the review the licensed nurse initials and signs the log form where indicated” .... Upon review of the Facility’s Daily Water Treatment Log; April 5, 2024-Line 22 the calculation for the Ultrafilter Outlet Pressures was incorrect April 19, 2024- Line 22 the calculation for the Ultrafilter Outlet Pressures was incorrect April 20, 2024- Line 22 the calculation for the Ultrafilter Outlet Pressures was incorrect April 23, 2024- Line 22 the calculation for the Ultrafilter Outlet Pressures was incorrect May 16, 2024- Line 22 the calculation for the Ultrafilter Outlet Pressures was incorrect June 21, 2024- Line 22 the calculation for the Ultrafilter Outlet Pressures was incorrect June 22, 2024- Line 22 the calculation for the Ultrafilter Outlet Pressures was incorrect April 23, 2024-Missing licensed nurse initials April 29, 2024 Missing licensed nurse initials May 7, 2024-Missing licensed nurse initials May 4, 2024-Missing teammate initials June 22, 2024-Missing end-of-day teammate’s initials June 24,2024-Missing the end-of-day values, and signature, and the CM-130 was put into idle mode July 6, 2024- Missing the end-of-day values, signature, and the CM-130 was put into idle mode The Daily Water Treatment Log was missing dates on the following days; May 14, 2024 May 15, 2024 May 16, 2024 May 17, 2024 May 18, 2024 Employee #1, confirmed in an interview conducted on July 8, 2024, that staff did not document as required per facility procedure.”

“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: 45999 Based on review of facility policies and procedures, observations and staff interviews, it was determined, by the department, that the facility failed to require staff dispose of expired supplies and medications, which has the potential risk of infection by using outdated items that may have lost their intended effectiveness for patients receiving hemodialysis treatments. Findings include: Facility policy, “ Infection control for dialysis facilities” revealed: “...Sterile items will be checked before use to ensure that they have not expired...Appropriately dispose of sterile items that have reached the expiration date...” Observation on 07/08/2024 revealed the following expired supplies were found in the patient care area: Influenza vaccine, Fluzone High-dose Quadrivalent. 10ml single-dose pre-filled syringes 0.7ml each- Sanofi Pasteur. Influenza vaccine- flucelvax Quadrivalent- Seqirus 0.5ml, single-dose, pre-filled syringes 17 doses. BD vacutainer PST gel lithium heparin 56 units Embrace pro- 9 test strips-omnis health BD Vacutainer clear top 34 tubes Cobas pcr media uniswab sample packet 10 units Nitroglycerin sublingual tablets usp 0.4mg- Glenmark 97 tablets BD safetyglide 1ml syringe 26g x 3/8 one count BD 3ml syringe luer-lok tip 1 count BD safety-lok 3ml syringe luer-lok tip with precision glide needle 8 syringes BD safteyglide insulin needle 1ml 29x1/2 42 count RPC E-Z chek teststrips 92 count Puritan-sterile regular tongue depressors 87 pieces During an interview on 07/10/2024, Employee #1 confirmed that the medication and/or supplies had not expired.”

“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: 51021 Based on document review, observation, and interview, the Department determined that the facility failed to ensure medications in the treatment area were locked and secured to prevent unauthorized access. 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: The facility policy titled “Medication Policy” requires: “...Non-refrigerated medications are to be stored in cabinets(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 07/08/2024 revealed an unsupervised, unlocked medication lockbox in pod D containing one unlabeled heparin bottle. In pod F there was one labeled heparin syringe in an unlocked medication lockbox. Employee #2 confirmed on 07/10/2024 that the unlabeled unlocked heparin bottle and heparin syringe found at two PCT work stations on the treatment floor were not locked and secured as required by facility policy.”

“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: 49430 Based on observation, review of facility documentation, policy and procedures, and interviews with staff, it was determined that the facility failed to ensure: 1. The hourly infusion of heparin was followed as the doctor ordered with a stop time of sixty minutes prior to end of treatment. This deficient practice poses a health risk to patients including the potential risk of insufficient anticoagulation, blood loss, and hospitalization. 2. Ensure staff administered treatment medication for hypertension as ordered by the patient’s nephrologist for (1) of (1) patient (Patient #2) which has the potential risk to patients for adverse outcomes related to untreated hypertension. -Findings Include: 1. A review of a policy “ANTICOAGULATION” (Policy: 1-06-02; Revision Date: April 2024) revealed, “ ...heparin is the primary anticoagulant used to prevent clotting ...to anticoagulated the patient ...hourly dose of heparin is administered ..at start of treatment and ended 60 minutes prior to the end of the hemodialysis treatment...”. 2. Active medication orders requested and provided by employee #1, reveals an active order for “PRN..Clonidine provider instructions...0.1 mg for SBP > or = 180 and/or DBP >or = 110. May repeat X 1 after 1 hour if SBP remains > or = 180 and /or DPB > or = 110.” 1. The following findings were discovered during review of patient treatment sheets: Patient #6 Patient treatment sheet 06/27/2024: The patient’s treatment was terminated at 18:15 and the documented time heparin stop time was 18:16. Patient treatment sheet 06/29/2024: The patient’s treatment was terminated at 18:20 and the start and stop times documented for the heparin infusion was both documented as 14:27. 2. The following findings were discovered during review of patient treatment sheets: Patient #2 Treatment sheet dated 06/27/2024: 06:15 BP 186/116. PCT documented RN aware. RN documented “Noted high BP: pt asx” at 06:17 06:26 BP 181/120 07:50 BP 150/110 Treatment sheet dated 06/28/2024: Pre-treatment BP 185/122 05:28 BP 178/118 05:52 BP 177/115 06:17 BP 177/115 06:38 BP 166/110 Treatment sheet dated 06/29/2024: Pre-treatment BP 193/121 06:17 BP 179/120 06:20 BP 185/126 06:47 BP 174/125 07:12 BP 175/125 07:37 BP 167/116 08:02 BP 159/113 Treatment sheet dated 07/02/2024: pre-treatment BP 171/119 06:08 BP 172/117 Treatment sheet dated 07/04/2024: Pre-treatment BP 166/117 05:44 BP 180/125 05:53 BP 180/125 06:02 BP 183/127 06:07 BP 179/129 06:32 BP 175/126 06:57 BP 175/124 07:22 BP 170/118 08:12 BP 170/118 08:37 BP 171/120 Treatment sheet dated 07/05/2024: pre-treatment BP 196/145 05:23 BP 186/130 05:48 BP 184/136 06:01 BP 183/136 06:04 BP 183/135 06:28 BP 187/137 06:53 BP 181/133 07:12 BP 175/127 The treatment sheet did not contain any documentation of assessment by the RN, or notification to the physician pre, intra, or post treatment. The medical record clonidine was not administered as prescribed, nor was there any documentation the patient was offered and/or refused administration of antihypertensive medication. 1. Employee #2 verified in an interview on 07/10/2024, that the hourly heparin was not stopped 60 minutes prior to the end of treatment as required by facility policy. 2. Employees #1 and #3 confirmed on 07/10/2024 that the RN did not administer medication for severe hypertension as prescribed by the patient’s nephrologist.”

“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: 49430 Based on a review of facility policy, medical records, and staff interviews, it was determined that the facility failed to ensure: 1. staff notify the licensed nurse when the patient’s heart rate (HR) and blood pressure (BP) was below the facility’s “abnormal findings” for patient’s #1, #2, #3 and #6 on treatment sheets reviewed, which poses the potential risk of cardiac compromise, adverse outcomes, and hospitalization. 2. failed to ensure that vital signs were monitored every 30 minutes while receiving dialysis by a personnel member for two (2) out of three (3) patients reviewed, Patients #3 and #6. 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: 1. Facility policy titled “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING, AND NURSING ASSESSMENT” revised October 2023, revealed: “...Abnormal findings or findings outside of any patient-specific physician ordered parameters will be reported to the licensed nurse immediately...ABNORMAL FINDINGS...Heart or Pulse Rate Pre/Intra/Post... Greater than 100 beats per minute and/ or less than 60 beats per minute ...: Systolic blood pressure greater than 180 mm/Hg, Diastolic blood pressure greater than 100 mm/Hg, Blood Pressure less than or equal to 90 mm/Hg systolic ....” Patient #1 Treatment sheets revealed: 06/20/2024 10:54 HR: 42 12:41 HR:113 07/04/2024 10:09 HR: 160 07/06/2024 14:08 BP: 135/111 Patient #2 Treatment sheets revealed: 06/27/2024 06:26 BP: 181/120 08:12 BP: 135/101 09:21 BP: 125/102 06/28/2024 05:28 BP: 178/118 06:17 BP: 177/115 06:38 BP: 166/110 07:03 BP: 164/104 07:28 BP: 159/107 07:53 BP: 150/102 07:53 HR 101 08:18 BP: 157/105 06/29/2024 06:47 BP: 174/125 07:12 HR: 104 08:02 HR: 102 08:26 BP: 150/112 08:52 BP: 150/103 09:17 BP: 149/102 09:20 BP: 139/106 07/02/2024 06:08 BP: 172/117 06:08 HR 113 06:23 BP: 151/103 06:23 HR: 103 06:48 BP: 148/103 07:14 BP: 146/103 07:39 BP: 139/103 08:04 BP: 138/100 08:28 HR: 102 08:53 HR: 101 07/04/2024 06:57 BP: 175/124 07:22 BP: 170/118 07:47 BP: 169/121 08:12 BP: 170/118 08:37 BP: 171/120 07/05/2024 05:48 BP: 184/136 05:48 HR: 109 06:01 BP: 183/136 06:01 HR: 107 06:04 BP: 183/135 06:04 HR 109 07:12 BP: 175/127 07:12 HR: 105 Patient #3 Treatment sheets revealed: 05/17/2024 18:02 BP: 130/107 Patient #6 Treatment sheets revealed: 06/20/2024 14:57 BP: 178/101 16:10 BP: 148/117 06/22/2024 18:14 HR: 102 06/27/2024 17:29 HR:104 18:15 HR: 103 06/29/2024 18:20 HR: 103 07/02/2024 17:18 HR: 102 18:14 HR: 103 Employee #1 confirmed during an interview conducted on 07/09/2024, that staff did not follow facility policy regarding notification to licensed nurse. 2. Facility policy titled, “...Pre-Intra-Post-Treatment Data Collection, Monitoring, and Nursing Assessment....” revised October 2022 revealed: “...Intradialytic Data Collection/Assessment...Vital Signs and Treatment Monitoring...For non-nocturnal treatments is completed at least every thirty (30) minutes....” “...Post Treatment....” sheets revealed: Patient #3 Treatment Date: 05/10/2024 Vitals signs documented 15:27 then next documented at 16:00. This is a thirty-three (33) minute interval. Treatment Date: 05/17/2024 Vitals signs documented 14:56 then next documented at 15:36. This is a fourty (40) minute interval. Vitals signs documented 16:27 then next documented at 17:0. This is a thirty-three (33) minute interval. Vitals signs documented 17:26 then next documented at 18:02. This is a thirty-four (34) minute interval. Treatment Date: 05/20/2024 Vitals signs documented 14:26 then next documented at 15:12. This is a fourty-six (46) minute interval. Treatment Date: 05/31/2024 Vitals signs documented 14:32 then next documented at 15:03. This is a thirty-one (31) minute interval. Vitals signs documented 15:03 then next documented at 15:35. This is a thirty-two (32) minute interval. Vitals signs documented 17:00 then next documented at 17:39. This is a thirty-nine (39) minute interval. Vitals signs documented 18:04 then next documented at 18:37. This is a thirty-three (33) minute interval. Treatment Date: 06/05/2024 Vitals signs documented 14:30 then next documented at 15:05. This is a thirty-five (35) minute interval. Vitals signs documented 15:48 then next documented at 16:33. This is a fourty-three (43) minute interval. Patient #6 Treatment Date: 06/25/2024 Vitals signs documented 15:12 then next documented at 15:53. This is a fourty-one (41) minute interval. Treatment Date: 06/27/2024 Vitals signs documented 16:40 then next documented at 17:15. This is a thirty-five (35) minute interval. Vitals signs documented 17:29 then next documented at 18:08. This is a thirty-seven (37) minute interval. Treatment Date: 07/02/2024 Vitals signs documented 14:31 then next documented at 15:38. This is a fifty-three (53) minute interval. Vitals signs documented 15:58 then next documented at 16:37. This is a thirty-nine (39) minute interval. Vitals signs documented 16:44 then next documented at 17:18. This is a thirty-four (34) minute interval. Employee #1 confirmed on 07/09/2024, that intradialytic vital signs were not taken in accordance with facility policies.”