032509 East Valley Dialysis (Fmc)

“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: 50568 Based on a review of facility policy and procedure, observation, and staff interview, the Department determined that the administrator failed to ensure: 1. staff aseptically cleaned (2) of (2) patients’ vascular access prior to cannulation (Patients #11, #12). Failure to adhere to infection control procedures prior to cannulation poses an increased risk of bloodstream and vascular access infection as bacteria at cannulation sites may not be reduced; and Findings include: 1. The policy/procedure titled “Access Assessment and Cannulation”...Disinfect the cannulation site as follows using any of the disinfectants below...07% isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating....” Observation on April 23, 2024, revealed Employee #7, disinfecting patient #11’s vascular access in preparation for cannulation. Employee #7, used an alcohol pad to cleanse the arterial cannulation site for 19 seconds and immediately cannulated the access with the fistula needle. Employee #7 then used a second alcohol pad to cleanse the venous cannulation site for 21 seconds and immediately cannulated the access with the fistula needle. Observation on April 23, 2024, revealed Employee #8, disinfecting patient #12’s vascular access in preparation for cannulation. Employee #5, used an alcohol pad to cleanse the arterial cannulation site for 15 seconds and immediately cannulated the access with the fistula needle. Employee #8 then used a second alcohol pad to cleanse the venous cannulation site for 12 seconds and immediately cannulated the access with the fistula needle. Employee #1, verified in an interview conducted on April 24, 2024, that staff did not follow appropriate policy and procedures for cannulation of an AV fistula.”

“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 a review of facility policies and procedures, observation on tour, and interview with staff, the Department determined that the facility failed to require that staff monitor and keep the arterial drip chamber 85-95% full, which has the potential for air entering the bloodlines which can lead to a patient’s injury or death, due to an air embolism. Findings include: A review of facility policy titled, “ Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyzer” revealed: “...The arterial chamber is 85-95% full ... monitor pressure changes in the arterial chamber to ensure adequate blood flow ... ensure that arterial chamber is filled to 85-95%....” Observation on a tour of the facility on April 22, 2024, and April 23, 2024, revealed 8 of 36 dialysis machines with arterial drip chambers filled less than 85-95% full. The arterial drip chambers on the dialysis machines at stations #3 (each day), #11, #18, #19 #20, #21and #24 were filled less than 25-50% full. Employee #1 confirmed in an interview on April 24, 2024, that the arterial drip chambers are not being monitored and filled per policy and procedure.”

“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 policy and procedure, observation, and interview, the Department determined that the facility failed to ensure staff secured medications when not in use. Failure to secure medications when not in use may result in unauthorized access to prescription medication not prescribed to an individual and the potential for tampering or other compromise to the integrity of medications administered or dispensed. Findings include: A policy titled “Medication Preparation and Administration” revealed, “ ...The following steps must be taken for the securement ...All medications will be kept in a locked cabinet except when in use ....” Observation on April 23, 2024, revealed an unlocked box in Pod 3 containing four bottles of heparin inside. In Pod 1 there was one bottle of open heparin and one unopend bottle of heparin in a drawer that also held catheter supplies. Employee #1 confirmed on April 24, 2024, that the facility medication cabinets were not locked when medications were not in use.”

“PE-FIRE SAFETY-LIFE SAFETY CODE CFR(s): 494.60(e)(1) (1) Except as provided in paragraph (d)(2) of this section, dialysis facilities that do not provide one or more exits to the outside at grade level from the patient treatment area level must comply with provisions of the Life Safety Code (NFPA 101 and its Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4) applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. This Standard is not met as evidenced by: 50568 Based on document request and staff interview, the Department determined that the administrator failed to ensure a current fire inspection report was maintained. Failure to ensure a current fire inspection report is maintained poses a potential patient safety risk in the event of a fire due to hazards not identified and/or corrected. Findings include: A copy of a current fire inspection report was requested on April 22, 2024, no documentation from the local fire department of a current fire inspection was provided. Employee #1 confirmed on April 24, 2024, that the facility did not have a current fire inspection report.”

“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: 50568 Based on review of facility policy, medical records, and interview with staff it was determined that the facility failed to ensure: 1. registered nurse notify the patient’s nephrologist when the patient’s weight deviated one (1) or more kilograms from the estimated dry weight (EDW). 2. staff administer clonidine based on physician’s standing orders. 3. initial loading dose of heparin at least 3-5 minutes prior to the initiation of treatment for an identified patient. The lack of reporting EDW not achieved and neglecting to assess and respond to hypertension increases the risk for inadequate treatments, fluid overload, dehydration, hospitalizations, stroke and death. The lack of administration of a prescribed antihypertensive medication increases the risk for inadequate treatment, hospitalization, stroke, disruption of blood prefusion to vital organs, and death. This deficient practice regarding heparin poses a potential health risk to patients including the potential risk of insufficient anticoagulation, blood loss, and hospitalization. Findings include: 1: The facility policy titled “Patient Assessment and Monitoring” states that, “ If the PCT/LPN notes any changes or abnormal findings in the patient’s condition ... the registered nurse must assess the patient ... The RN will notify the patient’s physician/physician’s extender of any abnormal findings ...” Patient #1 medical records reveal leaving (5) of (6) treatments with a weight difference greater than 1 KG over the estimated dry weight without any documentation of a physician being notified. Patient #3 medical records reveal leaving (2) of (6) treatments with a weight difference greater than 1 KG over the estimated dry weight without any documentation of a physician being notified. Patient #6 medical records reveal leaving (3) of (6) treatments with a weight difference greater than 1 KG over the estimated dry weight without any documentation of a physician being notified. Patient #2 medical records reveal leaving (1) of (6) treatments with a weight difference greater than 1 KG over the estimated dry weight without any documentation of a physician being notified. Patient #5 medical records reveal leaving (3) of (6) treatments with a weight difference greater than 1 KG over the estimated dry weight without any documentation of a physician being notified The facility policy titled “2024 AZ Incenter Hemodialysis Standing Orders” requires that Hypertension be treated, “ If BP remains consistently >180 systolic or > 120 diastolic for 30 minutes after changing the machine temperature, give Clonidine 0.1 mg po. May repeat q 30 mins x2. If BP remains >180 systolic or >120 diastolic after 3 doses given, call MD/Phyician extender ... Notify MD/Physician extender if pt is symptomatic ... If post treatment standing BP (sitting if pt. is unable to stand) is >180 systolic or >120 diastolic call MD/Physician extender.” 2. Patient #3 treatment sheet dated 04/22/24, reveals continuous hypertension prior to treatment, during, and post treatment. Treatment dated 04/06/2024 initial at 08:00 with a BP of 182/129, and continued until 10:03. The BP readings for the treatment were as followed: 8:04 189/127 8:22 221/151 9:04 228/ 151 9:40 210/146 Patient #3 did have an active standing order for Clonidine, with once dispensation occurring at 08:00. No further dose was given to the patient at the 30 minute mark, despite being within the parameters set forth by the facility policies Patient #3 treatment sheet dated 04/20/24, reveals continuous hypertension prior to treatment, and during treatment. Intitial BP for the patient was 211/164 and post treatment 96/56. No note made by the RN on duty reflections notifying the MD/extender for instances of hyper and hypotension. Patient #3 treatment sheet dated 04/18/24, reveals continuous hypertension prior to treatment, during treatment. Initial BP for the patient was 202/147, with no documentation of notifying the MD/extender for instances of hypertension. The BP readings for the treatment wee as followed: 9:13 175/137 9:22 190/141 9:44 187/133 10:06 188/137 10:23 213/139 10:43 205/149 11:01 203/150 11:21 186/135 11:40 188/136 11:40 191/138 12:00 188/121 12:21 164/131 12:24 175/131 Patient #3 did have an active standing order for Clonidine, with once dispensation occurring at 09:47. No further dose was given to the patient at the 30 minute mark, despite being within the parameters set forth by the facility policies. Treatment was terminated at 12:24 by the PCT on duty with the note “ ...Pt not feeling good requested end TX”. No nursing assessment of symptoms were documented, and no notification to the MD/extender of the patient symptoms were documented. Additional review of Patient #3 treatment sheets dated 4/13/2024, 4/16/2024, and 4/17/2024 revealed similar issues with continuous hypertension and no dispensation of Clonidine despite standing orders. Further review also revealed that post-treatment blood pressures greater than 180 systolic were not reported to the MD/extender. An interview with employee #1 was conducted on April 24, 2024 confirming the BP was outside of parameters set forth in the titled “2024 AZ Incenter Hemodialysis Standing Orders”, and that no action was taken by on duty nursing staff during the hypertensive crisis. Employee #1 also confirmed instances of no documentation of notification to the MD/extender regrading hypertensive crisis. 3: Review of A.R.S. revealed: “...If an outpatient treatment center provides medication administration, an administrator shall ensure that...policies and procedures for medication administration...ensure that medication is administered to a patient only as prescribed....” Review of a policy, “Heparinization” (Fresenius Kidney Care, No Policy Number, Published: 08/03/2020) revealed: “...Following infusion, prior to treatment initiation, wait 3-5 minutes to allow systemic anticoagulation to occur....” Observation and review of the provided records conducted on April 23, 2024. Continued observation of the record revealed a physician’s order for a loading dose (before treatment) of heparin (blood thinner) 4000 units intravenous (IV). Additional review of the record revealed treatment sheets (run sheets) documenting previous dialysis treatments. Further review of the run sheets revealed the following: On 04/12/2024 at 0802 patient #2 received heparin 3500 units IV before treatment. On 04/12/2024 at 0800 dialysis treatment was initiated for patient #2. On 04/13/2024 at 12:20 patient #3 received heparin 5000 units IV before treatment. On 04/13/2024 at 12:21 dialysis treatment was initiated for patient #3. In an interview conducted on 04/24/2024 staff #1 agreed during the exit conference that the heparin for patients #2 and patient #3 was not administered per facility policy and should have been.”

“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: 50568 Based on review of facility policy, medical records, and staff interviews, the Department determined that the facility failed to require clinical staff to notify the nurse and provide a documented intervention for 6 out of 6 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. Based on a review of policy and procedure, medical records, and staff interviews, the Department determined the administrator failed to ensure staff performed safety checks every 30 minutes per facility policy for (4) of (6) patients (Patients #2, #4, #5, #6). Failure to monitor patients every 30 minutes during dialysis treatment has the potential risk of patient harm if staff do not recognize and provide necessary interventions for problems patients may experience during treatment. Findings include: Facility policy titled, “...Patient Assessment and Monitoring....” published December 2022, revealed: “...Monitoring During Treatment...Report to the nurse: Systolic blood pressure greater than 180 mm/Hg, Diastolic blood pressure greater than 100 mm/Hg, Blood Pressure less than or equal to 100 mm/Hg systolic...Heart rates that have dropped below 60 or risen above 100 ...Report to the nurse any significant findings....” “...Treatment Sheets....” revealed the following data that was not reported to a licensed nurse: Patient # 1 April 22, 2024, revealed: 08:45 HR 59 09:06 BP 158/78 09:45 BP 100/78 10:00 BP 179/100 April 15, 2024, revealed: 06:26 HR 58 08:43 BP 103/59 09:08 BP 143/92 April 10, 2024, revealed: 09:03 BP 96/64 09:42 HR 54 There was no documentation of the RN being made aware of vital signs out of range. Patient #2 April 19, 2024, revealed: 07:04 BP 183/114 07:20 171/100 08:02 HR 100 08:26 172/112 HR 109 08:42 BP 162/116 HR 106 09:00 BP 94/77 09:21 BP 94/77 09:42 133/97 HR 109 09:55 BP 150/101 HR 107 April 17, 2024, revealed: 08:24 BP 173/109 HR 108 09:02 BP 184/143 HR 100 April 12, 2024, revealed: 10:00 HR 100 11:00 BP 126/106 11:24 HR 101 11:40 HR 112 There was no documentation of the RN being made aware of vital signs out of range. Patient #3 April 13, 2024, revealed: 12:43 BP 203/146 13:01 BP 195/138 13:24 BP 183/108 HR 58 13:42 BP 174/131 14:04 BP 169/132 14:41 BP 167/135 15:22 BP 163/120 April 16, 2024, revealed: 08:48 BP 176/117 HR 103 09:03 BP 187/123 09:22 BP 170/112 09:40 BP 188/122 10:02 BP 178/112 10;23 BP 180/123 10:40 BP 175/120 11:01 BP 183/116 11:40 BP 187/126 11:44 BP 182/87 12:05 BP 166/118 12:27 BP 190/126 12:33 BP 166/124 April 17, 2024, revealed: 12:44 BP 247/178 13:05 BP 249/185 13:24 BP 257/178 13:45 BP 229/171 14:04 BP 199/164 14:23 BP 204/163 14:43 BP 193/155 15:02 BP 205/157 HR 100 15:19 BP 207/153 April 18, 2024, revealed: 09:22 BP 190/141 10:23 BP 213/139 11:01 BP 203/150 11:40 BP 188/136 11:40 BP 191/138 April 20, 2024, revealed: 09:00 BP 170/133 09:24 BP 173/118 09:43 BP 174/132 10:01 BP 190/131 10:22 BP 159/113 10:41 BP 159/113 11:00 BP 158/121 11:21 BP 127/110 April 22, 2024, revealed: 08:04 BP 189/127 08:22 BP 189/127 08:30 BP 221/151 09:04 BP 228/151 09:40 BP 210/146 There was no documentation of the RN being made aware of vital signs being out of range. Patient #4 April 12, 2024, revealed: 06:20 HR 59 06:48 HR 59 07:02 HR 57 07:24 HR 58 07:43 HR 58 08:02 HR 67 April 15, 2024, revealed: 06:41 HR 57 07:01 HR 58 07:24 HR 59 07:43 HR 58 08:22 HR 59 08:42 HR 59 April 17, 2024, revealed: 06:20 HR 58 06:45 HR 57 07:00 HR 57 07:24 HR 56 07:42 HR 56 08:03 HR 57 08:20 HR 56 08:42 HR 57 09:04 HR 57 April 20, 2024, revealed: 06:34 HR 57 07:01 HR 57 07:23 HR 58 07:42 HR 57 08:02 HR 59 08:21 HR 56 0841 HR 58 8:42 HR 58 09:00 HR 58 09:29 HR 58 April 22, 2024, revealed: 07:25 HR 59 07:41 HR 56 08:01 HR 59 08:21 HR 58 08:40 HR 59 There was no documentation of the RN being made aware of vital signs being out of range. Patient #5 April 12, 2024, revealed: 08:51 BP 135/114 April 15, 2024, revealed: 08:00 BP 149/118 April 22, 2024, revealed: 07:49 BP 197/88 There was no documentation of the RN being made aware of vital signs being out of range. Patient #6 April 20, 2024, revealed: 06:15 HR 56 06:27 HR 54 06:45 HR 53 07:10 HR 53 07:25 HR 57 07:42 HR 57 08:06 HR 56 08:25 HR 57 08;45 HR 56 April 18, 2024, revealed: 06:25 Hr 55 06:40 HR 54 07:02 HR 55 07:23 HR 54 08:07 HR 51 08:23 HR 54 08:45 HR 53 09:15 HR 59 April 17, 2024, revealed: 08:02 HR 53 09:03 BP 184/86 HR 58 09:21 BP190/75 HR 47 09:45 HR 53 10:20 HR 53 10:25 HR 55 10:43 HR 43 11:03 BP 185/85 HR 58 April 16, 2024, revealed: 06:04 HR 55 06:20 HR 55 06:40 HR 55 07:02 HR 54 07:35 HR 54 08:01 HR 56 08:42 HR 57 09:06 HR 57 April 13, 2024, revealed: 05:55 HR 48 06:30 HR 46 07:00 HR 44 07:30 HR 43 8:26 HR 53 08:57 HR 46 There was no documentation of the RN being made aware of vital signs being out of range. Employee #1 confirmed during an interview on April 24, 2024, that no documentation of RN notification and/or intervention for out range vitals was provided as required per facility policy. Findings include: The facility policy titled “Patient Assessment and Monitoring” requires: “...During Treatment...Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. Document machine parameters and safety checks every 30 [sic] or more often as needed but not to exceed 45 minutes or per state regulations....” Patient #2: Patient #2’s treatment sheet dated April 10, 2024 revealed blood pressure/safety checks were not done every 30 minutes as follows: 09:22 10:23 Patient #2’s treatment sheet dated April 15, 2024 revealed blood pressure/safety checks were not done every 30 minutes as follows: 09:41 10:29 Patient #4 treatment sheet dated April 10, 2024 revealed blood pressure/safety checks were not done every 30 minutes as follows: 07:02 07:33 08:02 08:35 09:03 09:34 Patient #5 treatment sheet dated April 15, 2024 revealed blood pressure/safety checks were not done every 30 minutes as follows: 06:30 07:01 07:35 Patient #5 treatment sheet dated April 12, 2024 revealed blood pressure/safety checks were not done every 30 minutes as follows: 06:06 06:47 Patient #5 treatment sheet dated April 10, 2024 revealed blood pressure/safety checks were not done every 30 minutes as follows: 08:28 09:06 Patient #6 treatment sheet dated April 13, 2024 revealed blood pressure/safety checks were not done every 30 minutes as follows: 05:55 06:30 Employee #1, confirmed during an interview conducted on April 4, 2024, that staff did not perform and document blood pressure and safety checks every 30 minutes as required by regulation and facility policy.”

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 50568 Based on a review of staff job descriptions and staff interview, it was determined that the facility failed to ensure that Licensed Social Workers are available to provide counseling services as required under Conditions of Participation by CMS. This lack of resources increases the risk of hospital admissions, hospital readmissions, and death and decreases the risk for adherence to dialysis prescription and treatment plan compliance. Findings include: Document titled “Job Description “ states that, “PRINCIPAL DUTIES AND RESPONSIBILITIES ... Patient Assessment/Care Planning/Counseling” and further states “Provides supportive counseling services to patients ...”. Additional information within the document states, “ EDUCATION AND REQUIRED CREDENTIALS ... Must have state required license.”. A review of employee file for employee #13 revealed that the employee is not licensed by the state. Employees #1, confirmed in an interview on April 24, 2024, that employee #13 is not licensed by the of Arizona state.”