Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391
Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 012306 (X3) Date Survey Completed 06/24/2021
Name of Provider or Supplier Childrens Hospital Of Alabama Esrd Street Address, City, State 1600 7th Avenue South, Birmingham, AL
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID Prefix Tag Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)
V0403 PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU
CFR(s): 494.60(b)

The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.


This STANDARD is not met as evidenced by:
Based on observations in the PD (peritoneal dialysis) exam/therapy rooms, review of the facility equipment visual/electrical safety inspection procedure and staff interviews, it was determined staff failed to complete PD cycler inspections. This had the potential to negatively affect all PD patient served by the facility. Findings include: Procedure Detail Report Procedure #: 430 OVP60CLS-60 Day Verification of Rental Equipment in the Hospital Type: Preventative Maintenance (PM) Task Date-3/2/17 2) Do a visual inspection 3) Verify proper operation 4) Check with operator concerning proper operation 5) Verify safety of device and if applicable perform electrical safety On 6/22//21 at 2:00 PM, tour of the 2 PD exam/treatment/training rooms with EI (Employee Identifier) # 9, PD, Home Therapy RN (Registered Nurse) revealed in exam 1, a HomeChoice Pro PD cycler SN 71631 (serial number) with inspection documentation, due date 1/2021. EI # 9 reported this is a rental machine and PM (preventative maintenance) was overdue. Found in the Home Therapy Room was 1 Amia (automated PD system) PD Cycler with machine documentation, electrical safety check inspection due 5/2021. In an interview on 6/22/21 at 2:35 PM, EI # 9 confirmed the PD cyclers PM inspections were overdue and not current. During an interview on 6/24/21 at 10:00 AM, EI # 6, Biomedical Supervisor confirmed the PD cyclers PM had not completed as required.