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Get Annex To Iso 15189 Application Form For Blood Banks - Inab
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How to fill out the Annex To ISO 15189 Application Form For Blood Banks - INAB online
This guide provides comprehensive instructions for completing the Annex To ISO 15189 Application Form for Blood Banks - INAB online. Following these steps will ensure that all necessary information is accurately submitted, facilitating the evaluation process.
Follow the steps to successfully complete the form online.
- Click ‘Get Form’ button to obtain the Annex To ISO 15189 Application Form for Blood Banks - INAB and open it in your online editor.
- Begin by filling out your organization details, including name, address, and contact information at the beginning of the form. Ensure accuracy to avoid processing delays.
- Upload the organization chart that outlines reporting relationships and interactions between the Blood Bank and the Haemovigilance and Traceability Functions. This should clearly define roles within your organization.
- Provide a list of Liaison Personnel for Haemovigilance and Traceability, detailing their technical qualifications and relevant experience to demonstrate capability.
- Prepare and submit a chart that illustrates the relationships between your Blood Bank, blood establishments, and other recipient organizations. Confirm whether contracts are in place and summarize traceability and haemovigilance arrangements for each external location.
- Create process flow diagrams describing the physical flow of blood and blood components from receipt through to transfusion, including all satellite storage locations to ensure comprehensive understanding.
- List all blood and blood component fridges and freezers, confirming storage conditions, validation of temperatures, and details of continuous monitoring systems to demonstrate compliance with standards.
- Draft a schematic diagram of the Traceability and Verification System, highlighting the steps of receipt, issue, transfusion, destruction or wastage, and the return of blood to the clinical area, along with applicable records.
- Include the schedule of Blood Transfusion Committee meetings for the past year, detailing any other relevant meetings to provide transparency and accountability in your procedures.
- Maintain a log of notifications sent to The National Haemovigilance Office regarding serious adverse reactions and events that occurred in the past 12 months.
- Summarize blood usage for the last 12 months, including the number of units cross-matched, issued, transfused, wasted, or destroyed, and those returned to suppliers, for all relevant locations.
- Provide the schedule of Blood Bank Audits related to Haemovigilance and Traceability Functions for the locations mentioned earlier.
- Compile a full list of Standard Operating Procedures (SOPs) for Haemovigilance and Traceability, referencing the relevant SOPs in AML-BB.
- Finally, list all tests undertaken in the Blood Bank, identifying the tests that are proposed for the scope of accreditation.
- Once all sections are filled out accurately, save your changes, and choose to download, print, or share the form according to your needs.
Complete the Annex To ISO 15189 Application Form For Blood Banks - INAB online today to ensure compliance and facilitate your evaluation.
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