This is a policy I made for NGHA Jeddah many years ago but is still useful today.
Principle:
All technical staff are required to read and understand the manufacturer package inserts that apply to the procedures that they perform. This policy establishes a means of documenting compliance with this requirement.
Policy Details:
- Technical staff are defined as anyone who uses the reagent in the performance of a procedure or process or anyone reviews or supervises that process or procedure. This includes the supervisor, medical technologists, medical technicians, nurses, phlebotomists, and assistants.
- All technical staff are required to read and understand ALL product inserts for each procedure applicable to the section(s) that they work in—apheresis, donor room, component preparation, and/or transfusion service.
- If they have any questions about a particular insert, they should refer it to the supervisor, senior technologist (Med Tech 1), or in the latter’s absence, the blood bank medical director/section head.
- Each staff member must sign the Manufacturer’s Package Insert Review Form for that particular policy/procedure, including his signature, employee identification number, and date.
- Each Manufacturer’s Package Insert Review Form will be retained with a copy of the package insert by the Blood Bank Supervisor in a special file while the material is being used and for at least five (5) years after a new or revised manufacturer package insert is applicable.
- A new Manufacturer’s Package Insert Review Form should be used for each revision of the insert.
Insert Review Form
Type of Insert: New Revised |
Product Name: |
Date of Insert: |
I have read this insert and understand its contents and accept responsibility for following its instructions and directions.
Staff Name & Badge #–PRINT! | Signature | Date |