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SOP:91:QA:002:12:NIBS PAGE 1 of 15 Northern Ireland Blood Transfusion Service STANDARD OPERATING PROCEDURE (Operational Copy) Document Details Document Number: SOP:91:QA:002:12:NIBS No. of Appendices:

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How to fill out blood component re-call procedure

How to fill out a blood component re-call procedure:

01

Start by gathering all necessary information about the blood component that needs to be recalled. This includes the component type, lot number, expiration date, and any other relevant details.

02

Identify the reason for the recall. Determine whether it is due to quality issues, safety concerns, or any other specific issue that needs to be addressed.

03

Clearly document the reason for the recall in the designated section of the recall procedure form. Provide a detailed explanation of the problem and include any supporting evidence or data.

04

Record the contact information of the individuals involved in the recall. This includes the person initiating the recall, the person responsible for carrying out the recall procedure, as well as any other relevant stakeholders or authorities that need to be informed.

05

Outline the steps that need to be taken to complete the recall process. This may include notifying healthcare facilities, conducting patient tracing if necessary, arranging for replacement or disposal of the affected blood component, and implementing corrective actions to prevent a similar incident in the future.

06

Clearly indicate the deadline for completing the recall procedure. It is essential to establish a timeline to ensure the process is executed promptly and efficiently.

Who needs blood component re-call procedure?

01

Blood banks and blood centers: These organizations need the recall procedure to ensure the safety and quality of blood components they provide.

02

Healthcare facilities: Hospitals, clinics, and other healthcare institutions need to be aware of any recalls to prevent the use of potentially unsafe blood components and to take appropriate actions.

03

Regulatory bodies: Government agencies responsible for overseeing blood supply and safety require blood component re-call procedures to ensure compliance with regulations and to protect public health.

04

Patients and their healthcare providers: Those receiving or administering blood components need to be informed about recalls to avoid adverse reactions or health risks associated with the use of recalled products.

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What is blood component re-call procedure?

Blood component re-call procedure is a process to recall defective or potentially harmful blood components from the market to ensure patient safety.

Who is required to file blood component re-call procedure?

Blood component re-call procedure must be filed by blood establishments, hospitals, and other healthcare facilities that distribute blood components.

How to fill out blood component re-call procedure?

To fill out a blood component re-call procedure, detailed information about the affected blood components, reason for recall, and steps taken to address the issue must be provided.

What is the purpose of blood component re-call procedure?

The purpose of blood component re-call procedure is to prevent the distribution of unsafe blood components, and to effectively manage any potential risks to patients.

What information must be reported on blood component re-call procedure?

Information such as the affected blood components, reason for recall, lot numbers, distribution details, and corrective actions must be reported on the blood component re-call procedure.

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