When we preparation the component the surfaces and the environment area must be clean, hygienic condition and free from microbial contamination.
Procedures must detail the specifications of any substances that affect the quality of the final blood component. The specifications should be applied to blood and blood components, like starting materials, additive solutions, primary packaging material (bags) and equipment. Sterile conductors should be used . The welding resulting from the pathological alignment must be checked and verified.
? Component labeling and information
First, all blood components should be labeled with donor identification information and The type of label to be used.
the information must be provided in a machine-readable format to eliminate transcription errors.
The responsible of the preparation of blood components must provide clinical users of the blood components with information and the information that not appears on the component label.
? Release of blood components
Each blood facility must be capable of proving that the blood or blood component has been approved for release by an authorized person.
Where release is subject to computer derived information, the following requirements must be met:
• The computer system must be validated to ensure that all test criteria or criteria for selection of donors are safe
• Manual input of critical data, such as laboratory test results
• The computer system should block the unacceptable blood or blood component for release.
In the absence of a computerized system must be :
• The label identifies the component status must clearly distinguish a released from a non-released component.
• must Check all current donor declaration forms, relevant medical records, and test results by an authorized person.
• Before the final component release. If the donor donated before, A comparison with previous records should be made to ensure that the current records accurately reflect the date of the donors.
• There should be a quarantine and administrative system for blood and blood components to ensure that they are not released until all mandatory requirements have been met.
? Storage and distribution
Storage areas should provide an effective separation of materials, insulation or release. There should be a separate storage area for rejected components and materials.
The storage and distribution procedures shall be carried out in a safe manner and controlled to ensure the quality of the components during the storage period.
1. All transport and storage procedures, including receipt and distribution, must be specified.
2. Storage conditions must be controlled, monitored and inspected.
Before distribution, the blood components must be examined visually. There must be a record identifying the person who distributes the components and the institution you receive.
? Irradiation of blood components
Radiation indicators are used as aids to differentiating irradiated from non-irradiated blood and blood components
The component must ensure that receives a dose less than 25 Gray or more than 50 Gray of The irradiation process.
Exposure time must be set and standardized for each irradiation source and revalidated at suitable intervals. Should not receive more than the maximum recommended dose.
Red cell components may be irradiated up to 28 days after collection.
Irradiated cells should be transfused as soon as possible, but no later than 14 days after exposure to radiation
? Leucocyte depletion
This process is used to validating leukocyte depletion
For quality control, an appropriate validated method must be used for counting leukocytes. should be performed by using the manufacturer’s instructions and against the requirements for leukocyte depletion and other quality aspects of the components.
? Bacterial safety
A systematic program to ensure that the blood collection and processing procedures are bacterial safety.