9.6 Generic protocol for the evaluation of blood packs for whole blood donations and apheresis collections
This protocol sets out in generic form the essential features of blood pack evaluations as required by the UK Blood Transfusion Services. National Services should exercise discretion in the extent to which the protocol should be applied. It may be appropriate to consider an abbreviated format, e.g. when the change to be evaluated represents the attachment of a filter to a pack assembly that is already in routine use, or where the change consists of a modified port access design.
The protocol is not intended for use with packs for stem cell collection and storage, although the principles outlined may be helpful. The principles of this section apply to components produced from whole blood donations as well as whole blood itself.
Each trial will be fully documented and will have a unique trial reference number. The key requirements are as follows:
an evaluation outline – what type of pack is being investigated, where, when and the standards against which the assessment will be based
the evaluation objective – to demonstrate the packs are and remain free from defects and are suitable for the production and storage of components that meet current guidelines
identification of any restrictions, e.g.
situations where an evaluation would be required
agreement on ownership and release of the evaluation report with the supplier/ manufacturer
limitations of the report and its distribution
how the trial will be controlled, e.g.
the identity of the person/persons responsible for the trial and their reporting lines
sign-off procedures and authorities including concessionary changes
the trial protocol will be agreed with the supplier and any concessionary changes will require agreement in accordance with local procedures.
trials will be conducted in three phases. Satisfactory performance and sign off in Phase 0 is a prerequisite to progression to Phase 1 and satisfactory performance in Phase 1 is a prerequisite to progression to Phase 2
blood collected in Phase 0 will not be used for transfusion
all components prepared in Phase 1 will be subject to routine quality monitoring tests
a minimum of 1% of components prepared in Phase 2 will be subjected to routine quality monitoring tests
any testing that exceeds the minimum set out herein must be fully incorporated within the report
confidentiality: any data collected will normally be the property of the organization performing the trial; blood pack suppliers/manufacturers who wish to release information arising from the trial will require confirmation in writing from the organization performing the trial that they may do so
quality monitoring: it is expected that packs evaluated under the trial protocol will be subject to routine quality monitoring and reporting procedures, e.g. pack faults, compliance with component specifications, etc. It follows that any adverse findings during the trial would generate a corrective action.
A summary of the numbers to be tested for each evaluation or validation phase is given in Table 9.7. The numbers given are the minimum required. More detail is given in the relevant sections below.
Table 9.7 Summary of testing numbers required for evaluations and validations
|Process||Testing||Phase 0||Phase 1||Phase 2||Local process qualification|
|Whole blood||Component evaluation||10|
See Tables 9.2 to 9.5
|2000 from each of 2 batches|
Minimum 1% tested
|Apheresis collection||Component evaluation||10|
See Tables 9.2 to 9.5
|10 (each machine)|
Phase 0: evaluation
After an initial familiarization with novel bag/filters (pre-Phase 0) the purpose of Phase 0 studies is to
assess suitability to progress to Phase 1
determine suitable quality monitoring parameters
disclose any quality problems that might prevent components collected or prepared in these packs from being used for transfusion.
Phase 0 evaluation comprises the preliminary evaluation process and normally will require no fewer than 10 packs at the Centre undertaking the trial. Deviations from this number must be agreed in accordance with local procedures.
Processing conditions used in the Phase 0 evaluation should be the same as those applied to Phase 1 and 2 evaluations.
Component quality monitoring
Starting donations and all final components will be tested for compliance with relevant parameters listed in the component specifications in this book. Where relevant, additional assays should be performed as specified in the 'Red Book' generic evaluation protocols for new or novel blood components.
Goods inward inspection
Check that appropriate storage information is shown on the packaging
Check the condition of packaging on receipt. Document damaged cartons and examine contents to assess the extent of any damage.