Section 9.6 (Part 1)

9.6   Generic protocol for the evaluation of blood packs for whole blood donations and apheresis collections

Introduction

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.

General principles

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.

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.