Clarifications on the 'Aide Memoir'
Issued December 2006
|As specified in aide memoir||Interpretation|
|Process records||Completeness of records associated with laboratory processes, e.g. cleaning, daily QC controls, pre-transfusion testing (worksheets). Completeness of these records, filing, transcription systems (if appropriate).
Policy documents are more likely to be generally assessed as part of the Quality System.
|QI and process deviation||Quality Incidents, errors, non-conformances, out of specification results (may have numerous names) - may be planned or unplanned. A planned deviation from procedure should be pre-approved or rejected, following a documented assessment on product quality. The approval should be made by a senior person authorised to do so. Unplanned events should be reported, together with initial action (to re-supply or make safe, i.e. Corrective action); root cause analysis and a description of actions to be taken to prevent recurrence, e.g. SOP amendment, or system improvement (Preventative Action). These should be documented and approved by appropriate senior staff (Quality Manager or lab manager). Trending and periodic assessment should be carried out to identify recurring events, which could identify areas for improvement in systems or amendment of SOPs etc.|
|Inventory control||Stock controls of reagents, consumables and blood component stocks. Systems to check that electronic or paper inventory records match physical stock.
BN recording where appropriate.
|Critical supplies controls||Temperature and humidity (if appropriate) monitoring, to ensure that materials are stored in compliance with supplier requirements. Controls over the purchasing process, to ensure that consumables, reagents and blood components are of the required type and specification, and are sourced from the approved supplier (some of these aspects are more applicable to non-blood components). Approved supplier status should encompass more than just price / contract control. Other aspects to consider are suitability of material supplied for its intended use (may vary with different manufacturer of the same material), and potential for impact on the validation status of a particular process (e.g. in the case of a change in reagent supplier).|
|Concessionary release||When a crossmatch is incompatible but the clinical situation demands immediate transfusion, or where blood may be suitable, but not compatible, for transfusion. The system should differentiate between these situations and ABO mismatch (potentially fatal) situations (e.g. would allow O pos to an A pos patient, but not B pos to an A pos patient etc)|
|Release/issue process controls||What controls are available to ensure the process is completed correctly this could be sign off of G&S or crossmatching
Also - controls over the label and compatibility report printing process to minimise the possibility for cross-over errors (wrong labels applied etc). Sufficient space should allow orderly, uncluttered working conditions to further minimise the risk of incorrectly labelling units.
|Line clearance||Ensuring the right label only is available for each crossmatch, issue of components. For instance ensuring that the end of one label print run cannot remain at the start of the next run. Reconciliation and accounting for all printed labels.|
|Customer approval of supplied satellite sites and satellite fridges||The supplying blood bank should ensure that an approved Technical Agreement is in place with the supplied site to clearly define the arrangements and responsibilities of each party regarding the requirements for traceability, SAE/SAR reporting, and appropriate fridge maintenance, calibration, cleaning, and temperature mapping, etc. Also ensuring the bona fides of the site - are they entitled to receive blood?|
|Delivery||Is the cold chain maintained (if so - validation). If not, how are times out of fridge recorded (particularly relevant for returns of unused components)|
|Storage of components||That all are stored as identified for the component. Documented evidence of reasons when the storage system is outside the system limits i.e. 10OC for 10 minutes (large delivery of blood received).
Also that any alarm settings applied to storage equipment are appropriate, and would warn of storage temperature excursions outside those required on the label.
|Contract delivery companies and subcontractors||SLA with all companies and sub contractors
Also how the delivery is managed. If external courier companies, have the drivers been trained? Are delivery times monitored? Are temperatures monitored? Are transport containers validated?
|Breakdown contingencies||Identify what should happen if a taxi breaks down what they can do in these circumstances|