Policies and procedures must include all aspects of the operation including donor selection, assessment, consent, microbiological testing, collection, labelling, system of numbering, processing, quality management and improvement, proficiency testing, storage, including alternative storage strategies if the primary storage device fails, transportation, outcome analysis, audits, expiry dates, emergency and safety procedures, equipment and supplies, maintenance and monitoring, cleaning procedures, personnel training, disposal of medical and biohazard waste, release procedures, including criteria for exceptional release, references, tolerance limits, corrective actions, recall, returns and discard policy. A risk management approach must be demonstrated.
The medical director/advisor and laboratory director/manager must review and approve all policies, procedures and research protocols annually to determine that they are clinically appropriate and consistent with the requirements of users of the service. They should seek to maximise safety for both donors and recipients.
Procedures carried out by third parties (e.g. donor assessment and harvesting centres, clinical transplant units and testing laboratories) must be described by written agreements. These must define and document relationships between the facility and the third party. The details of the agreement including responsibilities must be clearly specified, documented and agreed between parties. The agreement must include an option for audit of procedures carried out by the third party. Documented procedures to review these agreements should be in place.
All clinical and laboratory facilities should conform to the relevant EU Directives and both FACT-JACIE and NetCord-FACT Standards as appropriate. Laboratories must participate in appropriate recognised external quality assurance schemes. All clinical and laboratory facilities must be compliant with the requirements of the EU Clinical Trials Directive. Documentation of all research protocols performed by the facility must be maintained. This must include copies of research and ethics committee approvals for all relevant procedures.