Use of Expired Reagents

This is a sample document for use of expired reagents I wrote for HMC Qatar.

Principle:

Due to logistics issues including the long distance between suppliers in Europe and North America and Qatar and the importation/customs clearance of critical materials, Transfusion Medicine has developed a contingency variance policy to minimize disruption of the essential transfusion medicine testing and component preparation.  Approval for use of outdated reagents in special circumstances is not meant to be an excuse for untimely monitoring and improper ordering of supplies.

Definition:

Rare Reagent:  Any reagent that is either used uncommonly or is in short supply and difficult to obtain in a timely matter.

Policy:

  1. Maintain a minimum six (6) months’ supply of each reagent when feasible.
    1. This cannot be done for short-outdate reagents such as reagent red cells for panels and antibody screens.
  2. If an in-date reagent is not available for use, then an outdated reagent may be considered for use if:
    1. It passes an in-run quality control including negative and positive controls as applicable specific for the test in question.
    1. Supervisor reviews the results and approves their use:
      1. Results using such outdated reagents may only be used if they pass the validation rules in that procedure.
    1. The Division Head, Transfusion Medicine, or designate reviews the supervisor’s recommendations and approves their use.
  3. All such variances must be documented as follows:
    1. Variance document form
    1. In the comments for results within the Medinfo Hematos IIG software.

References:

Sections 1.3.2 and 7.0, Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA