Requests for variances to standards must be submitted to the Standards Department. Variances are alternate methods of achieving the intent of a standard. It should be noted that variances that propose alternative methods or approaches to meeting a standard may equal or exceed safe practice and should not be considered a negative mark against an accredited facility.
Approved variances can and have led to revisions in Standards while promoting innovation in the field for which they are approved.
NOTE: Granted variances apply only to the edition of Standards for which they are requested. Renewals of previously granted variance requests must be submitted prior to the subsequent edition has become effective, except in cases where the standard has been updated or the facility is in compliance with the wording of the standard.
To submit a request for variance, please fill out the Variance Request Form. Before filling out the electronic form, have the following documentation prepared in PDF format to be attached to your request.
Infectious Disease Testing Questionnaire, relevant national or local laws or regulations, validation data for alternative methods, etc., as applicable to the variance request
Variance requests are considered by the entire standards committee either at the standards committee's next meeting, or, if no meetings are scheduled for more than two months, at a conference call scheduled specifically to discuss the variance request. The committee will elect to do one of the following:
If the standards committee asks for more information before making a final decision, the facility requesting the variance should respond with a cover letter addressing each of the committee’s specific inquiries. In this response, the facility should also include previous communications such as the standards committee's response and the original variance request.
If a request is denied, the facility can appeal to the Standards Review Committee, which is composed of the Chair of the Standards Program Committee, the Chair of the Accreditation Program Committee, a Quality liaison, and the Chair of the relevant Standards Committee. If the Standards Review Committee also denies the request, the requestor can then appeal to the AABB Board of Directors.
Decisions are communicated to requestors in writing. If you have a question about the status of a variance request you have made, please contact the Standards Department.
The Standards Department can be reached by email, fax, or mail.
Fax: +1.301.657.0957, Attn: Standards
AABB, c/o Standards Department
4550 Montgomery Avenue
Suite 700 North Tower
Bethesda, MD, 20814
November 20, 2020
November 20, 2020
October 03, 2020