Requesting a Variance

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.

  1. Initial submissions:

    1. Infectious Disease Testing Questionnaire as it relates to screening for acute infection and risk of exposure due to travel to endemic areas, relevant national or local laws or regulations, validation data for alternative methods, etc., as applicable to the variance request

  2. Variance renewals:

    1. Infectious Disease Testing Questionnaire as it relates to screening for acute infection and risk of exposure due to travel to endemic areas, relevant national or local laws or regulations, validation data for alternative methods, etc., as applicable to the variance
    2. Previously granted requests for variance and any relevant correspondence to and from AABB;
    3. An explanation of any changes to the process described in the previous variance request

Variance requests are considered by the appropriate standards committee either at the standards committee's next meeting, or, if no meetings are scheduled via email specifically to discuss the variance request. The committee will elect to do one of the following:

  1. Approve the request;
  2. Deny the request;
  3. Require more information before making a decision.

If the standards committee asks for more information before making a final decision, the facility requesting the variance should respond addressing each of the committee’s specific inquiries. The response, 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.

Please note, AABB Standards and Accreditation staff review all initial requests for variance prior to the request being shared with the appropriate committee to determine if necessary information is missing. If a submission is lacking in key information, AABB Standards and Accreditation staff will communicate what is needed from the requesting facility to ensure that a comprehensive request that can result in a granted or denied variance from the initial committee review is achieved.

Contact Us

The Standards Department can be reached by email, fax, or mail.

Email: standards@aabb.org
Fax: +1.301.657.0957, Attn: Standards
Phone: +1.301.215.6493

Mail:
AABB, c/o Standards Department
4550 Montgomery Avenue
Suite 700 North Tower
Bethesda, MD, 20814