Requesting a Variance to a Standard

Requests for variances to standards must be sent to the Standards and Global Development Department. Variances are alternate methods of achieving the intent of a standard. It should be noted that variances which 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 lead to revisions in Standards while promoting innovation in the field for which they are approved.

The following Accredited Cellular Therapy Facilities have been granted a variance(s).

Request forms can be downloaded in PDF format.

Type of Request

Documentation Required

First time submission

  • Completed variance request form
  • Appropriate supporting documentation

Re-application of a previously granted variance request with a new edition of Standards

  • Completed variance request form
  • All previous correspondence to and from AABB
  • An explanation of any changes to the process described in the previous variance request

Response to the appropriate standards program unit following a request for more information or denial

  • Cover letter responding to each specific request made by the appropriate standards program unit
  • Appropriate standards program unit response to the accredited entity
  • Original completed variance request form and supporting documentation

 

Variance requests are considered by the entire program unit at the earliest opportunity. This will either be the program unit's next meeting, or, if no meetings are scheduled for more than two months, a conference call will be scheduled specifically to discuss the variance request. The program unit may elect to do the following:

  1. approve the request
  2. deny the request
  3. require more information before making a decision

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 and Global Development Department.

Obtaining Clarification of a Standard

Standards clarifications can be obtained by submitting a question in writing to the Standards and Global Development Department. Written requests should contain the following information:

  • Your name
  • Your contact information
  • Standard in question, identified by number, as well as name and edition of Standards

Please note that this clarification process is intended to address only standards (such as the rationale behind a standard, or how to meet the intent of a standard).

Responses are written by a member of the appropriate standards program unit. The response is then reviewed by other members of the standards program unit to ensure the best and most complete response possible.

The usual time frame for the response is between four and six weeks at the most. If it has been more than six weeks since you submitted your request for clarification, please contact the Standards and Global Development Department.

Contacting Us

The Standards and Global Development 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 and Global Development Department
8101 Glenbrook Road
Bethesda, MD 20814-2749