Frequently Asked Questions About AABB Standards
How long is this edition effective for?
All sets of AABB Standards are effective for two years. The following are the dates by which all AABB Standards take effect:
Are Standards requirements or merely recommendations?
The Standards represent requirements that must be implemented by AABB-accredited facilities. A requirement contains the word “shall,” which indicates that the statement is mandatory. Failure to meet the requirement would constitute a nonconformance under the AABB Accreditation Program. There are rare instances in which a standard uses the term “may.” A statement that uses “may” is not a requirement.
What does the Pencil Symbol () mean?
When the pencil symbol precedes a standard, users are required to maintain a record of that activity in order to meet the standard. Users should refer to the reference standard at the end of Chapter 6 to identify the content(s) of the record and the associated retention time.
In the Standards for Cellular Therapy Services, users will note that a (C) or an (F) precedes the pencil symbol. In this case, the (C) and the (F) symbols provide additional details on the required retention time: a (C) indicates that a record must be retained for ten years from the creation of the record, while the (F) symbol indicates that the required retention time is ten years from the final disposition of the product.
What does it mean when Code of Federal Regulations are hyperlinked to a standard?
In many cases, a requirement in the AABB Standards may be associated with a requirement in the U.S. Code of Federal Regulations (CFR). Unless the standard specifically requires users to follow the requirements in the CFR, the reference is for information only. Under the new electronic publication format, resources such as the CFR can be accessed via a hyperlink in the portal.
Even if the reference to the CFR is informational, users may want to review the FDA requirements, particularly if your facility is subject to FDA regulations. In certain circumstances, the referenced resource may provide additional information, and in some cases, the regulation cited may actually differ from the standard. As a reminder, your facility is responsible for ensuring that all of your policies, processes, and procedures are in compliance with applicable federal, state, and local regulations.
The Standards for Cellular Therapy Services does not comprehensively address all requirements for cellular therapy products also regulated as biological drug products under section 351 of the Public Health Service (PHS) Act. Applicable regulations for these products may include 21 CFR Parts 201, 202, 210, 211, 312, 600, and 610. The CT Standards does not differentiate between 361 or 351 products (as regulated by the PHS Act).