AABB announced the launch of the AABB Standards-Compliant Product Evaluation (SCoPE) Program, an initiative designed to offer assurance that products for the blood community are in compliance with AABB standards.
As part of the AABB SCoPE Program, vendors of lab equipment and supplies can apply to have AABB review their products. If a product is approved, it will receive an “AABB Standards-Compliant” seal.
“The AABB SCoPE Program was created to benefit both vendors and customers by certifying that a product is in compliance with AABB Standards,” said Anne Chenoweth, MBA, MT(ASCP)CM, CQA(ASQ), Senior Director of Accreditation and Quality at AABB. “AABB-accredited facilities must adhere to a set of rigorous standards, all of which promote optimal approaches to quality, and donor and patient safety. This new program assures facilities that any product deemed compliant adheres to relevant AABB Standards.”
The SCoPE Program has already been met with a positive response and vendors have stressed that earning an AABB Standards-Compliant seal will convey quality to their customers.
Product approval in the framework of the program applies exclusively to the specific make and model of the product submitted for AABB review, as well as to the current version(s) of customer information. When a product and/or user instructions are updated, the vendor must submit the changes for review to maintain the AABB seal of approval. Software programs, testing equipment that requires FDA approval with CLIA complexity classification, and supplies outside the range of AABB Standards are not eligible for the program.
The list of approved products will be available on the AABB website. Questions about the program should be directed to AABB’s Accreditation Department at 1-301-215-6492 or [email protected].
