AABB Briefs Members on New Quality Systems Template

By Naomi Greer, Laurie Munk and Tanya Brown

Members of the AABB Standards Quality Management Subcommittee (QMS) provided the latest information on the new quality systems template during session 5228-QE, “AABB’s Proposed Quality Management Standards.” First announced in the January 2007 issue of AABB News, the new template would serve as the basis for development of all future standards. The template presents requirements in a logical process flow sequence, incorporates user-friendly language and focuses on expected outcomes.

Where We’ve Been and Where We’re Heading

The new quality systems template is being developed to streamline the standards-setting and accreditation  processes that have been complicated by the use of multiple templates, according to Tania Motschman, MS, MT(ASCP)SBB, CQA(ASQ), chair of the QMS, which has been leading this effort.

Standards for blood banks and transfusion services, immunohematology reference laboratories, relationship testing laboratories and perioperative activities currently adhere to the quality system essential (QSE) template, while those for cellular therapy product services have been following the Core 10 template. Thus, there have been variations in the numbering scheme for standards as well as the meaning of the “same” requirements in different sets of standards. And because single facilities may be accredited under multiple sets of standards, they may be following more than one set of quality standards and may have implemented more than one quality system within the facility.

“It has been 10 years since the last systematic update of quality template concepts, and the new tool is intended to standardize minimum quality requirements across all programs,” Motschman noted. “Ultimately, this single template will provide uniform interpretation of terms, facilitate accreditation and preclude the need for program variances.”

QSEs: Then to Now

Lucia M. Berte, MA, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE, from the Laboratories Made Better consulting firm, then addressed the specifics of the proposed changes to the quality management template.

Simply put, Berte said, the QSEs would be reordered and some renamed. She reviewed the current list of 10 QSEs and compared it to the proposed listing of 12 QSEs (see table). The QSE order and content within each “chapter” of standards will be in process flow order — the sequence of steps that would need to be taken if a facility or process were being set up for the first time.

Berte explained how all of the QSEs that relate to the facility and its infrastructure would appear first, followed by the QSEs that relate to the work itself and, finally, the QSEs that relate to measurement of the work. With the QSEs forming the building blocks that support the path of workflow, the proposed changes reflect a “ground up” philosophy.

In closing, she noted that the new template for QSEs is intended for universal application to all AABB standard sets currently available and any developed in the future. The changes will create better consistency across all AABB standards and will harmonize with requirements of other groups, such as the Clinical Laboratory Standards Institute, The Joint Commission and ISO 15189.

New Steps

The presentation of the proposed QSE changes in this session and solicitation of feedback from members before posting these changes for official public comment are new steps in the AABB standards-setting process. (Feedback should be submitted to standards@aabb.org.)

The QMS will be considering all member feedback received before Dec. 1. However, the QMS will continue to monitor all feedback received throughout the standards-setting process. The subcommittee will make revisions as necessary and send a recommendation for a public comment period to the AABB Board of Directors for consideration at its January 2008 meeting. 

Decisions on the implementation of the new template in the five standard sets as well as decisions about the timing of the implementation will be made by the AABB Board of Directors at a later date. Also under consideration is the possible publication of the basic template as a stand-alone document before the changes are made across all AABB standards. Availability of a stand-alone document would give users a head start on planning for changes that might be needed.

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