Advanced

Home

Members Area

About AABB

Join AABB

Accreditation

About Blood and Cellular Therapies

Donate Blood

Programs and Services

Professional Development

Bookstore

Newsletters and Journal

Meetings and Events

News and Media

Standard Setting Activities

Since 1957, the AABB has been a leader in the development of standards for voluntary compliance in blood bank blood component collection, processing and transfusion. In the years since, AABB standards-setting programs have expanded to encompass several new disciplines. In addition to the Standards for Blood Banks and Transfusion Services, AABB now publishes Standards for Cellular Therapy Product Services (including hematopoeitic progenitor cells, somatic cells and cord blood), Standards for Immunohematology Reference Laboratories, Standards for Relationship Testing Laboratories (formerly Standards for Parentage Testing Laboratories), Standards for Perioperative Autologous Blood Collection and Administration, and Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens.

Each set of Standards is developed by a volunteer committee of experts. The requirements contained in Standards are based on good medical practice, scientific data, principles associated with good manufacturing practices and quality assurance, applicable regulations, and the requirements of other standards-setting and accrediting bodies. These standards, along with the requirements detailed in the Accreditation Information Manual have provided the basis for the AABB Accreditation Program.

AABB Standards are a matrix that combines internationally accepted quality management system requirements with technical requirements appropriate for each given discipline. As such, the Standards can serve as the basis for accreditation anywhere in the world. Due to the fact that some requirements are based on the United States of America’s Food and Drug Administration, a committee of volunteers with international expertise can review requests for variance that involve a departure from U.S. public health priorities.

AABB has also sought to promote the development of public health systems through international standards-setting. AABB is using standards templates that incorporate blood banking terminology and are compatible with the universally accepted ISO (International Organization for Standardization) 9000 standards to assist the Latin American, Caribbean, and African regions in developing region-specific standards. AABB is hopeful that these standards templates can continue to be used as the foundation for standards-setting and accreditation programs in any region of the world.

AABB’s Standards and Accreditation Programs are separate departments of AABB and operate independently of AABB’s Consulting Services.

Standards for Blood Banks and Transfusion Services
Standards for Cellular Therapy Product Services
Standards for Immunohematology Reference Laboratories
Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens
Standards for Perioperative Autologous Blood Collection and Administration
Standards for Relationship Testing Laboratories
Standards Source
Quality Templates
Standards Library

Standards for Blood Banks and Transfusion Services

While work on the 1st edition of Standards for Blood Banks and Transfusion Services began in 1957, the book was published in 1958. The Standards for Blood Banks and Transfusion Services is revised and published on an 18-month cycle. Work on the 26th edition of Standards for Blood Banks and Transfusion Services has been completed and the book is available for purchase. The 26th edition became effective on November 1, 2009.

Standards for Cellular Therapy Product Services

Requirements relating to HPCs and bone marrow were first introduced in the 14th edition of Standards for Blood Banks and Transfusion Services in 1991. In 1996, the AABB published the 1st edition of Standards for Hematopoietic Progenitor Cells, and in 2001 the 1st edition of Standard for Cord Blood Services. In 2004 the HPC Standards and the Cord Blood Standards were merged into the 1st edition of Standards for Cellular Therapy Product Services. The CT Standards is revised and published on an 18-month cycle. The Cellular Therapy Standards Program Unit, has completed work on the fourth edition which is now available for purchase. The 4th edition becomes effective on March 1, 2010.

Standards for Immunohematology Reference Laboratories

The first edition of Standards for Immunohematology Reference Laboratories was published in 1999 and became effective on July 15, 1999. The IRL Standards is revised on a 24-month schedule, with new editions becoming effective on September 1 of odd-numbered years. The IRL Standards outlines requirements for these highly specialized laboratories that provide an essential service to patients who have specific serologic complexities and/or need rare blood components. The sixth edition became effective September 1, 2009.

Standards for Relationship Testing Laboratories

The AABB has been developing standards and accrediting laboratories in the parentage testing field since 1984. The Standards for Relationship Testing Laboratories is revised on a 24-month schedule, with new editions becoming effective on January 1 of even-numbered years. The RT Standards contains requirements for laboratories performing parentage testing as well as more complex relationship testing in cases where the following criteria are met:

the identity of the individuals being tested can be confirmed by the laboratory or through a legal chain of custody
the sample collection is witnessed by a third party with no interest in the test outcome; and
the individuals being tested have consented to the test (or a consent has been provided through a court order)

Work on the 9^th edition of Standards for Relationship Testing Laboratories has been completed and the book is available for purchase. The 9^th edition became effective on January 1, 2010.

Standards for Perioperative Autologous Blood Collection and Administration

The first edition of Standards for Perioperative Autologous Blood Collection and Administration was published in 2001 and became effective on March 1, 2002. Previously, AABB requirements for perioperative programs were published as part of the Standards for Blood Banks and Transfusion Services.

The AABB hopes that setting standards and accrediting facilities for perioperative activities, will contribute to the development of a national forum for anesthesiologists, perfusionists, surgeons, transfusionists, and other professionals involved in the delivery of perioperative services. The Perioperative Standards and the annual blood management conference are planned and developed with input from other organizations in the field, such as the American Society for Extra-Corporeal Technology (AmSECT) and the Society for the Advancement of Blood Management (SABM).

Currently, the Perioperative Standards is revised on a 24-month schedule, with new editions becoming effective on November 1 of odd-numbered years. The fourth edition of Standards for Perioperative Autologous Blood Collection and Administration became effective November 1, 2009.

Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens

The first edition of Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens was published in the fall of 2008 and will become effective on July 1, 2010. The Standards and an accompanying guidance document are available for purchase.

Quality Templates

AABB has developed two quality templates for use in standards-setting. The QSE and Core 10 templates are the framework for every set of Standards currently published by AABB. Both quality templates are managed and updated by the Quality Management Standards Subcommittee (QMS). The QMS is comprised of quality experts who represent each field for which AABB sets Standards. The QMS also maintains a liaison with the Quality Systems Subcommittee. Both quality templates have ten chapters representing the Quality System Essentials. Originally defined in Association Bulletin #97-4, the Quality System Essentials have evolved over time to encompass the following elements:

Organization
Resources
Equipment
Customer and Supplier Issues (Agreements)
Process Control
Documents and Records
Nonconforming Products and Services
Assessments (Internal and External)
Process Improvement through Corrective and Preventive Action
Facilities and Safety

The list above does not reflect the chapter headings of each set of Standards; rather, it describes the topic areas that are addressed by each Standards.

Each chapter begins by requiring that the facility have policies, processes, and procedures to satisfy the requirements in that chapter. These general quality requirements are followed by detailed technical standards, tailored to each discipline’s specific activities. Both templates include a common glossary that defines generic quality terms in addition to discipline-specific terms.

Standards Library

Much of the ongoing work in standards-setting is geared towards helping users understand the process by which standards are set and to understand how to effectively implement AABB requirements. In an effort to assist users, the following documents are currently available for public review: