Aabb Standards Pdf Free Download
Lekisha Gruenewald
The AABB Accreditation program is internationally recognized as a symbol of quality, and facilities that have achieved AABB accreditation are known to provide quality products and services. AABB has been a leader in developing standards and accrediting facilities in the blood and biotherapies community since 1958.
AABB standards incorporate both technical and quality systems standards to ensure that all facets are reviewed - from specification of equipment, materials management, and organizational structure to documents, resource management, and program assessment.
AABB sets standards for blood banks and transfusion services, designed to ensure the highest levels of quality and safety for patients and donors at all times. AABB accredits blood banks and transfusion services that meet these high standards.
The 33rd edition of Standards for Blood Banks and Transfusion Services (BBTS Standards) details the latest standards of practice in blood banking and transfusion medicine. As in the past, each chapter heading represents one of the Quality System Essentials and the quality standards are supplemented by technical requirements. The effective date of this edition is April 1, 2022.
The Standards Portal is also fully searchable by key word, chapter, or standard number, allowing users to navigate quickly to the most relevant standards to them at that time. Guidance is provided on how to implement a standard, why it was created, or why a change was made from this edition to the last. Any relevant documentation that would assist users in implementing the standard in question is provided.
All links to outside websites and cross references to other standards in the portal are live and appear in popup windows to allow users to be able to see both the standard in question and the linked post. The full edition of the BBTS Standards (not including any guidance) is printable at any time to ensure that users can take the BBTS Standards on the go.
The American Association of Blood Banks (AABB) represents institutions involved with transfusion medicine and biotherapy. The AABB develops standards for accreditation and offers educational programs that focus on optimizing care and safety for patients and donors. AABB members include physicians, nurses, scientists, researchers, administrators, medical technologists, and other health care providers in more than 80 countries.
AABB standards for blood bank refrigerators and freezers have existed for decades, but there is no certification process for products marketed as blood products. The U.S Food and Drug Administration (FDA) requirements in section 864.9700 of 21 CFR Part 864, Subpart J and European Medical Device Directive MDD 93/42/EEC state that manufacturers must list products intended for blood and blood product storage as Class II 510K exempt or Class IIa medical devices, respectively.
These listings only pertain to quality and design control; a Class II 510K or Class IIa Iisting does not guarantee that a device will fulfill industry needs. This leaves manufacturers to self-declare product compliance according to AABB standards. The burden of interpreting the standards to determine whether a refrigerator or freezer satisfies industry requirements is placed on the manufacturer and, by extension, the institutions that use the product.
To address this issue, the AABB recently launched the Standards-Compliant Product Evaluation (SCoPE) Program. The program is intended to benefit manufacturers and institutions by providing assurance that products designed for the blood community comply with AABB standards. SCoPE participation in combination with FDA and MDD listing helps ensure that manufacturers fulfill industry needs and have the necessary quality and design controls in place.
Benefits to Users
All links to outside websites and cross references to other standards in the portal are live and appear in popup windows to allow users to be able to see both the standard in question and the linked post. The full edition of the RT Standards (not including any guidance) is printable at any time to ensure that users can take the RT Standards on the go.
The AABB (formerly the American Association of Blood Banks) is a professional society for transfusion medicine. Amongst other activities, the AABB develops practice standards against which hospital transfusion services and blood collectors can be voluntarily audited in order to achieve AABB accreditation. These standards specify the conduct of all aspects of the practice of laboratory-based transfusion medicine. Accredited hospitals are required to adhere to the standards, although exceptions to the standards can be made to accommodate local practice variations. In the 30th edition of the standards, standard 5.15.1 specified that whole blood (WB) must be transfused in an ABO-identical manner with the recipient. This is problematic for hospitals that want to use WB in the pre-hospital setting or early in the in-hospital resuscitation of trauma patients when their ABO group is usually unknown.
All links to outside websites and cross references to other standards in the portal are live and appear in popup windows to allow users to be able to see both the standard in question and the linked post. The full edition of the CT Standards (not including any guidance) is printable at any time to ensure that users can take the CT Standards on the go.
What if a product is not standards-compliant?
If the product has not been approved as AABB standards-compliant, the reasoning behind this decision will be conveyed to the applicant, who will then have the opportunity to take corrective action.
"As new technology comes on board, like Rapid DNA, we watch how it is being used, and then roll it all into one area where standards can be written. We're always looking for what's coming up, down the road. We've been looking at Rapid DNA for a while," Chenoweth said.
AABB (Association for the Advancement of Blood & Biotherapies) is an international, not-for-profit association representing individuals and institutions involved in the field of cellular therapies and transfusion medicine. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB has been setting standards for both public and family cord blood banking for over 20 years.
Accreditation is based on compliance with the AABB Standards. The Standards are revised every two years by a committee composed of experts in the cord blood profession, an ethicist and stem cell transplant physicians. The Standards list requirements for all aspects of cord blood banking including maternal screening and testing, processing, storage, and patient outcomes. All aspects of the business operations are covered under the robust standards which require a complete quality system.
Those cord blood banks that perform their own testing in-house are eligible for CAP accreditation. It is a peer-based, voluntary, accreditation program that reviews laboratory procedures to ensure that they follow rigorous quality standards for specimen testing.
Good Manufacturing Practice for cellular therapy, known as cGMP, are standards that are usually established by the federal government. Hence they may be different in each country, which is why international standards have sprung up, such as JACIE in Europe.
In the US, the FDA establishes GMP standards. The FDA applies GMP standards to drugs and medical devices. The new FDA BLA licensing requires that public cord blood banks to handle cord blood as if it were a drug, and follow the GMP standards.
FACT, Foundation for the Accreditation of Cellular Therapy, is a non-profit organization devoted to standards, accreditation, and education in cellular therapy and regenerative medicine. FACT was created by the medical community under the premise that quality cellular therapy and cord blood banking can only be achieved with cooperation among collection, processing, and clinical professionals. In 1996, FACT was formed by the International Society for Cellular Therapy (ISCT) and the American Society for Blood and Marrow Transplantation (ASBMT). Then, in 2004, FACT began to partner with Netcord, an international consortium of cord blood banks, to administer joint standards and accreditation. The voluntary inspection and accreditation process is international.
Prior to 25 May 2005, the FDA only required family cord blood banks to be registered with them, and the list of FDA registered HCT/P establishments is on-line. Since then, the FDA also conducts inspections of family cord blood banks. Laboratories which process HCT/P's must follow current FDA standards of Good Tissue Practices.
HOKLAS is a voluntary accreditation operated by Hong Kong Accreditation Service (HKAS) and only available to organizations based in Hong Kong. HOKLAS accreditation is open to participation by any Hong Kong laboratory, testing provider, or reference material producer. The HKAS accreditation requirements are designed to align with relevant ISO accreditations for organizations that offer testing (both medical and non-medical), calibration, proficiency testing, and reference material providers. The accreditation standards contain both management requirements and technical requirements. A list of HOKLAS-accredited organizations is posted on-line.
The UK code of practice for tissue banks is consistent with EU standards established at the same time. On 31 March 2004 the European Parliament passed Directive 2004/23/EC (11 page pdf) titled "EU-Directive on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells". Compliance with this directive has varied among EU nations, but the UK was one of the first to establish fully compliant regulations.
Although ISO does not have standards for cord blood banking, many cord blood banks have ISO accreditation on certain aspects of their operations. Here are examples of ISO accreditations that are held by some cord blood banks:
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