Blogs

REGULATORY UPDATE: Circular of Information Updated for Cryoprecipitated AHF Manufactured From PF24

By Drew Case posted 07-26-2023
AABB updated the Circular of Information web page this week to include new language required by the Food and Drug Administration for the manufacture of cryoprecipitated antihemophilic factor (AHF) manufactured from plasma frozen within 24 hours after phlebotomy (PF24). It is important to refer to the FDA-approved use of the blood collection set described in the package insert and the regulations that apply to understand why it is necessary, under certain circumstances, to request FDA approval for an exception to those FDA requirements using the variance request process under 21 CFR 640.120 . Cryoprecipitated AHF is manufactured from plasma , as ...

AABB to Launch 'AABB Community,' Successor to 'AABB HUB,' Next Month

By Drew Case posted 02-22-2023
The AABB HUB , the Association’s members-only online forum, will be sunset next month. In its place, AABB is pleased to announce the launch of the AABB Community, an expanded online forum designed to better suit members’ needs. Like the AABB HUB, the AABB Community will be an exclusive, members-only benefit where users can connect with colleagues, ask questions, seek advice, and share information and resources. The upgraded platform will feature various discussion groups on specific topics, including transfusion medicine, biotherapies, patient blood management and more. To ensure continuity of conversation threads, the ongoing discussion groups currently ...

Abstract Submission Period Open for 2023 AABB Annual Meeting

By Drew Case posted 01-31-2023
The AABB Selection of Abstracts Committee invites members of the blood and biotherapies community to help shape the scientific content at the AABB Annual Meeting by submitting an abstract for the 2023 Meeting, to be held Oct. 14-17 in Nashville, Tenn. Abstract categories include various scientific and administrative categories in transfusion medicine and biotherapies. Abstract preparation and submission guidelines are available online . Submissions from both members and nonmembers are welcome. Abstracts are due by Thursday, March 23. Those whose abstracts are accepted are required to attend the 2023 AABB Annual Meeting, where they will have the opportunity ...

AABB/ISCT Joint Working Group Releases GTP Interpretative Tool

By Drew Case posted 01-31-2023
A joint working group of AABB and the International Society for Cell and Gene Therapy (ISCT) released a new Good Tissue Practice (GTP) Interpretive Tool on both the AABB and ISCT websites. The joint working group developed the AABB/ISCT (GTP) Interpretive Tool to educate those in the biotherapies community about the interpretation of GTP requirements and how best to prepare for FDA inspections of establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps). The AABB/ISCT GTP Interpretative Tool provides section-by-section guidance specific to the needs of biotherapies programs to help them achieve regulatory ...

Join an AABB Committee in 2023

By Drew Case posted 01-10-2023
Calling all dedicated blood and biotherapies professionals! AABB encourages all members to apply to join one of its committees for 2023. Applications are being accepted through Feb. 15, and the new term will begin in the summer of 2023. AABB committees are a vital link to the success of the Association. AABB offers a wide variety of committees for members in all aspects of the blood and biotherapies field to become more involved. Serving on a committee is an ideal way to help advance the field, influence new initiatives, meet like-minded professionals and expand your knowledge. AABB members find their committee experience to be fulfilling and rewarding. “I ...

REGULATORY UPDATE: AABB Updates December 2021 Circular with New Language for Pathogen-Reduced Apheresis Platelets “Warnings and Precautions” Section

By Drew Case posted 12-06-2022
AABB updated the Circular of Information for the Use of Human Blood and Blood Components web page following the Food and Drug Administration’s approval of new language to be inserted in the December 2021 Circular . AABB made the update to provide the approved statement regarding pathogen-reduced apheresis platelets “Warnings and Precautions ” for Intercept-treated platelets. The package inserts for the Intercept Blood System for Platelets were revised to remove acute respiratory distress syndrome (ARDS) from the “Warnings and Precautions” section. ARDS remains described in the clinical summary section of the package inserts. Accordingly, ...

AABB Seeking Applicants for New DEIA Committee

By Drew Case posted 11-23-2022
AABB is creating a new Diversity, Equity, Inclusion and Access (DEIA) Committee, which will comprise members committed to advancing the Association’s DEIA efforts. AABB is now seeking dedicated individuals to join the Committee and help shape critical DEIA work throughout the next few years. AABB encourages all members interested in advancing these efforts to apply to be part of the initial DEIA Committee. AABB believes that all people should have the support they need to succeed in a respectful, fair and equitable environment. AABB is committed to our staff, members and the community in embracing the values of DEIA. To affirm and advance its commitment ...

AABB Extends Application Deadline for Early-Career Laboratory Education Scholarships

By Drew Case posted 10-11-2022
AABB has extended the deadline to apply for the early-career laboratorian scholarship program , generously supported by an unrestricted grant from Abbott, through Oct. 28. AABB will award 100 eligible professionals with complimentary access to one of four courses in blood and biotherapies. Applicants are required to have seven or fewer years of experience working in a laboratory and have the support of their supervisor. AABB will notify awardees by Nov. 15.

AUGUST 18: Join AABB's Hot Topic Discussion on Injectable PrEP

By Drew Case posted 08-12-2022
AABB will host a Hot Topic Discussion on Aug. 18 to discuss the potential impact of long-acting, injectable cabotegravir as pre-exposure prophylaxis (PrEP) for the prevention of HIV. The Food and Drug Administration approved the injectable medication (Apretude, Viiv Healthcare) in December 2021. Studies have demonstrated that cabotegravir can linger in the body for up to 12 months or longer following injection, presenting new considerations for donor testing and screening. In this program, expert speakers will provide brief presentations on these considerations, followed by a question and discussion period. The program will take place from 2-3:15 p.m. ...

AABB Releases Blood Component Cards as Member-Exclusive Offering

By Drew Case posted 06-28-2022
AABB is pleased to introduce a series of blood component cards as a new member-exclusive offering. The series includes a card for each blood product – cryoprecipitate, plasma, platelets and red blood cells – that provides essential information for professionals working in the blood and biotherapies field. These complimentary resources include a description of each product, storage and handling instructions, an overview of clinical use and indications, and dosage and infusion information. In addition, the cards include a “risks” section that addresses adverse events that are associated with each product, along with risk mitigation strategies. Each card ...

AABB Develops New Fact Sheet for Clinicians Considering CCP to Treat COVID-19

By Drew Case posted 01-21-2022
AABB has developed a fact sheet for clinicians considering the use of COVID-19 convalescent plasma that reflects the changes in the Food and Drug Administration’s revised emergency use authorization for CCP issued Dec. 28. The fact sheet provides recently updated information about the qualification of high-titer CCP, which patient populations are eligible to receive CCP, and the new option for outpatient treatment with CCP. Information about CCP and the revised EUA for blood centers is available in AABB’s Jan. 14 CCP toolkit .

REGULATORY UPDATE: AABB Resource Highlights Crucial Regulatory Options Already Available from FDA to Support Blood Availability

By Drew Case posted 01-20-2022
Based on concerns and questions from hospitals and blood centers about inventory management strategies, AABB has confirmed its understanding with the Food and Drug Administration to help members identify existing flexible shipping options that are widely misunderstood. FDA’s clarification is included in the AABB resource “ Blood Supply: Summary of Crucial Regulatory Options Already Available from FDA .” The document clarifies crucial regulatory options available to facilities today: to correct widespread misconceptions on shipping limitations. to clarify that hospitals and unlicensed blood centers can ship licensed products across state lines. to increase ...

REGULATORY UPDATE: FDA Issues Revised CCP Guidance, AABB Updates CCP Toolkit

By Drew Case posted 01-11-2022
The Food and Drug Administration issued a revised final guidance on Friday that provides updated recommendations on the use of COVID-19 convalescent plasma (CCP) related to the December 2021 emergency use authorization (EUA) for CCP . FDA revised the guidance to reflect that the EUA authorizes CCP with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting. It also includes updated recommendations pertaining to CCP donors. AABB detailed the changes to the revised guidance in an updated CCP toolkit to assist ...

REGULATORY UPDATE: FDA Revises EUA for CCP

By Drew Case posted 01-07-2022
The Food and Drug Administration revised the emergency use authorization (EUA) for COVID-19 convalescent plasma (CCP) on Dec. 28 to permit the use of high-titer CCP for treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment, in either the outpatient or inpatient setting. The Dec. 28 EUA also revises the list of acceptable tests in Appendix A, increases qualifying result cutoffs to be used for the manufacture of high-titer CCP, and makes corresponding changes to the authorized fact sheets for health care providers and for patients and caregivers . AABB has posted a table to clearly track these ...

REGULATORY UPDATE: ‘Ask the FDA and CLIA/CMS 2021’ Annual Meeting Slides Now Available

By Drew Case posted 12-21-2021
The slide presentation from the 2021 AABB Virtual Annual Meeting session “Ask the FDA and CLIA/CMS” is now available with responses from each agency’s representatives included in the slides. Every year, AABB members submit questions for the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS) representatives to address during this popular AABB Annual Meeting session. In 2021, AABB presented 58 questions to solicit federal regulators’ current thinking on a wide range of topics. AABB encourages members to treat the session slides as a resource as they review their organizations’ current policies and procedures. Members with questions ...

REGULATORY UPDATE: AABB Releases HIV Testing, Lookback and Re-Entry Toolkit

By Drew Case posted 11-02-2021
AABB announces the availability of a new toolkit on HIV testing, lookback and re-entry . Developed at member request, it is the first in a series of resources created to assist blood centers and transfusion services with the regulatory actions necessary following a positive test for a relevant transfusion-transmitted infection (RTTI). The flowcharts are intended to assist members with compliance efforts but are not intended to replace the review of recommendations found in the Food and Drug Administration’s December 2017 guidance, Nucleic acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, ...

Complimentary AABB eCast Details Preparation for PBM Certification

By Drew Case posted 11-02-2021
As part of its #PBMAW2021 activities, AABB is pleased to offer the blood community complimentary access to an eCast on patient blood management (PBM) certification . This program will provide an overview on obtaining PBM certification with perspectives from a university hospital, a hospital system and a large community teaching hospital. Speakers will detail experiences from their journey and provide examples of what worked and what did not. Complimentary access is available for the duration of PBM Awareness Week, which ends Nov. 5.

AABB to Host Career Development Roundtable for Residents, BBTM Fellows

By Drew Case posted 10-05-2021
At the upcoming AABB Annual Meeting, AABB will host a virtual career development roundtable for residents, blood banking/transfusion medicine (BBTM) fellows and recent graduates to learn more about the career paths available to physicians specializing in BBTM. The roundtable – returning to the AABB Annual Meeting for the first time since 2015 – will also provide an opportunity for attendees to network with established BBTM physicians working in blood centers, hospital-based transfusion services, cellular therapy services and performing research to discuss lessons learned during their journeys. This invitation-only roundtable will take place from 12:30 – 2 p.m. ...

Latest ‘PBM Column’ Explores Pharmacologic Agents, Under-Transfusion of Plasma

By Drew Case posted 10-05-2021
AABB’s Transfusion Safety and Patient Blood Management (TS/PBM) Subsection recently released the latest article in its “PBM Column” series, “ How Can We Avoid the Under-Transfusion of Plasma and Encourage Pharmacologic Agents? ” In this complimentary resource, Mark T. Friedman, DO, from NYU Langone Health Long Island School of Medicine, discusses how the development of a robust PBM program – with an emphasis on education – is a key strategy for minimizing inappropriate plasma transfusions and underdosing. Friedman also explores how the use of pharmacologic hemostatic agents, when appropriate, can help to reduce or avoid use of plasma in select coagulopathic patients. ...

AABB Releases Digital Swag Toolkit for 2021 Annual Meeting

By Drew Case posted 09-28-2021
AABB developed a new digital swag toolkit that includes Zoom backgrounds and other social media graphics to help attendees participate in the 2021 AABB Annual Meeting in style . The toolkit includes social media images and email signatures for attendees, speakers, exhibitors and sponsors. Additionally, AABB encourages attendees to share their perspectives before and during the meeting using the #AABB21 hashtag.