AABB blood center accreditation is AABB's accreditation of facilities that collect, process, test, store or distribute blood and blood components, measured against the AABB Standards for Blood Banks and Transfusion Services, 35th edition, effective April 1, 2026. This service is for community blood centers and hospital blood banks that collect from donors, preparing for AABB's assessment. Integral Healthcare Solutions (IHS) drafts the quality-system documents and controls for blood center accreditation; your transfusion medicine staff own eligibility and release.
Last reviewed: October 2026. AABB's standards, blood collection, accreditation process, activities and fee pages, and 21 CFR Parts 606, 607 and 630 on eCFR, checked on October 2, 2026.
What is AABB blood center accreditation?
The governing text is the AABB Standards for Blood Banks and Transfusion Services. AABB says the 35th edition "Outlines requirements for donor qualification, blood collection, processing, storage, and transfusion," and lists the "Current edition : 35th edition Effective date : April 1, 2026" with a 24-month revision cycle (AABB BBTS Standards).
AABB accredits by activity. Its accreditation activities list (Version 3, effective 4/2/2026) defines the core blood center activity: "Donor Activity – A facility that performs, or is responsible for the performance of, the collection, processing, testing, storage, and/or distribution of human blood and/or blood components intended for transfusion and transplantation. The donor activity may be performed by a community blood center or a hospital blood bank" (AABB Accreditation Activities).
For blood centers, AABB lists "Donor Activity*", "Donor Testing Only Activity", "Immunohematology Reference Laboratory (IRL) Activity*" and "Molecular Testing Activity*", noting "*AABB can be the CLIA provider for facilities accredited in these activities" (AABB blood collection accreditation). AABB says it "provides accreditation in most of the key areas in which blood centers are active, allowing facilities to have a single accreditor for your donor center, immunohematology reference lab, molecular testing lab and other ancillary services" (AABB).
The process has "two phases ... the self-assessment phase, followed by the on-site assessment phase." The self-assessment is performed "in APEX, AABB's on-line accreditation portal," and the facility proceeds "to on-site assessment after AABB reviews and approves the self-assessment" (AABB Accreditation Process).
Who needs it and what triggers it
- Community blood centers and hospital blood banks performing the Donor Activity, which AABB says "may be performed by a community blood center or a hospital blood bank" (AABB Accreditation Activities).
- Centers that want one accreditor across donor, reference lab and molecular testing work, and AABB as CLIA provider for the activities it marks (AABB).
- New programs that have been operating for six months. "A facility must be in operation for a minimum of 6 months (in the desired accreditation activity) before the initial accreditation process can begin" (AABB Accreditation Process).
- Accredited centers due for reassessment, which comes "every two years" (AABB Accreditation Process), and centers updating procedures for the 35th edition.
Federal rules apply alongside accreditation. 21 CFR 606.100(b) states: "Establishments must establish, maintain, and follow written standard operating procedures for all steps in the collection, processing, compatibility testing, storage, and distribution of blood and blood components for allogeneic transfusion, autologous transfusion, and further manufacturing purposes" (eCFR, 21 CFR Part 606). 21 CFR 630.10(a) states: "You, an establishment that collects blood or blood components, must not collect blood or blood components before determining that the donor is eligible to donate or before determining that an exception to this provision applies" (eCFR, 21 CFR Part 630).
How IHS helps
IHS works from your center's copy of the AABB Standards for Blood Banks and Transfusion Services. The process:
- Gap assessment. Questionnaires on donor records, roles, deviations and suppliers, then a comparison of your quality system with each applicable standard.
- Document and evidence mapping. A crosswalk from each standard to the policy, process, procedure or record that shows it is met, set up for the APEX self-assessment.
- Drafting. IHS drafts document controls, donor-record governance, deviation reporting and supplier qualification procedures for your transfusion medicine and laboratory staff to review and approve.
- Mock assessment. A review against the Standards before AABB's on-site visit, listing what is missing.
- Readiness support. IHS drafts responses to assessment findings for your center to review and submit.
What you supply: the Standards, your SOPs, and transfusion medicine and laboratory staff who own donor eligibility, processing and product release. Your center applies, completes the APEX self-assessment and handles any FDA filings. For related programs, see the accreditation consulting practice.
The limit: technical blood-banking activities stay with your staff. IHS does not make donor eligibility, testing or release decisions, and the accreditation decision is AABB's.
What to have ready
- Your copy of the AABB Standards for Blood Banks and Transfusion Services, 35th edition, effective April 1, 2026 (AABB; prices on AABB Purchase Standards).
- A list of the AABB activities you perform, matched to the definitions in the Accreditation Activities list, Version 3 (AABB).
- Written policies, processes and procedures for every standard, since AABB expects "that all standards are addressed in policies, processes and procedures (PPPs), and that PPPs are followed as written" (AABB Accreditation Process).
- Written SOPs "for all steps in the collection, processing, compatibility testing, storage, and distribution of blood and blood components" under 21 CFR 606.100(b) (eCFR).
- Donor eligibility records showing the determination is made before collection, per 21 CFR 630.10(a) (eCFR).
- Your FDA establishment registration and product list, since 21 CFR 607.20(a) requires owners or operators of establishments "not exempt under section 510(g) of the act or subpart D of this part, that engage in the manufacture of blood products" to "register and submit a list of every blood product in commercial distribution" (eCFR).
- Evidence of at least 6 months of operation in each activity you seek (AABB Accreditation Process).
- Your annual collection or transfusion volume, which sets AABB's volume fee (AABB fees).
- A decision on whether AABB will be your CLIA provider for the activities it marks (AABB).
- A named owner for the APEX self-assessment (AABB Accreditation Process).
To go through the list with IHS, book the introductory call below.
How it compares
The table sets out the options the sources describe. Which apply depends on your activities and your customers.
| Option | What the sources say |
|---|---|
| AABB accreditation | Activity-based accreditation against the BBTS Standards; AABB can be the CLIA provider for Donor, IRL and Molecular Testing activities (AABB). |
| FDA compliance under 21 CFR Parts 606, 607 and 630 without voluntary accreditation | The federal requirements for written SOPs, donor eligibility and registration apply by regulation (Part 606, Part 630, Part 607). |
| CAP Laboratory Accreditation Program, for the testing side | CAP states: "The Centers for Medicare & Medicaid Services (CMS) granted the CAP Laboratory Accreditation Program deeming authority, which allows for a CAP inspection in lieu of a CMS inspection" (CAP). |
| AABB Fundamental Standards for Blood Collection and Transfusion | Listed on the AABB standards index. This page does not summarize its scope or eligibility. |
The sources reviewed do not say whether hospitals or payers require supplier blood centers to hold AABB accreditation.
What it costs
AABB publishes its 2026 institutional dues and fees (2026 AABB Institutional Dues Fees, read October 2, 2026). AABB states: "Annual institutional membership dues include basic membership, volume fee and an accreditation activity fee, which is based upon your primary business focus."
| Item | AABB's published amount |
|---|---|
| Basic Membership, Accredited Institutions | $1,714 |
| Application Fee (new members only) | $1,740 |
| Donor Center, Hospital Blood Bank | $2,508 |
| Donor Center, Blood Center Activity | $3,370 |
| Donor Center, Testing Activity | $3,370 |
| Accreditation fee for activities requiring lead assessor services, including the Blood Center and Testing activities | $3,694 |
| Annual volume fee, by units collected or transfused | From $146 (1-5,000) to $6,333 (greater than 500,000) |
| CLIA Fee, where AABB is the CLIA provider for each non-waived CLIA number | $1,421 |
| BBTS Standards, 35th edition, print | List $320.00; member $217.00 (AABB Purchase Standards) |
AABB notes that "Additional fees may apply if activities are performed at multiple sites." These are AABB's published dues and fees, not a total cost. The same AABB fee document lists a travel fee of $1,568 per year for non-U.S. locations (excluding Canada), notes that additional fees may apply for multi-site activities, and does not itemize other assessor charges. Verify current fees with AABB. IHS scopes each engagement after a free introductory call.
What this is not
- IHS is not AABB or FDA and does not grant, predict or influence an accreditation decision.
- IHS does not submit to or speak for your center to AABB or FDA. IHS drafts; your center applies, completes the self-assessment and makes any FDA filings.
- IHS does not make donor eligibility, testing or product release decisions, and this page is not legal or medical advice.
Frequently asked questions
What does AABB accreditation of a blood center or donor center involve?
AABB accredits by activity. A center that collects blood falls under the Donor Activity, and AABB also lists Donor Testing Only, Immunohematology Reference Laboratory and Molecular Testing activities for blood centers. The process is a self-assessment in APEX followed by an on-site assessment.
What is in the 35th edition of the AABB Standards for Blood Banks and Transfusion Services, effective April 1, 2026?
AABB says the 35th edition outlines requirements for donor qualification, blood collection, processing, storage and transfusion. It runs on a 24-month revision cycle.
Which AABB activities does a community blood center need: Donor Activity, Donor Testing, IRL, Molecular Testing?
AABB lists all four for blood centers, and the choice follows what your center does. The Donor Activity covers the collection, processing, testing, storage and distribution of blood and components for transfusion and transplantation.
How long does initial AABB accreditation take for a blood center?
AABB says the majority of facilities complete the self-assessment and on-site phases in 1 to 2 years. A facility must operate in the activity for at least 6 months before the process can begin.
How much does AABB accreditation cost for a blood center, by collection volume?
AABB's 2026 schedule lists $1,714 basic membership, a $1,740 application fee for new members, a $3,370 Donor Center Blood Center Activity fee and a $3,694 accreditation fee for lead-assessor activities. The annual volume fee runs from $146 for 1-5,000 units to $6,333 for more than 500,000. Verify current fees with AABB.
Can AABB serve as our CLIA accreditor?
AABB says it can be the CLIA provider for facilities accredited in the Donor, Immunohematology Reference Laboratory and Molecular Testing activities. Its fee schedule lists a $1,421 CLIA fee where AABB is the CLIA provider for each non-waived CLIA number.
How do AABB standards relate to FDA 21 CFR Parts 606 and 630?
The FDA rules apply by regulation. Part 606 requires written SOPs for all steps in collection, processing, compatibility testing, storage and distribution, and Part 630 bars collection before the donor is determined eligible. AABB accreditation is a separate program against AABB's own Standards.
Is AABB accreditation required to supply blood to hospitals?
The sources reviewed for this page do not say. Check your hospital customers' supply agreements and your state's rules.
Can a hospital blood bank that collects donors be accredited under the same standards?
Yes. AABB's Donor Activity definition says the activity may be performed by a community blood center or a hospital blood bank, and the fee schedule lists a Donor Center, Hospital Blood Bank fee of $2,508.