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EBAA accreditation is the Eye Bank Association of America's review of an eye bank's operations, policies and personnel against the EBAA Medical Standards, with an on-site inspection at least once every three years. It is open to any entity that performs one or more eye banking functions, member or not. Integral Healthcare Solutions (IHS) drafts the records and quality procedures for EBAA accreditation; your medical director and staff own suitability and release.

Last reviewed: October 2026.

What is EBAA eye bank accreditation?

EBAA describes the program this way: "EBAA's Accreditation program provides a thorough review of an eye bank's operations, policies and personnel. Performed by experienced eye bankers and corneal surgeons" (EBAA, Accreditation Process).

The governing texts:

EBAA lists the functions it accredits as "Recovery", "Storage", "Tissue Evaluation", "Donor Eligibility Determination", "Processing" and "Final Distribution" (EBAA). A bank is reviewed for the functions it performs.

Who needs it and what triggers it

The program is for entities that perform eye banking functions. EBAA states that "EBAA Accreditation is open to all entities that perform one or more eye banking functions, regardless of their EBAA membership status" (EBAA, Accreditation).

Events that can start the work:

How IHS helps

IHS works from your bank's copy of the EBAA Medical Standards and Procedures Manual. The process:

  1. Gap assessment. IHS reviews your recovery, storage, evaluation, eligibility, processing and distribution functions against the standards and lists what is missing or out of date.
  2. Document and evidence mapping. IHS builds a crosswalk from each standard to the record that shows it, and helps assemble the evidence the pre-inspection questionnaire asks for.
  3. Drafting. IHS drafts record controls, donor documentation procedures, training records and quality-review procedures. Any clinical or technical content is drafted for your medical director and staff to review and approve.
  4. Mock inspection review. IHS walks your records and procedures the way the two-day site inspection does, so staff have practiced the records review and interviews.
  5. Readiness support. IHS helps you organize corrective and preventive action (CAPA) material so it can meet EBAA's ten-day window after the inspection.

What your bank supplies: the standards, your SOPs, donor files, and eye banking and medical staff, including the medical director, who own donor suitability, tissue evaluation and release. Your bank applies to EBAA and hosts the inspection.

The limit: donor suitability and tissue evaluation are medical and technical judgments. IHS does not make them, review them or sign off on them.

What to have ready

This list draws on EBAA's Accreditation Process page and the Medical Standards page (edition not stated on the public page).

  1. Your current copy of the EBAA Medical Standards and Procedures Manual, and the date of the version your SOPs were written to.
  2. A list of the functions you perform, using EBAA's six: recovery, storage, tissue evaluation, donor eligibility determination, processing and final distribution.
  3. Staff qualification and training records. The pre-inspection questionnaire documents "its staff's qualifications and training."
  4. Agreements with outside agencies. The questionnaire covers "the facility's relationships with outside agencies for serology and infection disease testing, sterilization and other services."
  5. Equipment testing and maintenance records for "all the eye bank's significant processing and storage equipment," also from the questionnaire.
  6. Your policies and procedures, indexed, since the site inspection covers policies and procedures.
  7. Donor and tissue records retrievable for the records review.
  8. Staff available for technique observation and interviews during the two inspection days.
  9. A CAPA process that can produce a written response quickly. EBAA states: "Unresolved CAPA must be submitted to the inspection team and the Accreditation Board within ten days of the inspection."

If you want to talk through where your bank stands on this list, the introductory call is the place to start.

How it compares

Eye banks meet more than one framework. This table describes them; it does not say which ones apply to your bank.

FrameworkWho runs itWhat it is
EBAA accreditationEye Bank Association of AmericaReview of eye banking functions against the EBAA Medical Standards, open to members and non-members (EBAA).
21 CFR Part 1271FDAFederal regulation that sets registration and listing, donor-eligibility and current good tissue practice requirements for establishments that manufacture human cells, tissues, and cellular and tissue-based products (eCFR, Part 1271). It is regulation, not accreditation.
AATB accreditationAATBPrivate accreditation of tissue establishments against the AATB Standards for Tissue Banking, 15th edition; accreditation is valid for three years (AATB).

How Part 1271 applies to your bank's activities is a question for your regulatory counsel. This page does not say whether any state or hospital requires EBAA or AATB accreditation; check your state's rules.

What it costs

EBAA does not publish an accreditation fee schedule on the pages we reviewed. EBAA does state the price of the Medical Standards: "If a non-member individual would like to purchase the standards, they can be purchased for $90." Members access them free, and international organizations may request them free (EBAA, Medical Standards). Verify current fees with EBAA.

IHS scopes each engagement after a free introductory call.

What this is not

Frequently asked questions

What is EBAA accreditation and who can apply?

It is the Eye Bank Association of America's review of an eye bank's operations, policies and personnel, performed by experienced eye bankers and corneal surgeons. EBAA states that accreditation is open to all entities that perform one or more eye banking functions.

Do we have to be an EBAA member to be accredited?

No. EBAA states that accreditation is open to all entities that perform one or more eye banking functions, regardless of their EBAA membership status. Membership does change the price of the Medical Standards: members access them free, and non-member individuals can buy them for $90.

Which eye banking functions can be accredited?

EBAA lists six: recovery, storage, tissue evaluation, donor eligibility determination, processing and final distribution. A bank is reviewed for the functions it performs, so list yours before the gap assessment.

What goes into the pre-inspection questionnaire?

EBAA states that the questionnaire documents the staff's qualifications and training, the bank's relationships with outside agencies for serology and infectious disease testing, sterilization and other services, and the testing and maintenance of the bank's significant processing and storage equipment. Those records should be current before you start it.

What happens during the two-day EBAA site inspection?

EBAA states that the site inspection stretches over two full days. It covers policies and procedures, records review, equipment, observation of technique and interviews. The inspection is led by an experienced eye banker and a corneal surgeon.

How quickly must we submit corrective and preventive actions after inspection?

EBAA states that unresolved CAPA must be submitted to the inspection team and the Accreditation Board within ten days of the inspection. Ten days is short, so the CAPA process and its owners should be set before the inspection.

How often is an eye bank re-inspected, and what are the possible outcomes?

EBAA states that every accredited eye bank has an on-site inspection at least once every three years. The Accreditation Board meets twice a year to decide the status of banks inspected since its last meeting, and the outcomes are Three Year Accreditation, One Year Accreditation or Denial of Accreditation.

How much does EBAA accreditation cost?

EBAA does not publish an accreditation fee on the pages we reviewed. The Medical Standards cost $90 for a non-member individual and are free to members. Verify current fees with EBAA. IHS scopes its own work after a free introductory call.

How do the EBAA Medical Standards relate to FDA 21 CFR Part 1271?

They are separate. The Medical Standards are EBAA's standards, approved by the American Academy of Ophthalmology, and accreditation is a review against them. Part 1271 is FDA's regulation on registration, donor eligibility and current good tissue practice for establishments that manufacture human cells, tissues, and cellular and tissue-based products; how it applies to your bank is a question for your regulatory counsel.

How often do the Medical Standards change and how do we keep procedures current?

EBAA states that its Medical Advisory Board updates the standards regularly, typically twice a year. Record which version each SOP was written to and check each update against your procedures. IHS can run that check as part of a gap assessment.

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