Established in 1981, EBAA Accreditation is the gold standard for eye banking. Recognized by FDA, CDC and other federal agencies, this program ensures consistently safe, quality ocular tissue by confirming that our Medical Standards, which are endorsed by the American Academy of Ophthalmology, are consistently followed by all eye bank staff. EBAA Accreditation is open to all entities that perform one or more eye banking functions, regardless of their EBAA membership status.
A team consisting of an eye banker and a corneal surgeon visit an accredited eye bank no less than every three years to review donor records, standard operating procedures, and tissue and administrative documentation. They also interview the eye bank’s executive director, medical director, and other relevant staff, and observe technicians’ recovery and tissue processing skills.
The results are masked and reported to EBAA’s full Accreditation Board to determine whether accreditation has been earned, or if corrective action or status revocation is required.
Please contact Jennifer DeMatteo to learn more about EBAA Accreditation.
For a more in-depth description of the accreditation process, continue reading.
Eye banks are accredited to perform one or more of the following eye banking functions:
An eye bank seeking accreditation is assigned an inspection team consisting of an eye banker and a corneal surgeon. Both inspectors serve on EBAA’s Accreditation Board and possess extensive experience in eye banking and/or corneal transplantation. They are required to participate in semi-annual meetings to review and discuss new developments and innovations in the profession.
The eye bank completes a pre-inspection questionnaire (PIQ) documenting its staff’s qualifications and training; the facility’s relationships with outside agencies for serology and infection disease testing, sterilization and other services; and the testing and maintenance of all the eye bank’s significant processing and storage equipment. The PIQ and the eye bank’s policy and procedures manual are reviewed by the inspectors prior to their site visit, and additional information may be requested as needed.
The site inspection stretches over two full days and includes review of all aspects of the eye bank’s operations, including:
The inspection team completes a site inspection questionnaire (SIQ) to record their findings in each of the areas listed above and to determine the eye bank’s score. Any deviations from Medical Standards or the eye bank’s policy are categorized as one of the following:
Before ending the inspection, the team meets with key eye bank personnel to discuss their findings. During this conference, inspectors outline corrective actions and preventive actions (CAPA) the eye bank must perform to address citations noted during the inspection. Eye bank staff have the opportunity to respond and to offer immediate corrections. Eye bank staff may also discuss other aspects of eye bank management with the inspectors.
Unresolved CAPA must be submitted to the inspection team and the Accreditation Board within ten days of the inspection. Inspectors notify the Accreditation Board co-chairs if they feel submitted CAPA are insufficient, and further action may be required.
EBAA’s Accreditation Board meets twice annually to decide the accreditation status of all banks inspected since the previous meeting. Each inspection team presents its findings in detail, noting all citations and providing context, including corrective actions taken by the eye bank; members of the Accreditation Board may ask questions of the inspectors to fully understand the circumstances of the inspection.
At the conclusion of the presentation, the full Accreditation Board casts anonymous votes on the accreditation status of the eye bank. There are three possible outcomes:
A majority vote determines accreditation status, which may be granted contingent on additional CAPA proposed by the Accreditation Board during its deliberations.
An off-cycle inspection may be initiated if EBAA learns of changes in an eye bank’s operations, an increase in adverse patient reactions, or other quality measures that call into question its adherence to Medical Standards or the eye bank’s policies. This can include formal notification of deviations reported by eye bank staff, recovery partners or surgeons using the eye bank’s tissue.