Term
What are EBAA active membership requirements for accredited eye banks? |
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Definition
1. Demonstrate compliance with EBAA standards
2. Maintain accreditation status by passing site inspection as administered by the EBAA accrediation board.
3. Demonstrate proficiency in any aspect of eye banking including recovery, processing, tissue storage, evaluation, donor eligibility determination, and final distribution.
-proficiency shall be demonstrated by providing documentation the handling of at least 25 surgical corneas for each function seeking accreditation.
4. Certify compliance with Federal and State regulations
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Term
At what interval should an accredited eye bank be inspected and reaccredited to maintain active membership in the EBAA? |
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Definition
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Term
ANY written documentation of observations, findings, or results (including FDA 483s) received by an eye bank that are related to any inspection by an official agency shall be sent to the EBAA within what time frame? |
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Definition
Within 10 business days of receipt, the EBAA shall be copied on all future correspondence |
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Term
Who is responsible for the day to day operations of the eye bank? |
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Definition
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Term
What are the requirements of a Medical Director for an EBAA accredited eye bank? |
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Definition
Must be an opthalmologist that has completed a corneal fellowship or has demonstrated expertise in external eye disease, corneal surgery, research, or teaching in cornea and/or external disease.
- If said medical director has not served a corneal fellowship, the eye bank
must have a documented consulting relationship with an opthalmologist that
has.
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Term
What meetings must a medical director or physician providing verification of competency attend and at what intervals? |
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Definition
Must attend the medical directors' symposium at the annual meeting at least once every three years.
Must attend a medical advisory board meeting at least once every three years.
*Newly appointed medical directors must attend both the medical directors' symposium and a medical advisory board meeting within one year of appointment (unless a co-medical director has fulfilled the requirement)
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Term
Who is responsible for verifying competency for recovery and preservation for personnel applying for the CEBT exam? |
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Definition
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Term
Who is responsible for observing designated staff trainers on an annual basis performing the following...
1. In Situ excision or laboratory corneoscleral rim removal from whole globe
2. Posterior lamellar processing procedure that utilizes a microkeratome
3. At least one type of laser-assisted processing procedure
4. Each manual dissection processing procedure(s) for EK and ALK
(ie. DSEK or DMEK)
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Definition
Medical Director...
If staff trainers are not appointed in any of the described areas, the medical director must observe each technician qualified to perform those procedures on an an annual basis. |
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Term
Who is ultimately responsible for the suitability of each tissue for the transplantation in patients? |
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Definition
Transplanting eye surgeon |
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Term
How many months does an eye bank have to replace a medical director who has resigned? |
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Definition
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Term
What must an eye bank employ in supervisory and training role? |
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Definition
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Term
How many months does a eye bank have to replace a EBAA CEBT in a supervisory and training role? |
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Definition
Six months
Provided the bank notifies the EBAA that it is not in compliance with the standard, the bank submits evidence of intent to comply with the standard, and a documented interim relationship with a CEBT and that CEBT's organization is established. The non-CEBT incharge of the bank in the interim also must show competency to the medical director of the involved establishment.
*An extension may be requested and approved on a case by case basis. |
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Term
Within what time frame must a change in governance be communicated to the EBAA? |
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Definition
Within 30 days
This includes mergers of banks, affiliation of multiple banks, affiliation of other non eye banks such as OPO's or tissue banks, hospitals, blood banks, etc.
Also includes a name change of the bank or change to any required personnel such as director or medical director |
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