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EBAA Accreditation Inspection Application

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Review the Instructions Below

Complete this application to begin the process for inspection and accreditation by EBAA. See the EBAA’s Accreditation Policies and Procedures, Medical Standards, and Constitution and Bylaws for more information about EBAA inspections and accreditation policies and procedures.

This application should be completed for any establishment that performs any eye banking function and is seeking EBAA accreditation (e.g. comprehensive and limited function eye banks). To learn more about how the EBAA Accreditation Board defines these eye banking functions, visit Accreditation Governance and Functions.

All fields are required, unless about satellite or separate entities that are not applicable to the applying eye bank. By clicking the "Save and Continue Later" button at the bottom of the page, you will be able to start the form and finish it later. You will receive an email with instructions on how to go back to the form.

An application will not be considered complete and inspector(s) will not be assigned until all information is provided to the satisfaction of the EBAA Accreditation Board Chair(s). Additional documentation may be required upon review of your application. If you have questions about this application or the required supporting documentation, please contact Jennifer DeMatteo at 202-775-4999, ext.117 or via email at jennifer@restoresight.org.

Person Completing Application

Enter the information for the person completing this application.
Name of Contact

Eye Bank Applying for Inspection

Enter the information for the eye bank applying for inspection.
Organization Address

Parent Organization

If applicable, complete the fields below. Otherwise, skip to the Medical Director section.
Parent Organization Address

Medical Director

Medical Director Name
Is the Medical Director an ophthalmologist?
Has the Medical Director completed a corneal fellowship?
If no, do you have documentation of a consulting relationship with an ophthalmologist who has completed a corneal fellowship?
Does the Medical Director fulfill the role of an EBAA CEBT in a supervisory and training position?
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Accepted file types: jpg, pdf, png, doc, Max. file size: 25 MB.

    Back-up Medical Director

    Back-up Medical Director Name
    Is the Back-up Medical Director an ophthalmologist?
    Has the Back-up Medical Director completed a corneal fellowship?
    If no, do you have documentation of a consulting relationship with an ophthalmologist who has completed a corneal fellowship?

    Certified Eye Bank Technician

    Does your bank employ at least one EBAA Certified Eye Bank Technician?
    Is the organization EBAA accredited?

    Executive Director

    Executive Director
    Is the Executive Director also a CEBT?

    Eye Bank Operations

    Are cleaning and maintenance records, equipment certifications, and monitoring charts available for review at the main location applying for site inspection?
    Does your bank have donor records readily available for review including recipient follow-up information and adverse reaction files since your last EBAA inspection?
    Does the eye bank have sufficient whole eyes / corneoscleral discs to demonstrate practical recovery or processing techniques as outlined in the Accreditation Policy & Procedures? *If No, the Applying Eye Bank must make arrangements to acquire adequate tissue for the day of inspection.
    Does the eye bank have a Policy and Procedures Manual ready for submission and review by the Accreditation Board Inspectors?
    Have you had a Change in Governance since your last EBAA inspection including a change in the type(s) of Eye Bank Functions this bank performs?
    If yes, was the Change in Governance reported to the EBAA Office
    Has your facility been inspected by the FDA or Health Canada since your last EBAA inspection?
    Was a 483 or any other citation issued?
    Did your bank forward all written documentation of observations, findings or results to the EBAA Office?
    Drop files here or
    Accepted file types: jpg, pdf, png, doc, Max. file size: 25 MB.
      Has your facility been inspected by any other Official Agencies since your last EBAA Inspection?
      Did your bank forward all written documentation of observations, findings or results to the EBAA Office and the Chair(s) of the Accreditation Board as required by EBAA?

      Eye Bank/Entity Proficiency Verification

      Proficiency Verification
      Complete the table below to verify the handling of at least 25 surgical corneas annually for each eye banking function (as defined by EBAA) for which the eye bank/entity is applying for accreditation. Identify at least 25 surgical tissue ID numbers from within the past 12 months, and document every eye banking function that applies to that tissue ID number for which the eye bank/entity is applying for accreditation. To select the appropriate function, place an "X" in the box associated with that function. Multiple functions may be marked for any particular tissue ID. Click the "+" to add additional tissues.

      Please note, for each function, at least 25 tissues must be marked to be considered for Accreditation for that specific function.


      Tissue ID#
      Recovery
      Processing
      Tissue Storage
      Tissue Evaluation
      Donor Eligibility Determination
      Final Distribution
       
      Proficiency Verification
      Enter the total number of tissues listed above that were handled for each function.
      Recovery
      Processing
      Tissue Storage
      Tissue Evaluation
      Donor Eligibility Determination
      Final Distribution

      Eye Bank Function or Task Identification

      For each eye bank function / task listed below, identify every entity / location that performs the task for the organization applying for this site inspection.
      1. Perform body examination or physical assessment
      1. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      2. Perform a pen light examination
      2. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      3. Perform ocular recoveries (ie. Enucleation/in-situ)
      3. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      4. Perform laboratory corneoscleral disc excisions
      4. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      5. Preserve sclera
      5. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      6. Perform microkeratome processing (e.g. DSAEK processing)
      6. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      7. Perform manual dissection processing (e.g. DMEK processing)
      7. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      8. Perform laser (e.g. femtosecond) assisted processing
      8. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      9. Perform tissue transfers, scleral trims or blood rinsing
      9. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      10. Perform processing other than those listed above in #4-9 (see MS Glossary for definition of Processing)
      10. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      11. Perform plasma dilution calculations
      11. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      12. Obtain answers to the donor risk assessment interview (DRAI)
      12. Entities that perform that task
      If you have a physically separate satellite or contracted establishment (includes OPO or tissue bank) that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      13. Perform slit lamp examination
      13. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      14. Evaluate tissue using a specular microscope
      14. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      15. Determine donor eligibility
      15. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      16. Evaluate infectious disease testing results
      16. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      17. Store storage solution(s)
      17. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      18. Store ocular tissue
      18. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      19. Maintain refrigerator records
      19. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      20. Maintain cleaning and environmental monitoring records
      20. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      21. Maintain tissue evaluation records
      21. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      22. Store instruments
      22. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      23. Maintain donor files
      23. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      24. Perform instrument sterilization in-house
      24. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      25. Label tissue for distribution
      25. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      26. Provide a unique ISBT 128 Tissue Identifier for each tissue
      26. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      27. Track tissue
      27. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      28. Ship tissue released for transplant to surgeons or surgical facilities
      28. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      29. Maintain complete donor or recipient case records
      29. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       
      30. Seek required follow-up information 3-6 months post-op
      30. Entities that perform that task
      If you have a physically separate satellite or contracted establishment that performs the above task, enter their information below. Click the "+" to add additional satellites or contracted establishments.
      Name, City and State of Separate Satellite
      Name of Contracted Establishment
       

      Satellite Locations/Contracted Establishments - Skip and Proceed to Next Page if Not Applicable

      If a Satellite (or Other) Location or a Contracted Establishment was listed as performing a task outlined in the previous section, complete the chart below for each establishment, marking “yes” or “no” as appropriate. (The eye bank applying should not be included as it is addressed elsewhere in this application.)
      List
      Enter yes or no in each column. Click the "+" symbol to add a new row for each Satellite (or other) location.
      Organization Name
      Does the entity have a Medical Director?
      CEBT on Staff?
      EBAA Accredited?
      FDA Registered?
      CLIA Certified?
      Joint Commission Accredited?
      State Inspected?
       
      Is the applying eye bank/entity (the facility applying for site inspection), a subsidiary or part of another organization?
      For example, if this bank is a satellite, “yes” should be checked.
      Does the applying eye bank/entity (the facility applying for site inspection), own, operate or use any physically separate location(s) for the performance of any eye bank tasks or functions (not including contracted establishments)?
      List all physically separate locations.
      Click the "+" button to add rows for additional locations.
      Location: Name, City, and State
      Is this location separately registered with FDA? (Yes or No)
      Has this location already been included for inspection during a different EBAA Accreditation Cycle? (Yes or No)
       

      Separate Location Information - Skip and Proceed to Next Page if Not Applicable

      For each physically separate location, complete the following information. If you do NOT have separate locations, you can skip this page by clicking "Next" at the bottom of the page.

      Separate Location #1

      Organization Address
      Name of Lead Staff at This Location
      Lead Staff Email Address
      Does the location have its own Policy and Procedures Manual?
      Does the location have a CEBT on staff?
      If yes, provide CEBT Name
      If no, provide consulting CEBT Name
      Is the organization EBAA Accredited?
      Does the location have, or have access to, a qualified Medical Director or his/her designee?
      Is the Medical Director an Ophthalmologist?
      Medical Director Name
      Medical Director Address
      This includes any of the following: recovered, processed, stored, evaluated, determined donor eligibility, or distributed the ocular tissue.
      Do you have an additional location to submit information about?

      Separate Location #2

      Organization Address
      Name of Lead Staff at This Location
      Does the location have its own Policy and Procedures Manual?
      Does the location have a CEBT on staff?
      If yes, provide CEBT Name
      If no, provide consulting CEBT Name
      Is the organization EBAA Accredited?
      Does the location have, or have access to, a qualified Medical Director or his/her designee?
      Is the Medical Director an Ophthalmologist?
      Medical Director Name
      Medical Director Address
      This includes any of the following: recovered, processed, stored, evaluated, determined donor eligibility, or distributed the ocular tissue.
      Do you have an additional location to submit information about?

      Separate Location #3

      Organization Address
      Name of Lead Staff at This Location
      Does the location have its own Policy and Procedures Manual?
      Does the location have a CEBT on staff?
      If yes, provide CEBT Name
      If no, provide consulting CEBT Name
      Is the organization EBAA Accredited?
      Does the location have, or have access to, a qualified Medical Director or his/her designee?
      Is the Medical Director an Ophthalmologist?
      Medical Director Name
      Medical Director Address
      This includes any of the following: recovered, processed, stored, evaluated, determined donor eligibility, or distributed the ocular tissue.
      Do you have an additional location to submit information about?

      Separate Location #4

      Organization Address
      Name of Lead Staff at This Location
      Does the location have its own Policy and Procedures Manual?
      Does the location have a CEBT on staff?
      If yes, provide CEBT Name
      If no, provide consulting CEBT Name
      Is the organization EBAA Accredited?
      Does the location have, or have access to, a qualified Medical Director or his/her designee?
      Is the Medical Director an Ophthalmologist?
      Medical Director Name
      Medical Director Address
      This includes any of the following: recovered, processed, stored, evaluated, determined donor eligibility, or distributed the ocular tissue.
      Do you have an additional location to submit information about?

      Separate Location #5

      Organization Address
      Name of Lead Staff at This Location
      Does the location have its own Policy and Procedures Manual?
      Does the location have a CEBT on staff?
      If yes, provide CEBT Name
      If no, provide consulting CEBT Name
      Is the organization EBAA Accredited?
      Does the location have, or have access to, a qualified Medical Director or his/her designee?
      Is the Medical Director an Ophthalmologist?
      Medical Director Name
      Medical Director Address
      This includes any of the following: recovered, processed, stored, evaluated, determined donor eligibility, or distributed the ocular tissue.
      Do you have an additional location to submit information about?

      Separate Location #6

      Organization Address
      Name of Lead Staff at This Location
      Does the location have its own Policy and Procedures Manual?
      Does the location have a CEBT on staff?
      If yes, provide CEBT Name
      If no, provide consulting CEBT Name
      Is the organization EBAA Accredited?
      Does the location have, or have access to, a qualified Medical Director or his/her designee?
      Is the Medical Director an Ophthalmologist?
      Medical Director Name
      Medical Director Address
      This includes any of the following: recovered, processed, stored, evaluated, determined donor eligibility, or distributed the ocular tissue.
      Do you have an additional location to submit information about?
      Please use this section to provide any additional information you deem important for the Accreditation Board co-chairs to have regarding your inspection.
      Please upload any additional files or supplemental materials.
      Drop files here or
      Accepted file types: jpg, pdf, png, doc, Max. file size: 25 MB.

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        phone 202.775.4999
        fax 202.429.6036

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