Eye Bank Association of America Medical Standards 2022

Abstract

A1.000 INTRODUCTION AND PURPOSE These standards have been developed to assure consistently acceptable levels of quality, proficiency, and ethics in dealing with ocular tissue for transplantation and define the minimum standards of practice for eye bank functions, as determined by the ophthalmological medical community. A1.100 Scope These standards are intended to apply to any and all of the eye bank functions to include: • Recovery • Processing • Storage • Tissue evaluation • Donor eligibility determination • Distribution These standards shall be reviewed at least annually and revised as necessary to incorporate current research findings and improved clinical practice. B1.000 ACTIVE MEMBERSHIP In order for an eye bank to become an active member of the Eye Bank Association of America (EBAA), it must comply with the EBAA Bylaws and the following: Demonstrate compliance with EBAA Medical Standards. Maintain accreditation status by passing the site inspection as administered by the EBAA Accreditation Board. Demonstrate proficiency in any aspect of eye banking including recovery, processing, tissue storage, evaluation, and donor eligibility determination and distribution. Proficiency shall be demonstrated by providing documentation, at the time of completing the application, of the handling of at least 25 surgical corneas for each eye bank function for which it is seeking accreditation. Certify compliance with applicable Federal and State regulations. Maintain registration with ICCBBA for a Facility Identification Number (FIN). This is required for all eye banks that assign a DIN or apply an ISBT 128 label to ocular tissue. Once accredited, an eye bank must be inspected and reaccredited at least every 3 years to maintain active membership in the EBAA. B1.100 Eye Bank Inspection The Accreditation Board of the EBAA shall be responsible for inspecting member eye banks as outlined in the written procedures of the Board. Accreditation and reaccreditation site inspections shall be scheduled following written notification of the impending inspection. Unannounced inspections may be conducted should an allegation of violation of Medical Standards be made to the Accreditation Board or should the results of inspections by official agencies indicate violation of Medical Standards. Failure to permit an inspection will result in suspension or revocation of an eye bank's accreditation. Demonstration of proficiency in any and all aspects of eye banking may be required during the site inspection and of any or all technical personnel. The Accreditation Board may review and make a determination to accept findings from outside agencies. (Please refer to Accreditation Policies and Procedures.) B1.200 Inspections by Official Agencies Any written documentation of notices of inspection, observations, findings, or results (including but not limited to Food and Drug Administration (FDA) Form 483) received by an eye bank which are related to any inspection by an official agency shall be sent to the EBAA office within ten (10) business days of receipt. The EBAA office shall be copied on all future related correspondence. C1.000 PERSONNEL AND GOVERNANCE C1.100 Director All policies and procedures of each eye bank shall be under the supervision of a Director appointed by the eye bank's Board of Directors, Board of Regents, or other governing body. The Director shall be responsible for all administrative operations including compliance with these standards. The Director shall be the individual responsible for the day-to-day operation of the eye bank. It is this individual's responsibility to carry out policies of the eye bank's Board, to determine what functions will be performed by the eye bank, and to prescribe clinically acceptable means to perform these functions. The Director shall consult with the Medical Director, as well as other medical and legal authorities, in carrying out prescribed responsibilities as necessary. These consultations shall be documented and made for review during a site inspection. The Director shall all with to perform and of responsibility for the clinical of the eye bank shall be as Medical Director The eye bank must have a Medical the Medical Director is not a Medical Director shall be is of the responsibilities of the Medical Director on an The Medical Director and a Medical Director must be an a or demonstrated in eye research or in the Medical Director not a the eye bank must have and a with an Any of for tissue and shall the Medical at the of the EBAA at least every 3 years and a Medical Board every 3 appointed Medical Director shall a Medical and a Medical Board within of a Director the The eye bank shall written documentation of at the time of the eye bank site inspection. The Medical Director shall and on all medical aspects of the eye bank These but are not limited and of medical policies and in and of technical with to eye bank functions. in and operation of a for of for tissue and by for eye bank's Medical Director must the or the following procedures as applicable on an In or from that a least of for and or an eye bank Medical Director not any as must each have to perform any of the procedures on an The Medical Director may responsibility for eye bank functions to eye bank the Medical Director shall that the eye bank in compliance with the EBAA Medical Standards. responsibility for the of each tissue for the transplantation in with the eye eye bank 3 to a Medical Director Eye The Director shall technical and and that this the and for the of The Director shall that are a of eye bank and to perform all eye bank and procedures at a of proficiency by the bank. The eye bank Medical Director or Medical must in eye bank in which each member is and to perform eye bank must at least EBAA in and the function the is storage, a documented with a and the in which the is may be an acceptable to a on eye bank or other which eye banking functions in which to required EBAA The the EBAA office in that it not this The of to comply with the documented is with a and the in which the is The in the demonstrated to the Medical Director of the a be the may an by to the EBAA may be on a review by the of the Accreditation Board, in with the EBAA or in eye bank that a in must the EBAA office within in of eye of or eye of an eye bank with bank tissue a in the of the eye bank, or a in required that Director, Medical (Please refer to Accreditation Policies and and PERSONNEL AND and eye bank or other eye banking functions must a for each and the must be eye bank or other eye banking functions must a and that each is to This shall the and documentation of of the and of all eye bank eye banking functions. The responsible for this must be a or an individual been by a is of the of for eye banking functions is the responsibility of the Medical Director or and determined by the Medical This shall documentation each is to perform Eye bank seeking to EBAA or become must the in the EBAA for and of Eye Bank All eye banks must have an every 3 any eye bank function in Medical A1.100 must have and to the of performed with and The EBAA office shall be within days of the or of a to an eye bank. (Please refer to Accreditation Policies and Eye Bank The must be a with limited in which related to eye banking are The shall have a with a and must be for of donor The including and must be at all documentation of must be and on for a minimum of 3 eye bank must have an and a of for and eye bank shall have a with a the for The should the of the tissue under must be and within the of to The must be an for eye banks outside the a as by at least a The shall be for the of tissue and tissue and must and for all tissue that surgical tissue and research tissue. Eye banks must required and documentation in Policies and In the of a outside the acceptable must be for notification and to be of the must be performed and documented in with but at least The eye bank or must be and each and at scheduled to and must be on each of These must of inspection, and any procedures or The eye bank must in procedures the inspection, and procedures and for each of and for must be on for a minimum of 3 and or all surgical that in with eye tissue during or shall be and to and The eye bank shall in and procedures these are performed and shall be for and of and shall be inspected to that function The eye bank's and procedures shall these are documented and eye bank that shall to the the eye bank's current Association for the of Medical to and in The eye bank shall have documentation that that each The shall be and the The eye bank shall and define in procedures the The and shall be in the eye bank's are by a the eye bank shall the the The eye bank shall that the policies and procedures standards and applicable regulations. The eye bank shall that the is and that the are performed and documented to the the is not by the it should be performed shall be and for a minimum of 3 to shall be to be that the is the applicable are and the are acceptable at the time of and eye bank shall have a and in which and during tissue recovery, processing, or are and The shall be in the eye bank's The and shall be and in with the and shall not be for recovery, processing, and of tissue intended for surgical The and during the tissue recovery, processing, or of the ocular tissue must be and inspected to eye bank shall maintain policies and procedures that all aspects of eye bank functions and must be and by the Director and Medical review of each eye bank's with and by the Director and Medical Director is eye bank must maintain of each it and the of time the in must be to in the operations are Eye banks shall ICCBBA Eye Bank to ocular tissue and Eye Any eye bank functions must a a may this by a documented with a and the in which the is All or eye banking functions must have a Medical Director or to a Medical Director a documented with an This Medical Director must the of Medical Director as outlined in of these standards. eye banking functions may be inspected as of the EBAA accreditation of an in which Eye Bank by Any with that eye banking functions to must that the is for the eye bank functions or that the is in compliance with EBAA medical and to the eye bank functions This a written and the is responsible for compliance Policies and procedures shall the and and procedures for the eye bank operation shall be in compliance with the and of and the to of of the of Federal applicable which may eye banks not written procedures in compliance with the agencies are an acceptable All eye bank functions which may to or tissue must under the current for by the of the and Administration of the of to including but not limited to and These and make responsible for providing and in all the Federal These written procedures must be in the eye bank's tissue and shall be of in a as to any to eye bank and the and to comply with and regulations. and procedures shall be to and must be tissue is made for the Donor must be made by a responsible for related to the donor eligibility Eye banks outside of the should for related to the donor eligibility to an eligibility the donor must be to In to donor eligibility tissue must be for All must be by All shall a as as to the with to of and eye bank shall have a for and this eye bank shall have a for and documentation of the medical and of all on each donor shall be performed by an individual is by or to and is with the intended of the tissue. Medical and are aspects of donor eligibility but is not limited of the donor the Tissue evaluation Donor this must the and donor from at least of the following: or medical of by Medical Donor Medical or Medical to review any donor in the This shall be Donor The eye medical must be reviewed Eye banks the and Eye banks outside of the and as applicable as required by the of outside of the EBAA to of donor eligibility is an eye banking function including in Food and Drug Medical Director In to these the EBAA Medical Board determined that from with the following are for the or a to the of the and shall not be for surgical All of and is of other within the 3 active of or active or active or and within the by an to be with eye of the ocular or in the eye of or active ocular or or active active and or member with of active or and of with from this are to that of corneas in for and The and Tissue from clinical or of and with must not be for Eye banks outside the must for and to applicable Donor The eye donor must be • EBAA • Eye banks outside of the are not by but must in with and in the in which are • State applicable • of the of outside of the review of written results of shall be received by the eye bank to tissue for surgical The and must Eye banks outside the must a that is by and are by agencies. to the results of is the donor should be a or to days is or an to administered in the is that to the results not Eye banks outside of the shall a which the of agencies. shall an which EBAA The results of the following EBAA required must be or for the tissue to be for • • • to for donor and must be or for the tissue to be for as for to for donor and for eye banks outside the All must be to the eye bank's medical must review and on or the eye bank must have a the to be in to the individual of Donor Donor of medical reviewed must be and on all eye tissue as of the donor donor that medical or medical or shall be and in the donor and for of legal for is for procedures and must with and documentation for must be In medical the eye bank shall to the by the medical or in In each the and must be to and be the or of the Donor been the of donor tissue and the and is to the of the Medical and Processing time from or to may to the of and means of of the body. It is that as as All time for each that the time of to the time of and the time to the time to tissue processing, shall be The time that of ocular of the shall be Eye to Recovery The should be procedures for eye shall be in the procedures individual eye bank's is to the of the Medical Director and shall be Eye tissue that is and intended for surgical from a donor shall have the standards as for all for the donor medical shall be the outside the to for shall be required for tissue for transplantation that is in or AND processing, and must be for and for a shall be as for during ocular tissue and All procedures must be recovery, processing, and procedures be in the EBAA The EBAA is for as a This is reviewed and as necessary by the and are by the Medical Board. The Medical Director is responsible for the eye bank's procedures for recovery, processing, and of tissue. The Medical Director and Director are responsible for that eye bank comply with all applicable procedures for the recovery, processing, and of tissue. Recovery The shall be to Recovery may be performed or in shall the of any ocular tissue intended for transplantation at least the time of the and tissue in or eye in of is administered of a the must be to the and The time for each should not be and not should be from the ocular with a eye and to This of and the of ocular to the shall be in the eye bank's The shall be with a or for and to or in shall be during donor recovery, and all tissue handling procedures to eye bank from to Tissue from with the following is to eye bank or or of Processing and Processing must be performed in a or which an or documented annually to have 25 Tissue must be in a as to and tissue from may not be Eye Eye banks that and for or may as at to or other Eye banks that corneas intended for may of the following The Medical Director must tissue and the for each All must be or the eye bank shall review and the and perform Processing of the from Tissue Processing Processing of tissue may be performed or Processing may be to tissue or are of including or or other of or Storage Eye banks shall an that been in with The shall be and to the for and other The and to the eye bank shall be inspected for The of for each shall be on the tissue the ISBT 128 tissue to and and eye banks as of tissue and eye bank that shall the in procedures and to The of any all of the following on tissue intended for and to The responsibility for the of the tissue for transplantation with the The following must be performed to tissue for intended The shall be for and and in to be for must have the that have been for procedures shall be by to that to the tissue. the of the with to the and but not limited or The eye bank should a on each as a of of the of or other may be from as as of and are made to the are to surgical determination for the Eye banks are to a of an of of that may or surgical and of for shall be a of tissue evaluation to for all member eye banks of the are to the of the Medical it is to an this may be on a by the Medical of shall be to and on at least an procedures shall and for of The eye bank responsible for evaluation of ocular tissue shall the tissue the for and surgical for surgical Standards for or within intended or within intended of in eye bank's or of or for or within intended or of or for or within intended or within intended as in eye bank's and to on for within intended as in eye bank's for must be in eye bank's must be of to may be from of or of a for or or of for on Standards for for any surgical on from the eye that of or of a eye bank shall have a This shall include: and of procedures for all functions performed by the eye bank (including and and evaluation of functions by an not in the Identification of and to and to eye banking of for including for The shall applicable to the following and Recovery Processing and Storage and Donor eligibility donor and donor Tissue evaluation eye bank shall all aspects of to the shall be for a minimum of These shall be made at the time of site inspection. The shall a for and of for tissue to eye bank functions must be to the and EBAA within days of the of the The eye bank's shall a for the to from the transplantation of or other ocular tissue to the eye bank. The eye bank must the to the eye bank, which made the donor eligibility The bank must perform an and must the within days to the EBAA office for review by the Medical Board. In with a must be to the within days of of the the is is results in or or medical or surgical Any to a will be to EBAA. The bank must all in the recovery, processing, storage, tissue evaluation, and donor eligibility determination of the results of the of the must maintain documentation of the and results of the to it by the bank. of a that the medical to be or to donor tissue must be to all that or received or from that to the EBAA is any or other that is or to have been by transplantation of donor eye including by or and as donor or of as or in a or not it is to be to donor this must be to the EBAA The Medical Director shall and review all any are The Director shall prescribe and procedures for or of to the evaluation of for for and and with as well as individual of all or with on these findings, shall become of of all intended for surgical of eye bank donor may be performed the by that of donor not to and that or surgical may not with it should may be performed or at the time of Eye banks may to perform at the time of in shall be to the or eye bank. eye bank shall indicate on the the tissue for transplantation performed to distribution. results in of shall be to the eye bank that the tissue as well as to the eye bank that the tissue. Tissue or Tissue Eye banks must have a and for of tissue. results or or medical received of that indicate a for of a must be to Eye bank's medical the or eye within days EBAA within days or other within days notification of results or that not indicate a of of a not EBAA The of ocular tissue from a donor determined to be is not for as the and are and for Tissue for from a donor been determined to be for transplantation to results of required or from have not been for required must have a label to the individual tissue which the or for label the required must be to the individual tissue for tissue that is for All tissue shall be and in from the time of the donor eligibility determination been tissue must have a label the tissue as to the individual tissue All surgical tissue shall be in in a for or of other procedures as a donor eligibility determination been a donor is determined the tissue must be or in a for or other procedures must be that are to All tissue shall be at a to the of Eye banks must procedures for of tissue it is in the of the eye or the in an an must be on of processing, storage, and All ocular tissue for surgical shall be in a which is and to at least the of eye bank. ISBT 128 tissue The ISBT 128 tissue the Identification Number and Processing Facility of tissue indicate this on the the and Identification Number are not by the the label must the Processing Facility of tissue in the that the tissue is intended for that the tissue is not to be tissue been to a to of ISBT 128 shall be within to label ocular tissue of Donor Medical to of tissue for the Medical Director or shall review and that the medical and is in with medical standards and that any from not the of Distribution with EBAA medical standards shall be in eye bank functions performed distribution. eye bank shall the in of for and and with applicable and standards in eye bank functions performed is the responsibility of the and Eye banks shall and a of for tissue that is and to all by the eye bank. of and of eye tissue shall be for inspection by the Accreditation Board. to tissue shall be to or Tissue tissue and tissue and must be documented and made to the eye bank and for and tissue. research by of the Medical Board and by the EBAA Board of Directors, tissue and may be from the the eye bank in the or of any tissue or by the eye bank, an shall be performed to the of the The eye bank shall the and findings to the EBAA within days following of the The EBAA office shall the of the The eye bank will the EBAA on all future related to the during Tissue Form In research the Medical Board may label and tissue for must be in from the and must in to any of required Tissue for shall be by a tissue The tissue shall the following: All of eye bank of eye bank of eye bank ISBT 128 tissue of All shall be written as to with the is indicate the of performed or the Tissue evaluation to and EBAA Accreditation of each that any of the following in the of recovery, processing, storage, evaluation, and donor eligibility determination and distribution. of reviewed the eligibility of tissue for Form that the EBAA shall the tissue for This shall the following: for of tissue on for the should for of the and to the eye bank any of corneas in a the may indicate a in in which the tissue should not be and a made to the eye bank. performed by the eye bank. The shall the that the are with as to or for a and that the is responsible for the tissue is for The shall the that are responsible for The tissue and or of of of The of the the tissue is and The ISBT 128 tissue This is to the tissue from the donor to and from the to the performed by a and eye banks outside of the for as required by the and of which are for and that for eye banks outside of the of results for that This may be on the eye bank's donor as as it is a is and tissue for shall be and with a or in a tissue for by a shall be with a or in a tissue in shall be a to maintain and The should at the time of or to or of the tissue by other as or the shall be to the of shall be that the tissue label and documentation to the tissue not become shall be on a Eye banks shall ICCBBA Eye Bank to ocular tissue and All shall ISBT 128 tissue of Storage All shall be for a minimum of years from the of or is All eye bank and the eye bank and and shall be as and Donor Donor shall the the of a donor and medical that the eligibility of the tissue for transplantation may be to for donor and eye bank, or shall be and shall be for inspection by the EBAA Accreditation Board. Eye bank shall the following minimum for to be on the Tissue ISBT 128 tissue of eye bank of Storage donor of donor of eye bank and of donor of and time or in and time and time The and time that of ocular of the tissue and time of shall be to and review and for Accreditation Board as of inspection. of eye bank, or tissue Tissue from donor to eye bank or for each ISBT 128 tissue of of that or results of all EBAA required and results performed of donor from the that from the been eye bank shall and for each eye tissue for transplantation by the bank. eye bank shall • by • Medical to the is performed • of • • of tissue • of • of • • of for and tissue that be days may be at an it is for the eye bank must be to the tissue to the eye bank must 3 and from the on all for transplantation that to the by that bank. This must be to the and from the documentation that the eye tissue. research are by other by of the Medical Board and by the EBAA Board of Directors, eye bank of and documentation of will not be eye bank shall to the EBAA for eye bank shall on surgical for and EBAA shall maintain an which member eye banks must Eye banks shall days following the of and to be will be by the EBAA and the These standards may be as The Medical Board shall be with to these standards as medical and may be to the intended of Eye Bank Association of America to which are required to EBAA Medical Standards and applicable and regulations. the EBAA ICCBBA Eye Bank to ocular tissue and

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