Eye Bank Association of America Medical Standards 2023

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 • Process • 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 (accredited) member of the Eye Bank Association of America (EBAA), it must comply with the EBAA Bylaws and the following: 1. Demonstrate compliance with EBAA Medical Standards. 2. Maintain accreditation status by passing the site inspection as administered by the EBAA Accreditation Board. 3. Demonstrate proficiency in any aspect of eye banking including recovery, processing, tissue storage, evaluation, donor eligibility determination and distribution. 4. 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. 5. Certify compliance with applicable Federal and State regulations. 6. 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. An associate (unaccredited) member of the EBAA meets all the criteria for membership except that it has not yet met or does not currently meet the Association's requirements for accreditation. 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 available for review during a site inspection. The Director shall provide all staff members with adequate information to perform their duties safely and competently. Delegation of responsibility for the clinical work of the eye bank shall be as follows: C1.200 Medical Director The eye bank must have a Medical Director. When the Medical Director is not available, a back-up Medical Director shall be designated who is capable of fulfilling the responsibilities of the Medical Director on an interim basis. The Medical Director and a back-up Medical Director must be an ophthalmologist who has completed a corneal fellowship or who has demonstrated expertise in external eye disease, corneal surgery, research or teaching in cornea and/or external disease. If the Medical Director has not served a corneal fellowship, then the eye bank must have and document a consulting relationship with an ophthalmologist who has. Any physician who provides verification of competency for tissue recovery and preservations shall attend the Medical Directors' Symposium at the annual meeting of the EBAA at least once every 3 years and a Medical Advisory Board meeting once every 3 years. A newly appointed Medical Director shall attend a Medical Directors' Symposium and a Medical Advisory Board Meeting within 1 year of appointment, unless a Co-Medical Director has fulfilled the requirement. The eye bank shall provide written documentation of such attendance at the time of the eye bank site inspection. The Medical Director shall oversee and provide advice on all medical aspects of the eye bank operations. These include but are not limited to: 1. Formulation, approval, and implementation of medical policies and procedures. 2. Participation in training and oversight of technical staff with regard to eye bank functions. 3. Participation in establishment and operation of a quality assurance program. 4. Responsibility for verification of competency for tissue recovery and preservation by personnel applying for CEBT certification An eye bank's Medical Director must observe the designated staff trainer or trainers performing the following procedures as applicable on an annual basis: 1. In-situ corneoscleral disc excision or laboratory corneoscleral disc removal from whole eye 2. Posterior lamellar processing procedure that utilizes a microkeratome 3. At least one type of laser-shaped processing procedure 4. Each manual dissection processing procedure(s) for EK and ALK (ie, DSEK or DMEK) If an eye bank Medical Director has not designated any individuals as staff trainers, he/she must observe each technician they have qualified to perform any of the above procedures on an annual basis. The Medical Director may delegate responsibility for eye bank functions to qualified eye bank personnel; however, the Medical Director shall ensure that the eye bank operates in compliance with the EBAA Medical Standards. Ultimate responsibility for the suitability of each tissue for the transplantation in patients rests with the transplanting eye surgeon. An eye bank has 3 months to replace a Medical Director who has resigned. C1.300 Staff Performing Eye Banking Functions The Director shall appoint technical and supportive staff and ensure that this staff has the appropriate qualifications and training for the performance of their job responsibilities. The Director shall ensure that there are a sufficient number of qualified eye bank technicians and supportive staff to perform all eye bank laboratory tests and procedures at a level of proficiency established by the bank. The eye bank Medical Director or Medical Director's designee must document in writing those eye bank tasks in which each staff member is qualified and released to perform independently. Each eye bank must employ at least one EBAA CEBT in a supervisory and training role(s). If the only function the establishment performs is recovery and/or storage, a documented contractual, consultative relationship with a CEBT and the accredited organization in which the CEBT is employed may be an acceptable alternative to having a CEBT on staff. An eye bank or other establishment which performs eye banking functions has 6 months in which to replace their required EBAA CEBT(s) provided that: 1. The establishment notifies the EBAA office in writing that it does not meet this standard. 2. The establishment submits appropriate evidence of its intent to comply with the "required CEBT" standard. 3. A documented interim consultative relationship is established with a CEBT and the accredited organization in which the CEBT is employed. 4. The non-CEBT technician in charge in the interim has demonstrated competency to the Medical Director of the involved establishment. If a 6-month deadline cannot be met, the establishment may request an extension by writing to the EBAA office. An extension may be granted on a case-by-case basis after review by the Chair of the Accreditation Board, in consultation with the EBAA CEO or designee. C1.400 Change in Governance An eye bank that undergoes a change in governance must notify the EBAA office (in writing) within 30 days. Changes in governance include merger of eye banks, affiliation of two or more eye banks, affiliation of an eye bank with another non-eye bank organization (eg, tissue banks, organ procurement organizations hospitals, etc), a change in the name of the eye bank, or a change in required personnel, that is, Director, Medical Director. (Please refer to Accreditation Policies and Procedures E1.500.) C2.000 TRAINING, CERTIFICATION AND COMPETENCY REVIEWS OF PERSONNEL PERFORMING TASKS OVERSEEN AND/OR REGULATED BY THE EBAA, FDA, AND OTHER STATE AND FEDERAL AGENCIES An eye bank or other establishment performing eye banking functions must provide a formal orientation program for each new employee and the employee's participation must be documented. An eye bank or other establishment performing eye banking functions, must also establish a comprehensive and well-defined training program outlining specific job-related tasks that each employee is being trained to perform. This comprehensive training program shall include the implementation and documentation of annual competency reviews of the skills and job-related knowledge of all eye bank employees performing eye banking functions. The person responsible for this training program must be a CEBT or an individual who has been qualified by a CEBT who is part of the organization's comprehensive quality program. Determination of competency for eye banking functions is the responsibility of the Medical Director or trainer(s) designated and determined competent by the Medical Director. This training program shall contain documentation indicating when each employee is released to perform their job-related tasks independently. Eye bank technicians seeking to receive EBAA certification or become re-certified must meet the criteria set forth in the EBAA document Criteria for Certification and Recertification of Eye Bank Technicians. All EBAA accredited eye banks must have one CEBT attend an EBAA sponsored skills workshop once every 3 years. C3.000 FACILITIES Each establishment performing any eye bank function listed in Medical Standard A1.100 (Scope), must have sufficient space, equipment and supplies to accommodate the volume of services performed with optimal accuracy, efficiency, sterility, timeliness, and safety. The EBAA office shall be notified (in writing) within 30 days of the relocation, laboratory expansion or addition of a satellite to an eye bank. (Please refer to Accreditation Policies and Procedures E1.400.) C3.100 Eye Bank Laboratory The laboratory must be a separate area with limited access in which activities directly related to eye banking are carried out. The laboratory shall have a sink with a drain and running water. There must be adequate counter space for preparation of donor material. The room including walls, floor and sink must be kept clean at all times. Appropriate documentation of regular laboratory cleaning schedules must be maintained and kept on file for a minimum of 3 years. Each eye bank laboratory must have an adequate stable electrical source and a sufficient number of grounded outlets for operating laboratory equipment. C3.200 Equipment, Maintenance and Cleaning Each eye bank laboratory shall have a refrigerator with a device, visible without opening the refrigerator, for recording temperature variations. The temperature recording device should reflect the temperature of the stored tissue under normal storage conditions. Temperature variations must be recorded daily and remain within the range of 2 to 8o Celsius. The refrigerator's continuous temperature recorder must be calibrated against an NIST standard thermometer (or for eye banks outside the U.S.A., a standard thermometer as defined by their countries' regulatory agencies) at least once a year. The refrigerator shall be maintained for the use of tissue and tissue preservation solution and must contain clearly defined and labeled areas for all tissue stored, that is, quarantined tissue, surgical tissue awaiting distribution, and research tissue. Eye banks must detail required refrigerator cleaning intervals and documentation in their Policies and Procedures manual. In the event of a temperature deviation outside the acceptable range, there must be provision for immediate notification and action to be taken. Testing of the alarm system must be performed and documented in accordance with manufacturer recommendations, but at least annually. The eye bank laminar airflow cabinet or flow hood must be cleaned before and after each use and at regularly scheduled intervals to prevent cross contamination. Appropriate maintenance and qualification and/or certification records must be maintained on each piece of equipment. These records must show dates of inspection, performance evaluations and any maintenance procedures or repairs performed. The eye bank must include in its procedures manual, the monitoring, inspection, and cleaning procedures and schedules for each piece of equipment and laboratory area. Documented cleaning schedules for laboratory equipment must be kept on file for a minimum of 10 years. C3.300 Instruments and Reagents C3.310 Instruments To prevent contamination or cross-contamination, all surgical instruments that come in contact with eye tissue during recovery or processing, shall be properly cleaned, decontaminated, and sterilized prior to use and between different donors. The eye bank shall describe in their policy and procedures manual how these activities are performed and monitored. Adequate sterile instruments shall be available for sterile removal and processing of whole eyes and corneas. Instruments shall be inspected frequently to ensure that they function properly. The eye bank's policy and procedures shall also describe how these instruments are documented and tracked. An eye bank that sterilizes its instruments, shall adhere to manufacturer and/or the eye bank's respective regulatory authority (eg, current Association for the Advancement of Medical Instrumentation (ANSI/AAMI) Standard 79—"Comprehensive guide to steam sterilization and sterility assurance in health care facilities"). The eye bank shall have documentation that show that each load was properly sterilized. The sterilizer shall be appropriately qualified, and the sterilization process validated before use. The eye bank shall establish and define in their procedures the appropriate sterilization acceptance criteria. The calibration and preventive maintenance routine schedule shall be included in the eye bank's procedure manual. If instruments are sterilized by a third party, the eye bank shall qualify the contractor performing the sterilization. The eye bank shall ensure through external audits, that the contractor's sterilization policies and procedures follow standards and applicable regulations. The eye bank shall ensure that the qualified sterilizer is routinely calibrated and that the preventive maintenance activities are performed and documented according to manufacturer's recommendation. If the preventive maintenance is not defined by the manufacturer, then it should be performed annually. Sterilization records shall be maintained and readily available for a minimum of 3 years. Prior to use, instruments shall be verified to be sterile, that the packaging integrity is intact, the applicable indicators (when available) are acceptable, and that the sterilization expiration dates, if applicable, are acceptable at the time of use. C3.320 Supplies and Reagents Each eye bank shall have a policy and procedure in which supplies, and reagents used during tissue recovery, processing, or preservation, are properly identified, documented, and tracked. The critical supply/reagent receipt verification shall also be described in the eye bank's procedure manual. The supplies and reagents shall be stored and maintained in accordance with manufacturer's recommendations. Expired supplies and reagents shall not be used for recovery, processing, and preservation of tissue intended for surgical purposes. The supplies and reagents used during the tissue recovery, processing, or preservation of the ocular tissue must be sterile, where appropriate, and inspected prior to use. C3.400 Procedures Manual Each eye bank shall maintain its own policies and procedures manual that details all aspects of its specific eye bank functions, and quality assurance practices. Each procedure must be initially approved, signed, and dated by the Director and Medical Director. An annual review of each eye bank's procedure with signing and dating by the Director and Medical Director is required. Each eye bank must maintain copies of each procedure it uses and the length of time the procedure was in use. Procedures must be readily available to personnel in the area where operations are performed. Eye banks shall utilize ICCBBA Eye Bank Technical Advisory Group (EBTAG) nomenclature to describe ocular tissue classes and attributes, effective June 30, 2015. C3.500 Other Establishments Performing Eye Banking Functions Any establishment performing eye bank functions must employ a CEBT. A recovery and/or a storage-only establishment may meet this requirement by having a documented consultative relationship with a CEBT and the EBAA accredited organization in which the CEBT is employed. All establishments performing specialized or specific eye banking functions must have a Medical Director or access to a Medical Director through a documented consultative relationship with an EBAA accredited organization. This Medical Director must meet the requirements of Medical Director as outlined in section C1.200 of these standards. Establishments performing specific eye banking functions may be inspected as part of the EBAA accreditation process of an organization in which they provide services. C3.510 Eye Bank Functions Performed by Another Establishment Any EBAA accredited organization engaging with another establishment that performs eye banking functions prior to distribution must either: 1. Document that the establishment is currently EBAA accredited for the eye bank functions performed; or 2. Document that the establishment is in compliance with EBAA medical standards, state and federal regulations appropriate to the eye bank functions performed. This option requires a written agreement and the EBAA accredited organization is responsible for performing compliance audits. Policies and procedures shall describe the audit plan, scope, and frequency. C3.600 Infection Control and Personnel Safety Written safety procedures for the eye bank operation shall be established in compliance with the Occupational Safety and Health Act (OSHA) of 1970 and the 1991 amendments to Part 1910 of title 29 of the Code of Federal Regulations, Subpart Z and/or applicable state statutes, which may supersede. For eye banks where OSHA regulations do not apply, written safety procedures in compliance with the relevant regulatory agencies are an acceptable substitute. All eye bank personnel performing functions which may cause exposure to human body fluids or tissue must operate under the current Standard Precautions for health care workers issued by the CDC of HHS. (On December 6, 1991, the Occupational Safety and Health Administration [OSHA] of the U.S. Department of Labor [DOL] published its final rules regulating worker occupational exposure to bloodborne pathogens, including but not limited to hepatitis B virus [HBV] and human immunodeficiency virus [HIV]. These regulations went into effect March 6, 1992 and make employers responsible for providing and ensuring safe working conditions in all work settings. See the December 6, 1991, Federal Register, Vol. 56, no. 235. These written procedures must be included in the eye bank's procedure manual.) C3.700 Biohazardous Waste Disposal Human tissue and waste items shall be disposed of in such a manner as to minimize any hazard to eye bank personnel and the environment and to comply with state and federal regulations. Dignified and proper disposal procedures shall be used to obviate recognizable human remains and must be documented. D1.000 DONOR ELIGIBILITY DETERMINATION Before tissue is made available for distribution, the Donor Eligibility Determination must be made by a responsible person. Reference Appendix III for requirements related to the donor eligibility process (Supplemental Digital Content 3, https://links.lww.com/CB9/A11). Eye banks outside of the United States should reference Appendix V for requirements related to the donor eligibility process (Supplemental Digital Content 5, https://links.lww.com/CB9/A13). Prior to making an eligibility determination, the donor must be screened according to D1.200. In addition to donor eligibility determination, tissue must be evaluated for suitability per F1.000. All donors must be identified by name. All prospective donors shall undergo a physical examination as close as possible to the donation with special attention to physical signs of HIV disease, infectious hepatitis, and injecting drug use. Each eye bank shall have a consistent policy for conducting and documenting this examination. Each eye bank shall also have a consistent policy for examination and documentation of the prospective donor's available medical record and death investigation. Review of all available records on each donor shall be performed by an individual who is qualified by profession, education, or training to do so, and who is familiar with the intended use of the tissue. Medical and social histories are important aspects of donor eligibility. Adequately determining eligibility includes, but is not limited to: 1. Infectious disease testing (see D1.200) 2. Physical assessment of the donor (see above paragraph) 3. Tissue evaluation (see F1.000) 4. Donor history evaluation: this must include the donor's name, social history and donor information obtained from at least one of the following: a. Pathologist or medical examiner physical assessment of death report b. Police investigation report accompanied by (a) and/or (c) c. Medical examiner's investigative report d. Donor risk assessment interview e. Medical record or hospital chart f. Treating physician interview g. Medical director oversight to review any donor information where questions arise in the above areas (see C1.200). This shall be documented. D1.100 Donor Screening The eye donor's relevant medical records must be reviewed for: • EBAA specific contraindications (Ref. D1.110): and • (Eye banks inside the United States only): FDA defined relevant communicable disease agents and diseases (Ref. D1.120): and • (Eye banks outside of the United States only): relevant communicable disease agents and diseases as applicable (Ref. Appendix V, Supplemental Digital Content 5, https://links.lww.com/CB9/A13): and • Other diseases as required by the country of import, if exported outside of the United States D1.110 EBAA Contraindications to Transplant Determination of donor eligibility is an eye banking function including considerations listed in multiple sources (eg, U.S. Food and Drug Administration, Health Canada, various state departments, Medical Director input, etc). In addition to these sources, the EBAA Medical Advisory Board has determined that tissues from persons with the following are potentially health threatening for the recipient(s) or pose a risk to the success of the surgery and shall not be offered for surgical purposes: A. All Ocular Donors 1. death of unknown cause and there is likelihood of other exclusionary criteria; 2. congenital rubella; 3. Reye syndrome within the past 3 months; 4. Active viral encephalitis of unknown origin or progressive encephalopathy (eg, subacute sclerosing panencephalitis, progressive multifocal leukoencephalopathy, etc); 5. active bacterial or viral meningitis; 6. active bacterial or fungal endocarditis; 7. suspected rabies and persons who, within the past 6 months, were bitten by an animal suspected to be infected with rabies; 8. intrinsic eye disease; a. retinoblastoma; b. malignant tumors of the anterior ocular segment or known adenocarcinoma in the eye of primary or metastatic origin; c. active ocular or intraocular inflammation: conjunctivitis, keratitis, scleritis, iritis, uveitis, vitreitis, choroiditis, or retinitis; 9. active leukemias; 10. active disseminated lymphomas; 11. Parkinson, amyotrophic lateral sclerosis, multiple sclerosis, and Alzheimer disease; 12. Creutzfeldt-Jakob disease (CJD), variant Creutzfeldt-Jakob Disease (vCJD), or family member with CJD; 13. history of Ebola Virus Disease (EVD); 14. active Lyme disease (known or suspected) 15. history of melanoma with known metastatic disease* * Excluded from this contraindication are tissues subjected to terminal sterilization methods that deactivate neoplastic cells (eg, gamma irradiation of corneas preserved in albumin). D1.120 Screening for FDA Defined Relevant Communicable Disease Agents and Diseases The FDA defines communicable disease agents and diseases considered relevant (Ref. Appendix I, Supplemental Digital Content 1, https://links.lww.com/CB9/A9). Tissue from persons exhibiting risk factors for, clinical evidence of, or physical evidence of relevant communicable disease and high-risk behavior associated with relevant communicable disease must not be used for transplant purposes (Ref. Appendix II, Supplemental Digital Content 2, https://links.lww.com/CB9/A10). Eye banks outside the United States must screen for relevant communicable disease agents and diseases according to applicable regulations (Ref. Appendix V, Supplemental Digital Content 5, https://links.lww.com/CB9/A13). D1.200 Donor Testing The eye donor must be tested according to: • EBAA testing requirements (D1.210) • FDA testing requirements (D1.220). Eye banks located outside of the United States are not bound by FDA testing requirements but must test in accordance with national and local regulations in the jurisdiction in which they are located (Ref. Appendix V, Supplemental Digital Content 5, https://links.lww.com/CB9/A13). • State requirements, if applicable • Other testing requirements of the country of import, if exported outside of the United States A review of written results of infectious disease testing shall be received by the eye bank prior to releasing tissue designated for surgical use. The infectious disease testing laboratory and test kits used must meet FDA regulatory requirements (Ref. Appendix IV, Supplemental Digital Content 4, https://links.lww.com/CB9/A12). Eye banks outside the U.S. must use a laboratory that is accredited by, and whose tests are approved by their own countries' regulatory agencies. If plasma dilution sufficient to affect the results of communicable disease testing is suspected, the donor should be considered ineligible, unless a pre-transfusion or infusion sample drawn up to 7 days before recovery is tested; or an algorithm designed to evaluate volumes administered in the 48 hours before specimen collection is used, showing that plasma dilution sufficient to affect the results has not occurred (Ref. Appendix IV, Supplemental Digital Content 4, https://links.lww.com/CB9/A12). Eye banks outside of the U.S.A. shall use a plasma dilution algorithm which meets the requirements of their own countries' regulatory agencies. If no such requirements exist, they shall use an algorithm which meets FDA requirements. D1.210 EBAA Testing Requirements The results of the following EBAA required testing must be negative or non-reactive for the tissue to be eligible for transplant: • anti-HIV-1, anti-HIV-2 (or combination test) • Hepatitis B surface antigen (HBsAg) • anti-HCV D1.220 FDA Testing Requirements Refer to Appendix IV for FDA donor testing requirements and recommendations (Supplemental Digital Content 4, https://links.lww.com/CB9/A12). Results must be negative or non-reactive for the tissue to be eligible for transplant except as indicated for syphilis. Refer to Appendix V for donor testing requirements and recommendations for eye banks outside the United States (Supplemental Digital Content 5, https://links.lww.com/CB9/A13). D1.230 Non-Required Testing Results All non-required positive infectious disease tests must be reported to the eye bank's medical director, who must review and act on them, or the eye bank must have a standard policy regarding the action to be taken in response to the individual test. D1.300 Documentation of Donor Information Donor screening forms and/or copies of relevant medical records reviewed must be completed and retained on all donated eye