Andreea Bauknecht, ABOC, 20/20 IS IN SIGHT: A LOOK CPOT, COA, CEBT Quality Services Manager INTO OCULAR DONATION Medical Director Designee OBJECTIVES 1. Eye Banking History and Lions Eye Bank of Wisconsin 2. Corneal donation statistics 3. Research and Education 4. Ocular Donation Process 5. Other resources FINANCIAL DISCLOSURES No financial disclosures. WHAT IS AN EYE BANK? An organization that retrieves, evaluates, processes and distributes donated eye tissue for use in transplantation, research and education. HISTORY . First corneal transplant in 1905 by Dr. Eduard Zirm in Czechoslovakia ( live donor) . First successful US corneal transplant performed in 1937 by Dr. R. Townley Paton – “Father of modern eye banking” who opened the first Eye Bank in 1944 in New York. .Success led to more eye banks opening and the establishment of Eye Bank Association of America (EBAA) in 1961 – the nationally recognized accrediting body for eye banks. Historical transplanting: Patient placed on long waiting list Surgeon would recover ocular tissue Patient would need to lay flat for days Did not obtain useful vision for weeks Death row inmates as donors TODAY . Outpatient procedure . Corneal transplant procedure lasts 1-2 hours . Eye Bank recovers tissue for surgeon . Eye Bank processes tissue for surgeon . 95% success rate TODAY •Eye Bank Association of America is made up of 57 US banks and 11 international banks. Since 1961, member eye banks have provided tissue for over 1,954,600 people whose sight was restored through corneal transplants. 2018: 51,294 corneas were transplanted in US meeting 100 % of U.S. demand. 27,913 corneas were exported internationally 23,161 corneas used for research/training REGULATORY U.S. Food and Drug Administration 21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products Eye Bank Association of America EBAA Medical Standards EBAA Procedures manual Wisconsin Statutes Section DHS 137, Section 157.06 Other regulations as dictated by country of import WHO CAN DONATE? ALMOST EVERYONE Chronic kidney disease patients Organ transplant recipients Certain cancer patients Hypertensive and diabetic patients Cataracts patients (with and without surgery performed) Patients with history of eye surgery Macular degeneration patients Glaucoma patients Blind patients INDICATIONS FOR CORNEAL TRANSPLANTATION .Ocular trauma .Complications from cataract surgery .Keratoconus .Repeat corneal transplant (95% of transplants are successful) .Corneal dystrophies ( Fuchs’, Lattice, ) .Microbial keratitis .Sterile ulcers (not related to infection) .Others THE LIONS EYE BANK OF WISCONSIN . 1953 - the first eye bank in the State of Wisconsin providing ocular tissue for transplant was opened in Milwaukee – sponsored by the Marquette University of Medical School. In 1964 it was taken over by the Wisconsin Lions Foundation (WLF) and was renamed the Wisconsin Lions Eye Bank. 1969 – a separate eye bank facility in Madison, WI was started with similar goals to the MKE program – administered through the University of WI and University Hospitals and Clinics. Both funded, in part, by the WLF. 1999 – the two eye banks merged to better serve the needs of Wisconsin under the name Lions Eye Bank of Wisconsin Inc. 501(c)3 non-profit organization . Serves 150 hospitals and most county coroners/Medical Examiners . FULL-SERVICE EYE BANK Provided close to 1600 Corneas for Transplant Local and Out of State Placement Wisconsin Transplants National & International Transplants CORNEA DISTRIBUTION 48% 52% 2018 Lions Eye Bank of WI 2018 Wisconsin Global Impact SURGICAL EDUCATION AND RESEARCH CENTER Building for Tomorrow . Providing surgeons with education and training opportunities . Webcasting Education and Training Internationally . Providing clinical space for researchers . Opportunities for surgical residents to train RESEARCH PARTNERSHIPS Diabetic Retinopathy Glaucoma in trabecular Columbia University Medical Center meshwork New York University of Wisconsin DOVS Madison, WI Keratoconus Study Instituto Universitario Fernandez-Vega Retinal cell culturing Oviedo, Spain University of Wisconsin DOVS Madison, WI Cataract formation University of Wisconsin-Biochemistry Madison, WI THE EYE DONATION PROCESS Referral Screening/ Evaluation Arrange Authorization/ Transport to Disclosure Surgeon and DRAI Process Tissue Recovery Evaluate for Donor Offer to Eligibility and surgeon Tissue Suitability DONOR SCREENING: REFERRALS • Mandatory hospital death reporting in the State of Wisconsin • Hospitals are required to report deaths to a referral organization. • Preliminary information obtained and triaged for automatic rule outs. • Age (2-75) for eye transplant • Referral passed to appropriate donation organizations REFERRAL PROCESS IN WISCONSIN Wisconsin has many donation organizations: • ORGAN: University of Wisconsin Organ and Tissue Donation/ Versiti Organ & Tissue Donation • TISSUE: American Tissue Services Foundation/ Versiti Tissue Bank • EYE: Lions Eye Bank of Wisconsin Hierarchy exists for who handles the referral Must be carefully coordinated As of August 1st, 2017 LEBW has an in-house Donor Support Center REFERRAL RECEIPT Coordinators receive the information and check Wisconsin’s Donor Registry Coordinators will call the referring facility to obtain further information about the potential donor to determine if and how we will approach All potential donors are screened for a variety of conditions and diseases to ensure the safety of the gift Not all contraindications can be detected through screening with the referring organization CONTRAINDICATED CONDITIONS Acquired Immunodeficiency Syndrome (AIDS/HIV) Active viral encephalitis or encephalitis of unknown origin Active viral hepatitis (Hepatitis B&C) Creutzfeld-Jacob Disease (CJD) Rabies CONTRAINDICATED CONDITIONS Cancer of the blood or eye • Leukemia • Lymphoma • Myeloma • Ocular cancer of primary origin (such as retinoblastoma) or ocular metastases CONTRAINDICATED CONDITIONS Neurological conditions (Multiple Sclerosis, ALS, Parkinson’s disease, Alzheimer’s, Dementia) High-risk behavior (intravenous drug abuse) Systemic infection (bacteremia, fungemia, viremia, etc.) Travel Restrictions Receipt of unacceptable medical products (human derived dura mater) OTHER CONTRAINDICATIONS Other active infections Circumstances (timing is limited – cornea recovered within 12 hrs from death) Eye conditions This is not a complete list of contraindications many other conditions can affect the outcome or safety of a potential transplant, or may limit the use for transplant ACCEPTED CONDITIONS FOR TRANSPLANT . Age for transplant 2 – 75 . No age limit for research/education/training purposes . CANCER ( except for certain types of blood, bone marrow and ocular cancer) . PREVIOUS ORGAN TRANSPLANT . Ocular surgery: cataract surgery, LASIK/LASEK . Conditions not affecting cornea such as glaucoma, macular degeneration, vitreous detachments . DIALYSIS PATIENTS NEXT STEPS: LOGISTICS If no contraindications are found during screening, coordinators will: • Work with referring organization to identify legal next-of-kin • Communicate with ME/Coroner • Communicate with funeral home • Request cooling and eye care be performed • Contact the next-of-kin for legal authorization or disclosure THE EYE DONATION PROCESS Referral Screening/ Evaluation Arrange Authorization/ Transport to Disclosure Surgeon and DRAI Process Tissue Recovery Evaluate for Donor Offer to Eligibility and surgeon Tissue Suitability Governed by Wisconsin State Statute 157.06 Anatomical Gifts TYPES OF Two general types of authorization: AUTHORIZATION First Person Authorization ( via Wisconsin Registry, Advance Directive, Power of Approach of LNOK FOR DONATION Attorney for Healthcare Document) Guided by the Uniform Anatomical Gift Act (UAGA) hierarchy Uniform Anatomical Gift Act (UAGA) hierarchy: 1. Donor 2. Healthcare agent or Power of Attorney 3. Spouse 4. Adult children 5. Parents 6. Adult Siblings 7. Adult grandchildren 8. Grandparents 9. Adults who exhibited special care or concern, except those who provided compensated health care for that individual 10. Legal guardian 11. Whomever the responsibility would lie with to dispose of the body Disclosure is notifying next-of-kin of decedent’s wishes to be a donor State/National Donor indicated desire Registry (Record to donate on a legally of Gift) binding document prior Advance DISCLOSURE Directive to death POAHC LEBW disclosures are performed via telephone and the conversation is recorded Approach is to obtain permission for donation from a legal decision maker Donor did not have a legally binding APPROACH FOR document of gift on file AUTHORIZATION LEBW authorizations are performed via telephone and the conversation is recorded Must be obtained prior to recovery DONOR RISK ASSESSMENT INTERVIEW Interview with ”knowledgeable historian” Allow us to obtain information falls outside of medical record Contains sensitive and personal subject matter that can be very difficult to cover with grieving family members Required by regulatory agencies to ensure the safety of the gift for recipients THE EYE DONATION PROCESS Referral Screening/ Evaluation Arrange Authorization/ Transport to Disclosure Surgeon and DRAI Process Tissue Recovery Evaluate for Donor Offer to Eligibility and surgeon Tissue Suitability Technicians are dispatched for recovery when authorization has been obtained RECOVERY TECHNICIANS On the road within 30 minutes of dispatch Technician travels to the recovery site and performs the recovery procedure