From Referral to Transplant Cincinnati Eye Bank From Referral to Transplant LODN DSA Presentation – Oct. 3, 2014

“The Cincinnati Eye Bank is dedicated to the restoration of sight.” Not-for-profit organization founded in 1956 to provide donor eyes for corneal transplantation and to restore sight to the blind and visually impaired Coverage area includes ~40 hospitals in the Greater Cincinnati area, including Ohio, Northern Kentucky and SE Indiana Technician is on call 24/7 to respond to donor referrals Overseen and routinely inspected by EBAA and FDA CEB provided over 1000 corneas for sight-saving surgery in 2013 LODN DSA Presentation – Oct. 3, 2014

Early Corneal Transplantation The first successful human corneal transplant took place in 1906 The first eye bank was founded in New York City in 1944 Early corneal transplants needed to take place within 36-48 hours from the death of the donor All corneal transplants (Penetrating Keratoplasty) involved the full thickness of the cornea (all 6 layers) LODN DSA Presentation – Oct. 3, 2014

Much has changed since those early days So now for how it works today … LODN DSA Presentation – Oct. 3, 2014

Hospital / Facility Referral Process Cincinnati Eye Bank (CEB) partners and coordinates with LifeCenter Organ Donor Network (LODN) from referral through evaluation and recovery LODN Communication Center handles the referral calls for all potential organ, tissue and/or eye donors It is crucial for potential donors to be referred in a timely manner to LODN Communication Center due to the time constraints involved in recovery of tissues and eyes Upon receiving a referral call, LODN Communication Center obtains demographic information and pertinent medical history on the potential donor LODN Communication Center staff follow a basic list of rule-out criteria provided by CEB to triage potential eye donors, including criteria for both surgical use and research / teaching LODN DSA Presentation – Oct. 3, 2014

Authorization for Donation LODN Communication Center determines if the potential donor documented their wish to be a donor through Donor Designation / 1st Person Authorization (Donor Registry) If the potential donor’s wishes were not documented, the family will be approached for authorization for donation Once authorization for donation has been obtained, a Medical – Social History Interview will be conducted with an appropriate historian if the donor meets the basic criteria for surgical use of the donated tissues and/or eyes –conducted at the same time as the authorization if reasonably possible. LODN DSA Presentation – Oct. 3, 2014

Assistance From Referring Facility CEB would ask that referring facility staff assist with the maintenance of the donor and the delicate eye tissue until recovery can take place Close eyelids Elevate the head 20-30° (pillows or bed tilt) Place cool, wet gauze over the closed eyelids (no ice) CEB may request that referring facility staff assist in verifying donor identity when necessary It is also important following eye/cornea recovery that the head remain elevated and that care is taken in transporting the body LODN DSA Presentation – Oct. 3, 2014

LODN DSA Presentation – Oct. 3, 2014 Donor Evaluation Once authorization has been obtained, the CEB on-call technician is notified by LODN Communication Center staff CEB performs a review of the potential donor’s medical record, either through remote access to EMR or an on-site review of the paper chart - dependent on the facility The medical and physical review is conducted to look for anything that would preclude either recovery or use of the corneas for transplantation, therefore it is generally conducted prior to recovery If the review indicates a rule-out for recovery, the LODN Communication Center is notified LODN DSA Presentation – Oct. 3, 2014

LODN DSA Presentation – Oct. 3, 2014 Recovery Process CEB and LODN recovery staff coordinate on all shared tissue and eye donors, including determination of recovery location on a case by case basis Recovery for eye donation can take place: At an appropriate location at the referring facility, such as a patient room or morgue At LODN - on-site recovery suite if a shared donor LODN Communication Center will coordinate and work with hospital security, the funeral home and the coroner’s office to assure a smooth process LODN DSA Presentation – Oct. 3, 2014

Recovery Process (cont.) If the eye recovery will take place at the referring facility, the CEB technician will generally arrive within ~3 hours, and often sooner, but multiple factors can impact this: Multiple donor referrals within a short time frame Time needed for review of medical chart if done remotely through EMR and donor had a lengthy stay Distance of facility Weather and road conditions LODN Communication Center can coordinate with CEB and help keep facilities informed in the event of any delays LODN DSA Presentation – Oct. 3, 2014

Recovery Process (cont.) A physical assessment of the eyes and the donor’s body will be conducted prior to recovery, looking for signs of high risk behavior or other factors that might preclude recovery or use of the corneas for transplantation A blood sample will be drawn for serologic testing for HIV, hepatitis B, hepatitis C and syphilis. A pre-mortem sample may need to be obtained from the hospital lab if review of the medical record indicates that the post-mortem sample may have been diluted by administration of blood products, colloids and/or crystalloids LODN DSA Presentation – Oct. 3, 2014

Recovery Process (cont.) CEB will recover just the cornea with a rim of scleral tissue when the donor is suitable for transplantation and will recover the whole eye when the donor is only suitable for research and teaching Recovery is completed using aseptic technique to avoid any potential contamination of the corneal tissue CEB technician will notify LODN Communication Center when recovery has been completed and LODN Communication Center staff will complete any necessary coordination with Security, the funeral home or coroner’s office, as appropriate LODN DSA Presentation – Oct. 3, 2014

LODN DSA Presentation – Oct. 3, 2014 Following Recovery Recovered corneas are evaluated for suitability for transplantation with the slit lamp and specular microscope Blood samples are sent for serologic testing and hard copy results obtained Preliminary autopsy results are obtained, if autopsy performed All information is reviewed and additional medical information obtained as needed Medical Director Designee completes review of all of the above information and determines whether corneal tissue may be used for transplantation LODN DSA Presentation – Oct. 3, 2014

Modern Corneal Transplantation Corneas must be used for transplantation within 14 days from recovery, and generally are used within 7-10 days Leaves a very short time frame to complete the donor review process, markedly different from other tissues that have a much longer storage capability CEB provides transplant tissue locally first, then shares with other U.S. eye banks, and then internationally in order to assure that the donor’s gift will be used by a patient in need Corneal transplants can now be performed using a partial thickness of the cornea – only transplanting the layers needed for the specific disease process, promoting faster healing and visual rehabilitation LODN DSA Presentation – Oct. 3, 2014

LODN DSA Presentation – Oct. 3, 2014 Hannah’s Story Hannah was only 6 years old in May 1999 when her eye was damaged by an object thrown by a lawn mower A corneal transplant, along with other eye surgeries, would be needed to save Hannah’s vision and the doctor told the family it would be a long road ahead – her grandmother was “grateful there was a road to be on” A donor cornea was provided by CEB for Hannah’s transplant and the family said “we have seen miracles happen” Today, Hannah is a young woman whose life was forever changed by a donor and their family who gave the gift of sight LODN DSA Presentation – Oct. 3, 2014

LODN DSA Presentation – Oct. 3, 2014 Joe’s Story Joe was teaching in the Cincinnati Public Schools when he was diagnosed with keratoconus in the early 1960’s Dr. Taylor Asbury, founding Medical Director of CEB, performed a corneal transplant on Joe on September 9, 1964 After 50 years, the corneal graft remains clear and functions beautifully and we recently celebrated this 50th anniversary with Joe and his family and friends LODN DSA Presentation – Oct. 3, 2014

LODN DSA Presentation – Oct. 3, 2014 Joe’s Success “I have used the restored sight to continue my career as a Teacher and Counselor… and participate in a wide range of professional activities.” “The restored vision has permitted me to more fully enjoy the companionship of my wife and to see the birth/arrival of our three children/grandchildren and watch them grow. The restored vision has enabled me to be an eyewitness to the beauty of the changing world in these last 50 years.” “I remember deeply and appreciate the concern and thoughtfulness of the donor of my cornea and his family. I realize how the donor is yet living on.” LODN DSA Presentation – Oct. 3, 2014

LODN DSA Presentation – Oct. 3, 2014 CEB Contact Information Cincinnati Eye Bank 4015 Executive Park Drive #330 Cincinnati, OH 45241 Phone: 513-861-3716 Fax: 513-483-3984 eyebank@cintieb.org www.cintieb.org Beth Binnion, CEBT – Executive Director Tina M. Mays, CEBT – Associate Director / Technical Director LODN DSA Presentation – Oct. 3, 2014