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
Hospitals (Morgues, Operating Rooms, patient rooms or other Coroner/Medical Examiner’s Funeral homes suitable areas) office RECOVERY TECHNICIANS
LEBW uses full-time recovery technicians
Experienced in sterile technique
On road within 30 minutes of dispatch
Backup coverage ELEMENTS OF RECOVERY
Penlight examination Blood draw – Donor identification & Physical infectious disease examination testing
In situ or enucleation Reconstruction and Ocular preparation procedure cleanup
RECOVERY DURATION: 80 minutes Recovery Technicians perform a penlight exam on all donors
SPOTLIGHT
ON Must be done prior to recovery, allows for assessment of ocular PENLIGHT and extraocular conditions EXAM
Physical evidence discovered during penlight can make tissue not transplantable: Previous Disease Infection Trauma surgery
SPOTLIGHT ON PHYSICAL EXAM
Recovery Technicians obtain a full physical exam on all donors
Looking for physical manifestations of infectious disease or high risk behavior
Evidence discovered during physical exam can make recovery unsafe to proceed
SPOTLIGHT ON IN SITU RECOVERY
In situ procedure comprises >95% of recovery procedures
The entire globe is not recovered (enucleated)- instead, the cornea is removed and immediately preserved in Optisol-GS
The posterior pole can be recovered for sclera
Enucleations are performed for research/education purposes Vitreous draw (when applicable) – forensic toxicology POST- Donor reconstruction & Site RECOVERY clean up STEPS
Packaging & Transportation back to LEBW laboratory CORNEA EXPRESS
Unique tissue transport system
•230 Lions Clubs, 2000 volunteer transporters participate
Receive special training through LEBW/Lions Clubs
Transport from 6am to 9pm, 7 days a week
Faster and more reliable then couriers/commercial carriers 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 DETERMINATIONS
In order for tissue to be transplantable:
• Tissue determined to be suitable
• Donor determined to be eligible
Final determination is typically made within 2-3 days of death TISSUE SUITABILITY
Tissue suitability is determined by specular and slit lamp microscopy
Specular microscopy performed to visualize and quantify corneal endothelial cells by projecting light onto the cornea and capturing the image that is reflected back
Slit lamp microscopy performed to examine each corneal layer
Both evaluations assist in rating the cornea for surgical suitability SPECULAR MICROSCOPY
Images of limited endothelial area taken and marked
Endothelial cell density is extrapolated
ECDs >2,000 cells/mm2 are acceptable for procedures utilizing the corneal endothelium
Can also be useful in detecting endothelial conditions
SLIT LAMP MICROSCOPY
Technician uses the microscope beam to visualize each corneal layer
Useful for identifying any conditions which would affect surgical outcomes
Cornea is rated for different surgery types
Specular evaluation acceptable
+ TISSUE SUITABILITY Slit lamp evaluation acceptable
Tissue deemed suitable for transplant Blood samples are obtained on all donors
•Post-mortem draw •Pre-mortem blood tube collection Sent out for testing to a CLIA-certified lab who utilizes cadaveric donor test kits (required by FDA)
All donors tested for, at a minimum:
SEROLOGY HIV 1&2 Ab DETERMINATION HBsAg
HBcAb
HCV Ab
HIV/HCV NAT
Syphilis Blood sample must be determined to be suitable for testing
SEROLOGY Ensure sample is not diluted by IV DETERMINATION fluids and blood products
Perform an algorithm which utilizes the donor’s weight to obtain plasma volume and blood volume that cannot be exceeded SEROLOGY DETERMINATION
Serology test results non-reactive +
Blood sample Serologies acceptable acceptable (not diluted) for transplant Established by Medical Director/Designee
Review of available relevant records
Medical record or Medical Examiner Donor Risk Assessment DONOR EMS reports hospital chart investigative report Interview ELIGIBILITY DETERMINATION Review performed to identify any contraindications
Gather information about the donor to report to the transplanting surgeon All records obtained, reviewed and found acceptable ELIGIBILITY DETERMINATION Donor deemed eligible for transplant 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 No longer a waiting list for recipients
Surgeons schedule patients and let eye bank know in advance
Surgeon is provided with Tissue Information Form ASSIGNMENTS which provides information about the donor and the AND OFFERS tissue
Surgeon ultimately decides if the tissue is suitable for their patient
Emergent cases are prioritized 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 TISSUE PROCESSING
Deep Anterior Lamellar Keratoplasty (DALK)
Descemet’s Membrane Endothelial Keratoplasty (DMEK)
Descemet’s Stripping with (Automated) Endothelial Keratoplasty (DSAEK) 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 DAYS 1-2
Authorization and DRAI obtained
Records requested
Recovery performed & tissue transported to eye bank
Evaluation of tissue performed
Blood sample sent for testing DAYS 2-3
Serology results received
Chart review performed
Additional records requested
Autopsy results obtained DAYS 3-5
Donor released
Tissue offered to surgeon
Tissue processed
Tissue packaged and shipped to surgery location DAYS 5-7 Tissue can still be offered if not yet placed
Odds of placement are decreased
Day 5 is last day to offer for international surgeries DAY 8-13 Tissue considered “too old” for sight-restoring surgery
Can be used for patch graft surgeries
Odds of discard outweigh odds of transplant DAY 14
Tissue is expiring and no longer able to be transplanted FAMILY SERVICES
Grief support
Donor Remembrance Ceremony
Facilitate communication with recipients FAMILY SERVICES
Donor families are sent printed materials and made aware of support groups
Outcome letters are sent once tissue is used
Started a donor quilt program DONOR QUILTS
Donor families invited to make a quilt square – each square represents a unique story
Squares are sewn together to make a quilt
Quilts are on display at the eye bank and at eye bank events
Quilts travel throughout the state to raise awareness of eye, organ and tissue donation REMEMBRANCE CEREMONY
Event to honor those who gave the gift of sight
Held annually
Donor families and recipients are invited
Opportunity to facilitate meetings between families and recipients FAMILY & RECIPIENT CONNECTION
Donor families and recipients are able to send letters.
Eye bank and physician facilitate the delivery of letter
Possible for direct communication and eventual face to face meeting FOR MORE INFORMATION
Contact:
Andreea Bauknecht [email protected] Ph: 608-298-2516 QUESTIONS?