December Issue of Insight

IN THIS ISSUE:


President's Address: Passing the Torch

- Patricia Aiken-O'Neill, Esq.

It’s time to say “goodbye.” There have been numerous generous acknowledgements and well wishes to date, and, as this year has progressed I’ve been committed to working at full speed until my formal “expiration” date. It’s funny how the work has not decreased in step with my decreasing tenure! But that time is near, and this provides an opportunity for me to say a sincere “thank you” to the great community of professionals who work in, and on behalf of, eye banking. It has truly been a pleasure and a wonderful learning experience. I’ve made friends and developed skills that have benefitted me in my personal as well as my professional life. I am grateful to all of you.

The Association has chosen a terrific person - Kevin Corcoran – to succeed me as President and CEO. I am confident that he will do a great job and will work with the community to identify new opportunities and to attain new heights. There is so much potential growth for the Association and for the eye bank community and Kevin brings skills to the position that will realize new goals.

Over the next year – 2012 – I will be “on call” as a “consultant,” and Kevin and I are in the process of identifying some projects that might benefit from my attention and commitment. I want to stress that while I welcome this continuation, I recognize and respect that Kevin will be the “go to” person. From January 1, 2012, when you call my extension, it will be Kevin who answers. My professional email will be discontinued and Kevin’s is kevin@restoresight.org (operational now, as many of you know). Emails to me can be directed to a new email address: pao@restoresight.org and messages can be left for me at the general number, ext. 125.

But, back to the message: go to Kevin. He wants to hear from you; he wants to know you; he is committed to serving you, as I have done for the past 21, almost 22, years. My New Year’s wish is for a productive relationship between you and the new leadership.


New Focus on National Eye Donor Month

- Kevin Corcoran, Incoming EBAA President/CEO

March is National Eye Donor Month. This is our opportunity to educate potential donors, the media and policymakers about our critical role in improving or restoring sight for over 50,000 people each year. To this end, we intend to enhance our commemoration of National Eye Donor Month 2012.

But first, we need to know if and how you celebrate National Eye Donor Month, and what tools and resources would help you do so more effectively. We distributed a brief survey to our eye bank members, to get their insights and suggestions. If you haven’t already done so, please go to this link by Friday, December 16 to complete the survey. While the questions are tailored to eye banks, Paton members are also invited to share their thoughts and ideas to help commemorate this event.

In order to learn from each other and unify the Association around this project, we’re also asking you to share tools, resources and success stories that you’ve developed for National Eye Donor Month. Please send them to us at EyeDonorMonth@restoresight.org; we will compile them and share them across the Association, giving appropriate credit to their creators.

Thank you in advance for your help with this project and for your commitment to EBAA.


Regulatory/Legislative Updates

- Jennifer DeMatteo, Director of Regulations and Standards

Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus

The Food and Drug Administration (FDA) released their draft document entitled, “Guidance for Industry: Use of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, (including Recovered Plasma, Source Plasma, and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of Hepatitis B Virus (HBV) and Requalification of Donors Who Test HBV NAT Positive,” dated November 28, 2011. The draft guidance, when finalized, will supplement previous memoranda and guidance for blood establishments and require FDA-licensed HBV NAT testing, in addition to HBsAg and anti-HBc testing.


Tavenner to Replace Berwick as CMS Administrator

The Centers for Medicare & Medicaid Services (CMS) Administrator Donald Berwick, MD, resigned after Republicans successfully blocked his Senate confirmation. President Obama has appointed Marilyn Tavenner, the agency’s principal deputy administrator, to serve as the new acting administrator during the confirmation process. Tavenner has an extensive health background as a nurse, Chief Nursing Officer, and Hospital Chief Executive at Hospital Corporation of America (HCA), and was later appointed as Secretary of Virginia’s Health & Human Services.


CMS Issues Final Rule on Outpatient and Ambulatory Care Payments for CY 2012

Centers for Medicare and Medicaid (CMS) released the final rule with comment period for the hospital outpatient payment system (OPPS) for CY 2012 and the ambulatory surgical center (ASC) payment system. Compensation rates for Medicare's outpatient prospective payment system will rise by 1.9%, while payments to ambulatory surgery centers will grow by 1.6%, according to a final set of rules released by the CMS. The agency is also set to launch a pilot program meant to enable more hospitals to participate in Medicare's electronic health record incentive program.


FDA Approves Supplemental Test for Chagas Disease in Blood

The FDA has approved Abbott Laboratories' ESA Chagas assay, which can identify antibodies to Trypanosoma cruzi, the parasite that causes Chagas disease, in human serum and plasma samples. The FDA said the test is the first licensed as a supplemental test for the disease.


Roche Gets FDA Approval for Acute Hepatitis B Blood Test

Roche has received FDA Premarket Approval for its IgM antibody to hepatitis B core antigen (Anti-HBc IgM) assay for use on the cobas e 601 analyzer, the immunoassay module of the cobas® 6000 analyzer series for mid-volume laboratories. The Anti-HBc IgM assay is also pending FDA approval for use on Roche's cobas e 411 and MODULAR ANALYTICS E170 analyzers.

The Anti-HBc IgM assay is used for the in-vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma. The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of an acute or recent hepatitis B virus (HBV) infection.


ACBSA Meeting To Address Informed Consent of Blood, Organ, Tissue Recipients

During its December 5-6 meeting, the Advisory Committee on Blood Safety and Availability (ACBSA) will address issues of informed consent for blood, organ and tissue recipients. Discussion topics will include current clinical consent practices and research opportunities for improving the informed consent process for blood transfusion and organ and tissue transplantation. David Glasser, MD, will speak on “Consent Practices in Ocular Tissue Transplantation.”

To view the meeting agenda, please click here.


Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) List of Registered Establishments

FDA updated their listing of registered HCT/P establishments on 11/14/2011.


Wanted: Articles for First-Ever Eye Banking Journal

- Jackie Malling, International Journal on Eye Banking, Editor-in-Chief

Have you heard about the new publication under development exclusively for the eye banking community? In collaboration with the EBAA, the International Journal of Eye Banking will launch next year as a quarterly, peer-reviewed, online journal--and the editors are seeking manuscript submissions from all corners of the world.

The Call for Papers is now posted on the journal’s website: www.EyeBankingJournal.org. There you will find information on the Journal’s mission, content formats, and submission procedures. Our goal is to make it as easy as possible to contribute to this global endeavor. We encourage everyone to sign up now as a subscriber (it’s free) or to volunteer as a reviewer.

The Journal’s editorial board consists of eye bankers and corneal surgeons from around the world, including Patricia Aiken-O’Neill, outgoing EBAA president/CEO, and Marian Macsai, MD, Chair of the EBAA Board of Directors, as well as representatives from the Association of Eye Banks of Asia, the European Eye Bank Association, the Eye Bank Association of Australia & New Zealand, and the Pan American Association of Eye Banks. The complete list appears on the Journal’s website; additional board members will be named in coming months.


IN THE NEWS

InHealth Seeking Proposals to Evaluate Role and Impact of Technological Innovation

The Institute for Health Technology Studies (InHealth) is seeking proposals to evaluate the role and impact of technological innovation in reducing the economic and clinical consequences of infection. Submitted proposals should concentrate on the technology contribution to clinical practices, not on creating or refining clinical practices or protocols.

All proposals must be submitted to InHealth by February 1, 2012. An independent panel of experts will conduct an extensive review of submissions; awards are expected to be announced on March 15, 2012.

To view or download the complete Request for Proposal, please click here.


Lions Clubs Celebrate "Lions Eye Bank Week"

Lions Clubs International is recognizing its 6th annual Lions Eye Bank Week. Celebrated annually during the first full week in December, Lions Eye Bank Week is an opportunity to celebrate and acknowledge the contributions of Lions eye banks worldwide.

During this celebratory week, Lions eye banks are encouraged to spearhead activities and events that honor the impact of Lions eye banks as a whole and promote their valuable sight-saving services.

The Lions Clubs support 53 Lions eye banks in eight countries. For additional information on Lions Eye Bank Week, please visit the Lions Clubs International website.


National Keratoconus Foundation Publishes Revised Corneal Transplant Booklet

The National Keratoconus Foundation (NKCF) will publish a newly-revised Corneal Transplant book in English and Spanish.

With the support of the EBAA and other organizations, NKCF created this third-edition booklet to help patients understand corneal surgery, including what to expect pre-op and post-op. The booklet also includes information on some surgical procedures used to perform corneal transplants, an "Advice from Transplant Recipients" section and frequently asked questions.

For additional information on this booklet, please visit NKCF's website.


Three Online Retailers Must Stop Sale of "Circle" Contact Lenses as Part of FTC Settlement

Three cosmetic (circle) contact lens marketers have agreed to enter into settlements with the Federal Trade Commission (FTC) to resolve charges for illegal sale of contact lenses without a prescription.

Royal Tronics, Inc. and Jamil Hindi, Gene Kim and Thy Xuan Ho were all fined by the FTC for violating the Contact Lens Rule, which requires that sellers verify a customer has a prescription for all contact lenses, including cosmetic lenses.

The settlements are part of FTC's efforts to enforce its Contact Lens Rule. The Food and Drug Administration has reported that improper use of contact lenses can result in corneal abrasions or ulcers, visual impairment or blindness.

Since the FTC instituted the Contact Lens Rule in 2004, there have been 10 contact lens enforcement actions, including the three recent settlements.

To view the FTC's news release on the settlements, please click here.


FDA Approves Drug for Age-Related Macular Degeneration

The Food and Drug Administration (FDA) has approved Eylea, a Regeneron Pharmaceuticals product, to treat wet age-related macular degeneration (wet AMD).

For patients who suffer from wet AMD, blood vessels grow beneath the eye's retina and leak, affecting the eye's light-sensitive tissue and central vision. Eylea is designed to prevent abnormal growth of blood vessels. In a November 18th Wall Street Journal article, Boston ophthalmologist Jeffrey Heier, who is also chair of a steering committee of one of Eylea's clinical trials, said the drug is as efficient as other current alternative drugs but requires less frequent injections and has no monitoring requirements. "This may reduce the need for costly and time-consuming monthly office visits for patients and their caregivers," he said.

To view the complete Wall Street Journal article, please click here.


ANNOUNCEMENTS

ATTENTION: CEBTS Who Need to Recertify in 2011 - Deadline December 31st!

Listed below are the individuals whose CEBT status will expire December 31, 2011. As a reminder, to be eligible for recertification, you must earn 16 CEUs in your three-year certification period, including attendance at two of the following: Medical Advisory Board Meeting, Technician Skills Workshop, Medical Directors Symposium and Scientific Symposium (which includes the Fall Educational Symposium).

To access the recertification application, please click here.

Submit your recertification applications today! (Please note that the Member fee is now $500).

Acosta, Margarita
Al-Talhi, Abid
Barrios, Liliana
Cady, Ryan
Davila, Ricardo
Fallo, Jan
Hernandez, Luis
Jordan, Richard
Kalkowski, Mischel
Lewis, Darrel
Money, Aaron
Polgar, Gene
Ramsey, Brett
Roberts, Russell
Scalf, Rene
Williams, Tracy


ATTENTION: Paton Society Members - Membership Renewals Due December 31st

For those Paton Society members who have not already done so, the EBAA encourages you to renew your membership by logging into the members only section of the EBAA website.

In addition to the Cornea Journal, your Paton Society membership provides you with access to the following member benefits:
  • Discounted Registration to the EBAA/Cornea Society Fall Educational Symposium
  • Discounted Registration to the EBAA's Annual Meeting
  • Access to the EBAA Website's Members Section
  • Updates on Legislative and Regulatory Issues
  • Complimentary EBAA Medical Standards and Advisories
  • Annual Statistical Report on Eye Banking and Corneal Transplantation

If you have any questions or inquiries regarding your Paton Society membership, please contact EBAA Membership Programs Coordinator Christa Aiken.


EBAA Congratulates New CEBTs

The EBAA is happy to announce the Fall 2011 Certified Eye Bank Technician (CEBT) class. Please join the Association in congratulating the following individuals:

Amy Albany, Cleveland Eye Bank
Marie Bowden, South Dakota Lions Eye & Tissue Bank
Joseph Brainard, Donor Network of Arizona
Anna Buckthorpe, Heartland Lions Eye Bank
Mara Budnetz, Lions Eye Institute for Transplant and Research
Roxanne Canter, Mid-America Transplant Services
Daniel Carney, The Eye-Bank for Sight Restoration
Jacob Chrzanowski, Donor Network of Arizona
Denise Graham, Mid-America Transplant Services
Stephanie Heilman, Northeast Pennsylvania Lions Eye Bank
Laura Coon, Central New York Eye & Tissue Bank
Rene Maldonado, SightLife
Angela McKean, Cleveland Eye Bank
Daniel Mercado, Lone Star Lions Eye Bank
Denis Normandin, Quebec Eye Bank
Thomas Robbins, Tennessee Donor Services
Marc Scalise, Donor Network of Arizona
Brandon Strike, East Tennessee Lions Eye Bank
Jennifer Suarez, Illinois Eye-Bank
Ryan Williams, Lions VisionGift


SightLife Appoints Rusty Kelly as Chief Marketing Officer

Rusty Kelly, former Director of California Operations for SightLife, has been promoted to Chief Marketing Officer.

As Director of California Operations since 2009, Mr. Kelly oversaw the building of SightLife's eye bank tissue laboratory and training facility in Brisbane, California; under his leadership, there was a 150 percent increase in cornea donations in the San Francisco Bay Area. He was also instrumental in reducing the amount of time it takes corneal tissue to reach surgeons by half a day. In his new position, Mr. Kelly will be responsible for all areas of business development, marketing and communications

Prior to his tenure at SightLife, Mr. Kelly served as the Vice-President of the Eye Bank Association of America and was the catalyst for the Cornea Collaborative.

The EBAA congratulates Mr. Kelly on his appointment and wishes him continued successes!


EBAA Holiday Schedule

In observance of the upcoming holidays, the EBAA office will be closed on Friday, December 23 and Monday, December 26. If you need to contact an EBAA staff member during that time, please leave a detailed voice mail or e-mail and you will be contacted at his or her earliest opportunity.

The EBAA wishes everyone a happy and safe holiday season!


UPCOMING EVENTS

8th Annual FDA and the Changing Paradigm for HCT/P Regulation
January 24-25, 2012
Hyatt Regency San Antonio
San Antonio, TX

For additional information or to register, click here.


2012 Technician Education Seminar
February 8-11, 2012
Lions Eye Institute for Transplant and Research
Tampa, Florida

To view the brochure and to register, click here.

To book a hotel room in the EBAA room block at Hampton Inn and Suites-Ybor City, please call 813-247-6700. (Don’t forget to mention the Eye Bank Association of America!)


Save the Date

EBAA Education Institute: A Revolution in Eye Banking: Ocular Coherence Tomography (OCT)
January 25th at 3:00pm (Eastern)
Speaker: Joshua Galloway, CEBT, Lions VisionGift
Registration coming soon!


Annual Meeting
June 20-23, 2012
Westin Diplomat
Hollywood, FL