Vascularized Composite Allografts – Written Comments Due By July 2

On March 3  HRSA published a notice in the Federal Register requesting feedback on the following questions: (a) whether vascularized composite allografts should be included within the definition of organs covered by the regulations governing the operation of the OPTN; (b) whether vascularized composite allografts should be added to the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984; and (c)  if either of the above changes is pursued, the optimal way to define vascularized composite allografts. An opportunity was presented on April 4 to provide testimony at HRSA headquarters and featured presentations by Melissa Honohan (AOPO), Alex Glazier (NEOB), Gordon Bowen (LifeBanc), and others. AOPO supports the inclusion of these allografts within the definition, primarily due to issues related to the role of OPOs and public trust. The deadline for written comments to HRSA has been extended to July 2, 2008., and should be sent to James F. Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 12C-06, Rockville, Maryland 20857; Telephone 301 -443-7577; fax 301-594-6095; or e-mail: jburdick@hrsa.gov

FDA Draft Guidance on NAT for West Nile Virus – Written Comments Due by July 28, 2008

On April 28, the FDA published in the Federal Register draft guidance, entitled “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” As summarized by AATB, the FDA’s guidance document recommends: (1) year-round WNV testing by “ID-NAT using a licensed screening NAT test;” and (2) any donor whose specimen tests reactive “be ineligible for donation.” FDA recommends the use of licensed NAT testing for WNV within 6 months after a final guidance is issued. Written or electronic comments on the draft guidance are requested by July 28, 2008.

End Stage Renal Disease Facilities – October 2008 Effective Date

The final rule, published in the April 15, 2008 Federal Register, finalizes the February 4, 2005 proposed rule entitled ‘‘Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities.’’ The rule establishes new conditions for coverage that dialysis facilities must meet to be certified under the Medicare program. It focuses on the patient and the results of care provided to the patient, establishes performance expectations for facilities, encourages patients to participate in their plan of care and treatment, eliminates many procedural requirements from the previous conditions for coverage, preserves strong process measures when necessary to promote meaningful patient safety, well-being, and continuous quality improvement. The rule goes in to effect on October 14, 2008.

Recent Events of Note

Thanks to Melissa Honohan and Manda Wong (The Health Policy Group) for organizing and coordinating a successful AOPO Congressional Fly-In Day on April 15. Participating this year were AOPO President Tom Mone, Legislative Committee Co-Chairs Larry Cochran and Tim Brown, along with Jerry Anderson, Joe Roth,  Jill Maxfield, Esther-Marie Carmichael, Mike Hudson (Health Policy Group), Melissa, Manda, and me. Representatives from NATCO and NKF joined with AOPO representatives for some of the sessions on the Hill.

On April 29, I joined representatives from the ASTS (John Roberts, MD), AST (David Cohen, MD), and Donate Life America (David Fleming) to provide a briefing for staffers of the Congressional Organ and Tissue Donation Awareness Caucus. The subject of the briefing was “Dispelling Myths Associated with organ Donation and Transplantation.”

Still Waiting

Historians may note that May 31, 2008 will mark two years since publication of the CMS final rule on OPO conditions of participation. Although the final interpretative guidelines have yet to be published as of this writing on May 1, there has been some recent feedback of note. In January, AOPO was given an opportunity to provide comments on draft interpretative guidelines and informal feedback received suggested that considerable changes were made in the guidelines based on information received from AOPO. In March, furthermore, AOPO received a written communication from CMS regarding outcome measures in the rule, which stated that “…we are writing our Interpretative Guidelines for this initial period of the new regulation to allow the OPOs that have a deficiency in an outcome measure to be re-certified if an acceptable plan of correction is received from the OPO and approved by CMS. Any failure to meet the minimum outcome measures during 2007-2009 data collection period will be cited as a deficiency by the surveyors during re-certification cycle 2010 visits and the OPO will be required to provide a detailed plan for correction.”

On December 22, 2006, the Veterans Benefits, Health Care, and Information Technology Act of 2006 was enacted,  which included the long awaited legislative authorization to loosen confidentiality provisions regarding information for organ, tissue, and eye donation. Interim Final regulations were published in the Federal Register on August 23, 2007.  Notwithstanding these developments, the Department of Veterans Affairs web site as of May 1, 2008 still directs VA facilities to use earlier policies and guidance as the new directives “are currently being updated and processed.” AOPO, AATB, and EBAA will be sending a letter to the Secretary of the Department of Veterans Affairs seeking closure on this long saga.

Stay Tuned

The HHS Office of Inspector General, out of its Western office based in San Francisco, is currently undertaking an audit of OPO financing with site visits being conducted at a series of OPOs. The audit is part of a study announced to our membership earlier in the year.

Omission of Note

On February 4, 2008, the US Department of Health and Human Services issued a report on FY 2007 Performance Highlights. The document reviews the Department’s four strategic goals and reviews the performance for 40 target areas. Organ donation and transplantation are not included in the HHS target areas, however, reference is made in one of the document’s appendices to the inclusion of organ transplantation as part of the Administration’s Program Assessment Rating Tool which was introduced in 2002.

25th Annual Meeting of the Association of Organ Procurement Organizations

June 10 – 13, 2008

Phoenix, Arizona

It is almost time for AOPO’s 25th Annual Meeting, June 10-13, in Phoenix, Arizona!

The brochures have been mailed out, the electronic version is on our website, and the meeting registration site has been available since early February.  The Program Committee listened to your suggestions for change and has tried to be responsive to them.  In case you haven’t taken care of details, here is some information you’ll want to know.

Within days of the publication of “The Gift that Heals,” the book I wrote at the suggestion of UNOS, Howard Nathan, executive director of Gift of Life Donor Program ordered five hundred copies. It took my breath away. I had been expecting initial orders by transplant groups of one copy so that they could see how it was received. It was, after all, a bit of a gamble because there is no other book on organ and tissue donation that covers personal stories at every stage of the transplantation process.

But Howard was not the only one willing to back his judgment. Rob Linderer of Midwest Transplant Network bought a copy for the CEO of all the largest hospitals in his region. Seven hundred donor family members crowded the National Presbyterian Church in Washington for the annual donor ceremony and Washington Regional Transplant Community gave a copy to each family. When LifeGift Organ Donation Center opened its spanking new offices in Houston, books were given to legislators, key hospital personnel and volunteers.         

Apparently the books are having an effect. “Reading this book must surely encourage every reader to sign up as an organ donor,” Dr. Sue McDiarmid, Professor of Pediatrics and Surgery, David Geffen School of Medicine, UCLA, commented,  

OPOs across the country have been the spearhead of the sales drive, which at the time of writing has made the book for the seventh week in a row the #1 best seller of all 30,000 titles produced by AuthorHouse, the world’s largest self-publishing company.

I would like to take this opportunity to say how grateful I am for these initiatives and to hope that our combined efforts will help make a significant and lasting increase in donation rates.              

“The Gift that Heals” can be ordered at http://www.nicholasgreen.org/ or through major online booksellers.

A Ride Across America

An Organ Donation Guide for Faith Leaders and Health Care Professionals

UNOS has developed An Organ Donation Guide for Faith Leaders and Health Care Professionals to assist faith leaders, social workers and all categories of healthcare professionals in their service to families in crisis. 

We all appreciate how difficult it can be to work with families during the organ donation process.  This new resource will help to improve awareness of organ donation and transplantation issues for those professionals in the donor hospitals, such as hospital chaplains or social workers, who assist in the care of the donor, donor family and transplant candidate and recipient.  

Some topics addressed in An Organ Donation Guide for Faith Leaders and Health Care Professionals include:

·         Descriptions of the OPTN and UNOS

·         Referral and Donation Process

·         Defining Brain Death

·         Donation After Cardiac Death (DCD)

·         Living Donation

·         Role of the Faith Leader  

·         Theological Perspectives

·         Family Support

·         Cultural Awareness

You will want to make sure that every donor hospital in your service area has copies of An Organ Donation Guide for Faith Leaders and Health Care Professionals.  It’s a great resource to help promote National Donate Life Month and is currently available at http://store.unos.org.

Hospital & OPO Collaboration to Design & Implement New Condition T Protocol

Condition T Will Enable People to Donate Organs In the Emergency Department

Condition T is a rapid response protocol that enables organ donation from patients who have designated themselves to be an organ donor, and who die in the emergency department after failing resuscitative attempts. According to the Condition T protocol, after efforts to revive patients fail and the patient is determined to be dead by the caring physician, emergency department staff per routine notification contact the local organ procurement organization (OPO) to determine whether the patient has a donor designation on his or her driver’s license. If so, the Condition T is activated. A responder team is alerted and includes members who support the family and prepare the cadaver for organ recovery.

Currently, willing people – who have provided consent by registering or signing donor cards – fail to become donors because circumstances preclude the recovery and the patients die unexpectedly. Both real and perceived logistical, legal, ethical and attitudinal challenges contribute to the difficulty of enabling donation in these situations. The most glaring setting is the emergency department where nationally potential organ donors are lost and never evaluated for organ donation. This is a tragedy because, 1) it is wrong to deny an individual their wishes for end of life care, and 2) 17 potential recipients die everyday because an organ is not available for transplant.

To help address this gap in the care of dying patients, the Federal Government initiated a nationwide effort, known as the Organ Donation Breakthrough Collaborative. This effort challenges medical centers and hospitals to design ways to close this gap. As a result of this effort, through the Health Resources and Services Administration (HRSA), the 3-year Condition T grant was awarded in late 2007 to a unique collaboration which includes:

• UPMC Presbyterian Hospital

• The Center for Organ Recovery and Education (CORE)

• The Winter Institute for Simulation Education and Research (WISER)

• The University of Michigan Hospital and Heath Systems

• Gift of Life Michigan.

UPCOMING MEETINGS