People in the News - American Association of Tissue Banks

Vol. 29 No. 3 Oct 2006 1320 Old Chain Bridge Road, Suite 450, McLean VA 22101 Phone 703-827-9582 Fax 703-356-2198 www.aatb.org
30th Annual Meeting
Tops 700 Attendees
This year’s 30th Annual Meeting in San Diego,
California, September 9 – 12, 2006, toppled all
previous year’s attendance records with more than
700 attendees.
The meeting kicked off on Friday with the
Association’s golf event and a behind the scenes tour
of Sea World. Participants enjoyed an afternoon of
socializing with friends while also experiencing a few
of San Diego’s favorite sites.
The meeting began on Saturday morning with
committee and task force meetings and the CTBS
Examination. The afternoon was dedicated to
council sessions, which included information on
musculoskeletal tissue engineering; the benefits of
using human allografts to treat burn patients; social
issues that affect sperm banks; advances in cord
blood banking; issues associated with mesenchymal
cell phenotyping; and the Transplant Transmitted
Dieseases Sentinel Network.
On Sunday, AATB President, Dr. James Forsell
officially opened the meeting and presented the
Association’s three most prestigious awards. The
Jeanne C. Mowe Distinguished Service Award was
presented to Richard J. Kagan, M.D., FACS, for his
years of dedicated service and leadership to AATB
and to tissue banking. The George W. Hyatt
Memorial Award was presented to William Fisher
Enneking, M.D., recognizing him not only as an
accomplished surgeon, researcher and educator, but
also as a pioneer in developing limb-saving
treatments for bone cancers and as a leader in
allograft advancements. The Kenneth W. Sell
Memorial Award was presented to Jeanne V. Linden,
M.D., M.P.H., for her lifelong service to improve the
quality and safety of tissue transplants.
Donor mom, Lynne Spencer, and tissue recipient,
Rudy Reyes, were also honored.
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National Donor Sabbath and
Give Thanks, Give Life
Donate Life America’s External Communications
Committee (ECC) has assembled a number of various
resources to assist members in planning and
implementing local events around Donor Sabbath
(November 10-12) and the Give Thanks, Give Life
time period (mid-November to the end of the year).
They have created a special web page,
www.donatelife.net/gtgl.html for members to view
and download these resources.
The web page contains Donate Life and Give Thanks,
Give Life logos, a localizable press release, a sample
newsletter article, church bulletin announcements,
references to sacred text and hymns with a
donation/transplantation theme, Papal prayer cards
and much more. In addition, some members have
also included sample best practices related to Donor
Sabbath and Give Thanks, Give Life, which may be
replicated in your area.
CTS to Offer Academic Training
in Tissue Banking
Community Blood Center/Community Tissue
Services (CBC/CTS) and Sinclair Community
College, a Dayton, Ohio-based community college,
are partnering to create a Tissue Banking
Technologist Certificate Program, which will be a
first of its kind in the United States. The partnership
will capitalize on the existing strength of Sinclair’s
academic resources while incorporating CBC/CTS’
tissue banking knowledge.
The certificate program is designed to be completed
in three academic quarters and includes full clinical
rotations (during the 3rd quarter) at CBC/CTS. The
goal is to pilot the program locally for one year, then
offer an online alternative for remote employees of
(Continued on page 2)
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(Annual Meeting - Continued from page 1)
In addition to receiving his award, Dr. Enneking also
presented the third annual Jeanne C. Mowe Memorial
Lecture on the biologic mechanisms of human
allograft incorporation.
The afternoon resumed with the PPR Committee’s
Media Relations and Crisis Communications
Workshop. This session focused on how to build and
maintain relationships with local media
representatives and how to prepare for a crisis.
Those who did not attend the workshop were given
the opportunity to “Ask the Standards Committee”
about its rationale for updates that have been made as
a result of federal regulations, sentinel events,
industry practice, and other non-regulatory
influences. The day ended with a controversial
presentation by Dr. Arthur Matas who discussed the
arguments for and against a regulated system of
organ sales.
Monday was divided into four concurrent sessions:
Recovery, Processing and Regulatory, Reproductive,
and a Management Workshop. The Recovery Track
included information about the AATB accreditation
process; how to conduct audits of recovery agencies;
the legal and ethical considerations of the terms
“informed consent” and “donor authorization”;
clinical applications of various allografts; and
outcomes of the Ross Registry. The Processing and
Regulatory Track discussed steps to be taken to
validate radiation sterilization using VDmax;
rationale for testing tissue for tuberculosis; how to
conduct audits of external suppliers; and special
considerations for validating procedures used in
processing cryopreserved skin grafts and
cardiovascular tissue, and fresh osteoarticular grafts.
The Reproductive Track focused on FDA and AATB
Standards updates, and recent legal topics related to
reproductive tissues. Based on the success of the
Management Workshop held at the Spring Meeting,
the Program Committee invited Bob Trouteaud to
speak again at this year’s Annual Meeting. Working
with Jim Colyn, Mr. Trouteaud focused this
workshop on organizational quality.
The meeting concluded on Tuesday with updates on
the Uniform Anatomical Gift Act (UAGA), Donate
Life America’s new strategic plan, and FDA’s donor
eligibility guidance document and CGTP draft
guidance document.
(CTS - Continued from page 1)
CBC/CTS and others who are interested in a career in
tissue banking. Once the on-line program begins, the
plan is to include other CTS tissue banking locations
as clinical rotation sites.
The partnership’s governance structure and decisionmaking
process is best described as an equal
partnership that seeks to capitalize on the strengths of
both organizations. CBC/CTS has assumed the lead
on curriculum and clinical rotation content decisions,
while Sinclair leads decisions on instructional and
curriculum design.
CBC/CTS’ employees will also be eligible to
complete the academic program, and CBC/CTS
supervisors will serve as preceptors during clinical
rotations. In addition, external students completing
the program may serve as a recruiting pool for
CBC/CTS.
Sinclair Community College has an enrollment of
approximately 23,000 students and operates a main
campus in downtown Dayton and nearly three-dozen
Learning Centers and off-campus sites. Sinclair is
among the largest community college campuses in
America, boasting a remarkable faculty, staff, and
student body that exhibits quality as evidenced by
frequent national and state awards. Sinclair is also a
board member college of the League for Innovation
in the Community College.
For more information about the Tissue Banking
Technologist Certificate Program at Sinclair College,
please contact Susan Willin-Mulay, Chairperson of
Surgical Technology at 937-512-2850.
Thank You to
30th Annual Meeting Sponsors
Special thanks to AlloSource, bioMerieux, Inc.,
Chiron, Clearant, CryoLife, Inc., Freight Services,
Laboratories at Bonfils, LifeCell, LifeNet,
Regeneration Technologies, Inc., and Tissue Banks
International for their generous sponsorship and
support of the AATB 30th Annual Meeting.
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LifeNet and Gift of Life Michigan
Form Partnership
LifeNet has announced a strategic affiliation with
Gift of Life Michigan. The Gift of Life - LifeNet
partnership will enhance Michigan’s tissue donor
program benefited by new state legislation that
allows for tissue donation from non-hospital referrals
made through the state medical examiner system.
The anticipated increase in tissue donations will
provide an expanded biomedical allograft tissue
product line for Michigan surgeons and patients,
while providing medical examiners with advanced
services targeted at augmenting medical
investigations.
Under this alliance, Gift of Life Michigan will
continue to direct tissue recovery efforts in its service
areas in Michigan, and LifeNet will provide tissue
processing and distribution services at its new stateof-the-art
facility in Virginia Beach. This partnership
will make LifeNet’s allograft tissue products more
readily available to Michigan surgeons.
Richard Pietroski, Associate Executive Director of
Gift of Life Michigan, stated, “LifeNet is a nationally
recognized leader in tissue banking, but it’s their
commitment to donation and service to the local
community that makes the partnership a natural fit.
Our goal at Gift of Life Michigan is to safeguard the
community’s gifts of organs and tissue with
uncompromising quality and service. The LifeNet
partnership will strengthen our ability to fulfill our
mission to donor families and patients in Michigan.”
Rony Thomas, CEO of LifeNet, stated, “LifeNet is
very pleased to expand its tissue services in Michigan
by partnering with this strong community
organization. Our commitment is to return donor
tissue to the local community and this new
partnership will ensure that all surgeons and hospitals
will have priority access to LifeNet’s full line of
musculoskeletal and cardiovascular allograft tissue.”
People in the News
Sue Strauss has joined LifeCell as Manager of
Professional Relations. In this newly created role,
she will assist with all donation community and
Tissue Recovery Partner relations and
communications.
Rony Thomas, LifeNet’s recently appointed
President and Chief Executive Officer, has
announced several promotions, assignments, and staff
additions at LifeNet, the nation’s largest full-service
tissue banking system. Douglas Wilson has been
promoted to Executive Vice President of LifeNet.
Wilson will direct all aspects of marketing, business
development, corporate public relations, legal
matters, and medical communications. Wilson had
been Vice President of Marketing and New Business.
L. Chester Brazzell has been promoted to Vice
President, Human Resources. Brazzell will direct
and oversee all aspects of human resources,
recruitment, benefits, and professional staff
development for the company. Brazzell had been the
director of the human resources department. Kevin
Myer has been promoted to Vice President. In
addition to his duties as Executive Director of the
LifeNet Organ Procurement Organization, Myer will
assist with corporate strategies and innovations
pertaining to organ and tissue recovery throughout
the state of Virginia. Robin Cowherd has been
promoted to Director of Donor Family Services for
LifeNet. Cowherd will direct all aspects of LifeNet’s
Donor Family Services. Cowherd had served as
manager of that group. Michael Plew joins LifeNet
as Vice President of Quality and Regulatory
Compliance. In this role Plew will direct and manage
all aspects of Quality and Compliance. Gordon
Berkstresser joins LifeNet as Chief Financial
Officer. Berkstresser joins LifeNet from RTI
International Metals where he was Vice President and
Controller. John St. John is appointed to the newly
created position of Vice President, International. St.
John will direct LifeNet’s strategic plan for the global
development of LifeNet’s allograft markets and
technology. Michael Bergevin, M.D., has been
promoted to Medical Director for LifeNet’s Tissue
Servcies, and will direct the medical review and
quality process for all of LifeNet’s allograft tissue
biomedical implants. Dr. Bergevin had been
associate medical director for several years.
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Banks Re-Accredited
Legacy of Life, Inc., San Antonio, Texas
Retrieval of Skin, Cardiac, Vascular, and
Musculoskeletal Tissue.
LifeShare Transplant Donor Services of
Oklahoma, Oklahoma City, Oklahoma
Retrieval and Storage of Skin and Musculoskeletal
Tissue, and Retrieval of Cardiac and Vascular Tissue
for Transplantation and Research.
NuMed Technologies, Inc., Tulsa, Oklahoma
Storage and Distribution of Musculoskeletal Tissue
as a Tissue Distribution Intermediary.
Regeneration Technologies, Inc., Alachua, Florida
Processing, Storage, and Distribution of
Musculoskeletal Tissue for Transplantation and
Research.
Upcoming AATB Meetings
2007
11th Annual Spring Meeting
Sunday, March 25 – Tuesday, March 27, 2007
(pre-meeting events on Saturday, March 24th)
Renaissance Hollywood Hotel
www.renaissancehollywood.com
2007 CTBS Training and Review Course
Thursday, May 3 – Sunday, May 6, 2007
Hilton Arlington Hotel
www.hiltonarlington.com
31st Annual Meeting
Saturday, September 15 –
Tuesday, September 18, 2007
Boston Marriott Copley Place
www.marriott.com
New Bank Accredited
LifeSource, St. Paul, Minnesota
Retrieval of Skin, Cardiac, Vascular and
Musculoskeletal Tissue.
AATB Bulletins Issued
The following AATB Bulletins were issued between
August 3 and October 10, 2006:
06-53 Government Affairs Survey
06-54 MMWR Reports of Chagas Disease
Transmission from Organ Transplantation
06-55 Recent FDA Publication of Interest
06-56 Special Oversight Task Force, Initial Report
and Recommendations
06-57 FDA Order to “Donor Referral Services” to
Cease Manufacturing and Retain HCT/Ps
06-58 FDA Announces Creation of New “Human
Tissue Task Force”
06-59 FDA Issues Public Health Notification
Regarding the Investigation of “Donor
Referral Services”
06-60 Statement on FDA Investigation of Donor
Referral Services
06-61 FDA Withdraws Final Rule on Blood Vessels
06-62 Recent FDA Publications of Interest
Regarding Manufacturing Arrangements
06-63 Call for Multicultural Empowering
Testimonials
06-64 Recent FDA Publication – Guidance for
Industry and FDA Staff: Minimal
Manipulation of Structural Tissue
Jurisdictional Update
06-65 Third Annual Conference: FDA and the
Changing Paradigm for HCT/P Regulation -
Limited Complimentary Registrations
Available
06-66 Survey of Accredited Tissue Banks
QA Workshop IX
Thursday, November 15 –
Saturday, November 17, 2007
Walt Disney World Swan and Dolphin
www.swandolpinmeetings.com
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Employment Opportunities
Director, Tissue Operations
Osiris Therapeutics, Inc., Baltimore, Maryland
Osiris Therapeutics, Inc. is seeking a qualified
candidate to lead all operational aspects of a GTP
manufacturing facility. Applicants must have a
Bachelor’s or Master’s degree in a scientific or
engineering discipline, and possess 7-10 years
experience in medical device operations and/or tissue
processing. This position requires a minimum of 5-7
years supervisory experience in GTP or GMP
development-phase production or commercial
manufacturing. Familiarity with regulatory standards
and guidances applicable to biopharmaceutical
manufacturing is preferred.
Osiris is a leading stem cell therapeutic company
focused on developing and marketing products to
treat medical conditions in the inflammatory,
orthopedic and cardiovascular areas. Osiris is a fully
integrated company, having developed stem cell
capabilities in research and development,
manufacturing, marketing and distribution.
Please e-mail resume to: hr@osiris.com or fax: 410-
522-5519. EOE.
Triage Coordinator (TC)
Donor Network of Arizona, Phoenix, Arizona
This full-time, non-exempt position is responsible for
(but not limited to) screening and triage of potential
eye and tissue donors, obtaining consent and MSHQ
from legal NOK, and coordination of the donor
recovery with the recovery team, hospital, Medical
Examiner, and other agencies. The TC also ensures
that all donor-related activity on the assigned shift is
conducted in a thorough, accurate, and professional
manner. Minimum education: CTBS, CEBT, or
Bachelor’s degree. Minimum experience: two years
in donor screening (to include obtaining consent and
MSHQ), tissue recovery, or a combination of both.
Must have strong communication and organizational
skills as well as a working knowledge of word
processing, spreadsheets, and database applications.
Please forward a resume and cover letter to Human
Resources, ATTN: Diane Ferguson, e-mail:
diane@dnaz.org or fax: 602-222-2202.
Tissue Bank Manager
Osiris Therapeutics, Inc., Baltimore, Maryland
Osiris is seeking qualified candidates for a Tissue
Bank Manager position. Applicants must have a
Bachelor’s degree in a scientific discipline and a
minimum of five years experience in tissue or blood
banking. Candidates need to have detailed
knowledge in human tissue (21CFR1271) or blood
product (21CFR600) regulatory affairs and quality
assurance and experience in the following functions:
donor eligibility review, document preparation and
control, report preparation and archiving, and quality
systems auditing. Knowledge of AATB and/or
American Association of Blood Banks (AABB)
Standards with CTBS/SBB preferred.
Osiris is a leading stem cell therapeutic company
focused on developing and marketing products to
treat medical conditions in the inflammatory,
orthopedic and cardiovascular areas. Osiris is a fully
integrated company, having developed stem cell
capabilities in research and development,
manufacturing, marketing and distribution.
Please e-mail resume to: hr@osiris.com or fax: 410-
522-5519. EOE.
Tissue Recovery Coordinator (TRC)
Donor Network of Arizona, Phoenix, Arizona
This full-time, non-exempt position is responsible for
(but not limited to) screening, medical record chart
review, coordination of the donor recovery, supplies
and laboratory cleaning. The TRC ensures that all
donor recovery activity on an assigned shift is
conducted in a thorough, accurate, and professional
manner. Minimum education: HS diploma or
equivalent. Bachelor’s Degree in Health Science or
CTBS preferred. Minimum experience: two years in
tissue recovery. Must have strong communication
and organizational skills.
Please forward a resume and cover letter to Human
Resources, ATTN: Diane Ferguson, e-mail:
diane@dnaz.org or fax: 602-222-2202.
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Supervisor/Coordinator Openings
Community Tissue Services, Toledo, Ohio,
and Fort Worth, Texas
Community Tissue Services of Toledo, Ohio, is now
accepting applications for a Supervisor and
Coordinator. Our Fort Worth, Texas, location has a
Supervisor opportunity. Applicants with a
background in tissue banking, surgical technology,
operating room and/or laboratory experience are
encouraged to apply.
Supervisor assists Director with daily operations by
performing quality control, record maintenance, and
technical training; also functions as a coordinator by
procuring bone and tissue. Bachelor’s degree
required; health related field preferable. Must
possess management experience, knowledge of gross
anatomy and sterile techniques with 1-3 years
procurement and/or processing experience. Requires
CTBS by 2007. Requires heavy lifting. Superior
communication skills are essential.
The Coordinator works with appropriate hospital
staff to meet tissue donation needs. Educates
professionals and public about tissue donation by inservice
presentations and hospital visits. Prefer
Bachelor’s degree and 2-3 years tissue banking or
operating room experience. High School Diploma or
GED required with valid drivers license and
insurability with our insurance carrier, on-call hours
and heavy lifting.
We offer an outstanding benefits package, including
medical, dental, as well as tuition assistance and 401k
with company match and up to 4 weeks of Paid Time
Off (PTO).
Send resume to: HR/CTS SUPR/COOR, Community
Tissue Services, 349 South Main Street, Dayton, OH
45402, or e-mail cbccts-t@cbccts.org. EOE/Drug-
Free Workplace. No phone calls, please.
Tissue Bank Coordinator
Lake Superior Centre for Regenerative Medicine,
Thunder Bay, Ontario, Canada
The Lake Superior Centre for Regenerative Medicine
is seeking a self-starter who will act as the
coordinator for a new Tissue Bank in Thunder Bay,
Ontario, Canada. This individual must have a
Bachelor’s degree in nursing, medical laboratory
technology, pathology, or in one of the life sciences,
or a combination of formal training and work
experience. The successful candidate must have a
minimum of two years’ experience in the health care
industry, preferably in a hospital setting. Working
experience with aseptic technique in a medical or
laboratory environment is considered an asset, as is
past experience in a research setting and writing
business plans.
This person must demonstrate superior organization
and project management skills and be willing to
obtain Certified Tissue Banking Specialist (CTBS)
training through the AATB. The individual must be
able to work flexible hours, possess excellent written
and verbal communication skills, and be willing to
engage in public speaking and education
opportunities.
The successful candidate will coordinate the
establishment of the tissue bank and will work with
the Board of Directors, the Medical Director and the
Thunder Bay Regional Health Sciences Centre.
To apply, please provide a cover letter, resume and
three references to: Judy Sander, President of the
Board of Directors, Lake Superior Centre for
Regenerative Medicine, Inc., 1294 Balmoral Street,
Thunder Bay, Ontario, Canada P7B 5Z5.
Applications will also be accepted via e-mail at
judy@notc.on.ca.
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Vice President Client Services
Science Care, Phoenix, Arizona
Science Care is an accredited non-transplant tissue
bank providing medical training facilities and
support.
The Vice President of Client Services will manage
medical training facilities growth and the
development of business relationships. This position
will report to the Vice President and COO. Direct
reports include the National Account Manager,
Customer Service Manager and Event Managers.
The successful candidate will oversee the growth of
our Arizona training facility, the development of
regional training facilities, and the direction of sales,
customer service and event support teams.
Responsibilities include staffing, facility
development, strategic planning, client relationships,
and operations.
The successful candidate will have a proven track
record of outstanding performance in operations
management.
We seek a person who is committed to helping others
while building long term relationships with service,
quality and respect in a team environment.
Please e-mail resume to James Rogers:
james.rogers@sciencecare.com or call: 602-288-
0036. www.sciencecare.com
Quality Control Laboratory Manager
Osteotech, Inc., Eatontown, New Jersey
Lab Manager will oversee microbiology, chemistry,
and the isolator; perform biological and chemical
evaluation of product for release; conduct
investigations and studies; evaluate and develop
employees; handle method and test development of
validation protocols; implement process
improvements. Requirements include Bachelor’s in
Lab Science, Microbiology or Chemistry; minimum 7
years experience; knowledge of field concepts,
practices/procedures; excellent judgment; ability to
work well under pressure; must take initiative and be
assertive and a strong communicator, both written
and verbal. Please e-mail resume to:
jlaino@osteotech.com or fax: 732-578-6684.
Director of Marketing and Community Relations
Science Care, Phoenix, Arizona
Science Care is an accredited non-transplant tissue
bank providing medical research and training.
We are looking for a sharp marketing and community
relations specialist. This exciting position will be
based out of our Phoenix, Arizona, offices and is a
direct report to the COO.
This position involves donor marketing, public and
community relations and the development and
management of strategies to increase community
awareness and raise the donor rate locally and
nationally for our Phoenix and Denver programs.
Requirements: 5+ years experience in marketing,
public and community relations in health care, blood,
organ or tissue donation; experience developing and
executing a strategic marketing plan; experience
managing a budget; outgoing personality and
excellent communications skills; creative and detail
oriented; positive “can-do” attitude.
We offer competitive compensation with full benefits
plus relocation.
Please e-mail resume to James Rogers:
james.rogers@sciencecare.com or call: 602-288-
0036. www.sciencecare.com
Education Coordinator
Central Florida Tissue & Eye Bank (CFTEB),
Orlando, Florida
CFTEB is accepting applications for an Education
Coordinator. The ideal candidate will possess RN
Licensure and have previous tissue banking
experience. CTBS certification is a plus. Candidate
will be responsible for providing educational
programs for staff and health care professionals,
coordinating training programs and will assist in
policy and procedure development/implementation.
CFTEB offers an exemplary benefits package and the
Central Florida area has many amenities to offer. To
apply, please forward a resume, cover letter, salary
requirements and references to:
lmoore@tissuebank.org.
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Children Journey to the Healing Garden:
A New Place in Cyberspace for “The Forgotten Mourners”
by Robin L. Cowherd
Director of LifeNet Donor Family Services
Our culture tends to avoid the important issues associated with the death of loved ones. Even more ignored are
the children, either because people don’t know how to work with them or they are paralyzed by their own loss.
Children are known as “the forgotten mourners” because they may not express their grief in the same way as
adults, or they may appear to be coping by adults who are often wrapped up in their own grief or who may
overlook a child’s hidden pain.
In response to a need for more child bereavement services and information, LifeNet recently launched the
Healing Garden at its annual In Celebration and Remembrance event held at the Chesapeake Conference Center
in Virginia.
The Healing Garden can be found online at www.healingthespirit.org, a web site developed and maintained by
LifeNet to provide information and support for organ and tissue donor families, and for anyone experiencing the
loss of a loved one. The Healing Garden can also be found on the grief resources web page
www.goodgriefresources.com under support groups for children.
In the Healing Garden, loss lessons are revealed with each bloom. The loss lessons help children understand
why their loved one lived, and shape the way they live their own lives in a positive way. There are also
opportunities to play in the Garden, an important aspect of learning for children. The Adult Companion Page
helps parents, educators, social workers, ministers and others to better understand grieving children, and directs
them to other resources.
Interactive activity allows children to deal with their grief and loss through creative expression and companion
interaction. Select from seed packs labeled to represent your feelings about your loved one, such as Honesty,
Caring, Love, Friendship and Happiness. Or you may label your own feelings by selecting an unnamed
wildflower seed pack.
“Not all feelings are good,” says Diana Veazey, a LifeNet Donor Family Advocate. “Both sunshine and rain
are needed to make your way through your garden of memories. The Healing Garden provides a safe place to
remember, engaging the heart in healing, and using technology to empower children on their healing journey.”
Plant the seeds and watch them bloom. Decorate your garden, name it in honor of your loved one, and then
print it out in color or black-and-white as a coloring sheet. Or e-mail your garden memorial to a friend or
relative.
When prompted to select their seed packs during a recent demonstration, one family chose Happiness and
Friendship to represent their beloved Grandfather. Through laughter and tears, the family used their time in the
Garden to recall the significance of their loved one’s life, and to draw conclusions for their own lives. The
Healing Garden provided a platform that allowed the children to tend to their loved one’s memories.
For generations, humans have reaped the rewards of gardening. Now children who are grieving and their adult
companions can discover the meditative benefits of gardening in a virtual setting.
Anyone can access The Healing Garden by going to LifeNet’s bereavement support website at
www.healingthespirit.org, and clicking on The Healing Garden icon, or call 1-800-847-7831 for more
information.
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