FDA
Seminar Updates
By Wendy D. Latash, Ph.D.
Last
month at the 2005 ASRM & CFAS conjoint meeting,
the FDA rulings were a very hot topic. It seems
that there is still a lot of confusion concerning
how to implement the regulations, and more importantly,
what to expect in the future. Much of the new
FDA information will be addressed at The Donor
Source International’s FDA Seminars, which
will be held in Long Beach, CA on November 9th,
and in San Francisco on November 10th. This article
will cover a few seminar highlights.
Donor
Eligibility:
There are numerous situations in which the FDA
requires a donor eligibility determination. It
is
important to understand when the regulations
apply, and what constitutes an exception.
The five most important
factors to consider are:
- Is this is an anonymous or directed (known)
donor situation?
- Which tissue(s) is (are) being donated and
from whom?
- Is the donor(s) determined to be “eligible”
or “ineligible”?
- Would the intended parents ever consider
donating their embryos in the future?
- Who is the recipient?
This
information is vital to handling most donor situations.
Remember:
The FDA now has a fully trained team of inspectors
who are out in force. The FDA can and
will come at anytime without notice to
enforce these rulings, and it has the legal authority
to enforce the regulations with severe consequences
such as:
Imprisonment
for up to 1 year, and/or fines of up to $250,000
if a death has resulted, or $100,000 — per
violation, if a death has not occurred.
A nurse whose clinic is currently being inspected,
stated that the inspector “is being very
thorough and reading everything.” An inspector
has stated that she spent eight weeks inspecting
one fertility clinic.
Mandatory
FDA compliance is a reality we all have to face,
and should be prepared for. In an effort to become
compliant with new regulations, establishments
tend to spend most of their time creating and
refining their standard operating procedures (SOPs).
Unfortunately, that is only about 50% of the battle.
The difficult part is applying those SOPs to the
fertility practice i.e., training personnel, conducting
internal/external audits, and preparing for an
FDA inspection. An SOP is only as good as the
employees that follow it—especially under
the pressure of an inspection.
One
of the most difficult tasks for the fertility
field is to figure out how to prepare for an FDA
inspection, what to do, and what NOT to do. What
does the FDA have the authority to do? Inspection
preparation is everything, from training
front-desk personnel on what to do when an inspector
walks through the door, knowing how to answer
specific questions, knowing what the FDA is allowed
to see, and what to do when deficiencies are found.
Preparing for inspections is an ongoing process
that encompasses performing regular audits to
determine any corrective actions that need to
be taken, creating and refining an SOP on how
to deal with an FDA inspection, training all personnel
on what to do and what NOT to do during an inspection,
and also performing a mock inspection in your
establishment to see how well your personnel are
trained.
Training:
One of the areas that the FDA has expressed increasing
concern over (and not just in the fertility field),
is documentation of employee training for performing
designated job-related tasks, and evidence of
training effectiveness. Since the fertility field
is very specialized, personnel receive much of
their education through on-the-job training. As
we know, this can vary widely from practice to
practice. When applying this to the donor eligibility
part of the regulations, it becomes even more
specialized. More experienced personnel are required,
due to the intensive screening, matching, and
cycle synching processes that are necessary. More
than likely, the FDA will eventually want to see
how a fertility establishment proves their personnel
are trained.
Wendy
D. Latash, Ph.D.
Jade Tree Solutions, LLC
www.jadetreesolutions.com
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Wendy
Latash, PhD: A Brief Bio
Dr. Latash is Director
of Advisory Services and partner of Jade Tree
Solutions, LLC based in Chicago, IL.
Dr. Latash holds a PhD in Biological Chemistry
from the University of Michigan; she is an active
member of ASRM, ESHRE, AATB, and ASBMB; she has
also published multiple articles.
Dr. Latash has extensive experience in the fertility
field from both the pharmaceutical and clinical
perspective. She has worked for Organon Pharmaceuticals
as a Medical Liaison in the Medical Affairs department,
assisting clinical staff in fertility practices
with their educational and clinical study needs.
She developed and presented numerous seminars
on many different academic and clinical topics
of fertility, as well as assisted fertility practices
in all aspects of clinical study, development,
and implementation.
Her direct clinical and business experience in
a fertility practice stems from serving as Vice
President of Clinical Services and Director of
Research for Karande & Associates, which is
a multiple physician fertility practice located
throughout the Chicago area. She was responsible
for overseeing the clinical departments operations
including: staff training, quality assurance,
and patient satisfaction. She managed all clinical
research studies for the practice while also acting
as the practice liaison.
About Fertility + FDA Experience:
Since no outside company has had direct experience
with how the FDA regulations specifically affect
the fertility field, Wendy and her partners enlisted
the assistance of leading FDA consultants in the
field to answer these questions, and support fertility
practices in this new era of fertility regulation.
They have combined fertility experience with FDA
experience to provide those necessary services
that are needed, and also serve as an independent
primary source for questions regarding the FDA
fertility regulations.
About
Jade Tree Solutions:
Jade Tree Solutions is a consulting company specifically
focused on the fertility field. Jade Tree Solutions
offers design and the implementation of customized
FDA compliance systems, such as SOP development,
clinical training, and quality assurance. Additionally,
they offer mock FDA inspections and FDA inspection
readiness training/assistance for responding to
FDA warning letters. Non-FDA related services
are also offered such as: clinical study development,
educational training, and publication assistance.
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A Resource Guide For Future Parents:
Talking To Your Children
By
Gail Sexton Anderson
 For
children, learning how they came to be part of a family is
an exciting adventure that they love to hear over and over,
regardless of how a family was created. If you are comfortable
with how you are creating your family, your child will be
too. Your child is an outgrowth of the love you and your partner
have for each other.
In this day and age, adopted children are usually told early
on how they became part of a family. Parents share the great
joy they experienced since welcoming the child into the family,
and they are advised to tell their child’s story in
a positive light.
On the other hand, because of the stigma sometimes associated
with male infertility, families have often remained silent.
In recent years, research has shown the damaging effects silence
has caused in families who have conceived through sperm donation.
The book Lethal Secrets, by Annette Baran,i
is an excellent example with many vignettes of children conceived
through sperm donation. They were never told until they were
either much older or discovered it by a harsh accident. It
can be devastating to discover that the ones you love and
trust most have chosen to be silent concerning such an important
issue. When third-party reproduction (specifically egg donation)
is involved, it is better for a child to hear the story from
their parents, rather than by accident or through another
source.
In conclusion, we can learn a lot about the advantages of
open communication by looking at the problems silence has
caused in both adoption, and sperm donation in years past.
Mary Watkins authored Talking With Young Children About
Adoptionii, which addresses issues you and
your partner may be facing, as well as addressing some tough
questions that involve egg donation and third-party reproduction.
Flight of the Storkiii by Anne Bernstein
is another helpful book that can be advantageous. Elaine Gordon
has written an excellent book for talking to any child about
reproductive issues, which is titled, “Mommy Did
I Grow In Your Tummy” iv. This is a
good tool for parents, no matter how they choose to build
their family. Another great resource, is a series of books
published by X, Y, and Me. Like Elaine Gordon’s book,
these are also geared toward children with a separate book
for each reproductive choice. Most of the books referred to
in this article can be ordered from a bookstore, or through
your local Resolve Chapter.
iBaran,
Annette, Reuben Pannor. Lethal Secrets: The Shocking Consequences
and Problems of Artificial Insemination. New York: Dodd
Mead, 1989. (Out of print, may be available used)
iiWatkins,
Mary. Talking To Your Child About Adoption. New Haven:
Yale University Press, 1995.
iiiBernstein,
Anne. Flight of the Stork. Indianapolis: Perspectives
Press, 1994.
ivGordon,
Elaine. Mommy Did I Grow In Your Tummy. Santa Monica:
EM Greenberg Press, Inc., 1992.
Gail
Sexton Anderson
The Donor Source
www.thedonorsource.com
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