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Volume 1 Issue 1 June 2005

Welcome to the inaugural
issue of The Source


We hope you will enjoy our monthly e-newsletter. The Source has been designed to keep you and your patients informed regarding updates and improvements to our donor program. Each month you will be able to immediately access new donor profiles, repeat donor profiles and donors by ethnicity. We will keep you up to date with tips and information for you and your patients. Our inaugural issue is dedicated to you, our valued clinicians.

If you would like to receive The Source
monthly, please click on the "subscribe" button to the right. If you have any patients who might be interested in receiving The Source please check the “forward to a friend" button to the right.

Gail Anderson
The Donor Source

www.thedonorsource.com

New FDA Regulations

The new FDA regulations
have given all of us in the fertility industry a lot to consider in relation to our own compliance. The Donor Source has been working with Wendy Latash, PhD of Jade Tree Solutions, a consulting firm for the fertility field that offers FDA compliance assistance, to help us answer the question, “How do the new FDA regulations affect us?” The answer depends on who you are. This article is the first of an on going series on the new FDA regulations and how they affect different players in the fertility field.

Interesting times. With all the debates and changes going on concerning embryonic stem cell research, embryo donation/adoption and the new FDA regulations, nobody can say that the fertility field is boring! Now that the new FDA regulations have gone into effect (May 25th, 2005), we have to determine how best to incorporate these regulations into everyday practice. Fortunately, the day before the ruling took effect, the FDA came out with welcome “11th hour” FDA changes of:

•  Expansion of the window of screening and testing for oocyte donors from 7 to 30 days;

For couples who want to consider donating their embryos AFTER their IVF cycle and have not undergone the 30-day window screening and testing, they now have the opportunity to donate with less strict provisions; and

An admission that labeling the actual vials and straws containing reproductive tissues with the numerous required warnings is impossible, and directions that the required labeling can be listed on the accompanying records.


The new FDA regulations
affecting the fertility field are a part of the ruling that regulates organ and tissue donor banks. The purpose of these FDA regulations is to help prevent the spread of infectious disease through tissue donation. The concern over tissue safety has finally resulted in the FDA publishing the ruling “Title 21 CFR Part 1271: Human Cells, Tissues, and Cellular & Tissue-Based Products.” This ruling has been added to others that went into effect over the past 12 years as an approach to regulate human tissue to try to ensure safety. Reproductive tissue came into the limelight over concern about the safety of donated semen in the early 1990s. Now all reproductive tissue—eggs, sperm, embryos, ovarian and testicular tissue—are subject to a portion of the Human Cell, Tissues, and Cellular & Tissue-Based Products (or HCT/Ps) ruling.

To enforce these new rulings, the FDA states that they can visit fertility practices announced or unannounced to inspect whether the practice is adhering to its rulings. They have also established the legal authority to enforce these regulations with consequences such as:

•  Imprisonment for up to 1 year; and/or

Fines of $100,000 if a death has not occurred or up to $250,000 if a death has resulted—per violation.

After all is said and done, this ruling comes down to four things: documentation of policies and procedures, following policies and procedures, reviewing procedures on a regular basis, and taking corrective action when problems are found.

Tune in to our next issue for...
A Breakdown of the FDA ruling

Wendy D. Latash, Ph.D.
Jade Tree Solutions, LLC

www.jadetreesolutions.com

Our best advice on
choosing a donor?


Our advice to intended parents… go with your heart. Most intended parents have in mind the qualities and characteristics they value most in a donor. They often are trying to find someone who looks just like the intended mother.

We encourage them to keep an open mind and to look for someone they really like, not a twin, but someone they are drawn to, who they feel they can relate to and who will fit into their family. We have found that most couples are happiest with their donor when they feel a connection to her.

Gail Anderson
The Donor Source

www.thedonorsource.com

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  Current Database Info
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Total Active Donors 267
New Donors 18
Repeat Donors 51
Asian Donors 33
Black Donors 13
East Indian Donors 4
Hispanic Donors 43
Jewish Donors 5
Middle Eastern Donors 10
White Donors 202
 

 
"Thank you for all your assistance with this process. I'm so glad that I found The Donor Source on the internet. What a blessing you all are!"

- D.R., Intended Parent

 
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Contact Information

Director of Business Development:
Gail Sexton Anderson

Administrative Office
4675 MacArthur Court. Suite 490
Newport Beach, CA 92660
Phone: 877.375.8888
Fax: 877.835.2401

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PMB 4054
800 Bellevue Way NE #400
Bellevue, WA 98004
Phone/Fax: 888.668.0744

email: info@TheDonorSource.com

Director of Case Management:
Catherine Pateman
877.375.8888 ext 304
Out of State Matches except Northwest

Case Managers:
Heather Zimmerman
877.375.8888 ext 303
Los Angeles and San Francisco

Kathy Jarvis
877.375.8888 ext 301
Orange County and San Diego

Jennifer Hobodides
888.668.0744
Northwest Region

Copyright ©2005 The Donor Source. All Rights Reserved. 
Subscriptions are FREE. While Fertility SOURCE Companies staff use their best efforts in collecting and preparing the information published herein, Fertility SOURCE Companies does not assume, and hereby disclaims, any liability for any loss or damage caused by using the contents of this newsletter, or from any errors or omissions, whether such errors or omissions resulted from negligence, accident or other causes. You may freely distribute Fertility SOURCE Companies "The SOURCE" material, as long as it bears the following attribution: Source: Fertility SOURCE Companies http://www.fertilitySOURCEcompanies.com. Fertility SOURCE Companies is published by The Donor SOURCE International, LLC. Material referenced by URL is the copyright of the respective owner.
 
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