From Us to You
Lab Mix-ups and PFC's Approach

As there has recently been extensive media coverage of an ongoing child custody case resulting from a mix-up of embryos transferred by another Bay area IVF Center, we want to convey to our readers just how serious we consider this matter. Recognizing the devastating consequences of such an embryo mistake, many years ago we developed and put in place a system of patient-embryo recognition we call Pacific Fertility Center's SurTransferSM protocol. To help dispel any unwarranted fears surrounding your IVF cycle, we are presenting in this issue a detailed explanation of this important system of multiple checkpoints and special procedures for ensuring proper recognition of all reproductive materials.
All of us who work in the field of assisted reproduction recognize the potential for human error. We feel very fortunate at Pacific Fertility Center to have never had a known case of mistaken identity and gamete or embryo mix-up in our In Vitro Fertilization program. However, we continually look for new and better ways to ensure these errors never will occur. Please know if ever there should be any mishaps with eggs, sperm or embryos, we are committed to immediate, complete and total forthrightness and honesty with our patients.
We find it reassuring there have been over 100,000 babies born in the U.S. with the help of IVF since the first birth in 1979 and instances of embryo or gamete mix-up are extremely rare. At Pacific Fertility Center we plan to maintain our positive track record through the continued use of our proven SurTransferSM protocol. Our fertility team strongly believes that, along with providing safe and successful infertility care, maintaining correct laboratory procedures is an equally important responsibility.
Sincerely,
Joe Conaghan, PhD, Philip Chenette, MD, Carolyn Givens, MD,
Carl Herbert, MD, Isabelle Ryan, MD, Eldon Schriock, MD
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Conception Health
The Law and ART

Law Tries to Keep Up with ART: A spate of judicial decisions here in California has family law attorneys paying close attention to a handful of unique conflicts, or "gray zones" made in some way possible by Assisted Reproductive Technologies (ART). As the definition of "family" expands more broadly, thanks to ART, new laws are actually being forged. Couples that don't fit the rubric of a traditional family (heterosexual man + woman = marriage) are being asked to make sure they have all of their legal ducks in a row.
A few California cases are summarized here, including at least one that may reach the state Supreme Court.
Lesbian Parents and Child Support: This complex case involves two lesbian partners, not registered as domestic partners, who jointly agreed to have children using the same sperm donor. Both women conceived, one year apart, and one of the infants was born with Down syndrome, prompting one of the women to remain at home as the care-giver. Two years later, the two women separated and the primary caregiver began receiving monthly child support payments from the woman who worked. When the child support provider halted payments after 18 months, county social workers attempted to tap her wages, a standard to which a biological father would have been held.
Although a Superior court judge agreed with the county that child support payments should continue because the woman showed initial "intent" to raise the children, this past May the Court of Appeal in Sacramento reversed that decision to the dismay of gay rights legal activists. This decision is particularly disturbing, asserts Deborah Wald, a San Francisco attorney who specializes in non-traditional family law. "Children of same-sex couples do not have the same rights compared to children that have two parents of opposite sex; this is a shocking ruling and one that we are confident that the state Supreme Court will overturn," she said. Posthumous Conception: Many are anxiously watching a case that is pending final decision by the Los Angeles federal court. A wife had medical personnel extract her husband's sperm for freezing after his unexpected death. This was not contested. Four years later, after she conceived a daughter with his sperm, the mother sought Social Security survivor benefits. Although she didn't seek inheritance or life insurance claims, the outcome of this case is expected to have implications in these other areas.
The Social Security Administration denied the benefits, insisting that the deceased dad is not recognized as the father under California law. The SSA follows specific state guidelines in resolving such issues, and has granted posthumous benefits in other states. But California has no
laws governing children conceived after the death of a parent. This case has simultaneously prompted the state Legislature to craft AB 1910, which is enjoying broad support. This bill establishes that a posthumously conceived child is entitled to inheritance rights and other benefits under the Uniform Parentage Act if the decedent intended his or her genetic material to be used for posthumous conception of the child and expressed it in writing. It is expected to be signed by the Governor in September. Copies can be found at www.assembly.ca.gov .
Lesbian Parents and Custody: A woman who provided the donor eggs for her female partner, enabling the partner to conceive twins, signed away her parental rights per a standard egg donor contract used by a Bay Area infertility clinic seven years ago. Nevertheless, the two women spent the next six years living together and raising the children. As the egg donor started pressuring the gestational mother about being identified as a legal co-parent, their relationship fell apart, and the gestational mother moved across country with the twins, eventually cutting off all contact between the children and the egg donor.
A California Court of Appeals ruling affirmed the gestational mother's hold on primary custody, saying its decision is based on the "intent" contract signed by the egg donor, which absolved her of all parental rights and future claims. The biological mother has appealed, the case has received a flurry of press, and the case may end up at the First District Court of Appeal in 2005.
-- Carolyn Givens, MD
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Ask the Experts
Lab Mix-ups and PFC's SurTransfer SM

Q. How can I be sure that PFC will not accidentally confuse my eggs and my husband's sperm and our embryos with someone else's?
A. PFC recognizes that even with the best intentions, human error can occur.
We've therefore designed our strict SurTransferSM laboratory security system of color-coding and clearly labeling all specimens and verbally identifying all patients. We have also devoted considerable time and effort into assembling one of the most highly trained teams in the country. Each of our Embryologists is Board Certified and Licensed, even though the State of California does not currently require licensure for Embryologists.
When a patient is scheduled for a procedure,

a written procedure requisition is sent by the Physician to the laboratory staff, giving them at least 24hour notice and clear instructions on what is to be done. Each patient is assigned a specific color for their test tubes and Petri dishes; no two patients having procedures on the same day will be assigned the same color. Each of the patient's specimens is carefully labeled with clear and unique identifying information that includes the patient's name and date of birth.
During their stay in the lab, eggs, sperm and embryos are kept in incubators. We avoid assigning two cases to a single incubator on the same day. Each incubator has an exterior door and an interior door. Both doors are clearly labeled with name and color code. This labeling protocol allows the embryologist to verify the name twice before ever handling the specimen.
We have two embryologists performing all critical procedures to ensure accuracy; generally one handles the material while the other observes and verifies. We are not required to assign two people to procedures, but redundancy eliminates the possibility of an error.
Both embryologists sign off after checking the paperwork, labeling the specimen and performing the procedure.

Accepting sperm samples: When a man delivers his sample, we require it to be labeled with his unique information, including name, birth date and signature. We ask to see identification. The embryologist receiving the sample will sign that s/he received it and note the time and date of receipt. If s/he passes the sample to another member of staff, that individual will sign for it, thus continuing a chain of responsible custody.
Egg retrieval: A patient undergoing egg retrieval is asked in the retrieval room to identify herself before receiving sedating drugs. The embryologist will not rely on the physician, nor state the patient's name and ask for a "yes or no" answer, but will instead ask her to state her full name. This avoids any possible miscommunication. As the procedure gets underway, two embryologists will take responsibility for accepting the collected eggs.
Inseminating eggs: This is arguably the most important part of the IVF procedure. While it is a relatively simple procedure to perform, we are sensitive to its significance. Without any exceptions, two embryologists perform the insemination. Even if there is only one egg to inseminate, or even if there is only one insemination on a given day, two people do it.
Embryo transfer: Similar to the retrieval procedure, one embryologist will ask the patient her name and a second embryologist will witness and verify that the correct embryos are loaded into the transfer catheter. As a final check, the embryologist will hand the catheter to the physician and state the patient's full name and the number of embryos.
Freezing and thawing of sperm or embryos:
  
Frozen specimens are extensively labeled and catalogued. Thawing can only be directed by a physician, and as a rule an embryologist never handles or thaws a specimen without a witness. Once a specimen is thawed, there's no going back.
-- Joe Conaghan, PhD
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Patient Odyssey
Donor Deliberations
After three failed IVF attempts, my partner, whom I'll call "Sam", and I decided to go the egg donor route. The choice actually reduced the degree of frenetic attention we had been paying to our "baby project". All along, we had been racing against my biological clock as I went from age 38 to 41 with only disappointing results, including one early miscarriage. Curiously, our decision to use a donor evoked a peculiar calmness as I realized that as long as we chose a young egg donor, I could be almost any age!
We then spent some time looking at the various donor databases, yet weren't truly happy with any of the candidates. Not that we could define the perfect donor profile, but none of the women felt just right. So I let our "baby project" sit on the back burner as life moved on, thinking autumn would be a good time to resume.
Given that the entire process can take up to three months, this past July, without too much expectation, I casually made a 2nd appointment to view PFC's binders, which contain photos and essays of each egg donor. I was fully prepared to go through the motions and leave without finding the "right one" but one particular donor's profile just leapt out.
Her photographs revealed a woman who just beamed with exuberance and yet seemed grounded. Other positive indicators included a completed college degree and a job in a field that interests me. Her intelligence, focus and motivation were good signals. I also noticed we shared the same favorite color, and had both played the flute and piano at one point.
A second woman, with a closer ethnic background also emerged as a good candidate. At age 21 she already had a child but no college whatsoever. I decided to return home with both profiles so that Sam could have some buy-in on our choice, although I had quietly decided on my favorite.
When Sam wholeheartedly chose my favorite, I felt an enormous wave of relief. The process started feeling less like an abstraction and I posted her portraits on my bulletin board and looked at her face on a daily basis. Her smile was actually encouraging and I grew increasingly comfortable with the notion of using her eggs and having her genetic material in my body and baby. After all, I am in a sense fusing with her.
We then had to decide whether to meet our donor. Sam opted out but I reluctantly decided yes. No doubt, the meeting would be awkward and my biggest fear was that I might change my mind after discovering an undesirable trait!
But the mediated 45-minute meeting* went well and felt relatively natural even though there was a drastic limitation to our conversation. Imagine making small talk and not being able to say much about work, home and so forth! Her quiet and reserved demeanor offset my nervous energy, and she just let me babble on. I enjoyed hearing her mention a few anecdotal points about her own childhood, giving me a good sense of her family past. We agreed that it would be a good idea to meet again at some far-off point, if a child indeed developed. I definitely got the impression that she would respect boundaries and she affirmed this.
Soon we'll know if our donor relationship is truly successful and results in a pregnancy. Sam and I have high expectations. He likes the favorable odds and I like the donor, so we hope for the best.
-- JMT / San Francisco (name withheld upon author's request)
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Patient Odyssey Extra
Meeting Your Donor
Each couple must grapple with the decision about whether or not to meet their donor. For some it is a simple decision; for others it may be a longer process. There is no correct answer to the question of whether or not to meet her.
Some recipients feel concerned that by meeting the donor they will be giving up their anonymity or signing on for a long-term relationship with the donor. While it is true that the donor may then be able to identify you in public, there is no identifying information shared, no last names, addresses, college names, etc. And during each meeting we discuss how the recipients would like to handle an unexpected encounter.
Most importantly, there is no expectation of an ongoing relationship with the donor!
Some couples feel complete satisfaction with no face-to-face contact with the donor; for them, not meeting is the best choice.
For those of you considering it, here are some concrete reasons you might want to go forward:
- It will reassure you that your donor is as wonderful as you had hoped;
- It will reassure you that the donor is completely clear that YOU are the parents;
- It will offer you the opportunity to ask questions that weren't answered on the bio: what kind of baby she was, what are her family members like, etc.;
- You will be able to say an "in person" Thank You to your donor;
- This is the time for a picture with your donor;
- You can discuss how the donor feels about your child contacting her when your child is grown;
- You will be able to tell your child that you met the donor.
At PFC, it has been our experience that the donors love the meetings. It personalizes the experience for them. Instead of a faceless recipient or couple, the donor is working for you, making an already positive experience more special.
The meetings can be enlightening, awkward, touching or funny. What they all share is that they are memorable!
-- Peggy Orlin, MFT
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-- Best regards from all of us at Pacific Fertility Center.
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