Genetics & IVF Institute, Inc.

Dear *** ***,
Thank you for the opportunity to respond to the complaint
submitted to the Revdex.com on 12/29/15; ID ***. We are very sorry to hear that one of our
clients has contacted you about donor semen quality. As noted in her submission to you,
she
contacted the Revdex.com on the same day she contacted us, and before giving us an
opportunity to review all of the clinical information necessary to evaluate her
request. We have since made a full
investigation, and are pleased to share with you our findings and response
Our primary mission is to help our clients achieve their goals of
building a family with donor sperm. Our
lab assesses semen quality for every specimen, both before and after freezing,
and only those that meet our standards are placed into inventory. Despite our best efforts, though, a small
fraction of those samples will not achieve the same results when thawed and
analyzed in a client’s clinic. This is
expected when you are working with human reproductive tissue, and when
personnel in different labs using different counting methods and equipment perform
the analysis. We clearly disclose this expected
variability to our clients, along with our policy for refunding or replacing
specimens that do not meet our high standards “in the field.”
Our specimen quality standard for the vials at issue here is
million total motile cells (TMC) upon thawing and prior to any processing. Of the seven vials about which this client
has complained, her doctor’s office has confirmed that four met or exceeded
that level, one had million TMC, one had million TMC and one had
TMC. Those counts are all within the
anticipated range of variability, and are capable of producing a pregnancy; in
fact, we have several pregnancies reported for this donor
We have shipped vials from this donor to other clinics containing
samples from the exact same specimens as those at issue here, with no
complaints. We pulled and analyzed one
of those vials from our own inventory and it had million TMC. Overall, we have had to refund or replace just
2.6% of this donor’s vials (including the three at issue here), meaning that
97.4% of his samples have not resulted in any complaints at all. Still, we accepted the analysis of this
client’s clinic, and provided her with two refunds and one free replacement,
which exceeded our contractual obligations to her. The client’s claim that one vial had “just
over million” TMC is simply not supported by the evidence produced by her own
clinic. That count would be expected
after processing at the clinic, but our quality standard is not applicable
then, as the client certainly knows
This client has asked for a number of additional remedies that are
not contemplated in her agreement with us.
We enter into those agreements with the expectation that our costs are limited
to those necessary to provide the products and services we offer, and the
remedies set forth in the contract. Given
the nature of working with human reproductive tissue, we do not and would not
make donor sperm available on the terms the client now demands
We would be more than happy to provide a refund for the remaining
vial in storage. The instructions for
claiming that refund are available on our website at www.fairfaxcryobank.com. We certainly
wish this client the best, and hope she will welcome a child into her home very
soon
If you have any
additional questions or concerns in the meantime, please contact me directly
Sincerely,Cheryl D***
Director of Client Services
###-###-####

*** ***,We are terribly sorry to hear that *** *** has not only rejected our offer, which is above and beyond the terms of the contract he signed at the time he opened his account, but that he also did not allow us the opportunity to discuss this further on the phone with him when we initially spoke. Since our initial response last week, we received and have processed the destruction as *** *** has requested and in order to provide the superior service that our clients have come to expect and we strive to provide at all time, we have removed the past three months storage fees that were previously posted to his account.Regardless, we do appreciate the feedback and have already modified protocols so that this type of situation does not happen again. Best, Cheryl D***Director of Client Services

Dear *** ***,
I have evaluated the information regarding the
complaint submitted to the Revdex.com by *** *** on 4/10/
10:47:AM; ID ***
I personally spoke with *** *** and I feel that it
is important to clarify our standpoint on this complaint as well
as clarify some
misinformation that was provided in the "Customer's Statement of the
Problem."
*** *** called just a couple of hours prior to the
receipt of this complaint to request a form to close his accountWhile reviewing
*** ***' account and sending him the requested form, I noticed that he had
an outstanding balance of $for unpaid storage fees, from February, March
and April of At that time, I felt that it was important to make him aware
that his account had an outstanding balance of $and that this would need
to be paid off to close his account and offered to assist him with this*** *** immediately became very upset that he had an outstanding balance on
his account and demanded to know how that could have happened, as he had a
credit card on file for monthly billingI explained that on February 6, I
saw a note on file that his CC declined when attempting to bill for storage
that monthDue to the card declining, we immediately mailed a notification to
the address on file that his card declined and asked for updated billing
information for his accountWe received no response or returned mailAgain on
March 10, the billing team mailed another letter regarding the credit card
declining and the $now due for storageThen on March 11, 2015, I personally
received his returned (undelivered) mail to the address we had on file, which
prompted me to perform an online search for a valid mailing addressI found a
new address and immediately mailed the February 6, letter back out, to the
new mailing address that *** *** confirmed as his new mailing address with
me on the phone this day The letter that was forwarded to him new
address was never returned undelivered, so it seems as though it must have
reached *** ***
Additionally, we do offer monthly billing with
statement so I'm unsure who told him that we were unable to bill him monthly,
but that is an option through our companyI also explained that in the original
storage agreement (Paragraph 5, Page 4) that *** *** signed on November 24, before banking
his semen samples with us, "Cryogenic Laboratories, Incwill send via
U.SMail, written notice of non-payment from Cryogenic Laboratories, Incto
Client at his latest address on file at Cryogenic Laboratories, Inc." Our
billing was not faulty; it was not billing him monthly, because his credit card
declined when we attempted to bill himSince I heard the frustration in *** ***' voice, I told him that I would be more than happy to write off
April's $storage fee, but he would still need to pay the $balance for
February and March, to which he replied that he refused to make payment for the
services we renderedI further explained that when accounts are left unpaid,
again, according to his storage agreement, he could be sent to collections and
I did not want that to happenHe promptly thanked me for offering to waive
April's storage fee, which had posted to his account a week prior to his call
and hung up the phone without any further dissatisfaction from my offer to
waive the most recent charge
Please know that we are not trying to harm *** ***
and we never refused him monthly billing of his account, we simply followed the
terms set forth in his agreement (Paragraph 5, Page 4), which includes the statement “It is
imperative that you notify Cryogenic Laboratories, Incof any change in
address and extended absences or sabbaticals," which clearly did not
happenWe complied with the terms and are simply asking that *** ***
upholds his signed agreement as well. Sincerely,Cheryl D***Director of Client Services

Dear [redacted]: Thank you for giving Fairfax Cryobank, Inc. the opportunity to address the latest claims of this client (ID #[redacted]).  Again, we are sorry that she is unhappy and wish her well.  Unfortunately, her claims suffer from a number of troubling misstatements and omissions. The Misstatements Her statements about “failure,” “low quantity vials” and “serious quality control issues” areuntrue. • Human sperm is not a commodity produced on an assembly line; some variability in total motile cell counts (TMC) is expected and this scientific fact is clearly disclosed on our website, in our customer contracts and on many of our competitors’ websites, as well.  As we explained in our first response, the three vials about which she complained were found by her own clinic to have TMCs within the expected range of variability and demonstrably capable of producing a pregnancy.  Nonetheless, we provided, and she accepted, two replacements and one refund.  We have the records to prove it. • There is no evidence whatsoever that we have ever intentionally produced a “low quantity vial.”  If we were going to do that, we would not promote our quality standard or offer to refund or replace vials that did not meet it.  To the contrary, our processing protocol contains several adjustment factors that ensure that we are adding more sperm to each vial than is required to meet the quality standard.Our lab staff undergoes a rigorous training process prior to working independently with specimens.  Once trained, they participate in monthly proficiency analyses and semi-annual proficiency testing of all semen evaluation parameters to ensure accuracy.  We have the training records and test results to prove it. • Our labs, policies, procedures and protocols are inspected regularly by the FDA and the American Association of Tissue Banks.  We conduct comprehensive, on-site internal or external audits at each of our facilities at least annually.  Every semen sample produced by our donors goes through a quality evaluation prior to processing.   We then aliquot a vial from each processed specimen and do a post thaw analysis to ensure that the aliquoted specimens survive the freeze and thaw process and continue to meet our quality standard.  All qualifying samples are then transferred to our distribution center, where we again sacrifice vials for quality testing.  We track the performance of every vial sold and sacrifice additional inventory for quality testing on a regular basis.  We have the records to prove it. The Omissions In addition to filing a complaint with the Revdex.com, this client has contacted us by private email, demandingmoney and threatening to “file complains [sic] with the Attorney General office and the Licensing Department” and to “broadcast my experience with your Cryobank on the national TV.”  Using this same back-channel, she has asked for, receivedand acceptedthe remedies we described in our first Revdex.com response, as well as a 100% refund on the unused vial she had in storage with us.  To state in a public forum that she finds our response “completely unsatisfactory” is misleading.  She took affirmative steps to accept the remedies we offered her, such as providing her credit card number for refunds and sending us written instructions to rescind her purchase of the unused vial.  I have personally reviewed all of the email communications to and from this client, and can state categorically that we have treated her with professionalism, compassion and respect.  We have the records to prove it. We stand by our words and deeds, and are not persuaded that we should accede to these threats and demandsfor additional cashpayments. Thank you, Cheryl D[redacted]Director of Client Services

[To assist us in bringing this matter to a close, you must give us a reason why you are rejecting the response. If no reason is received your complaint will be closed Administratively Resolved] Complaint: [redacted]I am rejecting this response because: One instance, years prior, my card was cancelled due to identity theft. As soon as the card was declined, the company promptly called me to inform me that the payment was rejected and asked for another payment method. When I spoke with the company this past time, they informed me that they have too many customers to call every one and inform them of payment issues. This is an unacceptable response. If you do not have sufficient staff to handle the billing of your company then you need to increase you staff levels. Insufficient staff is not an excuse. Regards,[redacted]

[To assist us in bringing this matter to a close, you must give us a reason why you are rejecting the response. If no reason is received your complaint will be closed Administratively Resolved]
 Complaint: [redacted]
I am rejecting this response because:All of my vials were processed by an independent andrology lab in the biggest fertility clinic in the entire Washington DC area and they found three vials out of seven vials below their own quality standard which makes it a 42% failure rate. Clearly, FairFax Cryobank has some serous quality control issues which need to be investigated by an independent lab not by their own technicians whom I suspect produce low quantity vials to make more product. If you do a quick internet search you will find multiple websites where customers similar to myself who used Fairfax reported the same issues with their vials and horrible customer service and issues with getting refunds. Clearly, there is a pattern here with poor quality and not which one should expect from a licensed Cryobank. There is no question that I was sold bad product and the Cryobank has agreed with me about that. I do not understand why I should be paying money for their mistakes. They need to be financially responsible for quality issues not clients buying their product. Therefore, I find their response completely unsatisfactory.Regards,
[redacted]

[A default letter is provided here which indicates your acceptance of the business's response.  If you wish, you may update it before sending it.]Revdex.com:I have reviewed the response made by the business in reference to complaint ID [redacted], and find that this resolution is satisfactory to me.  Regards, [redacted]