Physicians Info

xytex sperm donor and sperm bank faq for physicians

FAQ

Why should medical professionals refer patients needing human semen to Xytex?

What is ISO 9001:2000?

What is FDA’s expectation of Xytex and other reproductive tissue banks?

Is Xytex a health care provider as defined by American law (HIPAA)?

So, Xytex guarantees 30 million motile sperm per thawed milliliter?

Can patients, on their own, work with Xytex?

Will Xytex send semen directly to patients?

Why does Xytex require professional authorization for semen?

What is the relationship between my professional practice and Xytex?

How does Xytex protect patients from communicable diseases?  Does Xytex meet regulatory requirements?

Should my patient select a CMV negative donor?

When professionally deemed advisable, will Xytex provide supplementary evaluation of the donor?

What is a limited donor?

What comes in a semen shipment from Xytex?

What quality assurances does Xytex make?

What are the shipping arrangements?

How long may I keep the Xytex dry shipper?

Can I rent from Xytex a dry shipper so that I can send my frozen tissues to another facility?

When technical issues arise, is Xytex available?

Will I be notified of new information Xytex learns of medical importance to my patient or to her offspring from insemination?

Q.  Why should medical professionals refer patients needing human semen to Xytex?

A.  The fundamental reason, foremost, is the outstanding patient services unique to Xytex.  Of course, Xytex has appropriate, required regulatory approval licenses, it has also earned ISO 9001:2000 certification from the International Organization for Standardization.  Although Xytex provides technically superior semen (at least 30 million motile sperm per thawed milliliter) from a diverse panel of over a hundred medically qualified donors, it is far more than a sperm bank, a gamete vendor.  Xytex originated in 1975 from research at the Medical College of Georgia, giving Xytex a strong medical heritage and enabling it to become a world class participant in reproductive medicine.  The work of Xytex physicians and scientists is guided by an international medical advisory board encompassing expertise in reproductive endocrinology, internal medicine, human genetics, infectious diseases, and tissue preservation.  When invited to participate in your medical practice, Xytex professionals objectively counsel patients about donor selection and even about genetic and psychological concerns.  Combined technological and professional resources of Xytex Corporation, Xytex Research and Xytex Tissue Storage create fabulous new dimensions for patient care in reproductive medicine.

Q.  What is ISO 9001:2000?

A.  Xytex Corporation has achieved ISO 9001:2000 certification (International Organization for Standardization), becoming one of only 1,200 organizations in the United States to be certified in 2005.  A world-recognized set of quality management standards, ISO’s purpose is to facilitate international trade by providing a single set of recognized and agreed upon standards that people everywhere understand and respect.  This applies to medical organizations including the College of American Pathologists and to government organizations including the Centers for Disease Control and Prevention.  ISO 9001:2000 is a quality system that enables participants to evaluate operational effectiveness, increase efficiency and enhance user satisfaction as well as identify areas for improvement.  With auditing and monitoring criteria in place, the company focuses on continuous improvement methodologies to enhance its program.

Q.  What is FDA’s expectation of Xytex and other reproductive tissue banks?

A.  Actually, a great deal.  Foremost, Xytex complies with those expectations published by the FDA (21 CFR Part 1271). 

Q.  Is Xytex a health care provider as defined by American law (HIPAA)?

A.   HIPAA, the Health Insurance Portability and Accountability Act of 1996, is a complex law that, in large part, ensures privacy of electronic exchange of personal health information (PHI) between health care providers, with insurance companies and also with providers of business services, such as accounting.  The law requires specific duties of “covered entities: (e.g. physicians, health plans) and service companies that the law calls “business associates.”  Since there are substantial federal penalties for failure to comply with HIPAA, it is important to clarify the relationship of independent gamete banks to covered entities.

Let us cut to the chase by quoting from the Federal Register:  “We delete from the definition of ‘health care’ activities related to the procurement or banking of blood, sperm, organs or any other tissue for administration to patients” (65 FR 82572).  This is a pretty clear statement that gamete banks are not “health care providers,” i.e. “covered entities.”

The regulations could be interpreted to include tissue banks as health care providers because the definition of “health care” includes providers of care, services or supplies related to the health of an individual patient.  However, independent gamete banks are not required to have nor request knowledge of the chief complaint of the patient, her diagnosis, her treatment plan, or even the therapeutic outcome.  (Xytex asks that patients voluntarily submit an anonymous report of pregnancy outcome.  Xytex does not “chart” the patient).  Indeed, the bank only supposes that the patient is a patient because she is physician-referred.

Interestingly, some physicians who authorize their patients to interact with a gamete bank have asked that bank, namely Xytex, to execute a business associate contract.  The regulations define a business associate as an entity who must have individually identifiable health information in order to provide “legal, actuarial, accounting, consulting, data aggregation, management, administrative, accreditation or financial services to or for a covered entity.”  Also, by definition, a business associate does not have direct contact with patients.  Clearly, a gamete bank may have direct contact with patients, and clearly the bank does not provide any business associate services to the patient’s physician.  Therefore, gamete banks are not business associates.

It may be reasonably argued that the knowledge that a gamete bank gains of patients is acquired “incidentally” or “accidentally,” two means of health information disclosure specifically excluded from HIPAA regulation.  This puts gamete banks in a class of knowledge acquirers that includes patients in reception rooms and janitorial services, both of whom may come in contact with information that clearly identifies patients by name.  Such transfer of knowledge is “permitted” so to speak by HIPAA.

Nevertheless, it is the policy of Xytex to protect the confidentiality of individually identifiable information it has on physician-referred persons who select a gamete donor.  Xytex does not divulge the names of these persons nor their selected donors nor financial information that could be used to construct individually identifiable information.  Furthermore, it is Xytex’s policy of many years to immediately terminate any employee who discloses such information to persons other than Xytex employees with a defined need-to-know.

Q. So, Xytex guarantees 30 million motile sperm per thawed milliliter?

A. Xytex makes a “Quality Commitment” of providing 30 million motile sperm per thawed milliliter regardless of whether the sample is unwashed for ICI or washed for IUI. No sperm bank offers more. This is a commitment rather than a guarantee because there are numerous accepted methods of counting sperm; each yields different results. Please note that vials prepared especially for ART procedures will have at least 15 million motile sperm per thawed milliliter.

As a clinical laboratory, Xytex undergoes proficiency testing several times annually by an independent credentialing agency. Xytex does its counts using a Makler chamber in accordance with the procedures of the U.N. World Health Organization (WHO) manual, third edition.

The “Quality Commitment” is for seven (7) days after shipment of semen from Xytex and includes transit time. Xytex “Quality Commitment” applies while Xytex semen units remain in Xytex shipping dewar (“dry shipper”). Any procedure applied to semen other than insemination after shipment from Xytex voids Xytex “Quality Commitment.”

Q. Can patients, on their own, work with Xytex?

A. A patient contacting Xytex will be asked early on to identify her medical professional, usually a physician.  Xytex provides semen only with professional authorization.

Q. Will Xytex send semen directly to patients?

A. Only with professional authorization! Xytex must receive a signed Authorization to Ship to Alternate Location before it will ship to any address other than the medical facility.

Q. Why does Xytex require professional authorization for semen?

A. It is required by law in Georgia (USA), where Xytex processes semen, and also by New York State, which has regulatory authority over Xytex. A tissue bank in Georgia is regulated as a clinical diagnostic laboratory that is allowed to provide services only to qualified professionals. To comply, Xytex actually confirms credentials with the professional jurisdictional licensing authority, and then reconfirms the gamete order with the patient’s professional. This law is consistent with medical ethics; since the patient is seeking professional involvement in achieving pregnancy and the clinical process is subject to some risk, the patient deserves professional counseling. Technical nuances of clinical insemination and cryogenics are beyond common knowledge of most patients.

Q. What is the relationship between my professional practice and Xytex?

Xytex recognizes that you, the professional, is the ultimate decision maker.  On the most basic level, Xytex asks you to designate who will be responsible for paying for Xytex services: yourself, your clinic, or your patient.  Tell us using the very simple “Supply Agreement” which you can download in document or HTML version.  Complete and return a signed copy of the form by mail or fax:  706-736-9720.  Once our staff confirms the information, an account will be established.  You, your staff or your patients may place orders, but prior to shipment, all orders will be confirmed with your office. 

        The account does several things for your practice:

• Allows us to work with your patient.
• Allows you to establish inventory of donor semen in your clinic, available at a substantial discount.

Please let us know of your interest in any of these opportunities.

Invoices for donor semen will be enclosed with each shipment that is charged to the doctor or invoices will be mailed directly to the patients.  All invoices are payable within 15 days of receipt.  A service charge will be added to past due accounts equal to one and a half percent per month (18% annually) on the previous month’s balance, less payments received during that month.

Q. How does Xytex protect patients from communicable diseases? Does Xytex meet regulatory requirements?

A. Of course, Xytex meets regulatory requirements and has appropriate licenses. But Xytex goes further, as we shall explain. It is most important that the patient understand that there is no way she can be absolutely protected; this is a risk she must accept if she is to be professionally inseminated.

The United States Food and Drug Administration has regulations (21CFR1271) for screening and testing for specific sexually transmitted infections. The FDA even specifies the methodology. Beyond STIs, the state of New York and several organizations (American Association of Tissue Banks, American Society for Reproductive Medicine) expect screening and testing for a few genetic conditions. Xytex meets these expectations as shown on in the table comparing standards. The focus of Xytex screening and testing is made available to patients in the form of a “Semen Donor Screening Guide” and is further documented on a “Packing Slip” included with every shipment of Xytex semen. Part of this “Packing Slip” is the Summary of Records required by the FDA.

To help patients understand their risks for communicable diseases (both infectious and genetic), Xytex has made available to them an extensive discourse (FAQ) on this Web site. With each shipment of semen, Xytex provides you with a narrative (“Patient Information of Transmissible Diseases by Donor Insemination”) to facilitate your efforts to counsel patients about these matters. And since documentation of this counseling prior to insemination is important, Xytex includes with every shipment an “Informed Consent” for the patient to sign. It is to be used in addition to any other informed consent you may employ. PLEASE PLACE THE INFORMED CONSENT IN YOUR PERMANENT FILES; do not sent it to Xytex.

Q. Should my patient select a CMV negative donor?

A. A patient should not be inseminated with semen from a donor with an active CMV (cytomegalovirus) infection or from a donor shedding CMV!  CMV may be transmitted by various excretions including semen.  CMV infects more than 60% of Americans. Once infected with CMV, an individual probably carries the virus for life.  About 1% of American neonates are infected with CMV, almost always a result of primary maternal infection, or the result of maternal reactivation.  Most (but not all) of these congenital infections are asymptomatic at birth, but subsequently over the following several years, develop significant psychomotor, hearing, ocular or dental abnormalities in 5 to 25% of these infants.  These congenital infections can also result in spontaneous abortion.

Tests for antibodies to CMV can distinguish between current (recent) infection and past infection.  Persons with current or recent infection have IgM antibodies to CMV in their blood; once the infection has resolved, these antibodies disappear from the blood.  Persons with past infection will have IgG antibodies to CMV; these antibodies remain in the blood indefinitely.

Xytex tests its donors for IgG and IgM antibodies to CMV at least every six (6) months.  Approximately 60% of our donors are IgG positive.  All of our donors are IgM negative; we do not accept gametes from IgM positive donors.

Q. When professionally deemed advisable, will Xytex provide supplementary evaluation of the donor?

A. Screening and testing of Xytex donors is generally limited to procedures specified in the “Semen Donor Screening Guide” and on the “Packing Slip”. Unlimited supplementary testing is possible when the patient chooses a “limited donor.”

Q. What is a limited donor?

A. Limited donors are anonymous donors that provide semen for the exclusive use of only one recipient. Limited donors are recruited and evaluated by Xytex in the same way as other anonymous donors. Requests for supplementary evaluation of these donors will be considered.

Q. What comes in a semen shipment from Xytex?

A. Human semen from Xytex is shipped cryopreserved (“frozen”) in screw-cap vials.  Each vial contains 0.5 milliliter of sperm (unwashed or washed, as specified in the order) that has been cryopreserved with TEST yolk buffer (TYB); this represents one “insemination unit.”  Each vial is labeled to specify a particular donor, the date of preparation, and the name Xytex.  (Older vials may not have “Xytex.”  Some vials may indicate “product of Canada.”).  Each vial is clipped to a metal support rod (a “cane”) to facilitate removal from the dewar (the refrigerated “tank” or “dry shipper”).  The tank is a metal vacuum bottle refrigerated with liquid nitrogen trapped in spongy material to prevent spillage, hence the name “dry shipper.”  The tank, documents and any other requested items are in a cardboard shipping box.  The documents include a Physician and a Patient packet.  The Physician Packet includes a Packing Slip with the Summary of Records (required by the FDA), and informed consent, a return shipping label, a pregnancy reporting card, and instructions for thawing Xytex semen.

Q. What quality assurances does Xytex make?

A. Xytex guarantees that insemination materials will arrive on or before the requested date. The semen samples will either be unwashed (for ICI), washed (for IUI) or vials prepared especially for ART procedures, as specified by your clinic, within the technical meaning of washed and unwashed. Xytex agrees to waive all or a portion of shipping fees for shipment not received by the time requested by the physician.

Xytex makes a “Quality Commitment” of providing a minimum of 30 million motile sperm per milliliter in the thawed material, whether washed or unwashed. Xytex provides a minimum of 15 million motile sperm per milliliter in the thawed ART vials. This is a commitment rather than a guarantee because there are numerous accepted methods of counting sperm; each yields different results. The “Quality Commitment” is limited to the seven days after shipment of units from a Xytex warehouse including transit time. Washing an unwashed specimen voids the “Quality Commitment.” Semen is intended for insemination immediately after the required thawing time per Xytex instructions in the Physician Packet. Xytex will consider providing replacement vials for semen that, upon thawing, is found by the physician to have fewer than acceptable minimum concentration of motile sperm. Consideration will only be given to written reports from a qualified professional within 30 days of specimen arrival time. The report must include the donor number, the lot number, date shipment received, date of insemination, patient name (if patient was invoiced by Xytex), specimen evaluation, and the name and signature of the professional making the evaluation. Xytex may acquire further details about the situation through a phone call to the professional.

Q. What are the shipping arrangements?

A. Xytex makes and prepays for all arrangements to get the semen order to its destination on the guaranteed arrival date. The shipping containers keep vials of sperm frozen for seven (7) days (including one or two days in transit). Xytex also arranges for the pick-up and prepaid return of the shipping container.

Q. How long may I keep the Xytex dry shipper?

A. Xytex makes arrangements for pick-up of the dry shipper on the eighth day after it was shipped from Xytex. The shipper should be sealed in the original shipping box and the return shipping label, found in the Physician Packet, applied to the outside surface of the box. A rental fee of $25 daily applies to any dry shipper kept beyond the pick up date. Given notice, Xytex will work with your office to alleviate extenuating circumstances. Xytex holds the physician, not the patient, financially responsible for any dry shipper damaged after its receipt. It is therefore essential to notify Xytex of any evidence of damage (“Handling a Semen Shipment”). Also, Xytex will hold the physician responsible for any dry shipper not returned.

Q. Can I rent from Xytex a dry shipper so that I can send my frozen tissues to another facility?

A. Yes. Please call our client relation specialists for more information about this service.

Failure to properly prepare a Dewar (shipping container) for shipment can result in samples expiring in addition to a Federal Aviation Administration (FAA) penalty of up to $25,000!

Our shipping department encourages you to always call before shipping and they will be happy to walk you through the proper handling procedure. We appreciate your ongoing support and cooperation in this very critical matter. Please call our Shipping department at 706.733.0130 if you have questions.

Q. When technical issues arise, is Xytex available?

A. 24/7. Xytex is always available to professional health care providers.

Q. Will I be notified of new information Xytex learns of medical importance to my patient or to her offspring from insemination?

A.  A medical director at Xytex will communicate this information.