Why should medical professionals refer patients needing human semen to Xytex?
What is ISO 9001:2008?
What is FDA’s expectation of Xytex and other reproductive tissue banks?
Is Xytex a health care provider as defined by American law (HIPAA)?
What quality assurances does Xytex make?
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?
What comes in a semen shipment from Xytex?
What are the shipping arrangements?
How long may I keep the Xytex dry shipper?
May I rent a dry shipper from Xytex in order to 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. Xytex maintains
appropriate, required regulatory licenses and maintains ISO 9001:2008 certification for the quality
management system governing the manufacture of semen. Xytex provides technically superior semen from a diverse panel
of over a hundred medically qualified donors. 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 is guided by an international medical
advisory board encompassing expertise in reproductive endocrinology, internal medicine, human genetics, infectious diseases,
and tissue preservation.
Q. What is ISO 9001:2008?
A. The International Organization for Standardization (ISO) is a worldwide federation
of national standards bodies that works 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. Xytex is proud that the quality management system governing the manufacture of our
products is ISO 9001:2008 certified. Certification provides objective proof that Xytex has implemented an effective
quality management system, satisfying all of the requirements of the ISO 9001:2008 standard. Xytex's quality
management system enables Xytex 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.
The Federal Register states: "We delete from the definition of 'health car' 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 gathers 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. What quality assurances does Xytex make?
A. Please read our Quality Commitment page.
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?
A. Xytex recognizes that you, the professional, are 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.
Complete and return a signed copy of the "Supply Agreement"
(US physicians; International physicians) by
email (email@example.com) 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. All invoices are payable within
30 days of invoice date. 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. Xytex meets regulatory requirements and maintains appropriate licenses, however, it is 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 (STI). In addition to STIs, the state of
New York and several organizations expect screening and testing for a few genetic conditions.
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 encourages
the physician to counsel the patient. With each shipment of semen, Xytex provides a packing slip which contains
"A Letter from the Medical Director" 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 send 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.
Xytex urges you to discuss the issues of CMV with your patient. After all, you are in the best position to explain how the issue pertains to her specific situation. Most likely, she is already seropositive (IgG) for CMV. Even if she is seronegative, her risk of being infected with CMV from an IgG positive donor (who is IgM negative) is very slight. Please understand that restriction to CMV IgG negative donors dramatically limits your patient’s choice of donors. Therefore, Xytex believes it is important to determine if her particular situation mandates use of a CMV IgG negative donor. If you recommend use of a CMV IgG negative donor, please have your patient call Xytex at 800-277-3210 to confirm the CMV status of the donor she has chosen before placing her order.
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
Packing Slip with the Summary of Records (required by the FDA), thawing instructions and Medical Director letter,
informed consent (for your patient's file),
a return shipping label and applicable invoices.
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 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 (Thawing and Usage Instructions).
Also, Xytex will hold the physician responsible for any dry shipper not returned.
Q. May I rent a dry shipper from Xytex in order to 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 directly communicate this information to your patient. If unable to contact your patient, Xytex will contact your office to obtain any patient updated mailing addresses, phone numbers and email addresses.