Blood studies
FDA
● HIV1, HIV-2, HepB, HepC, syphilis, HTLV1, HTLV-2, NG, CT, CMV
● Client depositors: No screening required
● Directed donors do not need to pass donor suitability testing and can be released to parties accepting the risks
AATB
● Anti-HIV-1, anti-HIV-2, HIV-1 NAT, HepBsAg, HepB IgG and IgM, anti-HCV, HCV NAT, anti-HTLV-1, anti-HTLV-2, syphilis, NG, CT, anti-CMV IgG and IgM
● Client depositors: Anti-HIV-1, anti- HIV-2, HIV-1 NAT, HepBsAg, anti-HCV
● Donors with positive results are notified
ASRM
● Anti-HIV-1, anti-HIV-2, HIV-1 NAT, HepBsAg, HepB IgG and IgM, anti-HCV, HCV NAT, anti-HTLV-1, anti-HTLV-2, syphilis, NG, CT
● Additional screening for blood type and Rh
● Donors with positive results are notified
Medical history
FDA
● Perform donor screening of relevant medical records for risk factors of or behavior that would be high risk for HIV, HepB, HepC, syphilis, HTLV, NG, CT, Creutzfeldt–Jakob disease, disease associated with xenotransplantation
AATB
● “Donor risk assessment interview” must be completed by the donor or person knowledgeable of donor’s relevant medical history and social behavior that would put them at high risk for disease transmission
ASRM
● A complete detailed personal and sexual history should be obtained using “male donor examination form” from www.Sart.Org to detail any high-risk behavior
Physical exam
FDA
● None required; however a responsible person must sign off on determination that the donor is free of communicable disease
AATB
● Completed in accordance with AATB’s guidance document no. 1, “tissue donor physical assessment form”
ASRM
● Before acceptance and every 6 months as an active donor, complete physical examination to evaluate for any sign of high-risk behavior should be done using “male donor physical examination form” from www.Sart.Org
Lab requirements/personnel
FDA
● Must have adequate personnel in terms of education and experience, who are trained to perform their assigned roles
● Facility should be of adequate size and configuration to prevent cross contamination and transmission of disease
● Collection and processing should be done in a way to prevent cross contamination
AATB
● Sperm bank should have a director, medical director, and technical staff each with defined qualifications and responsibilities
● Staff members must demonstrate competency with policies, procedures, and processes and have continuing education as needed. All education should be documented
● All tissue banks should provide a safe working environment by enforcing safety protocols in accordance with occupational safety and health administration (OSHA) and the CDC
ASRM
● Strict qualifications and responsibilities are defined under CLIA for the lab director, general supervisor, testing personnel, technical supervisors, and clinical consultants
● Lab must be able to perform semen analysis, sperm penetration testing, sperm cryopreservation, preparation for intrauterine insemination, and computer-assisted semen analysis
Quality assurance
FDA
● Inspection from the FDA is permitted at any “reasonable time in a reasonable manner”
● Frequency of inspection is up to the FDA
● A complaint file should be kept and maintained
● Periodic audits should be performed to ensure adherence to CGTP
AATB
● On-site audits of procedures, policies, and documentation may be performed
● Twice yearly a bank is responsible for providing documentation that all procedures are done in accordance with AATB standards
● Routine and focused quality assurance performance audits should be done at least annually to identify trends of recurring problems
ASRM
● All protocols should be validated and reviewed annually by lab director
● Regular calibration and safety inspections according to National Safety Board Standards
● Protocol for detecting and reporting errors should be put in place
● Adverse event file should be kept
Records
FDA
● Records should be kept of all steps in specimen processing and all personnel involved
● Records should be kept 10 years after the date of latest disposition of the specimen
AATB
● Records of all steps of processing, storage, and distribution should be documented
● Records should be kept for 10 years after the tissue is distributed or destroyed
ASRM
● Keep permanent records of each donor’s initial selection process and all subsequent evaluations
● Keep records of outcomes of each insemination cycle and identify heritable diseases
Table 17.2
Regulations for reproductive tissue banks by state
State | Requirement | Authority |
|---|---|---|
California | License | CA Health & Safety Code §1635.1—with certain exceptions, all tissue banks operating in California must have a current and valid tissue bank license issued by the Department of Health Services |
Delaware | Registration | 16 Delaware code § 2801—all sperm banks and tissue banks operating in the state must register with the Department of Health and Social Services by May 1 of each year |
District of Columbia | License | DC code 7–1541.03 & CDCR 22–301—all tissue banks operating in the District of Columbia must have a valid license |
Florida | Certification | Florida statutes 765.542—an organization may not engage in tissue banking activities in Florida unless it is certified by the Agency for Health Care Administration |
Georgia | License | GA comp. Rules & Regs § 290–9–8-04—no clinical laboratory (i.e., tissue bank) may be operated without a license issued by the Department of Human Resources |
Illinois | Registration | 20 ILCS 2310/2310–330 and 77 Ill. Adm. Code 470.30—all sperm banks and tissue banks operating in the state must register with the Department of Public Health by May 1 of each year |
Louisiana | Authorization | 32 L.R. § 403 and LAC § 48:I.2901 and 2903—the secretary of the Department of Health and Hospitals will compile and disseminate a list of those nonprofit organ and tissue banks that are authorized to receive donations under this section. The nonprofit tissue banks must submit certain information to the secretary for authorization |
Maryland | Permit | MD code Ann. § 17–305—A permit issued by the secretary is necessary to operate a tissue bank in Maryland or to represent or service in Maryland a tissue bank located outside the state |
Massachusetts | ALM GL chapter 113, § 7—A tissue bank or storage facility is defined as “a facility licensed, accredited or approved by the Department of Public Health” | |
Mississippi | Certification | Miss. Code Ann. § 41–39-15—all tissue banks are required to be certified by the Mississippi State Department of Health, which must be renewed annually |
New York | License | NY CLS public health § 4364—tissue banks must obtain a license pursuant to this article |
Oklahoma | Permit | Oklahoma statutes § 2209.1 and O.A.C. § 310:505–5-1—all tissue banks that procure bone, skin, or connective tissue must obtain a permit issued by the State Department of Health |
Oregon | Registration | SB 341 (signed into law 6/11/07)—tissue banks doing business in the state must register with the Department of Health Services |
History
The idea of sperm cryopreservation has been around for a long time. As early as 1776, Spallanzani was noted to report that by cooling sperm they became motionless; however it was not until the 1800s that sperm were actually frozen [1, 2]. As science progressed for the next century scientists refined their technique for freezing sperm. In the 1950s A.S. Parkes and two British scientists developed the method of using glycerol as a sperm cryoprotectant. American Dr. Jerome K. Sherman further refined this method [3–5]. Dr. Sherman developed a protocol for slow cooling of sperm with storage using carbon dioxide. He then demonstrated that thawed sperm were able to fertilize an egg and begin the normal developmental cycle. In 1953 Sherman aided in the first successful human pregnancy with frozen spermatozoa [6, 7]. Due to the difficult social stigma around sperm cryopreservation and assisted reproduction at the time technology was slow to develop. This finding was finally reported and interest grew in sperm banking after the 11th International Congress of Genetics in 1963 [8]. By the early 1970s this interest developed into the beginnings of commercial sperm banking as we know it today.
Definitions
There are several terms that are commonly used in the standards and licensing documentation that will be defined now as they will be used throughout this chapter.
Donor: A living or deceased individual who is the source of tissue for transplantation in accordance with established medical criteria and procedures.
Directed donor (DD ): A reproductive cell or tissue donor who is known to the recipient but is not her sexually intimate partner.
Anonymous donor (AD) : A reproductive donor of cells of tissue whose identity is unknown to the recipient.
Client depositor (CD ): A person, or persons, who stores reproductive cells of tissues for future use in artificial insemination of assisted reproduction technology procedures for themselves or a sexually intimate partner; not considered a reproductive tissue donor.
Reproductive tissue (RT) : Any cell and/or reproductive tissue from the reproductive tract intended for use in assisted reproductive technology procedures. This might include oocytes, ovarian tissue, embryos, semen, vasal or epididymal fluid, and testicular tissue.
Reproductive tissue bank (RTB ): A facility that stores reproductive tissue which might include oocytes, ovarian tissue, embryos, semen, vasal or epididymal fluid, and testicular tissue.
Licensing Versus Accreditation
The main distinction between licensing and accreditation is that regulations and licensing are mandated by a governing body. In the United States this could be the Federal Drug Administration (FDA) which refers to their rules as a “Final Rule” or “Guidance” or states (Table 17.1) which often refer to their rules as a “Regulation.” Accreditation is a voluntary process by which the sperm bank agrees to abide by certain standards promulgated from private (nongovernmental) association or governing body. Licensing bodies are generally most concerned with sperm donor eligibility, documentation, and risk of communicable infectious disease. Accreditation delves further into the inner workings of a sperm bank and mandates the bank is managed in a professional manner, with appropriate staff performing tasks in a standard fashion, and has policies and procedures in place to ensure consistent and quality care.
Licensin g
In general licensing is needed to provide a minimum set of standards by which a service can be provided, in this case male reproductive tissue banking which we will interchangeably refer to as sperm banking. Licensing is mandatory in the United States by the FDA for all sperm banks and any establishment offering donor sperm services.
Required Reproductive Tissue Bank Regulations
Registration, within 5 days of beginning operation, is required by the FDA (http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/TissueEstablishmentRegistration/default.htm) for all sperm banks to operate. The reproductive tissue bank must comply with FDA Rules and Guidance and have a valid license if required by the state in which it operates.
What Regulatory Authority Does a Reproductive Tissue Bank Need to Comply with?
There are two regulatory authority mandates that a RTB needs to comply with: the FDA and any state regulations from states that the RTB operates in.
FDA Requirements
The FDA requires registration and compliance with their Rules and Guidance for all RTB that accept, process, or store any human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient. The most recent update from the FDA came in 2007 in a document titled “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P).” Semen and oocytes are considered HCT/P and thus are regulated as such by the Center for Biologics Evaluation and Research (CBER) under 21 CFR Parts 1270 and 1271. The main tenant of the FDA Rules and Guidance is to establish a system for receiving, processing, storing, and distributing HCT/Ps while minimizing the risk of transmission of communicable disease to HCT/Ps [9].
A summary of the salient portions of 21 CFR Parts 1270 and 1271 as applicable to sperm banks is outlined below. For more detailed information and current guidance as well as registration information please see http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/TissueEstablishmentRegistration/default.htm
General requirements and procedures
All tissue banks must be registered with the FDA and list all HCT/Ps with the FDA. The registration must be kept up to date and revised yearly if any changes occur.
Each tissue bank registry must include all HCT/Ps recovered, processed, stored, labeled, packaged, and distributed, or on which donor screening or testing was performed.
A tissue bank must establish and maintain procedures for all steps of screening, testing, and determining donor eligibility and continually revise and adjust them.
All procedures must be reviewed by a responsible person and their guidelines available to those performing the tests.
Any deviation from standard procedures must be recorded and justified at the time of occurrence.
Inspection from the FDA is permitted with appropriate notification of the RTB. Frequency of inspection is up to the FDA.
Donor Eligibility (AD, DD)
All tissue banks must evaluate donors via screening and testing for transmission of relevant communicable disease agents or diseases (RCDADs) . They must be determined to be free from risk factors or clinical evidence of infection from communicable disease. Although not required by the FDA, a sample questionnaire can be found in Appendix 1.
For anonymous donors, except for directed donors, a second specimen must be collected and tested 6 months after collection to confirm a communicable disease-free state.
RCDADs include human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), human transmissible spongiform encephalopathy, including Creutzfeldt–Jakob disease (CJD) , and syphilis (TP).
For donors of viable, leukocyte-rich cells and tissues:
Human T-lymphotropic virus (HLTV) , type I and I, cytomegalovirus (CMV).
For donors of reproductive cells or tissues:
Chlamydia trachomatis (CT),
Neisseria gonorrhoeae (NG).
Exceptions for screening include:
Reproductive cells or tissue donated by a sexually intimate partner of the recipient for reproductive use.
A specimen that was originally for use with an intimate partner but is subsequently intended for directed donor use instead (given appropriate measures to screen the donor. )
Records
Records must be maintained that each specimen has an ID number and a statement that the tests for communicable disease were completed together with the results of the screening tests.
Records of specimen processing must be kept, including all personnel involved, each step completed, and times and dates of activities.
Records should be kept for 10 years from the latest disposition of the specimen.
Quarantine
All specimens are kept in quarantine until donor eligibility testing is completed and required retesting is also completed.
Directed donors do not need to pass donor suitability testing and can be released to parties accepting the risks.
All tissue banks must follow current good tissue practices (CGTP ) in order to prevent introduction, transmission, and spread of RCDADs as is outlined in CFR 21 Part 1271 subpart D (AD, DD, CD)
Tissue banks should have adequate personnel in terms of education and experience, who are trained and retrained to perform their assigned roles.
All facilities must be of suitable size, construction, and location to prevent contamination of HCT/Ps with communicable disease agents and to ensure orderly handling of HCT/Ps without mix-ups.
Environmental controls, such as humidity and temperature controls, should be provided in handling and storage areas to prevent contamination or cross-contamination. Inspections of these should be done periodically to ensure their function.
All equipment must be installed properly, maintained regularly, and capable of producing valid results.
Collection of tissue must be done in a way that prevents contamination or cross-contamination.
Processing of HCT/Ps should be done in a way that does not cause contamination or cross-contamination.
Labeling and verification must be established and accurate to ensure proper HCT/P identification and to prevent mix-ups.
Storage areas must be controlled for temperature when appropriate and corrective action and documentation should be completed when proper storage is not met.
Before a sample is distributed its screening and testing must be reviewed to verify that the release criteria are met. A sample that is quarantined, is contaminated, not prepared with the accepted procedure, or is from a donor who has been determined to be ineligible should not be released or must be shipped in quarantine.
Receipt, Predistribution, and Distribution
All HCT/Ps received should be inspected to assure no contamination and decision made to accept, reject, or quarantine the specimen.
A specimen should not be released without tracking documentation of its processing, testing, and storage.
A specimen should not be released if it is in quarantine, contaminated, or from an ineligible donor unless the recipient has appropriate documentation and accepts these risks.
Quality Assurance
A tissue bank must maintain a quality program that is intended to prevent the spread of communicable disease.
It should investigate, evaluate, and document all information regarding core current good tissue practices (CGTP) and possible contamination or deviation from the accept protocol.
Corrective actions should be taken and documented for any deficiencies in CGTP.
All personnel should be adequately trained and reeducated about current or updated CGTP.
Audits should be performed periodically to ensure quality of performance and adherence to standards.
Changes in processes should be verified and validated by a responsible person.
A complaint file must be created, maintained, and available for the FDA.
State Requirements
Several states require RTB operating in their jurisdiction to be licensed. We have listed those that currently require this in Table 17.2 [10]. However, please check with your state’s Department of Health to verify current requirements. Please also be aware that the state in which the RTB facility is located may not be the only state in which licensing is required. If specimens are received or transferred to another state the RTB must also need licensing in that state.
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