Professional Documents
Culture Documents
These guidelines are designed to assist ART programs in establishing and maintaining a successful clinical practice
and set criteria that meet or exceed the requirements suggested by the Centers for Disease Control and Prevention
(CDC) for certification of ART laboratories. (Fertil Steril 2008;90:S1658. 2008 by American Society for Re-
productive Medicine.)
Treatments for the infertile couple are evolving rapidly, and quirement for expertise in one or more areas. An ART pro-
advances in assisted reproductive technology (ART) are the gram must include the following personnel:
best example. Periodically, the American Society for Repro-
A designated overall practice director, medical director,
ductive Medicine (ASRM) reviews and publishes updated
and laboratory director. One individual may fulfill more
guidelines to define the minimum standards for ART pro-
than one of these positions, but the medical director
grams and for human embryology and andrology laboratories.
must be a licensed physician.
This document is designed to assist ART programs in estab-
An individual with training and experience in reproduc-
lishing and maintaining a successful clinical practice and
tive endocrinology, particularly in the use of ovulation-
sets criteria that meet or exceed the requirements suggested
inducing agents and hormonal control of the menstrual
by the Centers for Disease Control and Prevention (CDC)
cycle. An individual who has completed an American
for certification of ART laboratories (1). This document re-
Board of Obstetrics and Gynecology (ABOG)-approved
places that entitled Revised Minimum Standards for In Vitro
fellowship in reproductive endocrinology and infertility
Fertilization, Gamete Intrafallopian Transfer, and Related
fulfills this requirement.
Procedures that was previously published in September,
An individual with experience in laparoscopic and ultra-
2003. This document is not designed to cover all clinical sit-
sound-guided oocyte retrieval techniques.
uations or practices, but rather should be reviewed carefully
An individual with specialized training and experience
by ART program and laboratory directors to ensure that their
in gynecologic ultrasonography who provides the mon-
programs practice reflects current recommendations. More
itoring of follicular development.
specific guidance on laboratory procedures is presented in
An individual experienced in male reproduction (androl-
the Practice Committee report titled, Guidelines for Hu-
ogy) with special competence in semenology. If this in-
man Embryology and Andrology Laboratories.
dividual is not a urologist, a consultant urologist with
expertise in reproductive surgery should be available.
An embryology laboratory director with personal expe-
DEFINITIONS rience in the organization and maintenance of a clinical
ART encompasses a variety of clinical treatments and labora- embryology laboratory and in tissue culture techniques.
tory procedures which include the handling of human oocytes, A consultant/mental health professional with expertise
sperm, or embryos, with the intent of establishing a pregnancy. in reproductive issues.
This includes, but is not limited to, in vitro fertilization (IVF), An individual with specialized training and experience
gamete intrafallopian transfer (GIFT), zygote intrafallopian in gamete and embryo cryopreservation techniques,
transfer (ZIFT), embryo biopsy, preimplantation genetic diag- when gamete and/or embryo cryopreservation is
nosis (PGD), embryo cryopreservation, oocyte or embryo do- offered.
nation, and gestational surrogacy. An individual with specialized training in gamete biol-
ogy and micro-operative techniques, if oocyte and/or
embryo micro-operative techniques are offered.
PERSONNEL Appropriate personnel to perform hormonal assays. An
outside laboratory that has demonstrated adequate com-
There should be a backup system in place for all personnel
petence, quality control, and service, may be used for
essential to a program. A single individual may fulfill the re-
rapid assays of all the necessary reproductive hormones
(including estradiol and progesterone). Such hormone
Guideline
Reviewed June 2008.
assays should be performed by a laboratory that meets
Received and accepted July 28, 2006. Clinical Laboratory Improvement Amendments of
Reprints will not be available. 1988 (CLIA) standards.
0015-0282/08/$34.00 Fertility and Sterility Vol. 90, Suppl 3, November 2008 S165
doi:10.1016/j.fertnstert.2008.08.098 Copyright 2008 American Society for Reproductive Medicine, Published by Elsevier Inc.
Appropriate nursing support. tion with experience in experimental design, statistics,
An individual or consultant with specialized expertise in and problem solving. The laboratory director should
genetics or genetic counseling. be responsible for formulating laboratory policies and
protocols and for communicating with the medical di-
rector regarding patient progress and protocols as they
SPECIALIZED TRAINING AND EXPERIENCE affect the laboratory aspects of treatment.
Medical Director Two years of documented pertinent experience in a pro-
As of January 1, 2000, a new programs medical director gram performing IVF-related procedures. This experi-
must be board-certified in reproductive endocrinology and in- ence should include:
fertility by the ABOG, be an active candidate for the same, or 1 Familiarity with laboratory quality control, inspec-
be grandfathered as a medical director, provided the individ- tion, and accreditation procedures.
ual has training and experience equivalent to a board-certified 2 Detailed knowledge of cell culture and ART and an-
reproductive endocrinologist. drology procedures performed in mammalian systems.
A period of training of at least six months (may be con-
Practice Director current with documented experience) and have com-
pleted at least 60 ART procedures under supervision.
The practice director is responsible and accountable for the
A procedure is defined as a combination of the examina-
activity of the practice relating to ART, and is responsible
tion of follicular aspirates, insemination, documentation
for officially communicating with the Society for Assisted
of fertilization, and preparation for embryo transfer. Sat-
Reproductive Technology (SART) and ensuring that the prac-
isfactory completion of this period of training should be
tice follows SART requirements for membership.
documented by a signed letter from the laboratory direc-
tor of the training practice.
Physician Performing Oocyte Retrievals Obtain at least 12 hours of accredited continuing educa-
Each physician performing oocyte retrievals should have per- tion annually in assisted reproductive technology or
formed at least 20 follicular aspirations under direct supervi- clinical laboratory practice.
sion within a practice that meets these standards. Satisfactory Demonstrate technical competence in the embryology
completion of this training should be documented by a signed laboratory by documenting performance of specific pro-
letter from the practice director. Each physician should con- cedures and results that are within acceptable standards
tinue performing a minimum of 20 aspirations per year. for that program.
It is recommended that the physicians involved in the su-
The responsibilities of the embryology laboratory director
pervision of the follicular recruitment and oocyte retrieval
include:
procedures be responsible for the ultrasound monitoring of
follicular development. Physicians responsible for ultrasound Providing accessibility for on-site, telephone or elec-
follicular monitoring should have familiarity with basic ultra- tronic consultations as needed.
sound physical principles and equipment. These physicians Ensuring that the physical plant (space, facilities, and
should have evidence of training and the requisite competence equipment) and environmental conditions of the labora-
to adequately perform diagnostic ultrasound examinations. tory are appropriate and safe.
Maintaining aseptic conditions in the laboratory.
Embryology Laboratory Director Ensuring that patient confidentiality is maintained
throughout the laboratory ART process.
The embryology laboratory director should be an individual
Providing an approved procedural manual to all labora-
with demonstrated knowledge of all laboratory aspects of
tory personnel and establishing and maintaining a labo-
ART. To be acceptable as an embryology laboratory director,
ratory quality assurance program.
an applicant should fulfill the following requirements:
Providing consultation to physicians and others, as ap-
An earned doctorate degree (Ph.D.) from an accredited propriate, regarding laboratory aspects of treatment.
institution in a chemical, physical, or biological science Employing a sufficient number of qualified laboratory
as the major subject, or a medical degree (M.D. or D.O.) personnel to perform the work of the laboratory. At
from an accredited institution, or have qualified as a lab- a minimum, there should be two qualified embryolo-
oratory director prior to July 20, 1999. Effective January gists. Table 1 provides minimum staff sizes for the vol-
1, 2006, all new laboratory directors should hold High ume of cycles (retrievals and cryopreservation cycles).
Complexity Laboratory Director (HCLD) or American Additional laboratory staff may be required if androlog-
Board of Bioanalysis Embryology Laboratory Director ical and/or endocrinological duties are also assigned.
(ABB-ELD) certification or its equivalent. Laboratory Ensuring that all personnel receive appropriate training
directors grandfathered in are strongly encouraged to for the ART laboratory procedures to be performed, ob-
seek HCLD or ELD certification. The laboratory direc- tain the required number of annual continuing education
tor should have expertise and/or specialized training in hours, and demonstrate continued competence for the
biochemistry, cell biology, and physiology of reproduc- ART laboratory procedures performed.
S166 ASRM Practice Committee Revised minimum standards for ART programs Vol. 90, Suppl 3, November 2008
TABLE 1 Perform at least 20 ART procedures per year.
S168 ASRM Practice Committee Revised minimum standards for ART programs Vol. 90, Suppl 3, November 2008