Comprehensive guidance for human embryology, andrology, and endocrinology laboratories: management and operations: a committee opinion
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Comprehensive guidance for human
embryology, andrology, and
endocrinology laboratories:
management and operations: a
committee opinion
Practice Committees of the American Society for Reproductive Medicine (ASRM) and the Society for
Reproductive Biologists and Technologists (SRBT)
American Society for Reproductive Medicine, Birmingham, Alabama
This document is a comprehensive guidance for human embryology, andrology, and endocrinology laboratories. Universal guidance
applicable to all laboratories includes requirements and recommendations for accreditation and staffing in the United States, and
specific guidance is included for each laboratory specialty. (Fertil SterilÒ 2022;117:1183-202. Ó2022 by American Society for Repro-
ductive Medicine.)
El resumen está disponible en Español al final del artículo.
Key Words: Andrology, assisted reproductive technology, embryology, endocrinology, laboratory
DIALOG: You can discuss this article with its authors and other readers at https://www.fertstertdialog.com/posts/34763
TABLE OF CONTENTS Laboratory Safety Embryology Training
Emergency Disaster Plan Recommended Laboratory
I. Introduction
Patient Reports Staffing Based on Cycle Volume
II. Universal Guidance for All ART (Table 2)
III. Embryology Laboratory Guidance
Laboratories
Definition of Service Patient Identification and
Laboratory Certification and
Laboratory Space and Design Traceability
Accreditation
Instrumentation Oocyte Retrieval
Quality Management System
Supplies and Reagents Sperm Preparation
Proficiency Testing
Daily Quality Control Conventional IVF
Laboratory Director Require-
ments and Duties for On-Site Embryology Laboratory Staff- Intracytoplasmic Sperm
and Off-Site ing (Table 1) Injection
Clinical/Technical Consultant Laboratory Supervisor: Defini- Fertilization Check
Laboratory Supervisor tion and Duties Embryo Culture and
Senior Embryologist and Development
Document Control System
Embryologist: Definition and Incubation
Employee Competency and
Duties Embryo Transfer
Employee Development
Junior Embryologist and Embryo Biopsy and PGT
Universal and Standard Precau-
Embryology Trainee
tions; Laboratory Sanitation Embryo Cryopreservation
Embryo/Oocyte Cryostorage
Received February 14, 2022; accepted February 15, 2022; published online April 27, 2022.
Reprint requests: American Society for Reproductive Medicine (ASRM), 1209 Montgomery Highway, Shipping of Cryopreserved
Birmingham, Alabama 35216 (E-mail: asrm@asrm.org).
Tissues
Fertility and Sterility® Vol. 117, No. 6, June 2022 0015-0282/$36.00 IV. Andrology Laboratory Guidance
Copyright ©2022 American Society for Reproductive Medicine, Published by Elsevier Inc. Definition of Service
https://doi.org/10.1016/j.fertnstert.2022.02.016
VOL. 117 NO. 6 / JUNE 2022 1183ASRM PAGES
Laboratory Space and Design
Instrumentation
Supplies and Reagents Table of Abbreviations
AAB: American Association of Bioanalysts
Daily Quality Control ABB: American Board of Bioanalysis
Laboratory Supervisor: Definition and Duties ABOR: AAB Board of Registry
Andrologist: Definition and Duties AH: Assisted Hatching
AI: Artificial intelligence
Andrology Training ART: Assisted Reproductive Technologies
Patient Accessioning and Semen Collection ASRM: American Society for Reproductive Medicine
CAP: College of American Pathologists
SA, Manual, and CASA CASA: Computer Assisted/Aided Sperm Analysis
CC: Clinical Consultant
Sperm Function Testing CDC: Centers for Disease Control
Sperm Preparation for IUI and IVF Procedures CLIA: Clinical Laboratory Improvements Amendments
CME: Continuing Medical Education
Semen Cryopreservation and Thawing CMS: Centers for Medicare and Medicaid Services
CRB: College of Reproductive Biologists
Management of Cryopreserved Semen DFI: DNA Fragmentation Index
Patient Reports DO: Doctor of Osteopathy
DOB: Date of Birth
V. Endocrine Laboratory Guidance DPM: Doctor of Podiatric Medicine
Definition of Service EHR/EMR: Electronic Health/Medical Records
Laboratory Space and Design ELD: Embryology Laboratory Director
eSET: Elective Single Embryo Transfer
Instrumentation ET: Embryo Transfer
FDA: Food and Drug Administration
Supplies and Reagents FET: Frozen-Thawed Embryo Transfer
Endocrine Laboratory Testing Personnel: Definition HCLD: High-Complexity Clinical Laboratory Director
HHS: Health and Human Services
and Duties HIPAA: Health Insurance Portability and Accountability Act
Endocrine Laboratory Training HSA: Human Serum Albumin
ICM: Inner Cell Mass
Daily Quality Control ICSI: Intracytoplasmic Sperm Injection
MD: Medical Doctor
Test Requisitions MEA: mouse embryo assay
Serum Collection, Accessioning, and Processing MESA/PESA: Microsurgical/Percutaneous Epididymal Sperm
Aspiration
Test Reports NASS: National ART Surveillance System
niPGT: non-invasive PGT
The American Society for Reproductive Medicine (ASRM) OSHA: Occupational Safety and Health Administration
PGT: Preimplantation Genetic Testing
has previously published guidance and minimum standards PhD: Doctor of Philosophy
for embryology and andrology (1) and embryology (2, 3) PN: Pronuclei
laboratories to serve as templates for assisted reproductive PT: Proficiency Testing
PVP: Polyvinylpyrrolidone
technology (ART) clinics to meet or exceed requirements QMS: Quality Management System
suggested by the Centers for Disease Control and Prevention SA: Semen Analysis
(CDC). This updated guidance was created in acknowledgment SART: Society for Assisted Reproductive Technologies
of the advances and changes in reproductive medicine and to SRBT: Society for Reproductive Biologists and Technologists
SSA: human sperm survival assay
be comprehensive in scope by providing general guidance to TE: Trophectoderm
embryology, andrology, and endocrinology laboratories. TESA/TESE: Testicular Sperm Aspiration/Extraction
Across the country, ART laboratories vary in the services TJC: The Joint Commission
TLI/TLM: Time-Lapse Imaging/Microscopy
provided, and laboratories may provide embryology, ZP: Zona pellucida
andrology, endocrinology, or some combination of 3 Practice Committees of the American Society for Reproductive Medicine (ASRM) and the So-
laboratories. Because of the significant overlap in standards ciety for Reproductive Biologists and Technologists (SRBT)*asrm@asrm.org. Guidance for labs
management and operations. Fertil Steril 2022.
between the 3 types of laboratories, universal guidance is
provided in this document that can be applicable to all
sections of the ART laboratories with specific guidance
detailed where necessary. Other non–US-based guidance
has been published elsewhere (4). UNIVERSAL GUIDANCE FOR ALL ART
This document is organized into 5 laboratory sections and
LABORATORIES
was written by laboratory directors and embryologists
ranging in setting (private, academic, and hybrid) and
Laboratory Certification and Accreditation
experience. Sections were edited and reviewed by the The Centers for Medicare and Medicaid Services (CMS)
executive council of the Society for Reproductive Biologists regulates all clinical laboratory testings performed on
and Technologists and the ASRM Practice Committee. humans in the United States through the Clinical Laboratory
1184 VOL. 117 NO. 6 / JUNE 2022VOL. 117 NO. 6 / JUNE 2022
TABLE 1
Embryology laboratory staff minimum requirements for education, training, continuing education, and experience.
Title Education Training Continuing education Experience
a
Laboratory supervisor Have an earned bachelor’s or Have documented completion of Obtain a minimum of 24 Minimum 4 (BS/BA) 2 (MS),
master’s degree in a training in and performance of a hours of documented and 1 (Doctoral) year of
chemical, physical, or minimum of 60 ART procedures CEUs experience. Perform 20
biologic science or in under supervision with every 2 years procedures or
medical technology from attestation from the training satisfactory number
an accredited institution laboratory annually to maintain
technical proficiency.
Senior embryologist Have an earned bachelor’s or Have documented completion of Obtain a minimum of 24 Minimum 3 years of
master’s degree in a training in and performance of a hours of documented experience. Perform 20
chemical, physical, or minimum of 30 ART procedures CEUs every 2 years procedures or
biologic science or in under supervision with satisfactory number
medical technology from attestation from the training annually to maintain
an accredited institution laboratory technical proficiency.
Embryologist Have an earned bachelor’s or Have documented completion of Obtain a minimum of 24 Minimum 2 years of
master’s degree in a training in and performance of a hours of documented experience. Perform 20
chemical, physical, or minimum of 30 ART procedures CEUs every 2 years procedures or
biologic science or in under supervision with satisfactory number
medical technology from attestation from the training annually to maintain
an accredited institution laboratory technical proficiency.
Junior embryologist Have an earned bachelor’s or Have documented completion of Obtain a minimum of 24 Minimum 1 year of
master’s degree in a training in and performance of a hours of documented experience. Perform 20
chemical, physical, or minimum of 30 ART procedures CEUs every 2 years procedures or
biologic science or in under supervision with satisfactory number
medical technology from attestation from the training annually to maintain
an accredited institution laboratory technical proficiency.
Embryology trainee Have an earned bachelor’s or Have documented completion of Obtain a minimum of 24 Less than 1 year of
master’s degree in a training in and performance of a hours of documented experience. Perform 20
chemical, physical, or minimum of 30 ART procedures CEUs every 2 years procedures or
biologic science or in under supervision with satisfactory number
medical technology from attestation from the training annually to maintain
an accredited institution laboratory technical proficiency.
Note: ART ¼ assisted reproductive technology; CEU ¼ continuing education
Fertility and Sterility®
credits/unit.
a
Laboratory supervisor: have the education and experience required of a technical supervisor accredited by the American Board of Bioanalysis regardless of whether the laboratory director is on-site or off-site. Accreditation by the American Board of Bioanalysis as a
technical supervisor in embryology is recommended but not required for the laboratory supervisor and/or the laboratory director.
Practice Committees of the American Society for Reproductive Medicine (ASRM) and the Society for Reproductive Biologists and Technologists (SRBT)*asrm@asrm.org. Guidance for labs management and operations. Fertil Steril 2022.
1185ASRM PAGES
(as opposed to a Certificate of Compliance) as well as the
TABLE 2
CAP or TJC Certificate of Accreditation. After initial
Recommended laboratory staffing based on embryology cycle
accreditation, clinical testing laboratories must submit to reg-
volume. ular biennial inspections by the state’s department of health or
Number Minimum number the laboratory’s accrediting organization. These inspections
of total cycles of embryologists may be announced or unannounced. They include review of
1–150 2–3
the laboratory’s quality management and quality assurance
151–300 3–4 programs, as well as all other aspects of preanalytic, analytic,
301–600 4–5 and postanalytic testings. The CMS and CLIA still have
>600 1 additional embryologist ultimate authority over the operations of the laboratory.
per additional 150 cycles
Laboratories that are part of a hospital or health system
Practice Committees of the American Society for Reproductive Medicine (ASRM) and the
Society for Reproductive Biologists and Technologists (SRBT)*asrm@asrm.org. Guidance where the parent entity is accredited by TJC are also subject
for labs management and operations. Fertil Steril 2022.
to TJC standards even if the laboratory is already accredited
by another accrediting organization, such as the CAP. It is
Improvement Amendments (CLIA). The full CLIA regulations important for the laboratory to work closely with the parent
and interpretive guidelines are available (5). The CLIA institution to ensure that the laboratory is compliant with
regulations and guidelines apply to clinical laboratories that the standards of all relevant accrediting organizations.
perform diagnostic tests on humans and generate reports of This document provides overview for setting up and orga-
test results. Before a clinical laboratory begins operations, nizing laboratories rather than an exhaustive checklist.
they are required by the CMS to apply for a CLIA Certificate Because the CLIA, CAP, and TJC have detailed standards
of Registration. At present, andrology and endocrine labora- and requirements with which ART laboratories in the United
tories are considered the reproductive clinical laboratories States must comply, laboratories should refer to specific
that fall under the CLIA and state (varies by state) regulations checklists and requirements provided by their accrediting
and guidelines. The CLIA regulations do not extend to the body to achieve and remain in compliance.
embryology laboratory, but fertility clinics that are members
of the Society for Assisted Reproductive Technology (SART)
must have an embryology laboratory that is accredited by Food and Drug Administration
either the College of American Pathologists (CAP) or The Joint The US Food and Drug Administration (FDA) is the federal
Commission (TJC). agency with regulatory authority over human cells, tissues,
If the andrology laboratory provides quantitative semen and cellular and tissue-based products (HCTPs). Sperm, oo-
analysis (SA) or any procedure that includes diagnostic quan- cytes, and embryos used in ART are classified as HCTPs by
titative analysis of sperm concentration (sperm count), the the FDA, and their use is, thus, regulated by Title 21 of the
laboratory must satisfy the requirements of and be registered Code of Federal Regulations (CFR), part 1271 (6).
as a high-complexity clinical laboratory as specified in the The FDA issues specific guidance on subjects such as
CLIA regulations (5). Laboratories or medical practices that donor eligibility (7). Laboratory staff are encouraged to re-
limit reporting to the presence or absence of sperm and detec- view the guidance and work in coordination with the desig-
tion of motility fall beneath the threshold requirement of a nated clinical individual overseeing eligibility determination
high-complexity clinical laboratory. It is important to note to ensure all donor materials are appropriately handled and
that even if only 1 test performed in the laboratory is high distributed. The ASRM also provides guidance based on best
complexity, the entire laboratory must be registered and practices, ideally evidence-based, on third-party reproduction
treated as a high-complexity laboratory. Endocrine within various Practice Committee documents (8, 9).
laboratories typically use automated immunoanalyzers to Those entities using HCTPs must, within 5 days of begin-
report serum fertility hormone levels for patients. Due to the ning operations, register their establishment with the FDA
automated nature of the analyzer, these laboratories are and submit to periodic unannounced inspections of the
considered of moderate complexity. Both andrology and fertility clinic including the laboratory for which the main
endocrine testings are considered nonwaived by the CLIA. focus of the FDA is cryostorage and labeling. The frequency
Waived testing in CLIA laboratories includes urine pregnancy of these inspections is at the discretion of the FDA, but gener-
testing and urinalysis. ally, they occur biennially. During inspection, the FDA will
Andrology and endocrine laboratories must submit to in- review compliance with donor eligibility requirements and
spection by individual states’ departments of health, which ensure that the fertility clinic is following FDA guidance to
ensure compliance with the CLIA regulations (5). If labora- prevent the spread of infectious disease in the context of
tories successfully pass inspection, the laboratory will be third-party reproduction. The FDA has the authority to order
granted a CLIA Certificate of Compliance. In lieu of inspection immediate cessation of patient care should they deem the
by the CLIA, the laboratory may be accredited by an authorized quality of care to be sufficiently low that there is an imminent
accrediting organization, such as the CAP or TJC. The require- risk to patient safety.
ments for accreditation by these organizations is as stringent, In addition to the FDA, some states may also require fertility
if not more so, as those enforced by the CLIA. If the laboratory clinics to have a tissue bank registration or license. The state tis-
is accredited by a CLIA-authorized accrediting organization sue bank may oversee activities and services provided, such as
(CAP or TJC), it will have a CLIA Certificate of Accreditation donor solicitation, artificial insemination, and all tissues in
1186 VOL. 117 NO. 6 / JUNE 2022Fertility and Sterility®
cryostorage. Regulations include requirements for facilities that consultant(s), technical supervisor(s), general supervisor(s),
recover, process, store, and/or distribute cells and tissues. Each and testing personnel.
fertility clinic should confirm with their State Department of Measurement of key performance indicators. Establish-
Health the existence and scope of a tissue bank license. ment, maintenance, and documentation of parameters in
Finally, the FDA issues specific guidance periodically on the preanalytic, analytic, and postanalytic phases.
emergent issues, such as testing for Zika virus, West Nile vi- Audits to assure the accuracy and completeness of labora-
rus, and coronavirus disease 2019 (10, 11). tory reports.
Each fertility clinic should have a policy regarding disclo-
Society for Assisted Reproductive Technology sure of medical errors involving gametes and embryos as soon
as they are discovered, such as loss, misdirection, or damage.
Membership in the SART is voluntary but is encouraged for Disclosure of errors causing no harm or near misses is recom-
fertility clinics. The mission of the SART is to ‘‘set up and mended (12).
help maintain the standards for ART in an effort to better
serve members and patients’’ (11). The SART works with the Proficiency Testing
CDC to analyze ART practice patterns and outcomes to ensure
The CLIA regulations require laboratories to participate in
that all clinics operate under the current standard of care. The
some form of proficiency testing (PT) for every test that
SART member clinics upload ART outcome data on an annual
they perform on patient specimens at an interval of not less
basis to the SART. The SART then reports those data to the
than twice per year. Accrediting agencies may have their
CDC National ART Surveillance System. Clinics who choose
own PT requirements for nondiagnostic tests or services
not to be SART members must report their outcomes directly
such as those provided by the embryology laboratory. Some
to the CDC National ART Surveillance System.
testing requires participation in an external PT program
Importantly, fertility clinics that elect to be members of
that compares ones results with those of colleagues, whereas
the SART must have an embryology laboratory that is ac-
for others, an in-house developed alternative assessment or
credited by either the CAP or TJC.
other method of proficiency may be conducted biannually.
For testing in which external PT is required, results are usually
reported directly to regulatory accreditation bodies (13). Ma-
Quality Management System
terials used for PT can be provided by accrediting bodies such
A quality management system (QMS) is the framework as the CAP or by other groups or industries such as the Amer-
established to manage and monitor activities related to ican Association of Bioanalysts (AAB).
quality standards to achieve an organizational goal. Quality The examples of testing that require participation in an
control, assessment, and improvement are essential parts of external PT program, such as from the CAP or AAB, include
the QMS. The QMS must cover all areas of the laboratory sperm count, sperm viability, and endocrine (hormone) as-
and must be reviewed at least annually by the laboratory says. The examples of testing that requires a minimum of
director for effectiveness. Major organizations providing an alternative assessment (not external PT) include sperm
infrastructure for creating a QMS are the Clinical and morphology, sperm motility, and all embryology proced-
Laboratory Standards Institute and the International ures/tests.
Standards Organization. Different accrediting agencies will
have their own specific elements required in a QMS. The Laboratory Director Requirements and Duties for
important elements of a QMS system include: On-Site and Off-Site
Meeting applicable regulatory, licensing, and accreditation Laboratory directors are responsible for the overall quality
requirements (CLIA, Occupational Safety and Health and function of the laboratory. The duties of the laboratory
Administration, Health Insurance Portability and Account- director will be similar for all laboratories, but the
ability Act, and Fire and Building codes). requirements may vary depending on the complexity of the
Customer service and satisfaction surveys. laboratory (high vs. moderate). Details are described in
Processes to identify and evaluate errors, incidents, or other the CLIA regulations in 42 CFR 493 and interpretive guide-
problems that may interfere with patient care, frequently lines as follows: https://www.ecfr.gov/cgi-bin/textidx?
achieved through documentation and review in an incident SID¼1248e3189da5e5f936e55315402bc38b&node¼pt42.5.
report format. 493&rgn¼div5 (14) and https://www.cms.gov/Regulations-
At least biennial review of laboratory documents including and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_
(but not limited to) policies, procedures, and forms. Laboratories.html (15).
Quality control of all equipment and procedures. This
should include daily quality control methods for each test Duties
performed and by each technologist performing the test. The laboratory director duties include the following:
Calibration maintenance of equipment, which includes mi-
croscopes, hoods, centrifuges, pipettes, thermometers, and Ensuring the testing systems provide quality services
environmental conditions—performed at defined intervals. in all phases of testing (preanalytic, analytic, and
Assurance of personnel satisfying education and training postanalytic) and are appropriate for the patient
requirements for the: laboratory director, clinical/technical population.
VOL. 117 NO. 6 / JUNE 2022 1187ASRM PAGES
Establishing and maintaining policies and procedures. OR
Approving and reviewing test methodologies. An MD, DO, Doctor of Podiatric Medicine (DPM) with a
Ensuring continued standards through quality control, current medical license in the state of the laboratory location
assurance, and improvement. and laboratory training/experience consisting of the
Overseeing training and continued competency of following:
personnel.
One-year experience as a director or supervising non-
Ensuring that the laboratory has the appropriate number of
waived tests OR
trained staff and each employee’s duties are specific in
Twenty Continuing Medical Education credit hours in-
writing.
laboratory practice commensurate with director responsi-
Ensuring that a general supervisor (high-complexity
bilities OR
testing) is available to provide day-to-day supervision of
Equivalent laboratory training (20 Continuing Medical Ed-
all testing personnel and reporting of test results as well
ucation credit hours) during medical residency OR
as provide on-site supervision for specific minimally qual-
A doctoral degree (Doctor of Philosophy [PhD]) in
ity testing personnel when they are performing high-
chemical, physical, biologic, or clinical laboratory sciences
complexity testing.
from an accredited institution with board certification OR 1
Ensuring that adequate space, equipment, and facilities and
year’s experience directing or supervising nonwaived
resources are available and that the environment for em-
testing.
ployees is safe from physical, chemical, and biologic haz-
ards and safety and biohazard requirements are followed. * While the CLIA permits non-physician or non-doctoral
Ensuring the quality of laboratory reports and turnaround degree candidates to serve as the director of a moderate-
time of testing. complexity laboratory, the CAP does not.
**If the laboratory has an annual test volume of
The duties of an on-site or off-site laboratory director are
>500,000, the director must be qualified as a high-
the same, and each must be available for consultations (in-
complexity clinical laboratory director (HCLD), even if only
person, telephone, or electronic) as needed by the laboratory
moderate-complexity testing is performed.
and referring clinicians. Off-site directors must visit the labo-
ratory frequently to monitor the function and quality of the
laboratory at minimum 4 times a year (the CAP). For any reg-
High-Complexity Clinical Laboratory Director (for
ulatory surveys for accreditation, certification, or licensure,
ART Laboratories)
the laboratory director must be present and on-site to ensure
immediate access by the surveyor(s). Laboratory directors An HCLD must have a doctoral degree (PhD) in a
may direct no more than 5 laboratories performing non- chemical, physical, or biologic science or a medical
waived testing (5 CLIA certificates) and no more than 5 degree (MD or DO) from an accredited educational institution
embryology laboratories (non-CLIA). Because the off-site lab- OR have qualified as a laboratory director before July
oratory director is responsible for the operation and perfor- 20, 1999.
mance of the laboratory and staff, meaningful visits to The laboratory director must have the following: specific
enable observation and evaluation of services and patient training and expertise in biochemistry, cell biology, and the
care at an appropriate frequency are required. physiology of reproduction and experience in experimental
design, data management, and statistical analysis and
knowledge of and experience with the full array of assisted
Requirements reproductive techniques, including but not limited to, culture
The requirements for education and experience for a labora- medium design, gamete and embryo culture, cryopreserva-
tory director will vary whether the laboratory is high tion, vitrification, experience in micromanipulation including
complexity or moderate complexity and whether the labora- assisted hatching (AH), intracytoplasmic sperm injection
tory includes embryology. Additionally, some states, such as (ICSI), embryo and blastocyst biopsy, and biopsy preparation
New York, New Jersey, Florida, and California, have specific for genetic testing.
requirements for the laboratory director, and ART laboratories As of January 1, 2006, a laboratory director must
are encouraged to check for any state-specific requirements. have earned certification as an HCLD or embryology labora-
These requirements may also vary by accrediting agency. tory director from the American Board of Bioanalysis (ABB).
Two years of documented relevant experience in a clinic
Moderate-Complexity Laboratory Director performing in vitro fertilization (IVF) and ART is required,
including the following:
A moderate-complexity laboratory director must possess a
current license as a laboratory director issued by the state in Cell and tissue culture and aseptic techniques.
which the laboratory is located, if such licensing is required Clinical andrology including diagnostic SA and semen pro-
AND cessing and preparation of sperm for treatment.
The laboratory director must be a Medical Doctor (MD) or Completion of a minimum of 60 ART procedures under su-
Doctor of Osteopathy (DO) with a current medical license in pervision, defined as a combination of egg retrievals from
the state of the laboratory location and be board certified in follicular aspirates, insemination, assessment of
anatomic and/or clinical pathology fertilization, assessment of embryo stage of development
1188 VOL. 117 NO. 6 / JUNE 2022Fertility and Sterility®
and morphology, and preparation of embryos for and per- year and can be recorded. The elements of competency
formance of embryo transfer (ET), with attestation of satis- include the following:
factory performance by the director of the laboratory in
Direct observation of routine test performance, including
which training was obtained.
patient identification and preparation, and specimen
Demonstration of technical competence in the performance
collection, handling, processing, and testing
of specific ART procedures as measured by the accepted
Monitoring the recording and reporting of test results
metrics of the clinic in which training was obtained.
including, as applicable, reporting critical results
It is recommended but not required that MD and PhD Review of intermediate test results or worksheets, quality
embryology laboratory directors hold the embryology control records, PT results, and preventative maintenance
subspecialty certification (technical supervisor, ABB) or records
equivalent to direct a CAP- or TJC-accredited, SART-re- Direct observation of performance of instrument mainte-
porting embryology laboratory. nance and function checks
Assessment of test performance through testing previously
Clinical/Technical Consultant analyzed specimens, internal blind testing samples, or
Laboratories that are high complexity require a clinical external PT samples
consultant (CC). The CC must be an MD, DO, DPM with a cur- Evaluation of problem-solving skills
rent medical license in the state of the laboratory location or a
Those individuals who hold a specific license or qualifica-
doctoral scientist certified by a Health and Human Services-
tion, such as HCLD (ABB), technical supervisor (ABB), embry-
approved board. The CC should be available to provide clinical
ology laboratory scientist (AAB), and/or andrology laboratory
consultation to the laboratory’s clients and ensure appro-
scientist (AAB), must complete the required number of hours
priate tests are ordered to meet clinical expectations.
of accredited continuing education to maintain their
Moderate-complexity laboratories only require a tech-
qualification.
nical consultant if the laboratory director is not qualified as
an HCLD. The technical consultant must be an MD, DO,
DPM with a current medical license in the state of the labora- Universal and Standard Precautions and
tory location that is certified in clinical or anatomic pathology Laboratory Sanitation
or has at least 1 year of experience or training in nonwaived Universal precautions are an approach to infection control
testing. Alternatively, the technical consultant can have a that treats all human blood and certain body fluids as if
doctoral or master’s degree in chemical biologic, physical, they may be infectious. Universal precautions should be
or clinical laboratory science with at least 1 year of experience used at all times when handling all samples. Details are
or training in nonwaived testing or a bachelor’s degree in described in the Bloodborne Pathogen Standard 29 CFR
chemical biologic, physical, or clinical laboratory science or 1910.1030(d) (1) (16).
medical technology with at least 2 years of experience or The samples encountered in ART laboratories that carry
training in nonwaived testing. the risk of disease transmission include semen, blood, and
follicular fluid. Serum from patients with semen, oocytes, or
Document Control System embryos destined to be cryopreserved should be tested for in-
Document control refers to a system to ensure only current pol- fectious diseases before cryopreservation. Sanitation of the
icies, procedures, and forms are in use and that there are re- work area and equipment using an approved disinfectant
cords of approval and review by the laboratory director and should occur any time that there is a spill and at the end of
records of discontinuance of retired documents are in place. every shift.
This is frequently accomplished through a control log of all Laboratories may handle gametes from virus-positive pa-
policies, procedures, and forms with the location of each. There tients. Patients who are positive for blood-borne viruses, such
should be a defined process and records indicating all as human immunodeficiency virus or hepatitis B or hepatitis C
personnel are knowledgeable about policies and procedures. virus, may seek fertility care, and laboratories should have
policies and procedures for safe handling of oocytes and
semen and sanitation of the laboratory. Guidance for estab-
Employee Competency and Employee lishing policies and procedures has been published (17). Aero-
Development solized viruses, such as severe acute respiratory syndrome
Employees must be evaluated for competency after 6 months coronavirus 2, may be transmitted between patients, staff,
of employment in the first year and then annually thereafter. and samples. Augmented sanitation protocols and risk miti-
Additionally, competency must be assessed before patient gation strategies should be established as part of each clinic’s
testing and reporting results when new methods or instru- safety program (18).
ments are put into place. The competency evaluation should
encompass all aspects of the job description and evaluate
the individual in all phases of the testing procedure, preana- Laboratory Safety
lytic, analytic, and postanalytic phases, and should be deter- In addition to the Bloodborne Pathogen plan described earlier,
mined via observation of sample handling. Several elements laboratories must maintain a chemical hygiene plan to protect
of competency assessment are performed throughout the laboratory workers from hazardous chemicals. Details are
VOL. 117 NO. 6 / JUNE 2022 1189ASRM PAGES
described in the Occupational Safety and Health Administra- such as oocyte cryopreservation, embryo biopsy for preim-
tion 29 CFR1910.1450 (19, 20). plantation genetic testing (PGT), and the ability to use fresh
Notable details include maintaining policies and proced- or frozen donor gametes or embryos.
ures for safety and ensuring that all personnel are trained and
reviewing safety procedures annually, written policies and Laboratory Space and Design
procedures for reporting laboratory accidents, a mechanism Embryology laboratories are highly specialized and sensitive
for the safe handling and disposal of biohazardous waste ma- areas that require thoughtful design and layout (22). The size
terial in the laboratory, properly maintaining equipment to of the laboratory will vary by IVF volume. General consider-
avoid possible injury, appropriate personal protective ations for all embryology laboratories are the following:
equipment, and correct storage and disposal of chemicals
and reagents in accordance to the manufacturer’s recommen- Use of low volatile organic compound paint and construc-
dations and/or local regulations. tion materials.
Floors, counters, and walls that can be easily cleaned and
Disaster Preparedness Plan disinfected and the use of solid ceilings (no drop-down
Every ART laboratory needs to maintain an up-to-date tiles).
disaster preparedness or emergency plan (21). The scope of Sufficient electrical outlets and outlets that are tied to a
the plan may vary based on the laboratory’s activities. Labora- backup power source (generator).
tory priorities should be considered ahead of time to reduce the Dedicated clean air into the laboratory, with consideration
decision-making burden during an emergency. Consideration given to high-efficiency particulate absorbing filters, car-
should be given to coordinating the plan with others in the bon, and permanganate filters to limit particles, volatile
same hospital system (where applicable), or other tenants organic compounds, and inorganic air pollutants.
within the same building, and local first responders. Androl- Positive air pressure inside the laboratory, relative to the
ogy and embryology laboratories need to have an exit strategy procedure room and any other adjacent rooms.
that includes a logical way to rescue storage tanks containing Use of incandescent lights with the ability to dim and no
cryopreserved specimens, as well as backup and contingency fluorescent or bright lights.
plans for specimens in culture and cryopreserved specimens An adjacent procedure room for oocyte retrieval and ET,
in the case of extended power outages or shortage of supplies. preferably with a pass-through window for materials.
Resources are available at www.Redcross.org, www. An adjacent or nearby room for gas tanks and liquid nitro-
disasterassistance.gov, and state agencies. Disaster prepared- gen tanks. The tanks should not be stored inside the
ness plans should routinely be evaluated to identify gaps. laboratory.
Sufficient gas line hookups inside the laboratory for incu-
Patient Reports bators and for antivibration tables as needed, with a backup
The laboratory should have a written record of each diag- system in place.
nostic test or IVF cycle that details the testing/procedures The ability to limit access through badge readers or similar
that were ordered and completed. These records can be either method.
paper based or based in an electronic record. In each case,
there should be adequate backup procedures, and the records Instrumentation
themselves should be easily retrievable. Each clinic/labora- Embryology laboratories require a wide array of specialized
tory should have a policy specifying the amount of time equipment. At a minimum, these would include the following:
they intend to retain these patient reports and records.
As a part of the American Recovery and Reinvestment Incubators: either ‘‘benchtop’’ style (humidified or nonhu-
Act, all public and private healthcare providers and other midified) or traditional ‘‘big-box’’ water or air jacketed in-
eligible professionals were required to adopt and demonstrate cubators. In addition to supplying CO2 to enable an
the ‘‘meaningful use’’ of electronic health records/electronic appropriate pH for embryo culture, incubators should pro-
medical records (EHRs/EMRs) by January 1, 2014, to maintain vide low O2 concentration through the use of a premixed
their existing Medicaid and Medicare reimbursement levels. gas or nitrogen gas input. A sufficient number of incuba-
The EHRs/EMRs have been shown to improve quality, safety, tors should be available to limit door openings and provide
and efficiency and reduce health disparities as well as main- enough space in the event of downtime or maintenance of
tain privacy and security of patient health information. an incubator.
Warming ovens: nongassed warming ovens are typically
needed to warm media or materials that do not require
EMBRYOLOGY LABORATORY GUIDANCE equilibration with CO2.
Definition of Service Heated stages and warm blocks: heated stages should be
Embryology laboratories provide safe and effective IVF pro- available for any surface that would hold embryo culture
cedures to requesting physicians with trained staff (embryol- dishes and/or micromanipulation dishes. This may include
ogists). Basic procedures provided by embryology laboratories microscope stages, stages inside workstations, or
are the identification of surgically retrieved oocytes, fertiliza- stand-alone warming stages. Warm blocks should be
tion of oocytes, culture, transfer, and cryopreservation of em- available to hold media or tubes containing fluid and oo-
bryos. Several laboratories also provide additional services cytes from oocyte retrieval procedures.
1190 VOL. 117 NO. 6 / JUNE 2022Fertility and Sterility®
Microscopes: stereo or dissecting microscopes for moving acceptable limits. Daily quality control performed in the
oocytes and embryos between dishes, retrieval of oocytes, embryology laboratory should include the following:
and vitrification and warming procedures should be avail-
Incubator gas concentrations
able. Some may require heated surfaces, and some may be
Gas supply, including line pressure and gas tank
used at room temperature depending on the vitrification
consumption
and warming protocol. It is useful to have the ability to pro-
Incubator temperature
vide both. Light microscopes with phase contrast and bright-
Refrigerator and freezer temperatures
field optics should be available if sperm preparation or
Temperatures of all heated surfaces
morphology is performed within the embryology laboratory.
Room temperature and humidity
Inverted microscopes should be equipped with Hoffman
Laser alignment
modulation contrast, differential interference contrast, or
Liquid nitrogen tanks
similar for micromanipulation procedures such as ICSI, AH,
and embryo biopsy and for embryo grading at high resolu- In addition to the standard daily quality control (QC)
tion. Inverted microscopes should also be equipped with a checks, the following should be performed in an embryology
micromanipulation system for ICSI, AH, and embryo biopsy, laboratory as part of the overall QC program:
as well as a laser objective for AH, blastocoel collapse, and
embryo biopsy. It is recommended that inverted microscopes All new protocols should be validated by parallel testing
used for micromanipulation procedures be placed on antivi- (when possible, before clinical implementation). Protocol
bration tables. documentation should include a description of the assay,
Refrigerators and freezers: both a refrigerator and freezer standards, controls, calibration, accuracy, precision, and
should be available in the embryology laboratory to hold tolerance limits where applicable.
media and other temperature-dependent supplies with an Equipment should be maintained and calibrated on a regu-
independent monitoring system. Typically, a 20 C lar basis (daily, weekly, monthly, and yearly). This includes
freezer is sufficient, and a 80 C freezer may only be a record of instrument calibration; functional checks of
needed for laboratories performing a significant amount equipment, when possible; evidence of an active review
of research. of records; and documentation of corrective action taken
Workstations and/or laminar flow hoods for media prepa- when instruments malfunction.
ration and during certain procedures such as ET. All reagents, media, and chemicals should have expiration
Some laboratories may use ‘‘isolette’’ style workstations dates recorded, and lot number if applicable, as suggested
that provide a gassed and heated environment for short- by the manufacturers. All outdated materials should be dis-
term embryo manipulation outside the incubator. carded in an appropriate manner.
Liquid nitrogen supply and tanks: a supply line of liquid ni-
trogen should be available within the laboratory, along
with adequate number of dewars and liquid nitrogen stor- Embryology Laboratory Staffing
age tanks and an O2 monitoring system. Table 1 summarizes the minimum embryology laboratory
Real-time monitoring and alarm system connected to staff requirements for education, training, continuing educa-
equipment and cryotanks: to monitor equipment in normal tion, and experience.
operational range and alarm laboratory personnel when
out-of-range or deviation has been detected.
Embryology Laboratory Supervisor: Definition
Supplies and Reagents and Duties
Embryo culture media are available commercially from a va- The laboratory supervisor provides oversight of the daily op-
riety of vendors. Similarly, disposable materials manufac- erations of the laboratory. Working closely with the labora-
tured specifically for ART laboratories are typically tory director and with responsibilities authorized in writing
available and are preferred. These generally come with data by the laboratory director, the supervisor may oversee staff
from a relevant bioassay, such as a mouse embryo assay, training and efforts for continual technical improvement
that demonstrate efficacy or sperm survival assay. Any mate- and delegate operational tasks such as instrument
rials or media that do not come with appropriate bioassay maintenance, inventory management, correspondence with
must be tested with an appropriate bioassay in-house before patients about their cryopreserved samples, and maintenance
using the materials. It is also recommended to verify that of laboratory records and documents. The supervisor is an on-
the pH of any new lot of culture media falls within the labo- site resource for the laboratory personnel for technical
ratory’s defined limits before use. If the media or protein sup- questions and assistance, as well as to the clinical and admin-
plements are modified or prepared in-house, records should istrative staff in the center. The laboratory director may also
indicate they were tested. fulfill the role of laboratory supervisor. In fertility centers
where the laboratory director is also the medical director or
where the laboratory director is off-site, there must be a desig-
Environmental Daily Quality Control nated full-time on-site laboratory supervisor. An embryology
Quality control can be determined by comparing a set of laboratory supervisor should have no less than 4 years of
inherent characteristics against a set of requirements or experience as an embryologist.
VOL. 117 NO. 6 / JUNE 2022 1191ASRM PAGES
Senior Embryologist and Embryologist: Definition may be individually altered (increased or decreased) at the
and Duties discretion of the trainer depending on the new employee
skills, performance, and prior ART experience. Generally,
The senior embryologist performs all, and the embryologist
the new employee will be cleared to perform most tasks
performs some or all, of the array of ART procedures for which
independently after approximately 3–9 months of the
training has been provided under the supervision of the labo-
training period. Some procedures (e.g., ICSI) may require a
ratory director or supervisor, as well as any other tasks as-
significantly longer training period. If the practice attempts
signed to maintain and operate the embryology laboratory.
are not successful, repeated steps may be necessary. After
An educational background or technical experience in cell
the initial 6 months of training, the laboratory director
and tissue culture and the reproductive biology of mamma-
will review all training records as well as directly
lian systems are desirable. Acquisition of skill in clinical
observe the trainee and at this point will decide if the trainee
embryology will be obtained through a documented training
has acceptable skills to continue with training in
program administered by the embryology laboratory. A senior
embryology.
embryologist has no less than 3 years of experience, and an
embryologist has no less than 2 years of experience, as an
embryologist. Recommended Laboratory Staffing Based on Cycle
Volume
Junior Embryologist and Embryology Trainee The complexity and time requirements for contemporary ART
Junior embryologists and embryology trainees perform some laboratory activities has increased compared with traditional
of the array of ART procedures for which training has been IVF cycle requirements. A traditional IVF cycle typically
provided under the supervision of the laboratory director or required roughly 9 personnel hours, but a contemporary cycle
supervisor, as well as any other tasks assigned to maintain can require up to 20 hours for completion (23). The increased
and operate the embryology laboratory. An educational back- use of PGT and embryo/oocyte vitrification and warming has
ground or technical experience in cell and tissue culture and driven this added complexity and time, and the number of
the reproductive biology of mammalian systems is desirable. embryologists, not including the laboratory director, required
Acquisition of skill in clinical embryology will be obtained for safe and efficient operation of the ART laboratory has,
through a documented training program administered by therefore, increased. Proper scheduling of cycles is required
the embryology laboratory. A junior embryologist has no to ensure appropriate staffing levels. The main reasons for
less than 1 year of experience as an embryologist. An embry- ensuring adequate laboratory staffing include avoidance of
ology trainee hasFertility and Sterility®
have been thoroughly trained in aspects of specimen hand-off corrective action are maintained when the acceptable levels
and in the basic laboratory protocols for specimen handling of performance are not achieved.
are qualified to serve as witnesses for such tasks. Depending
on the staffing level in the laboratory and the established Fertilization Check
workflow, an electronic witnessing system may be appro-
Written procedures for performing fertilization check should
priate for serving the purpose of witnessing key manipulation
include a defined period of time that fertilization check is to
events. The laboratory director is responsible for assessing
occur and the time and technician performing the fertilization
staffing needs and determining the best system for specimen
check, the status of each oocyte should be recorded (number
tracking.
of pronuclei and if not fertilized the maturity and number
All planned embryology procedures for a specific patient
of polar bodies as applicable), and there should be a written
should be clearly ordered in writing by a physician and pro-
procedure that for the immediate disposition of oocytes
vided to the laboratory in advance of the IVF cycle. If the lab-
with an abnormal number of pronuclei. This may include
oratory staff believe the plan should be amended, changes to
disposal, continued culture, freezing, training, or institutional
the orders should be approved and clearly documented by the
review board-approved research.
physician to ensure clear communication and responsibility.
Detailed protocols for oocyte retrieval, sperm preparation,
conventional insemination and ICSI, fertilization check, em- Embryo Culture and Development
bryo culture and development, incubation, embryo grading, Media. Today’s media products are predominately manufac-
ET, AH, embryo biopsy, embryo cryopreservation and warm- tured by large commercial entities capable of sustaining a
ing, embryo/oocyte cryostorage, and shipping of cryopre- high level of quality care, with minimal lot to lot variation
served tissues are described elsewhere and are customized not previously attained by traditional in-laboratory media
and validated by each embryology laboratory. General princi- preparations. The types of media used have been reduced to
ples and overviews are presented here. 2 schools-of-thought: sequential or one-step media. Detailed
reviews discussing the pros and cons of these opposing media
Oocyte Retrieval formulation strategies and the differential energy needs of the
developing embryos have been published (24–26). There are
During all embryology procedures, sterile technique should be also 2 types of protein supplementation: either purified or
used, and an appropriate pH should be accomplished using recombinant human serum albumin or a synthetic protein
either a gassed chamber or media buffered to maintain appro- supplement. Synthetic protein supplements contain human
priate pH in room air or performing the procedure in a timely serum albumin (80%–85%) and a residual fraction of
manner in media overlaid with oil. Before beginning the oocyte a- and b-globulins mixed with other macromolecules (e.g.,
retrieval, a time-out is called, and the following are recorded: growth factors, hyaluronic acid, and cofactors) that have
patient’s 2 identifiers (typically name and date of birth) and been shown to be beneficial supplements to media
planned procedure. Searching of follicular aspirates for oocytes formulations.
should be performed in an area that has appropriate communi- Variation also exists in terms of whether a laboratory
cation and proximity to the oocyte retrieval area. prefers culturing in microdroplet (10–50 mL) and microwell
(200 mL) culture dish setups, in conjunction with either single
Sperm Preparation embryo or group culture strategies. Although single embryo
microdroplet culturing is required after embryo biopsy, group
Preparation of sperm for oocyte insemination should be per-
culturing of embryos to the blastocyst stage is commonly per-
formed using sterile technique and universal precautions. If
formed to gain possible beneficial paracrine effects. In addi-
donor sperm is to be used for insemination, the FDA guide-
tion to diverse culture medium choices, IVF laboratories
lines described in 21CFR part 1271 and described elsewhere
must decide on a mineral oil brand and type (e.g., light min-
in this guidance should be followed. Acceptable criteria for
eral oil and paraffin oil) to use in their incubation system.
sperm samples to be used for conventional IVF or ICSI should
Most commercial oil sources are prewashed and chemically
be defined and may include, but are not limited to, concentra-
stable at 37 C in culture. Conversely, light (ultraviolet) expo-
tion, motility, morphology, forward progression, and/or
sure to the oil product in storage/use should be minimized to
frozen-thawed sperm.
prevent chemical changes caused by reactive oxygen species
(ROS) generation.
Conventional IVF and ICSI Incubation. It is well adopted that a tri-gas mix of CO2 (5%–
Defined criteria should be established for which patients may 7%), O2 (5%), and N2 (88%–90%) best mimics physiological
use conventional insemination/IVF or which patients require conditions for growing preimplantation embryos. CO2
ICSI. Intracytoplasmic sperm injection should only be per- adjustment is the key variable to adjust pH, typically between
formed by trained embryologists. Written protocols defining 7.25–7.35, but no single optimal pH has been defined. Con-
training requirements before performing ICSI, including ventional, high-capacity box incubators have been
acceptable levels of performance for the laboratory and for commonly replaced by miniaturized versions to provide
individual embryologists, should be in place. Records of improved gas recovery times, which help maintain ideal
VOL. 117 NO. 6 / JUNE 2022 1193ASRM PAGES
equilibration conditions and sustained reliability in both hu- directly confirm the plan for the number of embryos to
midified and nonhumidified chambers. Some incubators are transfer with the patient.
being further specialized to include time-lapse imaging/mi-
croscopy capabilities, which may combine with algorithm Assisted Hatching
or artificial intelligence software. Note that time-lapse imag-
ing/microscopy has proven to be an important technology to Assisted hatching is a laboratory procedure involving the
understanding early embryo development (i.e., time intervals breaching of the zona pellucida to facilitate herniation of
of cell divisions and documented anomalies) and serving as TE cells to facilitate embryo biopsy procedures, previtrifica-
an embryo selection/deselection tool but is still not standard tion blastocoel collapse, and/or post-ET implantation. The
practice in ART laboratories because it has not been shown process, history potential advantages, and concerns of AH
to improve pregnancy rates over standard embryo grading for fresh and frozen-thawed ET cycles and its necessity for
techniques (27). cell removing-embryo biopsy procedures have been previ-
ously reviewed by the ASRM (35). The value of AH on clinical
Embryo grading and selection. Embryo quality assessment outcomes remains debatable at this time. Computer-mediated
and grading are key procedures in the embryology safe infrared diode lasers have become a laboratory standard
laboratory and major determining factors for clinical as laser energy is delivered directly through an inverted mi-
outcome success. Transferring top-quality fresh or croscope objective to ablate a specific defined target (i.e.,
frozen-warmed embryos combined with selection criteria zona pellucida and cellular junctions). The infrared diode
and applicable elective single-embryo transfer has been laser (1,480 nm) pulses are nontoxic but generate damaging
associated with higher implantation rates and better clinical thermal energy in the form of localized heat, whose target
outcomes (28). range is controlled by presetting the energy levels and pulse
Each laboratory should choose the most feasible method- duration, and the total number of pulses delivered. Key com-
ology in grading and selecting embryos. Several grading/ ponents to effectively breaching the zona pellucida for AH
scoring systems have been developed by examining cell num- procedures have been described elsewhere (36).
ber (cleavage stage), symmetry, fragmentation, overall blas-
tocyst formation (blastocyst stage), inner cell mass, and
trophectoderm (TE) (29). Additional comments on unique Embryo Biopsy and PGT
characteristics of each embryo, for example, uneven cleavage, Embryo biopsy is a procedure required for PGT for aneuploidy
multinucleation, cytoplasmic granularity, thickness/color of screening, specific genetic defects involving monogenic dis-
the zona pellucida, and contamination, should be noted in orders (33), chromosomal structural rearrangement, or poly-
the laboratory records. Factors to consider when implement- genic disorders. Today, blastocyst biopsy has essentially
ing and revising the laboratory’s embryo grading system replaced pronuclear or cleavage-stage embryo biopsy proced-
include scientific basis, comprehensiveness, consistency, ures based on numerous advantages, including the following:
ease of use, efficiency, reliability, and interlaboratory increased accuracy and reliability of PGT; removal of a
communication. smaller proportion of total cells from embryo; removal of
nonfetal TE cells only; and no apparent negative impact on
cryopreservation or implantation potential (37, 38). Blasto-
Embryo Transfer cyst biopsy, like all micromanipulation techniques, should
only be performed by skilled personnel with proven compe-
The ET process is a key procedural step that has been the sole tency using metrics such as low no-result rates.
topic of prior Practice Committee guidelines (30), as have
limits pertaining to embryo number per age groups (31). Elec-
tive single-embryo transfer is recommended to increase the Embryo Cryopreservation
possibility of singleton, healthy, term live births while avoid- It is imperative that informed consent be obtained before
ing multiple pregnancies (32), especially in conjunction with cryopreservation of oocytes or embryos. The consent form
PGT for aneuploidy (33). must include options for disposition of the cryopreserved
The laboratory must manage and organize a daily samples and instructions for the fertility clinic and the labo-
schedule to optimize workflow and workload and ensure ratory to follow. It is common for the patients to be billed
that a doctor’s orders and signed consents are received. In for cryostorage. When a patient no longer wishes to continue
the laboratory, embryologists are responsible for proper ET storage, a discard consent needs to be filled out properly and
dish setup/labeling and equilibration of media products. completely before the oocytes or embryos being discarded.
Each laboratory may have unique variations in standard Further guidance on disposition of cryopreserved tissues
operating procedures pertaining to culture/ET medium, and unclaimed cryopreserved tissues can be found in the
culture ware, ET catheter selection, embryo loading, and ASRM Ethics Committee Opinion (39).
how the embryologist actually assists the physician (34). Embryo cryopreservation should be a requirement for a
Similar to fertilization events, the time of ET represents an modern embryology laboratory. Oocyte cryopreservation
acutely sensitive time where correct embryo selection and may be considered optional. Written protocols for cryopreser-
patient identification verification are of paramount vation should be developed specific for each laboratory.
importance. Embryologists typically perform a ‘‘time-out’’ Further guidance can be found in the ASRM Practice Commit-
procedure to verify patient identification, and they may tee Opinion on rapid-cooling vitrification best practices (40).
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