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andrology laboratories
The Practice Committee of the American Society for Reproductive Medicine and the Practice
Committee of the Society for Assisted Reproductive Technology
Birmingham, Alabama
These guidelines provide clinicians with specific guidance on laboratory procedures to ensure that their programs
practice reflects current recommendations. (Fertil Steril 2008;90:S4559. 2008 by American Society for Re-
productive Medicine.)
GUIDELINES FOR HUMAN EMBRYOLOGY LABORATORIES laboratories are not referral laboratories but main-
I. Organization of the Laboratory and Definition of tain specific affiliation with a physician group(s).
Services Embryology laboratories perform some or all of the
A. General Laboratory following steps:
1. The institutional affiliation, where appropriate, 1. Culture medium preparation and quality con-
plus the history and definition of services and trol testing
markets served, should be clearly defined for 2. Examination of follicular aspirates with oocyte
each embryology laboratory. identification
2. The laboratory must undergo certification and 3. Oocyte quality and maturity grading
accreditation by an appropriate agency, e.g., 4. Sperm preparation: semen collection and anal-
College of American Pathologists/American ysis, sperm washing
Society for Reproductive Medicine, Joint Com- 5. Insemination of oocytes
mission on Accreditation of Healthcare Organiza- 6. Evaluation of fertilization and zygote quality
tions, or New York State Tissue Bank and must 7. Embryo culture and embryo grading
be in compliance with any local, state, or federal 8. Embryo transfer (either uterine or tubal)
licensing requirements and/or regulations. Any 9. Oocyte/embryo/sperm cryopreservation, stor-
current licenses, permits, and certification by age and thawing
any other groups or agencies should be listed. 10. Micromanipulation of human oocytes and/or
3. The laboratory must satisfy Institutional Review embryos (e.g. Intracytoplasmic Sperm Injec-
Board (or equivalent Human Investigation Com- tion [ICSI], Assisted Hatching [AH], polar
mittee) requirements for any investigative proce- body or embryo biopsy for Preimplantation Ge-
dures, if applicable. netic Diagnosis [PGD]).
4. Laboratory animals should be maintained C. The laboratory must have evidence of informed
humanely according to local, state, or federal consent for all procedures prior to performing
requirements and/or regulations, if applicable. said procedures.
5. Embryology laboratories are considered manu-
II. Laboratory Personnel
facturers of transplantation products (gametes
A. Personnel Qualifications and Responsibilities
and embryos) according to the FDAs Cell/Tis-
There should be sufficient personnel to provide em-
sue Transplantation regulations (1). All embry-
bryology services as needed in a timely manner with
ology laboratories must be in compliance with
a mechanism in place to provide back up for the lab-
these FDA regulations.
oratory personnel. There are several categories of
B. Specific Laboratory Procedures
personnel. Staffing levels should be appropriate
Embryology laboratories are an integral part of In
for the size and volume of the program; a minimum
Vitro Fertilization (IVF), Gamete Intrafallopian
of two qualified persons is required who are capable
Transfer (GIFT), Zygote Intrafallopian Transfer
of performing all technical services.
(ZIFT), Embryo Cryopreservation, Oocyte or Em-
1. Embryology Laboratory Director
bryo Donation, and Gestational Surrogacy Pro-
a. Qualifications: The individual must fulfill
grams. These are collectively known as Assisted
both of the following requirements:
Reproductive Technologies (ART). Embryology
1) An earned doctorate degree (Ph.D.) from an
accredited institution in a chemical, physi-
Guideline
cal, or biological science as the major sub-
Revised August 2008.
Received and accepted July 28, 2006. ject or a medical degree (M.D. or D.O.)
Reprints will not be available. from an accredited institution or have
0015-0282/08/$34.00 Fertility and Sterility Vol. 90, Suppl 3, November 2008 S45
doi:10.1016/j.fertnstert.2008.08.099 Copyright 2008 American Society for Reproductive Medicine, Published by Elsevier Inc.
qualified as a laboratory director prior to 2) Ensuring that the physical plant (space, fa-
July 20, 1999. Effective January 1, 2006, cilities and equipment) and environmental
all new laboratory directors should hold conditions of the laboratory are appropri-
High Complexity Laboratory Director ate and safe.
(HCLD) or American Board of Bioanalysis 3) Maintaining aseptic conditions in the labo-
Embryology Laboratory Director (ABB- ratory.
ELD) certification or its equivalent. Labora- 4) Ensuring that patient confidentiality is
tory directors grandfathered in are strongly maintained throughout the laboratory
encouraged to seek HCLD or ELD certifica- ART process.
tion. The laboratory director should have 5) Providing an approved procedural manual
the expertise and/or specialized training in to all laboratory personnel, establishing
biochemistry, cell biology, and physiology and maintaining a laboratory quality assur-
of reproduction with experience in experi- ance program.
mental design, statistics, and problem solv- 6) Providing consultation to physicians and
ing. The laboratory director should be others, as appropriate, regarding labora-
responsible for formulating laboratory pol- tory aspects of treatment.
icies and protocols and communicating 7) Employing a sufficient number of qualified
with the medical director regarding patient laboratory personnel to perform the work of
progress and protocols as they affect the the laboratory. At a minimum, there should
laboratory aspects of treatment. be two (2) qualified embryologists. Table 1
2) Two years documented experience in a pro- provides minimum staff sizes for the vol-
gram performing IVF-related procedures. ume of cycles (retrievals and cryopreserva-
This experience should include: tion cycles). Additional laboratory staff
a) Familiarity with laboratory quality con- may be required if andrological and/or en-
trol, inspection, and accreditation pro- docrinological duties are also assigned.
cedures. c. The embryology laboratory director should
b) Detailed knowledge of cell culture and ensure that all personnel receive appropriate
ART and andrology procedures per- training for the ART laboratory procedures
formed in mammalian systems. to be performed, obtain the required number
3) The embryology laboratory director of annual continuing education hours, and
should have had a period of training of at demonstrate continued competency for the
least six months (may be concurrent with ART laboratory procedures performed.
documented experience) and completed d. An off-site laboratory director is one whose
at least 60 ART procedures under supervi- primary directorship is at another physical fa-
sion. A procedure is defined as a combina- cility, which has a separate identification
tion of the examination of follicular number (SART number) and a separate med-
aspirates, insemination, documentation of ical director. An off-site director has the same
fertilization, and preparation for embryo responsibilities as an on-site director. While
transfer. Satisfactory completion of this the laboratory is actively treating patients,
period of training should be documented the off-site director is required to physically
by a signed letter from the laboratory di- visit the laboratory at a frequency that will en-
rector of the training practice. In addition sure the proper functioning of the laboratory
to these qualification requirements, the and assure appropriate patient care. Minimum
embryology laboratory director should:
a) Obtain at least 12 hours of accredited TABLE 1
continuing education annually in assis- Recommended staff according to volume.
ted reproductive technology or clinical
Number of Minimum number of
laboratory practice.
laboratory cycles embryologists
b) Demonstrate technical competency in
the embryology laboratory by docu- 1150 2
menting performance of specific proce- 151300 3
dures and results that are within 301600 4
acceptable standards for that program. >600 1 additional embryologist
b. Responsibilities: These include: per additional 200
1) Providing accessibility for on-site, tele- cycles
phone or electronic consultations as
ASRM Practice Committee. Revised guidelines. Fertil Steril 2008.
needed.
S46 ASRM Practice Committee Revised guidelines Vol. 90, Suppl 3, November 2008
standards would require a frequency of no less procedures under continuous supervision
than 1 visit per month, while the lab is active. of the laboratory director or supervisor.
The lab director should also be available at all b. In addition to meeting these requirements, the
times by fax, phone, or email to address any embryology laboratory technologist should:
issues that may arise. The off-site director 1) Obtain at least 12 hours of accredited con-
must be present on site for any accreditation tinuing education annually in ART or clin-
or certification procedures. A laboratory di- ical laboratory practice;
rector shall direct no more than five separate 2) Perform at least 20 ART procedures per year.
laboratories of any type. c. Experience and documented training in tis-
2. Embryology Laboratory Supervisor sue culture, sperm-egg interaction, or related
The embryology laboratory may have one or more areas of animal reproduction is desirable.
qualified laboratory supervisors who, under the di- The embryology laboratory technologist
rection of the laboratory director, provide day-to- works under the supervision of a laboratory
day supervision of laboratory personnel perform- director or supervisor. Programs for the ap-
ing ART procedures. If the medical director is propriate training of embryology laboratory
also the laboratory director, there should be a des- technologists should be in place with docu-
ignated laboratory supervisor. If the embryology mentation of completion for each employee.
laboratory director is primarily located off-site, d. Responsibilities: These include processing
there should be a designated laboratory supervisor. specimens, being able to independently per-
a. Qualifications: The embryology laboratory form all the routine technical procedures car-
supervisor should either meet the qualification ried out in the embryology laboratory under
requirements designated for laboratory direc- the supervision of a laboratory director or su-
tor or fulfill both of the following require- pervisor, and reporting results.
ments: B. Personnel Records
1) Have an earned bachelors or masters de- There must be written documentation of compli-
gree in chemical, physical, biological, ance with the section described above. This should
medical technology, clinical or reproduc- include the following items:
tive laboratory science from an accredited 1. An itemized list of all personnel, their capacity
institution; (full-time versus part-time), and their shifts, if
2) Have documented training, which includes applicable. Include the total full-time equiva-
performing, at a minimum, at least 60 ART lents filled by full-time and part-time personnel.
procedures under supervision. 2. A list delineating the education, training, and job
b. In addition to meeting these requirements, the qualifications of all laboratory personnel.
embryology laboratory supervisor should: 3. An organizational chart documenting the chain
1) Obtain at least 12 hours of accredited con- of command so that a responsible individual
tinuing education annually in assisted re- can always be identified.
productive technology or clinical 4. An itemization of the training of personnel for
laboratory practice each specific laboratory test offered; definitive
2) Perform at least 20 ART procedures per year. training programs for all procedures should be
c. Responsibilities: These include day-to-day established.
supervision and oversight of the embryo labo- 5. An itemization of personnel participation in
ratory and laboratory director responsibilities training courses, educational programs, and/or
as authorized in writing by the embryology technical meetings and maintain a record of
laboratory director. such participation.
3. Embryology Laboratory Technologist 6. Documentation delineating the continuing labo-
a. Qualifications: Embryology laboratory tech- ratory experience necessary to maintain techni-
nologists who perform ART laboratory proce- cal competency.
dures should either meet the qualification 7. Documentation of the health status, physical ex-
requirements for laboratory supervisor, or ful- aminations, or laboratory tests on personnel
fill both of the following requirements: whenever required.
1) Have an earned bachelors or masters de- 8. Annual performance reviews for personnel.
gree in chemical, physical, biological,
medical technology, clinical, or reproduc- III. Laboratory Space and Design
tive laboratory science from an accredited The embryology laboratory should have adequate
institution; space to ensure safe and comfortable working condi-
2) Have documented training, which includes tions and be of a design that is appropriate for the vol-
performing, at a minimum, at least 30 ART ume of procedures performed.
S48 ASRM Practice Committee Revised guidelines Vol. 90, Suppl 3, November 2008
an appropriate bioassay system to evaluate the plement (e.g., human fetal cord serum, ma-
media is required. ternal or donor serum) prepared in-house is
b. Quality control testing is recommended when not recommended, if such media or supple-
commercial media is purchased and used ments are prepared, the laboratory must
within its labeled expiration period if pretest- test blood from the donor(s) with an
ing by the manufacturer does not reflect media FDA-licensed, approved or cleared test
suitability when in actual use in the labora- and show that the donor(s) is negative or
tory. Documentation of quality control testing non-reactive for the following: HIV-1 and
using an appropriate bioassay system must al- HIV-2, hepatitis B, hepatitis C, syphilis,
ways be supplied by the manufacturer. Labo- HTLV-I and HTLV-II. Each batch of
ratories should also establish tolerance limits blood-based media supplement should
for acceptable receiving conditions for trans- also be tested using an appropriate method
ported commercial media. before its use to ensure that it is not embry-
c. Procedures and documentation for prepara- otoxic.
tion of media. 7) Each batch of culture media should be
1) The sources of ultrapure (tissue culture tested before use for osmolarity. Media
grade) water should comply with College pH testing should be performed follow-
of American Pathologists (CAP) standards ing equilibration with C02 at concentra-
for reagent grade water. If water is pro- tions used for ART procedures. All lots
duced on site, a comprehensive program of media and media components should
of quality control for the water system be recorded and traceable to each patient
must be in place. This must include, but procedure (e.g. lot numbers recorded on
should not be limited to, system sanitiza- oocyte/embryo data sheets in case of re-
tion, cartridge exchange, part replacement, calls, adverse events, etc.).
endotoxin tests and bacterial contamina- 2. Examination of follicular aspirates with egg
tion (colony) testing, and chlorine and/or identification
formaldehyde testing (if applicable). If ul- a. All procedures should be performed using
trapure water is purchased, the source, sterile technique in an area that has appropri-
shelf life, and storage conditions must be ate communication with and proximity to the
strictly defined. While there are no set stan- egg retrieval area. If the egg retrieval room is
dards for levels of endotoxins in embryo separated from the embryology laboratory,
culture media, endotoxin testing of pur- then a mobile laboratory unit, modified infant
chased water is recommended if it is not isolette, or other appropriate method must be
certified endotoxin-free. in place for maintaining follicular fluid tem-
2) All lots of chemicals, prepackaged media, perature and pH.
and other media components should be re- b. Written procedures for the egg search and
corded and specific sources and product identification including media used for aspira-
numbers identified as part of the procedure tion, temperature, pH requirements of fluid,
manual and quality control sheets. Sepa- and rapidity with which each sample must
rate, designated chemicals should be main- be evaluated should be available.
tained specifically for ART. 3. Egg quality and maturity grading
3) Glassware washing protocols, including a. Written protocols should include description
detergent type and source, type of water of stages of oocyte quality and maturity, mag-
used, number of rinses, and exact proce- nification used, maximum time of observa-
dure to be followed, should be strictly de- tion, media for observation, and remedial
fined. Heat sterilization should be used steps to be used for immature oocytes.
whenever possible. b. The morphological condition of all eggs
4) All media preparation should be performed should be documented.
using sterile technique including location 4. Sperm preparation (including sample collection,
and appropriate environment. analysis and sperm washing)
5) Appropriate refrigerated facilities should a. The protocol for sample collection should in-
be available for media. It is suggested clude abstinence period, type of container
that periodic checks of media be made us- used, facilities for collection, and/or time pe-
ing an acceptable bioassay system. riod and conditions for sample collection out-
6) The protein source for medical use should side the laboratory, procedure and conditions
be strictly defined. While the use of blood- for sample collection with seminal pouches
based media or a blood-based media sup- and intercourse, and the acceptable time
S50 ASRM Practice Committee Revised guidelines Vol. 90, Suppl 3, November 2008
f. A disposable sterile transfer catheter should be external disaster preparedness (including provisions
used. for equipment back-up in the event of equipment fail-
8. Oocyte/embryo freezing ure). In addition, the following guidelines are recom-
Embryo or oocyte freezing may be considered mended (3):
optional. A. Every body fluid sample (semen, blood, follicular
a. A written protocol should include cryoprotec- fluid) should be handled using universal precau-
tant used (including source and shelf life), me- tions (i.e., as if it were contaminated). All donor tis-
dia used, type of freezing container (e.g., sues and fluids should be subjected to appropriate
straw, vial, or ampule), stage of embryo for infectious disease screens and quarantine periods
freezing, freezing rate including procedure where applicable.
for manual or automatic seeding, and storage B. All accredited laboratories are required to have an
conditions. Exposure Control Plan. A requirement of this plan
b. All embryo freezing containers (e.g., each is to offer and document Hepatitis B vaccination
straw or vial) must be permanently labeled to all laboratory personnel. Any employee that re-
with at least two unique identifiers. A method fuses is required to sign a waiver that is kept in
of ensuring prompt, accurate retrieval of cry- their employment record. Testing for additional
opreserved specimens must be employed. Du- STIs may be offered, but not required, with test
plicate records of all embryos in storage results to be directed as indicated by the em-
should be kept, in separate locations, exclu- ployee.
sive of the patient chart information. C. Extraordinary precautions should be taken to avoid
c. Time limits for embryo storage should be es- accidental wounds from sharp instruments contam-
tablished by each individual laboratory and inated with body fluids.
determined prior to freezing. D. Disposable, nontoxic (non-powdered) gloves
d. If the laboratory performs cryopreservation, should be worn when handling fresh or frozen
there should be a system in place for the body fluids or any material that has come in contact
detection of low levels of liquid nitrogen. with body fluids. Gloves should be removed and
e. Procedures for thawing embryos should in- discarded when leaving the laboratory or handling
clude cryoprotectant concentrations and me- the telephone. Gloves should never be reused.
dia used, temperature requirements for E. A laboratory coat or appropriate gown should be
thawing, criteria for assessing embryo viabil- worn in the laboratory and removed upon leaving
ity, time period for embryo culture prior to the laboratory.
transfer, protocol for patient preparation for F. Safety glasses or goggles are suggested where ap-
frozen embryo transfers and conditions under propriate.
which embryo transfers will take place. G. Hands should be washed after removing gowns and
9. Micromanipulation gloves and immediately if they become contami-
Micromanipulation is considered optional at nated with body fluids. All hand washing should
each facility. be done with disinfectant soap and hot water or al-
a. Protocols for micromanipulation should in- cohol-based solutions.
clude circumstances and screening criteria for H. Disposable laboratory supplies must be used when-
micromanipulation, procedures for processing ever possible.
sperm samples, types of microtools to be I. Contaminated laboratory equipment and/or work
made or purchased, media/protein source, and surfaces should be disinfected and sterilized after
conditions for micromanipulation including a spill (e.g., 1:10 dilution of 5.25% sodium-hypo-
temperature, pH and osmolarity, criteria for chlorite household bleach in water or other proce-
judging oocyte maturity and oocyte and embry- dures approved by the Centers for Disease
onic quality prior to micromanipulation, viabil- Control and Prevention [CDC]).
ity following micromanipulation, and J. Mechanical pipetting devices should be used for the
conditions under which embryo transfer will manipulation of liquids in the laboratory. Mouth pi-
take place. petting is never permitted.
b. Personnel should have demonstrated compe- K. All procedures and manipulation of body fluids
tence in performing micromanipulation. should be performed to minimize the creation of
droplets and aerosols. Complete facemasks or the
V. Laboratory Safety and Infection Control use of appropriate hoods should be considered
Procedures and policies on lab safety must be available when procedures are conducted which have a high
to all laboratory personnel and should be reviewed an- potential for creating aerosols or droplets. Centrifu-
nually by the laboratory director. Protocols should be gation or vigorous mixing of open containers repre-
available for fire and electrical safety and internal and sents examples of this problem. Centrifuges may be
S52 ASRM Practice Committee Revised guidelines Vol. 90, Suppl 3, November 2008
and resolve problems. A copy of this report F. Satellite facilities may be set up to perform GIFT
should be kept for review. Quality assurance procedures only if facilities are available to pro-
also includes the turnaround time for reports vide IVF procedures as needed on site.
and consistency of service as well as statisti-
cal analysis of outcomes data.
c. An adverse incident file should be maintained, REFERENCES
1. U.S. Food and Drug Administration. Tissue guidances, rules and re-
including but not limited to significant clerical
lated documents. Available at: http://www.fda.gov/cber/tissue/docs.
and analytical errors as well as unusual labo- htm.
ratory results. 2. The American Society for Reproductive Medicine. 2008 Guidelines
d. The practice must participate in data collec- for gamete and embryo donation. Fertil Steril 2008;90(Suppl
tion for purposes of clinic submission in 3):S3044.
3. Practice Committe of the American Society for Reproductive Medi-
compliance with guidelines established by
cine. Guidelines for development of an emergency plan for in vitro fer-
SART. tilization programs. Fertil Steril 2008;89:7935.
3. The laboratory must participate in proficiency 4. Mayer JF, Jones EL, Dowling-Lacey D, et al. Total quality improve-
testing for those procedures for which it is avail- ment in the IVF laboratory: choosing indicators of quality. Reproduc-
able. For those testing services in which a com- tive BioMedicine Online 2003;7(Comp. 1):1926.
mercial proficiency test is not available, the
laboratory must establish an internal quality as- GUIDELINES FOR HUMAN ANDROLOGY LABORATORIES
surance program. Consideration should also be
I. Organization of the Laboratory and Definition of Ser-
given to sharing samples with other laboratories
vices
or developing other means of external quality as-
A. General Laboratory
sessment. External quality assessment serves as
1. The institutional affiliation, history, definition of
a companion to a laboratorys internal quality as-
services, and the purpose of the laboratory
sessment program.
should be clearly defined.
VII. Satellite Facilities 2. The laboratory must be in compliance with any
A satellite facility is a facility in which there is an state or federal licensing requirements. As
off-site laboratory director whose primary direc- a high complexity laboratory, as defined by the
torship is at another physical facility, which has a sep- federal Department of Health and Human Ser-
arate identification number (SART number) and vices (HHS), an andrology laboratory falls under
a separate medical director. ART laboratory services the purview of Clinical Laboratory Improvement
may be provided in satellite facilities provided the Act of 1988 (CLIA88) regulations. These regula-
following criteria are met: tions undergo routine interval reviews with
A. A laboratory director (see above) oversees all ac- amendments made as appropriate. Readers are
tivities in the remote location. The director will advised to consult the most recent edition of the
establish protocols, decide on medium prepara- regulations in order to ensure current applicability.
tion and source, provide training to personnel, Any current licenses, permits, and certification by
and determine methodologies to be used. any other groups or agencies should be listed.
B. Qualified embryology technologists should be 3. The laboratory must satisfy any Institutional Re-
employed at the satellite facility or provided by view Board (or equivalent Human Investigation
the laboratory director as needed if the latter Committee) requirements for any investigative
does not perform the procedures. Embryology procedures, if applicable.
technologists should meet the educational and 4. Laboratory animals should be maintained ac-
training criteria described herein. cording to local, state, or federal requirements
C. The laboratory director should provide supervi- and/or regulations, if applicable.
sion and document appropriate lines of daily com- 5. Andrology laboratories that cryopreserve semen
munication with satellite facilities during all IVF for therapeutic use and/or prepare semen for use
procedures. While the laboratory is actively treat- in reproductive therapies are considered manu-
ing patients, the off-site director is required to facturers of transplantation products (sperm)
physically visit the laboratory at a frequency according to the FDAs Cell/Tissue Transplanta-
that will ensure the optimal functioning of the lab- tion regulations (1). All andrology laboratories
oratory and the delivery of quality patient care. involved in these activities must be in compli-
D. A satellite laboratory must meet the same stan- ance with these FDA regulations.
dards as any other embryology laboratory as de- B. Specific Laboratory Procedures
scribed in these guidelines. It is recognized that a single standardized protocol
E. Equipment and laboratory space should meet all of is inappropriate or unavailable for many andrology
the standards listed above as appropriate for proce- laboratory procedures. In the absence of a widely
dures that are performed at the satellite facility. accepted, standardized protocol, each laboratory
S54 ASRM Practice Committee Revised guidelines Vol. 90, Suppl 3, November 2008
8) That all necessary remedial actions are perience, or both, in high complexity test-
taken and documented whenever signifi- ing.
cant deviations from the laboratorys es- 4) Have previously qualified or could have
tablished performance specifications are qualified as a general supervisor on or be-
identified, and that patient test results fore February 28, 1992.
are reported only when the system is 5) On or before September 1, 1992, have
functioning properly. served as a general supervisor of high com-
9) That reports of test results include perti- plexity testing and as of April 24, 1995,
nent information required for interpreta- have graduated from an approved medical
tion. laboratory or clinical laboratory training
10) That consultation is available to the labo- program approved by the Accrediting Bu-
ratorys clients. reau of Health Education Schools
11) That the general supervisor provides on- (ABHES), the Commission on Allied
site supervision of high complexity test Health Education Accreditation (CA-
performance by qualified testing person- HEA), or other organization approved by
nel with high school degrees. HHS; and have at least two years of clinical
12) That the laboratory has sufficient number laboratory training or experience, or both,
of qualified personnel to perform testing. in high complexity testing.
13) That personnel have appropriate educa- 6) On or before September 1, 1992, have
tion and experience before performing served as a general supervisor of high com-
testing. plexity testing and as of April 24, 1995, be
14) That policies and procedures are estab- a high school graduate or equivalent and
lished to monitor individual testing per- have successfully completed an official
formance. U.S. military medical laboratory proce-
15) That an approved procedure manual is dures course of at least 50 weeks duration
available to all personnel responsible for and have held the military enlisted occupa-
testing. tional specialty of Medical Laboratory
16) That the responsibilities and duties of each Specialist; and have at least two years of
consultant, each supervisor, and each test- clinical lab training or experience, or
ing personnel are specified, in writing. both, in high complexity testing.
c. The laboratory director must be accessible to 7) On or before September 1, 1992, have
the laboratory to provide on-site, telephone served as a general supervisor of high com-
or electronic consultation as needed. plexity testing; and be a high school grad-
d. An individual may serve as a director of uate or equivalent and have had at least ten
a maximum of five (5) certified laboratories. years of laboratory training and experi-
2. Laboratory General Supervisor. The laboratory ence, or both, in high complexity testing,
should have at least one general supervisor including at least six years of supervisory
who, under the direction of the laboratory di- experience between September 1, 1982
rector, provides day-to-day supervision of test- and September 1, 1992.
ing personnel and reporting of testing results. b. Responsibilities. The laboratory general su-
a. Qualifications. The general supervisor must pervisor must:
have at least one of the following qualifica- 1) Be accessible, either on-site or via elec-
tions: tronic means, to testing personnel at all
1) Possess a current license issued by the state times testing is being performed.
in which the laboratory is located, if such 2) Provide day-to-day supervision of high
licensing is required; and be qualified as complexity test performance by testing
a high complexity laboratory director; or personnel.
as technical supervisor. 3) Must be on-site to provide direct supervi-
2) Be a M.D. or D.O. or have earned doctoral, sion when high complexity testing is per-
masters or bachelors degree in a chemical, formed by qualified testing personnel
physical, biological or clinical laboratory with high school degrees.
science, or medical technology from an ac- 4) Monitor testing analyses and specimen ex-
credited institution; and have at least one amination to ensure that acceptable levels
year of laboratory training or experience, of analytic performance are maintained.
or both, in high complexity testing. c. The laboratory director or technical supervi-
3) Qualify as testing personnel and have at sor may delegate to the laboratory general su-
least two years of laboratory training or ex- pervisor the responsibility for:
S56 ASRM Practice Committee Revised guidelines Vol. 90, Suppl 3, November 2008
reporting of test results and either must should have a unique identification number. A
correct the problems or immediately notify requisition slip or a form designating the patients
the general supervisor, technical supervi- name, unique identification number, assay(s) to
sor, clinical consultant or director. be performed, and the referring physicians
6) Document all corrective actions taken name should accompany the specimen.
when test systems deviate from the labora- 2. Procedure sheets for the tests performed by the
torys established performance specifica- laboratory including the principles of the test,
tions. preparation of any standards or controls, the
B. Personnel Records methodology used, references, and criteria for
There must be written documentation of compli- unacceptable results, if appropriate. If speci-
ance with the section described above. This should mens are to be rejected, the criteria for rejection
include the following items: and procedure for safe disposal of the specimen
1. A list of all personnel, their job descriptions, and must be established.
shifts, if applicable. 3. Laboratory manuals should be reviewed and re-
2. A list of the education, training, and qualifica- vised annually by the director and signed. Aux-
tions of all laboratory personnel. iliary personnel should be updated and trained in
3. An organizational chart documenting the chain any revised procedures.
of command so that a responsible individual B. Laboratories should have a procedure for specimen
can always be identified. A qualified individual log-in with the appropriate information on the spec-
must be on duty or on call at all times. imen and patient. For example, given a patient
4. Document and maintain records of personnel name and date, the laboratory should be able to doc-
training for each specific laboratory test offered. ument whether or not a specimen was tested, the re-
Definitive training programs for all procedures sults of the test, the referring physician, and some
should be established. unique code that identifies the patient.
5. Documentation of personnel participation in C. The location of all patient test records must be re-
continuing education. corded in a manual. The test records should identify
6. Annual performance reviews for personnel. the person performing the test, the test results, as
well as reference ranges. The results should be re-
III. Laboratory Space and Design viewed by the laboratory director or supervisor
The andrology laboratory should have adequate space and signed. These test results should be kept for
and a design that is appropriate for the volume and a minimum of two years.
type of procedures performed and that ensures safe D. Maintenance manuals for all laboratory equipment
and comfortable working conditions. must be kept in the laboratory. This manual should
A. The andrology laboratory may share space physi- include records of equipment performance and
cally with other laboratory activity. However, any maintenance.
activity requiring sterile technique (i.e., sperm E. All policy manuals should be maintained in the lab-
preparation for intrauterine insemination) should oratory. These policies should include, but are not
be physically separated from other activities. limited to, procedures for record keeping, result re-
B. Adequate space should be provided for record porting, laboratory communication, and consent
keeping, data entry, and related administrative procedures (if required by the institution).
functions.
C. Material for laboratory construction, ventilation of V. Laboratory Equipment and Supplies (9)
the area, and cleanliness should be appropriate to A. Laboratory Equipment/Facilities
the laboratory work. The use of carpet in tissue cul- Laboratories are required to maintain or have ac-
ture or work areas is prohibited. cess to equipment necessary to perform andrology
services. It is the responsibility of the laboratory di-
IV. Laboratory Policy and Procedure Manuals rector to ensure that the proper equipment is in
A. There should be a manual(s) in the laboratory place to perform the necessary assays.
written in National Committee for Clinical Labo- 1. Certain laboratory equipment (i.e., laminar flow
ratory Standards (NCCLS) publication GP-2A hoods, biohazard lab hoods, balances) must be
format, that describes all procedures in sufficient certified by a qualified agency on an annual ba-
detail to assure reproducibility and competence in sis. Certifications must be maintained on file
handling of mammalian gametes. Procedure man- for review.
uals should include, but are not limited to the fol- 2. The laboratory should have a program for check-
lowing: ing and calibrating laboratory equipment such
1. Patient instructions for proper collection, label- as pipettors, thermometers, pH meters, centri-
ing, and delivery of specimens. Each patient fuges, and refrigerators on a regular basis.
S58 ASRM Practice Committee Revised guidelines Vol. 90, Suppl 3, November 2008
a spill (e.g., 1:10 dilution of 5.25% sodium-hypo- a mechanism to review and analyze data in order
chlorite household bleach in water or other proce- to identify problems related to the quality of care
dures approved by the CDC). provided by the laboratory. This should include,
J. There must be sufficient space available for work- but is not limited to, the following:
ing. The room temperature, ventilation, noise level, 1. Mechanisms to detect clerical, transcriptional,
and fume removal should be adequate. Utilities, or analytical mistakes.
communication equipment, and housekeeping 2. Data from the laboratory should be gathered and
should be adequate. analyzed on a regular basis in order to identify
K. Radioisotopes or biohazardous chemicals cannot and resolve problems. A copy of this report
be used in the same room where sperm are pre- should be kept for review. Quality assurance
pared for intrauterine insemination or cryopreser- should also include the turnaround time for re-
vation. ports and consistency of service as well as statis-
L. Laboratory personnel should periodically review tical analysis of outcomes data.
additional published safety guidelines as they be- 3. An adverse incident file should be maintained.
come available (10). 4. The laboratory must participate in proficiency
testing for those procedures for which it is avail-
able. For those testing services in which a com-
VII. Quality Control/Assurance
mercial proficiency test is not available, the
A. Quality Control (QC)
laboratory must establish an internal quality as-
To assure reliable results, the following recommen-
surance program. Consideration should be given
dations must be followed:
to sharing samples with other laboratories or de-
1. All new protocols should be validated by parallel
veloping some other means of external quality
testing (when possible prior to clinical imple-
assessment. External quality assessment serves
mentation. Protocol(s) documentation should in-
as a companion to a laboratorys internal quality
clude a description of the assay, standards,
assessment program.
controls, calibration, and tolerance limits where
applicable.
Acknowledgment: This report was developed under the direction of the Prac-
2. The laboratory director and/or supervisor should tice Committee of the Society for Assisted Reproductive Technology and the
review and update all procedures on at least Practice Committee of the American Society for Reproductive Medicine as
a yearly basis. Copies of old protocols and up- a service to their members and other practicing clinicians. While this docu-
dated procedures must be kept for at least two ment reflects appropriate management of a problem encountered in the prac-
tice of reproductive medicine, it is not intended to be the only approved
years. Effective dates of all changes to protocols
standard of practice or to dictate an exclusive course of treatment. Other
should be recorded. plans of management may be appropriate, taking into account the needs of
3. Equipment should be maintained and calibrated the individual patient, available resources, and institutional or clinical prac-
against National Safety Board (NSB) Standard tice limitations. This report was approved by the Executive Council of the So-
Reference Materials, when possible, on a regular ciety for Assisted Reproductive Technology and by the Board of Directors of
the American Society for Reproductive Medicine.
basis. This includes a record of instrument cali-
bration, functional checks of equipment, when
possible, evidence of an active review of records,
REFERENCES
and documentation of corrective action taken
1. U.S. Food and Drug Administration. Tissue guidances, rules and related
when instruments malfunction. documents. Available at: http://www.fda.gov/cber/tissue/docs.htm.
4. All reagents, media and chemicals should have 2. Blasco L. Clinical tests of sperm fertilizing ability. Fertil Steril 1984;41:
expiration dates recorded. All outdated materials 17792.
should be discarded in an appropriate manner. 3. Kremer J. A simple penetration test. Int J Fertil 1965;10:20915.
4. World Health Organization. In: WHO laboratory manual for the exami-
5. Positive and negative controls should be used
nation of human semen and semen-cervical mucus interaction. 4th ed.
when performing sperm antibody testing. Posi- Cambridge: Cambridge University Press, 1999:1128.
tive controls should be used when performing 5. Bronson R, Cooper G, Rosenfeld D. Sperm antibodies: their role in infer-
the sperm penetration assay. tility. Fertil Steril 1984;42:17183.
6. Infection control: HIV-1 and -2, hepatitis B, hep- 6. Wolf DP, Sokoloski JE. Characterization of the sperm penetration bioas-
say. J Androl 1982;3:44551.
atitis C, syphilis and HTLV-I and -II screened se-
7. The American Society for Reproductive Medicine. 2008 Guidelines for
rum products should be used. Sterile techniques gamete and embryo donation. Fertil Steril 2008;90(Suppl 3):S3044.
and universal precautions to limit microbial con- 8. American Association of Tissue Banks. Standards for Tissue Banking;
tamination should be employed. 2002.
7. Daily monitoring of temperature, gases, and hu- 9. Gerrity M. Selection and use of equipment. In: Wolf DP, Bavister BD,
Gerrity M, Kopf GS, eds. In vitro fertilization and embryo transfer:
midity (when appropriate) for all equipment
a manual of basic techniques. New York: Plenum Press, 1988:724.
should be conducted on a daily basis. assoc. editors.
B. Quality Assurance (QA) 10. Schrader SM. Safety guidelines for the andrology laboratory. Fertil Steril
The quality assurance program should include 1989;51:3879.