[Federal Register Volume 64, Number 139 (Wednesday, July 21, 1999)]
[Notices]
[Pages 39374-39392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18405]



[[Page 39373]]

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Part IV





Department of Health and Human Services





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Centers for Disease Control and Prevention



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Implementation of the Fertility Clinic Success Rate and Certification 
Act of 1992--A Model Program for the Certification of Embryo 
Laboratories; Notice

  Federal Register / Vol. 64, No. 139 / Wednesday, July 21, 1999 / 
Notices  

[[Page 39374]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Implementation of the Fertility Clinic Success Rate and 
Certification Act of 1992--A Model Program for the Certification of 
Embryo Laboratories

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Final notice.

-----------------------------------------------------------------------

SUMMARY: The Fertility Clinic Success Rate and Certification Act of 
1992 (Pub. L. 102-493, 42 U.S.C. 263a-1 et seq.) requires that the 
Secretary, HHS, through the CDC, develop a model program for the 
certification of embryo laboratories, to be carried out voluntarily by 
interested States.
    This notice sets forth the model certification program 
requirements, including definitions, administrative requirements, and 
embryo laboratory standards. The model program incorporates comments 
received by CDC on the proposed model certification program that was 
published in the Federal Register on November 6, 1998 (63 FR 60178).

FOR FURTHER INFORMATION CONTACT: Robert Martin, Dr.P.H., Division of 
Laboratory Systems, CDC, telephone (770) 488-8295

SUPPLEMENTARY INFORMATION:

Introduction

    The Fertility Clinic Success Rate and Certification Act of 1992 
(FCSRCA), Public Law 102-493 (42 U.S.C. 263a-1 et seq.), was intended 
to provide the public with comparable information concerning the 
effectiveness of infertility services and to assure the quality of such 
services by providing for the certification of embryo laboratories.
    Section 2 of the statute requires that the Secretary, HHS, through 
the CDC, define pregnancy success rates, and seek public comment on the 
proposed definitions. In addition, Section 2 requires each assisted 
reproductive technology (ART) program to annually report its pregnancy 
success rates to the CDC, along with the identity of each embryo 
laboratory used by the program, and whether the laboratory is certified 
under Section 3 or has applied for such certification. Section 2 was 
addressed in a Federal Register notice published on August 26, 1997 (62 
FR 45259).
    Section 3(a) of the FCSRCA requires that the CDC ``develop a model 
program for the certification of embryo laboratories * * * to be 
carried out by the States.'' In developing the model certification 
program, CDC is to consult with ``appropriate consumer and professional 
organizations with expertise in using, providing, and evaluating 
professional services and embryo laboratories associated with assisted 
reproductive technology programs.''
    Section 3(b) lists State officials who are to receive a description 
of the model certification program, and requires that the Secretary 
encourage States to adopt such a program.
    Section 3(c) includes the requirements for administration of the 
certification program by the States, with provisions for the inspection 
and certification of embryo laboratories by States or approved 
accreditation organizations, and the requirement for application to the 
State by an embryo laboratory that seeks certification.
    Section 3(d) specifies the embryo laboratory standards that are to 
be in the model certification program. These include a standard to 
assure consistent performance of laboratory procedures; a standard for 
a quality assurance and quality control program; standards for the 
maintenance of all laboratory records (including laboratory tests and 
procedures performed, as well as personnel and equipment records); and 
a standard for personnel qualifications.
    Section 3(e) includes provisions for a State to adopt the model 
certification program if it applies to the Secretary, and is approved, 
and Section 3(f) allows for the use of accreditation organizations, 
approved under the requirements described in Section 4, to inspect and 
certify embryo laboratories in States that have adopted the program.
    Section 3(g) requires that States which qualify to adopt the model 
certification program conduct embryo laboratory inspections to 
determine if the laboratories meet the requirements of the program. 
Inspections are to be unannounced or be announced in circumstances in 
which the likelihood of discovering deficiencies in the operations of 
an embryo laboratory is not diminished. Section 3(g) also requires the 
Secretary to seek public comment on the circumstances under which 
announced inspections may be conducted. In addition, inspection results 
(including deficiencies and any subsequent corrections to those 
deficiencies) are to be reported and made available to the public.
    Section 3(h) provides for the Secretary to conduct validation 
inspections of embryo laboratories certified by a State or an approved 
accreditation organization to determine if the laboratories are being 
operated in accordance with the standards in the model certification 
program. If a validation survey demonstrates that an embryo laboratory 
is not in compliance with such standards, the statute specifies 
requirements for notification of the State, or as applicable, the 
accreditation organization. A subsequent investigation and inspection 
of additional certified embryo laboratories are to be conducted to 
determine if the State or accreditation organization is reliably 
identifying laboratory deficiencies. The Secretary may revoke the 
approval of the State certification program or accreditation 
organization if requirements applicable to the program are not being 
met.
    Section 3(i) limits the Secretary in developing the model 
certification program, and the States in adopting such program, from 
establishing any regulation, standard, or requirement that has the 
effect of exercising supervision or control over the practice of 
medicine in ART programs.
    Section 3(j) states that the Secretary may define the term of the 
certification issued by a State or an accreditation organization in a 
State, through the public comment process, and provides for application 
for recertification to be submitted when there is a change in ownership 
or administration of a certified embryo laboratory.
    Section 4 calls for the Secretary, through the CDC, to promulgate 
criteria and procedures for the approval and use of accreditation 
organizations to inspect and certify embryo laboratories in States 
which have adopted the model certification program, as well as in 
States which have not adopted the program. The section also includes 
provisions for annual evaluation of approved accreditation 
organizations by the Secretary, through the inspection of a 
representative sample of accredited embryo laboratories and other such 
appropriate means.
    Section 5 specifies the conditions under which a certification 
issued by a State or an accreditation organization shall be revoked or 
suspended, and the effect that such revocation or suspension would 
impose on the certification and application for recertification of the 
laboratory.
    Section 6 mandates that the Secretary, through the CDC, annually 
publish pregnancy success rates as reported by ART programs (Section 
2); the names of ART programs that fail to report pregnancy success 
rates; the identity and certification status of each embryo laboratory 
located in a State which has adopted the model certification program; 
the identity of each embryo laboratory in a State which has not

[[Page 39375]]

adopted the certification program and which has been certified by an 
approved accreditation organization; and in the case of an embryo 
laboratory which is not certified, whether the laboratory has applied 
for certification. The annual publication is to be distributed to 
States and the public. This section was also addressed in the 
previously mentioned Federal Register notice published on August 26, 
1997 (62 FR 45259). The first report, 1995 Assisted Reproductive 
Technology Success Rates: National Summary and Fertility Clinic 
Reports, was published in December 1997. The second report, 1996 
Assisted Reproductive Technology Success Rates: National Summary and 
Fertility Clinic Reports, was published in February 1999. Copies of 
these reports may be obtained by contacting CDC by calling 1-770-488-
5372 or via the Internet at www.cdc.gov/nccdphp/drh/art96/.
    Section 7 authorizes the Secretary to charge sufficient fees to 
cover the cost of administering the FCSRCA and authorizes States 
adopting the certification program to charge sufficient fees to cover 
the cost of administering their program.
    Section 8 includes a definition of assisted reproductive technology 
and provides for seeking public comment on any proposed expansion of 
the definition.

Background

    In accordance with the FCSRCA, in developing the model 
certification program, the CDC consulted with individuals, professional 
organizations and consumer groups with expertise and interest in ART. 
The organizations represented reproductive medicine--the American 
Society for Reproductive Medicine (ASRM) and the Society for Assisted 
Reproductive Technology, laboratory professionals--the College of 
American Pathologists (CAP) and the American Association of 
Bioanalysts, and a consumer group that serves to educate the public on 
infertility diagnosis and treatment--RESOLVE. The CDC also sought input 
from State programs and Federal agencies with regulatory 
responsibilities related to laboratory practice, tissue banking and 
ART.
    A useful example in developing the model certification program was 
the voluntary Reproductive Laboratory Accreditation Program (RLAP) 
developed jointly by the CAP and the ASRM, and administered by the CAP. 
The CAP/ASRM RLAP currently provides oversight of at least one third of 
embryo laboratories affiliated with ART programs and clinics in the 
United States and served as the basis for many of the standards in the 
proposed model program. Standards and guidelines from other 
professional organizations, State, Federal, and international programs 
were also used as resources, and the CDC made a number of site visits 
to embryo laboratories to observe the daily operation of these 
facilities. In addition, between November 1996 and August 1997, the CDC 
held several work sessions with technical consultants to obtain 
individual expert input on specific issues related to the embryo 
laboratory and the model certification program, including personnel 
qualifications and responsibilities, quality assurance and quality 
control (quality management), recordkeeping, specific definitions as 
they would apply to the model certification program, and State 
administration of the program.
    Subsequently, on November 6, 1998, the CDC published in the Federal 
Register (63 FR 60178) a notice soliciting public comment on a proposed 
model program for the certification of embryo laboratories. As 
mentioned above, the FCSRCA required the Secretary to facilitate public 
comment on specific aspects of the model certification program and the 
definitions as they relate to the model. To ensure appropriate 
consideration during the public comment period, the CDC highlighted the 
following issues in the preamble to the proposed model program:

     Based on the comments received during the previously 
mentioned work sessions with technical consultants (63 FR 60170), 
the proposed model's definitions for ``assisted reproductive 
technology'' and ``embryo laboratory'', have been elaborated from 
the definitions specified in the FCSRCA. The issue is whether the 
revised definitions are appropriate and accurate for use in the 
model certification program.
     The proposed model permits announced initial and 
routine inspections and unannounced inspections for complaint 
investigations. The issues are under what circumstances should 
announced inspections be permitted so as not to diminish the 
likelihood of discovering deficiencies in the operation of an embryo 
laboratory, and whether there are circumstances that should require 
unannounced inspections.
     The proposed model specifies a 2-year term for embryo 
laboratory certification. The issue is whether this is an 
appropriate period of time for the term of certification of a 
laboratory (i.e., renew biennially).

    In addition, we were interested in receiving comments on the 
following issue which was not specifically addressed in the proposed 
model certification program but could have been considered for 
inclusion in the finalized model:

     Proficiency testing (PT) currently available for the 
embryo laboratory is limited to determining whether culture media 
samples provided by the PT program are suitable for in vitro mouse 
embryo culture. While the performance of PT is not required in the 
proposed model, the model's standards do require a laboratory to 
perform quality control procedures to monitor the reliability of the 
ART procedures performed (including culture media checks). Equipment 
and instrument maintenance and function checks are also required to 
ensure their adequate performance. In addition, the laboratory must 
track and evaluate procedural outcomes such as fertilization rates, 
cleavage rates and embryo quality as a means of monitoring the 
quality of the procedures and services provided by the laboratory. 
The issue is whether these standards provide a sufficient means for 
monitoring laboratory performance or if a standard requiring PT 
should be included in the model.

    During the 60-day comment period the public had the opportunity to 
submit concerns and recommendations in response to the issues 
highlighted above, as well as any other aspect of the proposed model 
program. The letters we received provided helpful information for 
finalizing the model certification program. A summary of the comments 
and our responses to them are included below.
    Other information that was useful in finalizing this model 
certification program for embryo laboratories was data provided in a 
Survey of Assisted Reproductive Technology Embryo Laboratory Procedures 
and Practices, conducted under a CDC Task Order Contract with Research 
Triangle Institute and performed by Analytical Sciences, Inc. The 
purpose of this survey was to provide the CDC with an enumeration of 
those ART embryo laboratory procedures and practices that are currently 
in use. The final report of the survey was completed on January 29, 
1999, and can be accessed via the Internet at www.phppo.cdc.gov/dls/
pdf/art/ARTsurvey.pdf. A copy of the report may also be obtained by 
calling the CDC at (770) 488-8295.

Responses to Comments

    In response to our request for comments to the proposed model 
certification program, we received a total of 15 letters, four of which 
were from professional organizations, one from a consumer advocacy 
group, one from a manufacturer, and the rest from individuals employed 
in embryo laboratories or affiliated with infertility clinics/programs. 
The letters contained approximately 60 comments, 14 of which were in 
response to the issues highlighted for consideration in the proposed 
model program. Six of the commenters, which included two

[[Page 39376]]

professional organizations, expressed support for and/or complimented 
our efforts to develop a model certification program. There was no 
opposition to the model in its entirety, but rather the respondents 
provided comments on specific aspects of the proposed model. Comments 
to the highlighted issues and additional comments are addressed below.
    1. Are the revised definitions for ``assisted reproductive 
technology'' and ``embryo laboratory'' appropriate and accurate for use 
in the model certification program?
    One commenter believed that the definition for ``assisted 
reproductive technology'' was overly broad and could be interpreted as 
including intra uterine insemination (IUI) and intra vaginal culture 
(IVC), procedures which do not require the same level of quality 
control, quality assurance, etc., as do other ART procedures. The 
commenter suggested that the model be revised to contain new categories 
for IUI and IVC with requirements consistent with the complexity level 
of the procedures. Another commenter stated that while the term 
``embryo laboratory'' is technically correct, these laboratories would 
be more appropriately named ``embryology laboratories'' to reflect the 
science of the work performed in them.
    Response: The proposed definition for assisted reproductive 
technology (ART) was based on the definition of ART provided in the 
FCSRCA, which was modified for clarity based on the comments received 
during our work sessions with technical consultants. We do not agree 
with the comment that the ART definition is overly broad for use in the 
model certification program. The definition appropriately and 
accurately specifies ART as ``all clinical and laboratory treatments 
which involve the handling of human oocyte and sperm, or embryos, with 
the intent of establishing a pregnancy.'' The commenter's 
interpretation is incorrect; IUI is not covered by this definition of 
ART, as IUI is a procedure that involves the manipulation of sperm only 
rather than oocytes and sperm. However, IVC is covered by the ART 
definition, since it is a procedure in which oocytes and sperm are 
mixed and incubated together. In addition, we disagree with this 
commenter's viewpoint that IVC does not require the same level of 
quality control or quality assurance as other ART laboratory 
procedures. In performing IVC, oocytes and embryos must be accurately 
identified just as they are for other ART laboratory procedures, 
requiring qualified personnel with appropriate training and expertise, 
written procedures and policies outlining criteria for the 
identification of oocytes and embryos, etc., to ensure quality patient 
care.
    In response to the comment suggesting that the term ``embryology 
laboratory'' be used in place of ``embryo laboratory'', we are 
retaining ``embryo laboratory'' because it is the term used throughout 
the statute (FCSRCA). Although embryology refers to the science of 
studying the origin and development of an individual organism, in using 
the term embryo, we are specifically referring to the intended goal of 
the procedures performed in these laboratories--the manipulation of 
human gametes to produce viable human embryos.
    2. Under what circumstances should announced inspections be 
permitted so as not to diminish the likelihood of discovering 
deficiencies in the operation of an embryo laboratory, and are there 
circumstances that should require unannounced inspections?
    Five commenters, two of which were professional organizations, 
expressed concern with the proposed model's option to permit 
unannounced inspections for complaint investigations. The commenters 
cited the potential for disrupting embryo laboratory procedures and 
interfering with patient treatment. Maintaining patient confidentiality 
during an inspection was also of concern. Three commenters suggested 
providing the laboratory 48 hours notice to allow rescheduling of 
patient procedures or other alternative measures to reduce the risk to 
eggs, sperm and embryos. The consumer advocacy group supported 
unannounced inspections if precautions are taken to prevent 
interference with patient treatment and safeguard patient 
confidentiality.
    Response: We understand the commenters' concerns, and agree that 
the nature of the work performed in embryo laboratories is delicate and 
time sensitive, and that disruptions or delays in the process could 
have deleterious effects. We also agree that maintaining patient 
confidentiality during a laboratory inspection is of utmost importance. 
When performing inspections, it is not the intent to disrupt the 
laboratory's operations or divulge confidential patient information. In 
general, Federal, State and professional accreditation organization 
laboratory inspectors are health professionals with pertinent 
education, qualifications, and experience. They receive special 
training and are instructed to make every effort to avoid interrupting 
the routine workflow when conducting an inspection. They are also aware 
of the importance of safeguarding confidential patient information.
    The proposed model program did not mandate that unannounced 
inspections must be performed for complaint investigations, but it did 
provide the State that chooses to adopt the model the option to do so. 
We included this option so that investigations of complaints of truly 
egregious behavior could be conducted immediately and unannounced. In 
addition, this option would allow the State to incorporate embryo 
laboratory inspections into an already existing laboratory or health 
care facility regulatory program that may require unannounced complaint 
inspections. Based on the comments we received, and because of the 
unique nature of the procedures performed in embryo laboratories, we 
agree that in some cases there may be a need to allow 48 hours notice 
prior to conducting a complaint inspection. This could be done to give 
the laboratory time to reschedule ART procedures, if necessary, and to 
ensure that adequate staffing and the appropriate individuals are 
available on the day of inspection. In addition, we do not believe that 
a 48 hour notice would significantly diminish the likelihood of 
discovering systemic deficiencies in a laboratory's operation. 
Therefore, if a State determines that it is appropriate to provide some 
advance notice of a complaint inspection, the model certification 
program as written allows the State to provide the laboratory a 48 hour 
notice.
    3. Is two years an appropriate period of time for the term of 
certification of a laboratory (i.e., renew biennially)?
    Two individuals provided comments on the time period for the term 
of certification. One of the commenters viewed a two year term as 
reasonable. The other commenter suggested that three to five years 
would be more appropriate as long as there was no significant change in 
the laboratory's personnel, no change in the laboratory's location, or 
no complaints registered against the laboratory.
    Response: A two year term of laboratory certification is consistent 
with other similar laboratory licensure or accreditation programs 
currently in existence. Maintaining this consistency among programs may 
allow for easier coordination of inspections if a laboratory 
participates in more than one program offered by the same organization 
or agency. For example, a facility that has both a clinical laboratory 
and a reproductive laboratory accredited by the CAP may be able to have 
a joint inspection for both of the programs. For this reason, we agree 
with

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the commenter who stated that a two year term is reasonable, and have 
not revised this requirement in the model certification program.
    4. Do the proposed embryo laboratory standards provide a sufficient 
means for monitoring laboratory performance or should a standard 
requiring PT be included in the model?
    Each of the four professional organizations commenting on the 
proposed model addressed the issue of PT. Three of the organizations 
did not support the inclusion of a PT requirement in the model 
certification program. They did not believe appropriate PT was 
available or could be developed and standardized due to the specimens 
(human gametes and embryos) used in the embryo laboratory. They stated 
this is especially true if the purpose of PT is to measure a 
laboratory's performance by replicating ART laboratory procedures. One 
organization strongly believed PT must be applied to embryo 
laboratories as it is applied to laboratories performing clinical 
laboratory testing; not doing so would undermine any potential 
effectiveness of the model program.
    Response: We agree that, at this time, the inclusion of PT in the 
model certification program for embryo laboratories is not appropriate. 
Proficiency testing monitors laboratory performance by comparing the 
laboratory's evaluation or measurement of external samples that mimic 
patient samples to known test results, or results obtained by 
standardized methods. Proficiency testing results should be comparable 
to results that would be obtained when testing similar patient samples. 
Definitive PT programs are available for andrology procedures (sperm 
counts and microscopic semen evaluations), however, the one program 
currently available for embryo laboratories evaluates whether a 
laboratory's bioassay system can detect toxicity in culture media 
samples sent to the laboratory by the program. It does not test a 
laboratory's ability to examine oocytes and embryos, or successfully 
perform other embryo laboratory procedures. Standardized methods for 
monitoring these laboratory procedures have not yet been developed, in 
part due to the fact that the ultimate measure of the performance of 
most embryo laboratory procedures is a viable human embryo.
    Proficiency testing is only one measure of a laboratory's quality. 
Other measures such as quality control, personnel standards, and 
monitoring laboratory practices must also be considered in determining 
the overall quality of laboratory performance. As mentioned in the 
preamble to the proposed model, these measures are all included in the 
model certification program. Since appropriate, standardized PT is not 
available at this time for embryo laboratory procedures, we have not 
included it in the model certification program. At such time as 
definitive PT becomes available for embryo laboratory procedures, 
States that adopt the model certification program or develop an 
equivalent program should consider including it in their program as an 
additional indicator of laboratory performance.
    5. Additional comments.
    Comment: One commenter requested clarification of what regulations 
take priority, or must be met, when there is a conflict/difference 
between Federal and State laboratory requirements.
    Response: A laboratory must meet all applicable Federal, State and 
local requirements, and when differences exist among regulations, the 
laboratory must meet the most stringent requirement. By doing this, the 
laboratory should meet corresponding regulations that are less 
stringent.
    Comment: One professional organization strongly urged the CDC to 
approve accreditation organizations for embryo laboratory certification 
purposes. The organization believes that CDC approval of the CAP/ASRM 
Reproductive Laboratory Accreditation Program (RLAP) and others that 
could be developed would be the best means to protect the public health 
without creating overly burdensome and redundant regulation. An 
additional commenter endorsed the existing CAP/ASRM RLAP as the means 
to assure constructive assessment of embryologic methods and 
improvement in the quality of ART programs.
    Response: The CDC recognizes there are existing voluntary 
accreditation programs currently available that provide oversight of 
ART embryo laboratories and have had a positive impact on laboratory 
quality without Federal oversight. These programs were reviewed and 
served as examples in developing the model certification program for 
embryo laboratories, and could provide an excellent resource for States 
that wish to develop their own certification program. One such program 
is the CAP/ASRM RLAP, mentioned above.
    While we agree that Federal approval of an accreditation 
organization(s) could be beneficial to laboratories in States which do 
not adopt the model or have an equivalent certification program, as 
explained below, this would go beyond the proposed model's 
implementation plan which permits States to approve accreditation 
organizations to certify laboratories within their respective State. As 
stated earlier in the preamble, the FCSRCA authorizes the Secretary and 
States to charge fees to cover the costs of the model certification 
program. Since this is a voluntary program, and laboratories have not 
indicated they would opt into such a self-supporting program, at this 
time, the CDC is deferring the implementation of the approval and 
subsequent monitoring of accreditation organizations to States that 
choose to adopt the model certification program and wish to use an 
accreditation organization for State certification purposes.
    Although we have not officially approved any accreditation programs 
or determined their equivalency to the model certification program, as 
data become available, the CDC will publish the certification/
accreditation status of embryo laboratories affiliated with ART 
programs or clinics in conjunction with future annual publications of 
the ART Success Rates reports.
    Comment: One commenter asserted that any fees charged for 
certification must not be unduly excessive or burdensome to the 
laboratory. The commenter suggested the cost of certification be 
adjusted with respect to the laboratory's level of activity, i.e., 
higher volume laboratories should be charged more than smaller volume 
laboratories. A professional organization commented that the Federal 
government should share the costs of the certification and 
accreditation programs.
    Response: It will be up to each State that adopts the model program 
to develop fee schedules and the methodology for determining fees 
charged to the laboratory for certification. Many existing licensing/
certification programs do establish fees based on volume of testing or 
number of procedures performed. The requirement that addresses fees at 
Part II., B., 8. of the model certification program was included to 
reiterate the FCSRCA's provision (Pub. L. 102-493, sec. 7) that allows 
charging such fees necessary to recoup the cost of administering a 
certification program.
    To date, the Federal government has assumed the cost of 
implementing the FCSRCA, in development of the laboratory standards and 
administrative process for the model certification program for embryo 
laboratories and publication of both the proposed and finalized model 
programs. In addition, the CDC will distribute this model program to 
State officials and health authorities as outlined in the statute and 
will provide the certification/accreditation status of embryo

[[Page 39378]]

laboratories affiliated with infertility clinics and ART programs in 
its annual publication of ART Success Rates.
    Comment: Two commenters expressed concern over the model's 
administrative requirement for the State, or as applicable, 
accreditation organization to make available to the public, upon 
request, the laboratory's specific inspection findings, including 
deficiencies identified and any subsequent corrections to those 
deficiencies. One of the commenters believed this would discourage a 
laboratory's participation in the voluntary certification program and 
that the public would be unable to interpret the published inspection 
findings.
    Response: The requirement to make a laboratory's inspection 
findings available to the public upon request was mandated by the 
FCSRCA. This requirement is part of the overall effort in the 
legislation to provide the public with consistently reliable and 
comparable information about the effectiveness of infertility services 
provided by ART clinics. It is one piece of the information that may be 
used by consumers in choosing a clinic for ART services. We disagree 
that this requirement would discourage laboratories that are 
maintaining good laboratory practices from participation in the 
voluntary model certification program. In fact, successful 
participation in a voluntary program such as the model certification 
program could be viewed as an asset for a laboratory or ART program 
seeking new clients. We also disagree with the commenter that the 
public would not be able to interpret inspection findings. The model 
certification program requires States and accreditation organizations 
to include the necessary explanatory information for the public to 
interpret the findings.
    Comment: Two professional organizations were concerned the model 
did not sufficiently address due process procedures for laboratories 
found to be out of compliance with the certification program's 
standards.
    Response: Due process procedures for laboratories that are not in 
compliance with certification program requirements are not described in 
the model program because such a process would be developed and 
performed at the State level and may vary from State to State. The 
reference to State development of due process procedures is found at 
Part II., B., 7., a. of the model certification program.
    Comment: One commenter disagreed with the model's proposed 
guideline at Part III., A., that the laboratory employ one individual 
for every 90-150 ART cycles performed by the laboratory annually. The 
commenter suggested one individual for every 100 ART cycles is more 
appropriate.
    Response: We disagree. We included the recommended range as a 
guideline for adequate staffing of a laboratory, recognizing that some 
embryo laboratories do not provide as extensive service as others and 
may not need as many employees. In addition, a laboratory's workload 
may vary over time, and it may not be possible to keep the staffing 
level at an exact number. By giving an appropriate range as a guideline 
for staffing, we are providing some guidance for laboratories while 
maintaining flexibility for the reasons stated above.
    Comment: A few commenters promoted requiring board certification 
for laboratory directors with a doctoral degree, with one of the 
commenters stating, ``Board examinations are the only comprehensive 
measure available of a candidate's command of a unified fund of 
laboratory specific knowledge and are crucial in establishing a minimum 
competence level for laboratory directorship in our field.'' One of the 
commenters misinterpreted the requirements of the model, thinking it 
would allow an individual with a doctoral degree in English (or other 
non-science major) to qualify as a laboratory director.
    Response: We agree it is beneficial for the director of the embryo 
laboratory to be board certified, especially if that certification is 
specific to reproductive laboratory science. However, we do not believe 
it is the only way to ensure that a laboratory director is qualified 
for this position. Therefore, while not making board certification a 
requirement, we are adding language at Part III., A., 1., b., 
recommending board certification in embryology for doctoral scientist 
laboratory directors.
    In response to the commenter who misread the model certification 
program requirements for a doctoral degree, Part I., Definitions, 
specifies the earned doctoral degree must be in a chemical, physical, 
biological or medical laboratory science. This would preclude an 
individual with a doctoral degree in English or other nonscience from 
fulfilling the qualification requirements for an embryo laboratory 
director.
    Comment: Several commenters, which included three professional 
organizations provided their opinions on the use of documented hours of 
training and numbers of ART cycles in an embryo laboratory as an 
appropriate qualification requirement for laboratory personnel, in 
particular the laboratory director. Reasons given by commenters for not 
requiring a specific number of hours and/or cycles of training/
experience included the following:
    Training should bear a logical relationship to the complexity of 
procedures performed. Some ART laboratory procedures may require fewer 
or greater number of repetitions to ensure competency, i.e., 
intracytoplasmic sperm injection (ICSI) requires more manipulation and 
skill than in vitro fertilization (IVF) and should have a higher hour/
cycle requirement assigned;
    The laboratory director should determine the adequacy of each 
employee's training/experience and not be locked into requiring an 
exact number of hours and/or cycles;
    Consideration must be given to the laboratory director, who may not 
always perform bench work;
    The number of hours/cycles may be impossible to document if a 
current laboratory director was trained several years in the past; and
    Requiring the laboratory director to have 60 cycles of experience 
in ART procedures including IUI, IVC, conventional IVF, gamete 
intrafallopian transfer (GIFT), zygote intrafallopian transfer (ZIFT), 
ICSI, and assisted hatching, etc., if these procedures are not offered 
by a facility is unreasonable.
    On the other hand, one professional organization stated that, for 
laboratory directors, the number of ART laboratory cycles performed is 
a better measure of training and experience than a specific number of 
hours of training. This organization suggested 60 ART cycles and six 
months full time in an IVF laboratory is sufficient training for 
reproductive endocrinologists. Another professional organization agreed 
if the laboratory director was performing bench work, a requisite 
number of hours and cycles correlating with the skill level for a 
specific procedure should be met. Both organizations stated the model 
program should be flexible and accommodate future changes in embryo 
laboratory procedures.
    Response: Professional guidelines such as the ASRM's revised 
minimum standards for IVF, GIFT, and related procedures (see 
References) were a valuable resource in developing the model 
certification program. The ASRM guidelines recommend the embryo 
laboratory director or supervisor should have had at least six months 
training and completed at least 60 ART procedures in a program that 
performs at least 100 IVF procedures per year with a minimum annual 10% 
IVF live birth rate per retrieval cycle. The ASRM defines an ART 
procedure as ``a combination of the examination of

[[Page 39379]]

follicular aspirates, insemination, documentation of fertilization and 
preparation for embryo transfer.'' These guidelines also recommend that 
embryo laboratory technologists have evidence of completion of 30 
complete IVF procedures under continuous supervision of the laboratory 
director or supervisor.
    The ASRM recommendations for personnel training are similar to 
those proposed in the model certification program. The model's proposed 
training requirement for the laboratory director and supervisor of one 
thousand hours of laboratory training is approximately equal to the 
ASRM's requirement of six months of full-time (40 hour week) training. 
The ASRM's recommendation for completion of 60 ART laboratory 
procedures is synonymous with the model's requirement for ``performing, 
at a minimum, each laboratory component of the human ART cycle 60 
times''. For the reproductive biologist, the model program proposed to 
require training that included performing the ART laboratory 
procedure(s) to be performed in the laboratory, at a minimum, 30 times 
under direct and constant supervision.
    We do not agree with the commenters who recommended we not require 
a specific number of hours of documented training, and/or performance 
of a certain number ART laboratory procedures for laboratory director, 
laboratory supervisor, or reproductive biologist. Although we recognize 
it can be difficult to impose a blanket training requirement for the 
skill level needed for a diverse group of laboratory procedures, we 
believe the requirements in the model certification program are 
consistent with the ASRM guidelines and appropriate (with minor 
revisions) as minimum training requirements for the majority of ART 
laboratory procedures and job duties to be performed by each respective 
personnel category. We agree with the commenters who suggested some ART 
laboratory procedures require more extensive technical skill and 
manipulation (e.g., ICSI) and may need additional repetitions prior to 
assuring competence of an individual. As stated in the model, it is the 
responsibility of the laboratory director to ensure all personnel 
receive appropriate training, and can demonstrate reliable performance 
of procedures prior to working on patient specimens (Part III., A., 2., 
k.). If the director determines it is necessary to increase the number 
of repetitions for some ART laboratory procedures, he or she should 
require such for adequate personnel training.
    For clarification of the requirements in the model certification 
program and for consistency with the ASRM guidelines, we have replaced 
the laboratory director requirement at Part III., A., 1., b., ii., and 
c., ii., for at least ``1000 hours'' of documented training with ``six 
months.'' In this same section, and at Part III., A., 3., b., ii., and 
c., ii., we have substituted ``each ART laboratory procedure 60 times'' 
for ``each laboratory component of the human assisted reproductive 
technology cycle 60 times.'' Although we have deleted the word 
``human'' from this requirement, the model's definition for ART 
laboratory procedures specifies these are ``all laboratory procedures 
for the handling and processing of human oocytes and sperm, or embryos, 
with the intent of establishing a pregnancy.''
    In response to the comments regarding the role of the laboratory 
director, as outlined in the model program, the laboratory director is 
responsible for the overall operation, administration, and technical 
and scientific oversight of the embryo laboratory. Although in some 
laboratories this may not include day-to-day performance of ART 
laboratory procedures, it does require the director to have knowledge 
and technical skills pertaining to the ART laboratory procedures 
selected/developed and performed in the facility. He or she must also 
ensure all personnel receive appropriate training for the ART 
laboratory procedures to be performed, and the laboratory supervisor is 
technically qualified for that position. Based on these 
responsibilities, we believe it is necessary for the laboratory 
director to have at least six months training in an embryo laboratory, 
and have performed each ART laboratory procedure at least 60 times as 
part of the training process.
    Since the laboratory supervisor is responsible for day-to-day 
supervision and oversight of the embryo laboratory and may perform the 
laboratory director responsibilities if authorized in writing by the 
director, the model program also requires the supervisor to have 
training which includes performing each ART laboratory procedure at 
least 60 times. We note that in finalizing the model program, we have 
clarified at Part III., A., 2., that the laboratory director may 
delegate performance of his or her responsibilities to an individual 
qualified as a laboratory supervisor or laboratory director.
    In response to the commenter who was concerned about documentation 
of an individual's training if that person had been working for a 
number of years, the part of the training that may be difficult to 
document would be the number of ART laboratory procedures performed by 
that individual. In such cases, laboratory worksheets or logbooks, or 
other forms of laboratory documentation showing completion of ART 
laboratory procedures by a specific individual may be used as the 
documentation that adequate training has been completed.
    The commenter who interpreted the qualification requirements for 
laboratory director as being 60 cycles of IUI, IVC, * * * etc., 
misinterpreted the model program. As explained above, the model 
requires the laboratory director to perform at least 60 ART laboratory 
procedures as part of his or her training. Performing medical 
procedures that may be part of an ART cycle, such as IUI, GIFT, and 
ZIFT is not required. ART laboratory procedures do include, but are not 
limited to, ``the examination of follicular aspirates, oocyte 
classification, sperm preparation, oocyte insemination, assessment of 
fertilization, assessment of embryo development, preparation of embryos 
for embryo transfer, and cryopreservation of specimens.'' We believe it 
is appropriate for both the laboratory director and laboratory 
supervisor to be trained in the performance of all of these procedures 
to adequately carry out their duties and provide oversight of 
reproductive biologists who are performing any of these procedures. 
Although procedures such as ICSI, assisted hatching or other 
micromanipulative techniques are laboratory procedures, they are 
specific techniques for oocyte insemination and assessment of embryo 
development. We would not expect the laboratory director and supervisor 
to be trained in these specialized techniques, unless they perform them 
in their laboratory.
    Comment: One individual stated there should be a requirement for 
the laboratory director and supervisor to each perform at least 25 ART 
cycles per year.
    Response: We agree with the commenter that, to maintain their 
skills and expertise, embryo laboratory personnel performing ART 
laboratory procedures should perform a minimum number of these 
procedures on an annual basis. The ASRM guidelines, described in the 
previous response, recommend each staff embryologist (including the 
laboratory director or supervisor) perform at least 20 ART procedures a 
year, in contrast to the 25 ART cycles suggested by the commenter. We 
believe performance of a minimum of 20 ART laboratory procedures per 
year is a reasonable number to recommend if an individual

[[Page 39380]]

performs ART laboratory procedures as part of his or her 
responsibilities. Since it is consistent with what is recommended by 
the ASRM professional guidelines, we are recommending at Parts III., 
1., d., ii. and 3., d., ii., for the laboratory director and laboratory 
supervisor, that if the individual serving in either position performs 
ART laboratory procedures in the laboratory, he or she should perform 
each of these laboratory procedures at least 20 times annually. We have 
also added a recommendation at Part III., 5., d., ii. that each 
reproductive biologist perform each of the ART laboratory procedures he 
or she performs in the laboratory at least 20 times annually.
    Comment: One commenter was concerned the proposed model's personnel 
qualification requirements fail to address formal and specific 
education in reproductive medicine and promotes on-the-job training as 
the only option to fulfill the educational requirement because the 
model program would ``grandfather'' currently employed individuals who 
do not have an appropriate college degree. The commenter asked that we 
consider adding provisions that would allow formal education in 
reproductive laboratory science as an option to on-the-job training. A 
professional organization also suggested the proposed ``grandfather'' 
clauses at Part III., A., 3, c., and 5., c., include a minimum 
educational standard, specifically a bachelor's degree for the 
laboratory supervisor and an associate's degree for the reproductive 
biologist.
    Response: We agree with the commenter that it is appropriate to 
include reproductive laboratory science in the list of acceptable 
academic degrees for all categories of embryo laboratory personnel. 
However, we do not agree that having this degree is sufficient to 
delete the training or experience requirements for any of the personnel 
categories. In this rapidly changing field, where accurate performance 
of laboratory procedures is dependent on the skill and expertise of the 
individual performing the procedures, we believe in addition to an 
academic degree, it is critical to obtain adequate hands-on training 
and experience prior to working with human gametes and embryos. This is 
especially true for procedures that may differ significantly from one 
laboratory to another.
    We do not agree with the comment made by the professional 
organization that minimum educational standards should be included in 
the ``grandfather'' clauses at Part III., A., 3, c., and 5., c. of the 
model certification program. In developing standards for this 
relatively new area of laboratory technology, we do not wish to create 
a situation where individuals who have been working in the field would 
not meet the qualifications specified for their positions. In the model 
certification program, we have specified educational requirements which 
must be met by individuals who first become employed in an embryo 
laboratory after the date of this Federal Register notice. For the 
reason stated above, individuals serving in these positions on or 
before July 20, 1999 who have the specified experience and/or training 
requirements for their respective positions will be considered 
qualified.
    Comment: A professional organization and two individuals commented 
on the proposed requirements for the laboratory director, supervisor 
and reproductive biologist to obtain 12 contact hours of continuing 
education per year in ART or clinical laboratory practice. While the 
professional organization expressed the view that continuing education 
for non-supervisory personnel as specified in the proposed model 
program is acceptable, one of the individual commenters felt that 12 
contact hours was excessive for non-supervisory personnel as well as 
costly for the ART program. This commenter suggested reducing the 
requirement to 12 contact hours every two years. The other individual 
commenter noted the proposed requirement at Part III., A., 2., l., made 
the laboratory director responsible for ensuring each employee obtain 
the required continuing education. The commenter felt this should also 
be the reproductive biologist's responsibility and that reading 
appropriate literature should count as continuing education.
    Response: We agree with the professional organization that in this 
rapidly evolving field of science and technology, it is appropriate and 
necessary for all levels of laboratory personnel to maintain current 
knowledge and skills relevant to ART embryo laboratory procedures. We 
do not believe requiring 12 contact hours of continuing education (CE) 
on an annual basis is excessive. At the same time, we recognize there 
may be some cost to the laboratory or individual to obtain the 
continuing education. However, we believe the benefits outweigh the 
costs, especially when there are a number of ways in which CE may be 
provided, including video or audioconferencing seminars or self-study 
educational materials. As the one commenter suggested, reading relevant 
journal articles is another cost-effective way to obtain CE. However, 
we note that to meet the model's CE requirement, the specific vehicle 
used for earning CE contact hours must have been approved by an 
approved continuing education provider such as the International 
Association of Continuing Education and Training or other provider 
specified by the State implementing the model certification program.
    We agree that each reproductive biologist, as well as laboratory 
supervisor, should be pro-active in obtaining appropriate CE. However, 
as stated previously, it is the laboratory director who is ultimately 
responsible for the overall operation, administration and technical and 
scientific oversight of the laboratory. This includes employing 
qualified personnel and ensuring they receive appropriate training and 
continuing education to maintain and update their knowledge and skills 
in ART and laboratory practice.
    Comment: One commenter requested clarification of the proposed 
requirements at Part III., B., 1., and C., 2., which require the 
laboratory to have ``adequate'' space and ``sufficient'' equipment for 
the type and volume of ART laboratory procedures performed. 
Specifically, the commenter would like guidelines that address the 
number of procedures per square foot of space and the number of 
procedures per cell freezer, etc.
    Response: Although we appreciate the commenter's suggestion to more 
specifically define adequate space and sufficient equipment for an 
embryo laboratory, we have not specified exact laboratory measurements 
or numbers of required equipment in the model certification program in 
an effort to allow flexibility in the configuration and arrangement of 
laboratory facilities and equipment contained therein. Requirements may 
differ depending on the number and types of procedures performed, and 
the number of individuals that are employed by or using each 
laboratory. As noted in the proposed model standards, the physical 
space, utilities, and laboratory equipment must be able to accommodate 
the volume of ART laboratory procedures performed at its busiest time, 
in a manner that will reduce the potential for spilled, lost or 
misplaced patient specimens while they are being handled or stored. The 
laboratory must be secure and have limited access, and must include an 
isolated area for performing sterile techniques under aseptic 
conditions. The laboratory and administrative space must be 
conveniently located, but separate from patient areas, and immediate 
communication must be

[[Page 39381]]

possible with the oocyte retrieval and transfer room. As long as these 
requirements can reasonably be met, the space and equipment are 
considered adequate and sufficient.
    Comment: Four individuals pointed out the proposed requirement at 
Part III., B., 3., b., for animal specimens to be incubated separately 
from human specimens would disallow the use of an incubator containing 
human specimens when performing the mouse embryo bioassay for quality 
control purposes.
    Response: We agree with the commenters that the proposed 
requirement noted above could be interpreted to prohibit quality 
control procedures that require mouse embryos to be held in the same 
incubator as human specimens. However, there are acceptable alternative 
procedures (i.e., human sperm survival) that may be used for quality 
control if a laboratory does not have access to a separate incubator 
for checking media, glassware, pipettes, etc. The quality control for 
an incubator itself includes monitoring temperature, humidity and gas 
concentration, and does not require a bioassay to be performed.
    Although not mentioned by commenters, the use of live cells, 
tissues, organs from a nonhuman animal source transplanted or implanted 
into a human, or used for ex vivo contact with human body fluids, 
cells, tissues, organs that are subsequently given to a human recipient 
(xenotransplantation), raises a major public health dilemma. In its 
Guidance For Industry, Public Health Issues Posed by the Use of 
Nonhuman Primate Xenografts in Humans (April 1999), The Food and Drug 
Administration, in consultation with other Federal agencies, concluded 
that further scientific research, evaluation and public discussion is 
needed in order to obtain sufficient information to adequately assess 
and potentially reduce the risks (particularly the transmission of 
infectious agents) posed by the use of nonhuman primate cells, tissues 
and organs. A Federal Advisory Committee on Xenotransplantation is 
currently under development within the Department of Health and Human 
Services to address these issues, conduct discussions, and make 
recommendations regarding the use of nonhuman primate xenografts.
    To assure consistency with applicable Federal, State or local 
requirements as they are developed, we are revising the requirement at 
Part III., B., 3. , to state, ``If live nonhuman animal cells, tissues, 
and/or organs are used, all applicable Federal, State and local 
regulations regarding their handling, storage and use must be met.'' We 
believe this revision is appropriate and necessary in light of the 
serious public health issues that need to be addressed with their use 
in humans.
    Comment: One commenter expressed concern with the proposed 
requirement at Part III., C., 4., c., that states for oral requests for 
changes to the original written or electronic request for an ART 
laboratory procedure, the laboratory must receive written or electronic 
documentation within 24 hours from the authorized person requesting the 
change. The commenter states particularly in programs where the 
physicians and/or laboratory staff have multiple work sites, it is 
sometimes difficult to receive written confirmations within a 24-hour 
time frame.
    Response: It is critical for embryo laboratories to obtain written 
or electronic orders for procedures to be performed and that these 
orders are communicated clearly in a timely manner. This enables the 
laboratory to ensure adequate and appropriate staffing for scheduled 
procedures and, more importantly, it ensures that the patient's 
specimens used in the ART embryo laboratory procedures are handled 
appropriately. Some of the procedures are of a sensitive nature, and 
the laboratory could be subject to liability if an unauthorized 
laboratory procedure is accidentally performed due to miscommunication 
or lack of communication. The model certification program requires a 
written or electronic request by an authorized person prior to 
performing any procedure. It is only when there is a change to the 
original request that the model allows 24 hours for written or 
electronic verification of the change. We do not agree with the 
commenter that this time frame should be extended to 48 hours. In most 
cases, it is desirable to have written or electronic verification of 
revised orders at the time the decision is made to change the patient's 
treatment protocol. Allowing 24 hours provides a minimal amount of 
leeway for extenuating circumstances.
    Comment: One commenter was confused by the proposed requirement at 
Part III., C., 4., i., which states that clinical laboratory testing on 
specimens obtained by the embryo laboratory must be performed in 
accordance with the Clinical Laboratory Improvement Amendments of 1988 
(CLIA) regulations.
    Response: Examinations of materials derived from the human body to 
provide information for the diagnosis, prevention, or treatment of 
disease, or assessment of the health of human beings must be performed 
in accordance with the regulations (42 CFR Part 493) implementing CLIA. 
Examples of specimens that may be obtained by the embryo laboratory 
that would be subject to the CLIA regulations include blood or serum 
samples for endocrinology or hematology testing or microbiology culture 
samples. If the embryo laboratory performs this testing it must have a 
valid CLIA certificate for the testing to be performed, or if the 
laboratory is in a CLIA-exempt State it must be licensed by the State 
in which it is located. If the embryo laboratory refers specimens for 
clinical laboratory testing, the testing must be performed by a 
laboratory that meets the CLIA requirements. To clarify the requirement 
at Part III., C., 4., i., we are specifying the purpose of clinical 
laboratory testing is to ``provide information for the diagnosis, 
prevention or treatment of disease, or assessment of the health of 
human beings.''
    Comment: One professional organization suggested the quality 
control standards include an additional statement at Part III., C., 6., 
e., iv., that ``The use of blood-based media prepared in-house is not 
recommended. However, if such products are used then * * *'' This 
statement is to preface the proposed quality management requirement 
that the laboratory test blood-based media supplements prepared in-
house for several communicable diseases.
    Response: We agree with the commenter that it is not a recommended 
practice for the laboratory to prepare blood-based media or a blood-
based media supplement that could potentially contain and transmit 
communicable diseases. However, if blood-based media or supplements are 
prepared in-house, blood from the donor(s) used to make the media/
supplement must be tested to ensure the donor(s) is negative/
nonreactive for significant disease agents. We have added language to 
the requirement at Part III., C., 6., e., iv., to state that the in-
house preparation of blood-based media or a blood-based media 
supplement is not recommended. In addition, we have clarified that the 
blood donor(s) must be tested for the communicable diseases listed 
using FDA licensed, approved or cleared tests for markers of these 
diseases. Also, to maintain consistency with the FDA's requirements for 
the testing of blood and tissue product donors, we have added human T-
cell lymphotrophic virus, Type II, to the communicable diseases listed 
in this requirement.
    Comment: One commenter recommended that the proposed quality 
assurance requirement at Part III., C., 7.,

[[Page 39382]]

b., for the laboratory to track and evaluate procedural outcomes (e.g., 
fertilization rates and embryo quality) should be incorporated into the 
current Society for Assisted Reproductive Technology (SART) reporting 
computer program. The commenter believes capturing the data in the SART 
program would help to reduce the amount of additional paperwork for the 
laboratory.
    Response: We recognize that for some laboratories, it may be 
possible to maintain the data listed at Part III., C., 7., b. in a 
database similar to that used by SART to collect data on ART programs 
and clinics. However, we do not agree this should be required by the 
model certification program for several reasons. First, the data 
collected by SART is not specific to embryo laboratory activities, but 
their data relates to clinical ART practices and pregnancy success 
rates reported by ART programs/clinics. In addition, there are many 
instances in which there is not a direct, one-to-one relationship 
between ART programs/clinics and the embryo laboratories used by these 
facilities, and not all ART programs report to SART. To meet the 
standards in the model certification program, laboratories must record 
and track the data described in the model. These data are part of the 
laboratory's internal system to monitor the ongoing quality of its 
activities.
    Comment: One professional organization commented that the proposed 
ten year period for record retention is excessive and should be reduced 
to a five year period, while a consumer advocacy group felt indefinite 
record-keeping should be considered since consumers of ART procedures 
need to know if they, or their children, have ever had exposure to 
contaminants through laboratory procedures.
    Response: While we appreciate the consumer advocacy group's 
concerns, requiring indefinite retention of all laboratory records 
could be extremely burdensome for some laboratories. We proposed the 
ten year period for record retention because it was consistent with 
similar requirements mandated by the Food and Drug Administration for 
human tissue intended for transplantation. We continue to believe this 
time period is reasonable and have not changed the requirement in the 
model certification program. However, we note that the 1998 Survey of 
Assisted Reproductive Technology Embryo Laboratory Procedures and 
Practices conducted by the CDC indicated the majority of embryo 
laboratories are retaining most of their records indefinitely. If 
consumers are concerned they may not have indefinite access to 
pertinent laboratory records, it may be possible for them to request 
the laboratory provide them with all relevant information at the time 
of an ART procedure. The consumer could then maintain this information 
for as long as desired.

Additional Revisions to the Proposed Model Certification Program

    Although written comment was not received on the following, we are 
making a few additional revisions to the administrative requirements 
proposed in the model certification program for the reasons stated 
below.
     At Part II., B., 2., d., vi., we are extending the time 
frame in which the approved accreditation organization must provide the 
State advanced written notice of the effective date of any proposed 
changes in the organization's requirements from ``at least 30 days'' to 
``at least 60 days.'' We believe that this revision will provide the 
State a more reasonable period of time to review the organization's 
proposed changes for continued equivalency to the State's certification 
program.
     At Part II., B., 4., a., we are revising the language that 
states ``Initial inspections are performed when the laboratory applies 
for certification and may be performed for recertification after the 
laboratory has had a change in ownership or administration,'' to 
include a change in the laboratory's location. We believe a change in 
the laboratory's location may require an onsite inspection to ensure 
that the laboratory continues to meet the certification program's 
requirements for adequate space and appropriate environmental 
conditions. A conforming change is also being made at Part II., B., 3., 
ii., which requires the embryo laboratory to submit changes in its 
ownership or administration to the State within 30 days of the change.

A Model Program for the Certification of Embryo Laboratories

    With this publication, CDC has provided a model program for the 
certification of embryo laboratories which incorporates the definitions 
and laboratory standards called for in the FCSRCA and has included 
administrative requirements for States which choose to adopt the model 
program. CDC will distribute the model certification program to State 
officials and health authorities as outlined in the statute, and 
encourage their assistance in the State adopting the program.
    As stated in the preamble to the proposed model certification 
program, CDC will defer implementation of the approval of State 
certification programs or accreditation organizations, as well as 
Federal validation inspections of embryo laboratories certified by 
States adopting the model or accredited by an accreditation program for 
embryo laboratories. While Congress anticipated that the cost of 
Federal and State monitoring and oversight of embryo laboratories would 
be covered by the fees paid by participating laboratories, 
participation by embryo laboratories is voluntary and laboratories not 
willing to pay these fees would not be limited in their ability to 
operate. To date, embryo laboratories have not indicated they would opt 
into such a voluntary oversight program.
    While the model certification program for embryo laboratories does 
not provide for a Federal oversight role, we believe that this model 
provides an excellent resource for States that wish to develop their 
own programs and professional organizations with an interest in 
establishing or adopting standards for the embryo laboratory. In 
addition, as mentioned previously in this preamble, as the data become 
available, the CDC will publish the certification/accreditation status 
of embryo laboratories affiliated with ART programs or clinics in 
conjunction with future annual publications of the ART Success Rates 
reports.

Organization of the Model Certification Program

    This notice describes a model certification program for embryo 
laboratories and includes definitions (Part I), administrative 
requirements (Part II), and embryo laboratory standards (Part III). 
References are also provided as an addendum to this notice for 
background and educational purposes.

    Dated: July 14, 1999.
Thena M. Durham,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention.

A Model Certification Program for Embryo Laboratories

Contents

Part I. Definitions
Part II. Administrative Requirements
Part III. Embryo Laboratory Standards
Addendum References

Part I. Definitions

    Accredited institution. A school or program which--
    (a) Admits as a regular student only persons having a certificate 
of graduation from a school providing secondary education, or the 
recognized equivalent of such certificate;

[[Page 39383]]

    (b) Is legally authorized within the State to provide a program of 
education beyond secondary education;
    (c) Provides an educational program for which it awards a 
bachelor's degree or provides not less than a 2-year program which is 
acceptable toward such a degree, or provides an educational program for 
which it awards a master's or doctoral degree; and
    (d) Is accredited by a nationally recognized accrediting agency or 
association.
    This definition includes any foreign institution of higher 
education that HHS or its designee determines meets substantially 
equivalent requirements.
    Approved accreditation organization. An accreditation organization 
that has formally applied for and received the State's approval based 
on the organization's compliance with this model certification program 
and other requirements as specified by the State.
    ART. Assisted reproductive technology.
    Assisted hatching. A micromanipulation technique which involves 
making a small opening in the zona wall of the embryo to enhance 
implantation.
    Assisted reproductive technology. All clinical treatments and 
laboratory procedures which include the handling of human oocytes and 
sperm, or embryos, with the intent of establishing a pregnancy. This 
includes, but is not limited to, in vitro fertilization, gamete 
intrafallopian transfer, zygote intrafallopian transfer, embryo 
cryopreservation, oocyte or embryo donation, and gestational surrogacy.
    Assisted reproductive technology cycle. Any cycle in which (1) ART 
has been used, (2) in which the woman has undergone ovarian stimulation 
or monitoring with the intent of undergoing ART, (3) a woman has 
donated oocytes, or (4) in the case of cryopreserved embryos, in which 
embryos have been thawed with the intent of transfer. ART cycles can be 
stimulated (use of ovulation induction) or unstimulated (natural 
cycle).
    Assisted reproductive technology laboratory procedures. All 
laboratory procedures for handling and processing of human oocytes and 
sperm, or embryos, with the intent of establishing a pregnancy. These 
procedures include, but are not limited to, the examination of 
follicular aspirates, oocyte classification, sperm preparation, oocyte 
insemination, assessment of fertilization, assessment of embryo 
development, preparation of embryos for embryo transfer, and 
cryopreservation of specimens.
    Assisted reproductive technology program or clinic. A legal entity 
practicing under State law, recognizable to the consumer, that provides 
ART to couples who have experienced infertility or are undergoing ART 
for other reasons. This can be an individual physician or a group of 
physicians who practice together, and share resources and liability.
    Authorized person. An individual authorized under State law to 
order ART procedures.
    CDC. The Centers for Disease Control and Prevention.
    CLIA. The Clinical Laboratory Improvement Amendments of 1988.
    Certification. The certification of an embryo laboratory by a State 
certification program or through accreditation by an approved 
accreditation organization.
    Certification program. The model certification program for embryo 
laboratories described in this notice or a State certification program 
for embryo laboratories which meets or exceeds the requirements of the 
model certification program.
    Cryopreservation. A technique to preserve biologic material through 
freezing.
    Doctoral scientist. An individual holding an earned doctoral degree 
in a chemical, physical, biological, medical or reproductive laboratory 
science from an accredited institution. As defined here, doctoral 
scientist also includes individuals holding an earned doctoral degree 
in veterinary medicine.
    Embryo. The normal (2 pronuclei) fertilized egg that has undergone 
one or more divisions.
    Embryo laboratory. A facility in which human oocytes and sperm, or 
embryos, are subject to ART laboratory procedures.
    Embryo transfer. Introduction of an embryo(s) into a woman's uterus 
after in vitro fertilization.
    Fertilization. The penetration of the egg by the sperm and fusion 
of genetic materials to result in the development of a fertilized egg 
(or zygote).
    Gamete intrafallopian transfer. An ART procedure that involves 
removing eggs from the woman's ovary, combining them with sperm, and 
immediately injecting the eggs and sperm into the fallopian tube. 
Fertilization takes place inside the fallopian tube.
    HHS. The U.S. Department of Health and Human Services, or its 
designee.
    Intracytoplasmic sperm injection. The placement of a single sperm 
into the ooplasm of an oocyte by micro-operative techniques.
    In vitro fertilization. A method of assisted reproduction that 
involves removing eggs from a woman's ovaries, combining them with 
sperm in the laboratory and, if fertilized, replacing the resulting 
embryo(s) into the woman's uterus.
    Laboratory. Unless otherwise specified in this notice, means embryo 
laboratory.
    Micromanipulation. Microtechniques such as intracytoplasmic sperm 
injection and assisted hatching commonly used to overcome fertilization 
disorders.
    Oocyte. The female reproductive cell, also called an egg.
    Physician. An individual with a doctor of medicine or doctor of 
osteopathy degree who is licensed by the State to practice medicine or 
osteopathy within the State in which the embryo laboratory is located.
    Procedural outcome. The outcome of the ART laboratory procedure 
performed e.g., fertilization assessment-the presence of two pronuclei 
in the ooplasm.
    Specimen. Human biologic material (includes human reproductive 
tissue such as oocytes, sperm, zygotes and embryos).
    Sperm. The male reproductive cell that has completed the process of 
meiosis and morphological differentiation.
    State. Includes, for purposes of this model certification program, 
each of the 50 States, the District of Columbia, the Commonwealth of 
Puerto Rico, the Virgin Islands, and other territories of the United 
States, and a political subdivision of a State where the State, acting 
pursuant to State law, has expressly delegated powers to the political 
subdivision sufficient to authorize the political subdivision to act 
for the State in enforcing requirements equal to or more stringent than 
the model certification program.
    Zygote. A normal (2 pronuclei) fertilized egg before cell division 
begins.
    Zygote intrafallopian transfer. Eggs are collected and fertilized, 
and the resulting zygote is then transferred to the fallopian tube.

Part II. Administrative Requirements

A. Overview

    The certification program for embryo laboratories is a model 
program developed by the Centers for Disease Control and Prevention 
(CDC) in accordance with Pub. L. 102-493 (42 U.S.C. 263a-1 et seq.) and 
is to be administered by interested States.

[[Page 39384]]

B. Requirements for State Administration of the Model Certification 
Program for Embryo Laboratories

    The State may adopt and administer the model certification program 
for embryo laboratories described in this notice or administer a State 
certification program for embryo laboratories that meets or exceeds the 
requirements of the model certification program, and must, at a 
minimum, meet the following provisions--
    1. Certification Under State Programs. A State may qualify to adopt 
and administer the model certification program if the State submits an 
attestation to the CDC, Public Health Practice Program Office, Division 
of Laboratory Systems, 1600 Clifton Rd., Atlanta, GA 30333, providing--
    a. Assurances that the certification program for embryo 
laboratories administered by the State meets or exceeds the 
requirements of the model certification program specified in this 
notice.
    b. An agreement that in administering the certification program, a 
State will not establish any regulation, standard, or requirement which 
has the effect of exercising supervision or control over the practice 
of medicine in ART programs or clinics.
    c. An agreement that the term of State certification/
recertification issued to an embryo laboratory is for a period of not 
more than two years.
    d. An agreement to investigate, when appropriate and to the extent 
necessary, complaints received about an embryo laboratory certified 
under the State's program.
    e. An agreement to annually report to the CDC, Public Health 
Practice Program Office, Division of Laboratory Systems, 1600 Clifton 
Rd., Atlanta, GA 30333, the identity and certification status of each 
embryo laboratory in the State as well as any such laboratory which has 
applied for certification, and the ART programs or clinics with which 
each embryo laboratory is associated, for annual publication by the 
CDC.
    f. Information about any proposed use and approval and revocation 
of approval of accreditation organizations in accordance with 
paragraphs 2. and 5. of this section.
    g. An agreement to make such reports as the Secretary of the 
Department of Health and Human Services (through the CDC) may require.
    2. Use and Approval of Accreditation Organizations. Accreditation 
organizations approved by the State may be used to inspect and accredit 
embryo laboratories for the purpose of State certification and such 
accreditation shall constitute certification. The criteria and 
procedures used by the State to approve accreditation organizations 
must include, at a minimum, the following:
    a. The accreditation organization must provide assurances 
satisfactory to the State that its standards and requirements for 
accreditation of embryo laboratories meet or exceed the requirements of 
the certification program;
    b. The accreditation organization must, at a minimum, conduct 
inspections of embryo laboratories in accordance with the requirements 
under paragraph 4. of this section which includes making available to 
the public, upon request, the specific findings (with any explanatory 
information required to interpret the findings), including deficiencies 
identified in an inspection, and any subsequent corrections to those 
deficiencies, no later than 60 days after the date of the inspection;
    c. The accreditation organization must agree to revoke or suspend a 
laboratory's accreditation for one year, if the accreditation 
organization finds, on the basis of inspections, that the owner or 
operator of the laboratory, or any employee of the laboratory--
    i. Has been guilty of misrepresentation in obtaining the 
accreditation.
    ii. Has failed to comply with any standards of the accreditation 
program.
    iii. Has refused a request of the accreditation organization or 
State for permission to inspect the laboratory, its operations, and 
records; and
    d. The accreditation organization must agree to submit such reports 
and maintain such records as the State, or HHS, may require, to 
include, but not be limited to, the following:
    i. Notification to the State of each newly accredited embryo 
laboratory within the State within 30 days of the laboratory obtaining 
accreditation;
    ii. Notification to the State of any embryo laboratory within the 
State that has its accreditation denied, suspended, withdrawn or 
revoked, or that has had any other adverse action taken against it by 
the accreditation organization within 30 days of the action taken;
    iii. Notification to the State within 10 days of a deficiency 
identified in any accredited embryo laboratory within the State where 
the deficiency poses an immediate jeopardy to the laboratory's patients 
or a hazard to the general public;
    iv. Notification to the State if the accreditation organization 
finds, on the basis of inspections, that the owner or operator of the 
laboratory, or any employee of the laboratory--
    A. Has been guilty of misrepresentation in obtaining the 
accreditation.
    B. Has failed to comply with any standards of the accreditation 
program.
    C. Has refused a request of the accreditation organization for 
permission to inspect the laboratory, its operations, and records;
    v. Provide inspection schedules as requested by the State for the 
purpose of conducting onsite validation inspections of laboratories; 
and
    vi. Provide the State written notification at least 60 days in 
advance of the effective date of any proposed changes in its 
requirements.
    3. Embryo Laboratory Application Requirements. The State must 
provide for the submission of an application to the State by an embryo 
laboratory requesting certification, in such form as may be specified 
by the State. Such an application must include the following:
    a. Assurances satisfactory to the State that the embryo laboratory 
will be operated in accordance with the standards of the certification 
program;
    b. An agreement by the embryo laboratory to--
    i. Annually report to the State the ART programs or clinics with 
which the laboratory is associated.
    ii. Submit changes in the ownership, administration, or location of 
the laboratory to the State within 30 days of the change.
    iii. Permit the State to conduct onsite inspections including, as 
applicable, initial, routine, validation and complaint inspections, 
upon presentation of identification to the owner, operator, or agent in 
charge of the laboratory, during the laboratory's regular hours of 
operation to determine compliance with the certification program.
    iv. Permit the State to have access to all facilities, equipment, 
materials, records, and information which the State requires to 
determine if the laboratory is being operated in accordance with the 
standards of the certification program.
    v. Permit the State to copy any material, record, or information 
inspected, or submit such, upon request by the State.
    vi. Permit the State to make available, upon request, to the 
public, the laboratory's specific inspection findings (with any 
explanatory information required to interpret the findings), including 
deficiencies identified in an inspection, and any subsequent 
corrections to those deficiencies;

[[Page 39385]]

    c. If the State allows certification of an embryo laboratory on the 
basis of the laboratory's accreditation by an approved accreditation 
organization (e.g., issues a certificate of accreditation), the 
laboratory must, in addition to the requirements of subparagraphs 3.a. 
and 3.b. of this section--
    i. Submit proof of current accreditation.
    ii. Permit the accreditation organization to have access to all 
facilities, equipment, materials, records, and information which the 
accreditation organization requires to determine if the laboratory is 
being operated in accordance with the standards of the accreditation 
organization program.
    iii. Permit the accreditation organization to copy any material, 
record, or information inspected, or submit such, upon request by the 
accreditation organization.
    iv. Permit the accreditation organization to make available, upon 
request, to the public, the laboratory's specific inspection findings 
(with any explanatory information required to interpret the findings), 
including deficiencies identified in an inspection, and any subsequent 
corrections to those deficiencies.
    v. Agree to authorize the accreditation organization to submit to 
the State or HHS such laboratory-specific information or reports as the 
State or HHS may require; and
    d. Such other information, agreements and assurances as the State 
finds necessary.
    4. Initial, Routine and Complaint Inspections. Inspections must be 
conducted to determine if embryo laboratories applying for or renewing 
their certification meet the requirements of the certification program. 
In addition, inspections may be performed as part of the State's 
investigation of complaints received about a certified embryo 
laboratory. The inspections may be carried out by the State or, as 
applicable, by an accreditation organization approved by the State in 
accordance with paragraph 2. of this section.
    a. Initial inspections for embryo laboratory certification must be 
performed during the laboratory's regular hours of operation and may be 
announced. Initial inspections are performed when the laboratory 
applies for certification and may be performed for recertification 
after the laboratory has had a change in ownership, administration, or 
location.
    b. Routine inspections for renewal of the laboratory's 
certification must be performed biennially, during the laboratory's 
regular hours of operation and may be announced.
    c. Inspections to investigate complaints received by the State 
about a laboratory may be performed unannounced, during the 
laboratory's regular hours of operation.
    d. Inspection of a laboratory may be made only upon the 
presentation of identification to the owner, operator, or agent in 
charge of the laboratory being inspected.
    e. In conducting an inspection, the State or approved accreditation 
organization must have access to all facilities, equipment, materials, 
records, and information which the State or approved accreditation 
organization requires to determine if the laboratory is being operated 
in accordance with the standards of the certification program.
    f. The State or approved accreditation organization may copy any 
material, record, or information inspected or require it to be 
submitted to the State or, as applicable, to the approved accreditation 
organization.
    g. The specific findings (with any explanatory information required 
to interpret the findings), including deficiencies identified in an 
inspection, and any subsequent corrections to those deficiencies must 
be made available to the public upon request beginning no later than 60 
days after the date of the inspection.
    5. Validation Inspections. The State must annually evaluate the 
performance of each approved accreditation organization by performing 
validation inspections of a sufficient number of embryo laboratories 
within the State accredited by the organization, to allow a reasonable 
estimate of the performance of such organization.
    a. The State may enter and inspect, during regular hours of 
operation, embryo laboratories which have been accredited by an 
approved accreditation organization for the purpose of determining 
whether the laboratory is being operated in accordance with the 
standards of the certification program.
    b. A validation inspection of a laboratory may be announced and be 
made only upon the presentation of identification to the owner, 
operator, or agent in charge of the laboratory being inspected.
    c. In conducting a validation inspection, the State must have 
access to all facilities, equipment, materials, records, and 
information which the State requires to determine if the laboratory is 
being operated in accordance with the standards of the certification 
program.
    d. The State may copy any material, record, or information 
inspected or require it to be submitted to the State.
    e. If the State determines as a result of a validation inspection 
that the embryo laboratory is not in compliance with the standards of 
the certification program, the State must--
    i. Notify the accreditation organization which accredited the 
laboratory.
    ii. Make available to the public the inspection findings (with any 
explanatory information required to interpret the findings), including 
deficiencies identified in the inspection, and any subsequent 
corrections to those deficiencies.
    iii. Conduct additional inspections of other embryo laboratories 
accredited by the accreditation organization to determine if the 
accreditation organization is reliably identifying the deficiencies of 
the laboratories.
    f. If the State determines that the accreditation organization has 
not met the requirements of paragraph 2. of this section, the State may 
(under such notice and hearing standards to be developed by the State) 
revoke the approval of the accreditation program.
    6. Revocation of an Accreditation Organization's State Approval. If 
the State revokes approval of an accreditation organization under 
subparagraph 5.f., of this section--
    a. The State must notify each laboratory, accredited by the 
organization under the State certification program, that it has revoked 
its approval of the organization within 10 days of the revocation.
    b. The certification of any embryo laboratory accredited by the 
organization will continue in effect for 60 days after the laboratory 
is notified by the State of the withdrawal of approval, except that the 
State may extend the period during which the certification may remain 
in effect if the State determines that the laboratory submitted an 
application to another approved accreditation organization for 
accreditation or to the State, as applicable, in a timely manner after 
receipt of such notice.
    7. Embryo Laboratory Certification Revocation and Suspension.
    a. A certification issued by a State for an embryo laboratory must 
be revoked or suspended if the State or, as applicable, approved 
accreditation organization finds, on the basis of inspections and after 
reasonable notice and opportunity for hearing (under such notice and 
hearing standards to be developed by the State) to the owner or 
operator of the laboratory, that the

[[Page 39386]]

owner or operator or any employee of the laboratory--
    i. Has been guilty of misrepresentation in obtaining the 
certification.
    ii. Has failed to comply with any standards of the certification 
program.
    iii. Has refused a request of the State or approved accreditation 
organization for permission to inspect the laboratory, its operations, 
and records.
    b. If the certification of an embryo laboratory is revoked or 
suspended, the certification of the laboratory shall continue in effect 
for 60 days after the laboratory receives notice of the revocation or 
suspension, unless there is a finding that the laboratory's continued 
operation may constitute a public health threat, in which case the 
certification shall be immediately revoked or suspended.
    c. If the certification of an embryo laboratory is revoked or 
suspended, the laboratory may apply for recertification after one year 
after the date of the revocation or suspension.
    8. Fees. The State may require the payment of fees for the purpose 
of, and in an amount sufficient to cover the costs of, administering 
the certification program.

Part III. Embryo Laboratory Standards

A. Personnel Qualifications and Responsibilities

    The embryo laboratory must have a sufficient number of individuals, 
who meet the qualification requirements, to perform the functions 
necessary to provide timely services appropriate for the size and 
volume of the ART program(s) or clinic(s) served by the laboratory. As 
a guideline, for every 90-150 ART cycles performed annually, the 
laboratory should employ one individual who is capable of performing 
all ART laboratory procedures provided by the embryo laboratory. 
Regardless of workload, at a minimum, two qualified individuals should 
be available to provide the appropriate laboratory services.
    1. Laboratory Director Qualifications. The laboratory director must 
be qualified to manage and direct the laboratory personnel and the 
performance of ART laboratory procedures. The laboratory director 
must--
    a. Possess a current license as an embryo laboratory director 
issued by the State in which the laboratory is located, if such 
licensing is required.
    b. Be a physician or a doctoral scientist with a broad knowledge of 
the biochemistry, biology, and physiology of reproduction, and 
laboratory operations including experimental design, statistics, and 
problem solving. It is recommended that a doctoral scientist serving as 
a laboratory director be board certified in embryology. In addition, 
the laboratory director must meet the following:
    i. Have two years documented pertinent experience in a laboratory 
performing ART procedures. This experience should include familiarity 
with laboratory quality control, sterile technique and cell culture; 
and
    ii. Have documented training of at least six months in an embryo 
laboratory which includes performing, at a minimum, each ART laboratory 
procedure 60 times.

    Note: Documented experience and training may be acquired 
concurrently.

    c. If not qualified under paragraph 1.b. of this section, be the 
director of an embryo laboratory on or before July 20, 1999 and meet 
the following:
    i. Have two years documented pertinent experience in a laboratory 
performing ART procedures. This experience should include familiarity 
with laboratory quality control, sterile technique and cell culture; 
and
    ii. Have documented training of at least six months in an embryo 
laboratory which includes performing, at a minimum, each ART laboratory 
procedure 60 times.

    Note: Documented experience and training may be acquired 
concurrently.

    d. In addition to meeting the qualification requirements above--
    i. Obtain at least 12 contact hours of continuing education 
annually in assisted reproductive technology or clinical laboratory 
practice; and
    ii. If the individual serving as the laboratory director performs 
ART laboratory procedures in the laboratory, it is recommended that he 
or she performs each of these procedures at least 20 times annually.
    2. Laboratory Director Responsibilities. The laboratory director is 
responsible for the overall operation, administration, and technical 
and scientific oversight of the embryo laboratory, including the 
employment of personnel who are qualified to perform ART laboratory 
procedures, and record and report procedural outcomes promptly, 
accurately and proficiently. If the laboratory director delegates 
performance of his or her responsibilities to an individual qualified 
as an embryo laboratory director or laboratory supervisor, he or she 
must do so in writing. The laboratory director remains responsible for 
ensuring that all delegated duties are properly performed. The 
laboratory director must--
    a. Be accessible to the laboratory to provide on-site, telephone or 
electronic consultation as needed.
    b. Ensure that the physical plant (space, facilities and equipment) 
and environmental conditions of the laboratory are appropriate for the 
laboratory procedures performed and provide a safe environment in which 
employees and other occupants are protected from physical, chemical, 
electrical and biological hazards.
    c. Establish and monitor a program to ensure that aseptic 
conditions are maintained in the laboratory, as appropriate, for the 
ART laboratory procedures to be performed.
    d. Ensure that ART laboratory procedures selected or developed by 
the laboratory are appropriate to provide quality patient care.
    e. Ensure that adequate systems are in place to maintain patient 
confidentiality throughout those parts of the ART process under the 
laboratory's control.
    f. Ensure that an approved procedure manual is available to all 
personnel responsible for performing ART laboratory procedures.
    g. Establish and monitor a quality management program to assure the 
quality of laboratory services provided and to identify failures in 
quality as they occur.
    h. Ensure that all necessary corrective actions are taken, 
documented and reviewed for effectiveness whenever failures in quality 
are identified.
    i. Provide consultation to physicians and others, as appropriate, 
regarding the clinical significance of laboratory findings.
    j. Employ a sufficient number of qualified personnel with the 
appropriate education and documented experience or training to 
supervise and perform the work of the laboratory. Written records of 
the qualifications of all personnel must be maintained.
    k. Ensure that all personnel receive appropriate training for the 
ART laboratory procedures to be performed, and have demonstrated that 
they can perform the procedures reliably prior to working on patients' 
specimens. All training activities must be documented.
    l. Ensure that all personnel acquire, on an annual basis, the 
required number of continuing education contact hours. A record of each 
employee's continuing education participation must be maintained.
    m. Specify, in writing, the responsibilities and duties of each 
person who performs ART laboratory procedures, identifying which 
procedures each individual is

[[Page 39387]]

authorized to perform and whether supervision is required.
    n. Ensure that policies and procedures are established for 
monitoring each employee's continued competence to perform ART 
laboratory procedures, and whenever necessary, provide remedial 
training or additional continuing education to improve skills.
    o. Ensure that performance evaluations for each employee are 
performed and documented, at a minimum, annually.
    3. Laboratory Supervisor Qualifications. The embryo laboratory must 
have one or more qualified supervisors who, under the direction of the 
laboratory director, provide day-to-day supervision of laboratory 
personnel performing ART laboratory procedures. In the absence of the 
director, the laboratory supervisor must be responsible for the proper 
performance of all ART laboratory procedures. The laboratory supervisor 
must--
     a. Possess a current license issued by the State in which the 
laboratory is located, if such licensing is required.
    b. Meet the qualification requirements for an embryo laboratory 
director under paragraph 1. of this section, or meet the following:
    i. Have an earned master's or bachelor's degree in a chemical, 
physical, biological, medical technology, clinical or reproductive 
laboratory science from an accredited institution; and
    ii. Have documented training which includes performing, at a 
minimum, each ART laboratory procedure 60 times.
    c. If not qualified under subparagraph 3.b. of this section, be the 
supervisor of an embryo laboratory on or before July 20, 1999 and have 
documented training which includes performing, at a minimum, each ART 
laboratory procedure 60 times.
    d. In addition to meeting the qualification requirements above--
    i. Obtain at least 12 contact hours of continuing education 
annually in assisted reproductive technology or clinical laboratory 
practice. If also serving as the laboratory director, continuing 
education obtained to meet the laboratory director qualification 
requirements may be used to meet this requirement; and
    ii. If the individual serving as the laboratory supervisor performs 
ART laboratory procedures in the laboratory, it is recommended that he 
or she performs each of these procedures at least 20 times annually.
    4. Laboratory Supervisor Responsibilities. The laboratory 
supervisor is responsible for day-to-day supervision or oversight of 
the embryo laboratory operation and personnel performing ART laboratory 
procedures. The laboratory supervisor must--
    a. Be accessible to laboratory personnel at all times when ART 
laboratory procedures are performed to provide on-site, telephone or 
electronic consultation to resolve technical problems in accordance 
with policies and procedures established by the laboratory director.
    b. Provide day-to-day supervision of laboratory personnel 
performing ART laboratory procedures.
    c. Ensure direct and constant supervision of personnel undergoing 
training in ART laboratory procedures to fulfill the qualification 
requirements for a reproductive biologist.
    d. Perform laboratory director responsibilities as authorized in 
writing by the laboratory director.
    5. Reproductive Biologist Qualifications. Each individual 
performing ART laboratory procedures must--
    a. Possess a current license issued by the State in which the 
laboratory is located, if such licensing is required.
    b. Meet the qualification requirements for an embryo laboratory 
director under paragraph 1. of this section, laboratory supervisor 
requirements under paragraph 3. of this section, or meet the following:
    i. Have an earned bachelor's degree in a chemical, physical, 
biological, medical technology, clinical or reproductive laboratory 
science from an accredited institution; and
    ii. Have documentation of training appropriate for the ART 
laboratory procedure(s) to be performed before performing the 
procedure(s) without direct and constant supervision on patient 
specimens. Training must include performing the ART laboratory 
procedure(s), at a minimum, 30 times under direct and constant 
supervision.
    c. If not qualified under subparagraph 5.b. of this section, be 
performing ART laboratory procedures in an embryo laboratory on or 
before July 20, 1999 and have documentation of training appropriate for 
the ART laboratory procedure(s) to be performed before performing the 
procedure(s) without direct and constant supervision on patient 
specimens. Training must include performing the ART laboratory 
procedure(s), at a minimum, 30 times under direct and constant 
supervision.
    d. In addition to meeting the qualification requirements above--
    i. Obtain at least 12 contact hours of continuing education 
annually in ART or clinical laboratory practice. If also serving as the 
laboratory director or laboratory supervisor, continuing education 
obtained to meet the laboratory director or laboratory supervisor 
qualification requirements may be used to meet this requirement; and
    ii. It is recommended that each reproductive biologist perform each 
of the ART laboratory procedures he or she performs in the laboratory 
at least 20 times annually.
    6. Reproductive Biologist Responsibilities. The reproductive 
biologist is responsible for performing ART laboratory procedures, and 
recording and reporting procedural outcomes promptly, accurately and 
proficiently. The reproductive biologist must--
    a. Perform only those ART laboratory procedures that are authorized 
by the laboratory director, and for which training has been documented. 
If appropriate training has not been documented, perform ART laboratory 
procedures only under direct and constant supervision.
    b. Follow the laboratory's established policies and procedures for 
performing ART laboratory procedures, and recording and reporting 
procedural outcomes.
    c. Adhere to the laboratory's quality management policies, document 
all specimen and procedure management, quality control and quality 
assurance activities, and equipment and instrument calibration, 
function verification and maintenance performed.
    d. Identify problems that may adversely affect the performance of 
ART laboratory procedures and either immediately notify the laboratory 
supervisor or director, or correct the problem(s) in accordance with 
the laboratory's established policies and procedures and notify the 
laboratory supervisor or director of the problem(s) and the corrective 
action(s) taken.
    e. Document all corrective actions taken when failures in quality 
are identified.

B. Facilities and Safety

    The embryo laboratory must provide adequate space and the 
appropriate environmental conditions to ensure safe working conditions 
and quality performance of ART laboratory procedures.
    1. Requirements for Physical Space and Utilities. The laboratory 
must be constructed and arranged so that--
    a. The laboratory space, ventilation, and utilities are adequate 
for the volume of ART laboratory procedures performed during peak 
periods of activity.

[[Page 39388]]

    b. ART laboratory procedures are carried out in a secure area with 
access limited to authorized personnel.
    c. Movement of patient specimens and traffic around sensitive work 
areas is limited in order to reduce the potential for spilled or lost 
specimens.
    d. Incubator and storage space are configured to ensure positive 
specimen identification and minimize the potential for errors due to 
misplaced specimens or retrieval of the wrong specimen.
    e. Activities requiring sterile technique such as the handling, 
assessment and culturing of human oocytes and embryos, are performed 
under aseptic conditions in an area that is physically isolated from 
other laboratory activities.
    f. All laboratory work areas (does not include administrative 
areas) are easily washed and disinfected.
    g. The laboratory and administrative space are conveniently 
located, but are separate from patient areas.
    h. Immediate communication can occur with the oocyte retrieval and 
transfer room(s).
    2. Safety Requirements. Safety precautions, policies, and 
procedures must be established and posted, or readily available to all 
personnel, to ensure protection from physical, chemical, electrical and 
biological hazards.
    a. All personnel must be knowledgeable about and abide by 
applicable Federal, State and local regulations regarding protection 
from physical, chemical, electrical and biological hazards.
    b. Disposable materials should be used wherever possible for all 
procedures that involve exposure to tissue and body fluids.
    c. The laboratory must store and dispose of tissue, body fluids, or 
other potentially biohazardous materials as outlined in Federal, State 
and local regulations.
    d. Toxic chemicals, including toxic cleaning materials, must be 
used in a manner that is not harmful to patient specimens.
    e. Radioisotopes must not be used in a laboratory that performs ART 
procedures.
    f. The laboratory must have an emergency plan appropriate for its 
geographical location which specifies the actions to be taken to 
protect employees, patients, visitors and specimens in case of a 
natural disaster or other potentially devastating event.
    3. Laboratory Animals/Nonhuman Animal Cells, Tissues, Organs.
    a. If laboratory animals are used, all applicable Federal, State 
and local regulations regarding animal care and use must be met.
    b. If live nonhuman animal cells, tissues, and/or organs are used, 
all applicable Federal, State and local regulations regarding their 
handling, storage and use must be met.

C. Quality Management

    The embryo laboratory must establish and follow written policies 
and procedures for a comprehensive quality management program that is 
designed to monitor and evaluate the ongoing and overall quality of the 
ART laboratory procedures performed and services provided. All quality 
management activities must be documented.
    1. Procedure Manual. A written procedure manual including 
instructions for all ART laboratory procedures performed must be 
available in the embryo laboratory and followed by all laboratory 
personnel. The written procedures must be in sufficient detail to 
assure reproducibility and competence in the performance of the 
laboratory procedures.
    a. The procedure manual must include the following, when applicable 
to the ART laboratory procedure performed:
    i. Principle (scientific basis) of the ART laboratory procedure;
    ii. Clinical significance of the ART laboratory procedure;
    iii. Requirements for specimen collection and handling;
    iv. Step-by-step instructions for performance of the ART laboratory 
procedure;
    v. Preparation of required reagents, culture media, solutions, or 
other special supplies;
    vi. Equipment and instrumentation required for the performance of 
the procedure, including necessary function checks and calibration 
protocols;
    vii. Quality control procedures to be performed, including 
frequency of control testing, and criteria for acceptability;
    viii. Remedial action to be taken when function checks, calibration 
or control results do not meet the laboratory's criteria for 
acceptability;
    ix. Calculations and interpretation of procedural outcomes, 
including criteria for acceptable and unacceptable outcomes, and 
procedural outcomes requiring special notification;
    x. The laboratory's system for recording and reporting procedural 
outcomes;
    xi. Limitations in methodologies, including interfering substances 
and precautions;
    xii. Pertinent literature references;
    xiii. Description of the course of action to be taken if required 
equipment or instrumentation malfunctions or is inoperable;
    xiv. Criteria for the referral or transfer of specimens to another 
embryo laboratory for the performance of an ART laboratory procedure, 
including procedures for specimen submission and handling; and
    xv. Procedure for safe and appropriate specimen disposal.
    b. Manufacturers' instrument/equipment manuals and package inserts 
may be used, when applicable, to meet the requirements of this section.
    i. Any of the items listed under subparagraph 1.a. of this section, 
not provided by the manufacturer must be provided by the laboratory.
    ii. Any modifications to, or deviations from, the manufacturer's 
instructions, must be clearly documented and provided in the procedure 
manual.
    c. Appropriate reference materials (e.g., slides, pictures, 
textbooks, etc.) should be available in the laboratory to allow, as 
needed, comparison with patient specimens.
    d. Procedures must initially be approved, signed and dated by the 
laboratory director, and must thereafter, be reviewed by the laboratory 
director on an annual basis.
    e. Procedures must be re-approved, signed and dated if the 
directorship of the laboratory changes.
    f. Each change in a procedure must be approved, signed and dated by 
the current laboratory director.
    g. The laboratory must retain a copy of each procedure with the 
dates of initial use and discontinuance in accordance with the 
requirements of section D., Maintenance of Records, of this part.
    2. Equipment and Instrument Maintenance/Calibration. The embryo 
laboratory must perform and document equipment and instrument 
maintenance and, as applicable, calibration, and function verification 
that include(s) electronic, mechanical and operational checks necessary 
for the proper performance of ART laboratory procedures. The laboratory 
must--
    a. Have sufficient equipment for the type and volume of ART 
laboratory procedures performed, which may include but is not limited 
to, incubators, freezers, refrigerators, hoods, thermometers, 
centrifuges, microscopes, pipettes, and warming devices.
    b. Establish and follow written policies and procedures for 
equipment and instrument maintenance and, as applicable, calibration, 
and function checks, that ensure proper performance of the equipment 
and instruments used in ART laboratory procedures. The laboratory 
must--

[[Page 39389]]

    i. Define acceptable limits for equipment and instrument 
maintenance and, as applicable, calibration, and function checks prior 
to their use in ART laboratory procedures.
    ii. Perform maintenance and, as applicable, calibration, and 
function checks in accordance with the equipment/instrument 
manufacturer's instructions and at the frequency required to ensure 
adequate performance of the equipment and instruments used in ART 
laboratory procedures.
    iii. Monitor environmental conditions, using an independent 
measuring device, in critical equipment, including but not limited to, 
incubators, controlled-rate freezers and liquid nitrogen storage tanks, 
at a frequency that ensures timely detection of conditions that are 
deleterious to specimens. These conditions include, if applicable:
    A. Temperature;
    B. Humidity;
    C. Gas concentration; and
    D. Liquid nitrogen levels.
    iv. Maintain an alarm system on critical equipment that will 
immediately detect when pre-established limits for the environmental 
conditions listed in subparagraph 2.b.iii. (excluding humidity), of 
this section, are exceeded. The alarm system must be:
    A. Checked periodically to ensure that it will be triggered when 
preestablished limits for environmental conditions are exceeded; and
    B. Monitored 24 hours a day in the laboratory or at a remote site.
    v. Protect critical equipment and instrumentation from fluctuations 
and interruptions in electrical current.
    vi. Have available emergency back-up capability for critical 
equipment, including but not limited to, incubators, refrigerators and 
controlled-rate freezers.
    vii. Document all maintenance, calibration, and function checks 
performed.
    c. Identify, investigate, and correct problems with equipment or 
instrumentation that may adversely affect the performance of ART 
laboratory procedures.
    d. Document all corrective actions taken when problems with 
equipment or instrumentation are identified.
    3. Labeling, Handling, and Storage of Chemicals, Reagents, 
Solutions, Culture Media, Materials and Supplies. The embryo laboratory 
must label, handle and store chemicals, reagents, solutions, culture 
media, materials and supplies in a manner that ensures their positive 
identification, optimum integrity and appropriate reactivity in ART 
laboratory procedures. The laboratory must--
    a. Have a mechanism for ensuring sufficient chemicals, reagents, 
solutions, culture media, materials and supplies for the type and 
volume of ART laboratory procedures performed (e.g., inventory 
maintenance program).
    b. Define criteria that are essential for proper storage of 
chemicals, reagents, solutions, and culture media, including the 
following, as applicable:
    i. Temperature;
    ii. Humidity; and
    iii. Other conditions necessary for proper storage.
    c. Label all chemicals, reagents, solutions, and culture media to 
indicate the following, as applicable:
    i. Identity, and when significant, batch or lot number, titer, 
strength, or concentration;
    ii. Recommended storage conditions;
    iii. Expiration date; and
    iv. Other pertinent information required for proper use.
    d. Verify that materials which come in contact with sperm, oocytes, 
and embryos have been tested and found to be non-toxic to sperm, 
oocytes, and embryos. Documentation supplied by the manufacturer may be 
used to meet this requirement.
    e. Maintain records documenting the batch or lot number, date of 
receipt or preparation, and date placed in use, for all chemicals, 
reagents, solutions, and culture media.
    f. Prepare, store, and handle chemicals, reagents, solutions, and 
culture media in a manner to ensure that they are not used when they 
have exceeded their expiration date, have deteriorated, or are of 
substandard quality.
    4. Specimen and Procedure Management. The embryo laboratory must 
have written protocols and criteria for the laboratory procedures 
performed and employ and maintain a system that provides for proper 
patient identification and preparation; specimen collection, 
identification, and handling (transportation, processing, storage, 
preservation); and accurate recording and reporting of laboratory 
procedural outcomes.
    a. The laboratory must have available and follow written policies 
and procedures for each of the following:
    i. Instructions for patient preparation, if applicable;
    ii. Methods used for the positive identification of patients;
    iii. Specimen collection;
    iv. The labeling of patient specimens to ensure positive 
identification from the time of specimen collection through final 
disposition or disposal;
    v. Criteria for maintaining specimen integrity and viability during 
transport, storage and the performance of ART laboratory procedures 
including, as applicable, requirements for:
    A. Temperature;
    B. Humidity; and
    C. Gas concentration; and
    vi. Criteria for specimen acceptability and, as appropriate, 
instructions for special handling of suboptimal specimens.
    b. The laboratory must have adequate systems in place to ensure 
patient confidentiality throughout those parts of the ART process that 
are under the laboratory's control.
    c. The laboratory may perform ART laboratory procedures only at the 
written or electronic request of an authorized person. Oral requests 
for changes to the original written or electronic request must be 
documented by the laboratory and followed by receipt of written or 
electronic documentation from an authorized person within 24 hours of 
the oral request. The patient's chart or medical record may be used for 
written authorization, but must be available to the laboratory at the 
time of the laboratory procedure. Written or electronic authorization 
must include the following:
    i. The patient's name and an unique identifier;
    ii. When applicable, the partner's or donor's name or other unique 
identifier;
    iii. The name and address or other suitable identifiers of the 
authorized person requesting the procedure, and the name of the 
individual communicating the request;
    iv. The procedure(s) to be performed;
    v. The date(s) and time(s) the procedure(s) is to be performed; and
    vi. Any additional information relevant and necessary to the 
performance of the procedure(s) including verification of informed 
patient consent, and as applicable, special handling instructions and 
any instructions stipulated by the patient.
    d. As applicable, the laboratory must establish and follow written 
protocols, including documented criteria, for--
    i. Evaluation and assessment of oocyte morphology and maturity, 
fertilization, and embryo quality.
    ii. Insemination schedule relative to oocyte maturity.
    iii. Volume, numbers, and quality of sperm used for insemination of 
each oocyte.
    iv. Disposition of oocytes with an abnormal number of pronuclei.
    v. Disposition of excess oocytes.
    vi. The time period following insemination for examination of 
oocytes to determine fertilization.

[[Page 39390]]

    vii. Micromanipulation of oocytes and embryos.
    viii. Re-insemination of oocytes.
    ix. Cryopreservation of specimens.
    x. Embryo transfer procedures, which include the following:
    A. The length of time embryos are cultured prior to transfer;
    B. The medium and protein supplementation used for transfer, as 
applicable;
    C. Disposition of excess embryos;
    D. Types of catheters available, with circumstances for use of 
each;
    E. Method of transfer; and
    F. Technique for post transfer catheter check.
    e. The laboratory must maintain a record system, for each patient's 
ART cycle, to ensure reliable identification and control of the 
patient's specimens as they are received and the laboratory 
procedure(s) performed. The record system must include documentation of 
the information specified in subparagraph 4.c. of this section, and--
    i. The laboratory accession number, or other unique identification 
of the specimen.
    ii. The date and time of specimen receipt into the laboratory and, 
as applicable, the number of oocytes retrieved and assessment of each 
oocyte or cumulus corona complex.
    iii. The condition and disposition of all specimens including those 
that do not meet the laboratory's criteria for acceptability.
    iv. The records and dates of all laboratory handling and 
procedures, including the following, as applicable:
    A. Semen assessment before and after washing and concentration for 
insemination;
    B. Outcome of insemination or micromanipulation procedures (e.g., 
fertilization);
    C. Outcome of any culture (e.g., cleavage);
    D. Relative timing of protocol events (incubation hours, etc.);
    E. Assessment of the developmental status and quality of all 
embryos at transfer;
    F. Verification that no embryos remain in the catheter following 
completion of transfer;
    G. The identity and lot numbers of the media and media supplements 
used in each phase of the procedure; and
    H. The identity of the laboratory personnel who handled the 
specimens and performed the procedures.
    f. The laboratory must have a mechanism in place for promptly 
providing the authorized person who ordered the procedure a complete 
summary of all procedural outcomes and the occurrence of any unusual or 
abnormal events, including the condition and disposition of specimens 
that do not meet the laboratory's criteria for acceptability.
    g. The laboratory must have an accurate and reliable method of 
tracking cryopreserved specimens ensuring positive identification of 
each cryopreservation container. In addition, the cryopreservation 
container must be labeled with the patient's name or unique identifier, 
and the date the specimen(s) was frozen. All labeling must be of a 
permanent nature. Documentation must be maintained in duplicate log 
books or files for each liquid nitrogen storage tank and include the 
following:
    i. The patient's name or other unique identifier;
    ii. A description of each cryopreservation container's contents;
    iii. The freezing protocol used;
    iv. Date frozen;
    v. Type and location of cryopreservation container (e.g., straw, 
vial); and
    vi. Final disposition/disposal of the cryopreserved specimen(s).
    h. If cryopreserved specimens are received from or transferred to 
other facilities, the laboratory must have written policies and 
procedures for the receipt/transfer of cryopreserved specimens. 
Policies and procedures must include appropriate methods of 
transportation and the method for verifying the identification and 
number of cryopreservation containers received/transferred. In 
addition, documentation of the freezing protocol used, and copies of 
patient release forms and applicable log sheets must accompany the 
cryopreserved specimens.
    i. Clinical laboratory testing on specimens obtained by the embryo 
laboratory to provide information for the diagnosis, prevention or 
treatment of disease, or assessment of the health of human beings must 
be performed in accordance with the regulations implementing CLIA at 42 
CFR Part 493. In addition--
    i. The referring embryo laboratory must not revise results or 
information directly related to the interpretation of results provided 
by the testing laboratory.
    ii. The referring embryo laboratory may permit the testing 
laboratory to send the test result(s) directly to the authorized person 
who initially requested the testing. The embryo laboratory must retain 
or be able to produce an exact duplicate of the testing laboratory's 
report.
    iii. The authorized person who orders a clinical laboratory test 
must be notified by the referring embryo laboratory of the name and 
address of the testing laboratory.
    5. Method Validation. All ART procedures selected or established by 
the embryo laboratory must be validated by the laboratory prior to 
routine patient use. The laboratory must determine appropriate 
performance measures and demonstrate that the procedure, when performed 
by the laboratory's staff, meets or exceeds acceptable levels of 
performance as defined by the laboratory. In addition, the laboratory 
must periodically verify, through its quality management activities (as 
specified in this part), each procedure's continued acceptable level of 
performance. All validations must be documented.
    6. Quality Control. The embryo laboratory must establish and follow 
written quality control procedures at a frequency appropriate to 
monitor the reliability of the ART laboratory procedures performed. All 
quality control activities must be documented. The laboratory must--
    a. Establish acceptability criteria for all quality control 
procedures.
    b. Perform and document the remedial action(s) taken when problems 
are identified or quality control procedures do not meet the 
laboratory's criteria for acceptability.
    c. For each laboratory procedure performed and, as applicable, 
culture media preparation--
    i. Define and use the appropriate grade of water required.
    ii. Periodically monitor water quality to ensure that its quality 
continues to meet the laboratory's specifications for its intended use. 
As applicable, adherence to manufacturers' storage and handling 
requirements, and expiration dates may meet this requirement.
    d. As applicable, have and follow a written procedure for the 
preparation, washing and sterilization of glassware used in the 
laboratory's procedures that includes the following:
    i. Rinsing all washable glassware with distilled or deionized water 
prior to drying; and
    ii. If detergent is used, testing washed items for detergent 
removal.
    e. Have and follow a written procedure for the quality control of 
culture media which includes a visual check for physical damage to the 
media container and evidence of media contamination prior to its use 
and--
    i. For each batch of culture media prepared in-house, document the 
quality of the media by testing--
    A. pH.
    B. Osmolality.
    C. Culture suitability using an appropriate bioassay system.

[[Page 39391]]

    ii. For each batch of commercially prepared culture media--
    A. Verify and document the quality of the media with an appropriate 
bioassay system. Documentation of quality control performed by the 
manufacturer may meet this requirement.
    B. Follow the manufacturer's specifications for using the media.
    iii. Test and document the quality of any media supplementation 
(e.g., protein), when appropriate, using a bioassay system.
    iv. While the use of blood-based media or a blood-based media 
supplement (e.g., human fetal cord serum) prepared in-house is not 
recommended, if such media or supplements are prepared, the laboratory 
must test blood from the donor(s) used to make the media/supplement 
with a FDA licensed, approved, or cleared test and show the donor(s) to 
be negative/nonreactive for the following communicable diseases prior 
to use of the media/supplement:
    A. Human immunodeficiency virus, Type 1 (e.g., anti-HIV-1);
    B. Human immunodeficiency virus, Type 2 (e.g., anti-HIV-2);
    C. Hepatitis B virus (e.g., HbsAg);
    D. Hepatitis C virus (e.g., anti-HCV);
    E. Human T-cell lymphotrophic virus, Types I and II (e.g., anti-
HTLV I/II); and
    F. Such other diseases that may be later added to this list.

    Note: A batch of media (solid, semi-solid, or liquid) consists 
of all tubes, plates, or containers of the same medium prepared at 
the same time in the laboratory; or, if received from an outside 
source or commercial supplier, consists of all of the plates, tubes 
or containers of the same medium that have the same lot numbers and 
are received in a single shipment.

    7. Quality Assurance. The embryo laboratory must establish and 
follow written policies and procedures for a quality assurance program 
to monitor the quality of services provided by the laboratory, and 
resolve problems that are identified. The laboratory must have a 
mechanism to evaluate the effectiveness of its policies and procedures; 
identify and correct problems; and assure the adequacy and competency 
of the staff. As necessary, the laboratory must revise its policies and 
procedures based on the results of those evaluations. All quality 
assurance activities must be documented.
    a. The laboratory must have an ongoing mechanism for monitoring, 
evaluating and revising, if necessary, based on the results of its 
evaluations, the following:
    i. The criteria established for patient identification and specimen 
collection, identification, and handling;
    ii. The information requested and maintained on each patient and 
for each laboratory procedure performed for its completeness, relevance 
and necessity;
    iii. The timeliness and accuracy of recording and reporting 
procedural outcomes;
    iv. The accuracy and reliability of tracking cryopreserved 
specimens;
    v. The appropriate storage and retrieval of laboratory records such 
as procedural outcomes, and other data recorded and maintained; and
    vi. The corrective actions taken for--
    A. Problems identified during the evaluation of equipment and 
instrument maintenance, calibration, and function check data.
    B. Problems identified during the evaluation of quality control 
data.
    C. Errors detected in patient or specimen identification and 
handling.
    D. Clerical or analytical errors detected in laboratory records.
    b. The embryo laboratory must have an ongoing mechanism to--
    i. Identify and evaluate laboratory procedural outcomes that appear 
inconsistent with the patient or donor history.
    ii. Track and evaluate laboratory procedural outcomes including, 
but not limited to, fertilization rates, cleavage rates and embryo 
quality.
    iii. Maintain a file of adverse reactions occurring as a result of 
errors made during the performance of ART laboratory procedures.
    iv. Evaluate the effectiveness of its policies and procedures for 
assuring employee competence in performing ART laboratory procedures.
    v. Document problems that occur as a result of a breakdown in 
communication between the laboratory and referring physicians or others 
involved in the ART procedures, and take corrective actions to resolve 
the problems and minimize future communications breakdowns.
    vi. Assure that all complaints and problems reported to the 
laboratory are documented. Investigations of complaints must be made, 
when appropriate, and as necessary, corrective actions must be 
instituted.
    vii. Document and assess problems identified during quality 
assurance reviews, and discuss them with the laboratory staff and, as 
appropriate, referring physicians and others involved in the ART 
procedures. The laboratory must take the necessary corrective actions 
to prevent recurrences.

D. Maintenance of Records

    The embryo laboratory must retain records of all of its policies 
and procedures; personnel employment, training, evaluations and 
continuing education activities; and quality management activities 
specified in this part.
    1. Record Format. Laboratory records must be accurate, indelible, 
and legible. Records may be retained electronically, or as original 
paper records, or as true copies such as photocopies, microfiche, or 
microfilm.
    2. Retention Period. Laboratory records must be retained in 
accordance with time frames specified by applicable Federal, State and 
local laws or for ten years beyond the date of final disposition or 
disposal of all specimens obtained during each patient's ART cycle, 
whichever is later. Records must be retained on site for two years. 
Note: Transfer of cryopreserved specimens to another facility 
constitutes final disposition for the transferring facility.
    3. Record Retrieval. Laboratory records must be maintained in a 
manner which ensures timely, accurate and reliable retrieval.
    4. Laboratory Closure. In the event that the laboratory ceases 
operation, the laboratory must make provisions for these records to be 
maintained for the time frame required above.

Addendum

References

1. The American Association of Bioanalysts. Embryology and Andrology 
Review Course. American Association of Bioanalysts, St. Louis, 
Missouri, 1994.
2. The American Association of Tissue Banks. Standards for Tissue 
Banking. The American Association of Tissue Banks, McLean, Virginia, 
1996.
3. The American Society for Reproductive Medicine. Revised Minimum 
Standards for In Vitro Fertilization, Gamete Intrafallopian 
Transfer, and Related Procedures. Fertility and Sterility 1998; 70 
(Suppl 2) :1S-5S.
4. Association of Clinical Embryologists. Accreditation Standards 
and Guidelines for IVF Laboratories. Association of Clinical 
Embryologists, London, England, 1996.
5. California Health and Safety Code, Division 2, Chapter 4.1--
Tissue Banks. State of California, Department of Health Services, 
Berkeley, California, 1992.
6. Centers for Disease Control and Prevention. Reporting of 
Pregnancy Success Rates from Assisted Reproductive Technology 
Programs. 62 FR 45259, Aug. 26, 1997.
7. Centers for Disease Control and Prevention. Implementation of the 
Fertility Clinic Success Rate and Certification Act of 1992; 
Proposed Model Program for the Certification of Embryo Laboratories. 
63 FR 60178, Nov. 6, 1998.
8. Code of Federal Regulations, Title 42, Chapter IV, Part 493--
Laboratory Requirements.

[[Page 39392]]

9. The College of American Pathologists/American Society for 
Reproductive Medicine Reproductive Laboratory Accreditation Program. 
The College of American Pathologists, Northfield, Illinois, 1996.
10. The Fertility Clinic Success Rate and Certification Act of 1992 
(Public Law 102-493).
11. Guidance for Industry, Public Health Issues Posed by the Use of 
Nonhuman Primate Xenografts in Humans. Food and Drug Administration, 
Center for Biologics Evaluation and Research, April, 1999.
12. Keel BA and BW Webster. CRC Handbook of the Laboratory Diagnosis 
and Treatment of Infertility. CRC Press, Inc., Boca Raton, Florida, 
1990.
13. Rules and Regulations of the State of New York, Part 52 of Title 
10 (Health). Tissue Banks and Non-transplant Anatomic Banks. State 
of New York Department of Health, Albany, New York, 1992.
14. Senate Report 102-452 on H.R. 4773. Fertility Clinic Success 
Rate and Certification Act of 1992. 102d Congress, 2d Session, 1992.
15. Survey of Assisted Reproductive Technology Embryo Laboratory 
Procedures and Practices. www.phppo.cdc.gov/dls/pdf/art/
ARTsurvey.pdf.
16. Veeck LL. The Gamete Laboratory: Design, Management and 
Techniques. pp. 798--820 in: Infertility: Evaluation and Treatment. 
Edited by WR Keye, RJ Chang, RW Rebar and MR Soules. WB Saunders, 
Philadelphia, Pennsylvania, 1995.

[FR Doc. 99-18405 Filed 7-19-99; 11:53 am]
BILLING CODE 4163-18-P