Fertility Clinic Success Rate and Certification Act of 1992
PL 102-493 (H.R.4773), enacted 10/24/1992

106 STAT. 3146 
PUBLIC LAW 102-493—OCT. 24, 1992 
Public Law 102-493 
102d Congress 
An Act 
Oct. 24, 1992 
To provide for reporting of pregnancy success rates of assisted reproductive 
[H.R. 4773] 
technology programs and for the certification of embryo laboratories. 
Be it enacted by the Senate and House of Representatives of 
Fertility Clinic 
the United States of 
America in Congress assembled. 
Success Rate 
' 
^ 
and Certification 
SECTION 1. SHORT TITLE. 
42tj«?20l note 
"^^^ ^ * ^^^ ^ *^^*^ *^ *^® "Fertility Clinic Success Rate 
and Certification Act of 1992". 
42 u s e 263a-l. 
SEC. 2. ASSISTED REPRODUCTIVE TECHNOLOGY PROGRAMS. 
(a) IN GENERAL.—^Effective 2 years after the date of the enact-
ment of this Act, each assisted reproductive technology (as defined 
in section 7) program shall annually report to the Secretary through 
the Centers for Disease Control— 
(1) pregnancy success rates achieved by such program 
through each assisted reproductive technology, and 
(2) the identity of each embryo laboratory (as defined in 
section 7) used by such program and whether the laboratory 
is certified under section 3 or has applied for such certification. 
(b) PREGNANCY SUCCESS RATES.— 
Public 
(1) IN GENERAL.—^For purposes of subsection (aXl), the 
mformation. 
Secretary shall, in consultation with the organizations ref-
erenced in subsection (c), define pregnancy success rates and 
shall make public any proposed definition in such manner 
as to facilitate comment from any person (including any Federal 
or other public agency) during its development. 
(2) DEFINITION.—In developing the definition of pregnancy 
success rates, the Secretary shall take into account the effect 
on success rates of age, diagnosis, and other significant factors 
and shall include in such rates— 
(A) the basic live birth rate calculated for each assisted 
reproductive technology performed by an assisted reproduc-
tive technology program by dividing the number of preg-
nancies which result in live births by the number of ovarian 
stimulation procedures attempted by such program, and 
(B) the live birth rate per successful oocyte retrieval 
procedure calculated for each assisted reproductive tech-
nology performed by an assisted reproductive technologor 
program by dividing the number of pregnancies which 
result in live births by the number of successful ooc^rte 
retrieval procedures performed by such program. 
(c) CONSULTATION.—^In developing the definition under sub-
section (b), the Secretary shall consult with appropriate consumer 
and professional organizations with expertise in using, providing, 
and evaluating professional services and embryo laboratories assoa-
ated with assisted reproductive technologies. 
42 use 263a-2. 
SEC 3. CERTIFICATION OF EMBRYO LABORATORIES. 
(a) IN GENERAL.-— 
PUBLIC LAW 102-493—OCT. 24, 1992 
106 STAT. 3147 
(1) DEVELOPMENT.—^Not later than 2 years after the date 
of the enactment of this Act, the Secretary, through the Centers 
for Disease Control, shall develop a model program for the 
certification of embiyo laboratories (referred to in this section 
as a "certification program**) to be carried out by th$ States. 
(2) CONSULTATION.—^In developing the certification program 
under paragraph (1), the Secretary shall consult with appro-
priate consumer and professional organizations with expertise 
m using, providing, and evaluating professional services and 
embryo laboratories cuisociated with the assisted reproductive 
technology programs. 
(b) DISTRIBUTION.—^The Secretary shall distribute a description 
of the certification program to— 
(1) the Governor of each State, 
(2) the presiding officers of each State legislature, 
(3) the public health official of each State, and 
(4) the official responsible in each State for the operation 
of the State's contract with the Secretary under section 1864 
of tiie Social Security Act, 
and shall encourage such officials to assist in the State adopting 
such program. 
(c) IU:QUIREMENTS.—^The certification program shall include the 
following requirements: 
(1) ADMINISTRATION.—^The certification program shall be 
administered by the State and shall provide for the inspection 
and certification of embryo laboratories in the State oy the 
State or by approved accreditation organizations. 
(2) APPLICATION REQUIREMENTS.—^The certification program 
shall provide for tiie submission of an application to a State 
by an embryo laboratory for certification, in such form as may 
be specified by the State. Such an application shall include— 
(A) assurcuices satisfactory to uie State that the embryo 
laboratory will he operated in accordance with the stand-
ards under subsection (d), 
(B) a report to the State identifying the assisted repro-
ductive technology programs with which the laboratory 
is associated, ana 
(C) such other information as the State finds necessary. 
An embryo laborato^ which meets the requirements of section 
353 of the Public health Service Act shall, for the purposes 
of subparagraph (A) be considered in compliance with the stand-
ards refeiried to in such subparagraph which are the same 
as the standards in effect under such section 353. 
(d) STANDARDS.—^The certification program shall include the 
following standards developed by the Secretary: 
(1) A standard to assure consistent performance of proce-
dures by each embryo laboratory certified under tlie certifi-
cation program or by an approved accreditation organization 
in a State which has not adopted the certification program. 
(2) A standard for a quaUty assurance and a quality control 
program to assure valid, reliable, and reproduceable procedures 
m the laboratory. 
(3) A standard for the maintenance of records (on a program 
by program basis) on laboratory tests and procedures per-
formed, including the scientific basis of, and tiie methodology 
used for, the tests, procedures, and preparation of any stand-
ards or controls, criteria for acceptaSle and imacceptable out-
106 STAT. 3148 
PUBLIC LAW 102-493—OCT. 24, 1992 
Public 
information. 
Public 
information. 
comes, criteria for sample rejection, and procedures for safe 
sample disposal. 
(4) A standard for the maintenance of written records on 
personnel and facilities necessary for proper and effective oper-
ation of the laboratory, schedules of preventive maintenance, 
function verification lor equipment, and the release of such 
records to tlie State ujpon demand. 
(5) A standard for the use of such personnel who meet 
such qualifications as the Secretary may develop. 
(e) CERTIFICATION UNDER STATE PROGRAMS.—A State may qiial-
ify to adopt the certification program if the State has submitted 
an application to the Secretary to adopt such program and the 
Secretary has approved the application. Such an application shall 
include— 
(1) assurances by the State satisfactory to the Secretary 
that the certification program within the State meets tiie 
requirements of this section, 
(2) an agreement to make such reports as the Secretary 
may require, and 
(3) information about any proposed use of accreditation 
organizations under subsection (g). 
(f) USE OF ACCREDITATION ORGANIZATIONS.—A State which has 
adopted the certification program may use accreditation organiza-
tions approved imder section 4 to inspect and certify embryo labora-
tories. 
(g) INSPECTIONS.— 
(1) IN GENERAL.—^A State which qualifies to adopt the 
certification program within the State shall conduct inspections 
in accordance with paragraph (2) to determine if laboratories 
in the State meet the requirements of such program. Such 
inspections shall be carried out by the State or by accreditation 
organizations used by the State imder subsection (g). 
(2) REQUIREMENTS.—Inspections carried out under para-
graph (1) shall— 
(A) be periodic and imannounced, or 
(B) be announced in such circumstances as the Sec-
retary determines will not diminish the likelihood of discov-
ering deficiencies in the operations of a laboratory. 
Before making a determination under subparagraph (B), the 
Secretary shall make public, in such manner as to facilitate 
comment from any person (including any Federal or other public 
agency), a proposal indicating the circumstances under which 
announced inspections would be permitted. 
(3) RESULTS.—^The specific nndings, including deficiencies, 
identified in an inspection carried out under paragraph (1) 
and any subsequent corrections to those deficiencies shall be 
announced and made available to the public upon request begin-
ning no later than 60 days after the date of the inspection, 
(h) VALIDATION INSPECTIONS.— 
(1) IN GENERAL.—^The Secretary may enter and inspect, 
during regular hours of operation, embiyo laboratories— 
(A) which have been certified by a State under the 
certification program, or 
(B) which nave been certified by an accreditation 
organization approved by the Secretary under section 4, 
for the purpose of determining whether the laboratory is being 
operated in accordance with the standards in subsection (d). 
PUBLIC LAW 102-493—OCT. 24, 1992 
106 STAT. 3149 
(2) ACCESS TO FACiunES AND RECORDS.—In conducting 
an inspection of an embryo laboratory under paragraph (1), 
the Secretary shall have access to all facilities, equipment, 
materials, records, and information which the Secretaiy deter-
mines is necessanr to determine if such laboratory is being 
operated in accordance with the standards in subsection (d). 
As part of such an inspection, the Secretary may copy any 
material, record, or information inspected or require it to be 
submitted to the Secretary. Such an inspection may be made 
only upon the presentation of identification to the owner, opera-
tor, or agent in charge of the laboratory being inspected. 
(3) FAILURE TO COMPLY.—If the Secretary determines as 
a result of an inspection under paragraph (1) that the embryo 
laboratory is not in compliance with the standards in subsection 
(d), the Secretaiy shall— 
(A) not^ the State in which the laboratory is located 
and, if appropriate, the accreditation organization which 
certified uie laboratory, 
(B) make available to the public the results of the 
inspection, 
(C) conduct additional inspections of other embryo lab-
oratories under paragraph (1) to determine if— 
(i) such State in carrying out the certification pro-
S
am is reliably identi^ong the deficiencies of such 
i>oratory, or 
(ii) the accreditation organization which certified 
such 
laboratories 
is 
reliably 
identifying 
such 
deficencies, and 
(D) if tiie Secretaiy determines— 
(i) that such State in carrying out the certification 
program has not met the requirements applicable to 
such program, or 
(li) me accreditetion organization which certified 
such laboratory has not met the requirements of section 
4, 
the Secretary may revoke the approval of the Stete certifi-
cation program or revoke the approval of such accreditation 
organization, 
(i) LIMITATION.— 
(1) SECRETARY.—In developing the certification program, 
the Secretary may not estabUsh any regulation, standard, or 
requirement which has the effect of exercising supervision or 
control over the practice of medicine in assisted reproductive 
technology programs. 
(2) STATE.—In adopting the certification program, a State 
may not esteblish any regulation, standard, or requirement 
which has the effect of exercising supervision or control over 
the practice of medicine in assisted reproductive technology 
programs. 
(j) TERM.—^The term of a certification issued by a Stete or 
an accreditetion organization in a Stete shall be prescribed by 
the Secretary in the certification program and shall be valid for 
a period of time to be defined by tne Secretaiy through the public 
comment process described in subsection (hX2). The Secretaiy shall 
provide an appUcation for recertification to be submitted at the 
time of changes in the ovniership of a certified laboratory or changes 
in the administration of such a laboratory. 
106 STAT. 3150 
PUBLIC LAW 102-493—OCT. 24, 1992 
42USC263a-3. 
SEC. 4. ACCREDITATION ORGANIZATIONS. 
(a) APPROVAL OF ACCREDITATION ORGANIZATIONS.—Not later 
than 2 years £ifter the date of the enactment of this Act the Sec-
retary, through the Centers for Disease Control, shall promulgate 
criteria and procedures for the approval of accreditation organiza-
tions to inspect and certify embryo laboratories. The procedures 
shall require an application to the Secretary by an accreditation 
organization for approval. An accreditation organization which has 
received such an approval— 
(1) may be used by States in the certification program 
under section 3 to inspect and certify embryo laboratories, 
or 
(2) may certify embryo laboratories in States which have 
not adopted such a certification program. 
(b) CRITERIA AND PROCEDURES.—The criteria and procedures 
promulgated tmder subsection (a) shall include— 
(1) requirements for submission of such reports and the 
maintenance of such records as the Secretary or a State may 
require, and 
(2) requirements for the conduct of inspections under sec-
tion 3(h). 
(c) EVALUATIONS.—^The Secretary shall evaluate annually the 
gerformance of each accreditation organization approved by the 
ecretary by— 
(1) inspecting under section 3(i) a sufficient number of 
embryo laboratories accredited by such an organization to allow 
a reasonable estimate of the peiformance of such organization, 
and 
(2) such other means as the Secretary determines to be 
appropriate. 
(d) TRANSITION.—If the Secretary revokes approval imder sec-
tion 3(iX3)(D) of an accreditation organization after an evaluation 
luider subsection (c), the certification of any embryo laboratory 
accredited by the organization shall continue in effect for 60 days 
after the laboratory is notified by the Secretary of the withdrawal 
of approval, except that the Secretary may extend the period during 
which the certification shall remain in effect if the Secretary deter-
mines that the laboratory submitted an application to another 
approved accreditation organization for certification after receipt 
of such notice in a timely manner. 
42 use 263a-4. 
SEC. 6. CERTIFICATION REVOCATION AND SUSPENSION. 
(a) IN GENERAL.—^A certification issued by a State or an accredi-
tation organization for an embryo laboratory shall be revoked or 
suspended if the State or organization finds, on the basis of inspec-
tions and sifter reasonable notice and opportunity for hearing to 
the owner or operator of the laboratory, that the owner or operator 
or any employee of the laboratory— 
(1) has been guilty of misrepresentation in obtaining the 
certification, 
(2) has failed to comply with any standards under section 
3 applicable to the certification, or 
(3) has refused a request of the State or accreditation 
organization for permission to inspect the laboratory, its oper-
ations, and records. 
(b) EFFECT.—If the certification of an embryo laboratory is 
revoked or suspended, the certification of the laboratory shall con-
PUBLIC LAW 102-493—OCT. 24, 1992 
106 STAT. 3151 
tinue in effect for 60 days after the laboratory receives notice 
of the revocation or suspension. 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. 
SEC. 6. PUBLICATION. 
42 USC 263a-5. 
The Secretary, through the Centers for Disease Control, shall 
not later than 3 years after the date of the enactment of this 
Act and annually thereafter publish and distribute to the States 
and the public— 
(IXA) pregnancy success rates reported to the Secretary 
under section 2(aXl) and, in the case of an assisted reproductive 
technology program which failed to report one or more success 
rates as required under such section, the name of each such 
program and each pregnancy success rate which the program 
failed to report, and 
(B) from information reported under section 2(aX2)— 
(i) the identity of each embryo laboratory in a State 
which has adopted the certification program imder such 
program and whether such laboratory is certified under 
section 3, 
(ii) Uie identity of each embryo laboratory in a State 
which has not adopted such certification program and 
which has been certified by an accreditation organization 
approved by the Secretary under section 4, and 
(iii) in the case of an embryo laboratory which is not 
certified under section 3 or certified by an accreditation 
organization approved by the Secretary under section 4, 
whether the laboratory applied for certification. 
SEC. 7. FEES. 
42 USC 263a-6. 
The Secretary may require the payment of fees for the purpose 
of, and in an amount sufficient to cover the cost of, administering 
th^s Act. A State operating a program under section 3 may require 
the payment of fees for the purpose of, and in an amount sufficient 
to cover the costs of, administering its program. 
SEC. 8. DEFINITIONS. 
42 USC 263a-7. 
For purposes of this Act: 
(1) 
ASSISTED REPRODUCTIVE TECHNOLOGY.—The term 
''assisted reproductive technology" means all treatments or 
procedures which include the handling of human oocytes or 
embryos, including in vitro fertilization, gamete intrafallopian 
transfer, zygote intrsifallopian transfer, and such other specific 
technologies as the Secretary may include in this definition, 
after maJdng public any proposed definition in such manner 
as to facilitate comment from any person (including any Federal 
or other public agency). 
(2) EMBRYO LABORATORY.—The term "embryo laboratory" 
means a facility in which human ooc^ytes are subject to assisted 
reproductive technology treatment or procedures based on 
manipulation of oo<^tes or embryos which are subject to 
implantation. 
(3) SECRETARY.—^The term "Secretary" means the Secretary 
of Health and Human Services. 
106 STAT. 3152 
PUBLIC LAW 102-493—OCT. 24, 1992 
42 u s e 263a-l 
SEC. 9. EFFECTIVE DATE. 
This Act shall take effect upon the expiration of 2 years after 
the date of the enactment of this Act. 
Approved October 24, 1992. 
LEGISLATIVE HISTORY—H.R. 4773: 
HOUSE REPORTS: No. 102-624 (Conun. on Energy and Ck>mmerce). 
SENATE REPORTS: No. 102-452 (Comm. on Labor and Human Resources). 
CONGRESSIONAL RECORD, Vol. 138 (1992): 
June 29, considered and passed House. 
Oct. 8, considered and passed Senate.