Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1696592213091.pdf (United States)
106 STAT.

3146 PUBLIC LAW 102-493—OCT.

24, 1992 Public Law 102-493 102d Congress An Act Oct. 24, 1992 [H.R.

4773] To provide for reporting of pregnancy success rates of assisted reproductive technology programs and for the certification of embryo laboratories.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled.

Fertility Clinic Success Rate and Certification SECTION 1.

SHORT TITLE.
SHORT TITLE.

42tj«?20l note ' ^ "^^^ ^* ^ ^^ ^ *^^*^ *^ *^® "Fertility Clinic Success Rate and Certification Act of 1992".

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.— (1) IN GENERAL.—^For purposes of subsection (aXl), the 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.

SEC 3.

CERTIFICATION OF EMBRYO LABORATORIES.

(a) IN GENERAL.-— 42 u se 263a-l. Public mformation.

42 u se 263a-2.

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 (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- following standards developed by the Secretary: 106 STAT.

3148 PUBLIC LAW 102-493—OCT.

24, 1992 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 information.

Public information.

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) n o t^ 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- Sam is reliably identi^ong the deficiencies of such i>oratory, or (ii) the accreditation organization which certified such reliably identifying laboratories such deficencies, and (D) if tiie Secretaiy determines— is (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.
SEC.

6.

CERTIFICATION REVOCATION AND SUSPENSION.

42 u se 263a-4.
(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 se 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.