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Back to SB 2461
Tennessee General Assembly· SB 2461Signed by Governor.

Hospitals and Health Care Facilities - As enacted, requires each fertility clinic operating in this state to obtain a certificate from the department of health to perform assisted reproductive technology services. - Amen, the official text

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                             PUBLIC CHAPTER NO. 1139

                                                    SENATE BILL NO. 2461

                                   By Bailey, Massey, Bowling, Pody, Seal, White

                                           Substituted for: House Bill No. 2290

      By Williams, Slater, Rudder, Helton-Haynes, Cochran, Chism, Bricken, Littleton, Alexander

AN ACT to amend Tennessee Code Annotated, Title 4; Title 29; Title 36; Title 63 and Title 68,
          relative to assisted reproductive technology.

          WHEREAS, the Society for Assisted Reproductive Technology membership is the "gold
standard" for clinics providing assisted reproductive technology; and

          WHEREAS, the Society for Assisted Reproductive Technology is a standard that ensures an
abundance of regulation; and

          WHEREAS, the Society for Assisted Reproductive Technology clinics are committed to the
highest quality standards of care; and

          WHEREAS, all Society for Assisted Reproductive Technology clinics are required to
advertise truthfully; and

          WHEREAS, all Society for Assisted Reproductive Technology clinics accurately report
outcomes so that patients can trust their provider; and

          WHEREAS, all Society for Assisted Reproductive Technology clinics work with nationally
accredited laboratories to assure the best possible reproductive environments; and

          WHEREAS, the Society for Assisted Reproductive Technology requires:

                    (a) Annual submission of cycle-specific clinic outcome data to the Society for Assisted
          Reproductive Technology Registry, verified by the medical director, with permission to
          disclose such data to the public and to allow data to be validated. Approximately eight to ten
          percent of reporting clinics are validated each year;

                    (b) Accreditation of an embryology laboratory occurs every two years by either the
          College of American Pathologists or Joint Commission on Accreditation of Healthcare
          Organizations;

                    (c) The medical director of any new practice must be reproductive endocrinology and
          infertility (REI) subspecialty certified by the American Board of Obstetrics and Gynecology,
          an active candidate for subspecialty certification, or grandfathered in by having been a
          medical director of a Society for Assisted Reproductive Technology member practice prior to
          January 1, 2000;

                    (d) All assisted reproductive technology laboratory directors to meet uniform criteria
          and physicians not currently laboratory directors to complete the reproductive endocrinology
          fellowship training in the laboratory director track, attain sufficient hands-on experience to
          meet American Society of Reproductive Medicine/Society for Assisted Reproductive
          Technology guidelines and pass a certification exam administered by the American Board of
          Bioanalysis;

                    (e) Adherence to all American Society of Reproductive Medicine/Society for Assisted
          Reproductive Technology guidelines, including ethical, practice, advertising, and laboratory;
          and
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                    (f) Fulfillment of all financial obligations regarding dues and fees; now, therefore,

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:

          SECTION 1. Tennessee Code Annotated, Title 68, Chapter 1, is amended by adding the
following as a new part:

          68-1-2101. Part definitions.

                    As used in this part:

                              (1) "Assisted reproductive technology" or "ART" has the same meaning as
                     defined in 42 U.S.C. § 263a-7;

                              (2) "Department" means the department of health;

                              (3) "Fertility clinic" means:

                                        (A) A location that is considered an embryo laboratory, as defined in 42
                               U.S.C. § 263a-7;

                                        (8) A location where a person is practicing assisted reproductive
                               technology; or

                                        (C) A location where a person is engaging in the storage of

                              embryos; and

                              (4) "Society for Assisted Reproductive Technology" or "SART" means a United
                    States-based professional organization that sets clinical and laboratory standards for
                    assisted reproductive technology, collects and publishes in-vitro fertilization success
                    rate data from member clinics, provides patient education, provides professional
                    guidance, and works closely with the federal centers for disease control and
                    prevention on ART data reporting.

          68-1-2102. Certification required.

                    (a) Each fertility clinic operating in this state shall obtain a certificate to perform
          assisted reproductive technology services.

                    (b) The department shall issue a certificate to a fertility clinic that submits the
          following to the department biennially:

                              (1) Verification of the fertility clinic's membership in SART or an equivalent
                    organization subject to the approval of the department;

                              (2) An emergency plan for the transfer of embryos should the clinic close
                    permanently for any reason; and

                              (3) Proof of passing the most recent laboratory inspection from either the
                    College of American Pathologists or the Joint Commission on Accreditation of
                    Healthcare Organizations.

          68-1-2103. Clinical directors.

                    For a fertility clinic to operate in this state, the clinical director must:

                              (1) Be licensed to practice medicine or osteopathic medicine pursuant to title
                    63, chapter 6 or 9;

                              (2) Be board certified in obstetrics and gynecology by a member board of the
                    American Board of Medical Specialties;

                              (3) Have successfully completed a fellowship in reproductive endocrinology
                    and infertility accredited by the Accreditation Council for Graduate Medical Education
                    or possess equivalent training and experience;

                              (4) Demonstrate substantial clinical experience in assisted reproductive
                    technology procedures; and

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                               (5) Maintain continuing medical education relevant to reproductive

                     endocrinology, infertility, and assisted reproductive technology.
          68-1-2104. Genetic testing.

                     (a) The general assembly recognizes the importance of adherence to evidence-based
          best practices in the provision of genetic testing services in connection with assisted
          reproductive technology. Fertility clinics shall follow current clinical practice guidelines and
          professional standards for genetic testing issued by nationally recognized professional
          societies or organizations in the field of reproductive medicine or obstetrics and gynecology.

                     (b) This section does not require compliance with any specific guideline, create a
          private cause of action, establish a standard of care, or serve as a basis for liability.
          68-1-2105. Rules.

                 The department may promulgate rules to effectuate this part. The rules must be
      promulgated in accordance with the Uniform Administrative Procedures Act, compiled in title 4,
      chapter 5.

          SECTION 2. The headings in this act are for reference purposes only and do not constitute a
part of the law, enacted by this act. However, the Tennessee Code Commission is requested to
include the headings in any compilation or publication containing this act.

          SECTION 3. For the purposes of promulgating, rules, this act takes effect upon becoming a
law, the public welfare requiring it. For all other purposes, this act takes effect· January 1, 2027, the
public welfare requiring it.

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         SENATE BILL NO. 2461

PASSED:  April 23, 2026

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                         SPEAKER OF THE SEN

                         CAMERCJl'rSEXTON,SPEAKER

                         HOUSE OF REPRESENTATIVES

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ff APPROVED this
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                     BILL LEE, GOVERNOR
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