Bill 1A - Ultrasound Quality Assurance - Public leadership Institute

MODEL BILLS

Health & Safety Standards

Ultrasound Quality Assurance and Safety Act

Issue Overview

Unregulated Pregnancy Clinics (UPCs) often present themselves as free medical clinics to mislead clients seeking abortion. Their primary goal is to prevent clients, through persuasion, misinformation, or delay, from having an abortion. ³³. While these organizations have the right to oppose abortion, most use misleading tactics, including ads, signs, and websites presenting their facilities as conventional medical clinics, even, at times, as abortion providers.^33,34 Inside, they often resemble medical offices, with waiting rooms and exam rooms outfitted with medical equipment and staff in lab coats and scrubs. Clients must often fill out intake forms that ask for extensive private health information.³⁶

According to recent studies, around three-quarters of UPCs offer ultrasounds. ^37,38 These are not diagnostic tests. UPCs offer ultrasound to emotionally influence clients to continue their pregnancy and to telegraph medical legitimacy.^39,40 In states where ultrasound is required before abortion care, many UPCs falsely claim their services fulfill that legal requirement.⁴¹

The American Institute of Ultrasound in Medicine (AIUM) condemns using ultrasounds for any non-medical purpose. AIUM states, “The use of ultrasound without a medical indication to view the fetus, obtain images of the fetus, or identify the fetal external genitalia is inappropriate and contrary to responsible medical practice.”⁴²

Moreover, the operators of ultrasound machines at many UPCs do not meet the American Institute of Ultrasound in Medicine (AIUM) training guidelines. According to AIUM, proper diagnostic ultrasound exams must be conducted by, or under the direct supervision of, a physician, physician assistant, or nurse practitioner who has received specialized training.⁴³

Even Care Net, one of the largest UPC umbrella organizations in the U.S., acknowledges that performing ultrasounds outside of medical practice is unethical. Responding to, “Can we just do ultrasounds without becoming a medical clinic?” Care Net’s answer is unequivocal: “Absolutely not. The use of ultrasound energy in any form is considered the practice of medicine.”⁴⁴

Some states take ultrasound regulation more seriously for animals than for humans. For example, some states, including Georgia,⁴⁵ Minnesota,⁴⁶ Pennsylvania,⁴⁷ and Texas⁴⁸ prohibit unlicensed operators from conducting ultrasounds on livestock, defining it as the practice of veterinary medicine. Ironically, those same states currently allow unlicensed individuals to perform ultrasounds on pregnant people.

In addition to UPCs, for-profit “keepsake” photo businesses also perform non-medical ultrasounds to create souvenir images or videos. Unlike UPCs, these businesses are transparent and make no claim to offer medical services. Still, some states, including California and Washington, ban these companies due to health and safety concerns.

Ultrasound Quality Assurance and Safety Act

Summary

The Ultrasound Quality Assurance and Safety Act requires that an ultrasound device can only be used if it is operated or supervised by a licensed medical professional operating within their scope of practice.

Based on WA SB 6151 (2024)

SECTION 1. SHORT TITLE

This Act shall be called the “Ultrasound Quality Assurance and Safety Act.”

SECTION 2. FINDINGS

The legislature finds that:

An ultrasound machine is a medical device that uses high-frequency sound waves to create images of the inside of the body.
The U.S. Food and Drug Administration, which is responsible for approving all prescription drugs and medical devices for human use, considers the use of ultrasound energy on humans to be the practice of medicine and must be done for clear medical indications and be performed by trained and licensed medical providers. The FDA opposes the use of ultrasound machines by anyone other than appropriately trained and licensed medical professionals, under the supervision and authority of a licensed physician.⁴⁹
The American Institute of Ultrasound in Medicine (AIUM) official statements⁵⁰ on the use and safety of ultrasound in pregnancy strongly discourage the use of ultrasounds for any non-medical purpose, advise that diagnostic ultrasound in pregnancy should only be performed when there is a valid medical indication, and recommend that all fetal ultrasound examinations be performed by appropriately trained and credentialed medical professionals who have received specialized training in fetal imaging and meet the AIUM training guidelines.⁵¹ The AIUM also emphasizes that all pregnancy ultrasound imaging requires proper documentation and a final report for the patient’s medical record signed by a physician or an advanced clinical provider legally responsible for interpretation.⁵²
Nevertheless, ultrasound machines are being operated by untrained staff and volunteers in a number of circumstances. These include: “elective” standalone ultrasound “centers,” which may or may not have appropriately trained and supervised staff;⁵³ “keepsake” ultrasound photo studios to take pictures for framing;⁵⁴ and Unregulated Pregnancy Clinics (UPCs) [or use another name if it’s common for your state] that often offer “non-diagnostic” ultrasound imaging.
It is therefore necessary and appropriate for state law to specify under what conditions an ultrasound can be performed.

SECTION 3. QUALITY ASSURANCE FOR ULTRASOUND

After section XXX, the following new section XXX shall be inserted:

(A) OPERATION OF ULTRASOUND LIMITED TO LICENSED PROFESSIONALS

An ultrasound or a similar medical imaging device or procedure shall only be used on a person by:
(a) A health care provider holding an active license under [cite code sections which license a physician, nurse practitioner or other advanced practice clinician] and acting within their scope of practice; or
(b) A person acting under the direct supervision of a health care provider holding an active license under [cite same code sections as above], where all actions performed are within the supervising health care provider’s scope of practice.
This section does not apply to the practice of a licensed midwife providing care pursuant to (cite code) or the practice of a certified nurse-midwife providing care pursuant to (cite code). [If other medical exemptions should apply based on the licensing system in your state, they would go here.]
[OPTIONAL PROVISION, but note that the CA and WA laws have no exceptions for non medical uses.] This section does not apply if the ultrasound is performed for the sole purpose of creating keepsake photos or videos.

(B) ENFORCEMENT

Whenever the Attorney General or a district attorney [if applicable: a city attorney, a county counsel] has reasonable cause to believe that a facility has violated this section, the Attorney General may issue a civil investigative demand pursuant to [cite code].
The Attorney General may commence an action in any court of competent jurisdiction for injunctive relief to compel compliance with the provisions of this section, and for civil penalties for violations.
Prior to commencing an action in court, the Attorney General shall give written notice to the facility to cure such violations not later than 10 business days after receipt of the written notice.
Upon a finding by the court that a person, partnership, or corporation has violated this section, the state shall be entitled to recover:
(a) civil penalties of up to three thousand dollars for a first violation;
(b) civil penalties of up to ten thousand dollars for a second or subsequent violation; and
(c) reasonable attorneys’ fees and costs.
In determining the overall amount of civil penalties to assess against a facility, the court shall include, but not be limited to the following in its consideration:
(a) the nature and severity of the violation;
(b) the size, scope, and type of the offending organization; and
(c) the good faith cooperation of the offending facility with any investigations conducted by the Attorney General pursuant to this section.

SECTION 4. EFFECTIVE DATE

This law shall become effective on July 1, 20XX.