Bill Text: NJ S1921 | 2010-2011 | Regular Session | Introduced
Bill Title: Restricts sale or lease of certain ultrasound equipment; establishes registration requirements for certain organizations using such equipment.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2010-05-13 - Introduced in the Senate, Referred to Senate Commerce Committee [S1921 Detail]
Download: New_Jersey-2010-S1921-Introduced.html
SENATE, No. 1921
STATE OF NEW JERSEY
214th LEGISLATURE
INTRODUCED MAY 13, 2010
Sponsored by:
Senator FRED H. MADDEN, JR.
District 4 (Camden and Gloucester)
SYNOPSIS
Restricts sale or lease of certain ultrasound equipment; establishes registration requirements for certain organizations using such equipment.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning ultrasound equipment and supplementing Title 26 of the Revised Statutes.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. a. A person shall not sell, offer to sell, offer for promotional purposes, lease, or otherwise distribute in this State an obstetric-gynecologic ultrasonic imager, except to any of the following:
(1) a health care professional licensed pursuant to Title 45 of the Revised Statutes;
(2) a health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.);
(3) a dealer, distributor, manufacturer's representative, or sales agent that purchases an obstetric-gynecologic ultrasonic imager for the sole purpose of selling, leasing, or otherwise distributing the equipment in accordance with this act;
(4) a bank, leasing company, or financial institution that purchases an obstetric-gynecologic ultrasonic imager from a manufacturer or other person for the sole purpose of leasing the system in accordance with this act;
(5) an educational or research facility that purchases an obstetric-gynecologic ultrasonic imager for training or research purposes; or
(6) a non-profit charitable organization incorporated under State law that provides ultrasound services under the supervision of a physician or other health care professional licensed pursuant to Title 45 of the Revised Statutes at no cost to patients.
b. Nothing in this section shall be construed to permit a person who is not so authorized under federal law or regulations to buy, lease, or use an obstetric-gynecologic ultrasonic imager.
c. For the purposes of this section, "obstetric-gynecologic ultrasonic imager" means a prescription medical device defined by the federal Food and Drug Administration in 21 CFR 884.2225, the use of which is regulated by the federal Food and Drug Administration in the Department of Health and Human Services.
2. Any non-profit charitable organization incorporated under State law that provides or offers to provide ultrasound services, which is not otherwise registered or licensed with the Department of Health and Senior Services, shall register and provide documentation to the department regarding its ultrasound operations in accordance with regulations as prescribed by the department.
3. a. A person who violates the provisions of section 1 of this act shall be subject to a penalty of not less than $500 nor more than $1,000 for each offense, to be collected by the Commissioner of Health and Senior Services in a civil action through a summary proceeding under the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.). The municipal court and the Superior Court shall have jurisdiction of proceedings for the enforcement of the penalty provided by this subsection. If the violation is of a continuing nature, each day during which it continues constitutes an additional, separate, and distinct offense.
b. The Commissioner of Health and Senior Services may institute a civil action for injunctive relief to enforce this act and to prohibit and prevent a violation of this act, and the court may proceed in the action in a summary manner.
c. The Commissioner of Health and Senior Services shall revoke the registration, after notice and an opportunity for a hearing, of any non-profit charitable organization registered in accordance with section 2 of this act for a violation of this act.
4. This act shall take effect on the 30th day after enactment.
STATEMENT
This bill prohibits the sale, lease, or distribution of an obstetric-gynecologic ultrasonic imager in the State to any person other than the following:
1. a licensed health care professional;
2. a licensed health care facility;
3. a dealer, distributor, manufacturer's representative, or sales agent that purchases an obstetric-gynecologic ultrasonic imager for the sole purpose of selling, leasing, or otherwise distributing the equipment to a person pursuant to this act;
4. a bank, leasing company, or financial institution that purchases an obstetric-gynecologic ultrasonic imager from a manufacturer or other person for the sole purpose of leasing the system to a person pursuant to this act;
5. an educational or research facility that purchases an obstetric-gynecologic ultrasonic imager for training or research purposes; or
6. a non-profit charitable organization incorporated under State law that provides ultrasound services under the supervision of a physician or other health care professional licensed pursuant to Title 45 of the Revised Statutes at no cost to patients.
The bill mandates that any non-profit charitable organization incorporated under State law that provides or offers to provide ultrasound services, which is not otherwise registered or licensed with the Department of Health and Senior Services, shall register and provide documentation to the department regarding its ultrasound operations in accordance with regulations as prescribed by the department.
A person selling, offering to sell, offering for promotional purposes, leasing or otherwise distributing an obstetric-gynecologic ultrasonic imager, who is in violation of the provisions of section 1 of this bill, is subject to a civil penalty of not less than $500 and not more than $1,000 for each offense, to be collected by the Commissioner of Health and Senior Services. In addition, the bill stipulates that the Commissioner of Health and Senior Services shall revoke the registration of any non-profit corporation that provides or offers to provide ultrasound services in violation of the provisions of this bill.
