216-40-20 R.I. Code R. § 4.9

Current through June 20, 2024

Section 216-RICR-40-20-4.9 - Dual-Energy X-ray Absorptiometry (DXA) (Bone Densitometry)

4.9.1DXA Systems

A. DXA systems shall be:

1. Certified by the manufacturer pursuant to the Medical Device Act and Subchapter C - Electronic Product Radiation Control (EPRC) of Chapter V of the Federal Food, Drug and Cosmetic Act;

2. Registered in accordance with Part 3 of this Subchapter; and

3. At a minimum, maintained and operated in accordance with the manufacturer's specification and recommendations.

4.9.2[RESERVED]

4.9.3DXA System Operators

A. Operators of DXA systems shall be:

1. Licensed as a practitioner of the healing arts; or

2. Individuals who possess a current license in accordance with Subchapter 05 Part 34 of this Chapter, Licensure of Radiographers, Nuclear Medicine Technologists, Radiation Therapists and Radiologist Assistants, unless the individual is specifically exempted from licensure by said Regulations; or

3. Individuals who are not subject to licensure under Subchapter 05 Part 34 of this Chapter and have been instructed in the proper use of the DXA system. As a minimum, such instruction shall include:

a. Basic radiation protection;

b. Operating procedures for DXA systems, to include use of various system functions, safety, and maintenance; and

c. Patient positioning for the types of examinations performed.

4.9.4DXA System Operation

A. During the operation of any DXA system:

1. In the absence of a survey performed by or under the supervision of a Qualified Medical Physicist determining the minimum distance the operator may be from the patient and radiation source, the operator, ancillary personnel, and members of the general public shall be positioned at least two meters (2 m) from the patient and DXA system during the examination.

2. The operator shall advise the patient that the DXA examination is a type of X-ray procedure.

4.9.5Maintenance of Records

The registrant shall keep maintenance and QC test records for DXA systems as prescribed by §§4.9.1(A)(3) and 4.10.1(A)(6) of this Part. These records shall be maintained for inspection by the Agency for a minimum of three (3) years from the date the maintenance action was completed.

4.9.6DXA Examination Requirements

A. DXA on human patients shall be conducted only:

1. Under a prescription of a licensed practitioner of the healing arts; or

2. Under a screening program approved by the Agency.

4.9.7Submission of Information

Any person proposing to conduct a DXA screening program shall submit the information outlined in § 4.11 of this Part and include the name and address of the licensed practitioner of the healing arts who will interpret the screening results.

216 R.I. Code R. § 216-RICR-40-20-4.9

Adopted effective 1/1/2019
Amended effective 5/25/2022
Amended effective 11/28/2023