N.H. Admin. Code § He-P 4046.15

Current through Register No. 45, November 7, 2024

Section He-P 4046.15 - Bone Densitometry

(a) When an application for registration of a new or additional bone densitometry machines is received by DHHS/RHS in accordance with He-P 4040, registration shall be denied unless the application is accompanied by the following information:

(1) A detailed description of the x-ray examinations proposed in the screening program;

(2) A description of the diagnostic x-ray quality control program;

(3) The qualifications of each person who will be operating the x-ray system(s) ;

(4) The qualifications of the person who will be supervising the operators of the x-ray systems(s), the extent of supervision, and the method of work performance evaluation; and

(5) The name and address of the person who will interpret the radiograph(s) .

(b) Bone densitometry 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) Licensed in accordance with He-P 4040 of these regulations; and

(3) Maintained and operated in accordance with the manufacturer's specifications.

(c) Bone densitometry systems with a stepless beam limitation device shall be provided with means to both size and align the x-ray field such that at a plane of the image receptor the x-ray field does not extend beyond 2 percent of the SID.

(d) Operators of bone densitometry systems shall be:

(1) Licensed as a practitioner of the healing arts; or

(2) Complete a training course on bone densitometry which is provided by the densitometer manufacturer or vendor, and which shall include:

a. Basic radiation protection;

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

c. Patient positioning for the types of examinations performed.

(e) During the operation of any bone densitometry system:

(1) The operator, ancillary personnel, and members of the general public shall be positioned at least one meter from the patient and bone densitometry system during the examination; and

(2) The operator shall advise the patient that the bone densitometry examination is a type of x-ray procedure.

(f) The registrant shall keep maintenance records for bone densitometry records as prescribed by He-P 4045.05. These records shall be maintained for inspection DHHS/RHS for a minimum period of 5 years.

(g) Bone densitometry on human patients shall be conducted only under the prescription of a licensed practitioner of the healing arts.

N.H. Admin. Code § He-P 4046.15

Derived From Volume XXXV Number 32, Filed August 13, 2015, Proposed by #10893, Effective 7/21/2015, Expires7/21/2025.