N.J. Admin. Code § 7:28-22.3

Current through Register Vol. 56, No. 21, November 4, 2024

Section 7:28-22.3 - General provisions

(a) No person shall perform or permit the performance of a diagnostic x-ray procedure in the healing arts using radiographic, fluoroscopic, x-ray bone densitometry, or computed tomography (CT) equipment unless the registrant has developed and continues to implement a quality assurance program that satisfies the requirements of this subchapter.

(b) Subject to (c) below, the quality assurance program shall contain the following elements:

1. A quality assurance program manual as specified in 7:28-22.4;

2. Quality control tests as specified in 7:28-22.5, 22.6 or 22.7 (as appropriate for the diagnostic x-ray equipment);

3. An initial and annual (not to exceed 14 months) Medical Physicist's QC Survey as specified in 7:28-22.8, 22.9, or 22.10; and

4. A corrective action plan as required by 7:28-22.4(a)4.

(c) Registrants of x-ray bone densitometer equipment are required only to implement and continue to carry out the quality assurance programs for such equipment which are required by 7:28-22.11.

(d) The Department has prepared compliance guidance documents, listed below, which may be used by the registrants in developing and implementing quality assurance programs required by this subchapter. The compliance guidance documents are listed below:

1. Compliance Guidance for a Medical Diagnostic X-ray Quality Assurance Program Manual;

2. Compliance Guidance for Radiographic Quality Control;

3. Compliance Guidance for Fluoroscopic Quality Control; and

4. Compliance Guidance for Computed Tomography Quality Control.

(e) The compliance guidance documents listed in (d) above are available from the Department, and may be obtained by contacting the Department at the Bureau of X-ray Compliance, Mail Code 25-01, PO Box 420, Trenton, NJ 08625-0420 and can be obtained from the Bureaus web page at www.xray.nj.gov.

(f) A registrant or an organization representing a group of registrants may request approval from the Department of an alternative quality assurance program to be used by that specific registrant or a specified list of registrants. The application must fully document the provisions of the alternative quality assurance program and identify how the alternative program differs from the requirements in this subchapter. The applicant must demonstrate that the alternative program will be equally effective in achieving consistent high quality imaging and improving diagnosis while reducing unnecessary radiation to the patients and workers as the quality assurance program required by this subchapter. The applicant may request that a specific quality control test or other quality assurance provision be excluded from the applicant's quality assurance program if performing the test or provision is not possible or is inappropriate because of the nature of the applicant's equipment or practice.

(g) The Department, with approval of the Commission on Radiation Protection, may approve, or approve with conditions, a request for an alternative quality assurance program. To be approved, the alternative program must be equally effective in achieving consistent high quality imaging while reducing unnecessary radiation to the patients and the workers as the quality assurance program required by this subchapter.

(h) The Department may deny a request for an alternative quality assurance program should it determine that the alternative program would not be equally effective in achieving consistent high quality imaging and improving diagnosis while reducing unnecessary radiation to the patients and the workers as the quality assurance program required by this subchapter.

(i) Any registrant who receives approval from the Department for an alternative quality assurance program shall comply with the terms of approval.

(j) Any registrant may use forms that differ from any forms contained in the compliance guidance documents referenced in (d) above without approval, provided the form or procedure is sufficient to demonstrate compliance with the regulatory provision.

(k) Any registrant who submits an application for an alternative quality assurance program shall comply with the quality assurance program requirements of this subchapter until such time as the application for an alternative quality assurance program is approved by the Department.

(l) No person shall engage in the use or employment of dishonesty, fraud, deception, misrepresentation, false promise or false pretense while engaged in activities relating to this subchapter.

(m) No person shall falsify or make misleading statements on any record or report required by this subchapter.

(n) No person shall make misleading or false statements to a representative of the Department or Commission.

(o) No person shall falsify any records, nor destroy nor steal any property or records, relating to quality assurance as required by this subchapter.

N.J. Admin. Code § 7:28-22.3

Amended by 46 N.J.R. 768(a), effective 5/5/2014.