N.J. Admin. Code § 7:28-22.4

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

Section 7:28-22.4 - Quality assurance program manual

(a) The registrant of any diagnostic medical x-ray equipment used in the healing arts shall develop and continuously implement a quality assurance program that includes a quality assurance program manual that contains the following elements:

1. A list of clearly identified individuals and assigned responsibilities for maintaining the quality assurance program and for performing the quality control tests;

2. Quality control (QC) measures which shall include:

i. QC tests to be performed and the frequency of each test;

ii. A list of equipment to be tested;

iii. Acceptability limits for each test performed;

iv. A description of each QC test procedure;

v. Sample forms for each QC test performed;

vi. Processor and solutions maintenance; and

vii. An Annual Medical Physicist's QC Survey;

3. Policies and procedures which shall include:

i. A policy for holding patients and for presence of individuals in room during radiation exposure;

ii. A policy for pregnant patients and employees;

iii. A policy for gonadal shielding;

iv. A description of the orientation program for operators of radiographic, fluoroscopic and CT equipment including the duration and content of that program;

v. Procedures for proper use and maintenance of equipment;

vi. Policies and employee responsibilities concerning personnel radiation monitoring;

vii. A policy for releasing films;

viii. A policy for labeling films (that is, patient's statistics, facility information);

ix. A commitment to perform a Radiation Safety Survey of the Environs in accordance with 7:28-15.10 on newly installed x-ray equipment within 60 days of installation and an initial Medical Physicist's QC Survey as required by 7:28-22.8(a), 22.9(a), or 22.10(a) as appropriate for the type of x-ray equipment;

x. A policy for using technique charts; and

xi. A policy and rules on radiation safety as required by 7:28-15.9(a)8;

4. A plan for taking corrective actions which shall include:

i. Measures to be taken when the x-ray equipment is determined to need repair, service or calibration; and

ii. Measures to be taken when the processor is determined to need repair or service.

5. Recordkeeping which shall include:

i. Records for the most recent one year of the QC tests performed by the registrant;

ii. Records of the initial Medical Physicist's QC Survey plus the two most recent QC Surveys;

iii. Records of corrective actions for the most recent two years; and

iv. Personnel monitoring records;

6. Reference manuals (if any) and their location; and

7. A provision describing how the registrant and the qualified medical physicist will review the QA program annually (not to exceed 14 months).

(b) The Department has prepared a Compliance Guidance for a Medical Diagnostic X-ray Quality Assurance Program Manual, referenced at 7:28-22.3(d)1, which may be used by the registrants in developing and implementing the quality assurance program required by this subchapter. The compliance guidance document listed in 7:28-22.3(d)1 is 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.

N.J. Admin. Code § 7:28-22.4

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