N.J. Admin. Code § 7:28-22.7

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

Section 7:28-22.7 - Quality assurance program for diagnostic computed tomography equipment

(a) The registrant of any diagnostic computed tomography (CT) equipment used in the healing arts shall develop and continuously implement a quality assurance program that includes the following elements:

1. A quality assurance program manual that satisfies the requirements of 7:28-22.4;

2. Quality control tests, procedures, frequencies and standards including, but not limited to, those identified in Table 3, Computed Tomography Quality Control Requirements, below;

3. An initial and annual thereafter (not to exceed 14 months) Medical Physicist's Computed Tomography QC Survey as specified in 7:28-22.10(a); and

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

TABLE 3
Computed Tomography Quality Control Requirements
(To be performed by a licensed radiologic technologist, a qualified medical
physicist, or a trained service technician)
Item	Required Test or	Frequency	Standard
Procedure
1.	Equipment Function:	Daily, each	Must work properly
Indicators,	day x-rays
Mechanical, and	are taken
other Safety
Checks. Warm-up
2.	For film processing,	As specified	As specified in 7:28-22.5
items 2, 5, 7,	in Table 1,	Table 1, Radiographic Quality Control
and 11 QC tests as	Radiographic	Requirements
specified in Table	Quality
1, Radiographic	Control
Quality Control	Requirements
Requirements
3.	CT Number for Water	Daily	CT equipment or phantom manufacturers'
specifications
4.	Field Uniformity	Daily	CT equipment or phantom manufacturers'
specifications
5.	Laser Film Printer	Weekly	Recommended control	*OD=Optical
Quality Control	limits	Density
SMPTE Test Pattern	Inverted gray
scale
0% patch 2.45 +/-	0% patch 2.50 +
0.15 OD*	0.15 OD
10% patch 2.10 +/-	10% patch 2.25 +/-
0.15 OD	0.15 OD
40% patch 1.15 +/-	40% patch 1.35 +/-
0.15 OD	0.15 OD
90% patch 0.30 +/-	90% patch 0.30 +/-
0.08 OD	0.08 OD
*The 5% patch should just be visible
inside of the 0% patch.
The 95% patch should be visible inside
the 100% patch.
6.	Low Contrast	Initially and	CT equipment or phantom manufacturers'
Resolution	Monthly	specifications
7.	High Contrast	Initially and	CT equipment or phantom manufacturers'
Spatial Resolution	Monthly	specifications
8.	Noise	Initially and	CT equipment or phantom manufacturers'
Monthly	specifications
9.	Table Position	Initially and	+/- 2 mm
Indicator Accuracy	Monthly
10.	Scan Increment	Initially and	+/- 1 mm
Accuracy	Monthly
11.	Scan Localization	Initially and	+/- 5 mm
Light Accuracy	Monthly
12.	Medical Physicist's	Initially and	As required in 7:28-22.10
QC Survey	annually
13.	Quality Assurance	Initially and	As required in 7:28-22.4(a)7
Program Review	annually

(b) The Department has prepared compliance guidance documents, listed in 7:28-22.3(c)1 and 4, which may be used by the registrants in developing and implementing the quality assurance programs required by this subchapter. The compliance guidance documents 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.

(c) The registrant shall ensure that individual performing quality control tests described in Table 3, Computed Tomography Quality Control Requirements, above is either a licensed radiologic technologist, a qualified medical physicist for the supervision of quality assurance programs for computed tomography equipment, or a trained service technician.

(d) If any of the test results from item 2 in Table 3, Computed Tomography Quality Control Requirements, above indicate that the x-ray processing does not meet the standards in Table 3, the registrant shall immediately initiate steps to bring the processing into compliance. Films shall not be processed until the processing meets these standards.

(e) If any of the test results from items 3, 4, 6, 7, and 8 in Table 3, Computed Tomography Quality Control Requirements, above indicate that the computed tomography equipment does not meet the standards in Table 3, the registrant shall immediately initiate steps to repair the computed tomography equipment to meet the standards. All corrective actions shall be completed within 30 days.

(f) If any of the test results from item 5 in Table 3, Computed Tomography Quality Control Requirements, above indicate that the laser film printer does not meet the standards in Table 3, the registrant shall immediately initiate steps to repair the laser film printer to meet the standards. Films shall not be processed until the processing meets the standards.

(g) If any of the test results from items 9, 10, and 11 in Table 3, Computed Tomography Quality Control Requirements, above indicate that the computed tomography equipment does not meet the standards in Table 3, the registrant shall immediately initiate steps to repair the computed tomography equipment to meet the standards. All corrective actions shall be completed within 15 days.

(h) No person shall use or permit the use of film or processing chemicals beyond the expiration dates on the containers.

(i) The registrant shall ensure that records of each corrective action, repair and service are maintained for at least two years.

(j) The registrant shall ensure that:

1. All results of QC tests performed for items 2 through 11 in Table 3, Computed Tomography Quality Control Requirements, are recorded on forms available from the Department at www.xray.nj.gov, or a comparable form containing the same information, and maintained for at least one year;

2. All images (film or digital) produced and relied upon in the performance of QC tests for items 2, 3, 4, and 5 are maintained for at least 30 days; and

3. All images (film or digital) produced and relied upon in the performance of QC tests for items 6, 7, and 8 are maintained for at least one year.

(k) The registrant shall ensure that the initial Medical Physicist's Computed Tomography QC Survey is permanently maintained and the records of the annual Medical Physicist's Computed Tomography QC Survey are maintained for at least two years.

(l) The registrant shall ensure that the records of the quality assurance program review are maintained for at least two years.

N.J. Admin. Code § 7:28-22.7

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