N.J. Admin. Code § 7:28-22.6

Current through Register Vol. 56, No. 24, December 18, 2024

Section 7:28-22.6 - Quality assurance program for medical diagnostic fluoroscopic equipment

(a) The registrant of any medical diagnostic fluoroscopic 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 N.J.A.C. 7:28-22.4;

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

3. An initial and annual thereafter (not to exceed 14 months) Medical Physicist's QC Survey as specified in N.J.A.C. 7:28-22.9(a); and

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

TABLE 2
Fluoroscopic Quality Control Requirements
(To be performed by appropriately trained facility personnel)
Item	Required Test or	Frequency	Standard
Procedure
1.	Equipment Warm-up	Daily, each	Tube warm-up and ensure equipment is
Procedure	day fluorosco	working properlyFluoro phantom image is
py is perform	comparable to facility standard
ed
2.	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.
3.	For spot film and	As specified	As specified in N.J.A.C. 7:28-22. 5
radiography, items	in Table 1,	Table 1, Radiographic Quality Control
2, 4, 5, 7, 9 and11	Radiographic	Requirements
QC tests as	Quality
specified in Table	Control
1, Radiographic	Requirements
Quality Control
Requirements
4.	Phantom Images	Monthly	kVp +/- 5%, MA +/- 10% high & low
(Fluoro Video	contrast depends on phantom used
Monitor)
5.	Equipment Visual	Initially and	All tests passed
Checklist	quarterly
6.	Lead Aprons,	Initially and	No breaks in protective garments
Gloves, Gonadal and	annually
Thyroid Shield
Integrity Check
7.	Medical Physicist's	Initially and	As required in N.J.A.C. 7:28-22.9
QC Survey	annually
8.	Quality Assurance	Initially and	As required in N.J.A.C. 7:28-22.4(a)7
Program Review	annually

(b) The Department has prepared compliance guidance documents, listed in N.J.A.C. 7:28-22.3(d)1 and 3, 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 individuals performing quality control tests described in Table 2, Fluoroscopic Quality Control Requirements, above have an appropriate level of training to perform the tests competently.

(d) If any of the test results from item 2 in Table 2, Fluoroscopic Quality Control Requirements, above indicate that the laser film printer does not meet the standards in Table 2, 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.

(e) If any of the test results from item 3 in Table 2, Fluoroscopic Quality Control Requirements, above indicate that the x-ray equipment or processing does not meet the standards in Table 2, the registrant shall immediately initiate steps to bring the fluoroscopic equipment and processing into compliance. If processor sensitometry/densitometry does not meet the standards, films shall not be processed until the processing meets the sensitometry/ densitometry standards.

(f) If any of the test results from items 4 through 6 in Table 2, Fluoroscopic Quality Control Requirements, above indicate that the fluoroscopic equipment does not meet the standards in Table 2, the registrant shall immediately initiate steps to repair the fluoroscopic equipment to meet the standards. All such repairs shall be completed within 30 days.

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

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

(i) The registrant shall ensure that:

1. All results of QC tests performed for items 2 through 6 in Table 2, Fluoroscopic 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; and

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

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

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

N.J. Admin. Code § 7:28-22.6

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