N.J. Admin. Code § 7:28-22.5

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

Section 7:28-22.5 - Quality assurance program for medical diagnostic radiographic equipment

(a) The registrant of any medical diagnostic radiographic 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 1, Radiographic Quality Control Requirements below;

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

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

TABLE 1
Radiographic Quality Control Requirements
(To be performed by appropriately trained facility personnel)
Item	Required Test or	Frequency	Standard
Procedure
1.	Equipment Warm-up	Daily, each	Warm up tube; ensure equipment is
Procedure	day x-rays are	working properly
taken
2.	Processor Quality	Daily, each	Medium Density +/-0.15 Optical
Control (Sensitometry/	day x-rays are	Density (OD), Density Difference
Densitometry)	taken	+/-0.15 OD, Base + Fog + 0.03 OD
of operating levels
3.	Laser Film Printer	Weekly	As specified in 7:28-22.6
Quality Control	Table 2, Fluoroscopic Quality
Control Requirements
4.	Darkroom Cleanliness	Weekly	Free from dust and dirt
5.	Processor Maintenance	Initially and	Manufacturers' specifications
and Chemical Solutions	every 2 months
(more frequent
ly if needed)
6.	Equipment Visual	Initially and	All tests passed
Checklist	quarterly
7.	Film and Chemical	Initially and	Use film and chemicals with
Shelf Life	quarterly	earliest expiration date first
8.	Light Field/X-ray	Initially,	Not to exceed 2% of Source to
Field Alignment	quarterly and	Image Distance (SID)
after service
9.	Repeat Analysis	Semiannually	No standard, but goal should be <5%
(review
rejected films
immediately
for corrective
action)
10.	Artifact Evaluation	Examine every	No significant artifacts
film for
artifacts,
in-depth
evaluation
semiannually
11.	Analysis of Fixer	Initially and	<=5 micrograms/sq. centimeter or
Retention	semiannually	<=0.05 grams/sq. meter
12.	Darkroom Fog	Initially,	<=0.05 Optical Density Difference
semiannually
and after
service
13.	Screen-Film	Initially and	No areas of poor contact 2 cm. in
Contact/Cassette	annually or as	diameter
Integrity/Screen	needed
Cleanliness
14.	Lead Aprons, Gloves,	Initially and	No breaks in protective garments
Gonadal and Thyroid	annually
Shield Integrity Check
15.	Medical Physicist's QC	Initially and	As required in 7:28-22.8
Survey	annually
16.	Quality Assurance	Initially and	As required in N.J.A.C.
Program Review	annually	7:28-22.4(a)7

(b) The Department has prepared compliance guidance documents, listed in 7:28-22.3(d)1 and 2, 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 manual processing of films in medical diagnostic radiography shall use the time/temperature method. An example of the time/ temperature method is described in the compliance guidance documents listed in 7:28-22.3(d)2.

(d) The registrant shall ensure that individuals performing quality control tests described in Table 1, Radiographic Quality Control Requirements, above have an appropriate level of training to perform the tests competently.

(e) If any of the test results from item 2 in Table 1, Radiographic Quality Control Requirements, above indicate that the x-ray processing does not meet the standards in Table 1, the registrant shall immediately initiate steps to bring the processing into compliance. Films shall not be processed until the processing meets the standards required in Table 1.

(f) If any of the test results from item 3 in Table 1, Radiographic Quality Control Requirements, above indicate that the laser film printer does not meet the standards in Table 1, 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 6, 8, 10, 11, 12, 13, 14, and 15 in Table 1, Radiographic Quality Control Requirements, above indicate that the x-ray equipment does not meet the standards in Table 1, the registrant shall immediately initiate corrective actions to meet the standards. All corrective actions shall be completed within 30 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, 3, 5, 6, and 8 through 14 in Table 1, Radiographic 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 and 3 in Table 1, Radiographic Quality Control Requirements, 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 8, 11, 12, and 13 in Table 1, Radiographic Quality Control Requirements, are maintained for at least one year.

(k) The registrant shall ensure that the initial Medical Physicist's QC Survey is permanently maintained, and that the records of the annual Medical Physicist's 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 § 7:28-22.5

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