Introduction

A. Purpose

This guide describes the type and extent of information and standards by which the New York State

Department of Health will evaluate a facility's Radiation Safety/Quality Assurance Program.

Our Department has implemented this program to reduce radiation exposure and optimize diagnostic x-

ray image quality. It is our goal to assist facilities to be more actively involved and responsible for Quality

Assurance in their operations. It is important to review the program as a whole and not to become

enmeshed in the everyday quality control tests. Facilities may substitute quality control tests if the tests

are deemed equivalent by the Department prior to their implementation.

References can be found in the bibliography to assist you with test procedures and to answer questions

not addressed in this brief guide regarding Quality Control and Quality Assurance.

B. ALARA Principle (As Low As Reasonable Achievable)

The regulations in Part 16 and this guide have been established on the ALARA Principle to assure that

the benefits of the use of ionizing radiation exceed the risks to the individual and the public health and

safety.

C. Control Limits and Standards

The control limits and standards used in this guide have been taken from the Federal Performance

Standard for Diagnostic X-ray Equipment, Part 16, and other references listed in the

bibliography. Processor problems need to be addressed as they occur and before the limits are

exceeded. Equipment problems should be corrected and documented expeditiously and shall be

corrected with appropriate documentation within thirty (30) days of discovery. The RS/QA

program for Computed Tomography equipment is contained in a separate document.

D. Authority

The statutory authority for these rules and regulations is found in the New York State Public Health Law,

Section 225. The Radiation Safety/Quality Assurance requirements are outlined in Section 16.5 and

16.23 of Part 16 of Chapter 1 of Title 10 (Health) of the Official Compilation of Codes, Rules and

Regulations. Please note that this program is in addition to and does not replace other sections of Part

16, which pertain to your operation.

Radiation Safety/Quality Assurance Programs

A. Radiation Safety/Quality Assurance Responsibility

Each facility shall establish a committee of individuals to be responsible for the Radiation Safety/Quality

Assurance program. Hospitals will include those departments, which use xrays for diagnostic purposes.

This committee should be composed of a minimum of one radiologist, the Chief Technologist, the QC

Technologist(s), and a Medical Physicist and a member of the in-house x-ray service or engineering

group, if available. Individuals such as hospital administrators and representatives of contracted service

companies may also be valuable. The committee in a non-hospital facility might be composed of a

physician, radiologic technologist, office manager and service representative.

This oversight committee shall convene on a frequency adequate to meet their responsibilities, with a

minimum of one meeting annually. More frequent meetings will probably be important in the initial

stages of this program. The minutes of these meetings shall be kept for a minimum of three years.

It is the responsibility of this committee to provide direction to the program, assure that proper

documentation and testing is maintained, review the program's effectiveness and determine any

changes which should be made.

The committee shall assign Quality Control responsibilities in writing. Specific assignments shall be

recorded in the manual. The responsible individuals shall be properly instructed. Evidence of continuing

education shall be available for those individuals actively engaged in the Quality Control testing and

evaluation process.

B. Records

1. Manual

Each facility will establish a manual that includes the following items:

a. a list of the individuals responsible for testing supervising and repairing/or servicing

the equipment;

b. a list of the tests to be performed and the frequency of performance;

c. the acceptability limits for each test;

d. a brief description of the procedures to be used for each test (Appendix C-1 contains

an example of a manual item on light field/x-ray field alignment);

e. a list of the equipment to be tested;

f. protocol for correction;

 g. reference materials and their location;

h. a list of the equipment to be used for testing

i. sample forms to be used for each test; and

j. the committee organization and duties.

2. Equipment Records

Records shall be maintained for each x-ray room and mobile x-ray unit and include:

a. the initial test results (acceptance testing and radiation safety survey as appropriate);

b. the current year;

c. one set of test results from each intervening year to show changes over time.

Records of repairs and other pertinent data shall also be available. It is not essential that the

records be stored in the room with the x-ray equipment tested but must be easily accessible to

anyone who needs to use them.

3. Radiation Output and Exposure Rate Measurements for Selected X-ray Examinations

The facility shall have available the radiation output measurements for common radiographic

examinations they perform for patient and staff information for each x-ray unit. These

measurements shall be repeated whenever changes are made to the system, which would

impact the output. Appendix G is available for reference. Fluoroscopic exposure rates for the

patient phantoms specified in Section 16.58(a)(9) of Part 16 for the most common

examinations shall be posted so that they are conspicuous to the operator of each fluoroscopic

unit.

4. Processor and Sensitometer Logs

Control charts of sensitometry shall be maintained and used to regulate processing.

Processor maintenance logs shall include preventive maintenance, corrective maintenance and

cleaning (Appendix H). Each action shall be dated and initialed.

Processor charting of speed, contrast, and base + fog shall be graphed daily and posted as

close as possible to the individual processor from which the data is derived. The graphs for

each processor shall be kept for review for a period of time at least equal to the facility's

inspection interval.
 Facilities using dry image processing devices must evaluate those devices according to the

manufacturer's recommended test procedures and test frequencies. The results of the

evaluation must be compared to the manufacturer's published specifications for that type of

device. The results of those evaluations and any corrective actions taken must be retained for

a period of time equal to at least the facility's inspection interval.

5. QC Records for Test Equipment

Records shall be maintained and available for review for QC test equipment, which requires

calibration.

6. Radiation Safety Policies and Procedures

The written policy and procedures must be available for the holding of patients, use of gonad

and scoliosis (if performed) shielding, pregnant patients and operators, personnel monitoring,

x-ray screening and repeat, reject analysis. (Guidelines for information to be included can be

found in Appendix F).

C. Equipment Monitoring

Each facility shall make or have made the following tests, at the frequency specified, and

maintain records of the data. The type of tests and the frequency of the tests may be modified at

the discretion of the Department if the facility can show documented proof that alternative tests

or schedules will ensure good diagnostic image quality.

This guide describes a basic Radiation Safety/Quality Assurance Program and represents only a portion

of the Quality Control tests your facility may choose to perform as part of an individualized program.

A chart of tests and frequencies can be found in Appendix A.

1. Test frequency - Each day of operation

Equipment functioning: Each day during the x-ray generator warm-up, and before xraying the

first patient, the operator should check for indicator dial malfunction and also the mechanical

and electrical safety of the x-ray system. Malfunctions and unsafe conditions shall be corrected

promptly. Suggestions for visual and manual checks are in Appendix H.

Film processing: For each day of operation, the processing system must operate as close to

the film manufacturer's temperature and speed recommendations of the product as possible. It

is very important that corrective action be made when limits are exceeded or a pattern

develops indicating a degradation of the system.

 Parameters to be included in processing checks:

a. Speed Index or Medium Density:

Control limits +/-0.15 Optical Density O.D.

b. Contrast Index or Density Difference:

Control limits +/-0.15 O.D.

c. Base + Fog: Maximum density shall not exceed the established control limit by more

than 0.03 O.D.

Solution temperatures and replenishment rates should be checked when

troubleshooting speed and contrast problems.

2. Test frequency - Quarterly

a. Collimators

1. Light field/X-ray Field alignment (App. C-1)

The misalignment in either dimension of the edges of the light field versus

the x-ray field shall not exceed 2% of the Source-Image-Distance (SID).

2. Positive Beam Limitation (PBL) (App. C-2)

The x-ray beam size shall not differ from the image receptor size by more

than 3% of the SID in any one dimension or by a total of more than 4% of the

SID in both dimensions.

3. X-ray Field/Image Receptor alignment (App.C-3)

The misalignment of the center of the x-ray field as compared to the center of

the image receptor shall not exceed 2% of the SID.

b. Collimators - Fluorographic

This requirement applies to spot film and fluoroscopic beam size in worst case

conditions.

1. Image Receptor/X-ray Field alignment

i. For image intensified equipment, the x-ray beam shall not exceed

the visible area of the image receptor by more than 3% of the SID in

one dimension or by a total of more than 4% of the SID in both

directions.
 ii. For non-certified image intensified equipment, the x-ray beam shall

not exceed the visible area of the one/one spot film.

iii. For non-image intensified equipment, the x-ray field size shall not

extend beyond the visible area of the image receptor.

3. Test Frequency - Semiannually

a. Radiographic Timer (includes Automatic Exposure Control)

1. Reproducibility of the Output

Radiographic units or spot film devices are in compliance, if in field testing, it

can be shown that for four exposures at a specific time:

Xmax - Xmin/Xavg ≤ 10%

where X is an exposure measurement in mR.

The most commonly used exposure time settings should be selected for

testing. If the results of the four exposures are not compliant, make six

additional exposures and calculate the coefficient of variation. The coefficient

of variation of the exposure measurements shall be no greater than 0.05 and

shall be determined by the equation:

S/X ≤ 0.05,

where X is the average of the exposure measurements and S is the standard

deviation of the exposure measurements.

2. Accuracy

Certified equipment shall meet the manufacturers' specifications.

b. kVp Accuracy

Unless otherwise specified in the manufacturer's written specifications, all equipment

shall meet:

±2 kVp of the indicated for < 30 kVp,

±3 kVp of the indicated for 31-100 kVp, and,

±6 kVp of the indicated for > 100 kVp.

c. mA Linearity

For certified equipment, the average ratios of exposure to the indicated milliampere-

seconds product (mR/mAs) obtained at any two consecutive tube current settings

shall not differ by more than 0.10 times their sum.

That is (X1-X2) < 0.10(X1+X2) where X1 and X2 are average mR/mAs values

obtained at each of two consecutive tube current settings. A minimum of four (4)

measurements shall be done at each of the mA stations. The generator should be

capable of maintaining the above linearity across all the available mA stations.

d. Tomographic Equipment

Each tomographic unit shall be evaluated for:

1. Slice or tomographic cut level.

The slice or cut level shall be within 5 mm of the indicated level.

2. Slice or tomographic cut thickness.

The slice or cut thickness with an arc setting of 30° shall have a slice

thickness of 2.0 or 2.5 mm.

3. Uniformity of Exposure

For linear tomographic units, the exposure field using a pinhole trace, will

demonstrate uniformity of exposure on both sides of the center of exposure.

For complex motion tomographic units (elliptical, circular, hypo-cycloidal,

trispiral, etc.) the pinhole exposure trace shall not indicate any area of large

gaps in exposure on the trace pattern nor shall it show erratic motion.

4. Resolution

Each tomographic unit should be capable of resolving a #40 mesh pattern

and shall be capable of resolving a #20 mesh pattern.

Facilities with two or more tomographic units shall maintain those units so

that the slice or tomographic cut level is the same for each unit. It is

recommended that for such facilities, a Littleton or comparable phantom be

 used to evaluate tomographic systems, in particular, those systems

performing complex motion.

e. Fluoroscopic Image Evaluation

1. Spatial Resolution

The spatial resolution of the fluoroscopic system shall be measured using a

test tool composed of a line pair plate with discreet line pair groups and a

maximum lead foil thickness of 0.1 mm or an equivalent device. The

minimum spatial resolution at the center of the beam for a 6 inch field of view

(FOV) is 2 line pairs per mm. The minimum spatial resolution for all other

FOVs shall be determined by the following equation:

2 lp/mm x (6" (15 cm) FOV/size of the FOV used) = minimum number of

lp/mm.

2. Low Contrast Performance

The low contrast performance of the fluoroscopic system shall resolve a

minimum hole size of 3 mm using a test tool composed of a 1.0 mm

aluminum sheet with two sets of four holes of dimension 1.0, 3.0, 5.0 and 7.0

mm and 1 inches of Type 1100 aluminum or an equivalent device.

f. Exposure Switch

At exposure times of 0.5 sec or more the switch must terminate the exposure if

manual pressure is removed.

g. Interlocks

All interlocks shall forbid exposure when in the open position. This includes the

fluoroscopic primary barrier, which shall be in position for use in order for fluoroscopic

exposure to be possible.

h. Safelights/Darkroom Fog

An x-ray sensitized film should show less than 0.05 Optical Density (O.D.) in excess

of the optical density due to the radiation exposure when exposed to a safelight

exposure time of two minutes and shall not exceed 0.05 O.D. for one minute.

i. View Boxes
 The brightness of the viewboxes used to check films after processing shall be within

15% of the brightness of the viewboxes used by the radiologists to read the films.

j. Lead Aprons, Gloves and Drapes

Protective garments and drapes shall not have tears, which impair their radiation

protection function.

4. Test Frequency - Annually

a. Half Value Layer (HVL)

i. For certified equipment, the minimum HVL shall not be less than:

X-ray Tube Voltage

Designed Operating kVp
Range Measured Al (mm)

Below 50 30 0.3

40 0.4

49 0.5

50-70 50 1.2

60 1.3

70 1.5

Above 70 71 2.1

80 2.3

90 2.5

100 2.7

110 3.0

120 3.2

130 3.5

140 3.8

150 4.1

ii. For non-certified equipment, the minimum aluminum equivalent of total

filtration shall not be less than:

Minimum Total Filtration

Operative kVp (Inherent Plus Added)

Below 50 0.5 mm Al

50-70 1.5 mm Al

Above 70 2.5 mm Al
b. Timers - Fluoroscopic

0. Certified equipment shall indicate with a signal audible to the operator the

termination of a pre-set time interval, not to exceed five (5) minutes. When

engaged, the signal must continue until the reset button is depressed. For

uncertified equipment the passage of a preset time, not to exceed five (5)

minutes, must be noted by a signal audible to the operator or an interruption

of the fluoroscopic beam.

c. Fluoroscopic Exposure Rate Measurements

0. Exposure rate limits for certified fluoroscopic equipment manufactured before

May 19, 1995:

 Automatic Mode: 10 R/minute

 Manual Mode: 5 R/minute

 High Level Control (HLC) Mode: 5 R/minute (when not operating in

HLC)

 HLC Mode: 20 R/minute (when operating in HLC and not recording

the image)

1. Certified fluoroscopic equipment manufactured after May 19, 1995 and

capable of producing a radiation exposure rate in excess of 5 R/min must

have automatic exposure rate control. Such equipment is limited to maximum

exposure rate of 10 R/minute.

2. Certified fluoroscopic equipment manufactured after May 19, 1995 and

having HLC must meet requirement (2). Such units are limited to 20 R/min

when operating in HLC and not recording the image in a pulsed mode.

3. Uncertified fluoroscopic equipment is limited to a maximum exposure rate of

10 R/min.

4. The fluoroscopic exposure rate in automatic and/or manual mode must not

exceed 5 R/min when measured with a patient equivalent phantom

composed of 1 inches of Type 1100 aluminum and 0.5 mm of copper or an

equivalent device.

d. SID Indicators
 The measured SID shall be within 2% of the indicated SID.

e. Film/Screen Contract

Film/Screen contact shall not indicate areas of poor contact in the center of the image

receptor. Screens in use for over four years shall be evaluated annually for film/screen

contact.

D. Technique Charts

Each x-ray unit shall have an appropriate technique chart located in a conspicuous position for

reference by the operators. As a minimum this chart shall include patient size versus technique factors,

SID, grid data, film/screen combination, gonad or breast shielding as appropriate and patient exposure.

These charts must be updated when different film/screen combinations are purchased and when new x-

ray tubes or calibrations change the baseline data from which the charts were developed.

E. Log Book

Each facility shall maintain a log book or an equivalent record system containing the patient's name,

date of exam, type of examination, number of views taken, amount of fluoroscopic on-time (if applicable)

and when applicable the reason for holding the patient.

F. Repeat/Reject Analysis

Each facility shall conduct at least one reject analysis per year of their films. An ongoing repeat analysis

should be conducted more frequently; e.g. monthly or quarterly. It is important that the facility follow the

procedures established to assure that the studies are carried out in the same manner each time.

Appendix D is available for reference.

G. Purchase Specifications and Acceptance Testing

Before purchasing new equipment, the facility is encouraged to determine the desired performance

specifications for any new equipment including film, screens, and chemistry. Appendix E contains

information which facilities may find useful in preparing performance specifications.

This information should be requested by the facility from each prospective vendor, so that the facility will

be able to compare the advantages and disadvantages of competing systems.

H. Cassette Maintenance

Cassettes and screens shall be maintained to minimize the occurrence of artifacts. Screens should be

inspected and cleaned regularly with the cleaning solution recommended by the screen manufacturer.
The spectral characteristics of the light emitted by the intensifying screens must match the spectral

characteristics of the film.