EPA 520/4-76-002
BACKGROUND REPORT
RECOMMENDATIONS ON GUIDANCE
FOR
DIAGNOSTIC X-RAY STUDIES
FEDERAL HEALTH CARE FACILITIES
i ENVIRONMENTAL PROTECTION AGENCY
;/' INTERAGENCY WORKING GROUP ON MEDICAL RADIATION
SUBCOMMITTEE ON PRESCRIPTION OF EXPOSURE TO X RAYS
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EPA 520/4-76-002
RECOMMENDATIONS ON GUIDANCE FOR DIAGNOSTIC X-RAY
STUDIES IN FEDERAL HEALTH CARE FACILITIES
Report of
Subcommittee on Prescription of Exposure to X rays
Interagency Working Group on Medical Radiation
U.S. Environmental Protection Agency
Washington, D.C. 20460
March 1976
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PREFACE
The Administrator of the Environmental Protection Agency formed an
Interagency Working Group on July 5, 1974, to develop guidance to
reduce unnecessary radiation exposures from the use of x rays in the
healing arts in Federal health care facilities. The consensus of this
group was that it is desirable and possible in Federal facilities to
reduce exposure from diagnostic uses of x rays by: 1) eliminating
clinically unproductive examinations, 2) assuring the use of optimal
techniques when examinations are performed, and 3) requiring
appropriate equipment to be used. As a result of this consensus a
Subcommittee on Prescription of Exposure to X rays (SPEX) was
established to examine factors to eliminate clinically unproductive
examinations and consider the feasibility of reducing radiation
exposure in productive studies. Another Subcommittee on Techniques of
Exposure Prevention was formed to examine the second and to some extent
the third subject areas. The third area is being regulated by the U.S.
Food and Drug Administration which has recently issued x-ray equipment
performance standards.
The mission of SPEX was to examine diagnostic radiology procedures
and develop recommendations which have immediate applicability in
Federal facilities. The members of SPEX were especially mindful that
their recommendations should not preclude necessary uses of x rays in
diagnostic medicine. Serious efforts were made, however, to formulate
recommendations that would eliminate the prescription of unwarranted
examinations and eliminate the taking of unproductive radiographs.
This approach has recognized the need for expert diagnosticians,
principally radiologists, to be involved in medical decisions involving
the prescription of diagnostic x-ray examinations.
The SPEX recommendations basically result from two considerations:
1) the clinical decision to order a particular examination, and 2) the
optimization of the number of radiographic views required in an
examination. Fortunately, a reduction in unproductive radiation
exposure to the patient and the goals of good diagnostic radiology are
directly related in that elimination of unproductive diagnostic
examinations achieves both. We believe the recommendations represent
consensus judgment of appropriate prescription of x-ray examinations in
Federal health care facilities. It should be recognized that the body
of knowledge on both the radiation exposure and efficacy of x-ray
examinations is rapidly changing and the recommendations will, of
necessity, need periodic review and appropriate revision.
Charles W. Ochs, MC, USN
Chairman, Subcommittee on
Prescription of Exposure to X rays
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MEMBERS
Department of the Navy
Captain Charles W. Ochs, MC, USN, CHAIRMAN
Captain James Dowling, MSC, USN*
Captain William Bottomley, DC, USN
Commander James Spahn, MSC, USN
Commander Peter Kirchner, MC, USN
Veterans Administration
Leonard Bisaccia, M.D., VICE CHAIRMAN
Donald Knoeppel, D.D.S.
James Smith, M.D.
Department of the Army
Lt. Col. Robert Quillin, MSC, USA
Department of the Air Force
Colonel John Campbell, MC, USAF
Colonel Charles Mahon, MC, USAF
Environmental Protection Agency
James E. Martin, Ph.D.
DeVaughn R. Nelson, Ph.D.
Harry Pettengill, Ph.D.
Consultants
Otha Linton, M.S.J.
Director of Governmental Relations
American College of Radiology
S. David Rockoff, M.D.
Chairman, Department of Radiology
George Washington University Medical center
William S, Cole,- M.D.
Associate Director - Bureau of Radiological Health
U.S. Food and Drug Administration
John Doppman, M.D.
Chief of Radiology
National Institutes of Health
*Deceased
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CONTENTS
Page
PREFACE n
MEMBERS lii
INTRODUCTION AND RECOMMENDATIONS i
BACKGROUND 7
Administrative Control or Convenience
Criticism and Legal
Intellectual Curiosity
Inexperi ence
Public Health Screening
PRESCRIPTION CONSIDERATIONS 1C
Qualifications to Prescribe X rays
Screening and Administrative Programs
Mammography
Dental Radiography
Self-referral Examinations
PROCEDURAL CONSIDERATIONS 21
General Considerations and Review Plans
Minimum Number of Examinations and Views
Patient History and Physical Condition
EQUIPMENT CONSIDERATIONS 25
Equipment Use Policy
General Radiographic Equipment Policy
Fluoroscopic Equipment Policy
REFERENCES 32
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INTRODUCTION AND RECOMMENDATIONS
One of the most significant aspects of good medical care is the
use of x rays to diagnose and define the extent of disease or physical
injury. The per capita use of x rays in medicine and dentistry has
expanded rapidly in the United States due to wider availability of
services, new equipment, and an increase in sophisticated diagnostic
examinations. Although many procedures now produce less exposure per
film, the increased number of procedures has increased the radiation
exposure to the population. A number of medical and scientific groups
generally agree that there is unproductive radiation exposure from x-
ray uses that could, and should, be reduced and research efforts are in
progress by several organizations such as the American College of
Radiology to determine the efficacy of certain radiographic
examinations.
The most important factor in reducing radiation exposure is to
eliminate clinically unproductive procedures. The factors involved in
accomplishing this goal were examined by the Subcommittee on
Prescription of Exposure to X rays which was made up of physicians,
dentists, and physicists from the three military services, the Veterans
Administration, and the Environmental Protection Agency. The
Subcommittee had consultants from George Washington University, the
Public Health Service, the Food and Drug Administration, and the
American College of Radiology (see list on page iii) .
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Appropriate prescription of x-ray examinations involves two major
categories: the clinical decision to order a given examination, and the
choice of the number and type of views required to conduct it within
the principles of good radiological practice. Establishment of routine
examinations either for administrative non-medical reasons or
efficiency of clinic operation tends to be counterproductive to
minimizing exposure. In the first category the qualifications and
demonstrated proficiency of those who order diagnostic procedures
largely determine whether the procedure will be productive. The same
factors are also important in the second category with equipment,
technician training, and administration of x-ray examinations also
playing important roles. Within this framework, the Subcommittee has
made the following recommendations for guidance in the prescription of
diagnostic x-ray examinations in fixed Federal and contractor
installations:
1. Privileges to request general radiographic or fluoroscopic
examinations should be limited to Doctors of Medicine or Osteopathy who
are eligible for licensure in the United States or one of its
territories or commonwealths; exception should only be granted for
properly trained physician-supervised individuals such as physician
assistants, nurse practitioners, and persons in post-graduate training
status or for life-threatening situations.
2. Privileges to request dental x-ray examinations should be
limited to Doctors of Dental Surgery or Dental Medicine who are
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eligible for licensure in the United States or one of its territories
or commonwealths; exception should he granted only for persons in post
graduate training status under the supervision of a person meeting such
requirements.
3. Privileges to request specialized radiographic or fluoroscopic
examinations such as angiography, pneumoencephalography, tomography, or
other complex studies requiring many exposures should be restricted to
physicians and dentists meeting recommendations of credentialing
committees for prescription of general radiographic procedures and who
have had advanced training in the medical specialty involved in order
to determine the need for and to fully evaluate the results of such
special examinations for definitive medical care.
4. Routine chest x-ray examinations should not be performed for
tuberculosis screening, as a Federal requirement for employment, or as
an established part of periodic physical examinations except in
epidemiologically determined high-risk groups; performing such
examinations with photofluorographic equipment is not advised because
of high radiation exposure. Chest x-ray examinations should generally
not be done merely for hospital admission on patients under the age of
40, or as part of routine prenatal care, unless a clinical indication
of chest disease exists.
5. Mammography examinations should not be used to screen
asymptomatic women under the age of 35; for asymptomatic women between
age 35 and 50 the screening policy should be based on an annual review
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of current data on yield, radiation risks, and economic and social
factors. Screening of women above age 50 appears justified at this
time.
6, Radiographic examinations obtained for the evaluation of
cancer patients should be reviewed for their efficacy both for the
initial evaluation and required followup care. Existing protocol
studies should be evaluated periodically to establish the appropriate
studies for evaluating the various types of malignancy and its
metastatic spread.
7. Dental x-ray examinations should be prescribed only on the
basis of a clinical evaluation by a dentist; neither a full-mouth
series nor bitewing radiographs should be part of routine preventive
dental care. Exceptions may be made for certain groups for forensic
purposes.
8. The use of self-referral x-ray examinations should be limited
to studies unique and required by the specialty of the physician
performing them and be consistent with a peer review policy. The
examination should be performed only by physicians qualified to
supervise, perform, and interpret examinations unique to that
specialty.
9. A current document listing the standard views for defined
examinations should be provided for all x-ray equipment operators and
tailored to the department and equipment available. The number,
sequence, and types of standard views for an examination should be
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problem-oriented and kept to a minimum; additional views should only be
authorized by the supervising diagnostician.
10. Follow-up x-ray examinations should be done only at time
intervals long enough to make proper decisions concerning continuation
or alteration of treatment.
11. Requests for x-ray examinations should be considered as
medical consultations between the clinician and the diagnostician and
should state the diagnostic objective of the examination and detail
relevant medical history including results of previous diagnostic x-ray
examinations. The radiologic diagnostician should have the authority
to direct the examination to obtain the diagnostic objective through
the addition, substitution, or deletion of prescribed views; this
should be done in consultation with the requesting clinician whenever
practicable.
12. Operation of medical and dental x-ray equipment should be
permitted only under a policy which is established and reviewed
annually by the responsible authority; this policy should specify the
amount of training required for x-ray equipment operators and whether
authorization to operate x-ray equipment is limited or general.
13. Equipment used in Federal and contractor health care
facilities should conform to the Federal Diagnostic X-Ray Equipment
Performance Standard (21 CFR Subchapter J) as soon as practicable; in
the interim all equipment should conform with parts F. 4, F. 5, F.6, and
F. 7 of the 1974 "Suggested State Regulations for Control of Radiation"
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where applicable. A plan which is reviewed annually should exist for
timely replacement of diagnostic x-ray equipment used by Federal
agencies.
14. All fluoroscopy units in Federal and contractor health care
institutions should provide image-intensification; non-radiology
specialists such as orthopedists, neurosurgeons, gastroenterologists,
cardiologists, chest surgeons, etc. who are determined by the
responsible authority to require fluorcscopy, and are qualified to use
it, should be limited to the use of units with electronic image-holding
features when practicable.
15. These recommendations, which are intended for fixed health
care facilities in the United States or its territories and
possessions, should be reviewed at timely intervals to accommodate
advances in radiological practices and changing levels of technological
sophistication.
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BACKGROUND
The ideal circumstance in which to order a diagnostic x-ray
examination is for a physician or dentist qualified in his speciality
to have determined that sufficient clinical symptoms or history
necessitate the examination to either establish disease or injury or
its extent. Many x-ray examinations are prescribed, however, that do
not necessarily satisfy such clinical-historical prerequisites. The
major factors involved in ordering unnecessary x-ray examinations
appear to be:
Administrative Control or Convenience
Once an x-ray facility is established a minimum amount of use may
be required to justify its existence. A small health care unit may
tend to perform x-ray examinations because of location and "convenience
to the patient" rather than to refer him to a more appropriate
radiology facility. Patient, facility, and physician "convenience" may
be interrelated and difficult to separate in determining proper medical
care.
Criticism and Legal
Many x-ray examinations may be ordered principally to preclude
criticism that everything that could be done for the patient was not
done or that the established practice was not followed. This
consideration probably exists in all medical practice. In some cases
fear of criticism may be manifested in actions to provide a legal
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record that good practice was followed even though the physician's
course of treatment would not be altered by the result. Unfortunately,
such factors lead to established routines which eventually lead to
usual practice and unnecessary radiation exposure. Other routine x-ray
examinations may te decreed by local, state, or Federal laws for pre-
employment physicals for various occupations, workmans compensation,
and disability compensation. These examinations may be of economic
importance to the patient in deciding his compensation, yet have
minimal value for his medical care. Certain high risk groups require
survey studies for medical purposes; however, tney should be evaluated
periodically.
Intellectual Curiosity
Physicians, from time to time, obtain extra radiographic studies
to determine the presence, progress, or exact nature of some entities,
the knowledge of which has little immediate or long-term implication in
the care of the patient.
Inexperience
Medical students, interns, residents, and some non-physician
practitioners may not have developed medical judgment as to which test
would be most efficacious. Because of such inexperience, examinations
may not be ordered in the best sequence and may even interfere with the
next test to be done. Also, practitioners with inadequate training in
radiological techniques and interpretation may supervise both the
taking and interpretation of radiographic examinations. An extensive
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series of examinations is sometimes performed to rule out various
conditions for which there are no clinical indications.
Public Health Screening
Certain groups may be examined in large numbers by screening
programs for diseases such as tuberculosis, pneumoconiosis, or breast
cancer. Frequently the decision to take such an examination is made by
the patient without physician consultation. In an attempt to provide
comprehensive bill-of-health physicals, unnecessary x-ray studies may
be conducted as a routine part of the physical examination.
These five factors influence the number of x-ray examinations and
add to the radiation exposure received by the population. In addition
to the number of examinations, the number and type of radiographic
projections used in each examination, whether clinically indicated or
determined for other reasons, also influences the radiation exposure.
These factors, as well as other aspects of eliminating unproductive x-
ray exposure were examined by the Subcommittee on Prescription of
Exposure to X rays on the basis of three considerations: Prescription,
Procedure, and Equipment. The Subcommittee's recommendations were
developed from considerations directed toward health care in Federal
and contractor facilities and their implementation should promote a
reduction in patient exposure.
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PRESCRIPTION CONSIDERATIONS
Clinicians who prescribe an x-ray examination have a dual
responsibility to assure that requisite diagnostic information is
obtained and that the radiation administered is done so only with
commensurate benefit. The benefits derived from the use of x-ray
examinations in medical diagnosis are very high and account for its
widespread use. In 1970 the number of radiographic procedures per
capita was estimated to be increasing at rates varying from 1-4% per
annum (1). Since 1970, the rate is most likely higher due to new and
improved developments in radiological diagnostic modalaties and
procedures such as mammography, angiography, and computerized axial
tomography. Because of this upward trend in x ray use and the
importance of minimizing the aggregate population exposure, it is quite
important to insure that the prescription of any x-ray examination is
necessary.
Qualifications to Prescribe X rays
The qualification of medical personnel authorized to prescribe
diagnostic x-ray examinations is the most important factor in limiting
the prescription of unproductive examinations. Requests for x-ray
examinations in general radiography or fluoroscopy in Federal health
care facilities should be made only by a person possessing a M.D. or
D.O. degree who is eligible for licensure or licensed where required
by statute. Properly trained and physician-supervised individuals such
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as physician assistants, nurse practitioners, and persons in
postgraduate medical training status do not have to meet the above
requirements but they must be under the supervision of one who does.
Any requests in specialized radiography and fluoroscopy such as
angiography, pneumoencephalography, computerized axial tomography, or
other complex studies requiring many exposures should be made by a
person who meets the above requirements, and who, in addition, has
special training or expertise to evaluate the indications of the
examinations.
In addition to the privileges for which broad qualifications are
needed, there are a number of specialties which require only limited
types of x-ray examinations. For example, a D.D.S. or D.M.D. may
request appropriate examinations of the head, neck, and chest, although
such requests are normally confined to the oral region. Podiatrists
who have been granted clinical privileges may request x-ray
examinations appropriate to their specialty.
It is recognized that medical students, interns, residents, and
some non-physician practitioners may not have developed medical
judgment as to which test would be most efficacious. Such lack of
experience is remedied by work under conditions where there is
sufficient expert supervision to monitor the prescription of
examinations and to provide appropriate medical assistance.
Variances to the above qualification requirements should occur
only for emergency or life-threatening situations. Non-peacetime
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operations in the field and aboard ship would generally require such
variances wherein equipment designed for field use would need to be
operated by personnel available to perform necessary medical services.
Screening and Administrative Programs
Many x-ray examinations are the result of screening programs or
administrative decisions, the reasons for which may no longer be
justifiable. In general, such examinations are not preceded by
clinical evaluation by a physician to determine their need. All
screening programs should be under the auspices of an appropriate
medical staff committee which annually reviews and affirms the need to
continue the program. The annual review should eliminate all routine
or screening examinations which are not clinically justified.
Chest x-ray examinations to screen for tuberculosis are not
justified except for certain high risk population groups (2,3). The
U.S. Public Health Service, the National Tuberculosis and Respiratory
Disease Association (now the American Lung Association), the American
College of Chest Physicians, and the American College of Radiology have
publicly opposed such screening programs. A review board should
establish that the expected incidence of tuberculosis is sufficiently
high in a population before a screening program is started. The
radiation exposure and economic considerations suggest that the primary
screening examination for tuberculosis should be a tine or tuberculin
test even in populations exhibiting a higher than average incidence of
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the disease (4); radiological examinations should be used only to
followup clinical indications derived from such methods.
Where chest x-ray screening has involved large numbers of persons,
it has been common practice to employ photofluorographic techniques to
save time and expense. This technique uses a fluoroscope to produce an
image of the chest which is then photographed on 70 mm film. Whereas
the procedure is relatively fast and adaptable to examining patients
quickly at mobile stations, the exposure per examination is
considerably higher than an x-ray examination performed on general
purpose equipment which produces standard-sized radiographs. Also, the
size and quality of the 70 mm film is such that only gross
abnormalities can be diagnosed. Although the technique was perhaps
justified a few decades ago when there was a high incidence of
tuberculosis in the United States, the relatively higher exposure and
lower diagnostic yield of this technique make its use generally
unjustified even when chest x-ray screening may be justified. Whenever
possible, Federal agencies should not use photofluorographic equipment
to perform x-ray examinations.
A routine chest examination for hospital admission is not
suggested or presently required by the guidelines of the Joint
Commission on Accreditation of Hospitals. A chest examination is
currently not justified as a routine requirement for hospital admission
due to the low yield of abnormalities diagnosed. A recent study of
routine screening in a hospital population indicated that routine chest
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examinations, obtained solely because of hospital admission or
scheduled surgery, are not warranted in patients under the age of 20
and the lateral projection can generally be eliminated in patients
under age 40 (5). Careful evaluations should be made of the need for
existing admission x-ray examinations and, of course, should precede
the institution of new ones.
Other routine or screening x-ray examinations which should be
carefully evaluated are pre-employment lower back studies and routine
physical examinations which involve routine upper GI, barium enema,
gall bladder, and IVP examinations. Examinations required by
legislation for certain high risk populations in order to establish
worker disability compensation should be evaluated carefully to
determine their continuing necessity.
X-ray examinations which result in exposure of the fetus should be
avoided for pregnant women whenever possible (6). Examples of
exposures of pregnant women which may not be justified include routine
prenatal chest and routine pelvimetry examinations. When such women
have not received adequate prenatal care such examinations may well be
indicated.
Mammography
Breast cancer is recognized as one of the significant causes of
cancer death in the United States. Because of the importance of early
detection in control and survival, an increased emphasis on the use of
mammography has occurred. This technique has improved considerably,
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especially with respect to lowering exposure per examination with the
development of low-dose mammography and xeroradiography; however, even
at the current state of the art these techniques result in a dose of
several rads to each breast for a typical examination. Whereas the
technique is justified to examine symptomatic women at any age, the use
of mammography to screen asymptomatic women is still being seriously
examined by several groups, in particular the National Cancer Institute
and the American Cancer Society. Asymptomatic women are defined as
those without complaint, without history, without physical findings,
and without a strong family history of breast cancer. Symptomatic
women are those who exhibit a palpable breast mass, have skin changes,
or have a significant genetic or endocrinologic predisposition to
carcinoma of the breast.
The American College of Radiology formed a committee on
mammography which recently evaluated mammography data accumulated from
the Health Insurance Plan in New York and the National Cancer
Institute. On the basis of this evaluation, the Committee recently
made recommendations on mammography screening to the U.S. Food and Drug
Administration's Medical Radiation Advisory Committee for women in
three age categories (7) .
On the basis of the ACR findings, it is recommended that
mammography should not be used routinely to screen asymptomatic women
under the age of 35 for breast cancer. It is further recommended that
mammographic technique continue to be evaluated to obtain procedures
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that represent an appropriate balancing between low exposures and
diagnostic accuracy.
Current data on the effectiveness of mammographic screening for
breast cancer in asymptomatic women between the ages of 35 and 50 is
insufficient at this time to determine if such screening is justified.
The efficacy of routine mammographic examinations for this age group is
presently being studied through a joint screening project of the
American Cancer Society and the National Cancer Institute. Because of
the continuing development of new information on mammography. Federal
agencies should periodically evaluate data from this study and others
in developing screening policies for this age group.
Screening in asymptomatic women over 50 years of age appears
justified at this time.
Cancer Patient Evaluations
In many health care facilities it is common practice for cancer
patients to receive extensive x-ray studies as part of their treatment
planning and followup. Bagley, et. al., have reported the
effectiveness of several studies in managing the treatment of cancer
patients admitted to the National Institutes of Health (8). Their
findings indicate that once the primary diagnosis was made and
confirmed for some cancers, the results of routine x-ray studies such
as a barium enema and an upper GI series were found to have little
influence in the treatment of the patient. These findings also suggest
that the yield of certain x-ray examinations is too low to justify
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their use as a general screening tool for cancer evaluation. Although
any study that would assist in the control of cancer in a patient can
be justified, such examinations should be generally productive in the
care and followup of a patient. For this reason. Federal facilities
should periodically evaluate existing protocol studies to establish
those that are appropriate for evaluating patients with carcinomas. In
this respect, the American College of Surgeons recently recommended
that tumor committees be established to periodically review cancer
evaluations and management (9).
Dental Radiography
One of the most common radiographic procedures an individual is
likely to receive as a part of health care is a dental x ray. A large
portion of the U.S. population visits a dentist one or more times each
year for routine checkups and associated dental care. The 1970 X ray
Exposure Study estimated that 661 million radiographic films were
produced in 1970 and of this number 279 million were dental films (1).
A patient presenting himself to a dentist has a good chance of
receiving a dental x ray even though he may have no immediate dental
problems. A study of dental radiography in Nashville, Tennessee
indicated that 57 percent of the facilities surveyed routinely do
interproximal examinations each year on regular patients and 21 percent
do a full-mouth series every 1 to 3 years; on new patients 58 percent
routinely do interproximal examinations and 64 percent selectively do a
full-mouth series (10). The mean exposure per film in the Nashville
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study was 542 mR in 1972; after an educational program the mean dropped
to 340 mR per film, indicating the value of carefully controlled
procedures in reducing patient exposure due to dental radiography.
Because of the increased use of dental radiography in the U.S. it
appears reasonable to conclude that every effort should be exerted to
optimize the exposure per film and the number of films per examination.
The proper decision to use x-ray studies in dental examinations
should be based on a requirement for proper diagnosis or definition of
disease and the number of radiographs should be the minimum necessary
to obtain the essential diagnostic information (11). It is recommended
that dental radiographs be taken only after a dentist has examined the
patient and established by clinical indication the need for the x-ray
examination; neither a full mouth series nor a bitewing series is
justified as part of periodic preventive dental care. This recom-
mendation is consistent with those of the American Dental Association
which also decidely disagrees with any requirement to provide post-
operative radiographs as proof of services rendered (12).
Dental radiography may be justified for forensic purposes for
certain high risk groups such as military personnel. In such
circumstances it may be desirable to obtain a full mouth radiograph of
the teeth and jaw structure.
Self-referral Examinations
A 1970 study indicates that approximately 30% of the medical x-ray
examinations in the U.S. were performed by non-radiologic clinicians
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(1) . Some examinations performed by non-radiologists may occur because
of the convenience of having the x-ray unit and the patient in the same
location, or, in the case of civilian contract services, need to
justify the equipment purchased or maintenance costs. Self-referral
examinations are frequently performed by equipment operators lacking
adequate training and physician supervision by clinicians with
inadequate radiologic experience.
Patients are sometimes referred to another health care facility
for medical care and previous x-ray examinations conducted at the first
facility will be repeated. In a primary care facility, only the
studies needed for appropriate referral should be performed. When
examinations have been conducted prior to referral, these x-ray films
should accompany the patient to minimize the need for additional
diagnostic x-ray examinations and resulting patient exposure (13) .
Unnecessary radiation exposure caused by self-referral practices
generally need not occur in Federal health care installations where
facilities staffed by radiologists are normally provided. Exceptions
could be small operational units such as ships, field units, or
isolated stations where the normal work load does not justify a staff
radiologist. Thus, the conduct of self-referral x-ray examinations
should be permitted only for a physician whose qualifications to
supervise, perform, and interpret diagnostic radiologic procedures have
been demonstrated to the appropriate authorities.
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It is recognized that limited self-referral type examinations are
performed in Federal medical centers in certain clinical specialties.
In such situations, the examinations performed should be unique to the
specialty. Such examinations should be performed only by qualified
personnel and peer review policies should exist to assist in
eliminating unproductive practices.
Self-referral practices in contract civilian facilities should be
prohibited since such practices have been shown to lead to
overutilization (14). Exception may be made in remote areas where no
practicable alternative exists.
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PROCEDURAL CONSIDERATIONS
Although the largest reduction in radiation exposure is to prevent
the ordering of an unproductive x-ray examination, patient exposure can
also be reduced by the diagnostician by careful consideration of the
numbers and types of radiographs to be taken during the examination
(15). These considerations can also be classified as prescription
decisions. In conducting x-ray examinations, therefore, the
diagnostician should be capable of making the best diagnosis possible
and be aware of the quantity and potential risk of the radiation he is
administering.
General Considerations and Review Plans
Each x-ray examination should be as objective-related as possible
to accomplish the diagnosis with the minimum amount of exposure. Most
x-ray departments establish a set of standard examination procedures
which specify the number and types of radiographic views to be taken
when the procedure is performed. A periodic review of all standard
examination procedures should be performed to determine if the
established routine is achieving the objectives and whether
modifications are warranted. Continuation of a standardized
examination procedure should be predicated on satisfying the following
criteria: a) the efficacy of the examination is sufficiently high to
assure that the diagnosis could not have been made with less risk by
other non-radiological means or a lower number of views, b)
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consideration of the previous similar examinations performed with
multiple views established that in a significant number of the cases
all views were necessary for the diagnoses rendered, and c) the yield
of the examinations offsets the radiation exposure delivered.
A periodic review of standard operating procedures should be made
at least annually by the appropriate medical or dental staff committee
with the advice of referring physicians. Such reviews should consider
the consensus and advice of professional societies concerning the
efficacy of radiologic exams.
Minimum Number of Examinations and Views
A written outline containing the minimum number of views to be
obtained for each requested examination should be made available to
each clinician and equipment operator in every radiology facility.
Beyond the specified minimum views, the examination should be
individualized according to a patient's needs.
All examinations should be tailored to the individual department
taking into account the equipment available. In some instances,
certain examinations should be done only on certain types of equipment.
The outline of procedures should indicate who may authorize
deviations from the standard set of views for any examination. Every
effort should be made to reduce to a minimum the number of standard
views for any examination. The necessity of additional views, such as
comparison views, should be determined by the radiological
diagnostician. Follow-up for examinations should be done at reasonable
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time intervals so that significant changes in clinical information are
obtained for making proper decisions on continuation or alteration of
the management of the patient.
Patient History and Physical Condition
Whenever possible a radiologist should review all examination
requests requiring fluoroscopy or multiple film studies, especially
those associated with tomography or scanning techniques, before the
examination is given and preferably before it is scheduled (16). For
this reason, it is important that a thorough and accurate patient
history be included with each examination request. Based upon a review
of the history and previously documented studies, the radiologic
diagnostician should direct the examination to obtain the diagnostic
objective stated by the referring clinician through the addition,
substitution or deletion of views. It is preferable that changes in
the examination be done in consultation with the requesting clinician.
Another means by which the radiologic diagnostician may reduce
patient exposure is to avoid any repeat examinations due to improper
patient preparation for contrast media studies. Miller has reported
that poor bowel preparation is a frequent cause of marginal or repeated
contrast media studies of the lower GI tract (17). The radiology
department can minimize the number of marginal studies by instituting
appropriate pre-examination procedures (13). These procedures should
include assuring that patients have had the appropriate laxatives and
enemas prior to performing contrast media studies of the lower GI
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tract. It may also be advantageous to place bedridden, elderly, or
constipation-prone patients on low-residue diets several days before
scheduling the studies. Determination that a patient has had previous
surgery before GI tract examinations could also help minimize the
number of marginal studies. Similarly, the prior determination that a
patient had taken any prescribed oral contrast media would prevent
unnecessary retakes of such studies.
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EQUIPMENT CONSIDERATIONS
Once the physician or dentist determines that the prescription of
an x-ray examination is warranted for diagnostic purposes, other
factors become important in limiting patient exposure. These factors
are the design of good x-ray equipment, equipment use, and the
assurance that equipment operators have received adequate training to
perform the examination without unnecessary exposure to himself or the
patient.
Equipment Use Policy
The utilization and supervision policy of medical and dental x-ray
equipment should be approved by the responsible facility authority upon
the recommendations of medical and dental staff.
Criteria for the supervision of medical x-ray equipment should
also be established in each facility in a written policy. The formal
policy should be reviewed annually by medical staff committees and by
those departments whose members have privileges in radiology. The
definition of privileges in radiology should be made in terms of the
needs of the patients served by that facility, recognizing that the
availability of optimally trained physicians and the varying levels of
service and training will make each circumstance different.
Types of medical personnel eligible for utilization of x-ray
equipment may be classed as physicians, ancillary personnel, and
radiological technologists. Eligible physicians include radiologists
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and other physicians granted privileges in radiology. Such privileges
might include the use of x-ray equipment by cardiologists for cardiac
catheterizations and by dentists or podiatrists as part of their
practice. Before physicians and dentists are granted radiology
privileges they should have received adequate training in equipment use
and radiation protection. However, specific protocols establishing the
limit of radiology privileges to specified types of physicians or
dentists should be part of the written policy statement.
The use of x-ray equipment by ancillary personnel such as
radiation physicists and repairmen should be limited to testing and
evaluating equipment performance.
Radiographic technologists are by far the largest group to
directly utilize x-ray equipment. Eligibility to operate general
purpose x-ray equipment should be granted only to registered (ARRT)
technologists or those with equivalent training. Technologists in
training should be eligible to utilize equipment only while under the
supervision of a registered technologist. "Limited privilege"
technologists not having registration, equivalent training, or
supervision by a registered technologist may perform selected
examinations under the direct supervision of physicians granted
radiology privileges. "Limited privilege" technologists include those
who perform single or limited studies such as operating a photo-timed
chest unit.
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The utilization of dental x-ray equipment should be under the
supervision of a licensed dentist. Dental care personnel such as
dentists, dental hygenists, dental assistants, and dental technologists
should only perform dental x-ray examinations after proper training.
The training should include proper tube positioning and film placement,
technique selection, film processing techniques, and a thorough review
of radiation protection principles. The training in film processing is
to be stressed since a common error in dental radiography is to
overexpose and underdevelop a film, thus leading to excessive patient
exposure.
Other medical personnel such as nurses and laboratory
technologists should not be eligible to operate x-ray equipment. Their
use of such equipment could be warranted only in a life saving or
threatening situation during which qualified personnel as specified
above are not available to perform the examination.
General Radiographic Equipment
The Nationwide Evaluation of X-ray Trends survey has demonstrated
that the same technique factors used with different x-ray generators
may produce widely varying patient exposures. Thus, the performance of
x-ray equipment utilized for diagnostic x-ray procedures is an
important factor in limiting patient and operator exposure. The
Federal Diagnostic X-Ray Equipment Performance Standard (21 CFR
Subchapter J) requires that x-ray equipment manufactured after August
1, 1974. be certified by manufacturers to comply with performance
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standards issued by the U.S. Department of Health, Education, and
Welfare pursuant to the Radiation Control for Health and Safety Act of
1968 (PL 90-602).
All Federal health care facilities which perform diagnostic x-ray
examinations should, as soon as readily achievable, utilize medical and
dental x-ray equipment that conforms to the requirements of 21 CFR
Subchapter J. It is possible to obtain variances for special medical
and dental x-ray equipment purchased after August 1, 1974; however.
Federal use of this variance should be minimized.
All existing, non-certified equipment being used is not
necessarily substandard. In order to preclude substantial economic
costs involved with large-scale replacement or retrofit of all non-
certified equipment, while still providing for the elimination of
equipment which is determined to be sub-standard with reference to
currently accepted radiation safety standards, it is recommended that
all non-certified medical and dental x-ray equipment meet the criteria
in parts F.4, F.5, F.6, and F.7 of "Suggested State Regulations for
Control of Radiation (18)." Whereas the above criteria do not meet the
rigid requirements for certification according to the Federal
performance standard, they provide adequate conformance with those
parameters which affect radiation protection of the patient and
operator. Assurance that the x-ray generator meets the "Suggested
State Regulations for Control of Radiation" can be demonstrated with
test equipment considerably less complex than that required to
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demonstrate compliance with the equipment performance standards for x-
ray equipment required by 21 CFR Subchapter J.
Certain sections of the x-ray equipment performance standard
provide for planned obsolescence, such as the provision which permits
the use of non-certified components as replacement items in equipment
manufactured before August 1, 197U. Although such use of non-certified
replacement components is permitted until August 1, 1979, their use
should be justified. Stockpiling of either x-ray equipment or
components should also be minimized, since the technological advances
in x-ray equipment tends to preclude its use.
To insure that x-ray equipment used is justifiably representative
of present day technological advances, authorities should develop and
periodically review a planned replacement schedule for all types of
diagnostic x-ray equipment used in their programs.
Fluoroscopic Equipment Policy
X-ray equipment should not exceed the medical mission of the
facilities, i.e., fluoroscopy should not be available in facilities
where qualified medical personnel are not assigned. This will serve to
deter one source of unproductive radiation exposure.
Although the aggregate population dose is larger from the use of
general purpose diagnostic equipment, the highest exposures to
individuals are generally associated with fluoroscopic examinations.
Fluoroscopic examinations require large exposure rates for periods of
time long enough to observe dynamic changes; thus, it is of utmost
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importance that Federal health care facilities give particular
attention to minimization of fluoroscopic examinations.
Because the reduction of patient exposure is considerable and the
additional cost of image-intensified units is justifiable, fluoroscopic
units which do not contain image-intensification systems should not be
used. The retention of older non-image intensified units for the
reason that they may not be used with great frequency should not be
permitted because the patient exposure rates are an order of magnitude
greater than intensified units. If the medical mission requires
fluoroscopy, only image-intensified units operated by those with
demonstrated competence should be permitted.
Specialized procedures (hip replacements, transphenoid
hypophysectomy, biopsy and cannulizations via fibro optic scopes) may
require fluoroscopic assistance. In order to provide fluoroscopic
assistance for such special procedures and to minimize patient
exposure, non-radiological specialists such as orthopedists,
neurosurgeons, gastroenterologists, cardiologists, chest surgeons, etc.
should where practicable only use equipment with electronic image
holding features such as pulsed video-hold or equipment with similar
low-exposure features. The advantage of such units is that the
radiation exposure is about one-twentieth of that from continuous
fiuoroscopy and yet the image is adequate.
Non-radiologists who operate a special fluoroscopic unit should
take a course of instruction in radiation safety which meets guidelines
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established by responsible authority and demonstrate competence in the
use of this equipment. Such courses of instruction should be
considered as a standard part of the training program for physicians
who may have occasion to use such equipment in their practice. Use of
pulsed video-hold or similar dose-saving special equipment should be
approved by a senior radiologist in order to prevent use of such units
for studies other than those for which they were designed.
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REFERENCES
1. Population Exposure to X rays U.S. 1970, DHEW Publication No.
(FDA) 73-8047, November 1973.
2. The Chest X-ray as a Screening Procedure for Cardiopulmonary
Disease, Policy Statement, DHEW Publication No. (FDA) 73-8036,
April 1973.
3. "Chest X-ray Screening Recommendations for TB-RD Associations,"
NTRDA Bulletin, October 1971.
4. Ochs, C.W., "The Epidemology of Tuberculosis", JAMA, Vol. 179, pp.
247-252, January 27, 1962.
5. Sagel, F., et. al., "Efficacy of Routine Screening and Lateral
Chest Radiographs in a Hospital-Based Population," N. Engl. J.
Med., Vol. 291, No. 19, November 7, 1974.
6. Protection Against Ionizing Radiation From External Sources,
International Commission on Radiological Protection, Pergamon
Press, p. 19, 1969.
7. Minutes, 13th Meeting of Medical Radiation Advisory Committee,
U.S. Food and Drug Administration, Bureau of Radiological Health,
Rockville, Maryland, May 1975.
8. Bagley, D.H., et. al., "Barium Enema, Proctosigmoidoscopy, and
Upper Gastrointestinal Series in the Preoperative Evaluation of
the Cancer Patient," Surgery Branch, National Cancer Institute,
Bethesda, Maryland (To be published).
9. Position Statement on Cancer Patient Care Evaluation, American
College of Surgeons, Chicago, Illinois, December 1, 1975.
10. Crabtree, C.L., et. al., Nashville Dental Prelect: An Educational
Approach for Voluntary Improvement of Radiograph!c Practice, DHEW
Publication No. (FDA) 76-8011, July 1975.
11. Chamberlain, R.H., A Practical Manual on the Medical and Dental
Use of X-ray with Control of Radiation Hazards, The American
College of Radiology, Chicago, 1958.
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12. Council on Dental Materials and Devices, "Recommendations in
Radiographic Practices," JADA Vol. 90, pp. 171-172, January 1975.
13. "Memorandum on Implementation of the Second Report of the Adrian
Committee on Radiological Hazards to Patients," Brit. J. Radiol.
Vol. 37, pp. 559-561, 1964.
14. Childs, A.W., and Hunter, E.D., Patterns of Primary Medical Care -
Use of Diagnostic X-ray by Physicians, Working Paper No. 10,
Committee on Health Economics and Administration, Institute of
Business and Economic Research, University of California - Berkley
(1970) .
15. Payne, F.W., "Physicians, Radiologists, and Quality Control,"
Proceedings of the 1972 Radiological Health Section, American
Public Health Association, DHEW Publication No. (FDA) 74-8002,
Bureau of Radiological Health, Rockville, Maryland.
16. Abrams, H.L., "Observations on the Manpower Shortage in
Radiology," Radiology, Vol. 96, pp. 671-674, 1970.
17. Miller, R.E., "The Clean Colon," Gastroenterology, Vol. 70, No. 2,
pp. 289-290, 1976.
18. Suggested State Regulations for Control of Radiation, prepared by
The Conference of Radiation Control Program Directors in
cooperation with the U.S. Atomic Energy Commission and the U.S.
Food and Drug Administration, Published by FDA-Bureau of
Radiological Health, Rockville, Maryland, October 1974.
4 U. S. GOVERNMENT PRINTING OFFICE • 1976 —627-l63/9a
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