2. STANDARD: PERFORMANCE OF SCREENING MAMMOGRAPHY
Periodic mammography screening of asymptomatic women has been shown to reduce breast cancer mortality. Screening mammography is one area in which diagnostic radiology services can contribute positively to improve overall patient care. The principles for mammography do not basically differ from those applicable to other radiological examinations. Key points to be considered are the criteria for credentialing professionals, equipment specifications, monitoring and maintenance schedules, standards for image quality, standardized image evaluation procedures, meticulous record keeping and periodic review of data for outcomes of the mammography services when feasible.
A. Definition: "Screening mammography" means an effort to detect unsuspected breast cancer at an early stage in asymptomatic women.
(1) Intent: separate women into groups with low and high probability of breast cancer.
(a) Most screened women can be assured no significant abnormalities exist.
(b) The remainder of the screened women will be informed that an abnormality exists which must be investigated further.
(2) Exam: ordinarily limited to craniocaudal and mediolateral oblique views of each breast.
(a) Supplementary views may be needed but should not be done routinely.
(3) If breast physical examination is not available at screening site, women should be informed that physical examination is a complementary and necessary procedure.
B. Goal: Produce the optimum, reproducible quality image at the minimum radiation dose necessary to give adequate image information.
C. Indication: (1) asymptomatic women at least 40 years of age; (2) Women younger than 40 years who present with high risk factors.
D. Frequency: (1) every one to two years between 40 and 49 years of age, with same frequency if screening initiated prior to 40 years; (2) every year after 50 years of age.
E. Qualifications of Personnel
(1) Physician:
(a) Certification or eligibility for certification by the American Board of Radiology or American Osteopathic Board of Radiology, and
(b) Interpret mammograms on a regular basis. Physician should interpret or review minimum of 480 mammograms per year, recognizing that this number may not be achievable in low population areas, and
(c) Continuing Medical Education: initially should have 40 hours of CME credits in mammography, and thereafter 15 hours CME credits every three (3) years.
(2) Radiological Physicist:
(a) Certification by American Board of Radiology in Radiological Physics or American Board of Medical Physics in Diagnostic Radiological Physics recommended.
(3) Radiological Technologist:
(a) State licensure required, and
(b) Perform mammography on a regular basis, and
(c) Be competent in breast positioning and compression, and knowledgeable concerning technical factors, radiation safety, radiation protection, and quality control, and
(d) Should receive continual supervision on image quality from interpreting physician.
F. Equipment Requirements
(1) Designed especially for mammography with a compression device and removable grid.
(2) Precise Specifications
(a) Low energy beam to produce high subject contrast, and
(b) Compression device to improve contrast, minimize radiographic scatter, produce uniform density, and reduce dose and subject motion, and
(c) Film-screen mammography focal spot size 0.3 mm preferable, and
(d) Focal-object distance should be 50 cm or more, and
(e) A dedicated film processor with developer time and temperature setup specifically for the film being used is preferable for film-screen mammography.
G. Radiation Dose: The average glandular dose will be measured at least annually.
(1) For examination of a 4.5 cm thick, compressed breast, consisting of 50% glandular and 50% adipose tissue, the dose will be no more than 0.35 Rad per exposure.
H. Quality Control Program: Documented QC program with procedure manuals and logs.
(1) Technologists' Checks: darkroom cleanliness, processor quality control, screen cleanliness, view boxes and viewing conditions, phantom images, visual check list, repeat analysis, analysis of fixer retention in film, darkroom fog, screen-film, darkroom fog, screen-film contact, compression.
(2) Physicists' Checks: cassette holder assembly evaluation, collimation assessment, focal spot size measurement, Kvp accuracy/reproducibility, beam quality assessment (half value layer measurement), automatic exposure control (AEC) System performance assessment, uniformity of screen, breast entrance exposure and average glandular does.
(3) Professional Quality Assurance Program
(a) Systems for reviewing outcome data will be established. Included will be:
(i) disposition of positive mammograms,
(ii) correlations of surgical biopsy results with mammogram reports whenever possible.
It is understood that in some practice situations it will not be possible to obtain follow-up information on all positive mammograms.,
I. Mammography Report: Definitive diagnosis is usually not rendered, although in some instances a highly suspicious abnormality may be identified which will warrant a recommendation for biopsy.
(1) The report should include:
(a) Description of any abnormalities detected and their location, and
(b) Recommendations for subsequent follow-up studies when appropriate, and
(c) Comparison to prior mammograms when practical.
(2) Render report as soon as reasonably possible.
(3) All reports in high probability category should be communicated to the referring physician or his designated representative in such a manner that receipt of the report is assured and documented.
J. Film Retention: original mammograms shall be retained by a facility or made available to the patient or her designee for a period of at least five (5) years.
K. Self-Referral: Direct access by individuals is permissible without requiring physician referral in advance.
(1) Facilities must have well-developed notification procedures for the patient and her physician, or procedures for referral to a licensed physician who has agreed to accept such patients.
(a) Self-referred (i.e., those women who have no referring physician) patients should be notified of the results of the screening by mail
(b) Reports in high probability category should be communicated to the patient by certified mail; and,
(i) should indicate need for further consultation with a physician; and,
(ii) follow-up contact with patient or the physician should be made to determine compliance with follow-up care.
L. Free Standing and Mobile Settings
(1) Screening mammography may take place in nontraditional radiology settings where there may not be a physician in attendance.
(2) Mammography offered must follow all of the previously mentioned guidelines with strict adherence to documented protocols.
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