Current through Register Vol. 48, No. 12, March 22, 2024
a) Contents and terminology. Each facility
shall prepare a written report of the results of each mammography examination
performed under its certificate. The mammography report shall include the
following information:
1) The name of the
patient and an additional patient identifier;
2) Date of examination;
3) The name of the interpreting physician who
interpreted the mammogram;
4)
Overall final assessment of findings, classified in one of the following
categories:
A) "Negative." Nothing to comment
upon (if the interpreting physician is aware of clinical findings or symptoms,
despite the negative assessment, these shall be explained);
B) "Benign." Also a negative
assessment;
C) "Probably Benign."
Finding(s) has a high probability of being benign;
D) "Suspicious." Finding(s) without all the
characteristic morphology of breast cancer but indicating a definite
probability of being malignant;
E)
"Highly suggestive of malignancy." Finding(s) has a high probability of being
malignant;
5) In cases
where no final assessment category can be assigned due to incomplete work-up,
"Incomplete: Need additional imaging evaluation" shall be assigned as an
assessment and reasons why no assessment can be made shall be stated by the
interpreting physician; and
6)
Recommendations made to the health care provider about what additional actions,
if any, should be taken. All clinical questions raised by the referring health
care provider shall be addressed in the report to the extent possible, even if
the assessment is negative or benign.
b) Communication of mammography results to
the patient. Each facility shall send each patient a summary of the mammography
report written in lay terms within 30 days after the mammographic examination.
If assessments are "Suspicious" or "Highly suggestive of malignancy", the
facility shall make reasonable attempts to ensure that the results are
communicated to the patient as soon as possible.
1) Patients who do not name a health care
provider to receive the mammography report shall be sent the report described
in subsection (a) of this Section within 30 days, in addition to the written
notification of results in lay terms.
2) Each facility that accepts patients who do
not have a health care provider shall maintain a system for referring such
patients to a health care provider when clinically indicated.
c) Communication of mammography
results to health care providers. When the patient has a referring health care
provider or the patient has named a health care provider, the facility shall:
1) Provide a written report of the
mammography examination, including the items listed in subsection (a) of this
Section, to that health care provider as soon as possible, but no later than 30
days after the date of the mammography examination; and
2) If the assessment is "Suspicious" or
"Highly suggestive of malignancy," make reasonable attempts to communicate with
the health care provider as soon as possible, or if the health care provider is
unavailable, to a responsible designee of the health care provider.
d) Recordkeeping. Each facility
that performs mammograms:
1) Shall (except as
provided in subsection (c)(2) of this Section) maintain mammography films and
reports in a permanent medical record of the patient for a period of not less
than 5 years, or not less than 10 years if no additional mammograms of the
patient are performed at the facility;
2) Shall upon request by, or on behalf of,
the patient permanently or temporarily transfer the original mammograms and
copies of the patient's reports to a medical institution, or to a physician or
health care provider of the patient, or to the patient directly. Any fee
charged to the patient for providing the services in this subsection (d) shall
not exceed the documented costs associated with this service.
e) Mammographic image
identification. Each mammographic image shall have the following information
indicated on it in a permanent, legible, and unambiguous manner and placed so
as not to obscure anatomic structures:
1) Name
of patient and an additional patient identifier.
2) Date of examination.
3) View and laterality. This information
shall be placed on the image in a position near the axilla. Standardized codes
specified by the accreditation body shall be used to identify view and
laterality.
4) Facility name and
location. At a minimum, the location shall include the city, state and zip code
of the facility.
5) Technologist
identification.
6) Cassette/screen
identification.
7) Mammography unit
identification, if there is more than one unit in the facility.