Communication of Results to Providers
Citation:
900.12(c)(3)(i),(ii): 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:
(i) Provide
a written report of the mammography examination, including the items listed
in paragraph (c)(1) of this section, to that health care provider as soon
as possible, but no later than 30 days from the date of the mammography
examination; and
(ii) 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.
Questions:
-
What
are the requirements for notification of examination results to the
referring health care provider?
-
What
criteria will FDA use to determine that facilities meet the MQSA requirements
for providing lay summaries and mammography reports to their patients
and health care providers?
-
If
a facility issues an "addendum" or "comparison"
report after the initial mammography report has already gone out,
are these reports required to have an overall final assessment category?
Must the "addendum" or "comparison" report also
be provided to the referring health careprovider and the patient even
if there is no change in the final assessment category or recommended
course of action?
-
Our
facility's mammography reports are accessible to our health care providers
on computer. Because of this, we do not print out reports to send
to the providers. Will providing the mammography reports through the
use of computers (e.g., E-mail) be acceptable under the final regulations?
-
Must
a mammography report be provided to the health care provider or self-referred
patient if the images from an examination are re-read by a physician
not associated with the facility where the examination was originally
performed and interpreted (e.g., if the patient or health care provider
requests a second opinion from another facility)?
- Under
new Centers for Medicare and Medicaid Services (CMS) guidelines, we
can now charge for screening and diagnostic exams done on the same
patient on the same day. Can we combine the two exams into one report
or must we issue two separate reports?