Communication of Results to Patients
Citation:
900.12(c)(2)(i),(ii): Communication of mammography
results to the patients. Each facility shall send each patient a summary
of the mammography report written in lay terms within 30 days of 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.
(i) Patients
who do not name a health care provider to receive the mammography report
shall be sent the report described in paragraph (c)(1) of this section
within 30 days, in addition to the written notification of results in
lay terms.
(ii) 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.
Questions:
-
What
constitutes an acceptable system for notifying patients of examination
results?
-
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?
-
What
are the requirements for notification of examination results to patients
who have a primary health care provider?
-
What
are the requirements for notification of examination results to patients
who do not have a primary health care provider?
-
Our
facility currently gives the patient the examination results verbally.
Will this meet the patient communication requirements under the final
regulations?
-
Will
giving the referred patient a written lay summary of results at the
time of the examination satisfy the patient communication requirements
under the final regulations?
-
What
is the difference between self-referred and self-requesting patients
and how does this affect what types of reports these patients receive?
-
Does
a facility have to accept self-referred patients?
-
Must
lay summaries of the "addendum" or "comparison"
medical report be provided to all patients, even if there is no change
in the findings or recommended course of action?
-
A
facility performs non-mammographic breast imaging studies on the same
day as the mammographic examination. Must the facility provide the
patient a separate mammography lay summary, or can the facility provide
a combined lay summary that represents the overall results and recommendations
for all the breast imaging studies performed that day?
-
Our
facility currently uses a computerized telephone system for communicating
mammography results to our patients. Will this system meet the patient
communication requirements under the final regulations?
-
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 care provider and the patient
even if there is no change in the final assessment category or recommended
course of action?
-
Does
the lay summary have to be signed by the interpreting physician?
-
Does
the lay summary have to have a final assessment category?
-
Do
we have to provide lay summaries translated into different languages
for our patients who cannot read English?
-
How
should a facility handle a lay summary that is returned "undeliverable?"
-
How
is a facility required to deal with providing lay summaries to patients
who, for whatever reason, cannot communicate?
-
Must
the radiologic technologist performing the mammogram be identified
in the mammography report and lay summary?
-
Must
a lay summary be provided to the 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)?
-
Must
a facility provide the patient with a written lay summary even if
the results are incomplete and additional imaging is needed?
-
Our
facility's lay summaries are accessible to our patients on computer.
Because of this, we do not print out summaries to send to the patients.
Will providing the lay summary through the use of computers (e.g.,
E-mail) be acceptable under the final regulations?
-
What
type of lay summary should be sent to a patient who has a normal mammogram,
but the facility is aware that the patient has an abnormal physical
exam?
-
If
a patient specifically asks the facility not to provide her with a
lay summary, can the facility comply with her request?
- Are
there any additional issues we should be aware of when providing mammography
results to referring healthcare providers and patients?
-