Breast Imaging
Table of Contents
Page
No.
Policy
for Mammography Reports
4
Recommended
Biopsy Protocol / Medical Audit and Outcome Analysis 5
Attached: Sample Mammography Reports
Sample
Surgical Pathology Report
Sample
Letters
Policy
for Six Month Follow-up 6
Attached: Sample Mammography Report
Sample
Letters
Receptionist's
Routine for Scheduling Patients 7
Receptionist's
Instructions to Patients 8
Self
Referral Policy 9
Duties
of the First Mammography Technologist of the Day 10
Duties
of the Last Mammography Technologist of the Day 11
Patient
Reminder Card 12
Procedures
for Mammograms 13-14
The
Implant Patient 15
Credentialling for Lesion Localizations 16
Lesion
Localizations 17-18
Specimen
Radiography 19
Specimen
Radiography Technique Chart 20
Breast
Ultrasound 21
Credentialling for Cyst Aspiration 22
Cyst
Aspiration 23-24
Credentialling for Core Needle Biopsy 25
Core
Needle Biopsy (Ultrasound Guidance) 26
Core
Needle Biopsy (Stereotactic Guidance) 27-29
Core
Biopsy Results 30
Attached: Sample Reports
Galactography 31-32
PATIENT
INFORMATION:
Mammography 33-34
Microcalcifications 35
Needle Localization 36
Cyst Aspiration 37
Core Needle Biopsy 38
Image Directed Core Biopsy 39-40
Consumer Complaint Mechanism 42
Attached: Consumer Complaint Form
Infection
Control 43
Policy for Mammography Reports
1. The mammography report will be
completed within 24 hours of when the patient had her breast imaging evaluation
with few exceptions.
2. If the patient has had previous outside
films, we will still dictate a preliminary report and we will issue a complete
report when the previous films become available.
3. All mammography reports should describe
which views were performed and should also describe the type of breast parenchyma.
4. Any abnormalities of the breasts should
be clearly documented as to which breast, which clock position and how far from
the nipple it is located.
5. The radiologist should classify all
lesions into the ACR BiRADS categories of probably
benign, suspicious, or highly suggestive of malignancy.
6. The recommendation of the radiologist
should be clearly documented in the impression.
a. If
a patient is to return for a routine mammogram in a year, this should be stated
including the month and year of the next mammogram.
b. If
a six month follow-up is recommended, this should be documented also using the
month and year.
c. If
a biopsy recommendation is made, this also should be documented (see Biopsy
Recommendation Protocol).
7. A letter will be sent to the patient in
lay terms informing her of results and recommendations.
Recommended Biopsy Protocol /
Medical Audit and Outcome Analysis
1. Any patient for whom a biopsy is
recommended should have this recommendation discussed with her by the radiologist,
preferably at the time the patient is in the department. On rare occasions, the patient may have left
the department and it is the responsibility of the radiologist to contact the
patient over the phone and discuss the need for the breast biopsy.
2. All breast biopsy recommendations must
be called to the referring physician.
3. Both the fact that this was discussed
with the patient and with the referring physician should be documented in the
written report.
4. Each radiologist (or the Chief Technologist)
should keep a list of biopsy recommendations and should enter the pathology in
order to audit their "recommended biopsy" practice. This biopsy recommendation should have a
positive cancer rate which is within the standard of care in mammography.
5. The coordinator also will keep a list
of all biopsy recommendations and fills in the pathology results when they
become available. This often requires
calling the referring physicians to obtain the pathology results as some of the
patients have biopsies performed at other institutions.
6. In order to assist our coordinator with
obtaining pathology results, all mammography patients are requested to sign a
pathology report release form before the mammogram is performed.
7. The radiologist should classify lesions
according to the ACR BiRADS system. Any lesion that is either highly suspicious
for malignancy or compatible with malignancy that has not been biopsied should
be followed up by the coordinator and the radiologist by calling the referring
physician who should then, of course, contact the patient.
8. A letter may also be sent to the
referring physician regarding the need for obtaining pathology results (see
next page for attached letter).
Policy for Six Month Follow-up
1. After a proper breast imaging workup
(which includes additional views such as spot compression, spot compression
magnification, or sonography), a lesion may be placed into a six month
follow-up protocol.
2. It is the radiologist's responsibility
to communicate this recommendation to the patient, preferably while the patient
is still in the department. If the
patient has already left the department, the radiologist should call the
patient on the phone. A letter in lay
terms will also be sent to the patient.
3. The radiologist may also wish to
contact the referring physician over the phone but the referring physician will
get a copy of the written report.
4. It is the radiologist's responsibility
to document the need for six month follow-up and the fact that it was discussed
with the patient in the written report.
A patient information sticker will be placed in the six-month log
book. Additional information and
follow-up results and recommendations will be entered by the radiologist (or
the Chief Technologist) as they become available.
5. In addition, the patient will be sent a
patient reminder card through the mail approximately one month prior to the
time of the six month follow-up to remind her to schedule the appointment if
she has not already done so.
6. Our coordinator will also keep a list
of patients for six month follow-ups and if the patients do not return, she
will contact them. She will also notify
the radiologist who originally made the recommendation who will then contact
the patient's physician. A letter will
be sent to the referring physician stating that the patient did not return for
the six month follow-up (see next page for sample of letter). Sometimes, the patient will go for a six
month follow-up at another institution and, if this occurs, the coordinator
will know this by talking to the patient or the radiologist will know this by
talking to the referring physician.
7. Once the patient completes the six
month follow-up, the written report will be sent to the referring
physician. The patient will also be
instructed regarding the findings and whether or not she needs a biopsy (see
Recommended Biopsy Protocol) or whether she needs another six month follow-up.
8. Another patient reminder card will be
sent to the patient prior to the need for the next additional study.
Receptionist's Routine for Scheduling Patients
1. The
receptionist will ask:
a. Patient's history:
i. If patient has a problem, schedule as
soon as possible. Mammography
technologist will fit the appointment into the schedule.
ii. Does the patient have breast
implants? If yes, schedule patient as a
diagnostic mammogram.
b. Has patient had a previous mammogram?
c. Where?
1. CORA - our courier will pick up
2. EPRA - our courier will pick up
3. All other outside facilities, patient
is encouraged to call and arrange to pick up their films. Films are to be brought at time of
appointment.
d. When was their last mammogram done?
1. Must be at least 11 months prior unless
patient is having a problem, or a 6 month follow-up has been suggested.
e. If
the patient did not bring outside films, they must sign a consent release form
before leaving and we will send for previous films.
f. Ask for insurance information and
phone number in case of emergency.
2. Patient
preparation:
a. No deodorant or powder.
3. Scheduling
time:
a. Every fifteen (15) minutes
b. Emergency appointments added on as
needed
Receptionist's Instructions to Patients
When making appointments for mammograms, the
receptionist is to give the patient the following instructions:
1. Do
not wear any powder or deodorant for study.
2. Come
15 minutes prior to appointment time for registration.
3. Bring
last mammogram with you on day of study, if not done at AEMC.
4. Wear
two piece outfit for more comfort.
5. Bring
Doctor's note if patient has one.
6. Tell
patients to please call if they cannot keep their appointment.
7. Ask
all patients the correct spelling of their name.
8. Mammography Receptionist will be
responsible to call referring physicians for referrals if need for additional
studies. If there is a problem obtaining
a referral (document the person's full name, first and last, who you spoke to
at the referring doctor's office), the ordering radiologist will then speak
with the patient's primary physician.
NOTE:
These instructions are to be given
to the person making the appointment, whether it is the patient herself, her
physician, a nursing home, relative, etc.)
Self Referral Policy
1. A patient without a referring physician
will be referred to the
2. The patient will be examined by one of
the breast surgeons.
3. If a mammogram is needed, the surgeon
will refer the patient to the Gershon-Cohen Breast
Clinic.
Duties of the First Mammography Technologist of the Day
1. Turn on processor and water.
2. Turn on circuit breakers and machines
in each room.
3. Sign on computer - check to see if any
house patients have been ordered.
4. Test temperature in processor.
5. Develop QC film and test to make sure
processor is functioning properly to run mammogram films.
6. Clean
equipment prior to first patient and after each subsequent patient.
7. Clean
mammography cassettes.
Duties of the Last Mammography Technologist of the Day
1. Clean cassettes.
2. Prepare and stock rooms for next day.
3. Prepare work area for next day.
4. Place next day schedule on work desk
and make sure radiologist has a copy.
5. Turn off machine and turn off circuit
breakers.
6. Turn off processor and water.
Patient Reminder Card
1. This card is sent to all patients who
have a mammogram.
2. Reminder cards are submitted with films
and paper work.
3. The physician or transcriptionist
places the card into the appropriate box:
a. Annually
b. Six month follow-up
c. A
mammogram is needed at age 40
4. The coordinator collects the cards
daily and files them into the appropriate month.
5. At the end of every month, reminder
cards are sent to the patients who will need a mammogram the following month.
For Example:
At end of January, the cards for
March are sent out, allowing three to four weeks for the patients to schedule a
convenient appointment.
Procedures for Mammograms
1. Technologist greets patient and
instructs patient to change in the appropriate room and have a seat.
2. Review patient's previous films and
reports. Enter appropriate patient
information on log sheet and into mammography unit.
3. Bring patient into mammography room,
close all doors, seat patient.
4. Select correct size film holder, compression
paddle and aperture.
5. Review request form with patient, make
any necessary correction or additions.
6. Check referring physician's
prescription for appropriate exam and history.
7. Obtain history from patient, fill out
patient history sheet. This will include
information about implants.
8. All patients - when indicated -
sign release form for outside films if she did not bring them
9. Explain mammography procedure
thoroughly.
10. Do visual inspection.
11. Take views required.
12. Escort patient to changing room and
explain it will be approximately 10 minutes before films are processed and
checked by the radiologist. Ask the
patient not to get dressed.
13. Process films. While waiting for films to be processed:
a. Fill
out patient folder.
b. Fill
in technical factors, number of views taken, sign your name.
14. Check films.
15. Bring patient's folder with comparison
films and request form to the radiologist to be checked.
16. Obtain any additional films needed.
17. If ultrasound is requested by
radiologist: the technologist who
performed the mammogram will explain to the patient the reason for the
additional study and tell her she will be taken as soon as possible.
18. If patient requests to speak to the
radiologist, or the radiologist requests to speak to the patient: bring patient into mammography room, close
doors, and introduce patient to radiologist.
Stay in the room unless otherwise requested by the patient.
19. Release the patient.
20. Patient information written on log sheet:
a. Date
b. Patient
name
c. Patient
medical record number
d. Ordering
physician's name
e. Studies
done
f. Reading Radiologist's name
The Implant Patient
1. All patients will be asked by the
technologist if they have breast implants prior to their mammogram study. This information will be documented on the
patient history sheet and signed by the patient.
2. The Eklund
Technique will be used to maximize breast tissue visualization unless
contraindicated or unless modified by physician directions.
3. "ID" markers will be used for
implant displaced views.
4. All new technologists will show
documentation of implant training.
Credentialling for
Lesion Localizations
(under
Mammographic, Sonographic or Stereotactice
Guidance)
1. The radiologist must fulfill and
maintain MQSA requirements for mammography.
2. The radiologist must provide
documentation from either his/her residency or
previous job for doing at least 5 localization procedures and then may proceed
on his/her own.
3. If the radiologist is unable to provide
documentation, the Director of Breast Imaging will observe the radiologist
while he/she performs one mammographic- or stereotactic-guided
localization and one ultrasound-guided localization
prior to being able to perform them on his/her own.
4. If a radiologist has no experience with
localizations, he/she will observe a credentialled
radiologist perform one localization under ultrasound
guidance and one localization under mammographic or stereotactic
guidance. He/she will then be observed
by the Director of Breast Imaging performing one of each procedure.
5. To maintain credentialling,
at least 12 localizations per year must be performed.
6. All procedures will be reviewed for
quality assurance by the Director of Breast Imaging.
Lesion Localizations
1. If possible, review the films the night
before and decide on an approach, i.e., standard or sonographic
guidance and, if standard (using the alpha numeric grid), choose superior,
inferior, medial or lateral needle insertion.
If additional views are needed or an ultrasound has not been performed,
this decision may be deferred until the day of the localization.
2. CONSENT: Each physician may decide how they will
obtain consent. The physician needs to
be sure the patient understands the procedure and the risks involved.
3. STERILITY: The skin should be cleansed with alcohol (or
Betadine). Sterile gloves do not have to
be worn but gloves should be worn. If performing
the procedure with ultrasound guidance, the transducer should be covered with a
condom and alcohol is used as the coupling medium.
4. LOCAL ANESTHESIA: The use of local anesthesia, i.e., Lidocaine,
is up to each physician.
5. The needle is placed into the lesion
and the first views obtained. If the
needle is in proper position, the orthogonal view is obtained. It is from this view that the depth of the
needle and, therefore, the wire can be adjusted. The patient is left in compression while the
radiologist checks the films. Because
the patient is in compression, the entire team should work as quickly as
possible at this point.
6. Once the needle depth is satisfactory,
the wire is placed through the needle.
Ideally, the hook of the wire should be 1 cm distal to the lesion. A final image is obtained and the patient
taken out of compression.
7. If ultrasound guidance is used, the
needle tip can be and should be seen and should be placed 1 cm beyond the
lesion. The wire can then be placed
through the needle and the needle can be withdrawn. If one is not certain of the location of the
needle tip with respect to the lesion, the craniocaudal and true lateral views
should be obtained before placing the wire.
8. Specimen radiography should be
performed for all localized lesions unless the surgeon clearly can feel a mass
or see the abnormality (usually a carcinoma or fibroadenoma). If a lesion is not clearly noted on the
specimen radiograph, the radiologist must communicate this to the surgeon and
document it in the written report.
9. DICTATING REPORTS: The report should have a
"procedure" paragraph describing what was done and an
"interpretation" paragraph.
The interpretation section should discuss where the lesion is in
relation to the wire and the skin. A
specimen radiograph interpretation is a separate statement. The impression should simply state
"Satisfactory needle-wire location of the (size in cm) (mass,
calcification, etc.), at the (o'clock position) of (left or right)
breast." Also any complications
encountered should be included in the procedure portion of the paragraph. If no complications were encountered, this
should be stated.
An example of a report would be as
follows:
Procedure:
After sterile preparation of the
skin with alcohol and use of Lidocaine for local anesthesia, a 5 cm, 20 gauge needle was placed into the 1 cm mass at the
Interpretation:
The wire passes through the 1 cm mass
at the
The specimen radiograph confirms the
presence of the mass associated with the hookwire.
Impression:
Satisfactory
needle-wire location of the 1 cm mass at the
Specimen Radiography
This procedure must be done very quickly because the
patient is on the OR table and the surgeon cannot proceed until he/she knows
the radiologist's report of the breast specimen.
1. A breast specimen is brought to
Mammography in a plastic cup from the OR and it is also contained in a plastic
bag inside the cup. Paperwork for
Pathology will also accompany the specimen.
2. The technologist puts on gloves and
removes the specimen from the cup, a piece of wax paper is placed on the bucky tray and the specimen is placed on top of the wax
paper still enclosed in the plastic bag.
The appropriate marker "Right" or "Left" is placed
near the specimen so it will show up on the radiograph and should not be moved
until the pathologist has examined the specimen.
3. The specimen is compressed and two
films are taken. One is for the
patient's permanent Radiology file and one film is for Pathology. The film is then shown to the radiologist
with the original localization films and he/she will tell the technologist what
report to relay to the surgeon.
4. The technologist then takes the
specimen radiograph to the OR and shows it to the surgeon. If the abnormality is contained in the
specimen it is then taken to Pathology by the technologist with the specimen
radiograph and the appropriate paperwork.
If the specimen does not contain the abnormality the surgeon usually
takes another piece of tissue and the specimen radiographic procedure is
repeated.
5. Specimen radiography should be
performed for all localized lesions unless the surgeon clearly can feel a mass
or see the abnormality (usually a carcinoma or fibroadenoma). If a lesion is not clearly noted on the
specimen radiograph, the radiologist must communicate this to the surgeon and
document it in the written report.
6. See "Specimen Radiograph Technique
Chart" (next page)
Specimen Radiography Technique Chart
1. For Density or Breast Distortion:
a. Manual
b. 21 KV
c. 12 MAS (adjust according to specimen)
2. For Calcification of Breast:
a. Magnification technique, manual setting
b. Phototimed
c. 21 KV
d. 12 MAS (adjust according to specimen)
3. All
Radiographs
a. Compress specimen
b. Use appropriate compression paddle
c. Use appropriate spot aperture
d. Use appropriate focal spot
Breast Ultrasound
1. Indications for a breast ultrasound
vary depending upon the referring physician but most patients with a palpable
mass should have an ultrasound unless there is a clearly suspicious mass
compatible with carcinoma on the mammogram.
Even if this is the case, the radiologist may prefer to do an
ultrasound.
2. Breast ultrasound is not
performed as a screening procedure.
3. Breast ultrasound may be the first
study performed in young patients (approximately less than 25 years) or
pregnant or lactating patients. If the
radiologist thinks mammographic views are needed in addition, these can be
performed in this subset of patients.
4. All breast ultrasound will be performed
by the attending physician. If a
resident performs an ultrasound, this will be checked by the attending
physician.
5. All images will be labeled as follows:
a. Right
or left breast
b. Transverse
or longitudinal or diagonal imaging position
c. Clock
position
d. How far from the nipple in centimeters
6. Films should also be annotated as to
whether or not a palpable abnormality is present and to whom it is
palpable. If the area is an area of
tenderness or simply an area of concern, this should be annotated as well.
Credentialling for Cyst Aspiration
1. The radiologist must fulfill and
maintain MQSA requirements for mammography.
2. The radiologist must provide
documentation from residency or previous job for at least 5 cyst aspirations
and then may proceed on his/her own.
3. If unable to provide documentation, the
Director of Breast Imaging will observe the radiologist as he/she performs 3
cyst aspirations. Once this radiologist
is felt to be competent by the Director of Breast Imaging, he/she may perform
cyst aspirations.
4. If a radiologist has no experience with
cyst aspirations, he/she will observe a credentialled
radiologist perform one cyst aspiration and then follow #3.
5. To maintain credentialling,
at least 12 cyst aspirations per year must be performed.
6. All procedures will be reviewed for
quality assurance.
Cyst Aspiration
1. Indications
a. To
prove that a mammographic abnormality is the cyst found by ultrasound.
b. To
prove a mass that is suspected to be cyst on ultrasound but does not fulfill
the strict sonographic criteria for a cyst, is indeed a cyst.
c. At
the request of a patient or her physician either because the cyst is
uncomfortable or tender or because they are uncomfortable knowing there is a
breast mass (even after reassuring them it is a cyst and, therefore, benign).
2. Materials
Needed
a. 19 or 20 gauge spinal needle
b. 10 cc syringe
c. Extension tubing
d. 18 gauge 1 1/2 cm, 25 gauge 1 1/2 cm
needle
e. 3 cc syringe
f. Alcohol (poured over 4 x 4's),
Betadine
g. Lidocaine
h. 4 x 4 gauze pads
i. Transducer
cover (condom)
j. Gloves
k. Band-Aid
l. Sono
cassette with film
3. Procedure
a. An
image of the cyst in both the transverse and longitudinal planes with proper
annotation (what o'clock, how far from the nipple, palpable or not) must be
documented.
b. The
skin is prepped with Betadine or alcohol.
Alcohol is used as the coupling device.
c. Gel
is placed on the transducer and then a condom covers the transducer.
d. The
transducer is placed over the center of the cyst in either the longitudinal or
transverse plane. Local anesthesia is
achieved with Lidocaine by putting a small amount under the skin lined up with
the center of the transducer - 1 cm away from the edge of the transducer.
The path to the cyst can
also be anesthetized and during this one can be sure the correct path was
chosen (i.e., you should be able to see the needle - except in very dense
tissue).
e. The
aspiration needle (which has already been attached to the extension tubing - if
needed - and the syringe) is then placed into the cyst, suction is applied and
the cyst is aspirated.
f. A
post aspiration sonographic image with the needle
visualized is then taken. A mammographic
image (or both views) should be obtained if the purpose of the cyst aspiration
was to ensure that the mammographic and sonographic mass are the same.
g. If
an intracystic mass is suspected, the same amount of air as was aspirated
should be injected into the cyst cavity and a pneumocystogram
(2 mammographic views) should be obtained.
h. Once
the needle is withdrawn, the assistant will hold pressure over the location of
the previously aspirated cyst.
i. A Band-Aid can then be placed over the
site where the needle(s) was inserted.
4. Dictation
As
with any procedure, the dictation is divided into three parts:
Procedure:
The actual procedure
including the gauge of the needle and the amount aspirated should be dictated.
Interpretation:
This describes the
resolution of the mass confirmed by either using sonographic
or mammographic views.
Impression:
a. Satisfactory
aspiration of the (size in cm) cyst at (o'clock position) of the (right or
left) breast, how many cm from the nipple
OR
b. The
mass could not be aspirated. Further
evaluation with biopsy is recommended.
(Or, in some cases, a 6 month follow-up is recommended)
Credentialling for Core Needle Biopsy (CNB)
1. The radiologist must fulfill and
maintain MQSA requirements for mammography (including CME credits and minimum
mammographic interpretation).
2. For ultrasound guided core needle
biopsy, the radiologist must be competent at basic ultrasound-guided procedures
such as localization and cyst aspiration.
This competency will be judged by the Director of Breast Imaging via
direct visualization of the procedure.
Subsequently, the radiologist who is not yet credentialled
must watch another credentialled physician perform at
least one core needle biopsy or have attended a course which allows practice of
the procedure using phantoms. After
this, the radiologist must perform at least five (5) core needle biopsies (or
until he/she is felt to be competent by the Director) under supervision of the
Director of Breast Imaging.
3. For stereotactic
guided core needle biopsy, the radiologist must be credentialed in ultrasound
core biopsy and then watch at least one stereotactic
biopsy performed by a credentialed physician.
After this, the radiologist must perform at least five (5) stereotactic core needle biopsies (or until he/she is felt
to be competent by the Director) under the supervision of the Director of
Breast Imaging.
4. Once properly credentialled,
the radiologist can continue to perform procedures and will follow the core needle
biopsy protocol regarding pathology results and the communication of results to
the patient and her referring physician (see Core Needle Biopsy Protocol).
5. Any radiologist who completed a breast
imaging fellowship (six months or greater) and who performed at least
twenty-five (25) core needle biopsies during that fellowship is eligible to
perform core needle biopsies. The
Director of Breast Imaging will watch this physician perform at least one
biopsy under ultrasound (and when stereotactic
guidance becomes available, under stereotactic
guidance) to ensure quality.
6. Any radiologist who has performed core
needle biopsies at an outside institution may perform them if he/she has
performed at least 10 biopsies (documentation needed). This person will be observed performing a CNB
by the Director of Breast Imaging as a final credentialling
procedure prior to beginning on their own.
If he/she has performed less than 10 biopsies, it will be up to the
Director of Breast Imaging to decide when the physician may proceed by
him/herself after he/she has been observed performing 3 procedures.
7. After being credentialled,
the radiologist must perform at least 12 core needle biopsies per year.
8. All procedures will be reviewed for
quality assurance by the Director of Breast Imaging.
Core Needle Biopsy
(Ultrasound Guidance)
1. Indications
a. Solid
masses which do not fulfill the "probably benign" category (lobulated
or slightly irregular borders or increase in size, for example)
b. Lesions
felt to be "probably benign" but the patient is uncomfortable with
periodic 6 month follow-ups for 2-3 years
c. Suspicious
or highly suspicious lesions in patients who have seen a breast surgeon and
have discussed surgical options where the surgeon feels a core biopsy will
expedite a treatment plan and/or allow a one stage procedure
2. Contraindications
a. Suspected
radial scars
b. Palpable
lesions unless referred by a surgeon
3. Relative Contraindications /
Precautions
a. Patients
taking aspirin, coumadin, NSAIDS
b. Lesions
near chest wall or implants
4. Materials Needed
a. Betadine,
alcohol, gauze pads
b. Consent
c. Lidocaine
(with epinephrine)
d. 21
or 25 gauge needle for local anesthesia
e. BIP
gun and 14 gauge Tru-cut needle
f. Transducer
cover
g. Gloves
h. Sono cassettes
Core Needle Biopsy
(Stereotactic Guidance)
1. Indications
a. Solid
masses or calcifications which do not fulfill the "probably benign"
category.
b. Lesions
felt to be "probably benign" but the patient is uncomfortable with periodic
six month follow-ups for 2-3 years.
c. Suspicious
or highly suspicious masses or calcifications in patients who have seen a breast
surgeon and have discussed surgical options where the surgeon feels a core
biopsy will expedite a treatment plan and/or allow a one stage procedure.
2. Contraindications
a. Suspected
radial scars.
b. Palpable
lesions unless referred by a surgeon.
3. Relative Contraindications/Precautions
a. People
taking aspirin, Coumadin, NSAIDS.
b. Lesions
near the chest wall or implants.
4. Materials Needed
a. Consent.
b. Betadine
and gauze
c. Lidocaine
with epinephrine
d. Mammotome device
e. #11 blade
f. Gloves
5. Procedure
a. Arranging
the procedure
i. If the films are performed at our
institution, the patient can be scheduled assuming there are no
contraindications.
ii. If the patient has outside films, she
may be scheduled but she will be told that there is a possibility that the
abnormality may not be well suited to a stereotactic
biopsy and the procedure could be canceled.
b. Physician accreditation
i. See section entitled "Credentialling for Core Needle Biopsy"
c. Technologist
accreditation
i. The technologist must fulfill MQSA
requirements for mammography.
ii. Initial training will be performed by
the equipment manufacturer.
Subsequently, three hours of category A
continuing education in stereotactic breast biopsy
every three years is necessary.
iii. An average of at least twelve (12
biopsies per year after initial qualifications are met is necessary as per the
ACR stereotactic breast biopsy accreditation program.
d. Performing
the biopsy
i. A scout image is obtained by the
technologist. The physician will check
the scout image to determine if the abnormality is centered within the field of
view.
ii. Stereotactic
images are then obtained and the radiologist will target the abnormality.
iii. The skin is prepped with Betadine and
1% Lidocaine with epinephrine is used to anesthetize the skin. A #11 blade is then used to make a nick in
the skin through which the Mammotome probe is
inserted and pre-fire images are obtained.
The radiologist must ensure that the lesion is in the proper location
with regard to the needle tip.
iv. The Mammotome
gun is then fired and post biopsy images are obtained.
v. The radiologist will generally obtain a
minimum of twelve (12) tissue samples.
Any lesion containing calcifications will have the specimen x-rayed to
determine if calcifications are present.
vi. The lesions which contain calcifications
should be placed on a telfa pad in a line. When the specimen x-ray is obtained, the
technologist will put a metal marker on one side of the telfa
pad so that the radiologist may determine which specimens contain calcium. These specimens that do contain calcium are
to be placed in a separate container and labeled as such. The remainder of the samples will be placed
in a separate container. Both of these
containers contain formalin. The
radiologist should place each tissue sample directly into the formalin and not
leave it on the telfa pad.
vii. If a lesion is felt to be completely
removed, a sterile metal clip should be placed using the technique described in
the Mammotome Handbook. After this, stereotactic
images with the clip in place as well as a mammogram with the clip in place
should be obtained.
viii. The Mammotome
needle should be withdrawn at the end of the procedure and firm pressure should
be held over the nick in the skin until hemostasis is ensured. A gauze pressure dressing is placed over the
biopsy site and the patient is given a set of post biopsy instructions. She is told she will be called with the
results of the biopsy when they are available (usually within 48 hours).
4. Pathology Results
It is crucial that the radiologist
enter into the core needle biopsy log the patient's name and information and
the expected diagnosis. Any disconcordant results should be sent to a surgeon for an
excisional biopsy.
a. If
the results are benign and agree with the expected result, a follow-up in one
year is recommended.
b. If
the results are benign and do not correlate with the expected result, either a
six month follow-up or a repeat core needle biopsy or surgical biopsy is
recommended.
c. Any
patient with a pathology result which includes atypical ductal hyperplasia,
atypical lobular hyperplasia, or LCIS (lobular neoplasia) must be referred to a
surgeon.
d. Any
malignant result requires referral to a breast surgeon.
Core Biopsy Results
1. A patient who comes for a core needle
biopsy of the breast will have an informed written consent obtained by the
technologist or the physician performing the biopsy.
2. Once the biopsy has been performed, the
patient will be given the phone number of the
3. The patient will be told that she will
be notified (usually within two working days) of the results of the biopsy over
the phone by the radiologist.
4. The radiologist must call the patient
with the results and must also document the results in the written report.
5. Any result that is positive for
malignancy must also be called to the referring physician and this must be
documented in the written report.
6. If there is a pathology result which is
inconsistent with the expected result, the radiologist must decide with the
patient whether another core biopsy should be performed or whether a surgical
biopsy should be performed. This should
also be discussed with the referring physician.
For example, if a lesion which is felt to be suspicious for carcinoma
results in a pathology diagnosis of benign breast tissue, the patient either
needs a repeat core biopsy or surgical excisional biopsy and this must be
communicated to the patient and the referring physician.
7. A log book will be kept for all core
biopsies with the radiologist's anticipated diagnosis prior to the biopsy and
the pathology diagnosis once the biopsy has been completed. The Director of Breast Imaging will periodically
(monthly) review this log book to ensure that this process has been performed.
8. This policy also applies to fine needle
aspiration biopsies.
Galactography
1. Indications
a. Spontaneous nipple discharge of any
color
b. Bloody nipple discharge which is
spontaneous or non-spontaneous
2. Contraindications
We
will try to avoid performing ductograms on patients
who have:
a. Bilateral nipple discharge
b. Nipple discharge from multiple ducts
c. Non-spontaneous nipple discharge
3. Prior
to a ductogram, the following should be obtained:
a. Routine mammographic views
b. A true lateral view
4. Materials
Needed
a. Headlight with magnifying glass
b. 30 gauge ductogram
needle
c. Approximately 3 cc of contrast
d. Tape and alcohol wipes
5. Procedure
a. With
the patient lying supine, the radiologist should express the discharge from the
duct and then attempt to cannulate the duct after
swabbing some of the discharge with an alcohol wipe. If the duct cannot be cannulated,
it is often helpful to have the patient sit upright or to apply a warm compress
to the breast.
b. Once
the duct is cannulated, approximately 0.5 cc of
contrast is injected into the ductal system.
If resistance is felt, the radiologist should stop injecting
contrast. If it is felt that not enough
contrast has been introduced then the cannula tip can be repositioned.
c. Once
enough contrast has been introduced into the ductal system, the radiologist
should tape the cannula into the nipple and the patient should be carefully
escorted to the x-ray suite.
d. Magnification
views of the ductal system in the craniocaudal and tru
lateral positions should be obtained.
e. Once
satisfactory films have been obtained, the radiologist should remove the
cannula from the patient's nipple.
PATIENT INFORMATION
Mammography
a. What
is Mammography?
Mammography is a low-dose
x-ray examination of the breast which can detect early and high curable cancers
too small to be felt. A specially
trained mammography technologist will perform the examination. The x-ray images will be reviewed and
interpreted by a radiologist who is specially trained in breast imaging.
2. How
is Mammography Performed?
To obtain the clearest
possible images, firm pressure (compression) is applied to each breast briefly
during the mammogram. This pressure is
not harmful to your breast and allows for the use of the lowest possible amount
of radiation. Most women do not find a
mammogram painful for the short time needed to image the breast. Try to relax.
If the pressure becomes too uncomfortable, you can ask the technologist
to stop. For women who have breast
tenderness, the best time to schedule a mammogram is when your breasts are the
least tender (i.e., during the first 10 days of your cycle). It is also suggested that you take a mild analgesic
(Tylenol or Advil) before your mammogram.
3. Previous
Mammograms
If you have had previous
mammograms at another location, it is important to bring these x-ray films with
you to your appointment. Review of these
studies enables the radiologist to detect any changes that may have occurred
over time and may help avoid additional testing.
4. Preparing
For Your Exam
On the day of your
mammogram, please do not apply talcum powder or deodorant. These products can alter the quality of the
mammogram. Since you will be undressing
from the waist up, we recommend wearing a two-piece outfit.
5. Types
of Mammograms
a. Screening
Mammograms: By age 40, you should
begin having regular screening mammograms.
The screening mammogram is performed for women who are not experiencing
any breast symptoms, have no history of breast surgery, breast implants or
breast cancer. It includes two images of
each breast. One image is taken from the
side and one from the top. These are
interpreted by the radiologist after you leave the center. A written report is sent to your physician
within 7-10 days.
b. Diagnostic
Mammograms: This is a
problem-solving mammogram. If an
abnormality was seen on your screening mammogram, you will be called back to
have a diagnostic mammogram. You need to
schedule a diagnostic mammogram if you have any of the following symptoms.
1. A lump, thickening or swelling
2. Skin changes, i.e., redness, retraction
or dimpling of the skin
3. Spontaneous nipple discharge
4. History of surgery, breast cancer or
breast implants
c. Additional
mammographic views are often needed for further evaluation when you have
symptoms or if you are called back after your screening mammogram. These additional studies might include:
1. Spot compression: Used to spread out the breast tissue to
determine if the abnormality that is seen is superimposed breast tissue or an
actual lump or mass
2. Magnification view: An enlarged view of a possibly abnormal area
seen on the regular mammogram. This view
allows better visualization of an area.
3. Sonography: An ultrasound examination using sound waves
to image the breast tissue. This
technique is used to differentiate non-cancerous lumps, cysts (fluid filled
sacs) and solid tumors that might be breast cancer.
PATIENT INFORMATION
Microcalcifications
A common sign of breast disease that can be found on
a mammogram is a microcalcification (very small
calcium deposits). These are not caused
by having too much calcium in your diet.
These calcifications can be present in benign and malignant conditions
and are usually of varying shapes, frequently occur in groups or clusters. When calcifications occur in a group, a
biopsy is usually recommended. Other
calcifications are usually followed closely to watch for any pattern change or
increased amount of calcium deposits. It
is very important to return for follow-up if this is recommended for you.
PATIENT INFORMATION
Needle Localization
Your surgeon has ordered a procedure called
"needle localization" to be done prior to your breast biopsy. This is done to locate an area in your breast
to be biopsied that is seen on mammography but cannot be felt by your
doctor. The localization procedure can
be done by three different methods: stereotactic (using a computerized mammography unit),
ultrasound (using sound waves), and standard mammography. The technique used is based on what kind of
abnormality is present and where it is located in the breast. This is determined when the radiologist
reviews your films and will be explained to you on the day of surgery.
Procedure:
1. You will be positioned on a padded
examination table (ultrasound or stereotactic) or
sitting in a chair (standard mammography).
For localizations using mammography, your breast will be placed in
compression.
2. Images will be made to visualize the
area to be localized.
3. The skin is washed with an
antibacterial solution.
4. The skin is numbed with a local
anesthetic like the dentist uses.
5. A needle is placed through the numbed
area and directed toward the lesion.
This is used as a guide for the localization wire (the wire itself is
too thin to go through the skin by itself).
6. Images are made with the needle in
place. This is to determine accurate
placement o the needle.
7. The localization wire is then guided
through the needle.
8. Two final mammograms are taken to show
the wire in place. This serves as a
"road map" for your surgeon during surgery.
9. A dressing is then placed over the
wire.
The main sensations that you will feel during the
procedure will include a small needle stick and slight discomfort as the local
anesthetic is injected. This usually
lasts for about 10-15 seconds. You will
experience the feeling of pressure from the mammogram unit as well as from the
needle being placed after the skin is numb.
You may feel this sensation on the opposite side of your breast. This is normal. Let the radiologist know when you feel this
sensation.
We will try to make you as comfortable as possible
during this procedure. If you have any
questions or concerns at any time, please feel free to let us know.
PATIENT INFORMATION
Cyst Aspiration
An aspiration is a procedure that is done to remove
fluid from a cyst. Cysts are benign
(non-cancerous), fluid-filled sacs that are usually smooth, firm, moveable and
often tender.
Procedure:
1. The lump will be located by ultrasound
(sonogram) guidance
2. The skin will be cleaned with an
antibacterial solution
3. The radiologist will use a local
anesthetic (like the dentist uses) to numb the skin. You will feel a small needle stick and slight
discomfort as the anesthetic is being injected.
This usually lasts for about 15-20 seconds. Once the skin is numb, you should only feel
pressure.
4. A small needle will be inserted through
the numbed area and into the cyst. The
fluid is then drained until the cyst disappears.
5. When the needle is removed, a Band-Aid
will be applied.
PATIENT INFORMATION
Core Needle Biopsy
Your doctor has scheduled you to have a needle
biopsy at the breast center. The
following information is presented to help prepare you for this procedure. Our goal is to answer your questions and make
you as comfortable as possible during your biopsy.
After signing a consent form and receiving
"after procedure" care instructions from the nurse, you will be taken
into the room where the biopsy will be done.
Ultrasound-guided breast biopsy is performed using sound waves. The doctor will watch on a monitor as the
biopsy needle is placed in position and a tissue sample is obtained.
Procedure:
1. Your skin will be washed off with an
antibacterial solution.
2. The radiologist will use a local
anesthetic (like the dentist uses) to numb the skin.
3. A small skin incision is made where the
biopsy needle will enter the breast.
4. Five or more samples of tissue will be
taken from the area.
5. The biopsy "gun" makes a
snapping sound similar to the sound of a vaccination or ear piercing gun. We will demonstrate the sound to you. You will be told before each core of tissue
is taken so that this sound will not startle you.
6. You should feel pressure. It is important to remember not to move
during the procedure.
When the biopsy is completed, a dressing will be
placed on your breast and your post-biopsy instructions will be reviewed with
you at this time. Before leaving you
will know whether your doctor or the radiologist will be contacting you with
the results of your biopsy.
PATIENT INFORMATION
Image Directed Core Biopsy
1. What
is image directed core breast biopsy?
Image directed core breast
biopsy is a procedure using a needle to remove small amounts of tissue called
"cores" from an abnormal area in the breast. The needle is accurately guided into the area
by x-ray (stereotactic) or ultrasound (sonographic) imaging.
2. How are the needle biopsies performed?
Imaging directed breast
biopsy is an outpatient office procedure.
The stereotactic breast biopsy is done using a
specialized mammographic unit. The woman
lies on her stomach on a padded table containing an opening large enough for
her breast to fit through. The breast is
compressed as with a mammogram, but a three dimensional x-ray is taken to
exactly locate the area to be biopsied.
Local anesthesia is used to numb the breast and a special needle placed
within the abnormal area. Several pieces
of tissue, called "cores" are removed with the needle.
The ultrasound guidance
biopsy is also performed with local anesthesia but without x-ray. The woman lies comfortably on a padded table
during the biopsy. The physician can see
by ultrasound an image of the needle inside the breast and guide it to remove
tissue samples from the abnormal area.
3. How
long does it take to have an image directed biopsy?
With either technique, the
entire biopsy procedure takes about 30-45 minutes and the results are available
within 24 hours.
4. How
accurate is the image directed biopsy?
Thus far physicians have
found image directed biopsies to have the same accuracy as surgery. Several core specimens of breast tissue are
taken for microscopic analysis by a doctor (pathologist). Tissue is taken from the outer boundaries of
the abnormality as well as from the most central portion.
5. What
are the advantages of an image directed biopsy over a routine surgical biopsy?
Until recently, surgical
biopsy was the only definitive way to diagnose a breast abnormality. The surgical biopsy carries the same risk and
complications as with any other minor surgery and anesthesia. In addition, surgical biopsy may result in a
permanent scar or depression in the breast.
Image directed biopsy,
however, requires no general anesthesia, is less traumatic, and costs much less
than a surgical biopsy. In addition,
unlike some surgical biopsies, no residual scarring occurs. A woman can resume most of her normal
activities as soon as the biopsy is over.
6. Who
is a candidate for an image directed biopsy?
Image directed biopsies are
usually performed because of an abnormality found on a mammogram that cannot be
felt on a physical exam.
If an abnormality has a
greater change of being benign (non-cancerous) than malignant, the preferred
method of biopsy should be the one causing the least cosmetic change. The image directed biopsy method is the best
option.
If an abnormality requires a
large amount of tissue removal for accurate diagnosis, then a surgical biopsy
may be recommended.
Image directed biopsy may be
an alternative to having frequent medical follow-up for a breast problem that
is "being watched."
Image directed biopsy is
also quite useful when malignancy is suspected.
A tissue diagnosis can be made before surgery, treatment options
discussed and considered and, in some instances, a definitive surgical
procedure performed. Anesthesia and
surgical time can thus be reduced.
7. What
are the risks and complications of image directed biopsy?
Risk and complications of
this procedure are minimal. Some women
develop a small bruise around the biopsy site which usually disappears in one
to two weeks. Pain, if it occurs, has
been reported as minimal and lasts only a few hours. Tylenol or Advil, along with warm compress,
usually relives any minor discomfort involved.
Additionally, any time the
skin is penetrated, the risk of infection exists. However, this is only a possible complication
and, as yet, has not occurred.
8. In Summary:
Image directed core breast
biopsy is a new technique which has great promise. This non-surgical method of breast diagnosis
will improve early detection and diagnosis.
If you have additional
questions or would like to find out if you are a candidate for an image
directed biopsy, call the Gershon-Cohen Breast Clinic
any weekday between 7:30 a.m. and 3:30 p.m. at (215) 456-6253.
9. Did
You Know That . . .
35% of all breast cancers
detected in women between the ages of 40 and 49 are found by mammography
alone. As a result, despite the National
Cancer Institute's new recommendation that screening mammography not begin until age 50, we continue to adhere to the guidelines
recommending the following:
• Screening mammograms every one to two years between ages 40-49
• Mammograms yearly beginning at age 50
Breast cancers caught early offer women the best chance for
successful treatment and long term control (or even cure!). The best way to detect breast cancer early is
through a three step effort:
1) Monthly
breast self examination
2) Routine
clinical breast examinations
3) Mammography
Don't let your screening date slip by!
Mammograms save lives!
Call 215-456-6253
PATIENT INFORMATION
Consumer Complaint Mechanism
1. Definitions
a. Consumer:
patient or patient's representative
b. Adverse
event: includes but not limited to poor image quality, missed cancer,
unqualified personnel, failure to send reports within
30 days
c. Serious
adverse event: an event that significantly compromises clinical outcomes,
failure to take appropriate action in a timely fashion
d. Serious
complaint: report of a serious adverse event
2. System
for consumer complaints
a Designate a contact person: for Albert
Einstein Medical Center: Lisa Fisher; for Einstein Center One Radiology: Jill
Buckley; for Einstein Elkins Park Radiology: Leslie Velasco
b. Post
a sign in the mammography rooms for filing complaints: "We care about our patients. If you have comments and/or concerns, please
direct them to (name of contact person)."
c. Let
the consumer know how we plan to address complaints, how we will investigate
and resolve the complaint
d. We
will establish a response and contact the consumer within 30 days
e. We
will report unresolved serious complaints to our accreditation body
f. We
will provide the consumer with adequate written directions for filing with our
facility's accreditation body
g. All
records will be maintained for at least 3 years
3. Record
keeping
a. We
will keep the records for at least 3 years from the date the complaint was
received
b. We
will use a standard form for complaints:
- Name, address, and telephone number of
consumer
- Date of complaint and who was involved
- Date event occurred
- Precise description of the complaint, how
it was resolved and the date it was resolved
We will look for recurrent problems.
We will be sensitive and responsive to
language and culture.
Infection Control
1. Mammography equipment will be cleaned
after each use.
2. Disinfecting the mammography equipment
is required upon contact with blood or other potentially infectious materials
(blood, bodily fluids, and non-intact skin).
3. According to manufacturer directions,
disinfectant sprays may not be used directly since the mist which is generated
may penetrate into the unit, which may damage electronic components. The agent should first be applied to a cloth
and then apply the agent to the surfaces requiring disinfectant (compression paddles,
bucky, mag stand).
4. To clean up blood or other bodily
fluids begin by wearing clean gloves (latex or vinyl). Using a paper towel, remove the fluid and dry
the area. Place soiled paper towel in a
red bag. Next apply disinfectant (Hepacide Quat) to all
surfaces. Allow to remain on surface
according to instructions on product (10 minutes). Wipe off and then wash with clean water.
5. We will maintain documentation to show
that infection control procedures are being followed as standard operating
procedure.
6. Hand washing is the single most
important procedure for preventing transmission of infectious
microorganisms. Hand washing should be
done after:
a. Situations
during which contamination of the hands with blood or other body substances has
occurred.
b. Touching
any soiled surface
c. Removing
and disposing of gloves.
d. Using
the toilet, performing personal hygiene procedures, and before and after
consuming food.
e. Working
and performing an exam on each patient.