Question: Is medical outcomes audit data collected during facility
inspections used in a national database?

Answer: No. While medical outcomes audit data is reviewed during the
inspection to assure the facility is complying with the regulations, it
is not routinely collected by FDA. FDA does not maintain nor does it
supply information to such a national database.

Question: What type of lay summary should be sent to a patient who has a
normal mammogram, but an abnormal physical exam?

Answer: The facility has a great deal of flexibility in the format and
substance of the lay summary. The lay summary must inform the patient of
the results of the mammographic examination and follow-up actions, if
needed. In the example given, the lay summary should say that the
mammogram was normal, but the patient should consult with her/his
physician because of the abnormal physical exam.

Question: Must the compression paddle be placed in the x-ray beam during
half value layer (HVL) measurements?

Answer: If the HVL measurement is being used to calculate patient dose,
the compression paddle must be placed in the x-ray beam during the
measurement. If the HVL measurement is being used for purposes other
than patient dose, the position of the paddle is not specifically stated
in the regulations. However, FDA recommends inclusion of the compression
paddle in the x-ray beam because most manufacturers have designed their
equipment to be tested in this configuration.

Question: I have a Masters/Bachelor's degree specifically [in
physics]{.underline}. Do I still need to document my number of semester
hours in physics?

Answer: If the degree is stated to be specifically [in
physics]{.underline} (or any of its sub-specialties), it will routinely
be accepted during inspections as adequate documentation of the required
number of semester hours in physics. Therefore, during routine
inspections, you will not need to provide detailed transcripts to all
the facilities where you provide physics services.

If the degree was stated to be in the more general term, physical
science, or in one of the three non-physics categories of physical
science (chemistry, radiation science, or engineering), then you will
have to provide additional documentation demonstrating compliance with
the appropriate requirement for semester hours in physics.

Question: What are the minimum tests and/or review that the medical
physicist must perform for a facility survey, survey of a mammography
unit, equipment evaluation of a unit or processor that has been
installed or disassembled and reassembled, and an equipment evaluation
of a unit or processor that has undergone a major repair?

Answer:

+----------------------------+-----------------------------------------+
| Facility Survey            | All tests as described in 900.12(e)(2), |
|                            | (e)(5), and if applicable (e)(6).       |
|                            |                                         |
|                            | Evaluate adequacy of the results of all |
|                            | tests conducted by the facility in      |
|                            | accordance with 900.12(e)(1) through    |
|                            | (e)(7)                                  |
+----------------------------+-----------------------------------------+
| Survey of a mammography    | All tests as described in 900.12(e)(2), |
| unit                       | (e)(5), and if applicable (e)(6)        |
+----------------------------+-----------------------------------------+
| Equipment evaluation of a  | All applicable tests and equipment      |
| unit or processor that has | requirements described in 900.12(b) and |
| been installed or          | (e)                                     |
| disassembled and           |                                         |
| reassembled                |                                         |
+----------------------------+-----------------------------------------+
| Equipment evaluation of a  | Only those tests and equipment          |
| unit or processor that has | requirements described in 900.12(b) and |
| undergone a major repair   | (e) that are applicable to the repaired |
|                            | component of the unit or processor. The |
|                            | decision as to what constitutes an      |
|                            | applicable test for the repaired        |
|                            | component should be made by the medical |
|                            | physicist.                              |
+----------------------------+-----------------------------------------+

Question: While performing a physics survey, unit survey, or equipment
evaluation, the medical physicist determines that the unit fails a
required test(s) and needs to be adjusted or repaired. After the
adjustment or repair has been completed, does the test(s) have to be
repeated and must the medical physicist perform the test(s)?

Answer: After the adjustment or repair has been completed, the test(s)
have to be repeated and must show that the unit is within the
appropriate action limit before it can be used on patients. As to who
must perform the test(s), if the adjustment or repair constitutes a
"major repair," then the medical physicist must repeat the test(s) as
part of the required follow-up equipment evaluation. If the adjustment
or repair [does not]{.underline} constitute a "major repair," then the
test(s) can be performed by any qualified person (e.g. radiologic
technologist or repairperson with the appropriate training/experience).
However, in this circumstance, FDA recommends, at a minimum, that the
medical physicist be consulted during this process.

Question: Our facility has permanently glued the acrylic contrast disk
to the phantom at the center of the cover plate. The regulation states
that the OD be measured at the center of the phantom which would require
our repositioning the disk (which may leave permanent artifacts) or
replacement of the phantom cover. Is there another way to leave the disk
in place and still fulfill the requirement?

Answer: For the purpose of making the density measurements, FDA
interprets the "center" of the phantom to be equivalent to measurements
taken on the center line as described later in this paragraph. As an
alternative to repositioning the disk or replacement of the phantom
cover, you may choose to keep the disk in place. Facilities may measure
the background density at a different location along the center line of
the phantom in the direction parallel to the chest wall, as long this
location does not intercept any of the phantom objects. In addition, you
must measure the background density at the same location each time the
test is conducted.

In the process of removing the disk, permanent defects may be produced
in the cover plate. Such defects may produce permanent "artifacts" in
the phantom image. As long as they do not obscure the test objects,
facilities can continue to use the phantom. The facility should not
subtract these permanent "artifacts" from the phantom score.

Question: We use the same locum tenens interpreting physician on a
[recurring]{.underline} basis throughout the year. Do we need to handle
the personnel records for this person differently from our "permanent"
interpreting physicians? Which of his/her records will be reviewed at
the time of our next inspection?

Answer: If the locum tenens interpreting physician reads for the
facility on a [recurring]{.underline} basis throughout the year, the
facility can treat this person as "permanent" for purposes of the annual
inspection. In that event, the facility has to show that this person met
all the requirements (including the continuing requirements, when
appropriate) on the date of the inspection.

If the facility considered this person "temporary" and not working at
the facility at the time of the inspection, the facility has to show
that this person met all the requirements (including the continuing
requirements, when appropriate) on each of the multiple occasions this
person started reading at the facility. For example, if the person
worked for a week at a time starting the 15th day of each month, the
facility is responsible for documenting that the person was qualified on
each of those 12 occasions. This is not as daunting a task as it first
appears. The facility has to document that the person was fully
qualified the first time he/she started working at the facility. In
addition, in each of the calendar quarters the person worked, the
facility has to document (before letting the person provide mammography
services) that the person met the continuing requirements (when
appropriate) and maintained a valid medical license.

Question: We use the same "temporary" radiologic technologist on a
[recurring]{.underline} basis throughout the year. Do we need to handle
the personnel records for this person differently from our "permanent"
radiologic technologists? Which of his/her records will be reviewed at
the time of our next inspection?

Answer: If the "temporary" radiologic technologist performs mammograms
for the facility on a [recurring]{.underline} basis throughout the year,
the facility can treat this person as "permanent" for purposes of the
annual inspection. In that event, the facility has to show that this
person met all the requirements (including the continuing requirements,
when appropriate) on the date of the inspection.

If the facility considered this person "temporary" and not working at
the facility at the time of the inspection, the facility has to show
that this person met all the requirements (including the continuing
requirements, when appropriate) on each of the multiple occasions this
person started reading at the facility. For example, if the person
worked for a week at a time starting the 15th day of each month, the
facility is responsible for documenting that the person was qualified on
each of those 12 occasions. This is not as daunting a task as it first
appears. The facility has to document that the person was fully
qualified the first time he/she started working at the facility. In
addition, in each of the calendar quarters the person worked, the
facility has to document (before letting the person provide mammography
services) that the person met the continuing requirements (when
appropriate) and maintained a valid State license or certification.

Question: Under what situations should facilities establish new
processor operating levels?

Answer: The most warranted and common situations for a facility to
establish processor operating levels are when processor QC testing is
initiated for a new processor or when a significant change is made in
the processing system, i.e., different film brand/type, different
chemical brand/type, or a change in processing conditions (standard vs.
extended).

Facilities should not use the establishment of new operating levels to
correct problems in the processing system, but should troubleshoot and
solve the problem with appropriate corrective action.

Question: During the time a facility is establishing new operating
levels (typically done by performing a five-day data plot average): A)
does the facility continue to plot the data on the processor chart? B)
Is the facility exempt from having to stay within the old processor
action limits during the five-day averaging period?

Answer: While establishing new operating levels (during which time the
facility can continue to process mammograms), the facility [must
continue to perform the daily processor QC tests]{.underline} and should
plot the data in the same manner it usually does. This may be done on
the same graph as the previous data or on a different graph. In either
event, this new data should be clearly identified as being derived
during the establishment of the new operating levels, so that both the
facility and the inspector are aware of the origins of this data.
Because no operating level has yet been established, the facility is
exempt from having to stay within any processor action limits during
this five-day averaging period.

Question: What constitutes an equipment evaluation (what tests must the
medical physicist perform) for a processor that has undergone major
repairs or is a new processor to the facility?

Answer: At a minimum, the following tests must be done for a processor
that has been replaced, undergone major repairs or is a new processor to
the facility: processor testing as described in 900.12(e)(1), phantom
testing as described in 900.12(e)(2), and system artifact evaluation as
described in 900.12(e)(5)(ix). If the major repairs or the use of the
new processor necessitates a change in clinical technique factors (for
the standard breast), that could significantly increase patient dose, a
determination of dose as described in 900.12(e)(5)(vi) must be done.

Question: Must the equipment evaluation report be sent to the facility
within 30 days?

Answer: The regulations do not specify when the equipment evaluation
report must be sent to the facility. However, the facility cannot use
the equipment until it has documentation (equipment evaluation report)
showing that the equipment passes all the appropriate tests.

Question: What assessment category should be used for post lumpectomy
patients, whose mammograms are otherwise negative?

Answer: In the case described, the results could be categorized as;
"benign." In addition, qualifying statements such as "post surgical
changes noted" may be added. The regulations require that each
mammography report contain one of the six overall assessment categories.
The decision as to which category to assign is left to the interpreting
physician.

Question: Our group practice interprets mammograms sent to us by other
facilities under a contractual arrangement. This is the only service
that we provide in the mammography area. Does my group practice need an
FDA certificate to interpret mammograms?

Answer: No. The basic requirement established by MQSA is that any
facility that produces, processes, or interprets mammograms after
October 1, 1994, must have an MQSA certificate to continue to operate
lawfully. Generally, however, where procedures such as processing and
interpretation of the films are performed in a location different from
where the mammography is performed, the facility performing the
mammography will be responsible for obtaining a certificate.

There is no mechanism at the present time for accrediting and certifying
an organization such as yours. FDA\'s policy is that partial providers,
that is, groups such as yours that provide only part of the services
required for mammography, will be certified as part of a \"system\" for
producing, processing, and interpreting mammograms.

The provider of some component of that system that performs mammography
must take the lead in obtaining a certificate. FDA expects that the
owner of an X-ray unit or units will apply for accreditation and receive
a certificate. The application for accreditation must show that all
components of the system used to produce, process, and interpret
mammograms meet the MQSA requirements. If one or more of the facilities
for which you interpret mammograms is applying for accreditation and
certification, your responsibility will be to provide them with the
information necessary to prove that the physicians in your group meet
the MQSA quality standards requirements for interpreting physicians.

When the facilities performing mammography receive their certificate,
you will be included for the purpose of interpreting mammograms for that
facility. If you interpret mammograms for several facilities, your group
will be included under several certificates. Conversely, if one of the
facilities for which you interpret mammograms is not certified, then it
would be unlawful for them to continue to produce mammograms. Although,
as mentioned, the owner of the X-ray unit(s) will probably take the lead
in obtaining the certificate in most cases, any partial provider in a
\"system\" can seek the required certificate.

Your group practice could apply for accreditation and receive the
certificate, as a part of a system. In that case, your practice would be
responsible for assuring not only that your practice meets the MQSA
quality standards for interpreters, but also that the facilities that
produce and process the mammograms for your interpretation meet the
quality standards that apply to them. Your practice would also be
responsible for passing the review of clinical images from each facility
that produces images for your interpretation, and for meeting the other
requirements for accreditation. Finally, as a certificate holder, you
would be responsible for paying an annual FDA MQSA inspection fee.

Question: The regulations at 900.12(e)(5)(i) require that an x-ray unit
pass an annual test for AEC performance over a range of 2 to 6 cm thick
absorbers. If a unit is used clinically at combinations of kVp and
filtration that include tissue thickness outside the 2 to 6 cm range,
must it meet the AEC performance requirements at the thickness' where it
operates and must it be tested at those technique factors under the
annual quality control requirements?

Answer: No, the unit is not required to meet the AEC performance
specification outside the 2 to 6 cm range and the physicist is not
required to test the AEC performance requirements for thickness\'
outside this range during the annual survey. However, we strongly
recommend that in addition to the required testing in the 2 to 6 cm
range, the unit also be tested at all clinically used thickness\'
outside this range and that the action limits specified in the
regulations be applied to the extended test.

You should note that under the Equipment Evaluation outlined at
900.12(e)(10), an evaluation of the AEC under all conditions of use is
required, not merely recommended. This is because 900.12(e)(10) mandates
conformance with all pertinent aspects of 900.12(b) and (e). Under
900.12(b)((10) the AEC is required to be "operable" under
"configurations provided." In this context, "operable" means that it
must meet the density and reproducibility requirements of (e)(5)(i)
under all clinical use situations occurring at the facility.

Question: The Bucky assembly is being replaced on our x-ray unit. Is it
necessary that the medical physicist test and pass this prior to its use
on patients?

Answer: If the installation does not involve the replacement of the AEC
detector(s) on the system, the exchange of Bucky assemblies would not be
considered a major repair and would therefore not require the medical
physicist to evaluate the assembly prior to use on patients. If however,
the replacement does include the AEC detector, the medical physicist
must evaluate the assembly prior to use on patients. There are tests
that should be performed when the bucky is replaced (table artifacts,
grid artifacts, and x-ray field/image receptor alignment), but these can
be done under the direction of the physicist and do not require his/her
evaluation prior to the next annual survey.

Question: We are a mobile facility with a van that does not have
on-board processing. We have a film-changing room on the van where we
load and unload cassettes with film during the day. When the van returns
to our main office, we batch process the films. Do we have to perform a
semiannual test for darkroom fog in this film-changing room?

Answer: Yes. Since you use a room to load and unload cassettes with
film, you must test this room for darkroom fog as well as the darkroom
for your processor. Both rooms have the potential to fog films and
degrade image quality.

Question: I have my ARRT (M) certificate. Will this certificate be
sufficient documentation to show that I have received adequate training
in breast anatomy and physiology, positioning and compression, quality
assurance/quality control techniques and imaging of patients with breast
implants as specifically spelled out in 900.12(a)(2)(ii)(A)?

Answer: Yes. The ARRT (M) certificate will be accepted as documenting
that the areas of training in breast anatomy and physiology, positioning
and compression, quality assurance/quality control techniques and
imaging of patients with breast implants have been covered.

# **Required QC Tests\* for Facilities Using Multiple Units & Screen-Film Combinations**

(11/22/99)

+-----------------------+-----------------+---------------------------+
| **Test**              | **Units         | ## S-F Combinatio         |
|                       | Tested**        | ns Tested With Each Unit  |
+-----------------------+-----------------+---------------------------+
| **Focal Spot          | All units\*\*   | For a), all S-F           |
| Condition**           |                 | combinations clinically   |
|                       |                 | used with the unit in     |
| **a) System           |                 | question.                 |
| Resolution**          |                 |                           |
|                       |                 | For b), one S-F           |
| **OR**                |                 | combination or direct     |
|                       |                 | exposure film.            |
| **b) Focal Spot       |                 |                           |
| Dimensions (up to     |                 |                           |
| 10/28/2002)**         |                 |                           |
+-----------------------+-----------------+---------------------------+
| ### Phantom Image     | All units used  | All S-F combinations      |
|                       | to image the    | clinically used for the   |
|                       | standard\*\*\*  | standard breast           |
|                       | breast          |                           |
+-----------------------+-----------------+---------------------------+
| ### Phantom Image     | All units that  | One S-F combination,      |
|                       | are used        | using clinical techniques |
|                       | [on             | that would be used for    |
|                       | ly]{.underline} | the standard breast       |
|                       | for             |                           |
|                       | non-standard    |                           |
|                       | breasts, and or |                           |
|                       | magnification   |                           |
|                       | work            |                           |
+-----------------------+-----------------+---------------------------+
| ### Dose              | All units used  | All S-F combinations      |
|                       | to image the    | clinically used for the   |
|                       | standard breast | standard breast with      |
|                       |                 | their corresponding       |
|                       |                 | techniques                |
+-----------------------+-----------------+---------------------------+
| ### Dose              | All units that  | One S-F combination,      |
|                       | are used        | using clinical techniques |
|                       | [on             | that would be used for    |
|                       | ly]{.underline} | the standard breast       |
|                       | for             |                           |
|                       | non-standard    |                           |
|                       | breasts, and or |                           |
|                       | magnification   |                           |
|                       | work            |                           |
+-----------------------+-----------------+---------------------------+
| ### Darkroom Fog      | Any unit (one   | All film types clinically |
|                       | only)           | used                      |
+-----------------------+-----------------+---------------------------+
| ### Unifo             | Any unit (one   | All clinically used       |
| rmity of Screen Speed | only)           | screens (cassettes), one  |
|                       |                 | film type                 |
| ##                    |                 |                           |
| # Screen-Film Contact |                 |                           |
+-----------------------+-----------------+---------------------------+
| **AEC Performance -   | All units       | One S-F combination       |
| Reproducibility**     |                 | (typically used with the  |
|                       |                 | unit)                     |
+-----------------------+-----------------+---------------------------+
| **AEC Performance --  | All units used  | One S-F combination       |
| kVp & Thickness       | clinically in   | (typically used with the  |
| Tracking**            | the 2-6 cm      | unit)                     |
|                       | thickness range |                           |
+-----------------------+-----------------+---------------------------+
| **Collimation**       | All units       | One S-F combination       |
|                       |                 | (typically used with the  |
| **System Artifacts**  |                 | unit)                     |
+-----------------------+-----------------+---------------------------+
| **KVp Accuracy &      | All units       | None                      |
| Reproducibility**     |                 |                           |
|                       |                 |                           |
| **Decompression**     |                 |                           |
|                       |                 |                           |
| **Radiation Output**  |                 |                           |
+-----------------------+-----------------+---------------------------+

\* This table does not cover other required QC tests that are
independent of the x-ray unit or screen-film combination, e.g., the
daily processor QC, the fixer retention, and repeat analysis.

\*\* In this table, "All units" refers to those that are used
clinically.

\*\*\* The standard breast referenced in this table is defined in the
regulations as "a 4.2 centimeter (cm) thick compressed breast consisting
of 50 percent glandular and 50 percent adipose tissue."

**Verification Testing for Items that Fail QC Tests**

Question: For repairs made in response to a failure of one \> of the QC
tests, which of the following items on the list below would be
considered a \> "major repair", and hence must be evaluated by the
medical physicist following the repair and prior to clinical use of the
equipment?

Answer: The extent to which the medical physicist must be involved in
the following repairs is summarized in the table below.

#### Item Extent of Involvement by MP

> **\> Compression device adjustment:**
>
> \> a. pressure Not required\*
>
> b\. thickness scale inaccuracy Not required
>
> \> c. repair of auto decompression aspect. Not required
>
> \>
>
> **\> Compression paddle adjustment or replacement:**
>
> \> a. for deflection problem Not required
>
> b\. for extension beyond allowable limit Oversight\*\*
>
> \> \>
>
> **\> Collimation adjustment: \>**
>
> \> extension beyond allowable limit Oversight
>
> \>
>
> **\> AEC Adjustment:**
>
> a\. thickness compensation Conduct evaluation in person
>
> b\. image mode tracking Conduct evaluation in person
>
> \> c. reproducibility Conduct evaluation in person
>
> \> d. bring down dose or decrease output Conduct evaluation in person
>
> \>
>
> **\> Artifacts caused by filter:\>**
>
> \> a. filter replacement Conduct evaluation in person \>
>
> **\> Processor artifacts:\>**
>
> \> a. roller replacement Not required
>
> b\. replenishment adjustment Not required
>
> \> \>
>
> **\> KvP adjustment** Conduct evaluation in person **\>**
>
> **\> Addition or subtraction of filtration** (HVL problem) Conduct
> evaluation in person
>
> \*not a major repair
>
> \*\*the facility must, at a minimum, consult with the medical
> physicist to determine whether this represents a major repair for the
> facility's specific unit, and how the evaluation is to be performed